[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
HEARING TO REVIEW THE DEVELOPMENT OF THE 2015 DIETARY GUIDELINES FOR
AMERICANS
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 7, 2015
__________
Serial No. 114-29
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Agriculture
agriculture.house.gov
_________
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97-182 PDF WASHINGTON : 2015
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COMMITTEE ON AGRICULTURE
K. MICHAEL CONAWAY, Texas, Chairman
RANDY NEUGEBAUER, Texas, COLLIN C. PETERSON, Minnesota,
Vice Chairman Ranking Minority Member
BOB GOODLATTE, Virginia DAVID SCOTT, Georgia
FRANK D. LUCAS, Oklahoma JIM COSTA, California
STEVE KING, Iowa TIMOTHY J. WALZ, Minnesota
MIKE ROGERS, Alabama MARCIA L. FUDGE, Ohio
GLENN THOMPSON, Pennsylvania JAMES P. McGOVERN, Massachusetts
BOB GIBBS, Ohio SUZAN K. DelBENE, Washington
AUSTIN SCOTT, Georgia FILEMON VELA, Texas
ERIC A. ``RICK'' CRAWFORD, Arkansas MICHELLE LUJAN GRISHAM, New Mexico
SCOTT DesJARLAIS, Tennessee ANN M. KUSTER, New Hampshire
CHRISTOPHER P. GIBSON, New York RICHARD M. NOLAN, Minnesota
VICKY HARTZLER, Missouri CHERI BUSTOS, Illinois
DAN BENISHEK, Michigan SEAN PATRICK MALONEY, New York
JEFF DENHAM, California ANN KIRKPATRICK, Arizona
DOUG LaMALFA, California PETE AGUILAR, California
RODNEY DAVIS, Illinois STACEY E. PLASKETT, Virgin Islands
TED S. YOHO, Florida ALMA S. ADAMS, North Carolina
JACKIE WALORSKI, Indiana GWEN GRAHAM, Florida
RICK W. ALLEN, Georgia BRAD ASHFORD, Nebraska
MIKE BOST, Illinois
DAVID ROUZER, North Carolina
RALPH LEE ABRAHAM, Louisiana
JOHN R. MOOLENAAR, Michigan
DAN NEWHOUSE, Washington
TRENT KELLY, Mississippi
______
Scott C. Graves, Staff Director
Robert L. Larew, Minority Staff Director
(ii)
C O N T E N T S
----------
Page
Conaway, Hon. K. Michael, a Representative in Congress from
Texas, opening statement....................................... 1
Prepared statement........................................... 3
Hartzler, Hon. Vicky, a Representative in Congress from Missouri,
submitted report............................................... 61
Lujan Grisham, Hon. Michelle, a Representative in Congress from
New Mexico, submitted statements............................... 70
McGovern, Hon. James P., a Representative in Congress from
Massachusetts, submitted article............................... 70
Peterson, Hon. Collin C., a Representative in Congress from
Minnesota, opening statement................................... 4
Submitted article............................................ 55
Witnesses
Burwell, Hon. Sylvia M., Secretary, U.S. Department of Health and
Human Services, Washington, D.C................................ 5
Prepared statement........................................... 6
Submitted joint questions.................................... 127
Submitted questions.......................................... 139
Vilsack, Hon. Thomas ``Tom'' J., Secretary, U.S. Department of
Agriculture, Washington, D.C................................... 8
Prepared statement........................................... 9
Submitted joint questions.................................... 127
Submitted questions.......................................... 139
Submitted Material
Archer, Ph.D., M.S., Edward, NIH/NIDDK Research Fellow, Nutrition
Obesity Research Center, University of Alabama at Birmingham,
submitted statement............................................ 73
Campagna, Shannon, Director, Federal Government Affairs, Mars,
Incorporated, submitted letter................................. 102
Schoenfeld, M.S., R.D., Pamela, Executive Director; Adele Hite,
M.P.H., R.D., Public Policy Advisor, Healthy Nation Coalition,
submitted letter............................................... 106
Teicholz, Nina, Author, The Big Fat Surprise: Why Butter, Meat
and Cheese Belong in a Healthy Diet, submitted statement....... 110
Wilcox, Kristin Pearson, Vice President of Government Relations,
International Bottled Water Association, submitted letter...... 117
Grain Chain,* submitted letter................................... 119
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* American Bakers Association; American Institute of Baking
International Grain Foods Foundation; Independent Bakers Association;
National Association of Wheat Growers; National Pasta Association;
North American Millers' Association; Retail Bakers of America; USA Rice
Federation; Wheat Foods Council.
HEARING TO REVIEW THE DEVELOPMENT OF THE 2015 DIETARY GUIDELINES FOR
AMERICANS
----------
WEDNESDAY, OCTOBER 7, 2015
House of Representatives,
Committee on Agriculture,
Washington, D.C.
The Committee met, pursuant to call, at 8:59 a.m., in Room
1300 of the Longworth House Office Building, Hon. K. Michael
Conaway [Chairman of the Committee] presiding.
Members present: Representatives Conaway, Neugebauer,
Lucas, King, Rogers, Thompson, Gibbs, Austin Scott of Georgia,
Crawford, DesJarlais, Gibson, Hartzler, Benishek, LaMalfa,
Davis, Yoho, Allen, Rouzer, Abraham, Moolenaar, Newhouse,
Kelly, Peterson, David Scott of Georgia, Costa, Walz, Fudge,
McGovern, DelBene, Kuster, Nolan, Maloney, Kirkpatrick,
Aguilar, Plaskett, Adams, Graham, and Ashford.
Staff present: Anne DeCesaro, Callie McAdams, Haley Graves,
John Goldberg, Mary Nowak, Mollie Wilken, Scott C. Graves,
Stephanie Addison, Faisal Siddiqui, Lisa Shelton, Liz
Friedlander, Mary Knigge, Mike Stranz, and Nicole Scott.
OPENING STATEMENT OF HON. K. MICHAEL CONAWAY, A REPRESENTATIVE
IN CONGRESS FROM TEXAS
The Chairman. Well, good morning. Let us go ahead and get
started. Mr. Kelly, would you open us with a prayer, please?
Mr. Kelly. Dear Heavenly Father, we just ask that you bless
this Committee. We ask that you bless this government. We ask
that you bless all those who lead this great nation. Dear Lord,
we just ask that everything we do honor and please you. In
Jesus's name I pray, amen.
The Chairman. Thank you, Trent. This hearing of the
Committee of Agriculture regarding the review of the
development of the 2015 Dietary Guidelines for Americans, will
come to order. I want to thank our witnesses for being here
this morning. It is no small feat to get the Secretaries of two
of the most important agencies of government to come sit at the
same table at the same time, and so I thank you, Secretary
Vilsack, Secretary Burwell, for making this happen. We
certainly appreciate it.
We are joined today by the Secretary of Agriculture and the
Secretary of Health and Human Services to discuss development
of an important document: The 2015 Dietary Guidelines for
Americans. It is not this Committee's intention to legislate
specific recommendations or guidelines, however we will demand
that the guidelines be developed in a transparent and objective
manner. The DGA is not only a recommendation to the American
people on how to make healthy food purchasing decisions to live
a healthy lifestyle, but it also forms the basis of Federal
nutrition policy, education, outreach efforts used by
consumers, industry, nutrition educators, and health care
professionals.
It is essential that the guidance that comes out of this
process can be trusted by the American people. To achieve this,
it must be based on sound, consistent, and irrefutable science.
The DGA is Congressionally mandated under the National
Nutrition Monitoring and Related Research Act of 1990.
According to the Act, the DGA shall contain nutritional and
dietary information and guidelines for the general public,
shall be ``based on the preponderance of the scientific and
medical knowledge current at the time the report is prepared'',
and ``shall be promoted by each Federal agency in carrying out
any Federal food, nutrition, or health program''. Ensuring a
sound development process is important because it is extremely
difficult to reverse or change public policy once implemented
without causing consumer confusion. At a time when consumers
are already subjected to conflicting, and often contradictory,
nutrition and health information, staying within the scope of
the intent of the law by providing the public with science-
based realistic and achievable information is more likely to
improve public health outcomes.
The process of the 2015 DGA began in 2012, when Secretary
Vilsack and Secretary Burwell's predecessor, Secretary
Sebelius, created, and then appointed, the 15 members to the
Dietary Guidelines Advisory Committee. Though this committee is
not specifically authorized, it was chartered under the Federal
Advisory Committee Act, which requires that the advice rendered
by the Committee be ``objective and accessible to the public''
by formalizing the process for ``establishing, operating,
overseeing, and terminating'' the committees. This makes the
committee solely responsible to USDA and HHS, who are then
responsible for continually reviewing the committee's
performance and process compliance, which include activities as
detailed as approving all of the meeting agendas. It is
therefore the responsibility of USDA and HHS to maintain
control over the scope and methods used by DGAC.
I personally weighed in with both of you, as have many of
my colleagues, about our concerns with the process of
developing the guidelines. I raised concerns about the
committee's report shortly after its release, and called on you
to extend the public comment period, which you did, and I
appreciate that very much. USDA and HHS received over 29,000
public comments to the committee's report, many of which were
developed by nutritionists and other experts in the study of
human health. Included in their submitted comments, available
for public viewing on DGA's website, were scientific studies
and other evidence that observers assert had been ignored by
the committee. As a result, I repeatedly requested that each
and every comment be considered by USDA and HHS before the
final guidelines are published.
In May the Ranking Member and I sought, in writing, details
on your plan to review the more than 29,000 comments, and to
make sure that they were viewed properly. You response to us on
that plan, though, was less than sufficient, so I look forward
to hearing more today on this matter.
Uncertainty in the process leads to concern about whether
the committee's recommendations will maintain the scientific
integrity necessary to be actionable by Americans. It is my
hope that as USDA and HHS review of the 2015 recommendations,
that in that review they are mindful of the process failures
that lie squarely between each of the recommendations. It is
imperative to hear assurances from each of you that Americans
were ultimately presented with the best and most reliable
information for making healthy food and beverage choices.
Again, thank you, Secretary Vilsack and Secretary Burwell
for being with us today, and I look forward to our
conversation.
[The prepared statement of Mr. Conaway follows:]
Prepared Statement of Hon. K. Michael Conaway, a Representative in
Congress from Texas
I want to welcome our distinguished witnesses to today's hearing
and thank them for taking the time to be with us. We are joined by both
the Secretary of Agriculture and the Secretary of Health and Human
Services to discuss the development of an important document: The 2015
Dietary Guidelines for Americans (DGA).
It is not this Committee's intention to legislate specific
recommendations or guidelines; however we will demand that the
guidelines be developed in a transparent and objective manner.
The DGA is not only a recommendation to the American people on how
to make healthy food purchasing decisions in order to live a healthy
lifestyle, but it also forms the basis of Federal nutrition policy,
education, and outreach efforts used by consumers, industry, nutrition
educators, and health professionals. It is essential that the guidance
that comes out of this process can be trusted by the American people.
To achieve this, it must be based on sound, consistent, and irrefutable
science.
The DGA is Congressionally mandated under the National Nutrition
Monitoring and Related Research Act of 1990. According to the Act, the
DGA shall contain nutritional and dietary information and guidelines
for the general public; shall be ``based on the preponderance of the
scientific and medical knowledge current at the time the report is
prepared''; and ``shall be promoted by each Federal agency in carrying
out any Federal food, nutrition, or health program.''
Ensuring a sound development process is important because it is
extremely difficult to reverse or change public policy, once
implemented, without causing consumer confusion. At a time when
consumers are already subjected to conflicting and often contradictory
nutrition and health information, staying within scope of the intent of
the law by providing the public with science-based, realistic and
achievable information is more likely to contribute to improved public
health outcomes.
The process for the 2015 DGA began in 2012, when Secretary Vilsack
and Secretary Burwell's predecessor, Secretary Sebelius, created and
then appointed fifteen members to the Dietary Guidelines Advisory
Committee (DGAC). Though the DGAC is not specifically authorized, all
advisory committees must be charted under the Federal Advisory
Committee Act which requires that the advice rendered by the committee
be ``objective and accessible to the public'' by formalizing the
process for ``establishing, operating, overseeing, and terminating''
the committees. This makes the DGAC solely accountable to USDA and HHS,
who are then responsible for continually reviewing the DGAC's
performance and process compliance, which included activities as
detailed as approving all DGAC meeting agendas. It was therefore the
responsibility of USDA and HHS to maintain control over the scope and
methods used by DGAC.
I have personally weighed in with you both, as have many of my
colleagues, about my concerns with the process of developing the
Dietary Guidelines. I raised concerns about the DGAC report shortly
after its release and called on you to extend the public comment
period, which you did.
As we are all aware of by now, USDA and HHS received over 29,000
public comments to the DGAC report, many of which were developed by
nutritionists and other experts in the study of human health. Included
in their submitted comments, available for public viewing on the DGA's
website, were scientific studies and other evidence that observers
assert had been ignored by the DGAC. As a result, I repeatedly
requested that each and every comment be considered by USDA and HHS
before the final Dietary Guidelines are published.
In May, the Ranking Member and I sought, in writing, details on
your plan to review the more than 29,000 public comments because public
comments do matter. Your response to us on that plan was less than
sufficient so I look forward to hearing more from you today.
Uncertainty in the process leads to concern about whether the DGAC
recommendations will maintain the scientific integrity necessary to be
actionable by Americans. It is my hope that as USDA and HHS review the
2015 DGAC recommendations, they are mindful of the process failures
that lie squarely behind each of DGAC's recommendations. It is
imperative to hear assurances from USDA and HHS that Americans will
ultimately be presented with the best and most reliable information for
making healthy food and beverage choices.
Again, thank you Secretary Vilsack and Secretary Burwell for being
here today, I look forward to our conversation.
The Chairman. Are there any opening comments from the
Ranking Member?
OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE
IN CONGRESS FROM MINNESOTA
Mr. Peterson. Thank you, Mr. Chairman, and I welcome both
Secretary Burwell and Secretary Vilsack to the Committee, and I
look forward to your testimony. Given that USDA and HHS are
still reviewing comments, we are probably getting ahead of
ourselves here, but I do hope that today's testimony can shed
more light on the process to establish new guidelines, and what
they will actually mean for our constituents. There has been a
strong reaction to the Dietary Guidelines Advisory Committee
report. I have heard concerns about future sodium targets,
difficulties of small schools meeting the guidelines, and what
this could mean for cranberries and sugar. But these are mostly
coming from those who are directly impacted, industries,
schools, and the medical community. We are not really hearing
from the public.
I don't think the general public is paying much attention.
For those who are, I think they are very skeptical of the whole
process. For example, we were once told that butter and eggs
were bad for you. Now I guess they are okay. According to the
Washington Post this morning, they were wrong on milk as well,
and I don't know how much government subsidized powder we
bought because of it. So people may be losing confidence in
these guidelines. Given the public skepticism, maybe we should
reconsider why we are doing this. Is it because it is something
that we have always done? We may wish, at first look, to expand
on a provision in the 2008 Farm Bill that would help us
understand more about what people are actually eating, and then
go from there.
I am a little concerned that we have lost sight of what we
are doing, and we seem to be more focused on ideology and
marketing food products than providing clear nutrition advice
to the general public. But I do hope we can have a productive
hearing and achieve a good outcome. I know you are going to do
the best that you can breaking through all this noise, and I
thank the Secretaries for appearing before us today, and I
yield back.
The Chairman. I thank the gentleman. I would like to inform
my colleagues that Ms. Burwell has a hard stop at 11:30. She
has an international flight to catch. And so, with that, I
don't know who wants to go first. Secretary Burwell?
Secretary Burwell. I would be happy to, yes.
The Chairman. Okay.
STATEMENT OF HON. SYLVIA M. BURWELL, SECRETARY, U.S. DEPARTMENT
OF HEALTH AND HUMAN SERVICES,
WASHINGTON, D.C.
Secretary Burwell. Good morning. Thank you, Mr. Chairman,
and Ranking Member Peterson, as well as Members of the
Committee, for the opportunity to discuss the Dietary
Guidelines. I want to begin by thanking the Committee for your
interest in the Dietary Guidelines, and for your work to
support Americans, and a healthy agriculture sector.
One of the most important responsibilities that our
government is entrusted with is protecting the American public,
and that includes empowering them with the tools they need to
make educated health decisions. Since 1980, families across the
nation have looked to the Departments of Health and Human
Services and Agriculture for science-based Dietary Guidelines
to serve as a framework for nutritious eating and healthy
lives. Our guidelines also help lay a foundation for preventing
diet-related health conditions, like obesity, diabetes, and
heart disease.
As is required by the National Nutrition Monitoring and
Related Research Act, the Departments update these regulations
and guidelines every 5 years. The key elements that make up a
healthy lifestyle remain consistent, fruits and vegetables,
grains and lean proteins, and limited amounts of saturated
fats, added sugars, and sodium. We anticipate these will
continue to be the building blocks of the 2015 guidelines,
updated to reflect the latest research in science, as well as
our current understanding of the connections between food and
health. As part of our effort to rely on the best science
available, we have appointed an independent Advisory Committee
of nutrition and medical experts and practitioners to inform
each addition. The 2015 Advisory Committee evaluated research,
and considered comments from the public to develop
recommendations included in its finished report.
It is important to note that the Advisory Committee report
is one input into the Dietary Guidelines. The guidelines
themselves are written and reviewed by experts at both of our
Departments. In addition to the recommendations of the Advisory
Committee, our Department's experts perform their own extensive
review and consideration of public comments. In fact, as was
mentioned, we received 29,000 written comments during the 75
day public comment period. As a result, the 2015 Dietary
Guidelines will be informed by a review of thousands of
scientific papers, and decades of nutrition and medical
research, as well as input from the public.
We know that the guidelines are of critical importance to
many Americans. They contribute to a culture of wellness, and
empower individuals to better manage their own health, help
keep their families healthy, reduce the onset of disease, and
reduce the amount of money that we spend on healthcare. They
also provide guidance to public and private programs, and
support efforts to help our nation reach its highest standard
of health. At HHS, the Dietary Guidelines provide a roadmap for
the nutrition advice, and services that we deliver, such as
chronic disease prevention efforts, food assistance programs,
and educational initiatives.
HHS and USDA are working together to finalize the 2015
Dietary Guidelines, which are expected to be completed in
December of this year. Without a finished product, I am unable
to comment on the final content of the forthcoming edition at
this time. I expect, however, that the new guidelines will
continue to emphasize the importance of healthy eating habits
and individual food choices. I want to thank you again for your
interest in this topic, as well as the feedback that we have
received. I know many of you have specific questions and
concerns, and I want to assure you that we are taking your
concerns into consideration. And we are working hard to answer
your questions as thoroughly as we can as we are in the process
of doing the guidelines. I look forward to continuing to work
together, and look forward to your questions today. Thank you.
[The prepared statement of Ms. Burwell follows:]
Prepared Statement of Hon. Sylvia M. Burwell, Secretary, U.S.
Department of Health and Human Services, Washington, D.C.
Chairman Conaway, Ranking Member Peterson, and Members of the
Committee, thank you for the opportunity to discuss the Dietary
Guidelines for Americans (Dietary Guidelines).
I want to begin by thanking Members of this Committee for your
interest in the Dietary Guidelines and, more broadly, for your work to
support Americans and a healthy agricultural sector. The Dietary
Guidelines are a critical science-based initiative drafted by experts
at the Departments of Agriculture and Health and Human Services that
gives Americans advice on building healthy eating patterns that can
help prevent chronic diseases and promote the health and well-being of
our nation. I want to emphasize that the focus of the Dietary
Guidelines is on preventing diet-related health conditions, such as
obesity, diabetes, and heart disease, rather than treating these and
other diseases. The Dietary Guidelines are one part of a larger effort
to help lower disease rates in the United States and give every
American the tools they need to live healthy and productive lives.
History
The Dietary Guidelines are required under the 1990 National
Nutrition Monitoring and Related Research Act, which directs the
Departments of Health and Human Services (HHS) and Agriculture (USDA)
to publish a report entitled ``Dietary Guidelines for Americans'' at
least every 5 years. By law, each edition of the Dietary Guidelines
includes ``nutritional and dietary information and guidelines for the
general public . . . .'' The law also states that the Dietary
Guidelines should ``be promoted by each Federal agency in carrying out
any Federal food, nutrition, or health program.'' In our development of
these Guidelines, we follow this statute to guide the scope of our
work.
Historically, the Key Recommendations of the Dietary Guidelines
have not changed substantially from one edition to the next. Elements
of healthy eating patterns continue to include fruits, vegetables,
grains, dairy, and protein-rich foods such as lean meats and seafood,
and limit components like saturated fats, added sugars, and sodium. The
guidelines provide a science-based framework for policy makers,
nutrition educators, and healthcare providers to include nutrition as
part of an overall prevention strategy for lowering rate of disease.
The guidelines also help Americans make healthy food choices, enjoy
food, and celebrate personal culture through food, all of which are
important to Americans.
Development
HHS and USDA strive to develop Dietary Guidelines recommendations
that are based on the strongest available scientific evidence and
represent our current understanding of the connections between food and
health. One of the ways that we achieve this goal is by appointing a
Dietary Guidelines Advisory Committee (Advisory Committee). The
Advisory Committee is an independent group of experts and practitioners
in the fields of nutrition and medicine that is voluntary and solely
advisory, and although their work informs the government's work, they
are not directly involved in the Departments' development of the
Dietary Guidelines. It develops a scientific report and recommendations
to inform each edition of the Dietary Guidelines. The use of an
Advisory Committee is a best practice to ensure that the Federal
Government is obtaining sound, external scientific advice to inform
policy decisions. Advisory Committees have been used to inform the
development of the Dietary Guidelines since the 1985 edition.
The 2015 Advisory Committee used state-of-the-art standards to
develop its scientific recommendations to the Federal Government, which
were delivered to HHS and USDA in its Advisory Report in February 2015.
In addition to drawing on the expertise of the Committee members, the
Advisory Committee also received both written and oral public comments
over the course of its work. These comments helped ensure that the
Committee discussed topics and issues of interest to the public and
received evidence to consider in the scientific process.
The work of the Advisory Committee informs HHS and USDA's
development of the Dietary Guidelines; however, the Advisory Report is
only one component that the Departments consider when developing each
edition of the guidelines. The Guidelines themselves are written and
reviewed by the experts at our Departments and ultimately by Secretary
Vilsack and me. In addition to the Advisory Committee's report, HHS and
USDA consider public comments on the Advisory Report and look to
Federal agencies with expertise in nutrition to review both the
Advisory Report and the draft policy before Secretary Vilsack and I
approve it.
We recognize that the Advisory Report addressed many issues about
which nutrition and agricultural stakeholders care deeply. We received
over 29,000 written comments during the 75 day public comment period on
the Advisory Report, as well as 73 oral comments during a March 2015
public meeting. This demonstrates public interest and concern about
information in the Dietary Guidelines. In response to the high level of
interest and Congressional requests, HHS and USDA extended the public
comment period by 30 days to accommodate a high volume of public
comment submissions and ensure we were able to take the public's input
into account. These comments have been fully reviewed by staff within
our Departments and are being considered in the development of the 2015
Dietary Guidelines. While all public comments are reviewed, in order to
ensure the Dietary Guidelines are based on sound science, the
Departments focus heavily on public comments that include scientific
justification.
As a result, the 2015 Dietary Guidelines will be informed by a
review of thousands of scientific papers and decades of nutrition and
medical research, as well as significant input from the public. The
Guidelines will translate this science into succinct, food-based
guidance that Americans can rely on for choosing a healthy diet.
Impact
The 2015 edition of the Dietary Guidelines will build on this
strong scientific foundation to continue to provide guidance to help
encourage more healthy food choices across our nation. As Members of
this Committee know, this issue is of critical importance. We must
strive, together, to prevent nutrition-related disease and improve the
health of American families and communities.
The Dietary Guidelines are one of numerous important Federal policy
initiatives that aim to help Americans reach their highest standard of
health. For more than 25 years, over \1/2\ of our adult population has
been overweight or obese. Today, about \1/2\ of all American adults
have one or more preventable chronic diseases, which are attributable
to several causes, including poor-quality diet and physical activity
behaviors. All sectors of society play an integral part in contributing
to a culture in the United States that champions wellness and empowers
all people to achieve their highest standard of health. The Dietary
Guidelines provide the framework for not only the Federal Government
but also for other sectors of influence, including other policymakers,
health professionals, etc. who can apply the Guidelines in a multitude
of ways with the potential to lower nutrition-related disease rates.
At HHS, the Dietary Guidelines for Americans provide a roadmap for
the nutrition advice and services that we deliver to the public through
chronic disease prevention efforts, food assistance programs, and
educational initiatives. Examples include the Older Americans Act
Nutrition Services Programs and Head Start. The Guidelines are also
used to inform national disease prevention and health promotion
objectives related to nutrition and weight status, primarily through
Healthy People 2020. CDC's prevention campaigns, NIH's lifestyle
guidance, and FDA's Nutrition Facts Label regulations consider the
nutrition information in the Dietary Guidelines. As in the past, the
2015 edition of the Dietary Guidelines will help focus our resources on
efforts that have the greatest positive impact on health outcomes.
Dietary Guidelines for Americans, 2015
HHS and USDA are working together to finalize the 2015 Dietary
Guidelines, which are expected to be completed in December of this
year. We will conduct several layers of scientific review prior to
preparing a draft for final approval, which has not yet occurred. As
such, I am unable to comment on the final content of the forthcoming
edition of the Dietary Guidelines at this time. However, I expect the
new Dietary Guidelines will continue to focus on food-based
recommendations that emphasize the importance of consuming a total
``healthy eating pattern'' over time while recognizing the importance
of individual choices.
Closing
Again, thank you, Chairman Conaway, Ranking Member Peterson, and
Members of the Committee for this opportunity to discuss the Dietary
Guidelines and for your interest in this important topic. I am looking
forward to continuing our partnership so that together we can ensure
that every American has access to the building blocks of healthy and
productive lives. I am happy to answer your questions.
The Chairman. Thank you, Secretary. Secretary Vilsack?
STATEMENT OF HON. THOMAS ``TOM'' J. VILSACK, SECRETARY, U.S.
DEPARTMENT OF AGRICULTURE, WASHINGTON, D.C.
Secretary Vilsack. Thank you, Mr. Chairman, Ranking Member
Peterson, and all of the Members of this Committee, I want to
thank the Chairman for the opportunity to be here today, and I
want to thank my colleague, Sylvia Burwell, for the
extraordinary work that she and her team have done, in concert
with the Department of Agriculture, in getting us to this point
today.
I will tell you that I struggle with the Dietary
Guidelines, because it is important for people to understand
precisely what they are and what they are not. These guidelines
are a set of recommendations based on a series of well-informed
opinions that create a framework that is designed to encourage
and to educate Americans about what they can do to increase
their chances of preventing chronic diseases. This is not about
treating disease. This is about trying to prevent chronic
diseases.
As a result, the guidelines that we formulate are, and
should be, restricted, by law, to nutritional and dietary
information. The Advisory Committee report, which Secretary
Burwell mentioned, is not the guidelines, and sometimes there
is confusion about that. The report informs our work, but
certainly does not, and should not, dictate it. Only HHS and
USDA can, and should, write the guidelines, based on a variety
of inputs. This has been an open and transparent process.
Questions were posed by and to the Advisory Committee. A number
of studies, indeed thousands of studies, and tens of thousands
of pages of documents, were reviewed. Those reviews went
through a very strict and gold standard process for determining
what is the strongest, best, and most available science.
Multiple public meetings took place. Information was posted on
the web, and we indeed received 29,000 comments as a result of
the extended comment period, of which 8,000 comments are
probably considered unique.
I recognize that our process here is to determine the best
available science, and, based on that, and the preponderance of
that, we formulate the guidelines. I believe I have the same
goal that Secretary Burwell has, which is to finish our work on
time, before the end of the year, so that we can use these
guidelines, as directed by Congress. So I too look forward to
your comments and questions, and this hearing is an important
opportunity for us to educate folks about what these guidelines
are and what they are not.
[The prepared statement of Mr. Vilsack follows:]
Prepared Statement of Hon. Thomas ``Tom'' J. Vilsack, Secretary, U.S.
Department of Agriculture, Washington, D.C.
Chairman Conaway, Ranking Member Peterson, and Members of the
Committee, thank you for the opportunity to discuss the Dietary
Guidelines for Americans with you. I know it is important to all of us
that the Department of Health and Human Services (HHS) and Department
of Agriculture (USDA) deliver on our Congressional mandate.
The Dietary Guidelines are focused on promoting health and
preventing disease by providing food-based recommendations on diet and
nutrition. The Guidelines form the cornerstone for all Federal
nutrition programs. Over the years, they have also become an important
resource for policy makers, nutrition educators, health professionals,
and industry. What unites us all is the shared appreciation for the
importance of nutrition in helping to prevent chronic diseases such as
cardiovascular disease, high blood pressure, type 2 diabetes, diet-
related cancers, and obesity--and the knowledge that too many Americans
suffer from these preventable diet-related diseases.
It is important to note that the Dietary Guidelines are intended to
prevent these diet-related conditions, not to treat them. The
recommendations apply to individuals 2 years of age and older who are
healthy or at increased risk of chronic disease, not those with medical
conditions or special dietary needs. Dietary recommendations for
specific populations that suffer from various conditions are likely to
differ from those recommended by the Dietary Guidelines.
HHS and USDA currently are working together to develop the eighth
edition of the Dietary Guidelines, which is scheduled to be released by
the end of this calendar year.
Background
HHS and USDA have jointly published the Dietary Guidelines every 5
years since 1980, even before it was required by statute. The 1990
National Nutrition Monitoring and Related Research Act now directs HHS
and USDA to publish the Dietary Guidelines at least every 5 years. The
Congressional mandate states that the Dietary Guidelines ``shall
contain nutritional and dietary information and guidelines for the
general public, and shall be promoted by each Federal agency in
carrying out any Federal food, nutrition, or health program.'' The law
also requires that each edition of the Dietary Guidelines ``shall be
based on the preponderance of the scientific and medical knowledge
which is current at the time the report is prepared.''
Since the 1985 edition of the Dietary Guidelines, the Secretaries
of HHS and USDA have appointed an external, independent group of
experts and practitioners in the fields of nutrition and medicine to
provide independent, science-based advice and recommendations to the
Departments as we develop the Dietary Guidelines. Each Dietary
Guidelines Advisory Committee is compliant with the Federal Advisory
Committee Act, serves in a voluntary and advisory role only, and
submits a report of scientific recommendations to the Federal
Government. The Advisory Committee does not develop the Dietary
Guidelines; that is the role of HHS and USDA, and the recommendations
we receive from the Advisory Committee inform our work.
External Scientific Evidence Review Prior to HHS-USDA Dietary
Guidelines Development
The 2015 Advisory Committee was charged with reviewing the 2010
Dietary Guidelines and reviewing the current state of scientific
evidence on nutrition and health to develop food-based recommendations
of public health importance for Americans ages 2 years and older. Their
recommendations were outlined in the Scientific Report of the Dietary
Guidelines Advisory Committee, submitted to HHS and USDA in February
2015.
The Advisory Committee conducted comprehensive and rigorous
systematic reviews of scientific evidence on food, nutrition, and
health using state-of-the-art standards to develop its Scientific
Advisory Report. The Committee formulated and addressed more than 80
scientific questions using: (1) original systematic reviews conducted
through USDA's Nutrition Evidence Library (NEL); (2) existing high-
quality systematic reviews, meta-analyses, and reports from the
scientific community; (3) data analyses; and (4) food pattern modeling
analyses. These four approaches contribute to a comprehensive body of
scientific evidence upon which the Federal Government can develop
policy.
It is worth noting that systematic reviews were used to examine the
majority of the scientific evidence in diet and health. Considered the
gold standard and standard practice for more than 25 years in the
medical field, systematic reviews are relied upon to inform the
development of national guidelines for use by research and health
professionals. The NEL, developed in consultation with leaders in the
systematic review community such as the highly respected Cochrane
Collaboration, involves a structured, protocol-driven approach to
identify, evaluate, summarize, and synthesize peer-reviewed scientific
literature as a means to answer the scientific questions specifically
focused on diet and public health. Use of the NEL involves thorough
searches of all peer-reviewed scientific literature contained in
multiple electronic databases, and putting the results through pre-
determined inclusion/exclusion criteria to focus on those that answer
the scientific questions. Because the Dietary Guidelines focus on
disease prevention, and not treatment, these reviews excluded studies
that involved treating disease, such as those in which patients with an
existing condition followed a therapeutic diet. Of approximately 4,000
manuscripts screened for inclusion, the 2015 Advisory Committee
reviewed nearly 300 studies that met the criteria for the systematic
review questions.
In addition, the Advisory Committee used existing systematic
reviews from the NEL and external national and international scientific
organizations to prevent duplication of efforts and to conserve Federal
resources and time. All existing systematic reviews were screened by
Federal staff and underwent assessment to ensure the proper quality and
objectivity.
Public Participation in the Process
Public participation in the Dietary Guidelines scientific review
process has been important and extremely valuable. HHS and USDA issued
a public call for nominations of candidates for 2015 Dietary Guidelines
Advisory Committee members in the fall of 2012. Following a careful and
diligent process, members were appointed to the Advisory Committee by
Secretary Sebelius and me. The Advisory Committee proceeded to hold
seven public meetings spanning 19 months, which included an opportunity
for the public to provide oral testimony. After each public meeting,
the Committee's slides and videos were posted for public access on
DietaryGuidelines.gov, along with a list of all the scientific studies
discussed during the meetings and the inclusion-exclusion criteria the
Committee used. Throughout this time, the public was encouraged to
submit comments to the Advisory Committee on DietaryGuidelines.gov.
These comments ensured that the Committee considered all relevant
topics in preparation of the Scientific Advisory Report.
Once the Advisory Committee submitted its Scientific Advisory
Report to Secretary Burwell and me in February 2015, the report was
posted on DietaryGuidelines.gov for public review and comment. HHS and
USDA extended the public comment period from 45 days to 75 days; for
comparison, the public comment period to review the 2010 Advisory
Report was 30 days. In addition, the public was invited to provide oral
testimony to the Federal Government on the Scientific Advisory Report
in March 2015.
Public comments serve as a vital resource to our Departments in
drafting the Dietary Guidelines. In addition to the March public
meeting for oral testimony, we received more than 29,000 written
comments during the 75 day public comment period. Staff from both
Departments have reviewed all comments submitted and posted them online
at DietaryGuidelines.gov. To ensure the Dietary Guidelines are based on
the totality of sound science, the Departments' focus is primarily on
public comments with scientific justification.
HHS-USDA Development of the 2015 Dietary Guidelines for Americans
In addition to the Advisory Committee's report and public comments,
HHS and USDA look to Federal agencies with expertise in nutrition to
review both the Scientific Advisory Report and the draft of the Dietary
Guidelines for Americans. This ensures that the Dietary Guidelines are
grounded in the current scientific knowledge and are compliant with
existing Federal policies before Secretary Burwell and I review and
approve it for release and implementation across Federal nutrition
programs.
As a result of this multi-faceted process, the 2015 Dietary
Guidelines for Americans will be informed by thousands of scientific
papers, decades of nutrition and medical research, public comments, and
reviews by Federal experts. We will conduct several layers of review
prior to preparing a draft for final approval, which has not yet
occurred. However, I can assure you that the 2015 Dietary Guidelines
for Americans will be grounded in the preponderance of the best
available scientific evidence, represent our current understanding of
the connections between food and health, and integrate the science into
succinct, food-based guidance that Americans can rely on for choosing a
healthy diet.
The Dietary Guidelines has been referred to as the nutrition
backbone of our nation. We take this responsibility very seriously.
Again, thank you, Chairman Conaway, Ranking Member Peterson, and
Members of the Committee for this opportunity to discuss the Dietary
Guidelines for Americans.
The Chairman. Well, thank you. I got ahead of myself. Let
me mention that the Chairman requests that other Members submit
their opening statements for the record. And I rudely failed to
introduce Secretary Tom Vilsack, who is the Secretary of the
Department of Agriculture, and the Honorable Sylvia Burwell,
who is Secretary of Department of Health and Human Services.
Two folks who needed no introduction, and I didn't introduce
you, I apologize for that. The chair would remind Members that
they will be recognized for questioning in order of seniority
for the Members who were here at the start of the hearing.
After that, Members will be recognized in order of arrival, and
I appreciate the Members' understanding. And I recognize myself
for 5 minutes.
Ms. Burwell, you said in your comments that the guidelines
don't change substantially from one set to the next, but yet
the Advisory Committee reports have gone from 57 pages in 1995
to 571 pages for this one. So I am not sure we have gotten ten
times better information today than we did at that point in
time.
As I mentioned in my opening statement, the oversight we
are conducting today is on the development of the guidelines in
sight of concern for the integrity of the process, and its
resulting recommendations. The Federal Advisory Committee Act
defines how Advisory Committees operate. The law puts special
emphasis on open meetings, chartering, public involvement and
reporting. According to statute, a Federal Advisory Committee
shall, among other things, require the membership of the
Advisory Committee to be fairly balanced in terms of the points
of view represented and the functions to be performed, contain
appropriate provisions to assure that the advice and
recommendations of the Advisory Committee will not be
inappropriately influenced by the appointing authority, or by
special interests, but will instead be the result of Advisory
Committee's independent judgment.
Despite these statutory safeguards, serious questions have
been raised about the oversight of the overall DGAC process
while it was ongoing. This has tended to fuel concerns that
members of the commission may have been appointed in order to
achieve certain policy outcomes outside the legitimate purview
of the Advisory Committee. I refer specifically to an op-ed
published on October 1, 2015 by former Deputy Secretary
Kathleen Merrigan, who currently serves as the Executive
Director of the Sustainability Institute at George Washington
University. I note that Secretary Merrigan was serving as USDA
Deputy Secretary during the time the DGAC was chartered and
appointed. The suggestion of including sustainability and tax
issues by the DGAC has been a topic of intense discussion for
some time. I recognize that you both jointly published a blog
yesterday acknowledging that sustainability is out of the scope
of this exercise, and I hope to get some comments from you
about tax issues as well. I am likewise sure you recognize that
the inclusion of these issues in this process could have
resulted in misguided recommendations, which would have ill
effects on consumer habits and agricultural production.
The counter to potential bias in the process is the public
comment period. The 75 day period was the public's first real
opportunity to review the 571 page document. In your written
statement, Secretary Burwell, you mentioned that USDA and HHS
staff have already fully reviewed all the comments. You also
mentioned that you focused most heavily on those with
scientific justification. Help us understand, then, what is
going on right now. What have you done with the studies, such
as those evaluating low carbohydrate consumption patterns,
since the review has been taking place?
Secretary Burwell. I think there were a number issues
raised, and I apologize, I could not hear your final question.
The Chairman. What have you been doing? Have you been
studying the comments, and the report itself. Can you talk to
us about how you have been evaluating other information, like
low carbohydrate consumption patterns, as a part of that
review?
Secretary Burwell. With regard to one issue that you
touched on earlier that I want to go ahead and address, you
asked which was the tax issue, and the question of tax policy.
I think, like our comments yesterday in the blog that Secretary
Vilsack and I put out about the issue of sustainability, while
we haven't received recommendations from our staff speaking to
the specifics of what are in the Dietary Guidelines, that is a
question of scope, like the sustainability question, and that
is not an issue that we would address, on the tax issue, when I
address that.
With regard to the process that we are now going through,
and how, whether it is the carbohydrate issue, or any of the
specific issues, what is happening is we received the report of
the committee. Our staffs are reviewing that. At the same time,
we are reviewing all of the public comments that we have
received. In addition to that, we are bringing in the experts
from all of our Departments to make sure that they weigh in as
we do the consideration. And, for us, that includes the Food
and Drug Administration, the NIH, the Centers for Disease
Control, the Office of the Assistant Secretary for Health, and
many others. So that is the process that we are using now, to
review what we received, and to put together the guidelines.
The Chairman. Could the guidelines have things in them that
weren't necessarily directly reported in the recommendations
from the committee? Your own wisdom, your own thoughts, would
be reflected in the guidelines as well?
Secretary Burwell. In terms of the expert advice of our
staffs that exist, with regard to the question of studies and
pieces of work, it is important to reflect what Secretary
Vilsack said, which is there has been a systemic literature
review with regard to the studies, and that is part of keeping
integrity to the process. With regard to our experts who are
constantly involved in those issues, yes, they will be a part
of that process.
The Chairman. Thank you. Ranking Member?
Mr. Peterson. Thank you, Mr. Chairman. I think you both
know that sodium not only provides a benefit in making products
shelf stable, it also improves taste, and is an important food
safety component in cheese. Studies have shown that there is
insufficient evidence to conclude that lowering sodium intake
below 2,300 milligrams per day decreases risk of cardiovascular
disease, and the Dietary Guidelines Advisory Committee agreed.
So why has the committee continued to support further sodium
reduction, and is this something that you will be able to
address in your guidelines?
Secretary Vilsack. Well, let me take a stab at that. First
of all, again, we are going to probably respond to a number of
questions by pointing out these guidelines have not been
formulated yet, and we can't comment on the specifics of what
the guidelines will be because we haven't had an opportunity to
prepare them and to review them.
Having said that, the Advisory Committee, basically, they
go through a process, as Secretary Burwell indicated, of
reviewing a variety of studies. There, no doubt, were studies
that linked pre-hypertension, hypertension, to sodium
consumption. They probably looked at the National Academy of
Medicine studies, in terms of sodium, and they probably
concluded that there was evidence relating to sodium
consumption and these chronic diseases, which is why they have
recommended what they have recommended.
The reality of this situation is that science changes, and
we learn more information, and that is why it is important to
have a process that we have in place to review what the
Advisory Committee recommends, then to have public input, to
get public comments, to have our own staff review studies,
based on information they have accumulated during the course of
the 5 year period since the last Dietary Guidelines, and also
to refer back to the last set of guidelines, which is a
foundation for this set of guidelines. So, Congressman, I can't
comment specifically on why the Advisory Committee did what
they did because they sort of operate independent. We don't
inject ourselves into that process. But we do basically take
their input into consideration, along with many, many other
studies, many, many other opinions, to try to formulate the
best set of guidelines and framework for the country.
Mr. Peterson. Thank you, Secretary. I don't know if you
both have seen the Washington Post story today? Secretary
Vilsack, I guess you have seen it.
Secretary Vilsack. I have seen it, and several people were
mentioned in there. I have read books by those folks in
preparation for this. This is what has caused my concern about
what these guidelines are and what they are not.
Mr. Peterson. Well, my concern is that we have had these
guidelines that have pushed people away from eggs, and butter,
and milk, and so forth, and then they come back and say, well,
we were wrong. And so my question is, for both of you, what are
we going to do to make sure that doesn't happen in the future?
First of all, do you agree with this, and second of all, how
are we going to keep this from happening? Why are we going off
on these tangents if we have a process that is so heavily
vetted?
Secretary Burwell. I would say a couple of things. First,
the consistency over time for most issues has been there, and
it is right to point out that, with regard to the issue
specifically of dietary cholesterol, there has been a change
over time.
I can think of a couple things, to answer your question.
First, for the most part, things are consistent over time.
Second, we need to make sure we use the most scientific
evidence we can. And there has been an evolution and change,
and that does get reflected in what the Advisory Committee has
given us. They no longer will do recommendations based on
expert opinion. Instead, they will only do recommendations
based on the science, and that is a change that will occur.
The other thing that is an important thing to reflect is
that, in some cases, science does change. And in the case of
our understanding of blood cholesterol versus dietary
cholesterol, there has been an evolution in understanding of
the difference of those, and what they cause. And we want to be
prepared to make sure we review in a rigorous way changes that
happen. There is not one simple answer to the problem that you
raise, but a number of pieces of how we can work to get to a
place where we have the most consistent science-based advice.
Secretary Vilsack. And let me just simply add that Congress
has directed us to take a look at the preponderance of that
available science, which suggests, which is a term that I am
familiar with in the practice of law, it suggests that there
may be studies on both sides of an issue. And it is important
and necessary for folks to sort of weigh the studies. And one
of the challenges of this is to distinguish between one single
quality study that is absolutely solid versus a bulk of studies
over time that may have a slightly different view.
And this is the challenge here, and it is a reflection of
the fact that all of this is evolving. You are not going to
ever have something that just basically is going to be a fact
about this, because science evolves. We learn more, we
understand more. And I would hope that we would be flexible
enough to appreciate that, and to take that into consideration.
Mr. Peterson. Well, I thank both of you for your
observations, and you have made some points, but I just want
you to understand, for my constituents, most of them don't
believe this stuff anymore. You have lost your credibility with
a lot of people, and they are just flat out ignoring this
stuff. And so that is why I say I wonder why we are doing this.
From what I am hearing from my constituents,
Secretary Vilsack. Congressman----
Mr. Peterson.--what it is worth.
Secretary Vilsack.--can I respond to that for just a
second? Here is the challenge, though. We take these
guidelines, we incorporate them in our website,
choosemyplate.gov. We have had over 290,000,000 hits on
choosemyplate.gov. It may very well be that there are folks who
are concerned about this, but I still think there is merit in
it, as long as people understand what they are and what they
are not. They are not a hard and fast set of rules, they are a
guideline, a set of guidelines, a framework. And they are not
about treating disease, they are about preventing it.
The Chairman. Thank you. Mr. Neugebauer, for 5 minutes.
Mr. Neugebauer. Thank you, Mr. Chairman. I want to go back
to something that the Chairman was asking, and I want to make
sure that we are all on the same page here. So, taxes are off
the table, as far as consideration in the guidelines, is that
correct?
Secretary Burwell. With regard to the question of whether
there be a tax recommendation in our Dietary Guidelines, we do
not believe that that is something that is in the scope of the
work that we are doing.
Mr. Neugebauer. Secretary Vilsack?
Secretary Vilsack. Well, that is not within the scope. It
is not dietary, it is not nutrition, and it doesn't belong in
this context. There are probably many other ways in which that
conversation should be taken and should be had. As is the case
with sustainability, it doesn't belong here, it belongs
elsewhere. And I am happy to have that conversation with folks
if they are interested.
Mr. Neugebauer. So both of you agree, then, sustainability
and taxes are off the table, as far as these recommendations
are concerned?
Secretary Burwell. Both are important issues that we
believe should have conversations, but not in the context of
this document.
Mr. Neugebauer. Thank you. HHS and USDA have always stated
that they have looked to appoint members to the DGAC so it
consists of nationally recognized experts in the fields of
nutrition and health. As you know, the DGAC is subject to the
Federal Advisory Committee Act, which is widely used throughout
the Federal Government. This Act is designed to ensure that the
various Advisory Committees formed over the years are objective
and accessible to the public. The Act has formalized a process
of establishing and operating and terminating these advisory
bodies. For the 2015 guidelines, the HHS and the USDA began to
solicit nominations for the DGAC in 2012. Once selected and
appointed, the DGAC was composed of academics, including
professors, epidemiologists, and even a physician-scientist.
In a departure from prior Dietary Guidelines' Advisory
Committees, nutritionists and food scientists were not selected
to serve on this DGAC. Understandably, questions regarding the
inherent bias are being raised by the fact that no food
industry scientists were included in the DGAC committee.
Additionally, after the DGAC had officially disbanded, the
former Advisory Committee members decided to hold a public
event, acting in their capacity as DGAC members, which they
were not, according to the committee's charter and Federal
Advisory Committee Act.
Based on the charter, it is the DGAC's responsibility to
review the science and make recommendations to your
Departments, which is then developed for final recommendations
for the public. It is, however, not the responsibility of the
DGAC to educate the general public on the report that still
needed to be considered by the HHS and USDA claiming the
nutritional recommendations were based on Dietary Guidelines.
Secretary Burwell, what instructions were given the
Advisory Committee members regarding the FACA and the Advisory
Committee's disbandment?
Secretary Burwell. With regard to the specifics of the
disbandment, I can get back to you, Congressman, with regard to
the direction that was given as to review the science with
regard to the issues that were in front of them with regard to
the Dietary Guidelines, and present a report about that. So,
with regard to the question of disbandment, I don't know what,
if any, specific direction was given, but the point that you
have made, which is this is about an Advisory Committee
producing a document, an independent group of people producing
a document, that then is an element in the basis of what our
decisions will be on the Dietary Guidelines, is what their role
is.
Mr. Neugebauer. Well, was their role to then go out and
start doing a road show on their recommendation? Is that a part
of the scope of that committee?
Secretary Burwell. With regard to what we followed, at
least at the Department, and what I know about is the fact
that, once we received the committee's recommendations, and
those became public, that there was a public comment period.
That was the part that we have both been focused on, and the
29,000 comments that have come in from the public. As well as,
when we heard from you all that you asked for an extension of
the public comment, Secretary Vilsack and I very quickly agreed
that that was something we thought was an important thing to
do. That is the----
Mr. Neugebauer. Well----
Secretary Burwell.--part of the process, in terms of
public----
Mr. Neugebauer.--the question here is that; first, did they
follow the guidelines, and second, what steps were taken to
make sure that the committee followed the law? And then, from
an ethical standpoint, once you have served in your capacity on
that Advisory Committee, and made your recommendations, what is
your responsibility, moving forward? And one of the things we
don't want is that this turn into some kind of a profitable
situation on their behalf because of their participation on
that Advisory Committee.
Secretary Burwell. With regard to--these are voluntary,
non-paid. They all have to file financial disclosures on an
annual basis as they go through this process, and so those are
all things we want to protect against. With regard to the
specific question of a press briefing, or some kind of
briefing, I apologize, I am not familiar with that. As I said,
we have focused on the public comments and the steps and
process that we are following.
The Chairman. The gentleman's time has expired. Mr. Scott,
for 5 minutes.
Mr. David Scott of Georgia. Thank you very much, Mr.
Chairman. I am very concerned that you are not using the most
relevant, basic, and the best science-related information in
formulating these guidelines. You certainly did not use some of
the most recent peer-reviewed and published nutrition and diet-
related science. It was not even considered by the Advisory
Committee, and not even included in the evidence-based library
to be considered by the Advisory Committee when they were
finalizing the report. That is a fact.
And, Mr. Vilsack, you said you were using the best
information. Your quote was we have the best informed opinions.
But if you are not using the most recent peer review, that
information that is there, and your committee has not even
agreed to put it into the final report. So maybe you all can
give me some level of confidence that your staffs and you will
take into consideration the strong scientific evidence with the
final policy document, even though it was not included in the
evidence-based library throughout the working group process?
Secretary Vilsack. Congressman, can you be specific about
which study you are talking about?
Mr. David Scott of Georgia. I am talking about the
scientific study that came out that gave evidence that certain
things were very important. Let me just give you one example.
Let us look at the whole issue of the involvement of sugar, and
how it is not even included. Why, for example, that low calorie
sweeteners are not being recommended, when the study pointed
out that low calorie sweeteners could be used to lower weight,
to be able to help what is called atopocity, and it is not even
being used. What is wrong with low calorie sweeteners that can
be used, and it is not even in the report?
Secretary Vilsack. Congressman, let me try to respond to
the question as best I can. First of all, when you have a
process that is every 5 years, you, obviously, are going to
have to have, at some point in time, a cutoff of what
information you consider, because, theoretically, the minute
before we publish the guidelines, somebody could publish a
study, and you would be criticizing us for not taking the
latest science into consideration. So there has to be a cutoff
time in terms of consideration. Having said that, over 4,000
studies were reviewed, 300 manuscripts were reviewed, and they
went through a gold standard process for evaluating the
appropriateness and efficiency of those studies. That it is
unfair to the committee, and unfair to the process, to suggest
that we are not looking at the science. We are. Number one.
Number two, as far as sugars are concerned, look, here is
the problem. Our children, 15 to 17 percent of what they
consume is sugar. And so, obviously, we are looking for ways in
which we can reduce that. And what they were recommending and
suggesting is that if you are going to have sugared drinks, if
you are going to have sugar in your diet, you ought to at least
look for the most nutritionally dense foods that you possibly
can consume for that sugar, that you don't basically use empty
calories to obtain it. So you could have something like
chocolate milk versus a low cal drink. You would get more
nutrition bang for your sugar buck, if you will, out of that
process. And that is what they were suggesting.
Mr. David Scott of Georgia. But you are familiar with that
report? The Added Sugars Working Group said that moderate, and
generally consistent, evidence from studies conducted in adults
and children supports replacing sugar-containing sweeteners
with low calorie sweeteners to reduce calorie intake, body
weight, and atopocity.
So the issue simply is for both of you to be able to
explain why the DGAC, the Dietary Guidelines for America, would
then recommend that consumers not--that is the whole point. You
have used this evidence, it is pointed to where it could be
helpful, but then the committee recommends that the consumers
not use low calorie sweeteners as a tool in the toolbox to
reduce added sugars. All I am simply saying is that if this
report is going to have value for the welfare of the American
people, and you all say you are using the most relevant basic
information, then this clearly contradicts that.
Secretary Burwell. There are two different things. One is
what the Advisory Committee has in its report, and the other is
what we do in the guidelines. And the specifics of that, as we
have said, are not something we received as recommendations. My
understanding of what is in the committee report, with regard
to the question of substitution of the drinks, is that not
enough evidence exists one way or another to make a
recommendation, and that that is where the committee left the
issue of the specific of the substitution.
The Chairman. The gentleman's time has expired. Mike
Rogers, 5 minutes.
Mr. Rogers. Thank you, Mr. Chairman. I thank you all for
being here. You have both made reference to the fact that you
take these comment periods seriously, and that you consider
these comments in your guideline making process. And I take you
at your word. One particular area of concern to me, though, and
producers in my district, is in the Dietary Guidelines Advisory
Committee recommendations regarding red meat. The current DGAC
report seemingly recommends that Americans consume less red
meat. Will your agencies be reviewing studies submitted during
the comment period that address the recommendations for red
meat, both pro and con, and can you tell me more about that?
Secretary Vilsack. In terms of the issue of red meat, it is
fairly clear that there is a recognition that lean meat is, and
should be, part of a healthy diet. The challenge is to
understand that, as Americans, if we look at the obesity
epidemic that we are confronting in this country, that some of
us are consuming more calories than we should. And so the
recommendation is in relationship to the overall consumption of
calories. And one way to reduce the overall consumption of
calories is, obviously, to eat less of certain things. And in
that category would be red meat, but that is by no means the
only thing in that category. So I want to be clear here----
Mr. Rogers. What I don't understand. I am sorry, Mr.
Vilsack, but why would you include in that category red meat? I
mean, why wouldn't you just say anything that takes you over a
caloric level that is unacceptable, you shouldn't eat? Why
would there be a category of things not to eat?
Secretary Vilsack. Because of the importance of having
balance, in terms of what you consume, in terms of what a
healthy diet consists of. Again, remember what this is. It is a
set of guidelines which is designed to give you the best chance
of reducing cardiovascular, cancer, and chronic diseases.
Mr. Rogers. But wouldn't red meat be part of a----
Secretary Vilsack. It is.
Mr. Rogers.--list of things that you should eat, as long as
you eat lean?
Secretary Vilsack. It is. That is what I am saying. It is.
Mr. Rogers. I am sorry, I thought you said that you would
put it in a list of things not to eat.
Secretary Vilsack. No. Sir----
Mr. Rogers. Okay.
Secretary Vilsack.--what I said was, if you are concerned
about over-consumption of food generally, then obviously you
are going to suggest that people should eat less of something
that they are eating a lot of. That is the key.
Mr. Rogers. I agree.
Secretary Vilsack. To suggest that we are not going to have
a guideline, it is fair to say, regardless of the fact the
guidelines aren't fixed yet, that lean mean is going to be part
of a healthy diet. There is no question about that, as far as--
--
Secretary Burwell. Yes. The Advisory Committee's
recommendation on this is exactly the same as 2010. So I
think----
Mr. Rogers. Yes.
Secretary Burwell.--the Secretary's comments hold.
Mr. Rogers. Okay.
Secretary Burwell. The Secretary's comments are also
reflected--I have Fiesta plates, those are what my mother had.
Those are the plates, those colorful plates, and my mother used
those. The plates that I have from my mother, and the ones I
received for my wedding, they are a different size, reflecting
the issue that we, as a nation, I just think that is a visible
thing that people see. My mom's plates, they are smaller, the
ones I have from her. The ones that I received--and this gets
to the issue of the totality that we need to work on at the
same time that we think about the nutritional content. So we
have too much, and we have to get the right nutritional
content.
And what everybody wants is an opportunity to be able to
have guidelines to do that. And that is what the
choosemyplate.gov hits are about, and everything is about.
Being a mother of an 8 and a 6 year old, and your time in the
grocery story, having worked for the largest grocer in the
country, Wal-Mart. The average time for a working mom or dad
is, like, 20 minutes. And so your ability to get in there, get
it done, and try and do it in a way that is healthy for your
children, you need ease in decision-making. This is step one.
It is just the guidelines. How it gets translated into other
things are the next steps. That is what the Secretary's comment
about what this is, and what this isn't, and why we want
something that is useful for working families who are just
trying to get this right for themselves and their children.
Mr. Rogers. Great. Thank you both. I yield back.
The Chairman. The gentleman yields back. Mr. Walz, for 5
minutes.
Mr. Walz. Thank you, Mr. Chairman. And I want to thank both
of you for being here, for the work you do. And, Secretary
Burwell, I appreciate that last comment, too, as a father of a
young son, and someone who, as I often tell my colleagues, I
supervised the high school lunchroom for 20 years, so you see
that side of things, and how those school lunches impact. You
brought up great points here, and this is an important hearing.
And articulating what this is and what this isn't is really
important. Because, at the heart of this, with so much
information out there, and Americans are going to try and find
it, from their uncle's e-mail to them to Dr. Oz and others,
they are looking for the gold standard on what makes a
difference in their own lives as they search for this.
And all we have to do is look at the cost of obesity in the
United States, estimated at between $150 and $200 billion per
year. This is an important subject. We need to help people find
the information. They are busy, there is lots of it. And that
is why the questions that are coming up from colleagues about
the integrity of your suggestions, as many of us saw, and still
do believe, as the gold standard on how this gets done, and
valid concerns about the decisions we make here. And, in full
disclosure, I have the ninth largest agricultural district in
America. We produce lots of pork, lots of milk, lots of
turkeys, and all those things. When we make those decisions,
they have an economic impact. So the concern is valid, it is
warranted, but we have a responsibility to move headlong into
this to help the American public get it. So, for me, and more a
statement on this, we are concerned on process, and hearing
that. It is important to hear both of you articulate that, and
it is important for the American public to know that they can
trust these as guidelines for them, and they are going to make
decisions for their own family based on them.
So maybe what I would do is just ask you, what you are
hearing on this process, do you feel like the concerns you are
hearing from Members on the totality of the evidence and
things, are you comfortable that those are being included when
you make your guidelines? You are hearing about Members talking
about things that aren't included, specific commodities that
aren't in that? Are you comfortable? And maybe, Secretary
Burwell, start with you.
Secretary Burwell. Yes, that we are including these
comments. And whether that is the blog that we issued
yesterday, we had a number of questions about that
sustainability issue, or the tax issue that we tried to address
here today, that we are, across the board, hearing and
listening. And you can be assured that the questions that you
all are asking us are the questions that we will be asking our
teams as the recommendations come forward. It was mentioned
cranberries, and the issue of something that has high nutrient
value, and the question of how that interrelates with added
sugar, and how we think about those issues. Your questions
become our questions as part of this process.
And we do believe--I mean, the comments that came in, as
the Secretary mentioned, there were a number of repeat--8,000
were probably singular. There were 19,000 comments on
sustainability: 97 percent of those comments, so we are clear
and transparent, were positive, and that we should include
sustainability as part of the Dietary Guidelines. And I say
that to make the point that we want to hear. We are going to
ask the questions, and then, based on what the Dietary
Guidelines are, and the scientific evidence, that is how we
will go about making the decisions.
Secretary Vilsack. I would only add that the debate that we
are having here, and the debate that is taking place outside of
this room, is a reflection of people's interest in where their
food comes from, how it is produced, who is producing it, who
is benefiting from it. And that is a healthy debate----
Mr. Walz. Yes.
Secretary Vilsack.--for us to have, in the right context.
Mr. Walz. Yes.
Secretary Vilsack. It is a healthy debate for us to have in
the context of developing a farm bill. It is a healthy debate
for us to have in the context of conservation, in the local and
regional food system effort. All of those are avenues and
vehicles for having that conversation, and we are having that
conversation, and we should have that conversation. This,
however, is about dietary and nutrition, and that is what we
are going to focus on as we develop these guidelines.
Mr. Walz. Well, I very much appreciate that point of view.
I am not going to miss this opportunity, with my last 40
seconds, Mr. Chairman. Mr. Secretary, again, off topic, but I
am going to use it. The effect of sequestration on ARC and PLC.
I am going to ask, if my folks are out there, if you could help
me.
Secretary Vilsack. It will be a 6.8 percent reduction----
Mr. Walz. Okay.
Secretary Vilsack.--across the board, regardless of when
they came into the FSA office, or when they basically----
Mr. Walz. So what they are hearing is true, there will be a
reduction----
Secretary Vilsack. Yes.
Mr. Walz.--to them?
Secretary Vilsack. Unless something happens with the
sequester.
Mr. Walz. Very good. I yield back. Thank you.
The Chairman. The gentleman yields back. Mr. Gibbs, for 5
minutes.
Mr. Gibbs. Thank you, Mr. Chairman. I have to tell you,
hearing the Ranking Member's, Mr. Peterson's, comments that I
agree with about everything he said. Why are we doing all this,
if it is really necessary. And I make the comment that there is
a lot of information out there to consumers. You have the
medical associations, the cancer, heart. There are all kinds
out there. I am encouraged to hear you say that the process--to
make sure that the tax, sustainability issues aren't part of
this, because they shouldn't be.
I guess my only demand, demand, would be that you use
common sense, and say, moderation, people out there can make a
lot of decisions on their own. There is a lot of information
out there, and these guidelines should just be common sense
things, that if you have a weight problem, you need to lower
your calorie intake. So that is just my comment. I wonder if
you know how much--I won't even bother to ask how much all this
process costs, but I can just imagine.
But, Secretary Vilsack, what I want to ask you, these
guidelines are supposed to be guidelines. And how does that
have an affect on the school lunch program? Because we have
seen the school lunch program be turned on its head, and there
have been all kinds of reports of certain school districts that
want to get out of the program, and there are guidelines--part
of that effect of determining what is happening in the school
lunch program?
Secretary Vilsack. Well, the school lunch program is,
obviously, focused on compliance with the Healthy Hunger Free
Kids Act, which passed Congress in 2010. And in that, Congress
directed us to do a better job, in terms of the quality and
nutritional value of those meals. More fruits and vegetables,
more whole grains, more low fat dairy, and less fat, sugar, and
sodium, and we are compliant with that. And, in fact, 95
percent of school districts have been certified as following
the standards. Surveys of children, surveys of school
administrators, surveys of parents, and surveys of the public
all indicate strong support for what we are doing. And we are
helping school districts that are struggling through a series
of programs--for success, where we are seeing struggling
schools linked up with succeeding schools, and we are finding a
good success for that program as well.
So the Dietary Guidelines help to inform, as they do with
some of the other nutrition programs, as they do with the
Department of Defense, in developing what they are going to
serve our military. These Dietary Guidelines help to inform the
process.
Mr. Gibbs. Okay. Because I am just really concerned what is
happening in the school lunch program. I am hearing issues out
there that kids aren't eating, their food is going to waste.
There are things, when I was a kid, that I wouldn't eat that I
eat--I love to eat today, so there are different behaviors----
Secretary Vilsack. I can say a couple things about that.
Number one, there are several studies, University of
Connecticut, Harvard Public Health School, that suggest that
food waste is not as significant as it has been reported, and,
in fact, is no greater than it was prior to the new guidelines.
Number two, it is a matter of time. There is some research to
suggest that if kids are given more time to eat there is less
food waste. And the timing of the meal, in terms of whether it
is before or after recess, may also impact that.
And then, finally, I had an interesting conversation with
the President of Tufts yesterday, they did away with food trays
at Tufts, and what they have found is that that has reduced
significantly the amount of food waste, because kids came in
with a tray, and they feel like they have to fill up the tray,
as opposed to a plate. And they fill up the plate, they get
satisfied, they don't go back for seconds, there is less food
waste. So there is a lot of opportunity here for us, as a
nation, to reduce food waste, but I don't think it is a
reflection, or an indication, of the new school----
Mr. Gibbs. When USDA's working on the school lunch program
and stuff, is there much discussion about physical activity?
That is probably--maybe more so than what they are--I--
especially in kids.
Secretary Vilsack. Well, we have over 6,000 schools that
have now been certified under the U.S. Healthier School
Challenge, which is an effort on our part to encourage both
calories in and calories out. And we reward and acknowledge
school districts that are doing a good job of balancing
nutrition and exercise. We also have an interesting
relationship with the Dairy Association, and the NFL, on their
Fuel Up to Play 60----
Mr. Gibbs. Okay.
Secretary Vilsack.--program. So there is an----
Mr. Gibbs. Okay.
Secretary Vilsack.--emphasis on exercise.
Mr. Gibbs. Secretary, your comment about sustainability,
and all the comments you had, I guess my only comment would be
something that gets a little weighted by certain agendas, by
certain organizations, we saw this in the waters of the United
States. We saw a lot of comments that came in, and obviously
that was orchestrated, and there are agendas out there, just so
you are aware of that, and some of those comments are sometimes
subject to how credible they really are. I yield back.
The Chairman. The gentleman yields back. Ms. Fudge, 5
minutes.
Ms. Fudge. Thank you very much, Mr. Chairman, and I thank
you both for being here this morning. On August 24 the Center
for Nutrition Policy and Promotion issued a Federal Register
Notice asking for input as to how to better inform the public
about the 2015 Dietary Guidelines. I think that is a great
idea, because so many Americans really do not understand, and
are confused, about the guidelines, and the dietary patterns.
So tell me how you are planning your messaging around the
guidelines, and if you have any just straightforward
suggestions as to how Americans can improve their eating
habits?
Secretary Vilsack. Well, we take the guidelines and
incorporate it into our choosemyplate.gov initiative, which
Secretary Burwell referred to it earlier. It is an opportunity
for us to visually give people an idea of what a healthy plate
looks like. The choosemyplate.gov website, which I mentioned
before, is also part of our effort to try to do outreach. We
also have a super tracker program that if you are struggling
with weight--I have it on my iPhone--it basically gives you
daily updates on--and suggestions on how you might be able to
control your weight, tips on substituting foods and so forth so
that you have a healthier, balanced diet. So there are a series
of ways in which we incorporate the information from the
guidelines in our educational materials, which we then
disseminate through a variety of mechanisms, social media, and
legacy media.
Ms. Fudge. Thank you. How many American households do you
believe are at risk for food insecurity, and how can the 2015
DGA address the critical needs of our most vulnerable
populations?
Secretary Vilsack. Well, I can tell you our focus has been,
obviously, on children, and there are 15.8 million children who
live in food insecure homes. That number is down, which is good
news. We, obviously, still have work to do. There are a variety
of ways in which we can provide help and assistance. Some of
the obvious ways are the SNAP program, and expansion of summer
feeding, weekend feeding programs during the school year. There
is an opportunity for us to also work with day care facilities
and child care facilities to ensure that youngsters in those
facilities get decent snacks.
And we mentioned the school lunch program. Unfortunately, a
lot of kids today get \1/2\ or at least \1/3\, and in some
cases all of the calories they consume in schools. So, to the
extent that we can do a good job of not only providing school
meals, school breakfast and school lunch, but also after school
snacks through our snack program, these are all a variety of
ways in which we can try to provide help.
The last thing I would say is that we are also trying to
find creative ways for SNAP families to extend their SNAP
dollar by giving them tips on how they might be able to use
fruits and vegetables effectively in recipes. We are also
making access to farmers' markets more available. Over 6,200
farmers' markets today, that is a dramatic increase in the
number, now have the EBT cards that allow SNAP beneficiaries to
access farmer's markets.
Ms. Fudge. Which, by the way, works very, very effectively.
I have it in my district, so I thank you for that.
Last, tell me how important it is to maintain the 5 year
cycle for the Dietary Guidelines, so that Americans really do
get the benefit of the current science for diet and health.
Secretary Burwell. I think we think that the 5 year review
is a very important part of doing many of the things that we
are being asked to do, which is make sure that we have the most
up to date science, and make sure that we are listening to the
public, because it is a formalized process that we do hear from
the public, and there are those opportunities. While it is in
statute, and that is a big part of why we do it, I think we
would agree that it is important to have points in time where
you do the work, and settle, and do the analysis, and the
listening. And so I think we think that updating it on a
regular basis, on a 5 year cycle, is important.
Secretary Vilsack. I agree.
Ms. Fudge. Thank you very much, Mr. Chairman. I yield back.
The Chairman. The gentlelady yields back. Mr. Scott, 5
minutes, Austin Scott.
Mr. Austin Scott of Georgia. Thank you, Mr. Chairman. Madam
Secretary, Mr. Secretary, thank you for being here. As we talk
about the reports, the credibility of the report is arguably
the most important thing. It doesn't matter how much time and
money went into it, if we have a credibility gap, we have a
problem. There were certainly some questions about the fact
that Ms. Mylett was from the private sector now. I have read
her resume: 30 years at one of the major institutions,
certainly qualified in every way, shape, and form from her
academic career to be there. But there are questions about the
fact that she is now a member of the private sector, chairing
the committee.
Historically, we have not allowed industry representatives
on the panel. And I recognize that she doesn't represent, for
example, the cattle industry or the corn industry, because we
would believe that there would be the assumption--whether true
or not, there would be the assumption that there would be bias
in the opinions of people who represented a certain industry on
the panel. When I see issues like tax on sodas and other things
being recommended, it seems to me that ideology is taking
precedence over science, and that creates a tremendous
credibility gap as well.
And I would just ask, as we go forward, how do we make sure
that we don't have that credibility gap in the report? Because
the CDC and the others do use this information to send out
recommendations to the American public. And if the Nutrition
Evidence Library is not being used, how do we guarantee the
credibility of the report?
Secretary Burwell. Do you want to speak to the nutrition
library----
Secretary Vilsack. Yes, go ahead.
Secretary Burwell.--and I will speak with regard to the
credibility, that is a very important element of the trust of
what we have in front of us, and that is why we are having the
conversation. In the places where we can provide clarity, we
do, as well as providing clarity--and that is a little bit of--
some of our follow-up questions about, there is a scientific
approach to what documents are included, how they are included.
That is the standard of scientific research. The gold standard
is used. I have checked even with our economists, had them come
in and look at it.
Mr. Austin Scott of Georgia. Can I----
Secretary Burwell. So clearing----
Mr. Austin Scott of Georgia.--ask you a question there? If
the standard is scientific research, how do recommendations for
tax on sodas get into the report?
Secretary Burwell. It is important to reflect that in the
Advisory Committee's report that there wasn't a recommendation.
It was an articulation that some used policy, and so I don't
think there were recommendations. They did not make
recommendations. But with regard to the issue that has been
raised, when we get to the Dietary Guidelines, how we take what
we are given, that is one input, and use it will be an
important part of establishing a process that people believe
in.
Mr. Austin Scott of Georgia. I am down to a minute, so I
would like to hear what Secretary Vilsack has to say, but I
would suggest that, when you see those things in the report,
and whether it is a jump to conclusion or not, there is a
belief, then, that the people on the committee entered with a
bias in some way, shape, or form, and we are searching for the
science to back up what they already believe to be true,
instead of using the best available science. Whether it is true
or not, we can debate that there is a credibility gap from
those things working their way into the report.
Secretary Vilsack. Congressman, I would like just simply
to, again, emphasize there is a fundamental difference between
the Advisory Committee's report and the guidelines. And there
is confusion out there. For some reason, people seem to think
that the report equals the guidelines. It does not. It is one
aspect of information that will be taken into consideration,
relative to the dietary and nutrition guidelines that we have
to put together, number one.
Number two, the Nutrition Evidence Library was used, and
there is an extensive process that is involved in accumulating
information and putting it through a filter, if you will, of--
--
Mr. Austin Scott of Georgia. Secretary Vilsack, I am down
to 30 seconds, but it was used for 30 percent, at least the
reports, that a tremendous number of things were not taken from
that library. This is a text I received from a dad yesterday,
and he is saying that their school can't sell candy bars, which
they used to do to help pay for a kids' trip, and that they are
being told from our local school system that that comes from
the Federal Government----
Secretary Vilsack. That is not----
Mr. Austin Scott of Georgia.--that they can't sell candy
bars to raise money. Is that----
Secretary Vilsack. That is not true. Folks can sell outside
of school, which is what these candy deals are. Outside of
school, there is no prohibition. There are exceptions and
waivers that can be granted. Oftentimes it is not the Federal
law that is in place. It can be a state law that is that, or it
could be----
Mr. Austin Scott of Georgia. I don't think we would have
that in----
Secretary Vilsack. Well, that may be the case. Well, then
folks are mistaken about that.
Mr. Austin Scott of Georgia. Thank you, sir, for clearing
that up.
The Chairman. The gentleman's time has expired. Mr.
McGovern, 5 minutes.
Mr. McGovern. Thank you, and, Secretary Vilsack and
Secretary Burwell, thank you for being with us today, and thank
you both for your respective agencies' work on the Dietary
Guidelines Advisory Committee's report. I know that this is no
simple undertaking, and I appreciate the fact that it takes and
requires months and months of scientific analysis and
consideration of thousands of stakeholder comments, and
thoughtful collaboration among committee members and agency
staff. And I want to say that I appreciate the process that the
Advisory Committee went through. It is a solid process, one
that was open, and included, as you mentioned, many
opportunities for the public to weigh in.
And it is also important, to kind of put all this in
perspective here, my colleagues understand, that, in this
country today, one in three school-age children and adolescents
is overweight or has obesity. And more than one in three
American adults suffers from cardiovascular disease and
diabetes. Clearly we can do better. When I look at what we are
all talking about here today, this is an attempt for us to get
it better. And if people aren't interested in the well-being of
our citizenry, and all they are interested in is the bottom
line, they should be very supportive of what you are talking
about here today, because, at the end of the day, healthier
people mean lower healthcare costs. So we all benefit here.
You mentioned earlier the HHS blog yesterday, where the
issues of sustainability were taken off the table for inclusion
in the final guidelines. And I get that is the case, and I
respect your decision, but this is an important issue, and you
both have acknowledged that. Sustainability, somehow, in this
Congress is a dirty word. I don't quite get it, but it is
important, and we ought to be talking about sustainability when
we are talking about issues of diet and food security. And I do
think that it is important that at least we start this
conversation about this issue in the context of Dietary
Guidelines.
I also appreciate that both your testimonies do a good job
of emphasizing the importance of nutrition on disease
prevention, and putting these recommendations into context. In
Congress we ought to be focusing more on prevention as a way to
reduce healthcare costs and improve overall well-being and
economic productivity. We should be highlighting what the
science says on good nutrition for our kids and for our
families.
I have an op-ed here today that was in today's Hill
newspaper, penned by the Presidents of the American Academy of
Pediatrics and the American Medical Association. It is
entitled, Physician's Perspective, Keep Politics Out of Dietary
Guidelines, and I would like to insert that in the record. In
it they talk about the importance of Dietary Guidelines, and
the soundness of science used to inform them. The issue was
raised that sometimes science changes. Everything changes. We
know more today than we knew yesterday. Our research techniques
have improved over the last 10, 20, 30 years. So when we learn
the latest science, then we need to make the necessary
adjustments.
[The information referred to is located on p. 70.]
But, as you know, some of the biggest critics of these
guidelines are from industries that produce the least healthy
foods, and from special interests with questionable
credentials. I was reading about some billionaire from Texas
who is a former Enron executive who is funding some initiatives
to try to raise questions about what you are doing. I don't
know what Enron knows about Dietary Guidelines, but,
nonetheless, there are powerful special interests out there
trying to raise issues of credibility, trying to question
science.
And so I just would conclude by saying I encourage you to
keep, first and foremost, the health and well-being of our kids
and our citizenry in the forefront as you move forward. And
maybe, in my last minute, can you explain to me if we all
improved our diets, what would be the impact on the rates and
costs of diabetes, and heart disease, and obesity? Secretary
Burwell?
Secretary Burwell. When I examined both Medicaid and
Medicare costs over the 10 year period, and as a trustee, as
one goes out over periods of time, both heart disease,
something that we know about how to do--and diabetes are two
very, very large cost drivers for us as a nation. And they are
cost drivers because those are both conditions that continue
over an extended period of time, and especially as we have a
population that lives longer, which is a good thing.
But the idea that these are costs that are controllable--
and I would also say that in my engagement with the private-
sector, and CEOs of companies--and I am sure you all hear this
in your districts. They talk about wellness a lot. And the
reason they are so deeply focused on this issue, and want to
engage with us as a Department on the issue, is because they
are putting initiatives in place because they are starting to
see. And I was just actually with NAM this week, the National
Association of Manufacturers, and had one of the CEOs who says
she has done it now for almost 10 years, and she has the
analytics to show it. Those are analytics companies can make
decisions on. We want to see those to see if they are worthy
enough for us to make decisions on the taxpayers' money.
So it is across the board in both the public-sector
spending and the private-sector spending on these health
issues, and diabetes and heart disease are two of the leading
costs that we have, both publicly and privately.
The Chairman. The gentleman's time has expired. I would ask
my colleagues' indulgence, Secretary Burwell has a hard stop at
11:30, and, given the apparent interest everyone has in getting
these, I would ask for colleagues' unanimous consent to go to 4
minutes for questioning so that we give a chance for everybody
to get here to make that happen. So, without objection, we will
go to 4 minutes from this point forward. So, Mr. Crawford, for
4 minutes.
Mr. Crawford. Thank you, Mr. Chairman. Kind of keeping on
that subject, a lot of attention has been paid to the Dietary
Guidelines, and the fact that they are guidelines, they are not
rules. Am I correct in that?
Secretary Burwell. Yes. They are guidelines----
Mr. Crawford. Okay.
Secretary Burwell.--that then are used as a basis for
programmatic and policy decisions.
Mr. Crawford. Okay. So they actually are used pretty hard
and fast on rulemaking, then, correct?
Secretary Burwell. It depends on which program. So, for
instance, school lunch programs in our area--the Administration
for Community Living----
Mr. Crawford. Yes.
Secretary Burwell.--in terms of Meals on Wheels and those
types of programs, they are used, and they are applied in
different settings in different ways.
Mr. Crawford. We have heard a lot of talk about the school
lunch program, and it seems that--and I know that my colleague
mentioned he had gotten a text just in the last few minutes,
and I have gotten phone call, after phone call, after phone
call once the new school lunch program was implemented fully in
2012, but there has been very little attention paid to how we
roll this out and apply it rigidly to the SNAP program.
And so it seems like using the argument that, well, we can
be proactive, and we can sort of help to regulate the kind of
food that people eat that we can control, the Secretary
mentioned Department of Defense, and meals that our soldiers,
sailors, airmen, Marines receive. We mentioned the school
nutrition program, meals that our students receive, but we are
not talking about actively engaging in how we do a better job
in administering the SNAP program with respect to the sugary
drinks that are often purchased, and all the other things that
are bad, according to these guidelines. So why aren't we doing
a better job of actually going in and proactively engaging in
rules that help us do a better job on dietary structure, as it
applies to the SNAP program?
Secretary Vilsack. Well, first of all, we are trying to
address through a variety of mechanisms. The farm bill provided
for the Food Nutrition and Security Initiative, which is
designed to provide assistance and help for SNAP families to
purchase more fruits and vegetables and alike. The expansion of
access to farmers' markets is also giving them that
opportunity. We are looking at a--we had a data-based,
research-based program at Holyoke, Massachusetts for 2 years to
determine what would actually provide direction for SNAP
families, in terms of purchasing nutritious food, making
nutritious choices. What we found was that incentives work.
Also, there is a fairly serious technology challenge, in
terms of trying to prohibit people from using SNAP for certain
products.
Mr. Crawford. Okay, let me stop you right there, Mr.
Secretary, because I know that our travel card will deny a
purchase. If you try to fill up your car on official business
with your travel card, and then put a Snickers on there, it
will decline that purchase.
Secretary Vilsack. Well----
Mr. Crawford. So I know the technology exists that we can
do a better job in administering what the SNAP card can be used
for.
Secretary Vilsack. There are 300,000 different products
that are sold in grocery stores across the United States.
Mr. Crawford. Right. We ought to identify the ones that
aren't allowed.
Secretary Vilsack. Well, here is the problem. You want to
do sugared drinks? Does that include apple juice, 100 percent
apple juice? Do you want to permit that?
Mr. Crawford. But that is my question, why are we not
addressing that----
Secretary Vilsack. Well, I am asking, do you want to
exclude that? Because----
Mr. Crawford. No, I am asking you because we are not
marking up a bill here. I am trying to get feedback from you on
why the Dietary Guidelines are not more rigidly utilized in
the----
Secretary Vilsack. They----
Mr. Crawford.--SNAP program, they are in the school
nutrition program.
Secretary Vilsack. They are used in the SNAP program, in
terms of providing guidance and direction to SNAP families in
terms of how they can extend their SNAP dollar, where they can
buy fruits and vegetables, how they might be able to use
recipes.
Mr. Crawford. And you mentioned incentives. What kind of
incentives are being used to incentivize people to make those
smarter choices?
Secretary Vilsack. Well, the Food Insecurity Initiative is
providing resources to a number of groups that are providing
cash incentives. So when a person goes to a farmers' market,
and they buy $5 worth of tomatoes, they actually will be able
to buy $10 because of the additional incentive. So they get
more bang for their buck. It is also an opportunity for
associations involved to provide sales, to provide promotions,
to provide recipes. There are a whole series of programs. We
will be happy to provide you a list of all the grants that have
been made under that initiative, and what actually is being
done. I think that might be helpful to you.
Mr. Crawford. Thank you, I appreciate it. I yield back.
The Chairman. The gentleman's time--Mr. Aguilar, 5
minutes--4 minutes, excuse me.
Mr. Aguilar. Thank you, Mr. Chairman, and thank you both to
the Secretaries for being here. I wanted to expand a little bit
on that discussion. I participated, and I mentioned it to my
colleagues before, in the SNAP challenge earlier this year. And
the biggest piece that struck me was there was an end in sight,
when I went through this challenge, but it was the budgetary
constraints on healthy eating. And, Mr. Secretary, you were
just talking about those programs, and the success that you are
seeing there, and I hope that we can continue to grow those
programs.
And I understand that, within the Dietary Guidelines, both
USDA and HHS also plan to release marketing materials. And, Mr.
Secretary, you talked about choosemyplate.gov as an example,
showing folks how to live on a low budget and a balanced diet.
In the Advisory Committee report it is mentioned that the best
food patterns of healthy living include the healthy U.S. style
pattern, the healthy Mediterranean style pattern, and the
healthy vegetarian pattern. Do you know approximately how much
it would cost to afford each of these lifestyles per week, and
could you expand a little bit on the programs that educate low-
income families on healthy purchases like the food insecurity
program?
Secretary Vilsack. Well, the guidelines help to inform a
series of meal patterns, and it goes from the high end to the
low end. And the Thrifty Food Plan basically is the plan--I
don't know the specific dollar amount. Obviously, it depends on
the choices that people make, Congressman. But we need to sort
of dispel the myth that healthy eating necessarily has to be
more expensive. And here is why people think that. If you take
a portion of potato chips and a portion of broccoli, in the
past, the way we judge the value of that was by looking at 100
calories' worth of potato chips, and 100 calories' worth of
broccoli. Well, 100 calories' worth of potato chips would be
about three potato chips. One hundred calories' worth of
broccoli would probably fill \1/2\ this room. Obviously that is
going to be more expensive. But what we ought to be doing is
looking at portion sizes, because people eat more than three
potato chips, and they don't eat \1/2\ a room full of broccoli.
When you look at portion sizes, fruits and vegetables
become affordable, number one. Number two, if you look at
recipes, the use of canned and frozen vegetables and fruits
also is an opportunity--there are ways in which we can stretch
dollars, and so part of our education initiative is to provide
people with the recipes and the information that will allow
them to use fruits and vegetables more effectively, to
understand that it doesn't necessarily have to be more
expensive.
And then also the incentive programs that we have, where we
work with foundations to encourage farmers' market purchases by
incenting those, the food and nutrition incentives that allow
grocery stores to offer additional bonus points, if you will,
for SNAP families to purchase fruits and vegetables. I mean,
there are a wide variety of things. And we are also working
with food banks to make sure that the areas of opportunity that
they have to help struggling families also includes more
healthy choices. So there are a wide variety of steps and ways
in which we are attempting to make a difference.
Mr. Aguilar. I would love to see how we can stretch to
become healthier. But, I would say, it was incredibly tough,
Mr. Secretary, my wife and I, $66, on the SNAP challenge, to
include healthy portions and to manage our portions. I ate
peanut butter and jelly every day for at least one meal because
we were trying to have a couple salads for the week.
Secretary Vilsack. The SNAP program, as everyone knows, is
a Supplemental Nutrition Assistance Program. It is not
designed, and not engineered, and not funded to be the be-all
and end-all for a family----
Mr. Aguilar. But for countless Americans it is.
Secretary Vilsack. Well, I understand that, but that is why
we work with food banks, that is why we work with foundations,
that is why we work with shelters, that is why we work with
other avenues. That is why we have the school lunch and school
breakfast programs that are expanding. That is why we have
after school efforts, why we have a summer feeding program, to
try to supplement and to----
Mr. Aguilar. And I look forward to working with you to
carry out the mission of those programs----
The Chairman. The gentleman's time has expired. Mr.
DesJarlais, 4 minutes.
Mr. DesJarlais. Thank you. Thank you both for being here.
Secretary Burwell, I can count on one finger the number of
times that a sitting secretary has reached out to all the
Members of a Committee prior to the hearing to ask if they had
any concerns, and so thank you for that. I appreciate you doing
that. I know that is time consuming, but very thoughtful.
Historically, the Dietary Guidelines for Americans policy
document, which you say will be released in December, have not
made suggestions about specific ingredients of commodities, yet
that hasn't prevented the Advisory Committee from taking a look
at aggregate consumption by the U.S. population, and potential
health risks of ingredients such as low calorie sweetener
aspartame. Aspartame is one of the most widely studied food
additives in the history of the FDA, and its approval came
after more than a decade of review through an affirmative food
additive petition. FDA has asserted, and re-asserted, the
safety of aspartame, yet DGAC used a dubious process to call
into question its safety, citing extremely weak science against
the backdrop of decades of research that shows otherwise. And
now we are calling for more research, in spite of the fact that
FDA spent over a decade studying this ingredient's safety, and
concluded there is no increased risk of cancer from aspartame
consumption.
During your inter-agency review of the guidelines, are you
consulting with the FDA on recommendations after they spent
years reviewing the science?
Secretary Burwell. Yes, FDA is a part of the process at
HHS. And, with regard to the issue of the safety of aspartame--
and there are basically five products that FDA has said in
given contents are fine and safe. And so, yes, FDA is a part of
the HHS process.
Mr. DesJarlais. How did the inter-agencies review
ultimately impact the final recommendations?
Secretary Burwell. The inter-agency review is an extremely
important part of the process. Both the Secretary and I have
indicated that the input of the Advisory Committee is something
that we are reviewing, but our own experts across our
Departments, not just FDA for us, but CDC and NIH as well. The
whole Department is a part of this process. It comes together,
reviews everything together, and that is what forms the
recommendations that we will receive from our Departments
collectively together.
Mr. DesJarlais. Okay. Additionally, DGAC recommends
replacing sugared beverages with water or low fat milk only.
However, for the guidelines to be effective to most Americans,
we need to be able to meet them in the middle and offer
guidelines that are realistic, not idealistic. In your final
recommendations, how do you intend to balance dietary ideals
that are realistic and achievable for most Americans?
Secretary Burwell. With regard to that question, getting
ahead of where the recommendations are from our staff, I
wouldn't be able to comment on the specifics. But we do look
for a balanced approach and an evidence-based approach. With
regard to where we have the evidence about issues of--when we
say balanced, it is also about this issue the Secretary raised
of nutritional value. And so, when you are trying to have a set
number of calories, and you have to get in certain numbers of
nutrition, how you can get that puzzle to fit together is an
important part of what we will think about as we put together
the final guideline.
Mr. DesJarlais. Okay. Thank you, Secretary. Secretary
Vilsack, at the December meeting, before the final Advisory
Committee recommendations were voted upon, the committee got in
a discussion about the definitions of red versus lean versus
processed meat. At the end of the discussion they decided to
remove lean meat from the healthy dietary pattern, even though
the scientific data in their own report was not changed, and
the same, as the 2010 Dietary Guidelines, which recognized lean
meat as a nutrient-dense food, and nutrient-dense foods were
encouraged to increase.
It is important for the Dietary Guidelines to have a strong
scientific background, peer reviewed and published research to
give Americans clear advice on their diets and health. Can you
please give me the assurances that you have both taken into
account to ensure strong scientific evidence is the foundation
for the 2015 guidelines?
Secretary Vilsack. I can, and I can also suggest--it is my
understanding, and maybe I am wrong about this, that the report
basically is fairly consistent with the recommendation that was
made in the 2010 guidelines with reference to lean meat. I
would be surprised if our final conclusion is not to include
that as part of a healthy diet.
Mr. DesJarlais. Thank you, sir.
The Chairman. Mr. Costa, 5 minutes.
Mr. Costa. Four minutes, I got it. Thank both Secretaries
for your efforts in reaching out. I do appreciate that, and to
the degree that we collaborate on a greater basis, we all do a
better job.
A lot of discussion this morning has been talking about the
process in these guidelines, and I do appreciate your
emphasizing that they are guidelines, as a part of a total work
product. And I guess I would like to get your take, both of
you, on how we measure success. Clearly we all believe, or I
hope it is not in debate, that part of healthy Americans is a
healthy diet, and it is part of preventative health care. As
our mothers told us a long time ago, an ounce of prevention is
worth a pound of cure. So how do we measure success in terms of
the incredible changes that have been taking place in
American's dietary habits over decades, and this effort to use
these guidelines as a means to provide better diets so that we
have healthier lifestyles? Have you thought about that in this
process?
Secretary Burwell. So----
Mr. Costa. I mean, we are asking you the questions. How can
we make this process better?
Secretary Burwell. When we think about success, first, the
guidelines themselves being a quality product. We need to start
with that, and that is a lot of the conversation that we are
having today, about an evidence-based and quality product. The
second thing is how the guidelines get used in an appropriate
fashion, in terms of people understanding what they are and----
Mr. Costa. Do you think we are making progress along those
lines?
Secretary Burwell. I think it----
Mr. Costa. There is a lot of advertising out there that
tries to, especially among young people, skew their eating
habits.
Secretary Burwell. Yes, and so that comes to the third,
which is the knowledge has to be activated so that people are
acting and behaving. And those are all places where we believe
that we, as a nation, can improve. And we can improve it both
at a population health level, and then we improve it in the
ways that we use it in the programs. And whether that is the
programs at USDA, or the programs at HHS, in terms of applying
them. And CDC, and its work in population health, is another
place that I believe we can make progress.
Mr. Costa. Secretary Vilsack, you have been at this for 7
years.
Secretary Vilsack. Congressman----
Mr. Costa. How do you measure success?
Secretary Vilsack. I would only add to what Secretary
Burwell said, is that one way, potentially, of looking at this
is to take a look at the healthy eating index that we have,
which is a 100 point system. And currently today the average
American is about 57. We have seen improvement over the last
couple of years. That is good, but obviously--I don't know what
your mother said about 57 out of 100, but my mother wasn't
satisfied with that.
Mr. Costa. No.
Secretary Vilsack. So it is important for us----
Mr. Costa. Not good.
Secretary Vilsack.--to continue. That is one index. That is
one way of measuring. Another way is to measure whether or not
we are making headway on obesity. I am pleased by the fact
that, at least among young children, we are beginning to see
some indication of a plateauing, and potentially maybe even a
slight decline in obesity rates. That is good news. But we
still have work to do.
And in terms of improving the process, I would say that
this debate is healthy because it allows people to understand
what these recommendations are, and what they aren't. And there
is a misunderstanding between a prevention orientation, which
is what these guidelines are, versus a treatment orientation, a
lot of the criticisms often are because you aren't dealing with
certain diets that would be helpful in dealing with obesity.
And so maybe there is a way which we could potentially expand,
or create an avenue, for that kind of treatment discussion to
take place.
Mr. Costa. Okay. I have other questions regarding GMO
labeling, and biotech traits as it relates to that, and I will
submit that for the record, because there is no time. I guess,
just a final comment, and it is getting back to good habits.
When I grew up, it was a few years ago, but 8 ounces was
considered a regular thing, and a 12 ounces was really
considered big. And then I remember we were all floored by 16
ounces. Today, you see 24 ounces. It is a large part of the
problem, just sizes and amounts as it relates to obesity, and
how we combat against obesity. That is a comment.
The Chairman. The gentleman's time has expired. Mrs.
Hartzler, 4 minutes.
Mrs. Hartzler. Thank you, Mr. Chairman. Thank you,
Secretaries. I really appreciate the work that you are doing,
as a former family consumer sciences teacher who taught
nutrition for many years. It is very, very important, and very
important to be science-based. I am very encouraged to hear
that you are going to make sure that it is that, and doesn't
include sustainability, tax policies, other issues.
I wanted to focus on the Nutrition Evidence Library. We
have heard much about it, with even the USDA officials
describing it as the gold standard. But I have heard concerns
that the Nutrition Evidence Library has ignored a large
credible and growing body of peer-reviewed science on low carb
diets, as it contradicts the evidence from previous guidelines.
So can you elaborate on how scientific studies are added to the
Nutrition Evidence Library, and what can be done to ensure that
cutting edge research in nutrition science is considered?
Secretary Vilsack. Well, there are four approaches as it
relates to the library. There are original systematic reviews,
there are existing reports, there are new reports that are
funneled in from a variety of different locations. There is a
review of what the typical diet of an American might be. Food
pattern modeling is also included. So there is a broad array of
things that are included in this effort.
The issue of low carb diets raises the point that I just
made with Representative Costa. I think that is ultimately in
the context of how do you treat a particular condition,
obesity, for example? It may very well be that a low carb diet,
or a high protein diet, might be a way in which a physician
would prescribe for an obese individual to deal with obesity.
That is not what these guidelines are about. These guidelines
are about preventing that circumstance to begin with.
There isn't an avenue within the guidelines today for that
treatment discussion, and that is why there is a lot of
confusion about all of this, and why there is a lot of angst
about it, because some people are looking at the guidelines as
treating all health issues, and we are looking at what the law
requires us to do, and that is----
Mrs. Hartzler. Sure.
Secretary Vilsack.--focus on dietary and nutritional
guidelines relative to prevention.
Mrs. Hartzler. Now, some people point out that 52 percent
of U.S. adults are pre-diabetic, and they allege that a low
carb diet helps prevent people becoming pre-diabetic, so it is
actually----
Secretary Vilsack. So in that----
Mrs. Hartzler.--would be helpful to include that.
Secretary Vilsack. So in that circumstance you have
competing studies, which is why it is important to understand
this is really about well-informed opinion. I wish there were
scientific facts, but the reality is stuff changes, right?
Stuff changes. And the key here is taking a look at the
preponderance, the greater weight of the evidence, and trying
to make a judgment based on the greater weight of the evidence.
If you have one study on one side, and you have 15 studies on
another side, the preponderance of the evidence may be on this
side, with the 15 studies.
And that is a challenge, and that is why we do this every 5
years, to give an opportunity for that quality study to be
further enhanced so that, 5 years from now, maybe there are 15
studies on this side, and 15 studies on this side.
Mrs. Hartzler. In the guidelines----
Secretary Vilsack. It is an evolving process.
Mrs. Hartzler. In the guidelines, are there any disclaimers
mentioned in there that say for certain populations, this might
not be true, or for certain populations this might be helpful?
Do you include that, or do you just pick one and say, this is
it?
Secretary Vilsack. It isn't so much that. It is a caveat
that these are recommendations focused on prevention. They are
guidelines. They are not saying, ``You shall do this.'' They
are recommendations and suggestions that you should do this.
And that, sort of an indirect way----
Mrs. Hartzler. Yes.
Secretary Vilsack. We obviously haven't crafted the
guidelines yet, so I don't know whether or not they will be
caveats as----
Mrs. Hartzler. Yes, is there any population--I mean, there
has to be differences, perhaps, for different populations----
Secretary Vilsack. Well, there are----
Mrs. Hartzler.--the guidelines may not be one size fits
all, or do you present it as everybody--this is for----
Secretary Vilsack. It is a general guideline. It is a
general set of recommendations. It is--I mean, in theory, you
could have 317 million different guidelines----
Mrs. Hartzler. Yes.
Secretary Vilsack.--because we are all slightly different,
in slightly different circumstances. So you have to create kind
of a wide berth here, but within that wide berth, this is what
we are recommending. If you are interested in a healthy diet,
if you are interested in reducing the risk of diabetes and
cardiovascular, this is a course that you might want to
consider. Obviously, people are going to make choices and
decisions based on what is best for them.
The Chairman. The gentlelady's time has expired. Ms.
Plaskett, for 4 minutes.
Ms. Plaskett. Yes, thank you, Mr. Chairman, and good
morning to you both. Thank you so much for your time today. I
was just looking at the volume of comments that you had
received, the 29,000 comments after the report came out. Can
you explain how you are going to, and will you be able to, meet
the timeframe that you have for an evaluation of all of those
responses to be able to issue that report, the guidelines?
Secretary Burwell. Yes. Our staffs have gone through all of
the comments. One of the things that is helpful, in a sense, is
that a large percentage of them actually were form letters. So,
as the Secretary reflected, only about 8,000 were individual.
Not only, but that is less than 29,000----
Ms. Plaskett. Yes.
Secretary Burwell.--in terms of our ability to get through.
And the Secretary and I are both working very hard with our
teams to meet the deadline of this year.
Ms. Plaskett. Okay, great. And I guess my other question is
related to moderate alcohol intake. And, looking at the
guidelines that were issued in 2010, I noted in the 2015
Committee Statement that it confirmed the conclusions from
2010. Do we think that that is going to remain the same, or
what is considered moderation? Will that change as well?
Secretary Burwell. So, as you appropriately reflect, the
Advisory Committee has the identical recommendations from the
2010 report. While we are not going to comment on specifics, it
is important----
Ms. Plaskett. Yes.
Secretary Burwell.--to reflect that there was no change.
Ms. Plaskett. Okay.
Secretary Vilsack. After this hearing, I may be consulting
that guideline.
Secretary Burwell. The FDA would say he meets age
requirements.
Ms. Plaskett. And that is two for males, right?
Secretary Vilsack. Good enough.
Ms. Plaskett. Well, I just want to thank you all for the
tremendous work you have done. This is really important to the
American people. I am just echoing my colleagues' discussions
about proportion sizes, and the need for healthy diets,
particularly in communities in which there may be a dearth of
fresh foods that are available to them as well.
And also, let us not forget, in terms of obesity, the thing
we haven't talked about, which is not just your diet, but
exercise as well, which is something that Americans have been
woefully lacking for our young people for some time now. So
thanks very much. I yield the balance of my----
The Chairman. The gentlelady yields back, and I don't think
the Secretary--after 5 o'clock, did you? Mr. Rouzer, 4 minutes.
Ms. Plaskett. It will be 5 o'clock somewhere.
Mr. Rouzer. Thank you, Mr. Chairman, Secretary Vilsack,
Secretary Burwell. Thank you both for being here today. I
appreciate it very much, because this is an incredibly
important issue, and I am looking at this from a very macro
perspective. We have close to a $20 trillion debt. Medicare and
Medicaid, which you referenced a little earlier, is such a huge
component of that debt because the vast majority of our budget
is mandatory spending. Medicare and Medicaid are a huge
component of mandatory spending.
And so you consider the obesity issue that we are facing,
and you mentioned obesity and heart disease as two major
components that drive the cost of Medicare and Medicaid. All
that gets back to what we consume. And back to my time, when I
was in K through 12, versus the schools that I go in today,
when I look at the student population, I do not recall, at
least, when I was growing up, the number of overweight kids
that are in school that you have today.
And I visit all kinds of schools all across my district,
and I would say \1/3\ of them are clearly overweight. And some
of them are really young, I mean exceptionally young. And some
of them I know their parents, I knew their grandparents, and
obesity was not an issue in the family until this generation.
And so that leads me to think that clearly something has
changed in our society over the last 20 years, in particular,
and I look at it from the perspective of that you have
different movements out there influencing public policy. In the
Dietary Guideline Advisory Committee, there is the statement in
there that says common characteristics of dietary patterns
associated with positive health outcomes include lower
consumption of red meats.
It was mentioned earlier about caloric diet, trying to
maintain a certain number of calories. Well, not all calories
are the same. I would suggest, just from a common sense
perspective, 2,000 calories of beef versus 2,000 calories of
donuts are very different. Your body reacts to it very
different. Your body takes the carbohydrate and turns it into
sugar, and that often goes straight to the belly. Whereas
consumption of protein, same calorie amount, the body treats it
very differently. In fact, if you go and have a blood test
done, they measure protein level in your blood, which suggests
that obviously protein is a key component to a healthy
lifestyle.
So my main point that I want to drive home this morning is
that it is very, very important to understand that there is a
difference, not all calories are the same. And, from a public
policy standpoint, perhaps maybe we have gotten too smart for
our own good. I recognize science has improved dramatically,
but mankind has survived for many a thousand a year on red
meat, whole milk. In fact, I remember growing up when there was
a report that came out that said apple juice was bad for you,
and then they came out and said, actually, no, we are wrong.
Eggs, bacon. I remember growing up where they said, ``May
contribute to high cholesterol and heart disease.''
I want to make sure that we get back to common sense, and
that we do what is right for future generations, because--not
only for the health standpoint, but that translates directly in
terms of the public policy decisions we have to make as it
relates to our budget.
Finishing it up here, I want to ask both of you----
The Chairman. You can't ask anything at this point. We are
going to have to keep going. Ms.----
Mr. Rouzer. No problem.
The Chairman.--DelBene, 4 minutes.
Ms. DelBene. Thank you, Mr. Chairman, and thank you both
for being here and for your time today. First I wanted to ask
you about dairy. As you know, it has been a distinct food group
in the past, and, according to the report, dairy products
contribute many essential nutrients, Vitamin D, calcium,
magnesium, iron, Vitamin A, riboflavin. And yet, since 2010,
one percent flavored milks haven't been allowed in schools, and
we also know that dairy consumption has dropped in girls ages 4
to 8. And so I just had a couple questions: how do we continue
to make sure students have access to appealing and nutritious
dairy products, and do you expect that dairy would remain its
own food group, going forward?
Secretary Vilsack. Well, I don't want to assume what we are
going to do, in terms of the guidance, but I will tell you that
one of the things that we have done is to work yogurt into the
school lunch program. And we are also taking a look at the
issue of milk, relative to school meals. So that is in the
process, not in the context of the guidelines, but in the
context of our efforts to try to encourage healthier choices at
schools.
Ms. DelBene. Yes.
Secretary Vilsack. I don't think there is any question that
dairy is an important component. It is going to be recognized,
and should be recognized.
Ms. DelBene. And, kind of on a different note, given that
we have regional, cultural, socioeconomic diversity throughout
the country, how will the Dietary Guidelines meet the
challenges of being relevant, accessible, achievable for all
Americans, knowing that, folks have different backgrounds,
cultural backgrounds, that may impact the types of foods that
they are eating?
Secretary Burwell. I think that many of the programs that
the Secretary has spoken about, in terms of how you put those
out, it is about having information that is simple enough that
you can use it in your own cultural context, and then it is
about a number of the programs, in terms of how the information
moves. Not just the guidelines themselves, but then the
programmatic piece that follows on. So it is the step beyond
the guidelines. Having guidelines that are clear and simple
enough that can be applied across context is the first step,
but then it is how those guidelines are then implemented.
Secretary Vilsack. Right. Our work at USDA with Native
American populations, is a good example of where we are trying
to work to reflect the traditions and culture of Native
Americans and Indians to make sure that their dietary choices
are a wide enough range that they can meet their cultural and
traditional needs.
So there is a greater sensitivity, and that is the
challenge for us in the future, which is to understand those
differences, and to try to figure out creative ways from
recipes, and from direction and instruction, to reflect those
differences without necessarily getting to a circumstance where
we have to move away from the purpose of these guidelines,
which is a--sort of a general recommendation.
Ms. DelBene. Thanks. I guess it is also, then, important to
understand what the messaging might be, going forward, and how
different folks will understand and be able to learn about the
guidelines as well.
Secretary Vilsack. Well, there will be an extensive effort
at both Departments, but certainly at USDA we will be using all
of the tools that we currently have, which have been pretty
effective. The choosemyplate.gov has been one of the more
effective efforts on the part of USDA. We are going to refresh
that, obviously, the choosemyplate.gov, the super tracker, the
SNAP education and nutrition information that we provide to
SNAP families, the work that we will continue to do on menus
with school lunch personnel. There are a variety of ways in
which we can incorporate and assist folks in trying to follow
these recommendations.
Ms. DelBene. Thank you both again for being here, and I
yield back, Mr. Chairman.
The Chairman. The gentlelady yields back time. I need to
apologize, Mr. Rouzer. I was brusque and rude. I should have
simply said your time has expired. So, David, please accept my
apologies.
Mr. Rouzer. No problem, Mr. Chairman.
The Chairman. Mr. Kelly, 4 minutes.
Mr. Kelly. Thank you, Mr. Chairman. Thank you, witnesses.
The Dietary Guidelines for Americans have been published every
5 years since 1980. We are concerned that the public at large
has lost faith in the process to develop the Dietary
Guidelines, which will ultimately decrease the adherence to
them, with potentially costly effects on public health. In the
military, in my service, we often say you can have an SOP,
standard operating procedure, but if your units and your
soldiers don't know them and use them, you don't have an SOP.
It is the same thing with guidelines.
Before coming to Congress I was a prosecutor, and I
understand that two people can look at a problem and come to a
different solution. And, Secretary Vilsack, during your process
you talked many times about the preponderance of evidence, but
as a prosecutor, I didn't get by with that standard, because
the things that I was doing were so important that I had to
prove beyond a reasonable doubt my case.
Because for different things and different priorities, the
importance of them, sometimes we have to use a different
standard of evidence, and I would say maybe a preponderance of
the evidence for scientific evidence is not the right standard.
Maybe it is clear and convincing evidence. Or maybe it is
beyond a reasonable doubt that, when we have science, that we
hold them to a standard that makes sure that the end result is
something that we have a good belief that it will be viable,
and it will be the right answer. Although we won't always be
correct, if we raise the standard, maybe we will be correct
more often.
Secretary Vilsack. Congressman----
Mr. Kelly. Further--if I can finish--there have always been
disagreements about this, and there always will be, about what
the science is. I just say, sometimes we may want to look at
the standards. But over 1,350 percent increase in public
comments, it raises some concern with me that people don't have
faith in the system.
So, to both of you, I just ask you, what can we do? Because
it doesn't matter how good the standards are, and it does not
matter if we are doing the right things, if the public doesn't
have trust that it is the right thing, we have to build that
trust. And, Secretary Vilsack or Secretary Burwell, what would
you do to make sure that our public believes that the standards
of the guidelines that we are putting forward are the true and
correct ones? Thank you.
Secretary Vilsack. Congressman, first of all, the
preponderance of the evidence standard is a Congressional
mandate, so we have to follow the Congressional mandate. So if
you all believe that it should be a higher standard, that is
obviously your call, and whatever your call is, we will follow
it. Second, despite the fact that we had 29,000 comments, we
have also had 290,000,000 hits on our choosemyplate.gov
website, which would suggest to me that people are following
these guidelines, they are interested in these guidelines, and
they haven't necessarily lost confidence in them. So that is
another data point that I think is important to take into
consideration.
And I see this as a positive thing. Maybe I am looking at
this wrong, but the more public input that you have, the better
the decision-making can be. And we are obviously going to take
all this information into consideration, as we should, and
there are a variety of input focuses on all of this, and
hopefully we are going to come up with the best guidelines that
continue to have the faith and confidence in the American----
Secretary Burwell. And I would just add, even as we
implement the statute in preponderance, that, as you
appropriately indicate, there are different levels of evidence,
and it is related to your colleague's earlier comment about
aren't there different populations that are affected in
different ways? And the evidence that we look at, and whether
that is on the issue of sodium, and what that recommendation
will be, and what we did last time, it does look at different
places, where there is more evidence or less evidence. And that
is something that is important to do, and we do follow statute.
But we hear your point----
Mr. Kelly. Thank you.
Secretary Burwell.--and the scientific review actually--
when we get our----
Mr. Kelly. If I can just--I have 10 seconds. If I can have
one further point? I just think it is just important, that the
citizens want to know that we are not using science to justify
ideology, that it is the other way around. Thank you, and I
yield back, Mr. Chairman.
The Chairman. The gentleman's time has expired. Mr. Davis,
4 minutes.
Mr. Davis. Thank you, Mr. Chairman. Thank you, Secretary
Burwell. It was great to speak with you last week, and thanks
for being here and talking about this very important subject.
Secretary Vilsack, I know you are probably going to be
surprised by this, but I am not going to ask you about the
school lunch today. It has been discussed already, so I will
skip over that. But I do have some concerns.
My most serious concern today is what I see as a lack of
evidence to show that the recommended dietary patterns proposed
by the DGA have been based on any evidence on children.
According to the citations in some previous advisory reports
for recommendations, the recommended diet has been tested
almost exclusively on middle-aged men, and women, whose
nutritional needs, obviously, are very different from young
people and growing children.
In particular, I am concerned because young children need
certain vitamins and minerals, obviously, in order to grow and
develop. We are talking about where, in previous reports, the
expert report states that the recommended dietary patterns do
not meet sufficiency goals for potassium, Vitamin D, Vitamin E,
choline, and that Vitamin A sufficiency may be marginal. These
are essential basic nutrients for growth and health in
children, and as a dad of a freshman in high school, and a
coach, these are things that concern me on a regular basis too.
At the same time, the DGAC appear to be deficient in their
role in developing nutritional guidance to meet the basic
nutritional sufficiency for children to grow and be healthy.
They were expanding their review of what has been referred to
as the dining out topic. Specifically, the fast food category
was broadened to capture other types of dining out venues,
including, like, quick serve, casual, formal restaurants, and
grocery store take-out.
And, given today's busy lifestyle, and really, when you
look at restaurants, they have offered a lot more healthy
choice than what we saw just a decade ago. And, with that, I am
kind of disappointed, and others are disappointed, that
restaurants seem to be singled out, even though they are doing
their best to offer healthier options to customers, and that
concerns me. And I just find it difficult to understand that
location in which we would eat, without any other
consideration, automatically impacts the quality or nutritional
value of the food served. And I certainly understand that some
restaurants may serve better food than others, but that is the
consumer that can make that final decision on that too.
So, Secretary Burwell, wouldn't you agree that the nutrient
content of food is more important than where the food is
purchased, and that, rather than directing people away from
dining out, maybe we should focus on helping to educate them on
their nutritional choices?
Secretary Burwell. So, with regard to the issue of
children, and the amount of research and evidence that we have
in that space, even as we are preparing to complete where we
are now, the conversation--my team actually brought up the
issue of children yesterday, as we look to making sure we have
appropriate evidence for a number of the things that you are
talking about for the next set. Because, what you are
appropriately reflecting is the research doesn't exist because
it is on older, so we need to get started on that now. So with
regard to the issue of, do we need to understand this better,
we don't have the facts yet. We don't have a science base, but
if we start now, we will for the next.
With regard to the question----
Mr. Davis. Great.
Secretary Burwell.--the dining out----
Mr. Davis. And I appreciate that.
Secretary Burwell.--the dining out question, right now 30
percent of your calories, for Americans, are consumed outside
the home. And with regard to how we think about making sure
that----
Mr. Davis. What percentage?
Secretary Burwell. Thirty percent. So when that is
happening, what we need to focus on, with regard to this issue,
is making sure people have appropriate information. That is
what we want to do, is make sure that people have appropriate
information to make the choices. As you reflect, it is up to
people to make their own choices in that context. And that is
where we touch on that issue. And, again, always separating the
Advisory Committee's work with the work that we are doing.
Mr. Davis. Well, thank you again both. My time has expired.
The Chairman. The gentleman's time has expired. Mr.
Benishek, 4 minutes.
Mr. Benishek. Thank you, Mr. Chairman. Thank you both for
being here today. I want to follow up on a few of the thoughts
that Representative Hartzler had. As a physician, I have been
involved in peer-reviewed science in my training, and in my
career, and I am a little bit concerned about some of the
things you guys have said here. You brought up the fact that
the AMA brought out that 52 percent of Americans are pre-
diabetic, or diabetic, and yet, the dietary recommendations, as
I understand it, are not really appropriate for that. There are
too much carbohydrates. These people have a carbohydrate
intolerance, and there are more carbohydrates in the diet that
you are recommending than is really appropriate for that. And
you mentioned that this would be a treatment, but this is
really not a treatment. This is a preventative problem, and I
think that you have to address that more.
Those are my comments, but one of the questions that I had
is, how are the studies taken, how do you determine what
studies to base your science on? I have evidence that this
evidence library included some trials, while excluding several
other larger trials, some of which were funded by the NIH. I
don't know why all the studies aren't included in the data. How
does that not lead me to believe that there is a pre-determined
result that has been looked for?
Secretary Vilsack. Well, the process starts with a series
of questions that are formulated, and then information is
accumulated, and it goes through a process of evaluation.
Mr. Benishek. Is the NIH involved in this process?
Secretary Vilsack. Well, it is involved in the sense that
the NIH helps to fund studies that----
Mr. Benishek. I know, but I mean they are not involved as
inter-agency review of how the studies are picked?
Secretary Burwell. I think there are two different
processes. There are three. One is the library of materials
that people use, and that is housed at USDA. I think the second
is----
Mr. Benishek. So is stuff excluded from that library? Who
makes the choice of what goes in the library?
Secretary Vilsack. Well, there is a process that the folks
at the National----
Mr. Benishek. That is what I am asking. Is the NIH involved
in that process? I mean, I am just surprised that NIH funded
studies, some of which were larger than the studies that you
rely on for your data, contradictory studies, funded by the
NIH, are not included in the data. So I am just kind of
wondering why.
Secretary Vilsack. If you can give me specific----
Mr. Benishek. Well, yes, I can do that.
Secretary Vilsack. Yes, I will be able to provide you a
specific answer as to why that particular study, or series of
studies, were not included, or perhaps they were, and we are
having a----
Mr. Benishek. Well, my understanding is they are not. That
is----
Secretary Vilsack. Well----
Mr. Benishek.--why I am concerned, because that is leading
to my question, and some of your comments suggested that
diabetes, and pre-diabetes, and obesity are major problems in
this country. And, because of the cut down on the fat portion
of the diet, we are recommending more carbohydrates. Well, this
is a--that is exactly the problem that pre-diabetics and
diabetics have, is not being able to respond to carbohydrates.
So, I mean, for the majority of the people, 52 percent of the
people being pre-diabetic, this is the wrong diet to recommend.
So when you say it is a general diet, well, that is great,
but then shouldn't it be the caveats that Mrs. Hartzler
mentioned? This is pretty serious stuff here, somebody else
mentioned, when we were kids, people aren't as fat back when we
were kids, and we are eating more fat. And, frankly, it is not
an exercise thing, as far as I can see, because I am
experienced with it. If you eat a lot, you can exercise it all
off. You have to get it right.
The Chairman. The gentleman's time has expired.
Mr. Benishek. I am sorry. I did go on, but----
Secretary Vilsack. Mr. Chairman, if I could just have 30
seconds. I would say that the NEL website will provide you the
information as to why certain studies weren't selected, but if
you get us specific information, Congressman, we will be happy
to provide you specific answers to specific studies.
The Chairman. All right. Mr. Allen, for 4 minutes.
Mr. Allen. Yes, and I will just follow up on that question,
as far as the NEL was concerned, and as far as the Dietary
Guidelines Advisory Committee did not use the NEL for more than
70 percent of their research questions, why was the NEL not
used in these guidelines?
Secretary Burwell. For certain issues, like food pattern
analysis, that they needed to do to understand what we actually
are eating, an issue that has been brought up a number of times
in this hearing, that is not information that would be
available there, and they need to turn to other sources for
that information to understand what is it actually Americans
are eating? The sources for that are different. I think there
were some other issues.
The reason it is not all there is if the question--if that
is not where the source of information can come from, there are
certain data analytics, and there are also places where
systemic reviews have already been done on the issues, and
while they do their own systemic review, they at least consider
the other systemic reviews. And so I don't think those are
counted in that percentage. But, Secretary, since that is
housed at----
Secretary Vilsack. Well, the only other thing I would say
is that the review process goes through a series of mechanisms
to try to provide an understanding of what the best science is,
the best available science is, and the least biased science is.
And it is a series of things, the Cochran Collaboration, the
Academy of Nutrition and Dietetics, the Aging for Healthcare
Research and Quality, the Data Quality--all consistent with the
Data Quality Act. So that is the other parameter that we have
to work under, is that the Congress has given us direction,
under the Data Quality Act, as to how this is to be managed.
Mr. Allen. Well, the NEL is basically science-based. There
is very little ideology there. They go by exact science. And I
didn't quite understand why you--still don't understand why you
are not using them as a--more of a resource in these
guidelines.
Secretary Vilsack. They are used----
Secretary Burwell. Extensively.
Mr. Allen. Extensively.
Secretary Burwell. It is only when a question can't be
answered--one of the issues is certain of the data analytics
around what everyone is eating right now are different sources,
is my understanding of why the Advisory Committee didn't use
it. That is the kind of----
Mr. Allen. So they didn't have the information on more than
70 percent of the research?
Secretary Burwell. I think there are a number of other
places that the Advisory Committee has to turn to other things,
and they do that.
Mr. Allen. Regarding sodium, obviously, there are some of
us that retain fluid, and there are others who do not retain
fluid. Sodium, back in my athletic career, I took salt pills,
and I had a hard time retaining fluid. Of course, now it is the
opposite, I am on a low sodium diet. All this stuff is very
personal. It depends strictly on your DNA, and that sort of
thing. In my opinion, it is very dangerous to set forth
guidelines when everybody has a different DNA, and at different
ages you have different requirements. And, of course, we
already talked about it doesn't apply necessarily as much to
children.
And the mistrust here is that this one size fits all thing.
Because, folks are getting a lot of bad information in our SNAP
program. They are really not getting good information, and then
the consequences are this epidemic of diabetes that we have,
particularly in Georgia, with folks who do not know how their
diet works, and how it fits. Is there any way to get this more
locally based, rather than Washington top down?
Secretary Burwell. We want to get it to the place where it
is useful, and I think that is a big part of the conversation.
With regard to the issues like sodium, we do take care to not
put something--a standard that--it is the standard for
everyone, not the standard for individuals. And then, this is
about how one implements, in terms of--if it is the standard--
but if you have a certain disease condition, then we need to
figure out how we, in a public health setting, and other
settings, can provide the right information for you. Because
the IOM has said 2,300 milligrams of salt, but perhaps right
now, for you, in your current state, that is not actually
accurate.
Mr. Allen. Yes. I am less than 1,000. And I yield back, Mr.
Chairman.
The Chairman. The gentleman's time has expired.
Secretary Burwell. So we have to make sure, even though we
set at 2,300, that we can have a forum in which we can
communicate, so you know where to turn, together with your
physician.
The Chairman. Mr. Moolenaar, for 4 minutes.
Mr. Moolenaar. Thank you, Mr. Chairman, and Secretary
Vilsack, and Secretary Burwell. Thank you for being with us,
and my apologies for my voice. It still hasn't gotten better
since yesterday. I wanted to mention just a couple of themes
that I have heard, especially you, Secretary Vilsack, stating
today is that you don't want to assume what we will do with the
guidelines. You don't want to pre-determine what the outcome
will be. Is that a fair assessment?
Secretary Vilsack. The process hasn't been completed yet.
Mr. Moolenaar. Okay. And then one of the other themes I
heard you say was that the more public input you have, the
better decisions we will have. Is that a fair statement?
Secretary Vilsack. Yes.
Mr. Moolenaar. Okay. Well, one of the concerns I have about
the process that you are currently following, my understanding
is you have the Dietary Guidelines that are based on the expert
report from the Advisory Committee, and then that is translated
by you and your staff into--or your Department into actual
guidelines. Is that----
Secretary Vilsack. That is one aspect of it, Congressman.
It is not the only thing that we rely on or look at. It is one
piece of a large puzzle.
Mr. Moolenaar. Okay. Well, the concern is, and I know that
we have had a comment period to date, and it seems that right
now the process only allows for the American people to comment
after the committee releases its report, but does not allow for
public comment after USDA and HHS release the final Dietary
Guidelines. And I appreciate that you did extend the 60 day
public comment period by an additional 15 days following the
release of the report this spring, but, as you can tell from
the hearing today, there is still considerable criticism of the
report.
And there is a provision in the Fiscal Year 2016
agricultural appropriations legislation that, if enacted,
requires a 90 day comment period after the Dietary Guidelines
are formally released. And this process seems more in line with
the Administrative Procedures Act, which long pre-dates the
current process you are using for the Dietary Guidelines. And
considering the fact that more than 29,000 comments were
submitted on this report, while only 2,000 were received on the
2010 report, it really shows that there is a great deal of
interest in this by the public, and it seems to me that the
public should have a final opportunity to comment on this
report before it is finalized. And I guess my question is would
you agree to give the American people another comment period,
given the fact that the 2015 committee report generated the
most comments in the history of the guidelines?
Secretary Vilsack. Well, first of all, I would point out
that there were a number of places where the public could have
input in this process before even the public comment period. As
the dietary advisory group was meeting, there were a series of
public meetings, opportunities for people to have input, and
the like. There has also been continued opportunity to have
input in the process. The challenge I have, Congressman, is
when does the process--you have to have a finality to it. You
have to have a stopping point to it, and--in order for us to be
able to factor into the various other decisions we have to make
that are in some places based on the guidelines. So I am
concerned about how long you extend this process.
Mr. Moolenaar. Well, yes, but----
Secretary Vilsack. And the last thing I would say is the
public does have a way of commenting on this, and that is that
they could decide not to follow them. They could decide to be
critical of them once they are proposed. So, I mean, there is
an ongoing debate and conversation about this.
Mr. Moolenaar. I guess----
Secretary Vilsack. It never ends.
Mr. Moolenaar.--my concern is, right from the start you
made the comment, and I appreciated it, that you didn't want to
pre-judge what the guidelines will be. It is not a complete
process. You are taking in feedback now. But the reality is
that once you publish those guidelines, those are the
guidelines, and there is no avenue for the public to have input
on that. And I think that is----
Secretary Vilsack. Well, I would disagree with that, in the
sense that there have already been several places where they
have had input, and they can continue to have input. They
continue to respond to the 2010 guidelines, which are part of
the foundation and the information that we take into
consideration. So it is an ongoing education process. I don't
think it ever stops. Now, there may not be a formalized period
of time, but it never stops.
Mr. Moolenaar. Well----
The Chairman. The gentleman's time has expired.
Mr. Moolenaar. Thank you, Mr. Chairman.
The Chairman. Mr. King, 4 minutes.
Mr. King. Thank you, Mr. Chairman. Thanks to the witnesses
for testifying today. A few questions still come to mind, after
all this discussion that we have had here. And the first one
that I have is that when I look at data on the students that
are overweight or obese, have we had any evidence that of which
direction their weight has gone? I ask first Ms. Burwell. Do we
have any indication on whether this program is reducing the
obesity of our children in school, or whether it might be
working against us?
Secretary Burwell. So with regard to the specifics of
programs in schools, I would----
Mr. King. The lunch program, yes.
Secretary Burwell.--defer to my colleague, Secretary
Vilsack, in terms of those programs. What we do know is that in
younger children we are starting to see overarching across the
board, not just from a programmatic school base, but we are
starting to see the numbers go in the right direction. With
regard to the specifics of school programs, I would defer----
Mr. King. Well----
Secretary Burwell.--to Secretary Vilsack.
Mr. King. And I was actually prepared to redirect that
question after your response, so thanks for pointing that out.
I would say this information, Mr. Secretary, according to the
Centers for Disease Control, we saw the obesity rate of high
school students by nine percent in the 4 years prior to the
Healthy and Hunger Free Kids Act's implementation, and, in the
4 years after, that the obesity rate increased by 16 percent.
Have you seen any data like that from the Centers for Disease
Control, and does that cause you to wonder what the result of
that might be?
Secretary Vilsack. Congressman, I would be happy to take a
look at that information to better understand it, but there is
no question in my mind this is not a situation where we are
going to see fundamental change in a year. It is going to be a
generational process. And I am convinced that, from a
generational process, we are going to see progress. And
Secretary Burwell's correct, that we have begun to see
progress, particularly among younger children.
Mr. King. Let me just ask you another one. This data says
the opposite. It says the obesity rate of high school students
had reduced by--we just picked the 4 years since it has been
implemented and went to the 4 years prior, so it was the
longest period of time that we could have that would have
balance, 4 years before, 4 years after. In the 4 years before,
obesity rates went down nine percent, according to CDC, and the
4 years after obesity rates for high school students went up 16
percent, according to the CDC.
Now, I don't know how to explain that, because what I am
getting back from my constituents, and across this country, is
more and more complaints about not enough food for these kids.
And I would ask, Mr. Secretary, we are all very well aware of
those complaints, especially as this was implemented in the
fall of 2014. Now we are well into the school year of 2015. Are
those complaints going up or down, in comparison to the year
earlier?
Secretary Vilsack. They have gone down. In fact, some
school districts that left the program have come back into the
program.
Mr. King. Well, I am glad to hear that, and how is that
program doing in Rhode Island that was spawned by the waste,
and do you have any measure on the waste of the food that has
been--the program in Rhode Island that I am referring to is
aptly named--it is at North Smithfield, Rhode Island, where
they are feeding 3,000 pigs with the waste from the school,
essentially an industry that is created. And I still get a lot
of complaints on hungry kids.
Secretary Vilsack. So----
Mr. King. I am concerned. Is there any question, and then
is there evidence that our students, K through 12, are getting
overweight because of school lunch program, or are they eating
that food somewhere else that is making them overweight? Was
there ever any evidence that indicated it came from the school
lunch?
Secretary Vilsack. Congressman, in terms of food waste,
there is the Rudd study at the University of Connecticut. There
is the Harvard Public Health school study. There is a study at
Berkeley, University of California Berkeley, suggesting that
kids are eating more fruits and vegetables, no more food waste,
and, in fact, are eating more of their entrees than before. So
I don't think there is documentary evidence. There may be
anecdotal evidence from school to school, and we are,
obviously, focused on the food waste issue. I am sorry, the--
your second question?
Mr. King. Were they ever getting overweight on school
lunch? Was there ever any evidence prior to 2010?
Secretary Vilsack. Well, that is sort of an interesting
question. It could be answered yes and no. Yes, because it was
part of the overall caloric intake that a young person was
taking, and if they were taking more calories than they should,
then everything that they ate in that particular day, in a
sense, contributed. But if you are asking whether or not the
number of calories consumed in a school meal, if we fit it
within the standard, it shouldn't contribute to obesity.
Mr. King. Either before after----
Secretary Vilsack. Especially----
Mr. King.--2010?
Secretary Vilsack. Especially if we are reducing the fat,
sodium, and sugar, as we are.
Mr. King. I am out of time, I regret. Thank you,
Secretaries.
The Chairman. The gentleman's time has expired.
Secretary Vilsack. Thank you, Mr. Chairman.
The Chairman. Mr. Newhouse, for 4 minutes.
Mr. Newhouse. Thank you, Mr. Chairman, and thank you, Mr.
Secretary, and Madam Secretary, for being here with us this
morning. I appreciate your time. I have a couple observations,
but also some requests, and a question or two, and I will try
to get through in 4 minutes. I have spoken with a lot of
impacted constituents, and also through my own review. It seems
clear that this Dietary Guidelines Advisory Committee went
outside the scope of their mandate in developing the
recommendations for the report, including policy
recommendations from taxes to local restaurant zoning, to food
labeling, and sustainability policy. According to the
underlying statute, that was the sole product of this committee
back in 1990, each such report shall contain nutritional and
dietary information and guidelines for the general public.
Secretary Vilsack, back in March, the Wall Street Journal
reported you saying, ``I read the actual law, and what I read
was that our job ultimately is to formulate dietary and
nutrition guidelines, and I emphasize dietary and nutrition
because that is what the law says. It is my responsibility to
follow the law.'' Sustainable diets are an appropriate debate
to have, you said, however there are forums and places for that
to take place. And I was pleased to hear your comments, but
what concerns me is the lack of evidence to suggest that
neither of the agencies exercised any effort to instruct the
Advisory Committee on their scope, or mandate.
When you, Secretary Vilsack, and Secretary Burwell, your
predecessor established the committee, you did so under the
Federal Advisory Committee Act. This Act is designed to ensure
that advice by the various Advisory Committees formed over the
years is objective, and accessible to the public. The Act has
formalized a process for establishing, operating, overseeing,
and terminating these advisory bodies across government. The
DGAC members are not full time employees, and rely very heavily
on agency staff to carry out their duties.
To be clear, when I review portions of the report, such as
the Advisory Committee's conflict statements on encouraging
lower meat consumption, but then higher meat consumption for
the Mediterranean diet, or when I can see the Advisory
Committee's recommendations on added sugars versus natural
sugar, or use a lower scientific threshold than groups like the
Institute of Medicine have used to reach their conclusions, I
worry greatly about the process, and the guidance and oversight
that they have been given.
So it would be helpful for you to provide the Committee
evidence in writing to confirm that your agencies did, in fact,
make attempts to oversee the Advisory Committee once it became
clear they were delving to areas of public policy. In response
I would like to see evidence that your agencies provided
instructions to the committee during their assembly to ensure
they were staying focused on the right guidance, and not
straying into policy matters outside their scope or mandate.
And, likewise, I would like to receive documented evidence of
the instructions agencies provided to the committee on the
public law to help them understand their report must be based
on the preponderance of scientific and medical knowledge that
is current at the time of publication.
And, finally, I would like to welcome your comments on any
advice you could give future secretaries as to future Advisory
Committees, and how they could stay focused on their charter,
and produce a recommendation that really stays coloring with in
the lines. So I would appreciate a response. Thank you.
Secretary Vilsack. We will certainly provide a response to
your questions, Congressman, as we are bound to do, and would
be happy to do that in writing.
My advice to future secretaries will be to continue the
process of educating people about what these recommendations
are and what they are not, and the distinction between the
report and the guidelines. There seems to--again, I have said
this several times today, there seems to be a misunderstanding
upon some folks that the report equals the guidelines, and that
is not the case. The report is one aspect of our consideration,
one aspect of the data, or the information, that is used to
formulate these guidelines.
And, to me, this debate has been helpful, I hope, in
getting a better understanding of precisely what the
recommendations are. And the discussion we have had today is
also healthy, as it relates to what is the purpose of these
guidelines? Is it focused on prevention, or is it focused on
treatment, or should it be focused on both? I think that is a
healthy discussion.
The Chairman. The gentleman's time has expired. Mr.
Thompson, 4 minutes.
Mr. Thompson. Thank you, Mr. Chairman. Thank you, both
Secretaries. I really, really appreciate you being here. My
first question actually is very specific. It is an area I care
a lot about. So my question is, why do Americans, especially
children over the age of 4, continue to fall short of the
Dietary Guidelines' recommended servings of milk, and its nine
essential nutrients and vitamins, and what can we do to remove
policies that are hindering milk consumption, or promote
policies that could enhance milk consumption?
Secretary Vilsack. We can, basically we are taking a look
at those issues right now, Congressman, and that is the goal
here, is that, as we learn more, as we understand more, as we
re-learn lessons of long ago, that is obviously going to change
the direction and focus. That is the whole purpose, and the
whole reason why we do this every 5 years, is it is an evolving
process.
Mr. Thompson. Yes.
Secretary Vilsack. And as our information evolves, our
policies will evolve. And we are taking a look at the issue of
milk, and taking a look at ways in which milk can be introduced
into diets in a variety of different ways, dairy products.
Mr. Thompson. And we worked together on that, and I
appreciate those efforts. I want to know, how much of a factor
do you think that it is that we publish these guidelines once
every 5 years, and as you said, 5 minutes before you are ready
to publish it, there is new evidence that probably is contrary
to what you are publishing. And I am assuming, correct me if I
am wrong, that the rate of research within nutrition is
significant. Which is a really good thing, so the fact is, as
soon as you publish these guidelines, to some extent they are
inaccurate, and the longer they are there until the next 5
years, the more inaccurate they are. But when you publish them,
doesn't that influence the markets?
I would argue--I would think, I am not going to argue, but
I would think that when it comes to milk, the fact that at one
point the guidelines discouraged milk took all the flavor out
of it, because somehow fat was bad for you. And I know the
science today shows contrary to that. But you take the fat, you
take the taste out, and that somehow these guidelines that we
do every 5 years, that are never really totally accurate, and
increasingly more inaccurate towards the end of the 5 years,
increases the impacts on the ag commodity markets.
My question for you, given the fact that these were under--
I may be wrong--President Carter, so it would be late 1970s
when it was originated, are Americans healthier or less healthy
since the guidelines have been published, and therefore, are
these, in some way, haven't these guidelines somewhat failed?
We are talking about increasing obesity. The Pentagon is more
concerned than ever about having access to kids that would be
able to serve in the military. Have these guidelines really
been successful, given disease, and chronic illnesses, and
conditions? And that is not to be a criticism, because my
second question is, then, how do we use these in a way that
they could be successful? Because they don't seem like they are
accomplishing the objective, as you two have very well
articulated today.
Secretary Burwell. So we do want to--and I think the issue
of obesity is one that has a number of different elements. And
the physical activity guidelines, which are something that
Congress mandated----
Mr. Thompson. As a former rehabilitation guy, I am all in
on that. I agree, yes.
Secretary Burwell. So that is another piece that I think
that we need to focus on, and we need to make sure that these
things are being used. I think you are right to reflect. The
question is, what is the critical path issue, and what is the
counterfactual? That is the other thing that we all can't
answer. We are on the wrong trajectory, but would the----
Mr. Thompson. Yes.
Secretary Burwell.--trajectory have been worse, and then
second----
Mr. Thompson. Sure. Well----
Secretary Burwell.--what is the----
Mr. Thompson.--let me make a suggestion, and get a response
in the few seconds I have left. It seems like once every 5
years this doesn't work because it changes. And, in fact, it
can negatively impact ag commodities, which is irresponsible,
to tell people not to eat certain things when the next round of
research says that you want to eat more of it. Shouldn't we do
something, in this day and age, with technology that would just
share the best research with folks? A place where people can go
to get the best possible information in terms of eating, and
knowing that that changes all the time? Once every 5 years, I
don't think this is effective. Sorry, Chairman.
Secretary Vilsack. Honestly, this discussion suggests that
there is some extraordinarily bright line on science, that over
here there is the real science, and then over here, there is
not the real--the science is evolving. It is----
Mr. Thompson. That is my point.
Secretary Vilsack. And so----
Mr. Thompson. That is what science does.
Secretary Vilsack. It does. So you have to have general
guidelines that provide some parameters.
Mr. Thompson. Well, do we have static guidelines once every
5 years, or do we have----
Secretary Vilsack. Well, you could theoretically go through
this process every year, but I don't know that that would be
particularly helpful.
Mr. Thompson. No.
Secretary Vilsack. I think a 5 year period is good.
Obviously, it gets better informed. And this issue of obesity
is far more complex than just simply saying, because we have
these guidelines, that somehow we have become an obese nation.
It has to do with the fact that an average kid spends 7 hours
in front of a screen every day. I mean, that is part of it,
right? It is portion size, that is part of it. It is a variety
of factors. I suppose if every American followed the guidelines
it might be a different situation. But we don't.
The Chairman. The gentleman's time has expired.
Secretary Vilsack. Doesn't mean we shouldn't have them.
Mr. Thompson. Yes.
The Chairman. Mr. LaMalfa, for 4 minutes.
Mr. LaMalfa. Thank you, Mr. Chairman, and both Secretaries,
thank you for being here today. Ms. Burwell, let me follow up
on what Mr. Thompson was saying on that as well, we have been
hearing, ever since I was a kid, eggs are bad, so my
grandparents had a lot of powdered eggs, because of their age,
and factors like that. And it turns out eggs are okay later.
Then you hear beef, red meat, and then we have high protein
diets are supposed to help you lose weight. Somebody I was
talking to just over the weekend, a constituent, they lost
weight, but they are staying away from fruit, because fruit has
sugar in it. Well, I mean, how are people supposed to really
know when the ideals are changing all the time, the guidelines?
So, I guess following up on the 5 year thought, is it good
to have a hard and fast 5 year timeline of changing the Dietary
Guidelines, or should it be less frequent, more frequent, or
does it need to be even more--kind of change what you know to
change, and have the--and leave the rest alone? What do you
think of that?
Secretary Burwell. I think that the Congress, in making a
choice on 5 years, probably made a good choice. And the reason
for that is, while we heard from some of your colleagues about
extending the period--I think that this took 18 months for the
Advisory Committee to do its work, then you had an additional
75 days of the period of comment for us to receive comments on
that, and then you have the period for us to review and get it
out. And so when you add that up, and you think about that
timetable, if you tried to shrink that, the question is, would
you have relevant----
Mr. LaMalfa. Well, I guess what I am looking at is maybe
you have most of the guidelines are going to be consistent for
a long time. When you have school books, for example, it seems
like they throw out the whole school book. You are buying a new
one where maybe most of that math lesson is fine, so maybe you
are just changing the elements in there, since it is
electronic, and not doing something every 5 years.
So let me follow that up with should there be a legislative
change that we should produce that would help this process?
Secretary Burwell. I don't know that there should, and
actually, we are like the school books, in that most of this is
consistent. You reflected on, in terms of where there are
changes, the things that there are key recommendations on have
been relatively consistent over the period since the 1980s, in
terms of the importance of fruits and vegetables, the
importance of a balanced approach that provides nutrition that
is fewer calories than the nation currently consumes.
In several select areas, it is fair to appropriately
reflect the science has changed, but the dominant picture is a
very similar picture over the periods of time. And so I also
think it is important to distinguish between the Dietary
Guidelines and what is happening in our popular culture with
regard to different diets that are proposed by different people
in different ways. Distinguishing that is also an important
element, and this gets to what are the guidelines, and what are
they not?
Mr. LaMalfa. Certainly, there is a lot of overlap, a lot of
different messages being sent. The Dietary Guidelines, though,
they can be seen by people as confusing, or difficult to
follow. Do you think the 2015 Guidelines will be more
straightforward, giving people a little more straightforward
ideas of how to follow this pattern for what they need? Is the
2015 going to be an improvement over that?
Secretary Burwell. We will, obviously, work to make things
as simple as we can. But the real way that people interact with
these things is actually in their implementation in programs.
And whether that is the topic we have talked about in school
lunch, or another topic we haven't touched as much on, which is
the labeling issues. And that is how most people interact with
what the Dietary Guidelines are, in terms of how they get their
advice about what they are going to eat, and that sort of
thing.
Mr. LaMalfa. Well, let me ask, then, since most of the
efforts say to follow or be consistent with the guidelines,
what does follow the DGA mean to you, Madam Secretary?
Secretary Burwell. What it means to me is that there are
these guidelines, and when we apply those from a perspective of
the Federal Government to certain of our programs, that they
are the basis that we think about promoting the programs. And
whether that is our Meals on Wheels program, or, as we think
about our Million Hearts initiative at CDC to try and reduce by
a million the number of people with heart attacks, that an
important element of that is understanding what the Dietary
Guidelines say.
Mr. LaMalfa. Thank you. You have had a very difficult job
the last year or so, so thanks for coming.
The Chairman. The gentleman's time has----
Secretary Burwell. Thank you.
The Chairman.--expired. And before we adjourn, David Scott,
any comments you have from the Ranking Member?
Mr. David Scott of Georgia. Yes. Well, thank you very much,
Mr. Chairman. First thing I want to say is how much we
appreciate both of you Cabinet officials coming before us at
the same time. That is a rarity, and we really appreciate it.
Agriculture is indeed our most important industry. It is
the food we eat, it is the water we drink. It is our survival.
And you do get the feeling from this Committee of how important
this is. And I hope that what we have discussed today, that you
all will take back in the manner and the spirit in which we
have given it, because this is the single most important
industry in the world, our agriculture. My hope is that you
will take back and understand--even go back and review a bit.
Secretary Vilsack, you hit the nail on the head when you
stated that they sit there before the screen. That is exactly
right. When you and I were coming along, folks would say, Daddy
or Mama, can I go out to the playground? That is a phrase we
don't even hear now. I am going upstairs, or I am going
downstairs, I am going in the room, and get on the Internet,
sit before that screen hour after hour. And that is why it is
so important now that we use our science to make up for that.
And that is why I hope that you will take my suggestions to
go back, and look, and make sure we are using the strong
scientific evidence. And if there are things like the low
calorie sweeteners, where the study has already shown that it
will lower obesity, go back and review, and explain why you
don't use that. Or maybe you go back and you look at, and you
say, you know what, I think we can use this and make a
difference. And that is why, Mr. Chairman, this has been an
extraordinary and very important hearing, and I thank you for
calling it.
The Chairman. Well, I thank the gentleman. I also want to
thank our witnesses. This is a big deal, to get both of you at
the table at the same time. I appreciate that. The emphasis
today was on the process, and restoring trust.
And, Ms. Burwell, your testimony said that the guidelines
don't change much from issue to issue. Is that a bias that, if
I am a scientist, and I have a body of work that comes to
certain conclusions, and I am going to be hard bent to change
my conclusion against new evidence? That is going to be an
issue that is there. Hopefully the next time you will be asked
are the guidelines themselves contributing to the problem? For
example, the emphasis on carbohydrates over the last 20 years,
and the impact that has had on these issues that we are talking
about, whether it is obesity, or diabetes, or other things. Do
we have anybody who is going to live these guidelines for 5
years so we could see what it did to them? I know you guys try
to gather that information, because the guidelines are
important. They are voluntary for me. I am going to go have
lunch here in a little bit, and I will decide for myself. They
are not voluntary, though, when they get woven into school
lunch programs, and SNAP, and everything else. They become the
law of the land in many instances, so it is important that we
get these right.
And I appreciate both of your comments this morning about
limiting the criticisms about sustainability and taxes. You
laid those to rest. Thank you so very much for that, for the
emphasis on staying within the scope that was supposed to be
there. I appreciate that. And I really also appreciate your
work on trying to clarify that these are guidelines, and that
the report was one thing. You have work to be done between now
and December to make that happen. The idea that perhaps a
proposed rule might have some value. I understand time and that
getting it finished is an important process as well. I
appreciate that both of you came today, and the comments that
were made from my colleagues.
Under the rules of the Committee, the record of today's
hearing will remain open for 10 calendar days to receive
additional material and supplementary written responses from
the witnesses to any questions posed by a Member. This hearing
of the Committee on Agriculture is adjourned.
[Whereupon, at 11:25 a.m., the Committee was adjourned.]
[Material submitted for inclusion in the record follows:]
Submitted Article by Hon. Collin C. Peterson, a Representative in
Congress from Minnesota
The Washington Post
Wonkblog
For decades, the government steered millions away from whole milk. Was
that wrong?
By Peter Whoriskey October 6
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The United States Government once considered butter and
margarine as one of seven food groups to consume daily. Look
back at other advice that unfortunately is no longer a part of
the USDA's Dietary Guidelines. (Jayne W. Orenstein/The
Washington Post)
Video hyperlink: http://wapo.st/1VEwNVl.
U.S. Dietary Guidelines have long recommended that people steer
clear of whole milk, and for decades, Americans have obeyed. Whole milk
sales shrunk. It was banned from school lunch programs. Purchases of
low-fat dairy climbed.
``Replace whole milk and full-fat milk products with fat-free or
low-fat choices,'' says the Dietary Guidelines for Americans, the
Federal Government's influential advice book, citing the role of dairy
fat in heart disease.
Whether this massive shift in eating habits has made anyone
healthier is an open question among scientists, however. In fact,
research published in recent years indicates that the opposite might be
true: millions might have been better off had they stuck with whole
milk.
Scientists who tallied diet and health records for several thousand
patients over 10 years found, for example, that contrary to the
government advice, people who consumed more milk fat had lower
incidence of heart disease.
By warning people against full-fat dairy foods, the United States
is ``losing a huge opportunity for the prevention of disease,'' said
Marcia Otto, an assistant professor of epidemiology at the University
of Texas and the lead author of large studies published in 2012 and
2013, which were funded by government and academic institutions, not
the industry. ``What we have learned over the last decade is that
certain foods that are high in fat seem to be beneficial.''
Over Decades, Consumers Spurned Whole Milk
For decades, public health authorities have advised Americans to
switch away from whole milk, and they have obeyed. The chart shows
sales of milk in millions of pounds.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Source: USDA/The Washington Post.*
---------------------------------------------------------------------------
* Editor's note: this is an interactive graphic that was embed in
the article. To access the interactive functionality go to http://
www.washingtonpost.com/news/wonkblog/wp/2015/10/06/for-decades-the-
government-steered-millions-away-from-whole-milk-was-that-wrong/.
This year, as the ``Dietary Guidelines for Americans'' undergoes
one of its periodic updates, the Federal bureaucrats writing them must
confront what may be the most controversial and weighty question in all
of nutrition: does the consumption of so-called saturated fats--the
ones characteristic of meat and dairy products--contribute to heart
disease?
It is, without doubt, an important question. Heart disease is the
leading cause of mortality in the United States, and the Federal
Government has long blamed saturated fats.
[Whole milk is okay. Butter and eggs too. What's next--bacon?
(https://www.washingtonpost.com/news/speaking-of-science/wp/
2015/10/07/whole-milk-is-okay-butter-and-eggs-too-whats-next-
bacon/)].
But the idea that spurning saturated fat will, by itself, make
people healthier has never been fully proven, and in recent years
repeated clinical trials and large-scale observational studies have
produced evidence to the contrary.
After all the decades of research, it is possible that the key
lesson on fats is two-fold. Cutting saturated fats from diets, and
replacing them with carbohydrates, as is often done, likely will not
reduce heart disease risk. But cutting saturated fats and replacing
them with unsaturated fats--the type of fats characteristic of fish,
nuts and vegetable oils--might.
This shift in understanding has led to accusations that the Dietary
Guidelines harmed those people who for years avoided fats--as
instructed--and loaded up excessively on the carbohydrates in foods
such as breads, cookies and cakes that were marketed as ``low fat.''
It also has raised questions about the scientific foundations of
the government's diet advice: To what extent did the Federal
Government, and the diet scientists they relied upon, go wrong? When
the evidence is incomplete on a dietary question, should the government
refrain from making recommendations?
The dietary science has drawn the skepticism of some on Capitol
Hill. On Wednesday, a House Committee will air concerns regarding the
evidence for the guidelines with Agriculture Secretary Tom Vilsack and
Health and Human Services Secretary Sylvia Burwell.
[Read: Could 95 percent of the world's people be wrong about
salt? (http://www.washingtonpost.com/news/wonkblog/wp/2015/05/
26/could-95-percent-of-the-worlds-people-be-wrong-about-salt/
)].
The Dietary Guidelines have stepped back slightly from their
blanket advice to reduce saturated fats, adding the caveat that
saturated fats ought to be replaced with unsaturated fats. But Dariush
Mozaffarian, a cardiologist, epidemiologist, and dean of the Friedman
School of Nutrition Science & Policy at Tufts University said that in
his view the Dietary Guidelines have yet to retreat far enough from the
idea that saturated fat is a dietary evil, and their suspicion of whole
milk is a good example. Judging a particular food solely on how much
fat it contains, he said, can too easily blind people to its other
benefits.
``If we are going to make recommendations to the public about what
to eat, we should be pretty darn sure they're right and won't cause
harm,'' Mozaffarian said. ``There's no evidence that the reduction of
saturated fats should be a priority.''
Some, including representatives of the American Heart Association,
disagree. In their view, the evidence for the dangers of saturated fats
arises from these two ideas: Consuming saturated fats raises levels of
so-called ``bad'' cholesterol in the blood, and higher levels of
``bad'' cholesterol, in turn, raise risks of heart disease.
[Related--USDA: We will not steer people away from meat to
protect the environment (https://www.washingtonpost.com/news/
wonkblog/wp/2015/10/06/usda-we-will-not-steer-people-away-from-
meat-to-protect-the-environment/)].
In support of their position, they point to the trials of statin
drugs, which show that the drugs lower ``bad'' cholesterol levels and
lower risks of heart disease.
There is a ``mountain of evidence'' explaining how consumption of
saturated fats raises the risk of heart disease, said Penny Kris-
Etherton, a Nutrition Professor at Penn State University and a former
member of the Dietary Guidelines Advisory Committee.
How We Die
Heart disease is the leading cause of death in the U.S. and health
authorities have long blamed its prevalence, at least in part, on our
consumption of fatty foods.
The Case Against Saturated Fats Begins
Over the long tortured course of fat research, it certainly seemed
at times that there was strong evidence in the case against saturated
fats.
The history of the fat warning is usually traced to the work of
Ancel Keys, a scientist at the University of Minnesota, whose study of
heart disease in the 1950s startled the medical world.
Keys examined fat consumption and rates of heart disease in various
countries. In places where people eat lots of fat, he found high levels
of heart disease. One of his famous charts, from 1953, showed that in
the United States, where close to 40 percent of the diet came from fat,
people suffered a disproportionate number of heart disease deaths.
People in Japan and Italy, by contrast, consumed less fat and died of
heart disease less often.
Degenerative Heart Disease
1948-49, Men
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Fig. 2. Mortality from degenerative heart disease (Categories
93 and 94 in the Revision of 1938, categories 420 and 422 in
the Revision of 1948, International List. National vital
statistics from official sources. Fat calories as percentage of
total calories calculated from national food balance data for
1949 supplied by the Nutrition Division, Food and Agriculture
Organization of the United Nations.
In 1953, scientist Ancel Keys linked national fat consumption
to heart disease.
From the Keys, A., Atherosclerosis: A problem in newer public
health. 1953. Journal of Mount Sinai Hospital 20: 118-39.
In 1953, scientist Ancel Keys linked national fat consumption to
heart disease.
To Keys, the data offered proof that Americans could improve their
health by reducing the fats in their diets.
``It is now abundantly clear that degenerative heart disease is not
an inevitable consequence of aging,'' he wrote in the 1953 medical
journal article.
More evidence was coming. In the 1960s, several clinical trials--
from Oslo, Los Angeles, Finland, London and Minnesota--put his
suspicion to the test. Three of the five suggested that he was right.
The Oslo study, for example, studied 412 men who'd previously had a
heart attack. Half were given a special diet that was low in saturated
fat; the other half was allowed to eat their usual diet, which was
richer in saturated and trans fats. The special diet seemed to work:
After 5 years, 64 subjects on the special diet had a relapse of heart
disease, while of those eating their regular diet, 90 people did.
Public health authorities, including those in the United States,
were soon recommending that people reduce their consumption of
saturated fats--meat, eggs and dairy--as a means of lowering heart
disease risks.
The idea became a part of U.S. official advice in 1977, when the
U.S. Dietary Goals, a forerunner of the Dietary Guidelines, embraced
the position.
How a Hypothesis Became Dogma
But even as a Senate committee was developing the Dietary Goals,
some experts were lamenting that the case against saturated fats,
though thinly supported, was being presented as if it were a sure
thing.
``The vibrant certainty of scientists claiming to be authorities on
these matters is disturbing,'' George V. Mann, a biochemist at
Vanderbilt's medical school wrote in the New England Journal of
Medicine.
Ambitious scientists and food companies, he said, had ``transformed
[a] fragile hypothesis into treatment dogma.''
Indeed, the subsequent 40 years of science have proven that, if
nothing else, the warning against saturated fats was simplistic.
By itself, cutting saturated fats appears to do little to reduce
heart disease. Several evidence reviews--essentially summing up years
of research--have found no link.
``There is no significant evidence for concluding that dietary
saturated fat is associated with an increased risk of coronary heart
disease,'' said one published in 2010 in the American Journal of
Clinical Nutrition.
``Current evidence does not clearly support'' guidelines linking
saturated fat and heart disease, according to a review of experiments
and observational studies published in the Annals of Internal Medicine.
``Saturated fats are not associated'' with mortality, heart
disease, strokes or type 2 diabetes, a major review in the British
Medical Journal reported in July.
One of the most noted experiments on fats was the Women's Health
Initiative, which involved more than 48,000 older women. Some had
counseling to eat less fat and more vegetables and fruits; others
continued, more or less, with their normal diets. Subjects in the diet
group cut their saturated fat intake from 13 percent of their diet to
ten percent, as well as their consumption of other fats. Their levels
of ``bad'' cholesterol dropped. Yet when it came to heart disease,
researchers found no significant difference between the two groups.
To many critics, the trouble with the fat warning was not merely
academic.
The ``campaign to reduce fat in the diet has had some pretty
disastrous consequences,'' Walter Willett, dean of the nutrition
department at the Harvard School of Public Health has said. ``With more
fat-free products than ever, Americans got fatter.''
Best-sellers such as ``Good Calories, Bad Calories'' by Gary Taubes
and ``Big Fat Surprise'' by Nina Teicholz went further in their
critique of the government position.
``There's a large body of scientific literature to show that a
high-carb diet, as recommended by the Dietary Guidelines for Americans,
provokes a number of heart-disease risk factors,'' said Teicholz, whose
critique of the guidelines appears in a recent issue of the British
Medical Journal.
The Case Weakens
For the bureaucrats writing the forthcoming Dietary Guidelines, the
shifting evidence against saturated fats may be a lesson, experts said:
there were weaknesses in each of the three lines of evidence used.
First, there were those studies by Keys showing that a country's
fat consumption was linked to its rate of heart disease. After Keys'
paper appeared, scientists began adding other countries to his graph,
and when they did, the pattern suggesting a link between fat
consumption and heart disease became less distinct.
More importantly, by the very nature of his research, Keys' data
could only show that saturated fat consumption was associated with
heart disease, not that consuming saturated fat caused heart disease.
That's because his study was ``observational''--that is, it was based
on merely observing subjects rather than randomly assigning them to
high-fat and low-fat diets. It was possible, in other words, that some
unaccounted factor caused the varying rates of heart disease.
The second line of evidence in the case against saturated fats came
from those controlled experiments in the 1960s--in Oslo, Finland and
Los Angeles. These suggested that subjects who consumed less saturated
fat suffered less from heart disease.
As further scientific review showed, none of the experiments was
perfectly designed to assess the danger of saturated fats, and the
results in some cases were modest. Moreover, the diets showing a
benefit were not just low in saturated fats, they were also high in
unsaturated fats--the ones common in fish, nuts and vegetable oil.
Indeed, these trials, along with more recent studies, have led many
scientists to conclude that merely cutting back on saturated fats
provides no benefit, but replacing them with unsaturated fats does. By
contrast, cutting back on saturated fats and eating breads and cookies
instead won't help.
``We have strong evidence that replacing saturated fats with
carbohydrates has no effect on cardiovascular disease,'' said Alice
Lichtenstein, a Tufts University nutritionist who served this year on
the Dietary Guidelines advisory panel.
No More ``Blanket Recommendations''
Even so, the advisory panel has continued to tout the benefits of
limiting saturated fat to ten percent of the diet, and of swapping
whole milk for fat-free.
In doing so, the panel is relying on the third piece of the
argument against saturated fats, which is that two-step chain of logic:
that saturated fats raise the levels of ``bad'' cholesterol in the
blood, and that higher levels of ``bad'' cholesterol in turn raise the
risks of heart disease.
Scientists generally agree on the premises of that argument. The
trouble, according to critics, is that connecting the two and drawing
the conclusion that saturated fats lead to heart disease is a vast
oversimplification, for a handful of reasons.
First, while consumption of saturated fats tends to raise levels of
``bad'' cholesterol in the blood, they also tend to raise the levels of
``good'' cholesterol levels, too, and that may have compensating
effects.
Second, saturated fatty acids come in chains of carbon of varying
lengths, and each one differs in its effects on heart disease risks.
Some molecules appear to raise the amount of ``bad'' cholesterol in the
bloodstream, while other longer chains appear to have no appreciable
effect.
And it gets even more complicated. It turns out that ``bad''
cholesterol comes in two forms. One consists of particles that are
smaller and denser and these appear to be strongly linked to heart
disease; the other type of ``bad'' cholesterol consists of lighter,
fluffier particles that appear to have lesser effects on heart disease.
Saturated fats do raise the levels of ``bad'' cholesterol, but seem to
produce mainly the lighter, fluffier and less dangerous particles.
As a result of such complexity, as well as the ways in which food
sources vary in their health effects, ``blanket recommendations to
reduce total saturated fats may not be appropriate,'' according to the
most recent Annual Review of Nutrition, an academic publication that
provides summaries of the latest research.
So What About Whole Milk?
While nutrition advice is often presented in terms of
``macronutrients''--fats, proteins, carbohydrates--foods may be more
than the sum of their scientific parts.
Milk is a good example.
Repeated research on milk, not funded by the industry but by public
institutions, has provided evidence that the fats in milk are, for some
reason, different.
In 2013, New Zealand researchers led by Jocelyne R. Benatar
collected the results of nine randomized controlled trials on dairy
products. In tallying the tests on 702 subjects, researchers could
detect no significant connection between consuming more dairy fat and
levels of ``bad'' cholesterol. (Four of the nine studies included in
the tally were funded by the industry. Those results were consistent
with those of the trials funded by government entities.)
The same year, Otto and Mozaffarian, then both at the Harvard
School of Public Health, conducted another study on the effects of
milk. Their study sought to address a key weakness in the previous
research.
One of the flaws of nutrition studies is that they rely on people
to accurately recall what they've eaten over the course of a year.
Those recollections are vulnerable to inaccuracy, especially for dairy
fats which can be found in small amounts in many different foods. This
inaccuracy may be one of the reasons studies have yielded contrary
results on the link between milk and heart disease.
To improve estimates, Otto and Mozaffarian used a blood sample for
each of more than 2,800 U.S. adults. Using the blood sample, they could
detect how much dairy fats each had consumed. And over the 8 year
follow up period, those who had consumed the most dairy fat were far
less likely to develop heart disease compared to those who had consumed
the least.
The advocates of whole milk allow that it has more calories than
its low fat cousins, and for some, that might be reason to avoid it.
But the traditional case against whole milk--based on the risk of heart
disease--has frayed enough now that many argue the Dietary Guidelines
should yield to the new findings.
``There is no scientific basis for current dietary advice regarding
dairy,'' Benatar said. ``Fears [about whole milk] are not supported by
evidence. The message that it is okay to have whole fat food, including
whole fat milk, is slowly seeping into consciousness. But there is
always a lag between evidence and changes in attitude.''
Peter Whoriskey is a staff writer for The Washington Post
handling investigations of financial and economic topics. You
can email him at [email protected].
______
Submitted Report by Hon. Vicky Hartzler, a Representative in Congress
from Missouri
Scientific Integrity in Policymaking
A White Paper authored by Joanne L. Slavin, Ph.D., R.D.
Executive Summary
A scientific white paper was commissioned by a coalition of food
and agriculture trade associations to examine the use of scientific
research in U.S. food and nutrition policymaking efforts, including the
Dietary Guidelines for Americans (DGA). The white paper, authored by
Joanne Slavin, Ph.D., R.D., was published in Nutrition Journal
(Attachment). Following is an executive summary of the white paper's
main findings and recommendations.
Rationale
The current Administration, Federal agencies and regulators are
increasingly looking to policy and systems-change interventions to
improve public health in America. The process by which Federal agencies
and policymakers consult scientific research in developing proposed
regulations and policies varies and greatly impacts the nature of the
ultimate recommendations. Because of the profound effect that many of
these policies have on consumers, the food environment, Federal
nutrition assistance programs and subsequent policy and regulatory
recommendations, it is imperative that only the strongest, best
available evidence is used to inform and set policy.
White Paper Objectives
1. Describe the current U.S. food and nutrition policy environment.
2. Examine how science is used in Federal food and nutrition
policymaking efforts, using the Dietary Guidelines for
Americans (DGA) as an example.
3. Describe strong versus weak science as well as what types of
studies are most appropriate for use in policymaking.
4. Discuss the potential effects and consequences of making policy
recommendations in the absence of scientific consensus or
agreement.
5. Make recommendations to support the present and ongoing
development of science-based policy likely to positively
impact public health.
Barriers to Setting Evidence-Based Policy
Scientific studies are used by all agencies to set nutrition
policy. Yet, consistent guidelines for how to identify,
evaluate, and translate research into policy recommendations do
not exist. This can lead to national dietary guidance based on
research studies with varying degrees of methodological
strength and applicability.
Nutrition is a constantly evolving science and much of our
available knowledge and thus dietary recommendations are based
on observational data or research that is of a weaker quality.
It is critical that study methodology is carefully considered
and applied to our interpretation of nutrition science.
Limitations of such data are often underappreciated by
nutrition scientists and policymakers.
The DGA serve as the cornerstone for all Federal nutrition
education and program activities, including but not limited to
nutrition labeling campaigns, Healthy People objectives, and
nutrition assistance programs including the Supplemental
Nutrition Assistance Program (SNAP) and the National School
Lunch Program (NSLP). The Dietary Guidelines Advisory Committee
(DGAC) is the review committee responsible for formulating and
publishing recommendations that lead to the development of the
DGA policy document.
The nutrition and health topics investigated, as well
as the evidence review, interpretation, and grading
processes are at the discretion of DGAC members.
Final DGAC recommendations will be provided to the
Secretaries of the Department of Health and Human Services
and USDA by the end of 2014/early 2015. The content of the
ultimate DGA policy document is at the discretion of both
agencies.
It is extremely difficult to reverse or change public
policy, once enacted, without causing consumer confusion.
Inaccurate and conflicting dietary guidance messages are
detrimental to consumer understanding of nutrition and the
ability to build healthy diets. At a time when consumers are
already subjected to an overabundance of nutrition and health
information, providing the public with science-based, realistic
and achievable information is more likely to contribute to
improved public health outcomes.
Recommendations
It is imperative that food and nutrition policies reflect,
and do not get ahead of the strongest available scientific
evidence. It is unlikely we will ever have RCT data available
to answer most nutrition questions, but we should rely on our
strongest designs. We must demand stronger scientific standards
from appointed committee members who serve on authoritative IOM
and DGAC panels.
A universal system that grades evidence quality would help
achieve consistency in science interpretation and use across
all nutrition policies and regulations. Grading schemes should
be vetted and approved by authoritative bodies, so that
findings and recommendations are supported across a wide array
of credible groups.
Food and nutrition policy must be a cooperative effort of
scientists from universities, the government, commodity groups
and food companies. Dietary guidance that is produced in such a
collaborative system will more likely be translatable and
realistic for the general public.
When policy recommendations are developed by committees,
such as the DGAC, those committees should be comprised of a
balanced and well-rounded set of perspectives and expertise. A
scientific nutrition committee should not only include experts
in nutrition, biochemistry, physiology, epidemiology and
statistics, but also food science, food production and
processing, food policy and behavior. This would ensure that
the ultimate recommendations adequately reflect our entire food
system and food environment.
Policies should reflect what is practical and likely to have
the greatest impact on the general population. Simple, flexible
and straightforward messages that are rooted in the best
available evidence are likely to be most effective.
Joanne Slavin is a Professor in the Department of Food
Science and Nutrition at the University of Minnesota, St. Paul.
She is a Science Communicator for the Institute of Food
Technologists and served as a member of the 2010 Dietary
Guidelines Advisory Committee (DGAC).
attachment
Slavin Nutrition Journal (2015) 14:15 *
---------------------------------------------------------------------------
* Correspondence: [email protected], Department of Food Science and
Nutrition, University of Minnesota, 1334, Eckles Avenue, St. Paul,
Minneapolis, MN 55108, USA.
2015 Slavin.; licensee BioMed Central. This is an Open Access
article distributed under the terms of the Creative Commons Attribution
License (http://creativecommons.org/licenses/by/4.0), which permits
unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly credited. The Creative Commons
Public Domain Dedication waiver (http://creativecommons.org/
publicdomain/zero/1.0/) applies to the data made available in this
article, unless otherwise stated.
---------------------------------------------------------------------------
The Challenges of Nutrition Policymaking
DOI 10.1186/s12937-015-0001-8
Review, Open Access
Joanne L. Slavin
Abstract
In my over 3 decades of work in the field of food and nutrition, I
have participated in many efforts that seek new policy initiatives in
the hopes that these programs can curb rates of obesity and chronic
disease and help consumers make healthier dietary choices. Because of
the profound effect that many of these policies have on consumers, the
food environment, Federal nutrition assistance programs and subsequent
policy and regulatory recommendations, it is imperative that only the
strongest, best available evidence is used to set policy. This review
evaluates methods by which current nutrition policies use scientific
research as well as provides recommendations for how best to ensure
future nutrition policies are truly science-based and likely to have a
meaningful impact on public health. Specifically, this review will:
Describe the current food and nutrition policy environment
in the U.S.
Examine how science is used in Federal food and nutrition
policymaking efforts, using the Dietary Guidelines for
Americans (DGA) as an example.
Describe strong versus weak science as well as what types of
studies are most appropriate for use in policymaking.
Discuss the potential effects and consequences of making
policy recommendations in the absence of scientific consensus
or agreement.
Make recommendations to support the present and ongoing
development of science-based policy likely to positively impact
public health.
Keywords: Dietary guidance, Nutrition policy, Evidence based
review, Sodium, Added sugars
Introduction
The U.S. food and nutrition policy and regulatory environment is
highly active. The current Administration, Federal agencies and
regulators are increasingly looking to policy and systems-change
interventions to improve public health in America. For example, within
the last 5 years, Federal and state/local governments have instituted
significant changes to the school food environment [1], proposed state
and local initiatives to tax and/or ban certain foods and beverages
[2], and published proposed rules to significantly change nutrition
labeling regulations [3]. Additionally, the 2015 Dietary Guidelines
Advisory Committee (DGAC) [4] is presently meeting and will issue the
2015 DGAC report in the coming year.
The process by which Federal agencies and policymakers consult
scientific research in developing proposed regulations and policies
varies, and greatly impacts the nature of the ultimate recommendations.
An investigation into this process would yield important understanding
about how science is used to set policy and what impact this process is
likely to have on consumers.
Review
How Science Is Used in Policymaking
Science is used by all agencies to set nutrition policy. Yet,
guidelines for how to identify, evaluate, and translate scientific
research into policy recommendations vary among agencies. Policymakers
generally rely on published research and consensus reports by
scientific authorities and government bodies; however the manner in
which research findings and report conclusions are interpreted and
applied can differ from one initiative to the next. Government agencies
have outlined their approach for evaluation of scientific studies to be
used in decision-making. For example, NIH uses the AHRQ system [5] and
FDA has an accepted system of systematic review for health claims [6].
Because there is not a universally accepted evidence-grading scheme,
conclusions are based on research studies with varying degrees of
methodological strength and applicability. The fact that nutrition
research produces constantly evolving scientific findings further
complicates the development of objective, evidence-based policy
recommendations.
One example of a U.S. scientific authority with significant
influence is the Institute of Medicine (IOM). The IOM is one of the
premier authoritative bodies that conducts health-related research and
promulgates health and nutrition recommendations for policymaking
purposes. IOM reports are frequently commissioned by government
agencies for topics where policy and/or regulatory interest exists but
research gaps remain. Some recent examples include sodium [7] and
front-of-package labeling [8]. Once IOM recommendations are published,
they are often used as scientific basis for proposed regulations and
nutrition guidance. IOM recommendations aim to reflect our most current
scientific understanding and usually precede the actual setting of
policy to ensure any action is evidence-based. However, the IOM is
challenged to keep pace with advances in our understanding of
nutrition.
For example, the IOM completes the Dietary Reference Intake (DRI)
reports, which are considered the most reliable sources of nutrient
recommendations--they inform the very basis of our current nutrition
understanding. The DRIs are summarized in the 2006 volume [9] and are
an update to the Dietary Recommended Allowances (RDA) that have been
published since 1941. While DRI reports for certain nutrients have been
updated recently (vitamin D and calcium were updated in 2011), other
DRI reports have not been updated since 1997-1998. This means that the
body of research that has been completed for a number of nutrients
within the last 15+ years is not accounted for in our current IOM DRI
report conclusions.
Researchers and policymakers also rely heavily on the National
Health and Nutrition Examination Survey (NHANES), an ongoing group of
studies designed to assess the health and nutritional status of adults
and children in the United States. These studies are based on self-
reporting; they consist of 24 hour dietary recalls completed through
individual surveys. NHANES also collects biological data and
anthropometrical data with mobile units. NHANES information is a
valuable resource on changes in nutrient intake and health status of a
cross-sectional group of U.S. consumers.
Critics suggest the data are flawed because of biases that
accompany self-reporting measures [10]. As one might expect, survey
respondents have a tendency to under-report their caloric intake or
over-report the amount of more nutritious foods they consume and under-
report the amount of less nutritious foods they consume. Archer, et al.
[11] reported that 67% of women and 59% of men who participated in
NHANES provided caloric intake responses that were not physiologically
plausible. They calculated physiologically credible energy intake
values as the ratio of reported energy intake to estimated basal
metabolic rate and subtracted estimated total energy expenditure to
create disparity values. The greatest mean disparity values were ^716
kcal/day and ^856 kcal/day for obese men and women, respectively. The
limitations of our nutritional data are generally not acknowledged in
scientific reports or consensus statements. And yet, NHANES is cited by
virtually every government agency involved in health and nutrition as
an accurate representation of Americans' eating habits.
These examples raise important questions about the data that U.S.
nutrition policymakers have available to them. How confident can we be
that Federal dietary guidance is evidence-based when our foundational
measures are outdated and significantly limited? What controls can be
put in place to ensure that policies and regulations are likely to have
demonstrated, positive public health impact?
The Dietary Guidelines Advisory Committee
Another highly influential scientific authority is the Dietary
Guidelines Advisory Committee (DGAC), the appointed review committee
responsible for formulating and publishing (in the form of a
comprehensive report) an evidence-based review that provides scientific
support for the Dietary Guidelines for Americans (DGA) policy document.
The DGA are statutorily mandated (Section 301 of Public Law 101-445 (7
U.S.C. 5341, the National Nutrition Monitoring and Related Research Act
of 1990, Title III)) and are a collaborative effort between the
Department of Health and Human Services (HHS) and Department of
Agriculture (USDA); the DGA have been published every 5 years since
1980. The DGA aim to provide ``sound advice for making food and
physical activity choices that promote good health, a healthy weight,
and help prevent disease for Americans ages 2 years and over, including
Americans at increased risk of chronic disease'' [12]. DGA
recommendations serve as the cornerstone for all Federal nutrition
education and program activities, including but not limited to
nutrition labeling campaigns by the Food and Drug Administration (FDA)
and USDA Food Safety and Inspection Service (FSIS), the Office of
Disease Prevention and Health Promotion (ODPHP) Healthy People
objectives, and USDA Food and Nutrition Service nutrition assistance
programs including the Supplemental Nutrition Assistance Program (SNAP)
and the National School Lunch Program (NSLP). As a result, DGA reach
and impact are extensive.
The 2015 DGA process is underway, with the current DGAC holding
meetings to share their evidence review process and findings with the
general public. According to the 2015 DGAC charter, the Committee's
official responsibilities are to ``examine the current Dietary
Guidelines for Americans, take into consideration new scientific
evidence and current resource documents, and then develop a report to
be submitted to the Secretaries that outlines its science-based
recommendations and rationale which will serve as a basis for
developing the eighth edition of Dietary Guidelines for Americans''
[12].
The DGAC is governed by Federal Advisory Committee Act (FACA)
guidelines and an official charter and charge [13]. While the freedom
exists to explore food and nutrition topics that the DGAC deems
important and scientifically relevant, the charge explicitly states
that ``DGAC responsibilities include providing authorship for this
report; however, responsibilities do not include translating the
recommendations into policy or into communication and outreach
documents or programs'' [13]. In other words, DGAC recommendations
should be scientific in nature and not indicative of policy direction.
The DGAC Evidence Review Process
The DGAC process to identify, review, and evaluate available
nutrition research for a variety of topics is complex and time-
intensive. Typically, DGAC members are divided into subcommittees to
address specific research areas based on topic importance and DGAC
member expertise. In 2010, the DGAC consisted of thirteen scientists
with expertise in nutrition, physical activity, food behavior and
nutrition through the lifecycle. There were eight subcommittees
focusing on the following dietary issues: (1) alcohol; (2)
carbohydrate; (3) energy balance and weight maintenance; (4) fatty
acids and cholesterol; (5) food safety and technology; (6) nutrient
adequacy; (7) protein; and, (8) sodium, potassium and water. As a
member of the 2010 DGAC, the author of this paper served as chair of
the carbohydrate and protein subcommittees and also as a member of the
energy balance and the nutrient adequacy subcommittees.
The 2015 DGAC is organized somewhat differently, with fourteen
scientists serving on five subcommittees: (1) Food and Nutrient
Intakes, and Health: (2) Current Status and Trends; Dietary Patterns,
Foods and Nutrients, and Health Outcomes; (3) Diet and Physical
Activity Behavior Change; (4) Food and Physical Activity Environments;
and (5) Food Sustainability and Safety. There are separate working
groups for sodium, added sugar, saturated fat and physical activity.
The 2015 Committee is also using expert consultants to inform its
evidence reviews.
One of the first steps in the DGAC evidence review process is to
develop research questions regarding the relationship between diet and
health outcomes, including disease risk or health benefits (e.g., what
is the relationship between dietary fiber intake and specific health
outcomes). These questions should reflect the research gaps identified
by the previous DGAC, as well as areas of nutrition where there is new,
influential evidence since the previous edition of the DGA. Once the
research questions have been agreed upon, the DGAC, in concert with
USDA Nutrition Evidence Library (NEL) staff, gathers the relevant
available studies.
The research studies are then closely examined and evaluated based
on strength of study design as well as relevance of outcomes. In past
years, the DGAC used the NEL evidence-based review process [14], a
strict hierarchy of evidence and rigorous grading process. For each
question addressed in the 2010 evidence-based report, the DGAC
developed precise search criteria, inclusion and exclusion criteria for
all of the studies, including the range of dates searched, and made
this information available on the USDA DGA portal [14]. Such detailed
process and transparency in the NEL evidence-based approach minimizes
bias and therefore adds credibility to the findings. However, the
scientific review method ultimately used by the DGAC is at the
Committee's discretion--for example, at the time of this paper's
completion, the 2015 DGAC has decided to use the NEL process to answer
some research questions, but not others. This permitted subjectivity
and variability increases the potential for less rigorous studies to be
used to inform DGAC recommendations.
Once the DGAC has determined which studies to examine for each
research question, evidence conclusion statements are written. Within
the NEL system, the conclusions drawn can be deemed as strong,
moderate, limited, or lacking data to support them. There may also be
strong evidence of no relationship. For example, strong evidence was
found of no relationship between glycemic index and disease outcomes in
the 2010 DGAC review [15]. Agreeing on the strength of the relationship
is always difficult, as for each question, different types of studies
with a variety of outcomes have been published. A closer examination of
study methodology will help further illustrate this point.
The DGAC process is transparent and open to input from scientists
and consumers. The 2015 DGAC will hold seven public meetings with
public comments accepted throughout the process. Although the final
DGAC report is not released, the committee regularly updates their
progress on reviewing scientific questions at the public meetings.
Research Methodology: What Makes a Strong vs. Weak Study
The evidence-based medicine (EBM) hierarchy ranks research design
in the following order of strength (from highest to lowest): systematic
reviews of randomized-controlled trials (RCT), RCT, prospective cohort
studies, case control studies, cross-sectional studies, case series/
case reports and editorials/expert opinions. RCT are the strongest
study designs for determining cause and effect between a dietary
exposure and a health outcome [16]. Following RCT are prospective
cohort studies, where a group or cohort of subjects is studied over
time. Food frequency instruments are often used to collect dietary
information before any diagnosis of disease, making these studies more
reliable than cross-sectional studies where diet and outcome measures
are assessed simultaneously. Historically, in the case of DGAC reviews,
no case-control studies, animal research, or in vitro studies have been
considered due to their relative weakness and because their findings
cannot prove cause and effect in humans. Typically cross-sectional
studies are only included in DGAC reviews if no stronger prospective
studies are available.
Following this reasoning, food and nutrition policies would be best
served if only the strongest types of evidence--perhaps RCT alone--
informed their development. However, this is an unrealistic ideal as
not all diet and health outcome relationships can be practically or
ethically evaluated using RCT. For example, it is difficult to carry
out blind food treatments in dietary studies (subjects know they are
consuming an apple versus apple juice). However, such trials can work
with nutrients, as nutrients can be added to food or drinks without the
knowledge of the participants or investigators (the double-blind
mechanism).
Further, all RCT data are not created equal. RCT generally use
biomarkers as outcome measures rather than disease incidence due to the
length of time it takes healthy people to manifest disease symptoms.
Biomarker data can be extrapolated to infer relationships regarding
population health without adequately accounting for weaknesses in the
relationship between the biomarker and the disease state. Ultimately,
this can result in a strong study methodology being misapplied and used
to make assumptions that are not actually supported by the research.
For example, RCT are clear that sodium intake or excretion is directly
related to blood pressure, yet prospective cohort studies show that too
low sodium intakes actually increase risk of cardiovascular disease
(CVD). Thus, at low levels of sodium consumption, blood pressure does
not account for all of the CVD risks. Biomarker data fail to tell the
complete story.
In reality, many dietary recommendations are supported by evidence
primarily from observational data, particularly those from prospective,
cohort studies. Nutrition scientists and policymakers often under-
appreciate limitations of such data. Some of the limitations of
observational evidence for diet-disease relationships include imprecise
exposure measures, collinearity among dietary exposures, displacement/
substitution effects, healthy/unhealthy consumer bias, and residual
confounding. Maki, et al. [16] recommend greater caution in making
dietary recommendations for which RCT evidence of clinical event
reduction after dietary intervention is not available.
For these reasons and because nutrition science is complex and
changeable, it is critical that study methodology is carefully
considered and applied to our interpretation of nutrition science.
Ideally, observational data would be validated by stronger research
methods before being used to inform policy. While observational
research may be valuable to our understanding of nutrition and health,
its limitations must be acknowledged. Consider the 2015 DGAC
investigation into sustainable dietary patterns. This field of research
is arguably in its infancy--in fact, there is no scientific consensus
for even a definition of sustainability [17]. Any sustainability-
related recommendations in the 2015 DGAC report should be preliminary
at best, recognizing the need for additional, rigorous research to
validate initial findings. Without these underlying studies in place,
it would be premature for HHS and USDA to use sustainability
recommendations to inform nutrition guidance in the 2015 DGA policy
document.
Consequences of Non-Evidence-Based Policy
We don't have to travel very far back in time to witness examples
of dietary guidance recommendations that were made prematurely and are
now challenged as more research is introduced. Our understanding of
fats has evolved considerably, with dietary recommendations now
emphasizing healthy consumption of monounsaturated and polyunsaturated
fats, proving that healthier dietary patterns include, rather than
exclude, foods higher in fat content.
More recently, it could be argued that the 2010 DGA sodium intake
recommendation was made in the absence of scientific consensus. The
policy document recommends that individuals over 51 years old, African
Americans or those with hypertension, diabetes, or chronic kidney
disease reduce their daily sodium intake to 1,500 milligrams. This
applies to about \1/2\ the U.S. population, including children and the
majority of adults.
Since then, the IOM published its Sodium Intake in Populations:
Assessment of Evidence report. Findings stated that recent studies
``support current efforts to reduce excessive sodium intake in order to
lower risk of heart disease and stroke. However, the evidence on health
outcomes is not consistent with efforts that encourage lowering of
dietary sodium in the general population to 1,500 mg/day. Further
research may shed more light on the association between lower--1,500 to
2,300 mg--levels of sodium and health outcomes'' [7].
The 2010 DGA recommendations are now inconsistent with our most
recent scientific understanding of sodium and health. As noted, this
conflict could have been avoided if the DGA policy document had
withheld such extreme guidance until more rigorous studies were
fielded, reviewed, and published. Recent papers in the New England
Journal of Medicine cast further doubt on our low sodium
recommendations for the general public [18].
The sodium example is important because of the aforementioned
impact of DGA recommendations on other food and nutrition policies. The
Final Rule for the Nutrition Standards in the National School Lunch and
School Breakfast Programs [1] states that schools must ``reduce the
sodium content of meals gradually over a 10 year period through two
intermediate sodium targets of 2 and 4 years post implementation''. Now
that schools have begun to implement the new regulations, these severe
sodium reductions are proving difficult, costly, and may reduce student
participation rates [19]. These consequences are especially concerning
considering the underlying recommendation may not accurately reflect
the current evidence base.
Inaccurate and conflicting dietary guidance messages are also
detrimental to consumers' understanding of nutrition and their ability
to build healthy diets. At a time when consumers are already subjected
to an over-abundance of nutrition and health information, government
agencies should be held accountable for developing policies and
regulations that are rooted in strong science, and are realistic and
achievable for the majority of the population. In the case of sodium,
not only is there insufficient evidence to link highly restrictive
sodium intakes to improved health outcomes, but encouraging the general
public to reduce intakes from the estimated current average of 3,400
mg/day to 1,500 mg/day is self-defeating and unachievable [20].
Another example can be seen in the use of the 2010 DGAC review to
support the FDA proposal to mandate added sugars labeling on the
Nutrition Facts panel [3]. Added sugars have become the current
nutrition ``watch out'', believed by some to uniquely contribute to
obesity and other adverse health outcomes. However, the majority of
scientific evidence shows that all sugars (added or intrinsic) provide
4 kcalories/gram just like any other digestible carbohydrate and are no
more likely to cause weight gain or negative health outcomes than other
calorie sources [21]. In fact, even the proposed rule acknowledges this
fact:
``U.S. consensus reports have determined that inadequate
evidence exists to support the direct contribution of added
sugars to obesity or heart disease. Specifically, although it
is recognized that sugar-sweetened beverages increase adiposity
(body fat) in children (Ref. 30), neither the 2010 DGA nor the
IOM macronutrient report concluded that added sugars
consumption from all dietary sources, in itself, increases
obesity. In fact, the 2010 DGA states that added sugars do not
contribute to weight gain more than any other source of calo-
ries . . .'' [3].
FDA states that the basis for this proposed labeling requirement is
the 2010 DGA recommendation to reduce intakes of added sugars to assist
consumers in maintaining healthy dietary practices. The DGA rationale
is that lower intakes of added sugars will result in decreased calorie
intakes and increased nutrient density of individual diets, not reduced
risk of adverse health outcomes. Specifically, the 2010 DGAC energy
balance subcommittee investigated sugar-sweetened beverage intakes and
found that ``strong evidence shows that children who consume more
sugar-sweetened beverages have greater adiposity (body fat) compared to
those with a lower intake'' [15]. However, a closer look at the
evidence review shows that only 12 of the 19 studies (which included
crosssectional studies) found a positive association between sugar-
sweetened beverage intakes and adiposity in all or a subsample of
population studies. It is difficult to see how the subcommittee
concluded this to be ``strong'' evidence.
Furthermore, it is unclear why FDA proposed mandatory added sugars
labeling in the absence of consumer research to demonstrate whether the
change will in fact influence consumer understanding and purchasing
behavior. The proposed rules even preceded the agency's own study.
Existing consumer research suggests that consumers already find aspects
of the current nutrition label confusing [22]. In addition, public
misunderstanding about added sugars abounds. Some consumers believe
added sugars do cause unique adverse health outcomes compared to other
sugars and even contain more calories that intrinsic sugars [22]. Even
if the intention behind the proposed rule is to steer consumers away
from purchasing non-nutrient dense foods and beverages that contain
added sugars, current available research suggests they will do this for
the wrong reasons. This proposal stands to perpetuate misleading
beliefs about nutrition and lead to more consumer confusion.
It is extremely difficult to reverse or change public policy, once
enacted, without causing consumer confusion. There are few mechanisms
available to regulators and policymakers to make adjustments that
reflect new science and understanding. Furthermore, nutrition policy
recommendations, once adopted, appear frequently in the media and
online. Reversing consumer misunderstanding about nutrition is an
incredibly difficult task; providing the public with accurate,
realistic and achievable information first would go a long way in
improving our understanding of nutrition and health, and ultimately
contributing to improved public health outcomes.
Conclusions
It is imperative that food and nutrition policies reflect, and do
not get ahead of the strongest available scientific evidence. It is
unlikely we will ever have RCT data available to answer most nutrition
questions, but we should rely on our strongest designs, including
prospective cohort studies. We should not accept cross-sectional
studies as influential drivers of policy development. We must demand
stronger scientific standards from our appointed committee members who
serve on advisory IOM and DGAC panels.
A transparent system that grades evidence quality would help
achieve consistency in science interpretation and use across nutrition
policies and regulations. Grading schemes should be vetted and
discussed by experts across the wide expertise needed in dietary
guidance, including nutritionists, dietitians, food scientists,
physicians, applied economists, and food processors so that findings
and recommendations could be supported across a wide array of credible
groups. This would also help ensure that the dietary guidance messages
consumers are receiving are factual and consistent.
When policy recommendations are developed by committees, such as
the DGAC, those committees should be comprised of a balanced and well-
rounded set of perspectives and expertise. Ideally a scientific
nutrition committee would not only include experts in nutrition,
biochemistry, physiology, epidemiology and statistics, but also food
science, food production and processing, food policy and behavior. This
combination of skills would ensure that the ultimate recommendations
adequately reflect our entire food system and food environment.
Scientists who understand how we ``learn'' about nutrition must be
included, even if they have worked on research supported by commodity
groups or food companies. The IOM process considers bias of individual
committee members and whether they have taken such strong public stands
on issues that it is not possible for them to move to another position
based on the deliberations of the committee. Any linkages to the food
industry are criticized, yet there seems to be little concern about
committee members who are closely linked to professional groups, such
as American Heart Association or other advocacy groups. Improvements to
our food system and public health can only be realized if we work
together, respecting the strengths of all parties. Nutrition advice
that is produced in such a collaborative system will more likely be
translatable and realistic for the general public.
Policies should reflect what is practical and likely to have the
most impact on the general population. Simple, flexible and
straightforward messages that are rooted in the best available evidence
are likely to be most effective. For example, the majority of Americans
are unlikely to be interested in or able to prioritize building
sustainable diets, shop at farmers markets, or avoid processed foods,
which provide nutrition and convenience for individuals with less
access to full-service grocery stores and fresh produce.
I would finally suggest that the U.S. Government consider
elongating the DGA publication schedule. The DRI reports and nutrition
labeling regulations are not updated every 5 years; instead they are
reexamined when there is a sufficient level of new research to warrant
a change. Without new science to review, the DGAC may choose to focus
on fads and trends instead of updating the scientific data for the core
areas of dietary guidance. As every DGAC wants to be bold and set new
direction, nutrition science would support that first we must do no
harm with our dietary guidance. Moderation and variety must be kept
front and center, as well as an appreciation that a teenage active boy
may need two or three times more calories than an elderly man or young
child. A suggestion that all Americans should reduce sodium intakes is
not sound and is potentially dangerous. Targeting certain foods and
beverages, including chocolate milk, processed meats, added sugars, and
even the noble potato as villains in the nutrition wars is not a
science-based strategy and may need to be countered on the political
front if appointed scientific review committees continue to take this
approach.
As described by Schneeman [6], science is necessary for developing
effective food regulation and policy, but it is not sufficient. The
interface between nutrition and public health must include food science
and agriculture. Food technology can help all consumers, including
those of lower socioeconomic status, have access to safe, nutritious
foods that science has found to be linked to improved health outcomes.
Abbreviations
HHS: Department of Health and Human Services; USDA: Department of
Agriculture; DGAC: Dietary Guidelines Advisory Committee; DGA: Dietary
Guidelines for Americans; DRI: Dietary reference intakes; EBM: Evidence-
based medicine; FACA: Federal Advisory Committee Act; FDA: Food and
Drug Administration; IOM: Institute of Medicine; LDL: Low-density
lipoprotein; NHANES: National Health and Nutrition Examination Survey;
NSLP: National School Lunch Program; ODPHP: Office of Disease
Prevention and Health Promotion; RCT: Randomized-controlled trials;
SNAP: Supplemental Nutrition Assistance Program; FSIS: USDA Food Safety
and Inspection Service; NEL: USDA Nutrition Evidence Library.
Competing Interests
In the past 5 years Dr. Slavin has received research grants from
Minnesota Beef Council, Minnesota Cultivated Wild Rice Council,
Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle,
General Mills, Inc., USA Pears and American Pulse Association. In the
past 5 years Dr. Slavin has received speaking fees from food companies
and commodity groups with interests in processed foods, dairy products,
meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr.
Slavin has participated in scientific panels and advisory boards that
are funded by food companies, ingredient companies, commodity groups,
scientific societies, and trade groups. She holds a third interest in
the Slavin Sisters LLC, a 119 acre farm in Southern Wisconsin.
Author information
Joanne Slavin, Ph.D., R.D., is a Professor in the Department of Food
Science and Nutrition, University of Minnesota, St. Paul. She is a
Science Communicator for the Institute of Food Technologists and served
as a member of the 2010 Dietary Guidelines Advisory Committee (DGAC).
Acknowledgements
The author thanks Sarah Levy, M.P.H., R.D., for her support in the
development of this paper, which includes assistance with outline
development and revision of drafts. Ms. Levy is a Vice President with
FoodMinds LLC, a food and nutrition affairs company that represents a
range of food, nutrition, and wellness organizations. During this
paper's development, she worked for FleishmanHillard, a global
communications agency that represents the Corn Refiners Association.
This paper was funded by an unrestricted grant from the following
organizations: Corn Refiners Association, Grocery Manufacturers
Association, International Dairy Foods Association, American Beverage
Association, National Confectioners Association, and American Meat
Institute.
Received: 13 September 2014 Accepted: 20 January 2015.
Published online: 07 February 2015.
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04387.pdf.
4. ``Establishment of the 2015 Dietary Guidelines Advisory
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2015.asp#resources.
5. Agency for Healthcare Research and Quality, Rockville, MD. http://
www.ahrq.gov.
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7. Institute of Medicine. Sodium intake in populations: assessment
of evidence. Washington, D.C.: National Academies Press; 2013.
8. Front-of-Package Nutrition Rating Systems and Symbols. Promoting
Healthier Choices. Committee on Examination of Front-of-Package
Nutrition Rating Systems and Symbols (Phase II), Food and Nutrition
Board, Wartella E.A., Lichtenstein A.H., Yaktine A., Nathan R., eds.
Institute of Medicine, The National Academies Press, Washington, D.C.
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Essential Guide to Nutrient Requirements. Washington D.C.: The National
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10. Schoeller D.A., Thomas D., Archer E., Heymsfield S.B., Blair
S.N., Goran M.J., Hill J.O., Atkinson R.L., Corley B.E., Foreyt J.,
Dhurandhar N.V., Krol J.G., Hall K.D., Hansen B.C., Heitmann B.L.,
Ravussin E, Allison D.B. Self-report-based estimates of energy intake
offer an inadequate basis for scientific conclusions. Am. J. Clin.
Nutr. doi:10.3945/ajcn.113.062125.
11. Archer E., Hand G.A., Blair S.N. Validity of U.S. nutritional
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energy intake data: 1971-2010. PLoS One. 2013;8(10):e75532.
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www.health.gov/dietaryguidelines/dga2010/DietaryGuidelines2010.pdf.
13. Charter of the 2015 Dietary Guidelines Advisory Committee.
Approved January 9, 2013. Available online: http://www.health.gov/
dietaryguidelines/dgac2015-charter-final.pdf.
14. USDA Nutrition Evidence Library, 2010 Dietary Guidelines
process. http://www.nel.gov/category.cfm?cid=21.
15. Dietary Guidelines Advisory Committee. Report of the Dietary
Guidelines Advisory Committee on the Dietary Guidelines for Americans,
2010. To the Secretary of Agriculture and the Secretary of Health and
Human Services, U.S. Department of Agriculture. Washington, D.C.:
Agricultural Research Service; 2010.
16. Maki K.C., Slavin J.L., Rains T.M., Kris-Etherton P.M.
Limitations of observationalevidence: implications for evidence-based
dietary recommendations. Adv. Nutr. 2014; 5:7-15.
17. Johnston J.L., Fanzo J.C., Cogill B. Understanding sustainable
diets: a descriptive analysis of the determinants and processes that
influence diets and their impact on health, food security, and
environmental sustainability. Adv. Nutr. 2014; 5:418-29.
18. Oparil S. Low sodium intake--Cardiovascular health benefit or
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19. Protect School Meal Programs. School Nutrition Association
PolicyResources, July 2014. Available online: https://
schoolnutrition.org/uploadedFiles/Legislation_and_Policy/
SNA_Policy_Resources/July2014-Protect%20School%20Meal%20 Programs.pdf.
20. Maillot M., Monsivais P., Drewnowski A. Food pattern modeling
shows that the 2010 Dietary Guidelines for sodium and potassium cannot
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21. Hess J., Latuilippe M.E., Ayoob K., Slavin J. The confusing
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-------------------------------------------------------------------------
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______
Submitted Article by Hon. James P. McGovern, a Representative in
Congress from Massachusetts
The Hill
October 07, 2015, 06:30 a.m.
Physician Perspective: Keep Politics Out of Dietary Guidelines
By Sandra G. Hassink, M.D., F.A.A.P. and Steven J. Stack, M.D.
The process by which the Federal Government provides the best
available dietary advice to millions of Americans is under attack on
Capitol Hill. As physicians and leaders of professional medical
organizations, we are compelled to speak out.
Physicians routinely provide patients with guidance on how to stay
healthy. We rely on the best available scientific evidence to make
these recommendations, and fortunately, we have had the Dietary
Guidelines for Americans to turn to. Unfortunately, that could all
change; there are unprecedented attacks taking place in Congress right
now that threaten the scientific integrity of the guidelines.
Every 5 years, the guidelines are updated and published as
America's authority for nutrition advice. Important legislation, the
Healthy, Hunger-Free Kids Act of 2010, called for school meals to
conform to these guidelines, which makes sense: since children
typically consume up to \1/2\ of their daily calories in school, we
have an obligation to ensure those meals are healthy and nutritious.
At a time when nearly one in three school-age children and
adolescents is overweight or has obesity and more than one in three
American adults suffer from cardiovascular disease and diabetes,
science, not politics, should drive the Federal Government's efforts to
revise the guidelines. And indeed, the guidelines themselves are
informed by an expert committee made up of scientists, doctors and
nutritionists who are nominated by their peers and selected by the
Federal Government after a rigorous vetting process. They evaluate the
evidence and provide independent advice to the U.S. Government in the
form of Dietary Guidelines.
This process takes years, and is intentionally removed from the
political process. And yet, it is currently under threat on Capitol
Hill: Language pending in multiple spending bills would hinder the
Federal Government's ability to provide the best available advice to
millions of children and adults on healthy diets and lifestyles. If
enacted, efforts to reduce consumption of added sugars in order to
lower the risk of cardiovascular disease, type 2 diabetes and dental
caries would be stymied. Interventions to reduce screen time and
increase physical activity in children and adults would be disrupted.
What's more, the language would limit dietary information or
guidelines that can be included in the 2015 Dietary Guidelines for
Americans only to those with a ``strong'' evidence rating, which means
it is completely free from study design concerns or disagreements
between findings. As any nutrition scientist or dietician will tell
you, nutrition research is exceptionally difficult to perform. Meals
are so complex and varied that establishing an individual's true
pattern requires meticulous diet tracking; population-level data is
easier to obtain but less specific. In addition, there is an unlimited
amount of factors that influence health, including physical activity,
chemical exposure, and co-morbid health issues. A ``strong'' rating is
only given if virtually every study on a topic agrees. As this rarely
happens in science, the Dietary Guidelines for Americans have
historically relied on both strong and moderate evidence to make key
recommendations.
Our patients deserve nutrition guidance that is free of political
interference. The 2015 Dietary Guidelines for Americans will play a
crucial role in the lives of millions of children and adults. Nutrition
and physical activity are integral to a healthy population, and it's
essential that doctors are able to continue to advise our patients
based on what the evidence recommends. Congress should support, not
derail, what the science shows and keep the politics out of the
guidelines.
Hassink, is president of the American Academy of Pediatrics.
Stack is president of the American Medical Association.
______
Submitted Statements by Hon. Michelle Lujan Grisham, a Representative
in Congress from New Mexico
statement of academy of nutrition and dietetics; american academy of
pediatrics; american college of cardiology; american dental
association; american medical association
As the science leaders of the Academy of Nutrition and Dietetics,
American Academy of Pediatrics, American College of Cardiology,
American Dental Association and the American Medical Association, we
are writing to clear up possible misunderstandings regarding scientific
evidence and the 2015 Dietary Guidelines for Americans.
We are concerned that the proposed language in the House's
Departments of Agriculture, Rural Development, Food and Drug
Administration and Related Agencies (section 734) and Departments of
Labor, Health and Human Services and Education and Related Agencies,
(section 232) Fiscal Year 2016 Appropriations Bills is an overreach
regarding the intention of evidence-based science.
(1) Each revision to any nutritional or dietary information
or guideline contained in the 2010 edition of the Dietary
Guidelines for Americans and any new nutritional or dietary
information or guideline to be included in the eighth edition
of the Dietary Guidelines for Americans--
(A) shall be based on scientific evidence that has
been rated ``Grade I: Strong'' by the grading rubric
developed by the Nutrition Evidence Library of the
Department of Agriculture;
The Academy of Nutrition and Dietetics' Evidence Analysis Library
was established in 2004. The Nutrition Evidence Library was launched in
July 2008 by the Department of Agriculture's Center for Nutrition
Policy and Promotion and mirrors the Academy's EAL but specializes in
systematic reviews to inform Federal nutrition-related policies and
programs. The NEL conducts systematic reviews on food and nutrition-
related topics by using a rigorous, transparent and reproducible
methodology to support Federal nutrition policies and programs.
This process includes developing a specific research question on
diet and health, developing a corresponding search plan for literature
review designed to answer the research question, extracting data from
existing literature as directed by the search plan, developing a
conclusion statement to answer the question and grading the strength of
evidence supporting the conclusion. A conclusion can be graded Strong,
Moderate, Limited or Grade Not Assignable.
The strong rating is reserved for bodies of evidence completely
free from study design concerns or disagreements between findings. The
nature of science and statistics is such that a small number of
contrary findings is expected and a preponderance of evidence can
overcome limitations of individual studies. Therefore, recommendations
with a moderate rating, which indicates a sizable body of well-designed
research with which the committee had no more than minor doubts, are
more than sufficient to inform the Dietary Guidelines for Americans.
The exclusion of recommendations with a moderate rating would
strike several uncontested truths from the record available to USDA,
including the relationships between sugar and cavities and between a
sedentary lifestyle and obesity. Additionally, the current language
would bar USDA and HHS from supporting two recommendations derived from
emerging science that are vital to the health of Americans: the use of
school-based nutrition and exercise programs to prevent obesity and the
reduction of added sugar intake to prevent heart disease. Obesity and
heart disease are deadly and costly burdens to the nation and Americans
deserve access to the knowledge of every effective tool to combat them.
Nutrition focused systematic reviews, unlike pharmaceutical
research, use a plethora of methodology, not just randomize clinical
trials. The reason for a paucity of randomized clinical trials in
nutrition literature is multifactorial but basically people must eat to
survive and thus pure control groups are difficult. Fortunately, many
new research methods are becoming acceptable to study key research
questions relating to the health of the public. Unfortunately, many of
these have yet to be utilized to fill the current large gaps in human
nutrition research. Currently, the published food and nutrition
research, which has been funded by the government, foundation and
industry is a mixture of clinical trials, observational trials and
cohort and case studies the latter of which do not receive as high of a
grade value as randomized clinical trials. Thus, if the United States
is to continue to guide the American population on healthy eating
choices to prevent disease and have optimal health we must accept
conclusion statements that are less than Grade 1 while futuristically
funding rigorously designed food and nutrition studies in a variety of
populations to fill the prevalent nutrition research gaps.
The DGAC's scientific conclusions and HHS/USDA's final development
of the Dietary Guidelines use more than one question or source of
evidence, such as NEL systematic reviews. The DGAC considered seven
questions examining the relationship between dietary patterns and
health outcomes, including cancer, type 2 diabetes and cardiovascular
disease. The DGAC also reviewed evidence using a process known as food
pattern modeling to describe the combination of foods and drinks a
person should consume to meet nutrient needs and the impact on chronic
disease. The final Dietary Guidelines consider all this information.
Nutrition is an evolving science and a lack of evidence or limited
evidence for one specific question does not mean that there is not
strong evidence to support guidance. DGA recommendations have
historically been made drawing upon both ``Strong'' and ``Moderate''
strength evidence. The Dietary Guidelines are developed based on the
preponderance of the strongest available evidence. Limited or Moderate
evidence for one health outcome could greatly limit the ability to
provide guidance on dietary patterns when the evidence may be Strong
for other health outcomes. Using the cutoff of ``Strong'' will
significantly limit the ability to develop recommendations across the
Dietary Guidelines.
The 2010 Dietary Guidelines for Americans were based on the
strongest evidence available, not just the evidence that was identified
as Grade 1: Strong. Making a change for 2015 would create an
inconsistency between recommendations in the 2010 DGAs, some of which
are supported by ``Moderate'' evidence.
We ask that the House's Departments of Agriculture, Rural
Development, Food and Drug Administration and Related Agencies (section
734) and Departments of Labor, Health and Human Services and Education
and Related Agencies, (section 232) Fiscal Year 2016 Appropriations
Bills not be included in the final spending package for Fiscal Year
2016.
We would be glad to discuss this request further. Please feel free
to connect Alison Steiber, Ph.D., R.D.N., Chief Science Officer for the
Academy of Nutrition and Dietetics, with your questions.
([email protected]).
Thank you for your consideration.
Respectfully,
Academy of Nutrition and Dietetics;
American Academy of Pediatrics;
American College of Cardiology;
American Dental Association;
American Medical Association.
statement of academy of nutrition and dietetics; american society for
nutrition
As the food and nutrition leaders representing the of the Academy
of Nutrition and Dietetics and the American Society for Nutrition, we
ask for your support of the 2015 Dietary Guidelines process to continue
without interference by Congress. We are concerned that the proposed
language in the House's Departments of Agriculture, Rural Development,
Food and Drug Administration and Related Agencies (section 734) and
Departments of Labor, Health and Human Services and Education and
Related Agencies,(section 232) Fiscal Year 2016 Appropriations Bills
will halt the progress of this important nutrition policy that could
improve public health.
The Dietary Guidelines for Americans are founded in evidence-based
science and should be insulated as much as possible from political
influences. The Nutrition Evidence Library (NEL) was launched in July
2008 by the Department of Agriculture's Center for Nutrition Policy and
Promotion. The NEL was built as an outgrowth from the Academy of
Nutrition and Dietetics' Evidence Analysis Library (EAL), developed in
2004. The NEL mirrors the Academy's EAL but specializes in systematic
reviews to inform Federal nutrition-related policies and programs. The
NEL conducts systematic reviews on food and nutrition-related topics by
using a rigorous, transparent and reproducible methodology to support
Federal nutrition policies and programs. This process includes:
Developing specific research questions on diet and health.
Developing corresponding search plans for literature review
designed to answer the research questions.
Extracting data from existing literature as directed by the
search plans.
Developing conclusion statements to answer each question and
grading the strength of evidence supporting the conclusion.
A conclusion can be graded Strong, Moderate, Limited or Grade Not
Assignable. The Strong rating is reserved for bodies of evidence
completely free from study design concerns or disagreements between
findings, which is rare. Science and statistics expect a small number
of contrary findings and it is the ``preponderance of evidence'' that
can overcome limitations of individual studies. As a result,
recommendations with a Moderate rating, which indicates a sizable body
of well-designed research with which the Dietary Guidelines Advisory
Committee (DGAC) had no more than minor doubts, are more than
sufficient to develop the Dietary Guidelines for Americans. The
exclusion of recommendations with a Moderate rating would eliminate
several uncontested truths from the record available to USDA and HHS
and interfere with helping Americans consume a healthy diet.
Nutrition-focused systematic reviews draw on several types of
methodologies, not just randomized clinical trials. The reason for this
lack of randomized clinical trials in nutrition is multi-faceted, but,
most important, people must eat to survive and pure control groups are
ethically difficult. Large clinical trials are also very costly and
take many years to complete. Fortunately, new research methods are
becoming acceptable to study key research questions relating to the
health of the population, which will hopefully enhance nutrition
related research. Currently, the published food and nutrition research,
which has been funded by government, foundations and industry, is a
mixture of randomized controlled trials and observational studies which
include prospective cohort and case-control studies. The NEL and the
DGAC utilized only randomized controlled trials and prospective cohorts
and did not consider results from case-control studies due to the
potential for bias or weaker designs such as case reports or ecological
studies. If we are to continue to guide the American population on
healthy eating choices to prevent disease and have optimal health, we
must accept recommendations that are rated less than Strong. The DGAC's
scientific conclusions and HHS/USDA's final development of the Dietary
Guidelines use more than one question or source of evidence, such as
NEL systematic reviews. The DGAC also conducted de novo data analysis
using data from our national nutrition surveillance system (the
National Health and Nutrition Examination Survey, NHANES) and reviewed
evidence using a process known as food pattern modeling, which is used
to describe the combination of foods and drinks a person should consume
to meet nutrient needs without exceeding calorie intake to maximize
health benefits and reduce risk of diet-related chronic disease. The
final Dietary Guidelines for Americans will consider all this
information.
Nutrition, like all sciences, evolves with new research and
information. A lack of evidence or limited evidence for one specific
question does not mean that there is not strong evidence to support
guidance. The Dietary Guidelines will continue to be developed on the
preponderance of the strongest available evidence available at the
time. Limited or Moderate evidence for one health outcome could greatly
limit the ability to provide guidance on dietary patterns when the
evidence may be Strong for other health outcomes. Using the cutoff of
``Strong'' will significantly limit the ability to develop
recommendations across the Dietary Guidelines and could therefore
undermine advances in improving public health.
We ask that the House's Departments of Agriculture, Rural
Development, Food and Drug Administration and Related Agencies (section
734) and Departments of Labor, Health and Human Services and Education
and Related Agencies, (section 232) Fiscal Year 2016 Appropriations
Bills not be included in the final spending package for Fiscal Year
2016 based on their current language regarding the Dietary Guidelines
for Americans.
We would be glad to discuss this request further. Please feel free
to connect Alison Steiber Ph.D., R.D.N., Chief Science Officer of the
Academy of Nutrition and Dietetics, at [email protected] or Mary
Pat Raimondi, Vice President at [email protected] with your
questions.
Thank you for your consideration.
Respectfully,
Academy of Nutrition and Dietetics;
American Society for Nutrition.
______
Submitted Statement by Edward Archer, Ph.D., M.S., NIH/NIDDK Research
Fellow, Nutrition Obesity Research Center, University of Alabama at
Birmingham
Thank you Chairman Conaway, Ranking Member Peterson, and Members of
the Committee for the opportunity to submit this statement for the
record to the Committee on Agriculture, United States House of
Representatives. My name is Dr. Edward Archer and I am currently an
NIH/NIDDK Research Fellow at the Nutrition Obesity Research Center,
University of Alabama at Birmingham. I hold multiple graduate degrees
including a Doctorate and two Masters of Science degrees with extensive
training in physiology, psychology, nutrition, exercise science, and
epidemiology. I have conducted extensive research, lectured, and
published scientific papers in peer-reviewed journals regarding
obesity, nutrition, and physical activity, particularly as they relate
to the Dietary Guidelines published jointly by the United States
Department of Health and Human Services (HHS) and the United States
Department of Agriculture (USDA). My curriculum vitae is attached.\1\
---------------------------------------------------------------------------
\1\ Exhibit A.*
* Editor's note: this document is retained in Committee file.
---------------------------------------------------------------------------
I am submitting this Statement for the Record because my research
and a recent scientific paper of mine published in the July 2015 issue
of Mayo Clinical Proceedings directly address the subject matter of
this hearing, namely, the biased, unscientific methods used by USDA and
HHS to collect the dietary data that have informed dietary and
nutritional guidelines over the past 40 years. My paper, entitled The
Inadmissibility of What We Eat in America and NHANES Dietary Data in
Nutrition and Obesity Research and the Scientific Formulation of
National Dietary Guidelines,\2\ outlines the lack of valid scientific
evidence for and consequent confusion in Federal dietary guidance.
---------------------------------------------------------------------------
\2\ Exhibit B (Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and,
Carl J. Lavie, M.D., The Inadmissibility of What We Eat in America and
NHANES Dietary Data in Nutrition and Obesity Research and the
Scientific Formulation of National Dietary Guidelines, Mayo Clin.
Proc., 90(7): 911-926 (July 2015), also available at http://dx.doi.org/
10.1016/j.mayocp.2015.04.009 (last accessed Oct. 19, 2015).
---------------------------------------------------------------------------
As this paper explains, ``[t]he Scientific Report of the 2015
Dietary Guidelines Advisory Committee was primarily informed by memory-
based dietary assessment methods (M-BMs) (e.g., interviews and
surveys). The reliance on M-BMs to inform dietary policy continues
despite decades of unequivocal evidence that M-BM data bear little
relation to actual energy and nutrient consumption. Data from M-BMs are
defended as valid and valuable despite no empirical support and no
examination of the foundational assumptions regarding the validity of
human memory and retrospective recall in dietary assessment. We assert
that uncritical faith in the validity and value of M-BMs has wasted
substantial resources and constitutes the greatest impediment to
scientific progress in obesity and nutrition research.'' \3\
---------------------------------------------------------------------------
\3\ Id. at 911 (emphasis added).
---------------------------------------------------------------------------
The evidence is conclusive in this regard: ``M-BMs are
fundamentally and fatally flawed owing to well-established scientific
facts and analytic truths.'' \4\ This is so for the following reasons:
---------------------------------------------------------------------------
\4\ Id.
M-BM produce data that are ``physiologically implausible''
and often ``incompatible with life.'' \5\
---------------------------------------------------------------------------
\5\ Id. at 914 (emphasis added). ``Incompatible with life'' means
the survey respondent could notsurvive on the amount of food and
beverages he or she reported consuming.
``[T]he assumption that human memory can provide accurate or
precise reproductions of past ingestive behavior is
indisputably false.'' \6\
---------------------------------------------------------------------------
\6\ Id. at 911 (emphasis added).
``[T]he subjective (i.e., not publicly accessible) mental
phenomena (i.e., memories) from which M-BM data are derived
cannot be independently observed, quantified, or falsified; as
such, these data are pseudoscientific and inadmissible in
scientific research.'' \7\
---------------------------------------------------------------------------
\7\ Id. (emphasis added).
``Given the overwhelming evidence in support of our
position, we conclude that M-BM data cannot be used to inform
national Dietary Guidelines and that the continued funding of
M-BMs constitutes an unscientific and major misuse of research
resources.'' \8\
---------------------------------------------------------------------------
\8\ Id. (emphasis added).
The results of the research reported in my paper demonstrate that
the dietary data collected by the USDA and HHS via the National Health
and Nutrition Examination Survey (NHANES) and analyzed by the 2015
Dietary Guidelines Advisory Committee (DGAC) were derived from fatally
flawed, unscientific methods. As such, the USDA and HHS data are
meaningless numbers, not scientific evidence.
This finding is critical because, as Chairman Conaway correctly
stated, dietary guidance should be ``based on sound, consistent and
irrefutable science.'' \9\ I assert that because the NHANES dietary
data are ``incompatible with life'' \10\ and are therefore not
representative of what Americans actually eat, it is clear that these
data are unequivocally not ``sound, consistent and irrefutable
science.'' \11\
---------------------------------------------------------------------------
\9\ Chairman K. Michael Conaway, U.S. House of Rep. Comm. on
Agric., Full Committee--Public Hearing: 2015 Dietary Guidelines for
Americans (Oct. 7, 2015), Videotape at 00.01.05-00.01.08 (emphasis
added) (``Hearing Videotape''), available at https://www.youtube.com/
watch?v=x6DNns4oFao&feature=youtu.be (last accessed Oct. 19, 2015).
\10\ Ex. B at 914 (emphasis added).
\11\ See supra note 9.
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Importantly, the testimony and written statements of The Honorable
Tom Vilsack, Secretary, United States Department of Agriculture, and
The Honorable Sylvia Burwell, Secretary, United States Department of
Health and Human Services, do not bear up under scientific review. For
example, Secretary Burwell's testimony that food pattern analyses
allowed the DGAC to understand ``what is it actually Americans are
eating . . .'' \12\ is patently false. All food pattern analyses in the
DGAC report were based on dietary data that are ``incompatible with
life.'' \13\ Food pattern analyses based on physiologically implausible
data cannot be representative of ``what is it actually Americans are
eating.'' \14\
---------------------------------------------------------------------------
\12\ Hon. Sylvia Burwell, Sec'y, U.S. Dep't of Health & Human
Servs., Hearing Videotape at01.52.34-01.52.36 (emphasis added).
\13\ Ex. B at 914 (emphasis added).
\14\ See supra note 12.
---------------------------------------------------------------------------
Secretary Vilsack testified ``we should take a look at the Healthy
Eating Index.'' \15\ The Healthy Eating Index estimates are derived
from the physiologically implausible NHANES dietary data. It should be
obvious that a valid Healthy Eating Index cannot be created from
dietary data that are ``incompatible with life.'' \16\
---------------------------------------------------------------------------
\15\ Hon. Tom Vilsack, Sec'y, U.S. Dep't of Agric., Hearing
Videotape at 01.21.32-01.21.34(emphasis added).
\16\ Ex. B at 914 (emphasis added).
---------------------------------------------------------------------------
Secretary Vilsack also testified the DGAC review process produces
the ``strongest, best . . . available science'' \17\ and the ``best
science . . . best available science . . . and least biased science''
\18\ and wrote ``the 2015 Dietary Guidelines for Americans will be
grounded in the preponderance of the best available scientific
evidence.'' \19\ These statements are patently false. Data from
scientific papers demonstrating the implausible nature of both M-BM and
the NHANES dietary data \20\ were excluded from the 2015 DGAC's report,
and have been excluded from all previous DGAC reports. The decades-long
exclusion of contrary data is in violation of the Data Quality Act,\21\
and is indicative of the bias and scientific misconduct (i.e., omission
of data) of the DGAC.
---------------------------------------------------------------------------
\17\ See supra note 15 at 00.12.26-00.12.30 (emphasis added).
\18\ Id. at 01.53.12-01.53.17 (emphasis added).
\19\ Statement by Thomas J. Vilsack, Sec'y of Agric., U.S. House of
Rep. Committee on Agric.(Oct. 7, 2015) at 5.
\20\ See, e.g., Exhibit C (Archer E., Hand G.A., Blair S.N.,
Validity of U.S. Nutritional Surveillance: National Health and
Nutrition Examination Survey Caloric Energy Intake Data, 1971-2010,
PLoS One (2013), at 8(10):e76632), available at http://
journals.plos.org/plosone/article?id=10.1371/journal.pone.0076632 (last
accessed Oct. 19, 2015).
\21\ Pub. L. No. 106-554, H.R. 5658 (Treasury and Gen. Gov't
Appropriation Act for Fiscal Year 2001, 515 Appendix C, 114 Stat.
2763A-153 (2000) (effective Oct. 1, 2002).
---------------------------------------------------------------------------
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Edward Archer, Ph.D., M.S.
exhibit a *
---------------------------------------------------------------------------
* The document referred to is retained in Committee file.
---------------------------------------------------------------------------
exhibit b
The Inadmissibility of What We Eat in America and NHANES Dietary Data
in Nutrition and Obesity Research and the Scientific
Formulation of National Dietary Guidelines
Mayo Clinic Proceedings
Article in PressDSpecial Article
Mayo Clin Proc. n XXX 2015;nn(n):1-16 n http://dx.doi.org/
10.1016/j.mayocp.2015.04.009
www.mayoclinicproceedings.org 2015 Mayo Foundation for
Medical Education and Research.*
---------------------------------------------------------------------------
* From the Office of Energetics, Nutrition Obesity Research Center,
University of Alabama at Birmingham, Birmingham (E.A., G.P.); and
Department of Cardiovascular Diseases, John Ochsner Heart and Vascular
Institute, Ochsner Clinical School the University of Queensland School
of Medicine, New Orleans, LA (C.J.L.).
Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and Carl J. Lavie, M.D.
Abstract
The Scientific Report of the 2015 Dietary Guidelines Advisory
Committee was primarily informed by memory-based dietary assessment
methods (M-BMs) (e.g., interviews and surveys). The reliance on M-BMs
to inform dietary policy continues despite decades of unequivocal
evidence that M-BM data bear little relation to actual energy and
nutrient consumption. Data from M-BMs are defended as valid and
valuable despite no empirical support and no examination of the
foundational assumptions regarding the validity of human memory and
retrospective recall in dietary assessment. We assert that uncritical
faith in the validity and value of M-BMs has wasted substantial
resources and constitutes the greatest impediment to scientific
progress in obesity and nutrition research. Herein, we present evidence
that M-BMs are fundamentally and fatally flawed owing to well-
established scientific facts and analytic truths. First, the assumption
that human memory can provide accurate or precise reproductions of past
ingestive behavior is indisputably false. Second, M-BMs require
participants to submit to protocols that mimic procedures known to
induce false recall. Third, the subjective (i.e., not publicly
accessible) mental phenomena (i.e., memories) from which M-BM data are
derived cannot be independently observed, quantified, or falsified; as
such, these data are pseudoscientific and inadmissible in scientific
research. Fourth, the failure to objectively measure physical activity
in analyses renders inferences regarding diet-health relationships
equivocal. Given the overwhelming evidence in support of our position,
we conclude that M-BM data cannot be used to inform national Dietary
Guidelines and that the continued funding of M-BMs constitutes an
unscientific and major misuse of research resources.
2015 Mayo Foundation for Medical Education and Research
Mayo Clin Proc. 2015;nn(n):1-16.
When the facts change, I change my mind.
What do you do, sir?
John Maynard Keynes 1, p. 19
Success, Failure, and Confusion in Nutrition Research
During the past century, our nation's food supply and the
nutritional status of Americans have improved to a level unparalleled
in human history.\2\-\3\ Although this reality may be
contrary to the popular belief that our modern diet is inherently
inadequate, the data are clear. In the early 20th century, nutritional
diseases such as pellagra, beriberi, rickets, and goiter were
substantial public health challenges. In the United States alone,
pellagra (a disease of niacin deficiency) claimed more than 100,000
lives and severely affected more than three million people.\4\ Yet in
2013, the Centers for Disease Control and Prevention's Second National
Report on Biochemical Indicators of Diet and Nutrition reported that
nearly ``80% of Americans (aged %6 y) were not at risk of deficiencies
in any of the 7 vitamins'' 4, p. 938 examined via biomarkers
(i.e., vitamins A, B6, B12, C, D, E, and folate;
emphasis added).\2\ In addition, approximately 90% of women of
childbearing age (12-49 years) were not at risk for iron deficiency,
and folate levels have increased by approximately 50% since the
previous national report.2, 5 As such, most of the U.S.
population is not at risk for nutritional deficiencies, and neither do
they have nutritional deficienciesand associated diseases.
Given these important improvements in diet-related health and
recent work demonstrating that nongenetic evolution is the predominant
driver of the diseases of excess (e.g., obesity and type 2 diabetes
mellitus),\6\-\8\ it can be posited that diet is no longer a
major risk factor for disease for most Americans. If accurate, this
hypothesis suggests that the billions of research dollars targeted for
diet and nutrition-related health research are
misdirected.\9\-\10\ Nevertheless, despite the important
dietary milestones of the past century and the substantial increases in
Federal funding during the past 2 decades,\9\-\10\ research
into human nutrition has been increasingly
criticized.\11\-\13\ The genesis of these criticisms is the
appalling track record of highly publicized nutrition claims derived
from epidemiologic studies (e.g., see the studies by Stampfer, et
al.\14\ and Rimm, et al.\15\) that consistently failed to be supported
when tested using objective study designs. 11, 16 Young and
Karr examined \17\ more than 50 nutritional claims from observational
studies for a variety of dietary patterns and nutrient supplementation
and found that ``100% of the observational claims failed to replicate''
p. 117 and that five claims were statistically significant
``in the opposite direction.'' p. 117 These outcomes and
others \18\-\21\ suggest that as often as not, when
epidemiologic nutrition claims are tested against objective research
methods, the results are either inconclusive or indicative of a
contrary outcome.
A Failed Research Paradigm
Epidemiologic studies suggest that almost any nutrient can be
associated with a myriad of outcomes,11, 22 as observed in
Schoenfeld and Ioannidis' article, ``Is Everything We Eat Associated
With Cancer?'' 22, p. 117 With persistent cycles of specious
nutrition claims in the media, it is not surprising that the public is
confused and incredulous.\23\ Insofar as the provision of clear and
consistent Dietary Guidelines for the consuming public is a goal of
nutrition epidemiology, it has failed in decisively answering the
simple question, ``What should we eat?'' \24\ Nowhere is this fact more
evident than the shifting sands of opinion on the relative risks of
fat, salt, cholesterol, and sugar.\25\-\30\ Five decades of
controversy surrounding basic Dietary Guidelines and nutrition
recommendations is a public acknowledgement of a failed research
paradigm. The striking incongruence between the improvements in the
nutritional status of the U.S. population2, 5 and the
current state of confusion, controversy, and clinical failure of
epidemiologic nutrition research could not be clearer and necessitates
an examination of the validity and value of epidemiologic nutrition
research.
Purpose of this Review
Memory-based dietary assessment methods (M-BMs) (e.g., interviews,
questionnaires, and surveys \31\-\32\) are the dominant data
collection protocols in national nutrition surveillance \33\ and
government-funded epidemiologic nutrition \34\ and obesity \33\
research. Importantly, M-BM data are used to inform national
nutritional policy and Dietary Guidelines.\30\ The recent Scientific
Report of the 2015 Dietary Guidelines Advisory Committee (DGAC) stated
explicitly that most of the DGAC data analyses used the M-BMs of the
National Health and Nutrition Examination Survey (NHANES) dietary
component, What We Eat in America (WWEIA).\30\ Although decades of
unequivocal evidence demonstrate that the indirect, proxy estimates
derived from M-BMs bear little relation to actual energy or nutrient
consumption,13, 33, 35-45 the underlying assumptions
regarding the validity of human memory and recall in dietary assessment
have not been questioned. To the contrary, M-BM data are vigorously
defended as valid and inherently valuable despite no empirical support
for those assertions.\46\ Although the relationship between two
different constructs may be expected to be weak, the trivial
relationships between the proxy estimates (i.e., self-reported energy
intake [EI] and nutrient intake) and their referents (i.e., actual EI
and nutrient intake) are unacceptable. We assert that the explanatory
and predictive failure of epidemiologic nutrition research is explained
by its reliance on M-BMs, and, as such, the uncritical faith in the
validity and value of M-BMs has wasted significant resources and
constitutes the single greatest impediment to actual scientific
progress in the fields of obesity and nutrition research.
The purpose of this review is to survey the explanatory and
predictive failure of nutrition epidemiology in
general,11, 17 with a focus on the WWEIA-NHANES data,\33\
and argue that these failures are due to the reliance on M-BMs. First,
we present evidence that the anecdotally derived proxy data produced by
M-BMs bear little relation to actual EI or nutrient
consumption.13, 33, \35\-\45\ Second, we provide
interdisciplinary evidence that human memory is an amalgam of
constructive and reconstructive processes \47\-\52\ (e.g.,
imagination \53\) that render the archival model of human memory \54\
and the naive assumption that recall provides literal, accurate, or
precise reproductions of past events indisputably
false.50, 52, \55\-\58\ Third, M-BMs require
respondents to undergo protocols \59\ and perform behaviors \31\ that
mimic procedures known to induce false
recall.50, 52, 53, 60, 61 Fourth, the subjective (i.e.,
private, not publicly accessible) mental phenomena (i.e., memories)
from which M-BM data are derived are not subject to independent
observation, quantification, falsification, or verification; as such,
M-BM data are pseudoscientific and inadmissible in scientific
research.\62\-\66\ Fifth, the failure to accurately and
objectively measure and control for physical activity (PA),
cardiorespiratory fitness (CRF), and other obvious confounders annuls
inferences regarding diet-health relationships.
The M-BMs of Nutrition Epidemiology
Self-Reported Dietary Intake
The primary methods of data collection for nutrition epidemiologic
research (e.g., the WWEIA-NHANES) are M-BMs (e.g., 24 hour dietary
recalls [24HRs] and food frequency questionnaires [FFQs]
\31\-\33\). For clarity, these methods do not directly or
objectively measure EI or nutrient intake, and neither do they directly
or objectively measure food and beverage consumption. The actual data
derived from M-BMs are the a priori numeric values from nutrient
databases that are assigned by researchers to the participants' reports
of their memories of past eating and drinking behaviors. In other
words, nutrition researchers designate numeric values to whatever the
respondents are willing or able to recall about what they think (or
would like the researcher to think \67\) he or she consumed during the
study period. Given the indirect, pseudoquantitative (i.e., number-
generating \68\) nature of M-BMs and the fact that the respondents'
reports of their memories are subject to intentional and unintentional
distorting factors (e.g., perceptual, encoding, and retrieval errors;
\69\ social desirability; \42\ false memories; \55\ and omissions
48, 49, 70), it is not surprising that most conclusions
drawn from these number-generating protocols have not been supported
when subjected to rigorous objective examination.11, 17
The Implausibility of M-BMs in Dietary Assessment
It is the natural tendency of the ignorant to believe what is
not true. In order to overcome that tendency it is not
sufficient to exhibit the true; it is also necessary to expose
and denounce the false.
H.L. Mencken 71, p. 124
Research into M-BMs reports a wide range of EIs that are not
physiologically plausible (i.e., incompatible with survival) and that
do not accurately quantify the foods and nutrients
consumed.11, 33, 35, 38-40, 42 Recently, we used multiple
methods to ascertain the validity and plausibility of the NHANES and
WWEIA-NHANES EI data from 1971 to 2010 \33\ and found that they had
such severe systematic biases as to render them fatally flawed. Given
that ``[a] cross the 39 year history of the NHANES, [self-reported
energy intake] data on the majority of respondents (67.3% of women and
58.7% of men) were not physiologically plausible'' \33\ (Figure), we
concluded that these data are not valid for any inferences regarding EI
and the etiology of the obesity epidemic. A recent editorial in the
British Medical Journal concurred and stated that the NHANES dietary
data are ``incompatible with life.'' 11, p. 7
In a previous report,\33\ we used two objective, physiologically
based methods to determine misreporting: (1) Goldberg cutoff values
44, 45, 72 (i.e., reported EI [rEI] divided by basal
metabolic rate [BMR]) and (2) the disparity between the Institute of
Medicine total energy expenditure (TEE) equations \73\ and rEI via
NHANES MBMs. The two methods were in close agreement, demonstrating
significant misreporting. The cutoff values we used (i.e., rEI/BMR
<1.35 and >2.40) were more generous than the rEI/BMR cutoff value of
1.50 suggested by Goldberg et al.\45\ when using a single 24HR, and the
BMR is ``predicted from the Schofield equations'' with a sample size of
300 or greater.45, p. 577 Given the reduced sensitivity of
the cutoff values, we captured far fewer under-reporters. As reported,
when using the proposed cutoff value of 1.50, under-reporting increased
to more than 70% for the entire NHANES sample and to approximately 77%
and 85% for obese men and women, respectively. We also reported the
large and significant disparity between rEI and the Institute of
Medicine TEE: ^467 and ^554 kcal/d (>17% and 30%) for obese men and
women, respectively. In addition to under-reporting, there was
significant overreporting in all of the subpopulations (e.g., normal,
overweight, and obese men and women). One important caveat with the use
of cutoff values is that the term plausible reporter is not synonymous
with accurate reporter. Participants with high levels of PA may
substantially underreport yet still be considered plausible reporters.
Figure
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Percentage of implausible reporters by body mass index (BMI)
for U.S. women aged 20 to 74 years in the National Health and
Nutrition Examination Survey (NHANES) (1971-2010).
Physiologically implausible values were determined via the
following equation: (reported energy intake/basal metabolic
rate) 1.35. Implausible values may be considered
``incompatible with life.'' 11, p. 7
Given these results, we ask four questions, (1) What is the value
of WWEIA-NHANES M-BM data if 70% to 80% of obese women's self-reported
EI is physiologically implausible and, therefore, incompatible with
life (Figure)? (2) Given the extant objective data on the nutrition-
related health status of Americans,\2\ why does the DGAC rely on the
subjective M-BM data? \30\ (3) What is the ``unrealized potential''
46, p. 447 and ``utility'' 74, p. 5 of these data
when implausible overreporting and implausible underreporting are
demonstrated in all of the subgroups? (4) Can statistical alchemy
transform these implausible data into valid estimates of dietary
consumption, or will it continue to spawn searches for machinations
that generate numbers with improved correlations (i.e., post hoc data
manipulation) while ignoring the lack of validity?
The Pervasiveness of Implausible Results
The conclusions drawn by our study \33\ and the recent British
Medical Journal editorial \11\ are, in fact, supported by many decades
of evidence demonstrating that M-BMs have severe, intractable
systematic biases that render the data implausible and, therefore,
invalid.11, 13, 37, 44, 75, 76 Research with ``. . .
motivated . . . well-educated, non-smoking-Caucasians''
35, p. 957 (i.e., respondents less likely to misreport)
demonstrated that compared with doubly labeled water, a biomarker for
TEE, self-reported dietary intake was significantly
misestimated.35, 38 Men underreported EI 12% to 14% using
the average of two 24HRs and 31% to 36% using FFQs. Women underreported
by 16% to 20% using the average of two 24HRs and by 34%to 38% using
FFQs. Contrary to the oft-repeated statement that additional self-
reports improve precision and accuracy, the second administration of
the 24HR ``showed greater underreporting.'' 38, p. 12 These
results are in agreement with our analyses of the NHANES in which the
mean estimates for the second 24HR in every NHANES wave from 2001 to
2010 exhibited significantly greater levels of underreporting than the
first. We agree with the authors of the Observing Protein and Energy
Nutrition study when they wrote, ``[w]e measure energy so poorly . .
.'' 38, p. 12 and ``[t]he
24HR . . . may be particularly problematic in the obese.'' 35,p956
These words echo statements on underreporting from 60 years ago.\77\
Recently, some of the strongest proponents of M-BMs have provided
additional data that clearly demonstrate the futility of the continued
use of these methods.\36\ In the paper by Freedman, et al.,\36\ the
pooled, squared average correlation between true EI and self-reported
EI were similar to our results using NHANES data, ranging from 0.04 to
0.10. This suggests that the measurement noise (i.e., error) is more
than nine times greater than the signal (i.e., valid information)
derived from M-BMs. Nevertheless, an important finding from the
Observing Protein and Energy Nutrition study that Freedman, et al.\36\
overlook in their analyses is that despite the fact that the second
administration of the 24HR ``showed greater underreporting,''
38, p. 12 the correlations between true and reported EI
increased. This demonstrates an increase in precision with a
concomitant reduction in the accuracy of the estimate. These results
clearly support our position that M-BM data ``offer an inadequate basis
for scientific conclusions'' 13, p. 1413 and, more
importantly, that statistical machinations, however sophisticated,
cannot overcome the systematic recall bias that renders all inferences
suspect.41, 78
The phenomenon of misreporting is not limited to U.S. epidemiologic
studies or specific populations.\45\ The European Prospective
Investigation Into Cancer and Nutrition study is one of the largest
epidemiologic studies in the world and found strong evidence of
systemic underreporting across all study sites, with approximately 10%
to 14% of survey respondents being ``extreme underreporters,''
79, p. 1329 and ``. . . most centres were below the expected
reference value.'' 79, p. 1330 These results are consistent
with research from the early 1990s that found that more than 65% of the
mean rEI values were physiologically implausible in 37 studies across
ten countries.\45\ The misreporting value of more than 65% is
strikingly similar to our NHANES results using similar methods.\33\ In
2015, a multinational report demonstrated that misreporting ``in five
populations of the African Diaspora'' 80, p. 464 was
substantial, with the South African cohort exhibiting an astounding
52.1% underreporting of dietary EI.\80\ With respect to age, Forrestal
\81\ found in children and adolescents that misreporting ``. . .
appeared to be more common than it is among adults.'' p. 112
The ubiquitous nature of misreporting and the consistency of research
results over many decades and across multiple populations, cohorts, and
countries provide strong support that M-BM measures of EI are fatally
flawed, and, therefore, diet-health inferences from studies that use M-
BMs are essentially meaningless.
Examinations of Dietary Patterns via M-BMs
It is well-established that specific macronutrients, foods,
beverages, and food groups (e.g., protein, fat, carbohydrate, alcohol,
sugar, and vegetables) are subject to differential misreporting that
significantly affects subsequent estimates of
EI.38, 78, 82-88 Because EI is the foundation of dietary
consumption and all nutrients must be consumed within the quantity of
food and beverages needed to meet minimum energy requirements,\89\ it
is a logical and analytic truth that dietary patterns (i.e.,
macronutrient and micronutrient consumption; e.g., protein,
carbohydrate, fat, vitamins, and minerals) are differentially and
unpredictably misreported when total rEI is physiologically
implausible. For example, both macronutrient and micronutrient
composition are significantly altered in underreporters, with reported
fat and carbohydrate consumption often lower and reported protein,
fruit, and vegetable intakes higher.42, 82, 86 In other
words, participants qualitatively and quantitatively misreport owing to
both unintentional (e.g., forgetting and false memories) and
intentional (e.g., health-related perceptions) factors. This
nonuniformity of misreporting leads to macronutrient- and
micronutrient-specific errors,\86\ -\87\ which alter
nutrient to EI ratios in an unpredictable and nonquantifiable manner.
This simple fact renders energy adjustments fallacious
41, 78 and demonstrates that the assumption that M-BM data
can be used to examine patterns of diet or dietary composition is not
logically valid.
The Validity of Human Memory and Recall as Instruments for the
Generation of Scientific Data
Overview
The use of M-BMs requires faith in the belief that human
perception, memory, and recall are accurate and reliable instruments
for the generation of scientific data. Nevertheless, more than 80 years
of research demonstrates that this belief is patently
false.50, 58, 70, 90 The discrepancy between objective
reality and human memory is well established,48, 91 and the
limitations of recall are widely acknowledged in disciplines outside of
nutrition and obesity.47-49, 69, 70, 92 In fact, the
scientific study and analysis of memory would be impossible if it were
not for the inherent fallibility of memory.\49\ Bartlett \93\ presented
the first empirical evidence that the human memory is not a literal,
accurate, or precise reproduction of past events. During the ensuing 80
years, research has clearly demonstrated that the encoding of memories
69, 91 and subsequent recall depend on constructive and
reconstructive processes (e.g., imagination) 48, 69, 53 that
are susceptible to errors, distortions, omissions, complete
fabrications, false reports, and
illusions.50, 58, 69, 70, 90
Given the breadth of this research, reported memories, such as
those presented in 24HRs and FFQs, can be most accurately defined as
mere attributions based on mental experiences that are strongly
influenced by the respondents' idiosyncratic qualities (i.e.,
education), previous memories and information, knowledge and beliefs,
motives, goals, habitual behavior, and the social context in which the
memories are encoded or reported.47, 49, 58 Perhaps the most
salient example of the fallibility of memory and recall (and misplaced
confidence) is that false reporting (i.e., inaccurate eyewitness
testimony) was a key factor in approximately 75% of the first 100 cases
of individuals exonerated by DNA evidence after conviction for crimes
that they did not commit.\57\ The following subsections provide a
survey of the evidence to support the contention that data can be only
as valid as the accuracy of the instrument used in its collection and
that human memory and recall are not valid instruments for the
generation of data to be used in the scientific formulation of
nutrition guidelines.
The Social Sciences
Numerous studies, dating back more than 50 years, have reported
that there is little or no correlation between self-reported behavior
and actual behavior.\94\-\95\ Bernard, et al.\58\ reviewed
the validity of self-reported data in ``The Problem of Informant
Accuracy.'' Surveying multiple research domains, including health care,
child care, communications, nutrition, criminal justice, economics,
anthropology, and psychology, Bernard, et al.\58\ concluded that
``[t]he results of all of these studies leads to one overwhelming
conclusion: on average, about \1/2\ of what informants report is
probably incorrect in some way.'' p. 503 Bernard, et al.\58\
also provide a prescient commentary: ``In sum, despite the evidence,
the basic fact of informant inaccuracy seems not to have penetrated
either graduate training or professional social science research.
Informant inaccuracy remains both a fugitive problem and a well-kept
open secret.'' p. 504 Given the substantial funding of M-BMs
each year,\9\ -\10\ it seems that this 30 year old
commentary also applies to nutrition and obesity research.
Furthermore, when events or behaviors are commonplace (e.g., food
and beverage consumption), previous experiences (e.g., previous
memories and mental schema 69, 96 of past meals) will
determine what is encoded in memory and not the actual perception of
behavior. For example, Freeman, et al.\97\ demonstrated a 52% error
rate in recalling social interactions, with reports of social
interactions shaped by typical past experiences. They explain their
results by suggesting that when events are repeatedly experienced, each
specific event will be minimally processed and the ``actual memory of
such elements will be poor,'' and ``attempts at recall result in a
constructive process that taps into the general structure rather than
the specific memory.'' 97, p. 315
Importantly, Bernard, et al.\58\ lamented two common problems with
social scientific data: (1) the lack of an explicit formal theory of
human behavior and (2) objective evidence from which to test the
plausibility of self-reported data. Nevertheless, nutrition
epidemiologists have both a formal theory (i.e., human metabolism and
the basic energy requirements of human life) and voluminous objective
data \44\-\45\ by which to test the validity of M-BMs.\33\
Despite the availability of formal theory and overwhelming evidence
that self-reported EI data are not accurate, ``plausible,'' \33\ or
even ``compatible with life,'' 11, p.7 self-reported EI
continues to be assumed a valid-measure of actual energy and nutrient
consumption that can be used to inform public nutrition and dietary
policy.\30\
A detailed review of the social research literature is beyond the
scope of this paper, and we direct our readers to Bernard, et al.'s
review.\58\ Nevertheless, one more notable example is warranted.
Immediately on leaving a restaurant, Kronenfeld, et al.\98\ had
participants report on the attire of the waitstaff and the restaurants'
choice of music.\58\ Participants demonstrated much greater agreement
on what the waiters were wearing compared with the waitresses' attire.
The interesting finding was that these restaurants had an all-female
waitstaff (i.e., there were no waiters in the restaurants).
Participants also provided much greater detail on the music from
restaurants that were not playing music than from restaurants that
were.58, 98 These results raise the question: What is the
possibility that self-reported food and beverage consumption in a
restaurant setting will be a literal, accurate, or reliable
representation of actual ingestive behavior?
Cognitive Neuroscience
The domain of cognitive neuroscience supports the hypothesis that
human memory is an amalgam of dynamic constructive and reconstructive
processes.47-53, 55-57, 69, 70 For example, encoding is not
a process that begins de novo with each perception. Encoding is the
result of the limited amount of information available to perception at
any given moment being ``patched together to form memories with varying
degrees of accuracy'' 49, p. 149 (e.g., the process of
associative grouping via semantic relatedness 50, 92, 99)
and subject to ``the distorting influences of present knowledge,
beliefs, and . . . previous experience.'' 49, p. 149 As
such, the general knowledge and availability of mental schemas from
previous eating occasions intrude on the encoding of current
consumption to produce false and fuzzy (i.e., gist)
memories.51, 100 Memory and recall are subject to a myriad
of unintentional ``sins,'' \70\ including but not limited to
distortions, misattribution, suggestibility, simple forgetting,
falsehoods, and omissions.49, 90-91 Because selective and
elaborative processes operate on the perceptions that are encoded and
recalled, ``memory does not [and cannot] operate like a video
recording.'' 57, p. 119
Recently, the process of reconsolidation (i.e., the reconstruction
and re-encoding of memories after recall) has been demonstrated in
rodents, and the evidence in humans is
supportive.\101\-\102\ Reconsolidation involves the same
neural processes as the encoding of the original memory.\91\ Therefore,
each time a memory is recalled, it is irretrievably changed such that
the original memory no longer exists and a new memory of unquantifiable
error replaces it.\101\-\102\ This fact has implications for
the current state-of-the-art 24HR instrument the U.S. Department of
Agriculture (USDA) Automated Multiple-Pass Method.\31\ With each pass
of the multipass procedure, the process of reconsolidation alters the
original memory so that by the end of the data collection period, the
result will be an amalgam of multiple new memories and reports with
unquantifiable error. As such, neither the researchers nor the
participants know the validity or reliability of the reported food and
beverage consumption.
False Reporting: An Inherent Design Feature of M-BMs
False Reporting and FFQs
False reports are the recollection of an event, or details of an
event, that did not actually occur.\69\ False memories and recalls may
be produced in multiple contexts (e.g., during
research,55, 103 psychotherapy, and criminal investigatory
interviews \60\). Although research has demonstrated that false
memories of ingestive behavior and subsequent false reporting of foods
occur in laboratory settings,55, 61, 103 there is a larger
literature base outside of nutrition. The Deese-Roediger and McDermott
(DRM) paradigm is commonly used in research settings to elicit false
reports.\104\-\105\ In this protocol, a list of semantically
related words (e.g., breakfast, bacon, sausage, orange juice, and
cereal) are presented or read to participants. After a delay (minutes
to days), participants are asked to report the words they remember. The
mere presentation of lists of semantically related words induces
extremely high levels (i.e., >75%) of the false reporting of related
but nonpresented words (i.e., critical lures; 49, 99, 105
e.g., the word egg in the previous example). The DRM paradigm is so
effective at inducing false reports that memory distortions occur even
in the small percentage of individuals with highly superior
memories.\50\ With the DRM paradigm, respondents are often more
confident in their false reports than in the presented words.\92\
Researchers familiar with FFQs will recognize that, by design, FFQs
mimic the DRM protocol in that lists of semantically related words
(i.e., foods and beverages) are presented and respondents are expected
to provide a response. Given that FFQs mimic the procedures designed to
produce false recall, it is not surprising that FFQs with longer lists
of semantically related words elicit more responses.\106\ Given the
vast literature demonstrating misreporting with FFQs
35, 38, 42, 107 and the parallel literature on the extremely
high level of false reports using the DRM
paradigm,92, 100, 104-105 it is not a question of whether
FFQs induce false reporting but to what extent. As stated previously,
neither the researchers nor the participants know the validity or
reliability of the reported food and beverage consumption, and neither
can they quantify the error induced via false reporting. As we discuss
in a later section, the inability of current nutrition epidemiologic
research designs to independently falsify or confirm M-BM data renders
the error due to false reports unquantifiable and, therefore,
inadmissible as scientific data.
False Reporting and the WWEIA-NHANES 24HR
Recent research has examined the effects of creating ``false
memories for food preferences and choices.'' 55, 61, p. 134
We refer our readers to a review by Bernstein and Loftus.\55\ Their
work has established that it is relatively simple to ``implant false
beliefs and memories regarding a variety of early childhood food-
related experiences.'' 55, p. 138 We assert that false
memories and reports are induced via the NHANES interview protocol
itself, as has been demonstrated in other interviewing contexts.\60\
The factors that potentially induce false memories and reporting are
well established. For example, the development of a rapport between an
authority figure and respondents followed by the use of guided imagery,
silence in responding, repetition, props, suggestive or repeated
questioning, and encouragement to reminisce, imagine, or elaborate on
past behaviors have all been shown to increase false
recall.55, 69, 91, 92, 100, 105 All of these factors are
explicitly described in the training manual for the research personnel
who conduct the NHANES 24HR.\59\ The use of rapport, silence, imagery,
props, repeated questioning, eye contact, and ``expectant looks,''
p. 4-12 to ``motivate the respondent to answer more
fully'',p. 4-4 are explicit and noteworthy in the training
manual.\59\ For example, the following directive is an exemplar of the
potentially false memorye inducing protocol: ``If you sit quietly--but
expectantly--your respondent will usually think of something. Silence
and waiting are frequently your best probes for a `don't know' reply.
Always try at least once to obtain a reply to a `don't know' response,
before accepting it as the final answer.'' 59, p. 4-13 The
use of rapport combined with repeated questioning, silence, eye
contact, and expectant looks is especially coercive when applied by an
authority figure in a research context. In addition, NHANES personnel
are directed to ask respondents to ``imagine,'' and ``think'' about
their food intake and to ``encourage'' and ensure that the respondents
are ``convinced of the importance of the survey.''
59, p. 4-3 Throughout the manual there are examples of
guided imagery and suggestive questioning, such as directing
participants to begin ``thinking about where you were, who you were
with, or what you were doing, like working, eating out, or watching
television,'' 59, p. 6-2 and directives such as, ``Your own
state of mind your conviction that the interview is important will
strongly influence the respondent's cooperation. Your belief that the
information you obtain will be significant and useful will help
motivate the respondent to answer fully . . .'' p. 4-4
Although the NHANES training manual states that ``[t]his methodology is
designed to maximize respondents' opportunities for remembering and
reporting foods they have eaten,'' p. 6-2 the scientific
literature on false memories and recall strongly supports the
contention that the NHANESM-BM generates significant false reporting.
Given that imagination and coercive techniques (e.g., the use of
silence \59\) are known to increase the probability of illusory (i.e.,
false) recollections,53, 60 it may be that most 24HR data
are false reports. If true, the NHANES 24HR is a mere exercise in
number generation, and, therefore, by design, it does not provide proxy
estimates of energy or nutrient consumption. This premise provides an
empirically supported explanation why most M-BM data are implausible
and have trivial relationships with reality (i.e., actual EI and
nutrient intake.) Nevertheless, without objective corroboration it is
impossible to quantify what percentage of the recalled foods and
beverages are completely false, grossly inaccurate, or somewhat
congruent with actual consumption. Regardless, it is clear that people
consistently ``remember [and report] events that never happened.''
105 ,p. 803
The Inadmissibility of M-BM Data
Criteria for Scientific Research: Observable, Measurable, and
Falsifiable
Although the terms science and research are used interchangeably,
they are not synonymous. Science is more than mere data collection; it
is an attempt to discover order, a potentially self-correcting,
explanatory, and predictive process that demonstrates lawful relations
(e.g., diets high in vitamin C prevent scurvy). In contrast, research
is simply the process of collecting information, and many forms of
research do not meet the rigor necessary for the results to be
scientific. There is a long history of efforts to formally demarcate
scientific from nonscientific and pseudoscientific data, the most
famous of which may be Popper's falsifiability
criterion.\64\-\66\ For example, in U.S. jurisprudence, the
Daubert standard \108\-\109\ provides the rules of evidence
for the admissibility of expert testimony. The criterion of
falsifiability is central to expert scientific testimony and was used
by Judge William Overton in ruling in McLean v. Arkansas Board of
Education. This case determined that creation science was not a science
because it was not falsifiable and, therefore, could not be taught as
science in Arkansas public schools.\110\ As we detail in later
sections, we assert that M-BM data are akin to creation science in that
they fail to meet the basic requirements of scientific research.
Although philosophers continue to debate demarcation criteria,
practicing scientists must set forth principles from which to judge the
admissibility of data in scientific research. We extend Popper's
criterion and proffer the following widely accepted principles of
scientific inquiry. First, for results to be scientific, the study's
protocols must produce outcomes that are subject to replication. To
accomplish this goal, the data must be (1) independently observable
(i.e., accessible by others), (2) measureable, (3) falsifiable, (4)
valid, and (5) reliable. These nonmetaphysical criteria were first
suggested by Roger Bacon in the 13th century and later were elaborated
on by the ``father of empiricism,'' Sir Francis Bacon, in the late 16th
century.\111\ They were again reiterated by Sir Isaac Newton in the
17th century \112\ and have been subsequently clarified and
defined.62-66, 68 The skepticism and empirical rigor
inherent in these criteria are of such importance to science that The
Royal Society of London, the oldest scientific society in the modern
world, succinctly summarized them in its motto, Nullius in Verba. This
phrase, derived from Horace's Epistles,\113\ is translated as ``on the
word of no one'' or ``take no one's word for it'' and suggests that
scientific knowledge should be based not on authority, rhetoric, or
mere words but on objective evidence.
The first three criteria (i.e., independently observable,
measureable, and falsifiable) define the phenomena that are in the
domain of science (i.e., able to be examined via the scientific
method), and the final two criteria (i.e., validity and reliability)
refer to the concordance between a measurement and its referent as well
as the error associated with the measurement protocols used to collect
the data. Together, the five basic tenets distinguish scientific
research from mere data collection and pseudoscience. For example, if
someone is eating an apple, his or her behavior can be independently
observed, measured, and verified or refuted. Yet, if he or she reports
eating an apple at some point in the past (e.g., as with an FFQ or
24HR), neither the past behavior nor the neural correlates of the
memory of that behavior are independently observable or quantifiable,
and without additional information, his or her statement cannot be
falsified or confirmed. It is a rather obvious fact that the respondent
is the only person who has access to the raw data of M-BMs (i.e., his
or her memories of consumption). As such, researchers cannot examine
the validity of the memory and base M-BM research results on their
faith in the verbal report (i.e., the belief that the participant is
telling the truth). Nevertheless, faith and belief are basic tenets of
religion, not science. The unwavering credulity of nutrition
epidemiologists with respect to verbal reports is literally in direct
opposition to Nullius in Verba (i.e., take no one's word for it) and
skeptical, rigorous science. The confluence of these simple facts and
the well-documented failure of self-reported EI to accurately
correspond to reality,33, 35 demonstrate that the memory and
subsequent recall of ingestive behavior are not within the realm of the
scientific investigation of nutrition and obesity. As the philosopher
Karl Popper stated, ``all the statements of empirical science must be
capable of being finally decided, with respect to their truth and
falsity,'' 65, p. 17 and it is wholly impossible to verify
or refute something that cannot be directly or indirectly independently
observed and measured (e.g., memories).
The Pseudoscience of Nutrition Epidemiology
The term pseudoscience describes data or results that are presented
as scientific but lack plausibility because they cannot be reliably,
accurately, and independently observed, quantified, and confirmed or
refuted.\62\-\66\ When M-BMs are examined from the
perspective of the basic tenets of science, the reason for the
explanatory and predictive failure of epidemiologic nutrition research
becomes obvious. First and foremost, scientific conclusions cannot
result from nonempirical (i.e., unobserved) or subjective (i.e.,
private, not publically accessible) data that are not subject to
independent observation, quantification, and falsification. When a
person provides a dietary report, the data collected are not actual
food or beverage consumption but rather an error-prone and highly
edited anecdote regarding memories of food and beverage consumption. As
such, M-BMs do not meet the basic requirements of the scientific method
and, by definition, are pseudoscientific when presented as actual
estimates of energy or nutrient consumption. Two famous physicists of
the 20th century, Wolfgang Pauli and Arthur Schuster, summed up the
problem with pseudoscientific data eloquently when they stated,
respectively, that a pseudoscientific conclusion ``is not only not
right, it is not even wrong . . .'' 114,p. 186 and ``[w]e
all prefer being right to being wrong, but it is better to be wrong
than to be neither right nor wrong .'' 115, p. 117
It is difficult to determine the empirical consequences of M-BMs
because the primary data (i.e., memories: private information to which
the respondents have privileged access) do not meet the basic tenets of
scientific methods (e.g., independent observation of data,
falsifiability, and accuracy). If neither the researchers nor the
participants are able to quantify what percentage of the recalled foods
and beverages are completely false reports, grossly inaccurate, or
reports that are somewhat congruent with actual consumption, it is
impossible to know the validity and the error associated with each
report. As Dhurandhar, et al.\75\ recently suggested, the use of M-BM-
based data is a context in which ``. . . something is not better than
nothing.'' p. 1 Given the forgoing, M-BM-derived data are
inadmissible and constitute a substantial ongoing threat to nutrition
and obesity research and national Dietary Guidelines because the
greatest obstacle to scientific progress is not ignorance but the
illusion of knowledge created by pseudoscientific data that are neither
right nor wrong.
Nevertheless, performing rigorous science is a skill that can be
learned, but only if mentors understand and practice rigorous science.
Given the ubiquitous use of M-BMs over many decades, it seems that
nutritional epidemiologists have eschewed the inherent rigor and
skepticism of Nullius in Verba (i.e., take no one's word for it) and
literally replaced it with Totius in Verba (i.e., take everyone's word
for it). As a result, skeptical rigorous science is not practiced or
taught in nutrition and obesity epidemiologic research.\24\
National Nutrition Surveillance: M-BM Data and USDA Food Availability
Economic Data
If the two major components of U.S. national nutritional
surveillance are valid (i.e., NHANES M-BM data and USDA Food
Availability economic data), estimates from these surveillance tools
should track together and independently provide population-level
approximations of trends in food consumption or use. Nevertheless,
history demonstrates that this is not the case. Trends in estimates of
macronutrient consumption from population-level epidemiologic surveys
(i.e., M-BMs) exhibited statistically significant trends that were in
opposition to those of USDA economic data for fat, carbohydrates,
protein, and energy (i.e., kilocalories per day) from the 1960s to the
late 1980s.\116\ It should be apparent that U.S. residents could not be
simultaneously consuming more and less fat, protein, carbohydrates, and
energy over time. The contradictory patterns and striking lack of
correspondence between the two primary U.S. nutrition surveillance
tools suggest that one or more likely both protocols are invalid. As
with the severe misreporting demonstrated across the
globe,45, 80 these contradictory patterns are not limited to
the United States; many countries exhibit considerable disparity
between national surveillance via M-BMs and economic/food supply
data.\117\-\120\ This fact is further evidence that M-BMs
are fatally flawed and diet-health inferences from M-BM-derived data
are meaningless.
PA and CRF: Essential Elements in Nutrition, Obesity, and Health
Research
The lack of explanatory and predictive power of epidemiologic
nutrition research may also be explained by the limited acknowledgement
of nonnutritional determinants of health and disease, such as
nongenetic evolution,\6\-\8\ PA,\121\-\122\
CRF,\123\ and other components of nutrient partitioning and energy
balance.\124\-\130\ For example, more than 50 years ago the
Food and Agriculture Organization of the United Nations and the World
Health Organization determined that human food energy requirements
should be estimated using TEE and that PA and basal energy expenditure
were the primary determinants.\131\-\132\ Yet, most
nutrition research does not measure any form of energy expenditure or
objectively quantify PA. Currently, there is only one manuscript of
which we are aware that uses the NHANES objectively measured PA data to
directly assess nutrition-related outcomes \133\ and no nutrition-
related publications that include the NHANES treadmill CRF data in
analyses. The lack of publications may be due to the fact that only two
waves in the more than 40 year history of the NHANES include objective
measures of PA, and despite the widespread acknowledgment of the
necessity of daily PA for health and well-being, it is routinely
discounted by governmental public health funding agencies. For example,
PA, CRF, and exercise are not even listed on the National Institutes of
Health's spreadsheet of categorical spending of nearly 250
classifications through 2016.\9\ This is unfortunate given that 80% of
Americans are not at risk for most nutritional deficiencies,\2\ but 95%
of Americans are at risk for PA deficiency (i.e., inactivity or high
sedentary behavior) and do not meet the Federal recommendations of 30
minutes per day of moderate to vigorous PA.\134\
Given that PA and CRF are major determinants of health
122-123, 133, 135-137 and that PA is the only major
modifiable determinant of TEE and nutrient-energy partitioning (i.e.,
the metabolic fate of the foods we consume),6, 124-130, 133
it is clear that PA and CRF must be objectively measured and controlled
for in analyses if the health effects of any dietary intervention are
to be examined accurately. Yet, because PA questionnaires are
susceptible to many of the same systematic biases
75, 138-139 and inadmissibility issues as M-BMs, the failure
to objectively-measure PA and control for it in analyses renders health
inferences from previous nutrition epidemiologic studies moot.
Fortunately, for the science of health and disease, there are objective
tools for the measurement of PA (e.g., pedometers and accelerometry-
based PA monitors),\140\ and despite limitations,\141\ these should be
used in place of surveys and questionnaires to quantify PA in future
examinations of health and disease.
Summary and Future Directions
A wise man proportions his belief to the evidence.
David Hume 142, p. 87
This critical review provides empirical and analytic evidence to
support the position that (1) M-BM estimates of EI and nutrient intake
have trivial relationships with actual EI and nutrient intake; (2) the
assumption that human memory and recall provide literal, accurate, or
precise reproductions of past ingestive behavior is indisputably false;
(3) M-BMs require participants to submit to protocols that mimic
procedures known to induce false recall; (4) the subjective (i.e.,
private, not publically accessible) mental phenomena (i.e., memories)
from which M-BM data are derived are not subject to independent
observation, quantification, or falsification; therefore, these data
are pseudoscientific and inadmissible in scientific research; and (5)
the failure to objectively measure and control for PA and CRF in
analyses renders inferences regarding most diet-health relationships
moot.
Given the overwhelming evidence in support of our hypotheses, we
conclude that M-BM data cannot be used to informational Dietary
Guidelines and that continued funding of M-BMs constitutes an
unscientific and major misuse of research resources. In addition, given
that there are objective data on the nutrition-related health status of
Americans,\2\ we find the DGAC's reliance on M-BMs to be without
scientific support or merit. We think that skepticism and rigor are
essential requirements in scientific investigations, and we fault the
overly credulous nature of nutrition epidemiology for the obvious and
well-demonstrated failures of the scientific community to properly
inform previous Federal Dietary Guidelines (e.g., cholesterol
consumption).30, 143 We think that our nation's Dietary
Guidelines should not be based on the pseudoscientific and highly
edited anecdotes of M-BMs, and although others may disagree, we ask
that they do as we have done and provide empirical evidence rather than
rhetoric to support their positions. Without valid evidence, the
dogmatic defense of illusory knowledge and the status quo in nutrition
and obesity research (e.g., see previous commentaries and guidelines
30, 46, 74) is an impediment to scientific progress and
empirically supported public nutrition and obesity policy.
We began this critical review with evidence that our nation's food
supply and the nutritional status of Americans have improved to a level
unparalleled in human history.2-3, 5 Given this reality and
recent work on the intergenerational transmission of obesity and type 2
diabetes mellitus,\6\-\8\ we posit that the American diet is
no longer a significant risk factor for disease for most individuals.
This hypothesis is supported by multiple lines of evidence, such as a
40% decline in the age-adjusted mortality rate from 1969 to 2010,\144\
a progressive decades long reduction in age-adjusted cardiovascular
disease incidence and mortality,\145\-\146\ and a 1.5% per
annum reduction in age-adjusted mortality rates from all major cancers
as well as significant reductions in lung cancer incidence in men and
women between 2001 and 2010.\147\ Given the forgoing and the evidence
presented herein demonstrating the pseudoscientific nature of M-BMs, we
assert that research efforts and funding of M-BMs and diet-health
research are misdirected and argue that those resources would be better
targeted to the most prevalent disease of deficiency of the 21st
century: inactivity (i.e., a lack of PA and exercise and high levels of
sedentary behavior).121, 134
Conclusion
In this critical review, we argued that the essence of science is
the ability to discern fact from fiction, and we presented evidence
from multiple fields to support the position that the data generated by
nutrition epidemiologic surveys and questionnaires are not falsifiable.
As such, these data are pseudoscientific and inadmissible in scientific
research. Therefore, these protocols and the resultant data should not
be used to inform national Dietary Guidelines or public health policy,
and the continued funding of these methods constitutes an unscientific
and major misuse of research resources.
Acknowledgments
The content is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institutes of
Health.
Abbreviations and Acronyms: BMR = basal metabolic rate; CRF =
cardiorespiratory fitness; DRM = Deese-Roediger and McDermott; DGAC =
Dietary Guidelines Advisory Committee; EI = energy intake; FFQ = food
frequency questionnaire; M-BM = memory-based dietary assessment method;
NHANES = National Health and Nutrition Examination Survey; PA =
physical activity; rEI = reported energy intake; TEE = total energy
expenditure; USDA = U.S. Department of Agriculture; WWEIA = What We Eat
in America; 24HR = 24 hour dietary recall
Grant Support: This work was supported by grant T32DK062710 (E.A.,
G.P.) from the National Institute of Diabetes and Digestive and Kidney
Diseases of the National Institutes of Health.
Potential Competing Interests: Dr. Archer has received honoraria
from the International Life Sciences Institute and The Coca Cola
Company. Dr. Lavie reports receiving consulting fees and speaking fees
from The Coca-Cola Company and writing a book on the obesity paradox
with potential royalties.
Correspondence: Address to Edward Archer, Ph.D., Office of
Energetics, Nutrition Obesity Research Center, University of Alabama at
Birmingham, Birmingham, AL 35222 ([email protected]).
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exhibit c
Validity of U.S. Nutritional Surveillance: National Health and
Nutrition Examination Survey Caloric Energy Intake Data, 1971-
2010
PLoS ONE
PLoS ONEDwww.plosone.orgDOctober 2013DVolume 8DIssue
10De76632
Edward Archer 1 *, Gregory A. Hand,\1\ Steven N. Blair
1, 2
---------------------------------------------------------------------------
\1\ Department of Exercise Science, Arnold School of Public Health,
University of South Carolina, Columbia, South Carolina, United States
of America.
\2\ Department of Epidemiology and Biostatistics, University of
South Carolina, Columbia, South Carolina, United States of America.
* E-mail: [email protected].
---------------------------------------------------------------------------
Abstract
Importance: Methodological limitations compromise the validity of
U.S. nutritional surveillance data and the empirical foundation for
formulating dietary guidelines and public health policies.
Objectives: Evaluate the validity of the National Health and
Nutrition Examination Survey (NHANES) caloric intake data throughout
its history, and examine trends in the validity of caloric intake
estimates as the NHANES dietary measurement protocols evolved.
Design: Validity of data from 28,993 men and 34,369 women, aged 20
to 74 years from NHANES I (1971-1974) through NHANES 2009-2010 was
assessed by: calculating physiologically credible energy intake values
as the ratio of reported energy intake (rEI) to estimated basal
metabolic rate (BMR), and subtracting estimated total energy
expenditure (TEE) from NHANES rEI to create `disparity values'.
Main Outcome Measures: (1) Physiologically credible values
expressed as the ratio rEI/BMR and (2) disparity values (rEI-TEE).
Results: The historical rEI/BMR values for men and women were 1.31
and 1.19, (95% CI: 1.30-1.32 and 1.18-1.20), respectively. The
historical disparity values for men and women were ^281 and ^365
kilocalorie-per-day, (95% CI: ^299, ^264 and ^378, ^351), respectively.
These results are indicative of significant under-reporting. The
greatest mean disparity values were ^716 kcal/day and ^856 kcal/day for
obese (i.e., $30 kg/m2) men and women, respectively.
Conclusions: Across the 39 year history of the NHANES, EI data on
the majority of respondents (67.3% of women and 58.7% of men) were not
physiologically plausible. Improvements in measurement protocols after
NHANES II led to small decreases in underreporting, artifactual
increases in rEI, but only trivial increases in validity in subsequent
surveys. The confluence of these results and other methodological
limitations suggest that the ability to estimate population trends in
caloric intake and generate empirically supported public policy
relevant to diet-health relationships from U.S. nutritional
surveillance is extremely limited.
Citation: Archer E., Hand G.A., Blair S.N. (2013) Validity of U.S.
Nutritional Surveillance: National Health and Nutrition Examination
Survey Caloric Energy Intake Data, 1971-2010. PLoS ONE 8(10): e76632.
doi:10.1371/journal.pone.0076632.
Editor: Darcy Johannsen, Pennington Biomed Research Center, United
States of America Received May 9, 2013; Accepted August 25, 2013;
Published October 9, 2013.
Copyright: 2013 Archer, et al. This is an open-access article
distributed under the terms of the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction
in any medium, provided the original author and source are credited.
Funding: This study was funded via an unrestricted research grant
from The Coca-Cola Company. The sponsor of the study had no role in the
study design, data collection, data analysis, data interpretation, or
writing of the report.
Competing Interests: Dr. Gregory Hand has received consultancy fees
from the National Institutes of Health (NIH) and grants from the NIH,
and The Coca-Cola Company. Dr. James Hebert is supported by an
Established Investigator Award in Cancer Prevention and Control from
the Cancer Training Branch of the National Cancer Institute (K05
CA136975). Dr. Steven Blair receives book royalties (<$5,000/year) from
Human Kinetics; honoraria for service on the Scientific/Medical
Advisory Boards for Clarity, Technogym, Santech, and Jenny Craig; and
honoraria for lectures and consultations from scientific, educational,
and lay groups which are donated to the University of South Carolina or
not-for-profit organizations. Dr. Blair is a consultant on research
projects with the University of Texas-Southwestern Medical School and
the University of Miami. During the past 5 year period Dr. Blair has
received research grants from The Coca-Cola Company, the National
Institutes of Health, and Department of Defense. Funding for the study
was provided by an unrestricted research grant from The Coca-Cola
Company. The sponsor of the study had no role in the study design, data
collection, data analysis, data interpretation, or writing of the
report, and does not alter the authors' adherence to all the PLoS ONE
policies on sharing data and materials.
Introduction
The rise in the population prevalence of obesity has focused
attention on U.S. nutritional surveillance research and the analysis of
trends in caloric energy intake (EI). Because these efforts provide the
scientific foundation for many public health policies and food-based
guidelines, poor validity in dietary measurement protocols can have
significant long-term implications for our nation's health.
In the U.S., population-level estimates of EI are derived from data
collected as part of the National Health and Nutrition Examination
Survey (NHANES), a complex, cross-sectional sample of the U.S.
population. The primary method used in NHANES to approximate EI is the
24 hour dietary recall interview (24HR) [1]. The data collected are
based on the subject's self-reported, retrospective perceptions of food
and beverage consumption in the recent past. To calculate EI estimates,
these subjective data are translated into nutrient food codes and then
assigned numeric energy (i.e., caloric) values from food and nutrient
databases. Prior to 2001-2002, the NHANES relied upon databases of
varying quality and composition for the post-hoc conversion of food and
beverage consumption (24HR) data into energy values [2-5]. After 2001-
2002, the NHANES and the U.S. Department of Agriculture's (USDA)
Continuing Survey of Food Intakes by Individuals were integrated into
the ``What We Eat in America'' program [6], and the translation process
was standardized via use of successive versions of the USDA's National
Nutrient Database for Standard Reference (NNBS) [7].
Misreporting
Given the indirect, pseudo-quantitative nature of the method (i.e.,
assigning numeric values to subjective data without objective
corroboration), nutrition surveys frequently report a range of energy
intakes that are not representative of the respondents' habitual
intakes [8], and estimates of EI that are physiologically implausible
(i.e., incompatible with survival) have been demonstrated to be
widespread [9-11]. For example, in a group of ``highly educated''
participants, Subar, et al. (2003) demonstrated that when total energy
expenditure (TEE) via doubly labeled water (DLW) was compared to
reported energy intake (rEI), the raw correlations between TEE and rEI
were 0.39 for men and 0.24 for women. Men and women underreported
energy intake by 12-14% and 16-20%, respectively. The level of
underreporting increased significantly after correcting for the weight
gain of the sample over the study period [9], and underreporting was
greater for fat than for protein, thereby providing additional support
for the well-documented occurrence of the selective misreporting of
specific macronutrients (e.g., fat and sugars) [12-15]. These results
are consistent with earlier work, in which the correlations between
DLW-derived TEE and seven 24HR and the average of two 7 day dietary
recalls were 0.33 and 0.30, respectively [16].
Because the NHANES collected dietary data over the period in which
the population prevalence of obesity was increasing, these data have
been used (despite the widely acknowledged issues [17]) to examine the
association of trends in EI with increments in mean population body
mass index (BMI) and rates of obesity (e.g., [18-20]). Given that
implausible rEI values and the misreporting of total dietary intake
render the relationships between dietary factors, BMI and other indices
of health ambiguous [21], and diminish the usefulness of nutrition data
as a tool to inform public health policy, this report examines the
validity of U.S. nutrition surveillance EI data from NHANES I (1971-
1974) through NHANES 2010 (nine survey periods) using two protocols:
the ratio of reported energy intake (rEI) to basal metabolic rate (rEI/
BMR) [22,23] and the disparity between rEI and estimated total energy
expenditure (TEE) from the Institute of Medicine's (IOM) predictive
equations [24].
Table 1. rEI/BMR values for all men and women from NHANES I through
NHANES 2009-2010.
Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 =
plausible U.S. Men & Women (20-74 years); NHANES I-NHANES 2009-2010
------------------------------------------------------------------------
95% Confidence rEI Value
NHANES Estimate Standard Interval Plausible Y
Survey Sex rEI/RMR Error -------------------- = Yes N =
Year (mean) * Lower Upper No
------------------------------------------------------------------------
NHANES I Men 1.30 0.012 1.28 1.32 N
(n =
4,65
2)
Women 1.10 0.010 1.08 1.12 N
(n =
7,70
9)
NHANES Men 1.28 0.010 1.26 1.30 N
II (n =
5,23
6)
Women 1.08 0.008 1.06 1.09 N
(n =
6,00
6)
NHANES Men b 1.36 0.011 1.34 1.39 Y
III (n =
6,12
2)
Women a 1.22 0.009 1.20 1.24 N
(n =
7,12
7)
NHANES Men 1.31 0.018 1.27 1.34 N
I999-00 (n =
1,60
0)
Women a 1.23 0.016 1.19 1.26 N
(n =
1,88
6)
NHANES Men 1.31 0.015 1.28 1.34 N
2001-20 (n =
02 1,78
2)
Women a 1.24 0.011 1.22 1.26 N
(n =
2,02
9)
NHANES Men 1.32 0.013 1.30 1.35 Y
2003-20 (n =
04 1,67
1)
Women a 1.23 0.018 1.20 1.27 N
(n =
1,83
8)
NHANES Men c 1.34 0.013 1.31 1.36 Y
2005-20 (n =
06 1,74
9)
Women a 1.21 0.014 1.18 1.24 N
(n =
1,99
8)
NHANES Men 1.27 0.017 1.24 1.30 N
2007-08 (n =
2,15
4)
Women a 1.19 0.020 1.15 1.23 N
(n =
2,30
6)
NHANES Men 1.29 0.013 1.26 1.31 N
2009-20 (n =
10 2,31
9)
Women a 1.20 0.007 1.18 1.21 N
(n =
2,53
2)
---------------------------------------------------------------
All Men 1.31 0.005 1.30 1.32 N
Surve (n =
ys 27,2
85)
Women 1.19 0.005 1.18 1.20 N
(n =
33,4
31)
------------------------------------------------------------------------
* All estimates are weighted means.
a Significantly different from NHANES I at p50.001 (Women).
b Significantly different from NHANES I at p50.001 (Men).
c Significantly different from NHANES I at p50.05 (Men).
Note: rEI was from NHANES 24HR data and BMR was calculated using the
Schofield predictive equations. [26] Values <1.35 are considered
implausible and indicative of underreporting. TEE = estimated total
energy expenditure; IOM = Institute of Medicine; rEI = reported energy
intake; BMR = Basal Metabolic Rate calculated via Schofield predictive
equation.
Values <1.35 are not physiologically credible.
doi:10.1371/journal.pone.0076632.t001.
Methods
Population
Data were obtained from the National Health and Nutrition
Examination Surveys for the years 1971-2010 [1]. The NHANES is a
complex multi-stage, cluster sample of the civilian, non-
institutionalized U.S. population conducted by the Centers for Disease
Control and Prevention (CDC). The National Center for Health Statistics
ethics review board approved protocols and written informed consent was
obtained from all NHANES participants.
Inclusion Criteria
The study sample was limited to adults aged $20 and 574 years at
the time of the NHANES in which they participated, and had a body mass
index (BMI) $18 kg/m2, and with complete data on age, sex,
height, weight, and dietary energy intake.
Dietary Data
Estimates of EI were obtained from a single 24HR from each of the
nine NHANES study periods [1]. Energy content of the self-reported food
consumption was determined by NHANES using nutrient databases based on
previous versions of the USDA National Nutrient Database for Standard
Reference (NNDS) [7].
Table 2. rEI/BMR index for all women by BMI categories from NHANES I through NHANES 2009-2010.
Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Women (20-74 years);
NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
95% Confidence rEI Value
Estimate Standard Interval Plausible Y
NHANES Survey Year BMI Category rEI/BMR Error -------------------- = Yes N =
(mean) * Lower Upper No
----------------------------------------------------------------------------------------------------------------
NHANES I Normal (n = 4,222) 1.20 0.013 1.18 1.23 N
Overweight (n = 2,028) 1.00 0.012 0.98 1.02 N
Obese (n = 1,459) 0.88 0.014 0.86 0.91 N
NHANES II Normal (n = 3,171) 1.18 0.010 1.16 1.20 N
Overweight (n = 1,671) 0.98 0.012 0.96 1.01 N
Obese (n = 1,164) 0.89 0.012 0.87 0.91 N
NHANES III Normal (n = 2,661) 1.32 0.014 1.30 1.35 Y
Overweight (n = 2,150) 1.18 0.019 1.14 1.22 N
Obese (n = 2,316) 1.07 0.015 1.04 1.10 N
NHANES 1999-2000 Normal (n = 555) 1.36 0.020 1.32 1.40 Y
Overweight (n = 572) 1.19 0.033 1.12 1.25 N
Obese (n = 759) 1.12 0.030 1.06 1.18 N
NHANES 2001-2002 Normal (n = 630) 1.38 0.018 1.35 1.42 Y
Overweight (n = 639) 1.26 0.028 1.21 1.32 N
Obese (n = 760) 1.08 0.012 1.05 1.10 N
NHANES 2003-2004 Normal (n = 550) 1.35 0.031 1.29 1.41 Y
Overweight (n = 546) 1.19 0.027 1.14 1.25 N
Obese (n = 742) 1.15 0.026 1.10 1.20 N
NHANES 2005-2006 Normal (n = 615) 1.34 0.026 1.29 1.39 Y
Overweight (n = 558) 1.19 0.028 1.13 1.24 N
Obese (n = 825) 1.10 0.024 1.05 1.15 N
NHANES 2007-2008 Normal (n = 634) 1.30 0.038 1.23 1.38 Y
Overweight (n = 694) 1.17 0.026 1.12 1.22 N
Obese (n = 978) 1.10 0.020 1.06 1.14 N
NHANES 2009-2010 Normal (n = 690) 1.31 0.022 1.26 1.35 Y
Overweight (n = 745) 1.23 0.024 1.18 1.28 N
Obese (n = 1,097) 1.08 0.006 1.06 1.09 N
----------------------------------------------------------------------------------------------------------------
* All estimates are weighted means.
Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values
<1.35 are considered implausible and indicative of underreporting. TEE = estimated total energy expenditure;
IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield
predictive equation.
doi:10.1371/journal.pone.0076632.t002.
Table 3. rEI/BMR index for all men by BMI categories from NHANES I through NHANES 2009-2010.
Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Men (20-74 years); NHANES
I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
95% Confidence rEI Value
Estimate Standard Interval Plausible Y
NHANES Survey Year BMI Category rEI/BMR Error -------------------- = Yes N =
(mean) * Lower Upper No
----------------------------------------------------------------------------------------------------------------
NHANES I Normal (n = 2,115) 1.41 0.016 1.38 1.44 Y
Overweight (n = 1,945) 1.24 0.017 1.21 1.28 N
Obese (n = 592) 1.08 0.025 1.04 1.13 N
NHANES II Normal (n = 2,431) 1.37 0.009 1.35 1.39 Y
Overweight (n = 2,111) 1.25 0.015 1.22 1.28 N
Obese (n = 694) 1.08 0.018 1.05 1.12 N
NHANES III Normal (n = 2,275) 1.47 0.018 1.43 1.50 Y
Overweight (n = 2,482) 1.35 0.015 1.32 1.38 Y
Obese (n = 1,365) 1.20 0.018 1.17 1.24 N
NHANES 1999-2000 Normal (n = 476 ) 1.42 0.020 1.38 1.46 Y
Overweight (n = 655) 1.33 0.022 1.28 1.37 Y
Obese (n = 469) 1.16 0.036 1.09 1.23 N
NHANES 2001-2002 Normal (n = 493) 1.43 0.038 1.35 1.50 Y
Overweight (n = 774) 1.32 0.017 1.29 1.36 Y
Obese (n = 515) 1.18 0.027 1.13 1.24 N
NHANES 2003-2004 Normal (n = 465) 1.46 0.029 1.41 1.52 Y
Overweight (n = 659) 1.35 0.025 1.30 1.40 Y
Obese (n = 547) 1.18 0.035 1.11 1.24 N
NHANES 2005-2006 Normal (n = 413) 1.51 0.030 1.45 1.57 Y
Overweight (n = 735) 1.33 0.023 1.29 1.38 Y
Obese (n = 601) 1.22 0.014 1.19 1.25 N
NHANES 2007-2008 Normal (n = 539) 1.40 0.038 1.32 1.47 Y
Overweight (n = 835) 1.29 0.017 1.26 1.32 N
Obese (n = 790) 1.15 0.019 1.12 1.19 N
NHANES 2009-2010 Normal (n = 563) 1.38 0.027 1.33 1.44 Y
Overweight (n = 872) 1.35 0.021 1.31 1.39 Y
Obese (n = 884) 1.16 0.016 1.13 1.19 N
----------------------------------------------------------------------------------------------------------------
* All estimates are weighted means.
Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values
<1.35 are considered implausible and indicative ofunderreporting. TEE = estimated total energy expenditure;
IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via
Schofieldpredictive equation.
doi:10.1371/journal.pone.0076632.t003.
Determination of Physiologically Credible rEI Values
The ratio of rEI to BMR (rEI/BMR) <1.35 [22,23,25] was used to
determine EI values that were implausible. BMR was estimated via the
Schofield predictive equations [26]. The <1.35 cut-off for implausible
EI values was used because ``it is highly unlikely that any normal,
healthy free-living person could habitually exist at a PAL [i.e., TEE/
BMR] of less than 1.35'' [22].
It is important to note that the <1.35 cut-off does not assess all
forms of misreporting (e.g., over-reporting). To avoid the confounding
effects of potential over-reporting, all rEI/BMR values >2.40 [27] were
excluded from analyses of underreporting. One form of misreporting that
neither cut-off addresses is the underreporting of EI from a high
caloric intake associated with elevated levels of physical activity.
Disparity of the rEI and Estimated Total Energy Expenditure (TEE)
In 2002, the IOM used datasets derived from studies using DLW to
create factorial equations to estimate energy requirements for the U.S.
population. IOM TEE values were subtracted from the NHANES rEI to
calculate disparity values. Negative values indicate underreporting.
IOM Equations for Predicting TEE Normal Weight (NW) Adults only ($19
Years)
Equation 1 Men: TEE= 864^(9.72 age [y])+PA* (14.2 weight
[kg]+503 height[m]) (R202).
Equation 2 Women: TEE = 387^(7.31 age [y]+PA* (10.8 weight
[kg]+660.7 height[m]) (R156).
* Physical activity (PA) values were 1.12 and 1.14 for NW men
and women, respectively. The use of these values assumes
physical activity level (PAL) of $1.4 and <1.6, which is
indicative of a ``low active'' population [24].
Figure 1
Percent of Plausible Reporters
(rEI/BMR >1.35)
U.S. Men & Women (20-74 yrs)
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Percent of plausible reporters (i.e., rEI/BMR >1.35) by sex
from NHANES I to NHANES 2009-2010; U.S. Men and women (20-74
years).
IOM Equations for Predicting TEE Overweight (OW)/Obese (OB) Adults Only
($19 Years)
Equation 3 Men: TEE= 1,086^(10.1 age [y])+PA* (13.76weight
[kg]+416 height [m]).
Equation 4 Women: TEE= 448^(7.95 age [y])+PA* (11.46weight
[kg]+619 height [m]).
* PA values were 1.12 and 1.16 for OW/OB men and women,
respectively. The use of these values assumes a physical
activity level (PAL) of $1.4 and <1.6, which is indicative of a
``low active'' population [24].
Note: age (years); weight (kg); height (m; meters); BMI= body
mass index, (kg/m2), IOM= Institute of Medicine; TEE
= total energy expenditure.
Anthropometry [1]
Body mass was measured to R0.1 kg. Height was measured to R0.1 cm.
BMI was calculated as weight (kg)/height (m)2. The sample
was divided into three standard BMI categories: BMI $18 kg/
m2 and <25 kg/m2 were normal weight (NW), BMI
between 25 kg/m2 and 29.9 kg/m2 were overweight
(OW), and $30 kg/m2 were obese (OB).
Statistical Analyses
Data processing and statistical analyses were performed using
SAS', V 9.2 and SPSS' V.19 in 2012-2013. Analyses
accounted for the NHANES' complex survey design via the incorporation
of stratification, clustering and post-stratification weighting to
maintain a nationally representative sample for each survey period. All
analyses included adjusted means, and a <0.05 (2-tailed) was used to
identify statistical significance.
Results
Examination of Underreporting via rEI/BMR
Table 1 depicts the rEI/BMR values for men and women from NHANES I
through NHANES 2009-2010. rEI was from NHANES 24HR data and BMR was
calculated using the Schofield predictive equations [26]. Values <1.35
are considered implausible and indicative of underreporting.
Table 4. Disparity of rEI and TEE for men and women (20-74 years).
Disparity between rEI and IOM TEE U.S. Men & Women (20-74 years) NHANES
I-NHANES 2009-2010
------------------------------------------------------------------------
95% Confidence Validity:
NHANES Estimate Interval (CI) 95% CI
Survey Sex rEI minus Standard -------------------- includes
Year TEE (mean) Error zero (Y =
* Lower Upper Yes, N= No)
------------------------------------------------------------------------
NHANES I Men ^290.8 20.3 ^330.7 ^250.9 N
(n =
4,65
2)
Women ^479.7 14.5 ^508.1 ^451.3 N
(n =
7,70
9)
NHANES Men ^323.2 17.8 ^358.1 ^288.3 N
II (n =
5,23
6)
Women ^505.8 11.6 ^528.4 ^483.1 N
(n =
6,00
6)
NHANES Men b ^183.3 19.1 ^220.8 ^145.7 N
III (n =
6,12
2)
Women a ^325.3 13.5 ^351.7 ^298.8 N
(n =
7,12
7)
NHANES Men ^285.3 37.7 ^359.3 ^211.4 N
1999-20 (n =
00 1,60
0)
Women a ^328.7 27.3 ^382.3 ^275.1 N
(n =
1,88
6)
NHANES Men ^270.3 26.8 ^322.9 ^217.7 N
2001-20 (n =
02 1,78
2)
Women a ^306.0 15.5 ^336.3 ^275.6 N
(n =
2,02
9)
NHANES Men ^255.6 24.7 ^304.0 ^207.3 N
2003-20 (n =
04 1,67
1)
Women a ^308.2 27.2 ^361.5 ^254.8 N
(n =
1,83
8)
NHANES Men ^232.2 25.3 ^281.8 ^182.6 N
2005-20 (n =
06 1,74
9)
Women a ^347.5 20.8 ^388.4 ^306.6 N
(n =
1,99
8)
NHANES Men ^355.0 32.1 ^417.9 ^292.0 N
2007-08 (n =
2,15
4)
Women d ^379.4 28.5 ^435.3 ^323.5 N
(n =
2,30
6)
NHANES Men ^330.9 22.7 ^375.4 ^286.4 N
2009-20 (n =
10 2,31
9)
Women a ^366.9 9.8 ^386.1 ^347.7 N
(n =
2,53
2)
---------------------------------------------------------------
All Men ^281.4 9.1 ^299.3 ^263.5 N
Surve (n =
ys 27,2
85)
Women ^364.6 7.0 ^378.3 ^351.0 N
(n =
33,4
31)
------------------------------------------------------------------------
* All estimates are weighted means.
a Significantly different from NHANES I at p50.001 (Women).
b Significantly different from NHANES I at p50.001 (Men).
c Significantly different from NHANES I at p50.05 (Men).
d Significantly different from NHANES I at p50.05 (Women).
Note: TEE = estimated total energy expenditure; IOM = Institute of
Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate
calculated via Schofield predictiveequation.
These values were calculated by subtracting the IOM TEE from the NHANES
rEI. Negative values indicate the kilocalorie-per-day (kcal/day) value
of underreporting.
doi:10.1371/journal.pone.0076632.t004
As Table 1 depicts, the 95% confidence intervals (CI) suggest that
all mean rEI values for women and six of nine mean rEI values for men
were apparently implausible.
Table 2 depicts the rEI/BMR index for all women by BMI categories
from NHANES I through NHANES 2009-2010.
As Table 2 depicts, the 95% CI suggest that in 20 of the 27
measurement categories (i.e., three BMI categories and nine surveys)
the rEI values were not in the physiologically plausible range. The
overall mean for rEI/BMR values for the total sample of women (n=
33,431) across all NHANES was 1.19 (95% CI: 1.18, 1.20) and therefore
not physiologically plausible.
Table 3 depicts the rEI/BMR index for all men by BMI categories
from NHANES I through NHANES 2009-2010.
As shown in Table 3, the 95% CI suggest that in 12 of 27
measurement categories (i.e., three BMI categories and nine surveys),
the rEI values were not in the physiologically plausible range. The
overall mean value for rEI/BMR for the total sample of men (n = 27,285)
across all NHANES was 1.31 (95% CI: 1.30, 1.32), and therefore not in
the physiologically plausiblerange.
Percent of Plausible Reporters
Figure 1 depicts the percent of plausible reporters (i.e., rEI/BMR
>1.35) by sex from NHANES I to NHANES 2009-2010.
As Figure 1 depicts, across the entire study period (i.e., 1971-
2010) the majority of respondents did not report plausible rEI values
in any survey. When stratified by sex and BMI categories, plausible
reporting in OB women ranged from a low of 12% in NHANES I and II to a
high of 31% in NHANES 2003-2004. At no point in the history of the
NHANES did more than 43% of OW and OB women report plausible values.
Plausible reporting in NW women ranged from a low of 32% in NHANES II
to 52% in NHANES 2001-2002. Plausible rEI values in OB men ranged from
a low of 23% in NHANES II to a high of 35% in NHANES 2005-2006. At no
point in the history of NHANES did more than 49% of OW and OB men
report plausible rEI values.
Disparity between NHANES rEI and IOM TEE
Table 4 depicts the disparity of rEI and TEE for men and women (20-
74 years). These values were calculated by subtracting the IOM TEE from
the NHANES rEI. Negative values indicate the kilocalorie-per-day (kcal/
day) value of underreporting.
Table 5. Disparity between rEI and the TEE for women (20-74 years) by BMI categories.
Disparity between rEI and IOM TEE; U.S. Women by BMI categories (20-74 years) NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
95% Confidence Validity:
Estimate Interval (CI) 95% CI
NHANES Survey Year BMI Category rEI minus Standard -------------------- includes
TEE (mean) Error zero (Y =
* Lower Upper Yes, N= No)
----------------------------------------------------------------------------------------------------------------
NHANES I Normal (n = 4,222) ^316.0 17.7 ^350.8 ^281.2 N
Overweight (n = 2,028) ^595.3 17.7 ^629.9 ^560.6 N
Obese (n = 1,459) ^856.0 23.5 ^902.0 ^809.9 N
NHANES II Normal (n = 3,171) ^351.6 13.7 ^378.5 ^324.8 N
Overweight (n = 1,671) ^617.6 17.1 ^651.1 ^584.1 N
Obese (n = 1,164) ^850.6 19.5 ^888.9 ^812.3 N
NHANES III Normal (n = 2,661) ^158.6 17.7 ^193.3 ^123.9 N
Overweight (n = 2,150) ^357.1 26.5 ^409.1 ^305.2 N
Obese (n = 2,316) ^594.2 22.6 ^638.5 ^549.9 N
NHANES 1999-2000 Normal (n = 555) ^106.0 27.2 ^159.3 ^52.6 N
Overweight (n = 572) ^359.6 48.8 ^455.3 ^264.0 N
Obese (n = 759) ^530.1 50.2 ^628.5 ^431.6 N
NHANES 2001-2002 Normal (n = 630) ^74.0 21.7 ^116.6 ^31.4 N
Overweight (n = 639) ^239.6 38.7 ^315.5 ^163.7 N
Obese (n = 760) ^591.1 20.5 ^631.4 ^550.9 N
NHANES 2003-2004 Normal (n = 550) ^116.3 39.2 ^193.2 ^39.4 N
Overweight (n = 546) ^339.0 37.7 ^413.0 ^265.0 N
Obese (n = 742) ^477.1 42.2 ^560.0 ^394.2 N
NHANES 2005-2006 Normal (n = 615) ^131.1 34.1 ^198.0 ^64.3 N
Overweight (n = 558) ^342.8 38.0 ^417.4 ^268.3 N
Obese (n = 825) ^567.3 38.7 ^643.2 ^491.3 N
NHANES 2007-2008 Normal (n = 634) ^173.2 52.1 ^275.4 ^71.0 N
Overweight (n = 694) ^374.1 35.8 ^444.4 ^303.7 N
Obese (n = 978) ^567.3 33.2 ^632.5 ^502.1 N
NHANES 2009-2010 Normal (n = 690) ^173.0 27.8 ^227.5 ^118.4 N
Overweight (n = 745) ^288.9 34.0 ^355.7 ^222.2 N
Obese (n = 1,097) ^590.5 14.0 ^617.8 ^563.1 N
----------------------------------------------------------------------------------------------------------------
Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI =
reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation.
These values were calculated by subtracting the IOM TEE from the NHANES rEI for each respondent. Negative values
indicate the kcal/day value of underreporting.
doi:10.1371/journal.pone.0076632.t005
As Table 4 depicts, in no survey group (i.e., men & women in nine
surveys) does the 95% CI for the disparity between rEI and TEE include
zero. This suggests that that underreporting of EI occurred in both men
and women, and across all surveys. The overall mean value for the
disparity of rEI and IOM TEE for the total sample of women (n= 33,431)
across all NHANES was ^365 kcal/day (95% CI: ^378, ^351), or 18% of
TEE, and for the total sample of men (n= 27,285) was ^281 kcal/day (95%
CI: ^299, ^264), or 10% of TEE.
When stratified by sex and BMI categories (see Tables 5 & 6), the
disparities between rEI and TEE in OB women ranged from 2,856 kcal/day
(95% CI: ^902, ^810), an underreporting of 41% of TEE, to 2477 kcal/
day (95% CI: ^560, ^394), an underreporting of 20% of TEE. The
disparities between rEI and TEE in OB men ranged from ^717 kcal/day
(95% CI: ^790, ^643) in NHANES II to ^464 kcal/day (95% CI: ^527, ^401)
underreporting of 25% and 15%, respectively.
Trends in Underreporting
After the removal of over-reporters, both protocols, that is rEI/
BMR (Figure 1) and the disparity between rEI and IOM TEE (Table 4)
exhibited significant decreases in underreporting from NHANES II and
NHANES III (p<0.001). There were significant negative linear trends for
both men and women in changes in underreporting total caloric intake
from NHANES I to NHANES 2009-2010 (rEI/BMR: p<0.001, and disparity: p
=0.028).
Trends in Over-Reporting
Across the study period, approximately 4.9% of men and 2.9% of
women reported rEI/BMR values suggestive of over-reporting (i.e., rEI/
BMR >2.4) with no significant trends. The greatest increase in the
percentage of over-reporters between survey periods occurred from
NHANES II to NHANES III, with men increasing from 4.1% to 6.4%, and
women from 1.7% to 3.4% (both p<0.001). The greatest absolute
percentage of over-reporters was in NHANES III, with 6.4% of men over-
reporting and NHANES 2003-2004, with 3.9% of women over-reporting.
Table 6. Disparity between rEI and the TEE for all men (20-74 years) by BMI categories.
Disparity between rEI and IOM TEE; U.S. Men by BMI categories (20-74 years) NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
95% Confidence Validity:
Estimate Interval (CI) 95% CI
NHANES Survey Year BMI Category rEI minus Standard -------------------- includes
TEE (mean) Error zero (Y =
* Lower Upper Yes, N= No)
----------------------------------------------------------------------------------------------------------------
NHANES I Normal (n = 2,115) ^96.3 26.8 ^149.0 ^43.6 N
Overweight (n = 1,945) ^374.7 30.8 ^435.1 ^314.2 N
Obese (n = 592) ^702.1 49.7 ^799.7 ^604.5 N
NHANES II Normal (n = 2,431) ^178.7 15.9 ^209.9 ^147.6 N
Overweight (n = 2,111) ^367.6 27.0 ^420.5 ^314.6 N
Obese (n = 694) ^716.5 37.3 ^789.8 ^643.3 N
NHANES III Normal (n = 2,275) ^8.8 31.1 ^69.8 52.2 Y
Overweight (n = 2,482) ^191.5 27.9 ^246.3 ^136.7 N
Obese (n = 1365) ^494.4 38.0 ^569.0 ^419.9 N
NHANES 1999-2000 Normal (n = 476) ^87.2 34.8 ^155.6 ^18.8 N
Overweight (n = 655) ^221.8 41.5 ^303.3 ^140.2 N
Obese (n 469) ^590.9 76.8 ^741.6 ^440.2 N
NHANES 2001-2002 Normal (n = 493) ^64.1 63.1 ^188.0 59.9 Y
Overweight (n = 774) ^229.2 29.5 ^287.1 ^171.3 N
Obese (n = 515) ^527.5 55.3 ^636.1 ^418.9 N
NHANES 2003-2004 Normal (n = 465) ^6.8 47.3 ^99.6 86.0 Y
Overweight (n = 659) ^175.4 46.9 ^267.4 ^83.4 N
Obese (n = 547) ^549.8 72.0 ^691.1 ^408.5 N
NHANES 2005-2006 Normal (n = 413) 70.4 53.0 ^33.7 174.5 Y
Overweight (n = 735) ^222.4 39.7 ^300.3 ^144.4 N
Obese (n = 601) ^464.2 32.1 ^527.2 ^401.2 N
NHANES 2007-2008 Normal (n = 539) ^117.9 64.8 ^245.2 9.3 Y
Overweight (n = 835) ^286.7 31.3 ^348.1 ^225.2 N
Obese (n = 790) ^608.0 42.2 ^690.8 ^525.2 N
NHANES 2009-2010 Normal (n = 563) ^154.4 43.5 ^239.8 ^69.1 N
Overweight (n = 872) ^178.9 42.1 ^261.5 ^96.4 N
Obese (n = 884) ^590.9 32.9 ^655.4 ^526.4 N
----------------------------------------------------------------------------------------------------------------
Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI =
reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation.
These values were calculated by subtracting the estimated IOM TEE from the NHANES rEI for each respondent.
Negative numbers indicate the kcal/day value of underreporting.
doi:10.1371/journal.pone.0076632.t006.
Discussion
Validity of NHANES EI Data
Our results suggest that across the 39 year history of U.S.
nutrition surveillance research, rEI data on the majority of
respondents (67.3% of women and 58.7% of men) were not physiologically
plausible. The historical average rEI/BMR values for all men and women
were 1.31 and 1.19 respectively (Table 1). These values are indicative
of substantial underreporting. The expected average values for healthy,
free living men and women are 1.55, with a range of >1.35 to <2.40
[23, 27]. In no survey did at least 50% of the respondents report
plausible EI values (Figure 1). These data are consistent with previous
research demonstrating that the misreporting of EI in nutrition surveys
is widespread [9, 11, 28-34]. Goldberg, et al. (1991) demonstrated that
in 37 studies across ten countries, >65% of the mean rEI/BMR values
were below the study-specific plausibility cut-off [23]. In addition to
the extensive underreporting in our sample, 4.9% of men and 2.9% of
women reported rEI/BMR values suggestive of over-reporting (i.e., rEI/
BMR >2.40).
Disparity between NHANES rEI and IOM Derived TEE
Throughout the study period (i.e., 1971-2010) the disparity between
rEI and TEE values were large and variable across BMI and sex
categories suggesting substantial systematic biases in underreporting
(Tables 4, 5, 6). The overall mean disparity values for men and women
were ^281 kcal/day and 2365 kcal/day, respectively. The greatest mean
disparity values were ^717 kcal/day (25% of TDEE) and ^856 kcal/day
(41% of TEE) in OB men and women, respectively.
Trends in the Validity and Inferences from NHANES rEI Data
As depicted in Tables 1 and 2, and Figure 1, there were large
decreases in underreporting between NHANES II and NHANES III. This is
clearly evidenced by the increase in rEI/BMR index (Table 1), the large
and significant increase in the percent of plausible reporters (Figure
1), and the reduction in the disparity between NHANES rEI and NAS/IOM
EER (Table 4). This decrement in underreporting between NHANES II and
subsequent surveys across all sex and BMI categories is likely the
result of improvements in survey protocols for NHANES III, such as the
inclusion of more days of dietary recall (i.e., weekends), automated
multi-pass methodology, and increased staff training and quality
control (see [35]), The extent of these improvements is notable; for
example, the percentage of OB women reporting implausible values
decreased from 88% in NHANES II to 74% in NHANES III.
These changes in measurement protocols led to an apparent increase
in mean rEI values that has been reported as an actual increase in
population-level EI despite caveats that the ``Interpretation of trends
in energy and nutrient intakes is difficult when methodologic changes
occur between surveys'' [36]. Nevertheless, Briefel and Johnson state
(without caveat) in their abstract, ``During the 30 year period, mean
energy intake increased among adults . . .'' [37]. The data presented
in the present report refute this inference. When the NHANES dietary
measurement protocols were altered after NHANES II, the improved method
captured a higher percentage of actual intakes. The apparent increase
in mean rEI was merely an artifact of improved measurement protocols
and not indicative of a true increase in caloric consumption. Despite
this fact, the apparent increase has been regularly published and
uncritically accepted as a true upward trend in caloric consumption
(e.g., [37, 38]) and the cause of the obesity epidemic (e.g., [39,
40]).
Changes in Underreporting and Public PolicyRecommendations
In addition to the ubiquity of misreporting, there is strong
evidence that the reporting of `socially undesirable' (e.g., high fat
and/or high sugar) foods has changed as the prevalence of obesity has
increased [12-15]. Additionally, research has demonstrated that
interventions emphasizing the importance of `healthy' behaviors may
lead to increased misreporting as participants alter their reports to
reflect the adoption of the `healthier' behaviors independent of actual
behavior change [17, 41]. It appears that lifestyle interventions
``teach'' participants the socially desirable or acceptable responses
[17, 42]. As such, the ubiquity of public health messages to `eat less
and exercise more' may induce greater levels of misreporting and may
explain the recent downward bias in both self-reported EI [20] and body
weight [17, 43], especially given that social desirability bias is
often expressed in the underreporting of calorically dense foods [44].
Selective misreporting of specific macronutrients has important
ramifications for epidemiological research and nutrition surveillance.
Heitmann and Lissner (2005) demonstrated that the selective
misreporting of dietary fat by groups at an increased risk of chronic
non-communicable diseases may result in an overestimated association
between fat consumption and disease [45]. If the potentially negative
effects of high-fat diets are overestimated due to selective
misreporting, current recommendations for fat intake may be overly
conservative [45].
Additional Systematic Biases of Nutrition Surveillance Data
In addition to known sources of systematic reporting error, there
are numerous sources of systematic bias in nutrition surveillance
research protocols that are not addressed via our data. Another
potentially large source of error is the translation of food and
beverage consumption data (e.g., 24HR) into nutrient energy values via
nutrient composition databases. The accuracy of this translation relies
on a number of assumptions that are rarely justified. As cited earlier,
research on misreporting shows that reports do not accurately reflect
the quantity or number of foods consumed, and are not representative of
usual intakes [12-15, 46-50]. Given that the basic methodological
assumptions are violated, it is not surprising that research has
demonstrated that food data to nutrient energy conversions are
``riddled with potential pitfalls at all stages'' that ``hamper the
interpretability of the results'' [51-53], and represent a major source
of systematic error in national nutrition surveillance efforts [2].
Throughout its history, the NHANES has relied upon databases of
varying quality and composition for the post-hoc conversion of food and
beverage consumption (i.e., 24HR) data into energy values [2-5, 53].
This makes the analysis of trends extremely complex because the
nutrient energy (i.e., caloric) values in the databases varied
considerably over time [54, 55]. Additionally, research has
demonstrated that the energy content of restaurant food (and especially
fast-food outlets) vary significantly when compared to the industry
values used in the NNDS [56], and an internal quality review of NHANES
2003-2004 data led to 400 substantive changes in nutrient and energy
values. [57]. The result of these limitations are discussed in detail
elsewhere, see [4, 5, 58].
As with the improvements in the NHANES survey protocols, the
progressive alterations to the nutrient database combined with changes
in the types of foods that are available for consumption led to
artifactual differences in nutrient and energy consumption estimates
that frustrate efforts to examine trends in caloric consumption [58].
To account for these changes, researchers must maintain the real
differences in the composition of foods while correcting for
artifactual differences attributable to improvements in the quality of
nutrient data [58]. Given the lack of comprehensive crossover studies
and metrics for adjustment as the food and nutrient databases evolved,
papers examining trends in caloric consumption must be treated with
skepticism [51,58].
Commercially Prepared Foods and Meals Away From Home
One of the most prominent systematic errors from 24HR data-to-
nutrient energy conversions is due to the increased reliance on the
food service industry and the substantial rise in meals eaten `away
from home' [59-61]. As stated previously, the vast majority of foods
and beverages in the NNDS have not been evaluated empirically and
research has demonstrated that the energy and macro/micro nutrient
content of commercially prepared foods varies significantly compared to
the industry values used in the NNDS [56]. When foods or commodities
are not in the database, substitutions are necessitated. For these
interpolations to be accurate, the analogues must be similar in
composition to the consumed food or beverage. This is extremely
difficult to perform in practice because no two foods or commodities
are identical, and local vs. imported foods/commodities differ
significantly. For example, in survey data collection, knowledge of the
specific preparation and cut of beef are essential since the energy
content of generic beef substitutions may differ dramatically (e.g.,
166 kcals per 100 grams in round steak to 257 kcals in top sirloin
[62]) [63,64]. Given these realities, USDA estimates of caloric
consumption may be increasingly inaccurate as the number of food and
beverages supplied by the commercial sector expands rapidly.
Recent research has attempted to quantify the changes in consumer
packaged foods and beverages, and their impact on the American diet
[65]. Nevertheless, these efforts suffer from the same limitations as
all food data-to-nutrient energy value conversions via nutrient
composition databases. Additionally, the translation of ``as-
purchased'' foods and beverages (using information from the commercial
sector) to ``as-consumed'' energy and macro/micronutrient content for
national surveillance relies on the accurate quantification of food
preparation and waste [65]. Unfortunately, these data are limited and
highly variable [52, 66]. In a report from the USDA's Economic Research
Service, Muth, et al. (2011) state that the current data are incomplete
and overstate actual consumption because the level of ``documentation
of food losses . . . ranged from little to none for estimates at the
retail and customer levels.'' [67]. These results clearly demonstrate
the conceptual and methodological complexity of translating food and
beverage purchases into nutrient energy and macro/micronutrient intake
in the context of a rapidly evolving food supply.
Methods of Adjustment for Systematic Biases
There are various methods that attempt to improve estimates of
caloric consumption derived from self-reported dietary intake [32, 68-
72]. While these methods may improve the shape of the distribution of
the estimates, none can address the significant systematic biases
described in this report. For example, the National Research Council
and the Iowa State University methods provide significantly improved
estimates of the shape of the distribution, but do not substantially
improve estimates of mean energy intake (10-15% underestimation) or
protein consumption (6-7% underestimation) [70]. 291.
Strengths and Limitations
A strength of the present study was the use of the established rEI/
BMR method for the determination of physiologically implausible EI
values. We used a liberal cutoff (i.e., <1.35) that is below the study-
specific theoretical cutoff for our smallest subgroup (i.e., n >400).
The use of the more conservative cutoff of rEI/BMR <1.50 recommended by
Goldberg, et al., (1991) [22] increased underreporting by 10% in women
and 7% in men across all surveys. A second strength was the use of a
rEI/BMR >2.4 for the elimination of potential over-reporters to correct
the limitations of previous research [29].
Finally, the use of the IOM factorial equations for estimating TEE
for specific subgroups (i.e., OW & OB respondents) in the calculation
of disparity values is a significant strength. The results of this
additional protocol demonstrated significant underreporting in all
surveys, and that the disparity values closely paralleled the
implausible values in 15 of the 18 sub-groups (i.e., men & women in
nine surveys). The close agreement between these two dissimilar
protocols increases confidence in our results and conclusions.
A potential limitation to our analysis was the use of the Schofield
predictive equation for estimating BMR. The Schofield predictive
equations may overestimate BMR in some populations [73, 74]. If the
Schofield equation overestimated BMR, a greater percentage of survey
respondents would be classified as underreporters. To address this
potential limitation, we performed the analyses using the Mifflin
equation [75], which has been validated in OW and OB populations such
as the U.S. [74]. The results of those analyses were similar to those
obtained using the Schofield equation, with substantial underreporting
(>50%) in all surveys, significant trends in changes in underreporting,
and a small increase in over-reporting. To remain consistent with past
research on implausible rEI and underreporting [29, 33], we chose to
present the results from the Schofield predictive equations.
Conclusions
Throughout its history, NHANES dietary measurement protocols have
failed to provide accurate estimates of the habitual caloric
consumption of the U.S. population. Furthermore, successive changes to
the nutrient databases used for the 24HR data-to-energy conversations
and improvements in measurement protocols make it exceedingly difficult
to discern temporal patterns in caloric intake that can be related to
changes in population rates of obesity. As such, there are no valid
population-level data to support speculations regarding trends in
caloric consumption and the etiology of the obesity epidemic. Because
under-reporting and physiologically implausible rEI values are a
predominant feature of U.S. nutritional surveillance, the ability to
generate empirically supported public policy and Dietary Guidelines
relevant to the obesity epidemic based on these data is extremely
limited.
Acknowledgments
The data used in this study are available at: http://www.cdc.gov/
nchs/nhanes/nhanes_questionnaires.htm.
Author Contributions
Conceived and designed the experiments: E.A., S.N.B. Performed the
experiments: E.A. Analyzed the data: E.A., G.A.H., S.N.B. Wrote the
paper: E.A.
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health data: their use in nutrition policy-making: WHO Regional
Publications, European Series, No. 34. 15-24.
54. Ahuja J.K.C., Goldman J.D., Perloff B.P. (2006) The effect of
improved food composition data on intake estimates in the United States
of America. Journal of Food Composition and Analysis 19, Supplement: S7-
S13.
55. Ahuja J.K.C., Lemar L., Goldman J.D., Moshfegh A.J. (2009) The
impact of revising fats and oils data in the U.S. Food and Nutrient
Database for Dietary Studies. Journal of Food Composition and Analysis
22, Supplement: S63-S67.
56. Urban L.E., McCrory M.A., Dallal G.E., Das S.K., Saltzman E., et
al. (2012) Accuracy of stated energy contents of restaurant foods. JAMA
306: 287-293.
57. Ahuja J.K.C., Perloff B.P. (2008) Quality control procedures for
the USDA Food and Nutrient Database for Dietary Studies nutrient
values. Journal of Food Composition and Analysis 21, Supplement: S119-
S124.
58. Guenther P.M., Perloff B.P., Vizioli T.L., Jr. (1994) Separating
fact from artifact in changes in nutrient intake over time. J. Am.
Diet. Assoc. 94: 270-275.
59. Guthrie J.F., Lin B.H., Frazao E. (2002) Role of food prepared
away from home in the American diet, 1977-78 versus 1994-96: changes
and consequences. J. Nutr. Educ. Behav. 34: 140-150.
60. Stewart H., Yen S.T. (2004) Changing household characteristics
and the away-from-home food market: a censored equation system
approach. Food Policy 29: 643-658.
61. Stewart H., Blisard N., Bhuyan., Nayga R.M.J. (2012) The Demand
for Food Away From Home. Full-Service or Fast Food? In: USDA, editor.
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62. USDA (2011) Nutrient Data Set for Retail Beef Cuts. Beltsvile,
MD: Nutrient Data Laboratory (NDL), Agricultural Research Service, U.S.
Department of Agriculture.
63. Smith A.M., Harris K.B., Haneklaus A.N., Savell J.W. (2011)
Proximate composition and energy content of beef steaks as influenced
by USDA quality grade and degree of doneness. Meat Sci. 89: 228-232.
64. O'Neil C.E., Zanovec M., Keast D.R., Fulgoni V.L., 3rd, Nicklas
T.A. (2011) Nutrientcontribution of total and lean beef in diets of
U.S. children and adolescents: National Health and Nutrition
Examination Survey 1999-2004. Meat Sci. 87: 250-256.
65. Slining M.M., Ng S.W., Popkin B.M. (2013) Food companies'
calorie-reduction pledges to improve U.S. diet. Am. J. Prev. Med. 44:
174-184.
66. FAO (2001) Food Balance Sheets: A handbook. Rome, Italy: Food
and Agriculture Organization of the United Nations.
67. Muth M.K., Karns S.A., Nielsen S.J., Buzby J.C., Wells H.F.
(2011) Consumer-Level Food Loss Estimates and Their Use in the ERS Loss-
Adjusted Food Availability Data. USDA Economic Research Service,
Technical Bulletin (TB-1927). 123 p.
68. Nusser S.M., Carriquiry A.L., Dodd K.W., Fuller W.A. (1996) A
Semiparametric Transformation Approach to Estimating Usual Daily Intake
Distributions. Journal of the American Statistical Association 91: 1440-
1449.
69. Dodd K.W., Guenther P.M., Freedman L.S., Subar A.F., Kipnis V.,
et al. (2006) Statistical methods for estimating usual intake of
nutrients and foods: a review of the theory. J. Am. Diet. Assoc. 106:
1640-1650.
70. Freedman L.S., Midthune D., Carroll R.J., Krebs-Smith S., Subar
A.F., et al. (2004) Adjustments to improve the estimation of usual
dietary intake distributions in the population. J. Nutr. 134: 1836-
1843.
71. Tooze J.A., Kipnis V., Buckman D.W., Carroll R.J., Freedman
L.S., et al. (2010) A mixed-effects model approach for estimating the
distribution of usual intake of nutrients: the NCI method. Stat. Med.
29: 2857-2868.
72. IOM (2003) Dietary Reference Intakes: Applications in Dietary
Planning: The National Academies Press.
73. Frankenfield D., Roth-Yousey L., Compher C. (2005) Comparison of
predictive equations for resting metabolic rate in healthy nonobese and
obese adults: a systematic review. J. Am. Diet. Assoc. 105: 775-789.
74. Frankenfield D.C., Rowe W.A., Smith J.S., Cooney R.N. (2003)
Validation of several established equations for resting metabolic rate
in obese and nonobese people. J. Am. Diet. Assoc. 103: 1152-1159.
75. Mifflin M.D., St. Jeor S.T., Hill L.A., Scott B.J., Daugherty
S.A., et al. (1990) A new predictive equation for resting energy
expenditure in healthy individuals. Am. J. Clin. Nutr. 51: 241-247.
______
Submitted Letter by Shannon Campagna, Director, Federal Government
Affairs, Mars, Incorporated
October 6, 2015
Hon. K. Michael Conaway,
Chairman,
House Agriculture Committee,
Washington, D.C.;
Hon. Collin C. Peterson,
Ranking Minority Member,
House Agriculture Committee,
Washington, D.C.
Dear Chairman Conaway and Ranking Member Peterson:
Mars, Incorporated (Mars) is pleased to submit these comments to
the House Agriculture Committee in advance of its hearing titled,
``Public Hearing: 2015 Dietary Guidelines for Americans'' scheduled for
Wednesday, October 7. Mars shares its recommendations to improve the
scientific review process of the Dietary Guidelines for Americans (DGAs
or policy document).
Mars, Incorporated is a private, family-owned business with more
than a century of history and some of the best-loved brands in the
world including M&M'S', PEDIGREE',
DOUBLEMINT' and UNCLE BEN'S'. Headquartered in
McLean, VA, Mars has more than $33 billion in sales from six diverse
business segments: Petcare, Chocolate, Wrigley, Food, Drinks, and
Symbioscience. More than 75,000 Associates across 73 countries are
united by the company's Five Principles: Quality, Efficiency,
Responsibility, Mutuality, and Freedom and strive every day to create
relationships with stakeholders that deliver growth we are proud of as
a company.
Recommendations to Improve the Scientific Review Process
Mars believes that the scientific review process of the DGAs can be
improved to ensure its integrity. For example, Mars understands that
the U.S. Department of Health and Human Services (HHS) and the U.S.
Department of Agriculture (USDA) can only address issues in the DGAs if
scientific studies have been properly submitted to the National
Evidence Library (NEL) and have been reviewed and rated by the Dietary
Guidelines Advisory Committee (DGAC). Mars' concern, however, is that
if the DGAC elects not to conduct a systematic review of the scientific
studies for a variety of reasons that do not pertain to the quality of
the studies, HHS and USDA cannot use their discretion to address the
issue in the policy document.
For example, during the most recent DGAC scientific review process,
over 50 scientific studies and literature on the oral health benefits
of chewing sugar-free gum were submitted properly and in a timely
manner to the NEL. The scientific studies covered over 40 years of
research showing that chewing sugar-free gum stimulates salivary flow,
which neutralizes plaque acids and enhances remineralization of the
tooth enamel, as well as reduces dental caries.
The 2015 DGAC, however, decided for reasons unclear to us not to
conduct a scientific review of this evidence, which means that these
studies were never rated as strong, moderate, or weak. Because these
studies were never rated, HHS confirmed that neither Department has the
discretion to include guidelines on the oral health benefits of chewing
sugar-free gum, even if the preponderance of evidence exists. As such,
stakeholders must wait until the 2020 DGAs to address the issue.
Therefore, we recommend that if the DGAC decides not to conduct a
scientific review of studies on a specific topic, then it must provide
a justification for its decision. This would be especially helpful when
past DGACs have provided recommendations on that topic and there are
properly submitted studies and literature looking to update those
recommendations. By taking this approach, USDA and HHS would then have
greater discretion to decide whether the agencies should address the
topic in the policy document along with stakeholder input and other
considerations.
For example, in the 2005 scientific report, the DGAC concluded that
there is a relationship between the intake of sugars and starches and
the formation of dental caries. The report also focused on how to best
optimize oral hygiene practices and recommended drinking fluoridated
water and/or using other fluoride containing dental hygiene products to
help reduce the risk of dental caries.\1\ The 2010 DGAC affirmed these
recommendations in its scientific report, but the 2015 DGAC did not
reaffirm these conclusions or make additional recommendations on oral
health measures despite receiving over 50 studies on the oral health
benefits of chewing sugar-free gum.\2\
---------------------------------------------------------------------------
\1\ 2005 Dietary Guidelines Advisory Committee, ``The Report of the
Dietary Guidelines Advisory Committee on Dietary Guidelines for
Americans, 2005,'' at Part A: Executive Summary, page 6, (2005),
available at http://www.health.gov/dietaryguidelines/dga2005/report/
(last accessed September 29, 2015).
\2\ 2010 Dietary Guidelines Advisory Committee, ``Report of the
Dietary Guidelines Advisory Committee on the Dietary Guidelines for
Americans, 2010,'' at Part D: Carbohydrates, page 286, (2010),
available at http://www.cnpp.usda.gov/sites/default/files/
dietary_guidelines_for_americans/2010DGACReport-camera-ready-Jan11-
11.pdf (last accessed September 29, 2015).
---------------------------------------------------------------------------
Mars also recommends that if a DGAC fails to conduct a scientific
review, HHS and USDA should have the discretion to address the issue in
the policy document if either Department has previously made a decision
on that issue in a formal rulemaking or through another significant
proceeding. As it relates to the oral health benefits of chewing sugar-
free gum, USDA previously recognized that chewing sugar-free gum after
meals reduces dental caries through the Smart Snacks rulemaking, which
was based on the exact same studies submitted to the NEL for the 2015
DGAC scientific review process. In the final rule allowing sugar-free
gum products to be sold in schools, USDA stated that ``[c]linical
studies have shown that chewing sugarless gum for 20 minutes following
meals can help prevent tooth decay.'' \3\ Therefore, if an issue has
already been reviewed through a formal rulemaking or another
significant proceeding within HHS or USDA, this could be considered to
be evidence, similar to a DGAC's scientific recommendation. Otherwise,
it would appear that the DGAC has absolute authority to foreclose
opportunities for USDA and HHS to address topics in the DGAs, even when
there is a preponderance of scientific evidence that the agency has
already examined. This raises concerns as USDA and HHS are
authoritative bodies, as opposed to the DGAC.
---------------------------------------------------------------------------
\3\ National School Lunch Program and School Breakfast Program:
Nutrition Standards for All Foods Sold in School as Required by the
Healthy, Hunger-Free Kids Act of 2010, 78 Fed. Reg. 125 (June 28, 2013)
(to be codified at 21 CFR pts. 210 and 220).
---------------------------------------------------------------------------
Last, Mars notes that during the 2015 scientific review process the
DGAC considered studies that were not submitted properly to the NEL. By
doing so, the DGAC has set a disruptive precedent that must be
addressed. Currently, studies properly submitted to the NEL do not have
to be reviewed, which means that they can be automatically disqualified
from consideration by HHS and USDA. Studies not submitted to the NEL,
however, can be used to support the DGAC's recommendations and thus
give authority for HHS and USDA to address the issue in the policy
document. We are not necessarily arguing that studies cannot supplement
the DGAC's findings, but we do have concerns that such studies may take
priority over those properly submitted to the NEL.
Conclusion
Once again, Mars recognizes the significant effort undertaken by
the DGAC, as well as USDA and HHS, to update the DGAs to reflect the
latest nutritional science. Specifically, Mars supports the DGAC's
recommendations on limiting intake of added sugars and sodium.
We also thank the Committee for considering our concerns with the
current scientific review process. For the Committee's review, we have
attached a letter signed by 13 Members of Congress expressing similar
concerns about the DGAC's failure to conduct a scientific review of the
studies on the oral health benefits of chewing sugar-free gum.
If you would like to discuss our positions, please do not hesitate
to contact Shannon Campagna at [Redacted] or [Redacted].
Sincerely,
Shannon Campagna,
Mars, Incorporated.
attachment
May 13, 2015
Hon. Thomas ``Tom'' J. Vilsack,
Secretary,
U.S. Department of Agriculture,
Washington, D.C.;
Hon. Sylvia Mathews Burwell
Secretary,
U.S. Department of Health and Human Services,
Washington, D.C.
Dear Secretaries Vilsack and Burwell:
We are concerned that the 2015 Scientific Report of the Dietary
Guidelines Advisory Committee (DGAC) did not meaningfully address oral
health despite the fact that both the 2005 and 2010 editions of the
Dietary Guidelines for Americans (DGAs) recognized oral health as a
public health priority.
The absence of oral health as a public health priority in the
Scientific Report of the 2015 Dietary Guidelines Advisory Committee is
a step backward in the Federal Government's long-standing effort to
address the chronic, yet preventable disease of tooth decay. Fifteen
years ago, in the first Surgeon General's report on oral health, the
Surgeon General called for a ``national effort to improve oral health
among all Americans.'' The report found that ``oral health is integral
to general health,'' and stated that ``you cannot be healthy without
oral health.''
In recognizing oral health as a public health priority, both the
2005 and 2010 DGAs concluded that there is a relationship between the
intake of sugars and starches and the formation of dental cavities.
Both DGAs also focused on how to best optimize oral hygiene practices
and recommended drinking fluoridated water and/or using other fluoride-
containing dental hygiene products to help reduce the risk of dental
cavities. The 2015 Scientific Report, however, did not make such
recommendations. Therefore, we request that the 2015 Policy Document
reaffirm the oral health conclusions from the 2005 and 2010 DGAs.
We also strongly encourage the U.S. Department of Health and Human
Services (HHS) and the U.S. Department of Agriculture (USDA) to
identify additional scientifically-proven ways to optimize hygiene
practices, including the chewing of sugar-free gum after eating meals.
Over 40 years of research has shown that chewing sugar-free gum
stimulates salivary flow, which neutralizes plaque acids and enhances
remineralization of the tooth enamel, as well as reduces dental
cavities.
This research, which includes over 50 scientific studies and
literature, was submitted properly and in a timely manner to USDA's
National Evidence Library; however, the 2015 DGAC decided for reasons
unclear to us not to conduct a systematic review of this evidence.
Therefore, we request HHS and USDA conduct a systematic review of the
submitted evidence or affirm USDA's science-based regulatory finding in
the Smart Snacks rule that chewing sugar-free gum after meals reduces
dental cavities. In that rule, and based on USDA's review of the same
studies submitted to the 2015 DGAC, USDA recognized that ``[c]linical
studies have shown that chewing sugarless gum for 20 minutes following
meals can help prevent tooth decay'' in allowing sugar-free gum
products to be sold in schools.
As a global leader, the United States should continue to make great
strides in addressing tooth decay, which remains the most prevalent
chronic disease in both children and adults, yet it is largely
preventable. We ask that HHS and USDA continue to make oral health a
public priority in the 2015 Dietary Guidelines for Americans because
oral health is essential to improving general health.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Doug Collins, Hon. Sanford D. Bishop, Jr.,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Brenda L. Lawrence, Hon. Steve Chabot,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Joseph J. Heck, Hon. Donald M. Payne, Jr.,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Joyce Beatty, Hon. Brian Babin,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Ryan A. Costello, Hon. Dina Titus,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Lynn Jenkins, Hon. Paul Cook,
Member of Congress; Member of Congress;
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Diane Black,
Member of Congress.
______
Submitted Letter by Pamela Schoenfeld, M.S., R.D., Executive Director;
Adele Hite, M.P.H., R.D., Public Policy Advisor, Healthy Nation
Coalition
House Committee on Agriculture U.S. Senate Committee on
Agriculture, Nutrition, and
Forestry,
Washington, D.C.; Washington, D.C.
Why the USDA/HHS Dietary Guidelines for Americans (DGA) development
process must be overhauled:
The DGA:
1. Exceed the language of their authorizing statute.
2. Do not achieve the stated goals of prevention of chronic disease
and promotion of healthyweight.
3. Are inappropriate for large sectors of the American population--
especially children.
4. Do not ensure that Americans meet essential nutrition needs.
5. Are out-of-step with our multicultural nation and diverse dietary
practices.
6. Do not reflect the most up-to-date and comprehensive research
findings.
7. Act to limit or restrict the availability of certain categories
of foods.
8. Are not held to rigorous scientific standards.
9. May be contributing in part to our nation's health problems.
10. Should be replaced by guidance, for use by the general public,
focused on essential nutrition.
1. The DGA exceed the language of their authorizing statute.
According to Secretary Vilsack: ``I struggle with the Dietary
Guidelines because I think it is important to understand precisely what
they are and are not. These guidelines are a set of recommendations
based on a series of well-informed opinions that create a framework
that is designed to encourage and educate Americans about what they can
do to increase their chance of prevention of chronic disease. This is
not about treating disease, this is about trying to prevent chronic
disease.'' \1\
---------------------------------------------------------------------------
\1\ Quote found at 00:12:18 of October, 7, 2015 Full Committee on
Agriculture hearing (http://www.c-span.org/video/?328598-1/secretaries-
tom-vilsack-sylvia-burwell-testimony-nutritional-guidelines); this is
the source for all quotation time marks used herein.
---------------------------------------------------------------------------
Vilsack continues ``We're looking at what the law requires us to
do, and that is focus on dietary and nutritional guidelines relative to
prevention.'' \2\
---------------------------------------------------------------------------
\2\ 01:25:00.
---------------------------------------------------------------------------
As posted on the Department of Health and Human Services website
(http://health.gov/dietaryguidelines/purpose.as):
These recommendations aim to:
Promote health.
Prevent chronic disease.
Help people reach and maintain a healthy weight.
Yet, there exists no language in the legislation that specifies
that the DGA should be designed for the prevention of chronic disease.
The key part of the legislative mandate is below:
7 U.S. Code 5341--Establishment of dietary guidelines
(1) In general
At least every 5 years the Secretaries shall
publish a report entitled ``Dietary Guidelines
for Americans.'' Each such report shall contain
nutritional and dietary information and
guidelines for the general public, and shall be
promoted by each Federal agency in carrying out
any Federal food, nutrition, or health program.
(2) Basis of guidelines
The information and guidelines contained in
each report required under paragraph (1) shall
be based on the preponderance of the scientific
and medical knowledge which is current at the
time the report is prepared.
Note that the report is to contain guidelines for the ``general
public.''
The ``general public'' is a demographically diverse population with
an equally diverse set of nutritional needs. Attempting to design
guidelines for the prevention of chronic disease has led to a narrow
and limited focus and has shifted our priority away from ensuring the
intake of adequate levels of essential nutrients demonstrated to be
required for human health, reproduction, and growth. In the past, USDA
dietary guidance emphasized the inclusion of a wide variety of animal
and plant foods with the goal of meeting essential nutritional
requirements.\3\
---------------------------------------------------------------------------
\3\ For examples of historical USDA dietary guidance please see:
http://www.nal.usda.gov/fnic/history/8549v.gif (WWII era); http://
www.nal.usda.gov/fnic/history/0007v.gif (post-war era); and others at:
https://nutritionhistory.nal.usda.gov/.
---------------------------------------------------------------------------
2. The DGA do not achieve the above stated goals of prevention of
chronic disease and promotion of healthy weight.
While there are no goals specifically mandated in the legislation,
the increases in the prevalence of obesity, diabetes, and related
diseases such as non-alcoholic fatty liver, demonstrate that the DGA
have not had the desired impact on the health of Americans.
These increases should not come as a surprise: the food patterns in
the DGA have ``not been specifically tested for health benefits.'' \4\
Although we might surmise that the ``goal'' of the DGA from their
inception was to reduce incidence of chronic disease, this has never
been shown to be the case.
---------------------------------------------------------------------------
\4\ 2010 Dietary Guidelines for Americans, p. 50
---------------------------------------------------------------------------
3. The DGA are inappropriate for large sectors of the American
population--especially children.
The following exchange from the hearing illustrates this critical
point:
Rep. Rodney Davis raised his ``most serious concern today is what I
see as a lack of evidence to show that the recommended dietary patterns
proposed by the DGA have been based on any evidence on children.
According to citations in some previous advisory reports for
recommendations, the recommended diet has been tested almost
exclusively on middle age men and women whose nutritional needs
obviously are very different from young people and growing children. In
particular, I am concerned because young children need certain vitamins
and minerals obviously in order to grow and develop.'' Of note is the
fact that the recommended diet has not been tested at all; the studies
used to support the guidelines have been conducted in adults, generally
males.\5\
---------------------------------------------------------------------------
\5\ 01:44:30.
---------------------------------------------------------------------------
Secretary Burwell addressed [her] concern: ``My team brought up the
issue of children yesterday as we look to making sure we have
appropriate evidence for a number of the things that you are talking
about for the next set [of guidelines in 2010]. Because I think what
you are appropriately reflecting is the research doesn't exist because
it is on older [adults]. So we need to get started on that now. So with
regard to the issue of do we need to understand this better. We don't
have the facts yet. We don't have a science base. If we start now we
will for the next'' [emphasis added].\6\
---------------------------------------------------------------------------
\6\ 01:47:10.
---------------------------------------------------------------------------
It is clear that applying guidelines to children where ``research
doesn't exist'' is irresponsible at best. We should be very careful not
to draw conclusions or make recommendations when we cannot even meet
the required preponderance of evidence standard. The DGA as they stand
now must not be applied to children (inclusive of birth to 18 years of
age). In the interim, guidelines to ensure essential nutritional needs
for children are met, including vitamins and minerals, should be
developed in their place. We already have a strong evidence base to use
in their development, which are the Dietary Reference Intakes published
by the Institute of Medicine (http://iom.nationalacademies.org/
Activities/Nutrition/SummaryDRIs/DRI-Tables.aspx).
4. The DGA do not ensure that Americans meet essential nutrition needs.
This is an extension of the previous concern.
In the 2015 DGAC report, the Committee characterized the following
as shortfall nutrients: ``vitamin A, vitamin D, vitamin E, vitamin C,
folate, calcium, magnesium, fiber, and potassium. For adolescent and
premenopausal females iron also is a shortfall nutrient. Of the
shortfall nutrients, calcium, vitamin D, fiber, and potassium also are
classified as nutrients of public health concern because their
underconsumption has been linked in the scientific literature to
adverse health outcomes. Iron is included as a shortfall nutrient of
public health concern for adolescent females and adult females who are
premenopausal due to the increased risk of iron-deficiency in these
groups.'' \7\
---------------------------------------------------------------------------
\7\ Scientific Report of the 2015 DGAC: Executive Summary. Part A.
p 2., herein cited as ``Report.''
---------------------------------------------------------------------------
Zinc, while not cited by the Committee as a shortfall nutrient, is
an important mineral that may be underconsumed when animal proteins,
especially red meat, are limited. This is of particular concern for
young children, who have high physiologic requirements for iron and
zinc to support rapid growth and brain development. The recommended
``healthy vegetarian pattern'' is devoid of red meat and is thus
inappropriate to indiscriminately recommend for children.
The recommendations of previous and the current DGA have actually
served to increase the risk for below-adequate intake of several of the
above-listed nutrients. We provide scientific support on the reasons
for this in the attached commentary previously submitted to the USDA/
HHS through their website during the allotted period.\8\
---------------------------------------------------------------------------
\8\ See point number 3 on page 9 of the attached commentary,* where
we address nutrient shortfalls. Your attention to the entire attached
letter (written by the undersigned on behalf of the Weston A. Price
Foundation) would be very much appreciated as we have outlined several
others scientifically supported concerns we have with the 2015 DGAC
Report as well as the process utilized for the development of the DGA.
* Editor's note: The document referred to is retained in Committee
file.
---------------------------------------------------------------------------
Of significance, as recent as 2000, the DGA continued to include
beef, turkey dark meat, and liver and other organ meats and dark meat
as good sources of iron.\9\ Previous DGA editions also included pork
and lamb. No mention of organ or dark meat is made in either the
current 2010 DGA or the 2015 DGAC Report. In addition, USDA-sponsored
family and consumer literature published by the University of Arkansas
Division of Agriculture in 2010 do recommend liver a source of iron for
infants and toddlers: and for young children.\10\ We highly recommend
that liver and other organ meats be re-evaluated as a nutrient dense
food for inclusion in the DGA recommendations.
---------------------------------------------------------------------------
\9\ https://nutritionhistory.nal.usda.gov/download/CAT40000623/PDF
\10\ https://nutritionhistory.nal.usda.gov/download/1759104/PDF;
https://nutritionhistory.
nal.usda.gov/download/1759103/PDF.
---------------------------------------------------------------------------
5. The DGA are out-of-step with our multicultural nation and diverse
dietary practices.
Unfortunately, the DGAC Report does not consider this diversity
when deciding on the three recommended dietary patterns: the Healthy
U.S.-style Pattern, the Healthy Mediterranean-style Pattern, and the
Healthy Vegetarian Pattern (Report: Part D. Ch 1. Line 2827). We ask
that the USDA and HHS be required to consider the foodways of our
immigrant and native populations when making population-wide
recommendations. This is especially necessary given the DGAC's
recognition of a need for future research to ``[e]xpand WWEIA (What We
Eat in America) participation to include more respondents from race/
ethnic minorities and non-U.S. born residents; while acknowledging that
`[v]ery little is known about the dietary habits of many of the
cultural subgroups in the United States. This knowledge is essential to
moving forward any nutrition programs for first and second generation
immigrants.' '' \11\
---------------------------------------------------------------------------
\11\ Report: Part D. Ch. 1, Line 2838.
---------------------------------------------------------------------------
Secretary Burwell discussed keeping the DGA information ``simple
enough'' that it can be used ``in your own cultural context''; \12\
Secretary Vilsack highlighted the USDA programs that are ``working with
Native Americans to reflect [their] traditions and culture.'' \13\ We
commend these ideas and efforts and urge they be emphasized in the
upcoming edition.
---------------------------------------------------------------------------
\12\ 01:37:40.
\13\ 01:38:10.
---------------------------------------------------------------------------
6. The DGA do not reflect the most up-to-date and comprehensive
research findings.
To illustrate the lack of sound scientific methodology that has
permeated the DGA processes from its inception please consider the
following:
The 2015 DGAC reversed the long-standing opinions of previous DGACs
and recommendation of previous DGA that dietary cholesterol should be
limited to less than 300 mg per day, stating: ``The 2015 DGAC will not
bring forward this recommendation because available evidence shows no
appreciable relationship between consumption of dietary cholesterol and
serum cholesterol, consistent with the conclusions of the AHA/ACC
report (2, 35). Cholesterol is not a nutrient of concern for over-
consumption.'' \14\ The same evidence was available to the 2010 DGAC
which continued to recommend cholesterol limits; these limits were
carried forward into the 2010 DGA.
---------------------------------------------------------------------------
\14\ Report: Part D. Ch. 1, Line 642.
---------------------------------------------------------------------------
Graded evidence is not provided by the 2015 DGAC to support this
revision. This is unfortunate considering the language of H.R. 3049:
``Each revision to any nutritional or dietary information or guideline
contained in the 2010 edition of the Dietary Guidelines for Americans
and any new nutritional or dietary information or guideline to be
included in the eighth edition of the Dietary Guidelines for
Americans--(A) shall be based on scientific evidence that has been
rated ``Grade I: Strong'' by the grading rubric developed by the
Nutrition Evidence Library of the Department of Agriculture.''
We strongly encourage your committees to reconsider the language of
the proposed bill. We respectfully offer that any standing guideline be
carried forward only if it can be supported by Grade I: Strong evidence
per the NEL process, subject to an independent scientific review.\15\
---------------------------------------------------------------------------
\15\ Other examples of weak scientific methodology are detailed in
the attached commentary * to the USDA/HHS; point number 1, page 2,
provides a key example.
* Editor's note: The document referred to is retained in Committee
file.
---------------------------------------------------------------------------
7. The DGA act to limit or restrict the availability of certain
categories of foods.
A key example here is the removal of whole (3.5% fat) milk from the
National School Lunch Program (NSLP). Preventive public health measures
must provide an expected benefit to the individual upon whom the
intervention is imposed, with minimal risk of harm, as ascertained by
strict standards of evidence. For example, whole milk has been removed
from the NSLP. However, there is limited evidence of benefit from
restricting whole milk, and there has been no recognition of potential
harm from alternative choices, such as inadequate nutrition (if
students refuse to drink milk at all rather than drink reduced-fat
milk) or excess intake of sugar (if students choose sweetened milk when
full-fat milk is unavailable). Parents may feel it is better for their
children to have whole milk rather than no milk or sweetened milk. That
choice should not be made by government officials without strong
evidence of the singular benefits of reduced-fat milk and the specific
harms of whole milk.
A recent Washington Post article (http://www.washingtonpost.com/
news/wonkblog/wp/2015/10/06/for-decades-the-government-steered-
millions-away-from-whole-milk-was-that-wrong/) presented more up-to-
date scientific findings that whole milk has a place in a nutritionally
balanced diet. Not mentioned in the article is additional research
showing that whole milk consumption is associated with a lower risk for
overweight/obesity in children.\16\
---------------------------------------------------------------------------
\16\ Berkey et al., 2005 Arch. Pediatr. Adolesc. Med. 159(6);
Scharf et al., 2013 Arch. Dis. Child. doi :10.1136/archdischild-2012-
302941.
---------------------------------------------------------------------------
8. The DGA are not held to rigorous scientific standards.
Notwithstanding Secretary Vilsack's current view that a ``gold
standard process'' \17\ is being adhered to, the current process lacks
rigor. For future DGA, scientific standards should be raised to
``beyond a reasonable doubt'' that a recommendation will provide
benefit and will not cause harm.
---------------------------------------------------------------------------
\17\ 00:13:40.
---------------------------------------------------------------------------
For the development of 2020 DGA, we concur with Rep. Trent Kelly
who suggested that the preponderance of evidence standard is not the
right standard to use: ``Maybe it is clear and convincing evidence or
maybe it's beyond a reasonable doubt that when we have science that we
hold them to a standard that makes sure that the end result is
something that we have a good belief that it will be viable and it will
be the right answer'' [emphasis added].\18\ The right answer may not be
a single answer for all individuals; it should however ensure that we
provide the best fundamental information so that the majority of
Americans can meet their basic nutritional needs. Secretary Vilsack is
in agreement with Rep. Trent and provides an opportune solution: ``We
have to follow the Congressional mandate. So if you all believe that it
should be a higher standard, that is your call and whatever your call
is, we will follow it.'' \19\
---------------------------------------------------------------------------
\18\ 01:41:04.
\19\ 01:42:09.
---------------------------------------------------------------------------
9. The DGA may be contributing in part to our nation's health problems.
During the hearing, statistics were cited on the rising prevalence
of obesity and diabetes. We cannot afford to wait another 5 years; our
survival as a great nation depends on getting this right. According to
Rep. David Scott, ``Agriculture is indeed our most important industry.
It's the food we eat. It's the water we drink. It's our survival. And I
think that you got the feeling from this Committee how important this
is.'' \20\ We wholeheartedly concur with the Rep. Scott and other
Members of the Committee and ask that the entire DGA process and
resulting guidelines be given an immediate and thorough review by
Congress and by an independent scientific panel selected by Congress
and under their direction.
---------------------------------------------------------------------------
\20\ 02:22:30.
---------------------------------------------------------------------------
10. The DGA should be replaced by guidance, for use by the general
public, focused on essential nutrition.
The DGA should, first and foremost, provide general dietary
guidance on selecting from a variety of foods that supply adequate
essential nutrients. This could look like previous editions produced by
the USDA (examples cited above in point 1), perhaps with multicultural
versions to meet our diverse population's dietary preferences. To
ensure scientific rigor, the DRIs should be utilized. Any and all
guidance for the prevention of chronic disease must be limited to that
designated as Grade 1: Strong evidence by the USDA Nutrition Evidence
Library and directed only at relevant demographic group(s).
In conclusion, any measurement of the success of the DGA must not
be in regard to how well the American public applies and adheres to
them as Secretary Vilsack states.\21\ Success must be measured by
nutrition and health outcomes including the following:
---------------------------------------------------------------------------
\21\ 01:24:20.
Are Americans, especially children, meeting all of their
---------------------------------------------------------------------------
nutrient needs?
Are we seeing meaningful declines in the prevalence of
obesity, diabetes, fatty liver, and other diseases that are
afflicting our children?
From the questions asked of Secretaries Burwell and Vilsack, we
know that a number of policymakers share our concerns. We commend the
language in the House's Departments of Agriculture, Rural Development,
Food and Drug Administration and Related Agencies (section 734) and
Departments of Labor, Health and Human Services and Education and
Related Agencies, (section 230) Fiscal Year 2016 Appropriations Bills
that indicates a call for the highest standards of evidence, and we
suggest that these standards be applied to all national nutrition
guidance.
Respectfully submitted by,
Pamela Schoenfeld, M.S., R.D.,
Executive Director,
Adele Hite, M.P.H., R.D.,
Public Policy Advisor,
The Healthy Nation Coalition.
www.forahealthynation.org
______
Submitted Statement by Nina Teicholz, Author, The Big Fat Surprise: Why
Butter, Meat and Cheese Belong in a Healthy Diet
I want to thank Chairman Michael Conaway (R-TX) and Ranking Member
Collin Peterson (D-MN) for holding this important hearing on the U.S.
Dietary Guidelines for Americans. My name is Nina Teicholz and I am an
investigative journalist who spent 10 years researching the science,
politics and history of U.S. nutrition policy and particularly how we
came to believe that dietary fat is bad for health. This work
culminated in my best-selling book, The Big Fat Surprise: Why Butter,
Meat and Cheese Belong in an Healthy Diet, which was named a ``Best
Book'' of 2014 by the Economist, Wall Street Journal, Forbes, Mother
Jones, Library Journal, and Kirkus Reviews, and received strong review
in both the BMJ and American Journal of Clinical Nutrition. In the
spring of 2015, I received a grant from the Laura and John Arnold
Foundation to undertake a comprehensive scientific analysis of the
Dietary Guidelines, resulting in a report (``Critical Review'') that is
available to the public at www.forbetterdietaryguidelines.com. Based on
that work, I wrote a comprehensive peer-reviewed, fact-checked
investigation of the guidelines that was published by the British
Medical Journal (BMJ), available to read here: http://www.bmj.com/
content/351/bmj.h4962. My testimony today is based on this body of
work.
In general, I found that expert report underpinning the next set of
U.S. Dietary Guidelines for Americans fails to reflect much relevant
scientific literature in its reviews of crucial topics and therefore
risks giving a misleading picture. The omissions seem to suggest a
reluctance by the committee behind the report to consider any evidence
that contradicts the last 35 years of nutritional advice.
My analysis for the BMJ found that the committee's report used weak
scientific standards, reversing recent efforts by the government to
strengthen the scientific review process. This backsliding seems to
have made the report vulnerable to internal bias as well as outside
agendas.
The 2015 report states that the committee abandoned established
methods for most of its analyses. Since its inception, the guideline
process has suffered from a lack of rigorous methods for reviewing the
science on nutrition and disease, but a major effort was undertaken in
2010 to implement systematic reviews of studies to bring scientific
rigor and transparency to the review process. The U.S. Department of
Agriculture set up the Nutrition Evidence Library (NEL) to help conduct
systematic reviews using a standardized process for identifying,
selecting, and evaluating relevant studies.\3\
However, my BMJ analysis found that on questions requiring reviews
of the scientific literature, the committee did not use the NEL for 63%
of them. The questions include some of the most controversial issues in
nutrition today.\4\ Instead, the committee relied on systematic reviews
by external professional associations, almost exclusively the American
Heart Association (AHA) and the American College of Cardiology (ACC),
or conducted ad hoc examinations of the scientific literature without
well defined systematic criteria for how studies or outside review
papers were identified, selected, or evaluated.
Use of external reviews by professional associations is problematic
because these groups conduct literature reviews according to different
standards and are supported by food and drug companies. The ACC reports
receiving 38 percent of its revenue from industry in 2012, and the AHA
reported 20 percent of revenue from industry in 2014. Potential
conflicts of interest include, for instance, decades of support from
vegetable oil manufacturers, whose products the AHA has long promoted
for cardiovascular health. This reliance on industry backed groups
clearly undermines the credibility of the government report.
Saturated Fats
On saturated fats, for example, the committee did not ask the NEL
to conduct a formal review of the literature from the past 5 years,
even though this topic clearly merited re-examination. When the
committee started its work in 2012, there had been several prominent
papers, including a meta-analysis \5\ that failed to confirm an
association between saturated fats and heart disease, and two major
reviews (one systematic) \6\-\7\ that did not consistently
show an causal effect of saturated-fat reduction on cardiovascular
mortality.
Restrictions on saturated fats have been a foundation of nutrition
policy since the first guidelines in 1980 and have had a dominant role
in determining which foods, such as low fat dairy and lean meats, are
considered ``healthy.'' Instead of requesting a new NEL review for the
recent literature on this crucial topic, however, the 2015 committee
recommended extending the current cap on saturated fats, at 10% of
calories, based on a review by the AHA and ACC,\8\ a 2010 NEL review,
and the 2015 committee's ad hoc selection of seven review papers (see
table A on thebmj.com).\9\
The NEL systematic review on saturated fats from 2010 \10\ covers
only the literature published from 2004 to 2009, the period which the
2010 committee had been asked to review. Fewer than 12 small trials are
cited, and none supports the hypothesis that saturated fats cause heart
disease (see table B on thebmj.com).
More significantly, the 2010 review omits a large controlled
clinical trial, the Women's Health Initiative, which included nearly
49,000 people and achieved a significantly lower intake of saturated
fat in the intervention group yet, compared with controls, observed no
benefits for this group in incidence of fatal and non-fatal coronary
heart disease events and total cardiovascular disease, including
stroke.\11\
Papers on saturated fats published since 2010 were covered by the
committee's ad hoc review, which did not use a systematic method to
select or evaluate studies. One of the meta-analyses it cited was
arguably inappropriately included because it considered polyunsaturated
vegetable oils rather than saturated fats.\12\ Another analysis cited
in great detail had already been covered by the 2010 NEL review, so
including it again amounted to double counting.\13\ Three meta-analyses
concluded that saturated fats did not increase cardiovascular
mortality,\14\-\16\ but the committee downplays these
findings. And two other included meta-analyses had mixed results:
saturated fats generally looked more atherogenic than polyunsaturated
fats but less atherogenic than carbohydrates or monounsaturated
fat.\17\-\18\ Despite this conflicting evidence, however,
the committee's report concludes that the evidence linking consumption
of saturated fats to cardiovascular disease is ``strong.''
Perhaps more important are the studies that have never been
systematically reviewed by any of the Dietary Guideline committees.\19\
These include the large, government funded randomized controlled trials
on saturated fats and heart disease from the 1960s and 1970s. Taken
together, these trials followed more than 25,000 people, some for up to
12 years. They are some of the most ambitious, well controlled
nutrition studies ever undertaken.\20\-\25\ These studies
showed mixed health outcomes for saturated fats, but early critical
reviews, including one by the National Academy of Sciences, which
cautioned against the inconclusive state of the evidence on saturated
fats and heart disease, were dismissed by the USDA when it launched the
first Dietary Guidelines in 1980.\26\ Subsequent guideline committees
have never gone back to systematically review these early trials but
instead relied on other government reports.
Low Carbohydrate Diets
Another important topic that was insufficiently reviewed is the
efficacy of low carbohydrate diets. Again, the 2015 committee did not
request a NEL systematic review of the literature from the past 5
years. The report says that this was because, after conducting
``exploratory searches'' of the literature since 2000, the committee
could find ``only limited evidence [on] low-carbohydrate diets and
health, particularly evidence derived from U.S. based populations.''
\27\
The report provides no documentation of these ``exploratory
searches,'' yet many studies of carbohydrate restriction have been
published in peer review journals since 2000, nearly all of which were
in U.S. populations. These include nine pilot studies, 11 case studies,
19 observational studies, and at least 74 randomised controlled trials,
32 of which lasted 6 months or longer (see table C on thebmj.com). A
meta-analysis and a critical review have concluded that low
carbohydrate diets are better than other nutritional approaches for
controlling type 2 diabetes,\28\-\29\ and two meta-analyses
have concluded that a moderate to strict low carbohydrate diet is
highly effective for achieving weight loss and improving most heart
disease risk factors in the short term (6 months).\30\-\31\
Weight loss benefits on different diets tended to converge over the
long term (12 months), according to various reviews, but a recent meta-
analysis found that if carbohydrates are kept ``very low,'' weight loss
is greater than with a low fat diet maintained for a year.\32\ Given
the growing toll taken by these conditions and the failure of existing
strategies to make meaningful progress in fighting obesity and diabetes
to date, one might expect the guideline committee to welcome any new,
promising dietary strategies. It is thus surprising that the studies
listed above were considered insufficient to warrant a review.
New Strategies
The committee's approach to the evidence on saturated fats and low
carbohydrate diets reflects an apparent failure to address any evidence
that contradicts what has been official nutritional advice for the past
35 years. The foundation of that advice has been to recommend eating
less fat and fewer animal products (meat, dairy, eggs) while shifting
calorie intake towards more plant foods (fruits, vegetables, grains,
and vegetable oils) for good health. And in the past decades, this
advice has remained virtually unchanged.\33\
Because the guidelines have obviously not led to better health,
however, there has been a need to find new strategies to tackle
nutrition related diseases. The committee's most significant shift,
which began in 2010, however, has been to redouble its efforts towards
emphasizing a plant based diet. This can be seen in a number of ways in
the 2015 report, none of which is supported by strong evidence.
New proposals by the 2015 report include not only deleting meat
from the list of foods recommended as part of its healthy diets, but
also actively counseling reductions in ``red and processed meats.''
\34\ This advice has been the subject of much debate, which guideline
supporters have successfully characterized as a conflict between the
self interested meat industry versus virtuous efforts to safeguard
health (and the environment).\35\-\36\ Yet framed this way,
the debate fails to address the question fundamental to nutrition:
would reducing meat lead to better health? Consulting the NEL for a
review on this topic turns up a surprising fact: a systematic review on
health and red meat has not been done. Although several analyses look
at ``animal protein products,'' these reviews include eggs, fish, and
dairy and therefore do not isolate the health effects of red meat, or
meat of any kind.\37\
Importantly, some of the report's findings also contradict the
dietary committee's advice on red meat. For example, to support the
idea that red meat harms health, the committee repeatedly cites one
large randomized trial conducted in Spain. However, this trial did not
intend to lower consumption of red and processed meats in the
experimental group, compared with the control group, so cannot be said
to support the committee's advice.\38\ Also, the sole diagram on red
meat in the committee's report, which plots the data from observational
studies, shows a roughly equal number of health benefits associated
with the diets higher in red meat as with diets lower in red meat.\39\
Recommended Diets
Another clear move towards a plant based approach in the report is
the introduction of the ``healthy vegetarian diet'' as one of three
recommended diets (the others are: ``healthy Mediterranean-style'' and
``healthy U.S.-style'').\2\ A NEL review of a healthy vegetarian diet
does exist, but it concludes that the evidence for this diet's disease
fighting powers is only ``limited,'' which is the lowest rank for
available data.\40\ Moreover, although the NEL conducted eight reviews
on fruits and vegetables, none found strong (grade 1) evidence to
support the assertion that these foods can provide health benefits.\41\
In general, the quality of the evidence supporting the report's
three recommended diets is limited (table D on the bmj.com). The
committee could find only ``limited'' to ``not assignable'' evidence to
show that its diets protect against osteoporosis, congenital
abnormalities, or neurological or psychological illnesses.\27\ The NEL
review found only ``limited'' or ``insufficient'' evidence that the
diets could combat diabetes.\42\ In a highly unorthodox move, the
guideline committee overruled the NEL's systematic reviews on this
topic and decided to upgrade the rank to ``moderate,'' based on its
opinion that one review paper on observational data, which showed
positive results, was particularly strong.
And are the recommended diets better than other diets in helping
people lose weight? On this question, the report ranked the evidence as
moderate, yet to support this claim, it presents only a single clinical
trial in 180 people with metabolic syndrome, which found the
Mediterranean diet produced more weight loss than a low fat diet.\43\
One randomized controlled trial listed by the review did not actually
test weight loss, only the ability to adhere to the diet,\44\ which,
although important, is relevant only if the diet works. Three trials
\45\-\47\ and an AHA/ACC review \48\ concluded that compared
with other diets, those recommended by the Dietary Guidelines offered
at best a marginal advantage in fighting obesity (less than a pound
over trial periods lasting up to 7 years).
The report also gave a strong rating to the evidence that its
recommended diets can fight heart disease.\27\ Again, several studies
are presented, but none unambiguously supports this claim. Eight trials
reviewed by the NEL to support its strong grade include one trial that
should not have been included because it lacked a comparable control
group; \49\ three that showed no beneficial effects on cardiovascular
health other than improved blood pressure (and studied hypertensive
populations) \50\-\52\; another, also in hypertensive
people, showing that the recommended diet had poorer cardiovascular
outcomes than other options that were higher in monounsaturated fat or
protein; \53\ one showing mixed results on cardiovascular risk factors
(although low density lipoprotein cholesterol fell, so did ``good''
high density lipoprotein cholesterol); \54\ and the largest one, which
concluded that the diet was ineffective for reducing cardiovascular
risk.\11\ The committee also cites an AHA/ACC review, but this paper
examines trials already covered by the NEL review, so including them
again amounts to double counting.\8\ The committee reviewed other, more
recent studies but not using any systematic or predefined methods.
In conclusion, the recommended diets are supported by a minuscule
quantity of rigorous evidence that only marginally supports claims that
these diets can promote better health than alternatives. Furthermore,
the NEL reviews of the recommended diets discount or omit important
data. There have been at a minimum, three National Institutes of Health
funded trials on some 50,000 people showing that a diet low in fat and
saturated fat is ineffective for fighting heart disease, obesity,
diabetes, or
cancer.\46\, \11\, \55\-\59\ Two of
these trials are omitted from the NEL review. The third trial is
included, but its results are ignored. This oversight is particularly
striking because this trial, the Women's Health Initiative (WHI), was
the largest nutrition trial in history.\55\-\56\ Nearly
49,000 women followed a diet low in fat and high in fruits, vegetables,
and grains for an average of 7 years, at the end of which investigators
found no significant advantage of this diet for weight loss, diabetes,
heart disease, or cancer of any
kind.\11\, \56\-\59\ Critics dismiss this trial
for various reasons, including the fact that fat consumption did not
differ enough significantly between the intervention and control
groups, but the percentage of calories from both fat and saturated fat
were more than 25% lower in the intervention group than in the control
group (26.7% v. 36.2% for total fat and 8.8% v. 12.1% for saturated
fats).\57\ The WHI findings have been confirmed by other sizeable
studies and are therefore hard to dismiss. When the omitted findings
from these three clinical trials are factored into the review, the
overwhelming preponderance of rigorous evidence does not support any of
the dietary committee's health claims for its recommended diets.
My Critical Review makes additional points about the recommended
diets. One is that although the committee states that these diets offer
``multiple ways'' for people to eat a healthy diet, they are, in fact,
all still virtually the same. In other words, the committee is still
recommending a ``one-size-fits-all'' diet. This is problematic, given
that there is clearly great variation in the nutrition needs of various
populations, depending on age, gender, genetic background and state of
metabolic disease state. (see Critical Review, pages 31-32). Moreover,
the recommended diets are nearly identical to previous DGA dietary
advice (pages 29-30), so in effect, ``Dietary Patterns'' are simply a
new name on the same diet that has been recommended for more than a
decade.
Moreover, this diet is modeled, in the tables of the report, to be
low in fat (32-34% of calories as fat), even though the report
concludes that a diet low in fat worsens important heart disease risk
factors. In effect, this low-fat advice may potentially worsen heart-
attack risk.
Another serious problem with the recommended diets is that,
according to the committee, they are not nutritionally sufficient. The
committee states that the nutrients ``for which adequacy goals are not
met'' in most of the recommended diets are ``potassium, vitamin D,
vitamin E, and choline.'' [1] Vitamin A sufficiency is
reported as borderline,[2] and without consumption of
fortified grains, primarily refined-grain breakfast cereals, the diets
are also deficient in iron and folate.[3] Thus, although the
committee recommends consuming primarily whole grains, the reality is
that the recommended diets remain just as high in refined grains as in
the past, due to the need for nutrients from fortification. Indeed, the
recommended diets contain an equal amount of refined grains as whole
grains.
---------------------------------------------------------------------------
\[1]\ DGAC report, (Part D, Ch. 1, p. 22, lines 827-828 (http://
www.health.gov/dietaryguidelines/2015-scientific-report/06-chapter-1/
d1-2.asp)) (Appendix E-3.1, Text and Figure 4 (http://www.health.gov/
dietaryguidelines/2015-scientific-report/15-appendix-E3/e3-1.asp)).
\[2]\ 2015 DGAC report, Part D, Ch. 1, Figure D1.1, p. 131.
\[3]\ Appendix E-3.2, Table 3, (http://health.gov/
dietaryguidelines/2015-scientific-report/15-appendix-e3/e3-2.asp) see
``grains'' for the contributions of these foods to nutritional
sufficiency.
---------------------------------------------------------------------------
The committee does not address the issue of how its recommended
diets might become nutritionally sufficient. However, it does note that
for a number of nutrients for which the American population is
currently ``under-consumed,'' including calcium, iron, and Vitamin D,
the best and most bioavailable sources of these nutrients are animal
foods. For example, red meat is ``an excellent source'' of heme iron,
and the greatest amount of calcium, in its most bioavailable form, is
in hard cheeses, yet these foods are limited in the recommended diets
due to the overall cap on saturated fat. The evidence suggests that
easing or eliminating the limit on saturated fat would eliminate these
nutritional deficiencies. A more complete discussion of these issues
can be found in my Critical Review.
A final area examined by The BMJ where the report offers advice
that contradicts its data is on sodium. The committee says that it
``concurs'' with a recent report by the Institute of Medicine, which
states that the evidence is ``inconsistent and insufficient to conclude
that lowering sodium intakes below 2,300 mg/day will have any effect on
cardiovascular risk or overall mortality.'' \9\ Yet the report
recommends that sodium intake ``should be less than 2,300 mg/day'' and
encourages the choice of low salt options without reservation.
Questions About Bias
The overall lack of sound science and proper methods in the 2015
report could be seen as a reluctance to depart from existing dietary
recommendations. Many experts, institutions, and industries have an
interest in keeping the status quo advice, and these interests create a
bias in its favor. Abandoning the NEL review methods, as the 2015
committee has done, opens the door not only for bias but also for
influence from outside agendas and commercial interests, and all of
these can be observed in the report.
For example, a bias towards the longstanding view that saturated
fats are harmful can be seen in the report's designation of them,
together with sugar, as a new category it calls ``empty calories.'' \2\
The report repeatedly mentions the need to reduce ``sugar and solid
fats,'' because, ``both provide calories, but few or no nutrients.''
\2\ Yet this pairing is unsupported by nutrition science. Unlike sugar,
saturated fats are mostly consumed as an inherent part of foods such as
eggs, meat, and dairy, which together contain nearly all of the
vitamins and minerals needed for good health.
Not following the NEL methods has also allowed outside agendas to
enter into the report, most clearly in the form of the new
consideration for environmental sustainability. Although, as the report
states, the environmental effects of food and drink production are
considerable, they are outside the committee's formal mandate to
provide the Federal Government with the ``current scientific evidence
on topics related to diet, nutrition, and health.'' \2\ In a new
development for 2015, the USDA hired a food policy analyst focused on
environmental issues to oversee the guideline committee's work,
reflecting a new agenda in the process.\60\
Much has been written about how industries try to influence
nutrition policy, so it is surprising that unlike authors in most major
medical journals, guideline committee members are not required to list
their potential conflicts of interest. A cursory investigation shows
several such possible conflicts: one member has received research
funding from the California Walnut Commission \61\ and the Tree Nut
Council,\62\ as well as vegetable oil giants Bunge and
Unilever.\63\-\64\ Another has received more than $10,000
from Lluminari, which produces health related multimedia content for
General Mills, PepsiCo, Stonyfield Farm, Newman's Own, and ``other
companies.'' \65\ And for the first time, the committee chair comes not
from a university but from industry: Barbara Millen is President of
Millennium Prevention, a company based in Westwood, MA, that sells web-
based platforms and mobile applications for self health monitoring.
While there is no evidence that these potential conflicts of interest
influenced the committee members, the report recommends a high
consumption of vegetable oils and nuts as well as use of self
monitoring technologies in programs for weight management.
Still, it's important to note that in a field where public research
dollars are scarce, nearly all nutrition scientists accept funding from
industry. Of far greater influence is likely to be bias in favor of an
institutionalized hypothesis as well as a ``white hat'' bias to distort
information for what is perceived as righteous ends.\66\
The report is highly confident that its findings are supported by
good science, stating that ``The evidence base has never been stronger
to guide solutions.'' \2\ Millen told The BMJ, ``You don't simply
answer these questions on the basis of the NEL. Where we didn't feel we
needed to, we didn't do them. On topics where there were existing
comprehensive guidelines, we didn't do them. We used those resources
and that time to cover other questions. The notion that every question
that we posed should have a NEL is flawed.'' She said she would ``go to
the mat'' to defend the committee's approach. ``That's why you have an
expert committee . . . to bring expertise,'' including ``our own
original analyses.''
``These folks know how to do this work. People who criticize this
are coming from the point of view that they don't like the answer. They
don't like the fact that randomised controlled trials testing these
dietary patterns are successful. I think you have to read the report.
NEL helped us to do the searches to update the literature. That is
stated. If it doesn't satisfy you, that is all I can say. It's well
stated and been reviewed by dozens of people.''
On saturated fats, especially, she said, ``We thought we nailed
it.'' Millen said that her committee's work had not been entirely
without methodology but had ``worked with the NEL and USDA assistance
to identify the research literature.'' She said that ''it was clear
that polyunsaturated fats reduced heart disease risk and mortality,''
yet that the ``evidence is not as clear on whether replacement of
saturated fat with monounsaturated fats or carbohydrates reduces
cardiovascular disease risk, and likely depends on the type and
source.''
On diets low in carbohydrates, she said that there was ``not
substantial evidence'' to consider. ``Many popular diets don't have
evidence. But can you achieve healthiness, the answer is yes.''
Regarding the committee's conflicts of interest, she said that
members were vetted by counsel to the Federal Government. She would not
reveal details of her company's activities. Critics of the report, she
said, ``are coming from the point of view that they don't like the
answer.''
The argument by the USDA has been that the Guidelines have not been
successful because people do not adequately follow them. However,
government data contradicts this explanation: from 1970 to 2005,
Americans increased consumption of vegetables by 23% (with one of the
biggest percentile increases being in leafy greens), fruit by 13%,
grains by 41% and vegetable oils by 91%. At that same time, Americans
have decreased consumption of animal fats by 16%, red meat by 17%,
(beef by 22%), whole milk by 73%, butter by 14%, and eggs by 17%. (67)
These numbers suggest that Americans have successfully followed the
Guidelines, yet clearly better health has not been the result.
After 35 years of pursuing the same flawed nutrition policy, the
time has come for an objective scientific review of the proposed
Dietary Guidelines. Congress initiated the guidelines 35 years ago and
Congress should require an objective scientific review of the
guidelines by the National Academy of Sciences, and the Administration
should embrace this transparent, objective analysis of one of the
fundamental tenets of national nutrition policy.
Notes
Competing interests: I have received modest honorariums
for presenting my research findings presented in the book to a
variety of groups related to the medical, restaurant, financial,
meat, and dairy industries. I am also a board member of a
nonprofit organization, the Nutrition Coalition, dedicated to
ensuring that nutrition policy is based on rigorous science.
This article was fully funded with a grant from the
Laura and John Arnold Foundation. The analysis was conducted
independently, and the report reflects the views of the author
and not necessarily those of the foundation. The article was
submitted in June and provisionally accepted for publication in
July of 2015.
Provenance and peer review: Commissioned; externally
peer reviewed and fact checked.
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Major Trends in U.S. Food Consumption, 1970-2005,'' Economic
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2008.
______
Submitted Letter by Kristin Pearson Wilcox, Vice President of
Government Relations, International Bottled Water Association
October 7, 2015
Hon. K. Michael Conaway, Hon. Collin C. Peterson,
Chairman, Ranking Minority Member,
House Committee on Agriculture, House Committee on Agriculture,
Washington D.C.; Washington D.C.
Dear Chairman Conaway and Ranking Member Peterson:
On behalf of the members of the International Bottled Water
Association (IBWA), thank you for holding the hearing today on the
importance of basing the 2015 Dietary Guidelines for Americans (DGA) on
sound science.
IBWA is the primary, authoritative source of information on bottled
water. This includes all types of water, such as spring, mineral,
sparkling, artesian and purified bottled water. Our membership includes
over 700 United States and international bottlers, suppliers and
distributors that are small, medium and large-sized companies. IBWA and
the bottled water industry are committed to making safe and healthy
products. In addition to U.S. Food and Drug Administration (FDA) and
state regulations, IBWA member bottlers must adhere to the IBWA Bottled
Water Code of Practice. In some cases, the FDA and IBWA standards for
bottled water are more stringent than the U.S. Environmental Protection
Agency (EPA) regulations for tap water.
We appreciate your attention today to the nutritional health of our
citizens. Every American is affected by the nutritional recommendations
made in the Dietary Guidelines. It is essential for them to be based on
consistent, and sound nutritional science. We want to provide you with
our insights on the nutritional importance of water, and its role in
health, as you examine the Administration's efforts to finalize the
2015 Dietary Guidelines. We believe the science supports having the
final guidelines stress the importance of water consumption, including
bottled water consumption.
Making healthy hydration an equally important part of the wellness
equation, along with a well-balanced diet and daily physical activity
for all Americans, should be a clear focus of the 2015 DGAs. Bottled
water presents a healthy option for consumers when making a beverage
choice. Having no calories and no sugar, it is often the best choice as
a beverage on the go. This simplicity gives bottled water an advantage
over other packaged beverages when consumers are trying to make a
healthy beverage selection.
Scientific studies clearly demonstrate the importance of water
consumption, and science and health professionals are speaking up on
behalf of water. For example, on September 10, 2014, fourteen
researchers, scientists, nutritionists, clinicians, and public health
professionals wrote a letter to the Dietary Guidelines Advisory
Committee (DGAC) asking them to strengthen the language for drinking
water in the 2015 Dietary Guidelines and adding a water graphic to the
MyPlate nutrition guide. We think the science is clear, and researchers
and clinicians are saying Americans should drink more water. And,
consumers are listening.
Americans' consumption of bottled water increased by 7.3 percent to
11 billion gallons in 2014 and bottled water sales were up 6.4 percent
to $13 billion (wholesale) over the previous year. Americans upped
their annual bottled water consumption by almost 11 gallons per person
during the period 2004 to 2015. It went from 23.2 gallons per person in
2004 to 34 gallons in 2014, according to Beverage Marketing Corporation
(BMC). BMC reported that over the past 5 years alone, bottled water has
increased its ``share of stomach'' of the overall beverage market from
14.4 percent in 2009, to 17.8 percent in 2014.
We hope that the revised DGA's will take this growth, and the
advice of nutrition experts, into account in the final 2015 DGA
document. Numerous peer-reviewed scientific studies indicate that water
consumption can aid in weight management and that there is a need to
promote the consumption of water. IBWA submitted a full list of the
scientific research supporting the importance of water consumption to
the DGAC.
This impressive list of academic endorsements of the importance of
water consumption is supported by the government's own data. The U.S.
Department of Agriculture's (USDA) National Health and Nutrition
Examination Survey (NHANES) IV data show that older adults are not
consuming enough water. Neither are children. Water accounted for only
29% of children's total fluid intake; the majority coming from soda,
sports drinks and teas. Of children 4-8 years, 75% failed to satisfy
the Daily Recommended Intake (DRI) for water. Dr. Adam Drewnoski, of
the Center for Public Health Nutrition at the University of Washington,
who conducted this study of NHANES data, concluded, ``Increasing total
water consumption can be achieved through various means, though
promotion and encouragement of non-caloric beverages is likely to be
the most successful avenue for increasing water consumption.''
IBWA and its members believe the Dietary Guidelines should
encourage the consumption of water of all kinds: bottled, filtered, and
tap. It is our hope that the 2015 Dietary Guidelines will reinforce
those healthy behaviors that are already changing for the better. As
noted, people are forming new habits like drinking more water--both
bottled and tap. Besides growing in consumption nationally, bottled
water is already outselling carbonated soft drinks in supermarkets here
in Washington, D.C. and in 17 other major markets, including New York,
Los Angeles, Miami, and Philadelphia. And according to BMC, bottled
water will become the number one beverage product in the United States
by 2020.
The message to drink more water is resonating around the world. For
example, the Mediterranean Diet Pyramid includes drinking water as an
essential component of a healthy diet. The DGAC has discussed the
merits of the Mediterranean Diet during its deliberation of the 2015
Guidelines. The Japanese Food Guide also includes water at the top of
its pyramid. Again, they all recognize water as an important element of
a well-balanced lifestyle. Other countries, such as France, Spain,
Germany, and Austria, include water in their dietary guideline visual
depictions. We believe the U.S. should join these countries and include
water in its Dietary Guidelines and on the MyPlate visual.
The DGAs do not need to pit healthy foods and beverages against
each other. No one supports healthy beverage choices, such as milk,
more than our industry and we recognize the nutrient value of milk and
100% fruit juice. We are, however, suggesting that science supports
having water, along with milk and dairy, on the MyPlate nutrition
guide. According to a recent W.K. Kellogg Foundation poll, 90 percent
of the people polled say they support making water a preferred beverage
in the new 2015 Dietary Guidelines for Americans. IBWA commissioned a
study by the Artemis Strategy Group on the different MyPlate visuals.
One of the visuals included the original USDA/HHS MyPlate, which has a
dairy cup next to a plate. Another visual had a cup of dairy and cup of
water next to one another alongside the plate. Among the 76% of those
surveyed who reported that they are very or somewhat likely to consume
dairy when viewing the original MyPlate, 49% of them said they that
they would drink both water and dairy when they saw a MyPlate visual
including water and dairy.
The 2015 Dietary Guidelines and MyPlate will serve as a platform
for Americans to begin or continue living a healthy lifestyle. We hope
that both will include messaging and visuals to encourage the adoption
of healthy hydration habits. Americans should be healthier and drink
more water. If we want Americans to drink more water, there should be a
consistent ``think water'' encouragement in the Dietary Guidelines'
final recommendations. Delivery of this message to American families is
critical.
We are concerned about two messages in the DGAC recommendations. In
particular, its steps into providing economic rather than nutritional
advice when the DGAC stresses that consumers should drink ``free''
water. We think the final Guidelines should encourage consumers to
drink ``accessible'' water.
We are also concerned about the DGAC's straying into a discussion
of environmental sustainability. We want to make sure that you are
aware of bottled water's small impact on the environment, and on our
small water use, as you deliberate on what beverages to promote.
Bottled water has the smallest environmental footprint among all
packaged beverages.
Statistics show that the bottled water industry is a sustainability
leader. From an environmental standpoint, when people choose bottled
water instead of any other canned or bottled beverage, they are
choosing less packaging, less energy consumption, and less use of
natural resources. According to a 2014 Antea Group Study, bottled water
facilities have the lowest water use ratio and energy use ratio when
compared to other beverage products, including sugar-sweetened
beverages. These ratios represent the average amount of water and
energy used within the facility to produce 1 liter of bottled water.
The Antea study found that it only takes 1.32 liters of water to
produce 1 liter of bottled water and that includes the liter that is
consumed.
PET plastic bottled water containers are the single most recycled
item in nationwide curbside collection programs. And large 3 and 5
gallon bottled water containers are washed, sanitized and reused
between 30-50 times before being recycled. Data derived from EPA
figures demonstrate that plastic water bottles make up less than \1/3\
of 1 percent of the entire U.S. waste stream.
Bottled water producers, like the American farmers this Committee
works to uplift and protect, care about the quality of the water and
land that produce the food and beverage products that Americans and
people around the world consume.
We pledge to remain good stewards of water resources. And we stand
ready to partner with you and the Administration to help ensure good
nutritional health for all Americans.
Thank you for this opportunity to comment on this important issue.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Kristin Pearson Wilcox
Vice President of Government Relations.
______
Submitted Letter by Grain Chain *
---------------------------------------------------------------------------
* American Bakers Association; American Institute of Baking
International Grain Foods Foundation; Independent Bakers Association;
National Association of Wheat Growers; National Pasta Association;
North American Millers' Association; Retail Bakers of America; USA Rice
Federation; Wheat Foods Council.
---------------------------------------------------------------------------
October 19, 2015
Hon. K. Michael Conaway,
Chairman,
House Agriculture Committee
Washington, D.C.
RE: Grain Chain Comments for Hearing Record: House Agriculture
Committee Hearing on 2015 Dietary Guidelines for Americans
(October 7, 2015)
Dear Chairman Conaway:
As the organizations comprising the Grain Chain, a grains industry
coalition from farm to table, we are pleased to provide written
comments for the public hearing record on the House Agriculture
Committee's recent hearing to review the 2015 Dietary Guidelines for
Americans.
We commend the Chairman and the Committee on analysis of the
dietary guideline review process and for emphasizing that as the 2015
recommendations are finalized by HHS and USDA, there needs to be a base
of strong scientific evidence and within scope.
The Grain Chain comments provide detailed justification for the
following specific recommendations:
1. Retain the DGAC 2010 recommendation for six servings of grains
with balance between whole and enriched (refined);
2. Use the term ``enriched grains'' when referring to refined
grains, since more than 95% of the refined grains in the
U.S. are enriched and fortified;
3. Reject the DGAC 2015 recommendation to limit added sugar to no
more than 10% of total calories;
4. Reject the DGAC 2015 recommendation to restrict dietary sodium to
less than 2300 mg per day;
5. Acknowledge the emerging evidence of the beneficial effects of
whole grains on maintaining a healthy microbiome;
6. Note the negative health implications of fad diets.
In the following sections we provide the scientific rationale for
each of our recommendations.
1. Retain the DGAC 2010 Recommendation for Six Servings of Grains with
Balance Between Whole and Enriched (Refined)
The Crucial Role of Enriched Grains in the Diet
The Grain Chain fully endorses the 2015 Dietary Guidelines Advisory
Committee's decision to ``bring forward'' the recommendation of the
2010 Dietary Guidelines for Americans which called for \1/2\ of all
grain intake to come from whole grains. This would allow Americans to
reap the multiple, established health benefits of whole grains, leaving
the other \1/2\ of daily grain intake for enriched grain products,
which have their own unique benefits. Furthermore, because at least 95%
of the refined grains in the U.S. are enriched and fortified and
labeled as such, it is more appropriate to use the term ``enriched
grains'' as opposed to ``refined grains,'' especially when speaking to
staple grain products [see below, section on ``Clarification of
Terminology'']. Since Americans have yet to achieve the current Dietary
Guidelines recommendation for whole grain intake, the recommendation's
goal is still valid and vital in the setting of a calorically
appropriate diet. As well, the science does not show that there are
benefits to higher daily intake of whole grains beyond ``making \1/2\
your grains whole grains,'' reinforcing that all grains have a place in
a balanced eating pattern.
As a category, grain foods contribute vital, and often
underconsumed, nutrients to the American diet, including 43.7% of all
fiber.\1\ Approximately \2/3\ of the grain contribution to total fiber
intake comes from enriched grains.\2\ The contributions of both whole
and enriched grains to total fiber intake are important because more
than 90% of adults and children fall short of dietary fiber
recommendations.\2\ Enriched grains also are the largest contributor of
folate in the American diet.\3\ Although the current dietary fiber
shortfall could theoretically be made up by consuming more fruits and
vegetables, which together contribute 43.8% of total dietary fiber
intake,\1\ a reduction in enriched grain intake could have unintended
health consequences (e.g., nutrient shortfalls from reduced intake of
enriched grain products--see section 2, below). Furthermore, a number
of scientific reports have demonstrated the distinctive benefits of
cereal fiber compared to fiber from fruits and vegetables. For example:
A 2007 meta-analysis including nine cohort studies
demonstrated a 33% reduction in type 2 diabetes incidence
associated with cereal fiber intake, but no association with
either fruit or vegetable fiber intake.\4\
A 2014 analysis of data from 17 prospective studies found an
inverse linear relationship between cereal fiber intake and
reduction in type 2 diabetes risk but no such associations with
fruit or vegetable fiber intake.\5\
A 2014 publication using data on survivors of myocardial
infarction among participants in the Nurses' Health Study and
Health Professionals Follow-up Study showed a 27% reduced risk
in all-cause and CVD mortality associated with cereal fiber
intake, but no association with fiber from either fruit or
legumes.\6\
These articles are not presented to diminish the established
benefits of fruits and vegetables, but rather to highlight the findings
that when compared head-to-head, a considerable body of evidence (i.e.,
28 separate cohorts examined in these three studies) indicates that
cereal fiber may be more important for reducing all-cause and some
cause-specific mortality. Fiber from enriched grains makes up
approximately \2/3\ of total cereal fiber in the American diet.
While whole grains have a well-established link to reduced obesity
risk, the 2015 DGAC has overstated the evidence against refined
(enriched) grains. For example:
A systematic review of the literature showed little
relationship between refined (enriched) grain intake and body
mass index.\7\
A 2012 special review for Nutrition Reviews concluded that
the published data on the relationship between refined
(enriched) grain intake and body weight are mixed, with no
clear and consistent trends.\8\
Refined (enriched) grain intake was not associated with any
measure of body fat distribution in older adults.\9\
Among adolescent girls and boys in the NHANES III study,
both refined (enriched) grain intake and whole grain intake
were inversely associated with central adiposity, measured by
waist circumference.\10\
With respect to facilitating weight loss, both refined (enriched)
grains and whole grains may be equally effective:
A 2014 report showed that when consuming a hypocaloric diet,
enriched-grain foods and whole-grain foods were equally
effective in facilitating weight loss and reducing abdominal
adipose tissue in men and women with increased waist
circumference.\11\
A 2008 publication demonstrated that whole- and enriched-
grain diets produced equal weight loss and improvements in
several CVD risk markers in men and women with the Metabolic
Syndrome.\12\
Refined (Enriched) Grain Intake and Chronic Disease: Weak Scientific
Evidence
The 2015 DGAC concluded that higher consumption of refined
(enriched) grains is linked to higher risk of several chronic diseases.
This conclusion is not consistent with a large body of scientific
evidence and again, reflects the disconnect in how staple grain
products are classified. We have shared some examples of these
inconsistencies but ultimately request a continued recommendation for
balanced intake between enriched and whole grains.
Some examples:
The 2015 DGAC report cited a 2014 meta-analysis in the
Journal of Human Nutrition and Dietetics that indicated a
positive relationship between refined (enriched) grain intake
and risk of type 2 diabetes.\13\ However, refined grains were
not analyzed separately, but only as part of a dietary pattern.
Surprisingly, the 2015 DGAC report did not cite a 2013 meta-
analysis published in the European Journal of Epidemiology that
showed no relationship between refined (enriched) grain intake
and diabetes risk.\14\ The impact factor for the Journal of
Human Nutrition and Dietetics is 2.07, while the impact factor
for the European Journal of Epidemiology is 5.15. It is
important to note that the article not cited by the committee
found no association between diabetes risk and refined grain
intake, even up to seven servings per day. This information is
extremely relevant because Figure D1.28 in the DGAC report (p.
144) shows that refined (enriched) grain intake ranged between
three and 6.5 servings per day, depending on sex and age group,
between 2001 and 2010 (based on NHANES data). Furthermore, the
reduced diabetes risk associated with whole grain intake was
maximized at three servings per day, which is completely
consistent with the current recommendations of 3 servings per
day of whole grains. If total grain intake is to stay at six
servings per day, there is no reason to advocate that all
servings should come from whole grains.
A report from the Framingham Heart Study showed that the
lowest level of visceral abdominal fat was observed in persons
who consumed approximately two servings per day of refined
(enriched) grains and approximately three servings per day of
whole grains. There was no benefit of reducing refined
(enriched) grain intake to less than one serving per day.\15\
A 2012 review concluded, ``The totality of evidence shows
that consumption of up to 50% of all grain foods as refined-
grain foods (without high levels of added fat, sugar, or
sodium) is not associated with any increased disease risk.''
\16\
Among 28,926 participants in the Women's Health Study,
refined (enriched) grain intake was not associated with
hypertension, but whole grain intake was inversely associated
with hypertension risk. The lack of an association with refined
(enriched) grain intake was observed even at intakes of six or
more servings per day.\17\
All Grain-Based Foods Can Be Part of a Healthy Diet
Recent data analyses presented at the 2015 Experimental Biology
meeting in Boston that was supported by the Grain Foods Foundation
revealed how many grain-based foods can cost-effectively fit into a
healthy diet.18-20 The results of these three separate
analyses are described below:
The 2015 DGAC relied on food pattern modeling analyses
performed by the 2005 and 2010 DGACs to answer questions
related to the impact of reducing refined/enriched grain
consumption, and overall grain consumption, on nutrient intake.
We would like to bring to your attention recent modeling
research, supported by the Grain Foods Foundation, and
presented at the 2015 Experimental Biology meeting.\18\ The
modeling analysis was conducted within a 2,000 kcal/d USDA
ideal food pattern where the ideal USDA grain food composite
was replaced with ten different grain food patterns based on
data from What We Eat In America 2005-2010. All patterns were
compared to the USDA ideal and USDA typical food patterns. All
ten models examined provided less energy in comparison to the
USDA typical food pattern. Several grain patterns, including
refined grains, contributed nutrient and energy intakes similar
to USDA recommendations. In fact, a pattern that included three
servings of refined grains, two high-fiber grain servings and
one serving of whole grains resulted in less sodium intake and
greater intake of folate and fiber than a dietary pattern that
included six servings of whole grains.
A cluster analysis using data from What We Eat in America
2005-2010 found that there were no significant differences
observed comparing those in the ``no grains'' cluster to those
in several different grain patterns, including many non-whole
grain-based foods, for body mass index or fasting blood
concentrations of glucose, insulin, total cholesterol, LDL-
cholesterol and triglycerides.\19\ Thus, inclusion of several
grain foods patterns in the diet is associated with several
health- and nutrition-related outcomes in adults.
A cost-of-nutrients analysis used NHANES 2003-2004 data and
the USDA Center for Nutrition Policy and Promotion prices
database to show that certain grain-based foods are a
``nutrition bargain'' for American consumers.20 The rolls/buns
category and the rice category were particularly cost
effective, each ranking in the top five most cost effective
food categories for 13-14 of the nutrients/substances
evaluated, including dietary fiber, protein, folate, iron,
magnesium, calcium, niacin and thiamin.
2. Clarification of Terminology: Use the Term ``Enriched Grains'' When
Referring to Refined Grains
We would like to clarify some important points on grains
terminology.
Although the 2015 DGAC acknowledged the enrichment and
fortification of grains, its repeated recommendations to reduce
consumption of ``refined'' grains to improve health undermines the
established benefits of enriched grain products.
Furthermore, rather than ``refined,'' ``enriched'' is a more
appropriate term to describe the grain products that the average
American sees in the grocery aisle. These staple foods contain some
fiber and are enriched with important nutrients, like thiamin, niacin,
riboflavin and iron. They are fortified with folic acid, which is
essential for women of childbearing age to help prevent neural tube
birth defects. The rate of neural tube defects in the United States has
decreased by 35 percent since the fortification of enriched grains
began in 1998.\21\
Enriched grains, as mandated by the U.S. Government since 1941,
have the three major B vitamins and iron replaced in equal or larger
amounts to those in whole grain products as defined by the standards of
identity. These essential B vitamins help maintain a healthy nervous
system, increase energy production, and may play a role in lowering
cholesterol. Due to this enrichment policy, serious diseases, including
pellagra and beriberi, have been eradicated from the U.S. population.
The reduction in neural tube defects has reduced health care costs
associated with spina bifida and anencephaly, resulting in annual
savings in total direct costs of approximately $508 million for the
NTD-affected births that were prevented with folic acid
fortification.\21\
Enriched, fortified grain foods are the primary source of folic
acid in Americans' diets. This is particularly important for women of
child-bearing age, the majority of which do not take folic acid
supplements. Furthermore, folic acid is better absorbed by the body
than natural folate, almost twice as efficiently.\22\ The U.S. also has
a growing Hispanic population, and adequate consumption of folate-rich
foods is critical for this group since statistically, Hispanic women
are 1.5 to 3 times more likely to have a baby with an NTD.\23\
A Centers for Disease Control and Prevention (CDC) proclamation in
2011 named the fortification of folic acid to enriched grains as one of
the top ten health achievements in the first decade of this
century.\24\ This fortification policy has also almost totally
eradicated folate-deficiency anemia in older adults in the U.S.\25\
3. Reject the DGAC 2015 Recommendation To Limit Added Sugar To No More
Than 10% of Total Calories
The 2015 DGAC recommends limiting added sugars to a maximum of 10%
of total daily caloric intake. This recommendation was based on the
food pattern modeling analysis conducted by the 2015 DGAC and on the
scientific evidence review on added sugars and chronic disease risk
conducted by the Committee. The DGAC rated the evidence as ``strong.''
But the two major meta-analyses that the 2015 DGAC relied heavily upon
reported rather small associations between sugar intake and body
weight.26-27 Moreover, the committee did not include several
published reports that showed no significant relationships between
sugar intake and a number of health outcomes.28-34
The association with obesity, for example, has been shown to be
primarily due to caloric excess rather than sugar
itself.31-32 Furthermore, data on adults from the 1999-2006
National Health and Nutrition Examination Surveys (NHANES) demonstrated
that sugar consumption was not positively associated with body weight
or indicators of the metabolic syndrome.\33\ Similarly, among children
ages 6-18 participating in the 2003-2006 National Health and Nutrition
Examination Survey, intake of added sugars was not associated with body
weight, BMI z-score or any measure of adiposity.\30\ In fact, added
sugar consumption explained less than 0.25% of the variance in BMI z-
scores of the children in this study, indicating that more than 99.75%
of the variation in BMI z-scores of these children was due to factors
other than sugar. It is difficult to justify specific recommendations
for sugar consumption when this macronutrient's contribution to body
weight and blood biomarkers for cardiovascular health is so small.
Sugars have no specific role as a determinant of body weight other than
being one of many sources of energy.\34\
We would also like to point out that the benefits of whole-grain
consumption are independent of sugar consumption, and can be documented
even with relatively high sugar intakes:
In children ages 2-5, 6-12, and 13-18, whole-grain intake
was found to be associated with higher diet quality (assessed
by the Healthy Eating Index that reflects recommendations of
the Dietary Guidelines for Americans), despite the fact that
total sugar intake did not differ across quartiles of whole-
grain intake. Highest diet quality was observed in children
consuming more than three servings of whole grains per day.
Sugar intake in these groups accounted for 19-23% of total
calories.\28\
In adults ages 51 and older participating in the National
Health and Nutrition Examination Survey, 1999-2004, whole-grain
intake was associated with a significantly higher Healthy
Eating Index score, despite no differences in total sugar
intake across quartiles of whole-grain intake.\29\
4. Reject the DGAC 2015 Recommendation To Restrict Dietary Sodium to
Less Than 2,300 mg Per Day
The recommendation of the 2015 DGAC for dietary sodium intake to
below 2,300 mg may not be compatible with minimizing risk for mortality
or cardiovascular disease as stated in the 2013 Institute of Medicine
(IOM) report on ``Sodium Intake in Populations: Assessment of
Evidence'' and in other peer reviewed journals.35-41
Evidence linking sodium intake to mortality outcomes is scant and
inconsistent.36-41 Several publications in 2014 and 2015
have demonstrated an increased mortality risk associated with low
sodium intake.38-41 Because sodium reduction has
physiological effects that may adversely affect health outcome, it is
premature to recommend sodium levels lower than 2300 mg until more
definitive data can justify such broad population-wide advice.
5. Acknowledge the Emerging Evidence of the Beneficial Effects of Whole
Grains on Maintaining a Healthy Microbiome
In recent years there has been heightened interest in the role of
the gastrointestinal system in overall health, but after conducting an
exploratory search the 2015 DGAC concluded that there was insufficient
evidence to address the role of diet in the microbiome.
While we agree that this is an emerging area of study, we would
also like to emphasize that published research indicates that grains,
especially those with high amounts of resistant starches, are important
for maintaining a healthy composition of gut bacteria. Whole grain
cereals, among other plant foods, are associated with the up-regulation
of various bacteria that are beneficial to gut health.\42\ Resistant
starches found in whole grains have a prebiotic action that helps
create a healthy composition of gut bacteria which may reduce risk of
some cancers, inflammatory conditions and cardiovascular
disease.43-50 Despite the relatively small number of
studies, the data that have been published call attention to a very
prominent role for grain-based foods in creating a healthy microbiome.
We think that this should be at least acknowledged in the 2015 Dietary
Guidelines, especially as an area for future study.
6. Note the Negative Health Implications of Fad Diets
Fad diets are temporary interventions that may carry long-term
health consequences for the American public.
Contrary to the nature of fad diets, the Dietary Guidelines for
Americans are focused on setting the stage for a long-term, healthful
eating pattern for all Americans, one that is based on a common sense
approach built on balance, variety and moderation. As a Grain Chain, we
believe that healthy weight maintenance/loss relies on the simple
equation of balancing calories in (consumed) with calories out
(expended), not eliminating specific foods or relying primarily on one
food group.
While there are countless fad diet plans available to the average
American, we would like to briefly address the evidence countering
three plans which often receive attention in the popular press: low-
carbohydrate/Atkins, grain- and wheat-free (such as the plans detailed
in the books Wheat Belly and Grain Brain) and gluten-free.
Low-carbohydrate/Atkins: Two meta-analyses published in 2014 showed
no difference between low-fat and low-carbohydrate diets for weight
loss or cardiovascular risk factors; researchers concluded that weight
loss is determined by calorie deficit regardless of calorie type and
asserted most cardiovascular improvements can be attributed to the
weight loss.51-52 More importantly, in a sample of nearly
44,000 Swedish women followed for an average of 15.7 years, study
organizers found ``low carbohydrate, high-protein diets used on a
regular basis and without consideration of the nature of carbohydrates
or the source of proteins are associated with increased risk of
cardiovascular disease.'' \53\ Carbohydrate consumption is also
associated with better body weights. According to a study published in
the Journal of the Academy of Nutrition and Dietetics, those who
consume a medium-to-high percentage of carbohydrates in their diets
have a reduced risk of obesity. The study also showed that people
following a low-carbohydrate diet actually had a higher risk of being
overweight or obese.\54\
Grain- and wheat-free: Carbohydrates are the preferred fuel source
for the human brain; beyond this necessary role, grain consumption has
been shown to have positive effects on brain function, specifically:
As part of an overall healthful eating pattern, specifically
one that follows the principles of the Mediterranean diet,
consuming whole grain foods has been shown to positively impact
cognitive function.55-60
Consumption of dietary fiber and B vitamins found in grain
foods is associated with better cognitive
health.61-63
Folic acid fortification of enriched grain foods has been
shown to be a cost effective method of improving cognitive
health and brain development in utero.64-68
Gluten-free: Gluten-free dieting has gained popularity in the
general population out of proportion to the prevalence of gluten-
related disorders such celiac disease (CD), non-celiac gluten
sensitivity (NCGS), and wheat allergy; supporting this are findings
from a 2013 survey by Mintel indicating that 65% of American adults say
they eat gluten-free products because they think they are more
healthful, and 27% eat gluten-free products to lose weight.
Despite these claims for gluten-free eating, no published
experimental evidence supports a weight loss claim for a gluten-free
diet or suggests that the general population would be better off by
avoiding gluten.\69\ Furthermore, no published studies have found that
a gluten-free diet produces weight loss in patients without CD or NCGS.
This may be because gluten-free foods are not necessarily low-calorie
and often times contain more calories than their gluten-containing
counterparts. Moreover, a gluten-free diet may also result in lower
intake of whole grains and dietary fiber and some evidence suggests
that following a gluten-free diet reduces concentrations of beneficial
gut bacteria; on the other hand, a gluten-rich diet may boost the
numbers of beneficial gut bacteria.
We appreciate the opportunity to provide comments to the public
hearing record. Should the Committee have questions or seek additional
information, please contact Lee Sanders, American Bakers Association
Senior Vice President for Government Relations and Public Affairs at
[Redacted] or at [Redacted].
Sincerely,
American Bakers Association (ABA);
American Institute of Baking International;
Grain Foods Foundation (GFF);
Independent Bakers Association;
National Association of Wheat Growers (NAWG);
National Pasta Association (NPA);
North American Millers' Association;
Retail Bakers of America;
USA Rice Federation;
Wheat Foods Council (WFC).
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64. Fajardo and Varela-Moreiras, Int. J. Vitam. Nutr. Res., 2012.
Efficacy of Adding Folic Acid to Foods.
65. Bhate, et al., J. Dev. Origins Health Dis., 2012. Vitamin B12
and Folate during Pregnancy and Offspring Motor, Mental and Social
Development at 2 Years of Age.
66. Veena, et al., J. Nutr., 2013. Higher Maternal Plasma Folate but
not Vitamin B-12 Concentrations during Pregnancy Are Associated with
Better Cognitive Function Scores in 9- to 10-Year-Old Children in South
India.
67. Rajasekaran and Kalaivani, J. Food Sci. Technol., 2013. Designer
Foods and Their Benefits: A Review.
68. Ramakrishnan, et al., Pediatric Perinatal Epidemiol., 2012.
Effect of Women's Nutrition before and during Early Pregnancy on
Maternal and Infant Outcomes: A Systematic Review.
69. Gaesser G, Angadi S. Journal of the American Academy of
Physician Assistants, 2015. Navigating the gluten-free boom.
Descriptions of Grain Industry Organizations
American Bakers Association (ABA) is the Washington, D.C.-based
voice of the wholesale baking industry. Since 1897, ABA has represented
the interests of bakers before the U.S. Congress, Federal agencies, and
international regulatory authorities. ABA advocates on behalf of more
than 700 baking facilities and baking company suppliers. ABA members
produce bread, rolls, crackers, bagels, sweet goods, tortillas and many
other wholesome, nutritious baked products for America's families. The
baking industry generates more than $103 billion in economic activity
annually and employs 633,000 highly skilled people. [Redacted]
American Institute of Baking International (AIB) is a corporation
founded by the North American wholesale and retail baking industries in
1919 as a technology transfer center for bakers and food processors.
The original mission of the organization was to ``put science to work
for the baker,'' which is still central to all of the programs,
products, and services provided by AIB to baking and general food
production industries worldwide. [Redacted]
Grain Foods Foundation (GFF), a joint venture of members of the
milling, baking and allied industries formed in 2004, is dedicated to
advancing the public's understanding of the beneficial role grain-based
foods play in the human diet. Directed by a board of trustees, funding
for the Foundation is provided through voluntary donations from private
grain-based food companies and is supplemented by industry
associations. [Redacted]
Independent Bakers Association (IBA) The Independent Bakers
Association is a Washington, D.C. based national trade association of
over 400 mostly family owned wholesale bakeries and allied industry
trades. The Association was founded in 1968 to protect the interests of
independent wholesale bakers. [Redacted]
National Association of Wheat Growers (NAWG) is a federation of 21
state wheat grower associations that works to represent the needs and
interests of wheat producers before Congress and Federal agencies.
Based in Washington, D.C., NAWG is grower-governed and grower-funded,
and works in areas as diverse as Federal farm policy, trade,
environmental regulation, research and climate change. [Redacted]
National Pasta Association (NPA) Founded in 1904, NPA is an
organization of pasta and pasta-related product manufacturers, millers
and suppliers to the U.S. pasta industry serving as a cohesive industry
advocate, a promoter of pasta and a center of knowledge for its
members, the government and the public. [Redacted] and [Redacted]
North American Millers' Association (NAMA) is the trade association
of the wheat, corn, oat, and rye milling industries. Member companies
operate mills in 38 states and Canada, representing more than 90
percent of total industry production capacity. [Redacted]
Retail Bakers of America (RBA) was founded in 1918. Its purpose is
to assist retail bakers in furthering the health of the nation by
making available delicious bakery foods; to foster a better
relationship between the public and the baking industry; to promote and
encourage the production of high quality, wholesome, healthful bakery
foods; and to represent the baking industry, especially its retail
branch, to the government. [Redacted]
USA Rice Federation is the global advocate for all segments of the
U.S. rice industry with a mission to promote and protect the interests
of producers, millers, merchants and allied businesses. Over 20 billion
pounds of long, medium, and short grain, and organic and specialty rice
is grown and harvested each year by farmers in Arkansas, California,
Louisiana, Texas, Mississippi and Missouri. [Redacted]
Wheat Foods Council (WFC) is a nonprofit organization formed in 1972
to help increase public awareness of grains, complex carbohydrates, and
fiber as essential components of a healthful diet. The Council is
supported voluntarily by wheat producers, millers, bakers and related
industries. [Redacted]
______
Submitted Questions
Joint Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department
of Health and Human Services; Hon. Thomas ``Tom'' J. Vilsack,
Secretary, U.S. Department of Agriculture
Question Submitted by Hon. Randy Neugebauer, a Representative in
Congress from Texas
Question. Secretary Burwell, what instructions were given to the
Advisory Committee members regarding the FACA and the Advisory
Committee's disbandment?
Answer. HHS and USDA are strongly committed to an open and
transparent process around their Federal Advisory Committees. The two
Departments conducted an administrative webinar with the 2015 Dietary
Guidelines Advisory Committee (DGAC) in January 2015 a few weeks before
its Advisory Report was submitted to HHS and USDA. At this webinar, the
Committee was reminded that it would formally disband upon submittal of
its Advisory Report to the Secretaries as specified in its charter; the
transition from being a Special Government Employee (SGE) as a Federal
advisory committee member to being a former SGE/member after
disbandment was described. Included in this discussion was a specific
instruction that after disbandment each former member cannot speak on
behalf of the U.S. Government or the DGAC (while in no way limiting
their ability to speak as individual citizens on their own behalf).
This instruction is an important point that each individual should
convey in any situation that he/she chooses to engage in regarding the
Committee's works, such as media interviews or professional
presentations. After disbandment, each former DGAC member only
represents themselves. When former Committee members held a public
event regarding the Advisory Report, they were no longer SGEs and were
not speaking on behalf of the Committee or the Federal government. They
were private citizens voicing their opinions. As such, the Federal
government has not assisted or provided support for former members for
public speaking events.
Questions Submitted by Hon. Eric A. ``Rick'' Crawford, a Representative
in Congress from Arkansas
Question 1. In light of the controversial nature of many of the
comments and recommendations of the 2015 Dietary Guidelines Advisory
Committee (DGAC), and in light of the fact that the final Guidelines
are prepared with very limited transparency, will the Departments of
Health and Human Services, and Agriculture consider publishing the
draft Guidelines in the Federal Register, and allowing for a 60-90 day
public comment period before producing your final Guidelines?
Answer. We understand that an open and transparent Dietary
Guidelines process is a priority and share your interest. We place a
high value upon public input and have prioritized it throughout the
development of the Dietary Guidelines. The Dietary Guidelines Advisory
Committee (DGAC) deliberated on the scientific evidence through seven
public meetings, spanning June 2013 to December 2014. The public
attended the meetings, provided oral comments during one of the
meetings, and was invited to submit written comments to the DGAC
throughout the 19 months of its deliberations. All of the scientific
studies they reviewed were posted on DietaryGuidelines.gov after each
public meeting, during which the studies' topics were discussed and
deliberated, providing transparency of the evidence being examined and
allowing the public to provide sufficient comment on that and anything
else the DGAC covered. A new public comment period opened when the 2015
Advisory Report was published in February 2015. During this period, HHS
and USDA also held a public meeting for oral testimony from the public.
The public comment period also was extended from the scheduled 45 days
to 75 days. For context, the public comment period for the 2010
Advisory Report was 30 days. In addition, HHS and USDA provided several
briefings on the Dietary Guidelines to House Agriculture Committee and
Appropriations Subcommittee staff in 2015. We have and will continue to
conduct our business with the utmost integrity and transparency, in
accordance with all legal requirements.
Question 2. I recognize this would be a slightly extraordinary step
in the process, but don't you agree that the American public's
acceptance of the scientific validity of the data supporting the final
Guidelines outweighs an arbitrary deadline for their publication?
Answer. The National Nutrition Monitoring and Related Research Act
of 1990 (NNMRRA) requires HHS and USDA to publish the Dietary
Guidelines for Americans at least every 5 years. The public was invited
to participate in the process through meeting participation and public
comment throughout the 19 months of the DGAC's scientific review, and
during the 75 day period for public comment on the published Advisory
Report. Throughout this time and up to the present, all science
informing the Advisory Report has been listed for the public on
DietaryGuidelines.gov. Every comment received from Federal agencies and
the public is reviewed by HHS and USDA. Although all public comments
are valued, to ensure the scientific foundation of the 2015 Dietary
Guidelines for Americans, emphasis is placed on those comments with
scientific justification. As required by the NNMRRA, the 2015 Dietary
Guidelines will be based on the preponderance of the scientific and
medical knowledge which is current at the time the report is prepared.
Question 3. On several occasions during the House Agriculture
Committee hearing you noted that the final Dietary Guidelines will be
based on `the preponderance of scientific evidence'. In light of the
fact that the Dietary Guidelines Advisory Committee acknowledged it
employed the USDA's Nutrition Evidence Library (NEL) for less than 25%
of its final recommendations--and based many of its findings on
limited-grade evidence (nearly the lowest of the NEL's grading scale)--
how are the Agencies interpreting the term ``preponderance''?
Answer. The 2010 and 2015 Dietary Guidelines Advisory Committees
(DGAC) both utilized four science-based sources of evidence to answer
their research questions: (1) Original systematic reviews conducted by
USDA's Nutrition Evidence Library (NEL); (2) High-quality existing
reports, comprised primarily of systematic reviews; (3) Data analyses
of the typical American diet; and (4) Food pattern modeling to ensure
Americans meet their food and nutrient needs. For each research
question, the DGAC determined which method was appropriate, given the
nature of the question. For example, questions regarding current
intakes of different foods and nutrients in the United States were
answered using data analyses, as this information is not available
through a systematic review of scientific studies. Food pattern
modeling was used to answer questions about how Americans can meet the
Daily Reference Intakes (DRIs).
The NEL is a systematic review methodology designed specifically to
analyze food, nutrition and public health science. For context, the
medical field has used systematic reviews as the gold standard and
standard practice for more than 25 years to inform the development of
national guidelines for health professionals. Use of systematic reviews
in nutrition, became common practice more recently. At the time that
the NEL was created by USDA for use in informing the 2010 Dietary
Guidelines for Americans, it was among the first to apply the
systematic review methodology in the field of nutrition--thus, there
were very few existing nutrition-focused systematic reviews that the
2010 DGAC could draw from. Since that time, systematic reviews in the
nutrition field have become common practice. Therefore, as stated in
their Advisory Report on DietaryGuidelines.gov, ``unlike the 2010 DGAC,
the 2015 Committee was able to use existing sources of evidence to
answer an additional 45 percent of the questions . . .'' and that
``[t]his was done to prevent duplication of effort and promote time and
resource management.'' The 2015 DGAC answered 70 percent of its
research questions using NEL systematic reviews or existing reviews and
reports. The Committee used existing systematic reviews when available
and complemented them with original reviews of evidence newly published
since the existing review was conducted. Existing systematic reviews
underwent quality assessment to ensure they were just as rigorous and
were held to the same high standards as the NEL systematic reviews. The
remaining questions were answered using data analyses and food pattern
modeling, consistent with the 2010 DGAC's scientific review.
The Committee considers all evidence at the time of the systematic
review that (1) addresses the question they seek to answer and (2)
meets the pre-determined inclusion criteria. The quality of each
included study is evaluated using the NEL Bias Assessment Tool. The
DGAC then looks at the entire body of evidence as a whole to draw a
conclusion statement and uses predefined criteria to evaluate and grade
the strength of the evidence. The grade communicates to decision makers
and stakeholders the strength of the evidence supporting a specific
conclusion statement. The grade for the body of evidence and conclusion
statement is based on five elements outlined in the NEL grading rubric:
quality, quantity, consistency, impact and generalizability.
Questions Submitted by Hon. Jackie Walorski, a Representative in
Congress from Indiana
Question 1. In testimony before the House Agriculture
Appropriations Subcommittee last month, Angie Tagtow of USDA's Center
for Nutrition Policy and Promotion described the Nutrition Evidence
Library as ``the gold standard for informing recommendations'' and
stated in her written testimony:
The NEL provides a rigorous and transparent system to review
the scientific literature and uses the preponderance of science
to inform nutrition policy and programs. The NEL also ensures
compliance with the Consolidated Appropriations Act of 2001, or
Data Quality Act, which mandates that Federal agencies ensure
the quality, objectivity, utility, and integrity of the
information used to form Federal guidance.
I applaud the NEL's development, which was first developed by 2005
Advisory Committee out of need to ensure a transparent process for
reviewing and ranking the overwhelming amount of science that needs to
be considered. Then the 2010 Advisory Committee was able to use it and
relied heavily on it for the majority of their recommendations.
Now the 2015 Dietary Guidelines Advisory Committee's report states
that it did not use the Nutrition Evidence Library for more than 70
percent of its analyses. Instead, the report states that it used the
following approaches:
Outside systematic reviews used for 45 percent of research
questions; and
Original data analyses and food pattern modeling analyses
used for 30 percent of research questions.
One example of the concern with systemic reviews is caffeine.
Secretary Vilsack, you mentioned in your written testimony the
``Cochrane Collaboration'' approach as being a well-respected and it
is. But in the example of caffeine, as stated on page 381 of the
report, it was a ``modification'' of that method that was used. So
while DGAC correctly acknowledge that new scientific evidence existed
since the last report, making it the first Advisory Committee on
caffeine's positive health benefits, it did not use the gold-standard
NEL. Instead they used a systematic review of the data that allowed
them to make claims that straight black coffee was the only acceptable
approach to consuming caffeine, as opposed to energy drinks or other
alternatives.
For comparison, the 2010 Advisory Committee used the NEL for nearly
three out of every four of their recommendations. Why did the 2015 DGAC
circumvent the NEL process for more than 70% of their recommendations?
Do the existing reports that were used follow the same scientific rigor
and approach as the NEL?
Under FACA, this is your Advisory Committee so I ask, how was the
decision made that the NEL should not be used for a particular research
question? Was it ad hoc, or were there established criteria?
Answer. Thank you for raising this issue. The 2010 and 2015 Dietary
Guidelines Advisory Committees (DGAC) both utilized four science-based
sources of evidence to answer their research questions: (1) Original
systematic reviews conducted by USDA's Nutrition Evidence Library
(NEL); (2) High-quality existing reports, comprised primarily of
systematic reviews; (3) Data analyses of the typical American diet; and
(4) Food pattern modeling to ensure Americans meet their food and
nutrient needs. For each research question, the DGAC determined which
method was appropriate, given the nature of the question. For example,
questions regarding current intakes of different foods and nutrients in
the United States were answered using data analyses, as this
information is not available through a systematic review of scientific
studies. Food pattern modeling was used to answer questions about how
Americans can meet the Dietary Reference Intakes (DRIs).
The NEL is a systematic review methodology designed specifically to
analyze food, nutrition and public health science. For context, the
medical field has used systematic reviews as the gold standard and
standard practice for more than 25 years to inform the development of
national guidelines for health professionals. Use of systematic reviews
in nutrition became common practice more recently. At the time that the
NEL was created by USDA for use in informing the 2010 Dietary
Guidelines for Americans, it was among the first to apply the
systematic review methodology in the field of nutrition--thus, there
were very few existing nutrition-focused systematic reviews that the
2010 DGAC could draw from. Since that time, systematic reviews in the
nutrition field have become common practice. Therefore, as stated in
the Scientific Report of the 2015 Dietary Guidelines Advisory Committee
(Advisory Report) on DietaryGuidelines.gov, ``unlike the 2010 DGAC, the
2015 Committee was able to use existing sources of evidence to answer
an additional 45 percent of the questions . . .'' and that ``[t]his was
done to prevent duplication of effort and promote time and resource
management.'' The 2015 DGAC answered 70 percent of its research
questions using NEL systematic reviews or existing reviews and reports.
The Committee used existing systematic reviews when available and
complemented them with original reviews of evidence newly published
since the existing review was conducted. Existing systematic reviews
underwent quality assessment to ensure they were just as rigorous and
were held to the same high standards as the NEL systematic reviews. The
remaining 30 percent of the questions that could not be answered using
the systematic review methodology were answered using data analyses and
food pattern modeling, consistent with the 2010 Advisory Committee's
scientific review.
Question 2. In a letter dated October 2, 2015 from Secretaries
Vilsack and Burwell to U.S. Senator Johnny Isakson you stated that ``in
regard to caffeine and energy drinks, the (Advisory) Committee noted
that these drinks are highly variable in caffeine content'' and that
``until safety has been demonstrated, limited or no consumption of
high-caffeine drinks or other caffeine-containing products is advised
for children and adolescents.'' This statement also holds true for
coffee (i.e., home brewed vs. coffee house, where the range could be
50-400mg of caffeine).
According to the American Beverage Association, mainstream energy
drinks--which represent more than 95% of the entire American energy
drink market--contain the same, or less, caffeine than coffee. Further,
there is no chemical difference between the caffeine in coffee and the
caffeine in energy drinks, tea, or soda and all leading and credible
health authorities from around the world have acknowledged that
caffeine metabolism is a function of body weight and composition (body
fat, etc.) rather than age.
Last, it is worth noting the conclusion reached by the European
Food Safety Authority, which was published in its extensive report,
Scientific Opinion on the Safety of Caffeine: ``The single doses of
caffeine considered to be of no concern for adults (3mg/kg bw per day)
may also be applied to children, because the rate at which children and
adolescents process caffeine is at least that of adults, and the
studies available on the acute effects of caffeine on anxiety and
behavior in children and adolescents support this level.''
Given this body of evidence, how do you rationalize the
recommendations made by the Advisory Committee to focus on only one
class of products when it comes to limiting caffeine intake? If there
is to be any recommendations consistent with the evidence, shouldn't it
be about caffeine intake generally, regardless of the class of
products?
Answer. The 2015 Dietary Guidelines Advisory Committee (DGAC)
developed its report to provide advice and recommendations to the
government on the current state of scientific evidence on nutrition and
health for the general public. The DGAC identified the area of caffeine
consumption as a public health concern. It included the safety of
caffeinated drinks for children and adolescents in its review of the
evidence because of case reports of adverse events associated with
consumption of high-caffeine drinks and in light of recommendations of
caution from the American Academy of Pediatrics and the American
Medical Association. The Committee also noted that the limited evidence
in regard to high-caffeine energy drinks and health outcomes shows
mixed results. Much of the available evidence on caffeine focuses on
coffee intake. The Committee stated that moderate coffee consumption
(three to five 8 oz. cups/day, or providing up to 400 mg/day of
caffeine) can be incorporated into healthy eating patterns.
HHS and USDA are considering the information in the Committee's
report as well as public and Federal agency comments in the development
of the 2015 Dietary Guidelines for Americans. We look forward to
working on this issue with you moving forward.
Question Submitted by Hon. David Rouzer, a Representative in Congress
from North Carolina
Question. Can the House Committee on Agriculture be assured that
you will both work to ensure that the final Dietary Guidelines state
that protein is critical to a balanced diet and that the inclusion of
lean meats are essential to a ``balanced diet?''
Answer. We understand this is a priority for you and share your
interest. The Scientific Report of the 2015 Dietary Guidelines Advisory
Committee (Advisory Report) states that ``lean meats can be a part of a
healthy dietary pattern.'' While we cannot comment on the content of
the 2015 Dietary Guidelines for Americans, which is still under
development, we can highlight that the amount of ``meat, poultry, and
eggs'' recommended in the Advisory Report is the same as the amount
recommended in the 2010 Dietary Guidelines for Americans--26 oz. per
week for a 2,000 calorie diet. The Advisory Report recommends reducing
the amount of red and processed meat consumed compared to current
consumption, not compared to the 2010 Guidelines.
Questions Submitted by Hon. John R. Moolenaar, a Representative in
Congress from Michigan
Question 1. I have personally met with a wide variety of
constituents on the topic of school nutrition in my District in
Michigan, including a local school food service director. On multiple
occasions, my constituents expressed concerns regarding sodium limits
in the National School Lunch and School Breakfast Programs, and the
dramatic effect the implementation of the target levels has had on
consumption and food waste.
As you are aware, the sodium limits were placed on a time line,
with key targets to reach by designated years. A primary concern I have
is the implementation of any further reductions to sodium to reach the
target two and final target levels. In your findings, is there sound
scientific evidence that the target two levels of sodium limits were
necessary?
If target two levels are implemented, what effect do you believe
this will have on other foods, such as cheeses and others that are
served in school meal programs?
Answer. USDA remains committed to applying the most up-to-date,
evidence-based guidelines to all nutritional parameters set forth in
Child Nutrition Programs regulations. As required by both the FY 2012
Agriculture Appropriations Act and the Consolidated and Further
Continuing Appropriations Act, 2015, USDA continues to evaluate the
science as it relates to sodium intake and human health. The 2015
Dietary Guidelines Advisory Committee (DGAC) reviewed and analyzed the
most recent scientific literature evaluating the relationship between
sodium intake and blood pressure among children and their findings can
be found in their Advisory Report, which was submitted to HHS and USDA
in February 2015. The DGAC used an extensive systematic review process
to critique relevant literature on this topic, and the Advisory Report
affirmed that sodium reduction to the levels reflected in the targets
is beneficial to children.
USDA is providing significant technical assistance to help school
food operators lower the sodium content of school meals. Consistent
with the Congressional directive, prior to requiring school compliance
with the second (school year 2017-18) and final (school year 2022-23)
sodium targets, USDA's Food and Nutrition Service (FNS) will review the
2015 Dietary Guidelines for Americans, once released. Because the
sodium goals apply to the average meal offered over the course of the
school week, menu planners have and will retain under target 2 the
flexibility to incorporate some higher sodium items, such as cheese,
into some of the meals. To help menu planners offer a variety of
nutritious and flavorful foods, while lowering the sodium content of
meals, USDA recently unveiled What's Shaking? Creative Ways to Boost
Flavor with Less Sodium. This is a national collaborative sodium
reduction initiative to foster creative ways to boost flavor and
maximize taste in an effort to lower the sodium content of school
meals. The website, http://healthymeals.nal.usda.gov/menu-planning/
sodium-reduction is dedicated to helping schools find the resources
they need to increase awareness of the need for dietary sodium
reduction, and move in the right direction.
Question 2. I am concerned about the selective nature taken by the
Dietary Guidelines Advisory Committee (DGAC) with respect to existing
data. For example, when it comes to energy drinks, the Committee noted
that the evidence was of a limited grade. At the same time, the DGAC
chose to completely disregard an extensive and authoritative body of
evidence developed by the European Food Safety Authority (EFSA), and in
particular its most recent Scientific Opinion on the Safety of
Caffeine. Is there any reason why the DGAC appeared to disregard the
EFSA's work? What are your thoughts on the information from EFSA that
was disregarded by the DGAC?
Also, as you develop the final guidelines, what threshold of
evidence will be used to determine whether to issue a recommendation,
and will limited grade evidence be permitted in the classification of
preponderance of scientific evidence`?
Answer. The European Food Safety Authority (EFSA) published its
Scientific Opinion on the Safety of Caffeine in May of 2015. The 2015
Dietary Guidelines Advisory Committee (DGAC) released its Scientific
Report in February of 2015. As such, the DGAC had disbanded prior to
the release of the EFSA report. It should be noted that the 2015 DGAC
did use the EFSA Scientific Opinion on the Re-evaluation of Aspartame
as a Food Additive for their question on aspartame and health. This
report was published within the timeframe of the DGAC's work. As
mandated in the National Nutrition Monitoring and Related Research Act
of 1990, the 2015 Dietary Guidelines for Americans will be based on the
preponderance of the scientific and medical knowledge which is current
at the time it is prepared. While we cannot comment on the content of
the 2015 Dietary Guidelines for Americans, which are still under
development, the recommendations will be made based on the strongest
available evidence. The 2010 Dietary Guidelines included statements
supported by different grades of evidence. As described in the 2010
Dietary Guidelines, ``[w]hen appropriate, specific statements in
Dietary Guidelines for Americans, 2010 indicate the strength of the
evidence (e.g., strong, moderate, or limited) related to the topic as
summarized by the 2010 DGAC. The strength of evidence is provided so
that users are informed about how much evidence is available and how
consistent the evidence is for a particular statement or
recommendation. This information is useful for educators when
developing programs and tools. Statements supported by strong or
moderate evidence can and should be emphasized in educational materials
over those with limited evidence.'' When only limited evidence is
available on a topic, it may still be appropriate for discussion in the
Dietary Guidelines, such as when the evidence for that topic reinforces
recommendations on related topics that have a stronger evidence base,
to clarify that it is not possible to make a recommendation, or to
identify an area of emerging research.
Question 3. According to the Charter for the 2015 Dietary
Guidelines Advisory Committee (DGAC), Committee members were selected
based upon their knowledge in the fields of human nutrition and chronic
disease. However, it appears the DGAC made many recommendations far
outside of the scope of its Charter and far beyond issues of human
nutrition and chronic disease.
For example, matters involving ingredient safety (i.e., caffeine
and aspartame) and risk assessment rest squarely within the scope of
the Food and Drug Administration (FDA), not the Dietary Guidelines.
Despite this, the DGAC chose to offer recommendations on what is and is
not safe.
During your testimony you noted that the FDA, along with the
National Institutes of Health and the Centers for Disease Control and
Prevention, are providing technical expertise as you finalize the
Guidelines.
Is it the intention of both Departments to make new assertions
about ingredient safety in the Dietary Guidelines that have not been
previously made by the FDA? If yes, will matters of such importance be
subject to the appropriate rulemaking by the relevant agency in charge?
Answer. No, the Departments will not make new assertions about
ingredient safety in the Dietary Guidelines. The purpose of the Dietary
Guidelines does not include rulemaking. The charge of the 2015 DGAC
included identifying areas it felt were of public health concern. The
DGAC chose to address the relationship of caffeine consumption and of
aspartame consumption to health because they are of high public health
concern, are commonly consumed in food and beverages, and evidence had
been recently updated in the scientific literature. Dealing with these
issues was within the scope of the DGAC's charge to provide the
Government with advice and recommendations on the current state of
scientific evidence on nutrition and health. We appreciate your
feedback on this topic.
Questions Submitted by Hon. Dan Newhouse, a Representative in Congress
from Washington
Question 1. I understand the HHS and USDA are planning to note that
moderate alcohol consumption is an important part in a healthy diet
pattern, which I appreciate. What are your Departments doing to provide
recommendations on how best to inform consumers about what that looks
like?
Answer. Thank you for raising this important issue. HHS and USDA
are working together to finalize the 2015 Dietary Guidelines, which are
expected to be completed in December of this year. We are unable to
comment on the final content of the forthcoming edition of the Dietary
Guidelines at this time, as they are still under development. However,
to clarify, the Dietary Guidelines Advisory Committee (DGAC) found that
moderate alcohol consumption can be a component of a healthy eating
pattern but did not include alcohol in its three examples of healthy,
nutrient dense food patterns (Healthy U.S.-style, Healthy Vegetarian,
and Healthy Mediterranean-style). The DGAC stated, ``it is not
recommended that anyone begin drinking or drink more frequently on the
basis of potential health benefits.''
Question 2. The 2010 Dietary Guideline's section on sodium seems to
suggest that all alcoholic beverages are the same, and there is such a
thing as a standard drink. It does nothing to differentiate different
benefits or risks derived from wine, beer, distilled spirits, hard
ciders, and so on, or that alcohol levels can vary significantly even
internally in each of these categories. Many scientific studies claim
different health effects depending on the type of alcohol consumed, and
the Tax and Trade Bureau guidance from May 2013 refutes the idea of a
``standard drink'' as a tool to inform consumers. Can you tell me if
there are any plans in the 2015 Dietary Guidelines to clarify or
establish different nutritional benefits or drawbacks related to
different alcohol types?
Answer. As noted above, HHS and USDA are working together to
finalize the 2015 Dietary Guidelines for Americans, which is expected
to be completed in December of this year. We are unable to comment on
the final content of the forthcoming edition of the Dietary Guidelines
at this time, as they are still under development. HHS and USDA are
cognizant of the variability of alcohol content in different alcoholic
beverages and the value in better articulating this variability in
dietary guidance. Several industry associations and individuals have
provided both oral and written comments on this issue, which we will
take into consideration as we develop the Dietary Guidelines.
Question 3. The Dietary Guidelines Advisory Committee claimed that
Americans are eating more meat than recommended; however, the DGAC also
holds up the so-called Mediterranean Diet as a healthy dietary pattern.
When compared to the Mediterranean Diet, Americans are consuming less
than recommended. How do you account for this discrepancy?
Answer. There are numerous studies based on different variations of
a Mediterranean Diet, and, as such, there is not ``one'' Mediterranean
Diet. Therefore, there is not a single, consistent recommendation on
meat for comparison. The DGAC used current research to inform the
development of its Healthy Mediterranean-Style Eating Pattern. As shown
in the Advisory Report, the quantitative amount of meat, poultry, and
eggs the DGAC recommended in the Healthy U.S.-Style Eating Pattern and
the Healthy Mediterranean-Style Eating Pattern are identical--26 oz.
per week for a 2,000 calorie diet.
Question 4. The Dietary Guidelines Advisory Committee recommends
that Americans continue to eat the same quantity of lean meat as the
2010 Dietary Guidelines recommend, but the current DGAC report also
recommends that Americans consume less processed meat. What is the
recommendation for lean, processed meat?
Answer. The Scientific Report of the 2015 Dietary Guidelines
Advisory Committee (Advisory Report) states that ``lean meats can be a
part of a healthy dietary pattern.'' While we cannot comment on the
content of the 2015 Dietary Guidelines for Americans, which are still
under development, we can highlight that the amount of ``meat, poultry,
and eggs'' recommended in the Advisory Report is the same as the amount
recommended in the 2010 Dietary Guidelines--26 oz. per week for a 2,000
calorie diet. The 2010 Dietary Guidelines for Americans and the 2015
Advisory Report do not make a quantitative recommendation specifically
for lean processed meat.
Question 5. In testimony before the House Appropriations
Agriculture Subcommittee, Angie Tagtow of USDA's Center for Nutrition
Policy and Promotion stated, ``the Nutrition Evidence Library (NEL)
provides a rigorous and transparent system to review the scientific
literature and uses the preponderance of science to inform nutrition
policy and programs.'' That being said, the 2015 Dietary Guidelines
Advisory Committee only used the NEL in 27 percent of their nutritional
recommendations, while the 2010 one used NEL for more than 70 percent.
What justification can you provide for the departure from such an
important resource? Did USDA or HHS provide any guidance to the Dietary
Guidelines Advisory Committee on what resources were available or which
should be used?
Answer. The 2010 and 2015 DGACs both utilized four science-based
sources of evidence to answer their research questions: (1) Original
systematic reviews conducted by USDA's Nutrition Evidence Library
(NEL); (2) High-quality existing reports, comprised primarily of
systematic reviews; (3) Data analyses of the typical American diet; and
(4) Food pattern modeling to ensure Americans meet their food and
nutrient needs. For each research question, the DGAC determined which
method was appropriate, given the nature of the question. For example,
questions regarding current intakes of different foods and nutrients in
the United States were answered using data analyses, as this
information is not available through a systematic review of scientific
studies. Food pattern modeling was used to answer questions about how
Americans can meet the Dietary Reference Intakes (DRIs).
The NEL is a systematic review methodology designed specifically to
analyze food, nutrition and public health science. For context, the
medical field has used systematic reviews as the gold standard and
standard practice for more than 25 years to inform the development of
national guidelines for health professionals. Use of systematic reviews
in nutrition became common practice more recently. At the time that the
NEL was created by USDA for use in informing the 2010 Dietary
Guidelines for Americans, it was among the first to apply the
systematic review methodology in the field of nutrition--thus, there
were very few existing nutrition-focused systematic reviews that the
2010 DGAC could draw from. Since that time, systematic reviews in the
nutrition field have become common practice. Therefore, as stated in
their Advisory Report on DietaryGuidelines.gov, ``unlike the 2010 DGAC,
the 2015 Committee was able to use existing sources of evidence to
answer an additional 45 percent of the questions . . .'' and that
``[t]his was done to prevent duplication of effort and promote time and
resource management.'' The 2015 DGAC answered 70 percent of its
research questions using NEL systematic reviews or existing reviews and
reports. The Committee used existing systematic reviews when available
and complemented them with original reviews of evidence newly published
since the existing review was conducted. Existing systematic reviews
underwent quality assessment to ensure they were just as rigorous and
were held to the same high standards as the NEL systematic reviews. The
remaining 30 percent of the questions that could not be answered using
the systematic review methodology were answered using data analyses and
food pattern modeling, consistent with the 2010 DGAC's scientific
review.
Question 6. FDA recently announced that it is proposing additional
revisions to the Nutrition Facts Panel. The supplemental proposal would
require the declaration of daily reference value and percent daily
value for added sugars. The additional declarations for added sugars
are based on new information and findings from the 2015 Dietary
Guidelines Advisory Committee's (DGAC) technical report. This is a
great departure from the past because FDA has a long history of relying
on the Institute of Medicine (IOM) to develop Dietary Reference
Intakes. The 2015 DGAC recommendation of less than 10% of total
calories from added sugar as noted in the supplemental proposal is
based on, ``modeling of dietary patterns, current added sugars
consumption data, and a published meta-analysis on sugars intake and
body weight.'' I am concerned that a balanced, scientifically rigorous
process such as that used by the IOM was not used to develop the
recommendation. Why is FDA applying the DGAC recommendations to develop
nutrition labeling regulations instead of the most recent IOM
recommendations? Do you believe this is appropriate, given your
testimony on the scope and nature of the DGAC recommendations, and how
they differ from the actual guidelines?
Answer. The Food and Drug Administration (FDA or the Agency)
considered the scientific evidence underpinning the recommendations
provided in the 2015 Dietary Guidelines Advisory Committee (DGAC)
technical report in setting a proposed Dietary Reference Value (DRV)
for added sugars. The 2015 DGAC report evaluated more recent scientific
evidence than the evidence that had been evaluated by the Institute of
Medicine (IOM) when it issued its 2002 report. FDA will consider all of
the public comments received by the Agency as it proceeds with this
rulemaking process and will keep your office updated as we progress.
Question 7. I am interested in the recommendations related to
coffee. According to the Dietary Guidelines Advisory Committee, three
to five cups of coffee per day are not associated with long-term health
risks. It was also noted that this amount of coffee correlated with
reduced risk for heart disease and type 2 diabetes. Can you share what
scientific evidence or process the DGAC used to suggest this change?
Answer. The 2015 DGAC examined the relationship between usual
caffeine consumption and health. Specifically, they asked the question,
What is the relationship between usual coffee/caffeine consumption and
health? Furthermore, they examined the relationship between coffee/
caffeine consumption and its impact on total mortality, cardiovascular
disease, type 2 diabetes, cancers, Parkinson's disease, cognitive
function, and pregnancy. Below is the list of scientific evidence
examined by the Advisory Committee to answer the questions related to
coffee/caffeine consumption.
It is important to note that while the DGAC was interested in usual
caffeine intake, most of the available research was conducted with
coffee as the source of caffeine. After reviewing the evidence, the
Committee stated that moderate coffee consumption can be incorporated
into a healthy lifestyle. However, the DGAC noted that caloric
additions from cream, milk, and added sugars should be minimized.
Furthermore, the Advisory Committee stated that individuals who do not
consume caffeinated coffee should not start to consume it for potential
health benefits alone. The Advisory Committee recommendations are not
binding on the Departments, but are intended to inform the Departments'
work.
For additional details on this body of evidence, visit: Appendix E-
2.39a Evidence Portfolio available at http://health.gov/
dietaryguidelines/2015-scientific-report/14-appendix-E2/e2-39a.asp.
(Attachment 1)
Question 8. I think it would be helpful for you to provide the
Committee evidence in writing to confirm that your agencies did, in
fact, make attempts to oversee the Advisory Committee once it became
clear they were delving to areas of public policy. In response I would
like to see evidence that your agencies provided instructions to the
committee during their assembly to ensure they were staying focused on
the right guidance, and not straying into policy matters outside their
scope or mandate. And, likewise, I would like to receive documented
evidence of the instructions agencies provided to the committee on the
public law to help them understand their report must be based on the
preponderance of scientific and medical knowledge that is current at
the time of publication.
Answer. Thank you for raising this issue. Shortly after the 2015
DGAC was appointed by the Secretaries of HHS and USDA in May 2013 and
before its first meeting held on June 13-14, 2013, HHS and USDA
conducted two administrative webinars with the Committee members to
provide orientation and training. (Note that meetings of the full
Committee that are solely administrative in nature are not required by
the Federal Advisory Committee Act (FACA) to be open to the public.)
Topics included the charge to the Advisory Committee, the National
Nutrition Monitoring and Related Research Act, the charter and bylaws
of the Advisory Committee, and FACA, which included a presentation by
an HHS attorney in the Office of the General Counsel.
Below are some of the materials you requested.
1. FACA Pamphlet--http://www.gsa.gov/portal/content/101010
(Attachment 2)
2. Ethics Rules for SGEs--https://ethics.od.nih.gov/topics/SGE-
Training-Oct-04.pdf (Attachment 3)
3. Charge--http://health.gov/dietaryguidelines/2015-BINDER/meeting1/
chargeCommittee.aspx (Attachment 4)
4. Charter--http://health.gov/dietaryguidelines/2015/committee-
resources.asp (http://health.gov/dietaryguidelines/
dgac2015-charter-final.pdf) (Attachment 5)
At the first public meeting (June 13-14, 2013), the charge was
reviewed by USDA Under Secretary Concannon and subsequently the
objectives and purpose of the Advisory Committee were presented by the
Designated Federal Officer (DFO). The agenda, meeting summary, and
videocast of this first meeting are available at http://health.gov/
dietaryguidelines/2015-BINDER/meeting1/index.aspx. In addition, at that
public meeting, the DGAC members were divided into three work groups,
which met separately in the afternoon of the first day of this meeting;
at those work group meetings, the first item on the agenda was a
discussion led by federal staff on the charge and guiding principles
for their work.
Throughout the DGAC's work, the DFO or his representative was
present on all work-group/subcommittee calls or meetings, and at all
public Committee meetings to ensure FACA was being followed; this
includes following the charge as approved by the charter. The DGAC's
charge was read at each public Committee meeting and during
Subcommittee meetings.
Question 9. And, finally, I would like to welcome your comments on
any advice you could give future secretaries as to future Advisory
Committees, and how they could stay focused on their charter, and
produce a recommendation that really stays coloring with in the lines.
So I would appreciate a response. Thank you.
Answer. We would advise future secretaries to continue the process
of distinguishing what the Dietary Guidelines for Americans are and
what they are not. There is a misunderstanding that the DGAC's report
is the Dietary Guidelines for Americans or a draft of the Guidelines--
it is not. The Guidelines are recommendations for the general public,
intended to prevent diet-related conditions, not to treat disease.
Diabetes and other chronic, diet-related diseases cost Americans
billions of dollars annually and contribute to rising health care costs
across the health system. However, we know that diet plays a critical
role in disease prevention and in both individual and public health--a
good diet can help prevent diabetes, high blood pressure, and
cardiovascular disease. The Dietary Guidelines are a critical tool to
help Americans make healthy choices in their daily lives to prevent
these diseases and enjoy a healthy diet. They are used to inform the
development of federal food, nutrition, and health policies and
programs.
Questions Submitted by Hon. Suzan K. DelBene, a Representative in
Congress from Washington
Question 1. Ensuring that the Federal Government is providing women
with latest, science-based nutrition advice based on the latest science
to benefit both their body and their children is of utmost importance.
One area where there is substantial confusion today is regarding
seafood consumption during pregnancy. It was encouraging when FDA
issued updated draft seafood advice in June 2014 that attempted to
clarify that confusion. According to the Federal Register notice
(http://www.gpo.gov/fdsys/pkg/FR-2014-06-11/pdf/2014-13584.pdf), this
draft advice was based on data from the Food and Agriculture
Organization of the United Nations (FAO), the World Health Organization
(WHO) and the FDA's net effects report entitled: ``A Quantitative
Assessment of the Net Effects on Fetal Neurodevelopment from Eating
Commercial Fish (As Measured by IQ and also by Early Age Verbal
Development in Children).'' Will FDA be issuing final seafood advice
that follows the draft advice with changes to make it consistent with
the FAO, WHO and FDA's latest science?
Answer. Thank you for raising this issue. The final seafood
consumption advice is undergoing review. In developing it, HHS has
taken and will continue to take steps to ensure that it is reflective
of the latest nutrition science.
By way of background, in June 2014, FDA and the Environmental
Protection Agency (EPA) jointly issued a draft update to the seafood
advice they last issued in 2004. The joint advice in the draft update
is consistent with the current recommendation in the Dietary Guidelines
for Americans 2010, in that it advises pregnant women, women who may
become pregnant, and nursing women to eat at least 8, and up to 12,
ounces per week of a variety of fish lower in mercury in order to
optimize the developmental benefits that fish could provide.
The FDA Risk Communication Advisory Committee held a public meeting
on the advice provided in the draft update in November 2014, and the
comment period for the draft updated advice closed in March 2015.
FDA and EPA have studied the public comments, are making the
appropriate modifications to the advice, and then will publish the
final advice. As with the 2014 draft version of the advice, the purpose
is to provide useful and science-based information to pregnant and
breastfeeding women and to caregivers of young children. We will keep
your office updated as we progress on this issue.
Question 2. I was interested to learn about the information related
to coffee consumption. The report indicated that consumption of coffee
within the moderate range (three to five cups per day) is not
associated with increased long-term health risks and is associated with
reduced risk of type 2 diabetes and cardiovascular disease in adults.
Can you share some of the other diseases prevention or risks also
associated with moderate coffee intake?
Answer. The 2015 Dietary Guidelines Advisory Committtee (DGAC)
addressed this issue in the question, ``What is the relationship
between usual coffee/caffeine consumption and health?'' In reviewing
chronic disease health outcomes, evidence was available primarily on
coffee consumption and total mortality, cardiovascular disease (CVD),
type 2 diabetes, and cancer. The Committee identified research on
coffee consumption and CVD, stroke, heart failure, hypertension, and
several intermediate outcomes including blood pressure, blood lipids,
and blood glucose; the specific findings are detailed in its Advisory
Report. The DGAC examined several types of cancer in regard to coffee
consumption, including lung, liver, breast, prostate, ovarian,
endometrium, bladder, pancreas, upper digestive and respiratory tract,
esophagus, stomach, colon, and rectum. Regular coffee consumption is
associated with reduced risk of cancer of the liver and endometrium.
Questions Submitted by Hon. James P. McGovern, a Representative in
Congress from Massachusetts
Question 1. According to the National Consumers League, a typical
serving of coffee, soda or an energy drink all contain about the same
amount of caffeine. The Dietary Guidelines Advisory Committee report
recommends the establishment of a guideline for caffeine but also
recommends that coffee be classified as a `normal' caffeine drink and
energy drinks as `high' caffeine drinks. If each of these products are
essentially the same, how can you support such a distinction? Can you
elaborate on the scientific rational for this distinction?
Answer. The Dietary Guidelines Advisory Committee (DGAC) did not
recommend that HHS and USDA classify coffee as a ``normal'' caffeine
drink or energy drinks as ``high'' caffeine drinks. Instead, the
references the Committee made to ``coffee'' and ``high-caffeine energy
drinks'' were to the evidence it reviewed related to intake of these
products and health outcomes. For example, the literature that the
Committee reviewed demonstrated the highly variable amount of caffeine
in energy drinks and shots; a table in the article by Reissig, et al.
(reference 122 in Part D, Chapter 5: Food Sustainability and Safety)
shows that many energy drinks are in the same caffeine concentration
range as coffee although many have serving sizes twice that of an 8 oz.
coffee serving. The table also lists ``higher caffeine energy drinks''
as well as ``high concentration energy drinks'' also known as energy
shots. Much of the available evidence on caffeine focuses on coffee
intake. The Committee stated that moderate coffee consumption (three to
five 8 oz. cups/day, or providing up to 400 mg/day of caffeine) can be
incorporated into healthy eating patterns. The Committee also noted
there is not currently enough available evidence to support a
recommendation for the general population regarding energy drinks.
Question 2. As you may know, cranberries are the state fruit of
Massachusetts, one of three fruits native to North America, and a
perennial crop grown commercially in five states. They are power packed
with unique compounds that have documented health benefits, but not
blessed by Mother Nature with natural sweetness like other juices and
dried fruit products.
Cranberry growers are concerned that if required to include a %
Daily Value (%DV) in a modified Nutrition Facts Panel for added sugar
in addition to total sugars as currently proposed, consumers will be
misled to believe that cranberry products, for which sugar is added for
palatability, are less nutritious than other fruit products containing
the same or higher levels of intrinsic or natural sugar. They are also
concerned that these consumers will be misled about how much total
sugar is contained in cranberry products.
While the Dietary Guidelines for Americans are updated every 5
years, modifications to the Nutrition Facts Panel happen less
frequently. Therefore, it is critical that we get the labels right. How
can FDA ensure that consumers will not be misled about the
healthfulness of cranberry products under the proposed FDA Nutrition
Facts Panel labeling regulation? Specifically, has FDA considered how
consumers will react when comparing products with natural sugars that
contain equal or more total sugars and calories than cranberry products
with a declared %DV? If not, is additional information needed?
Answer. FDA is reviewing its own consumer research and other
research that has been submitted to the Agency, along with the science
regarding an added sugars declaration and Percent Daily Value (%DV).
FDA will also consider all of the comments submitted regarding the
healthfulness of foods containing added sugars, including cranberry
products, as it proceeds with this rulemaking process.
Question 2a. Has FDA considered the potential economic impact to
agriculture producers of perennial crops like cranberries in which
producers cannot rotate into other fruit, vegetable or row crops to
offset potential losses and broader agribusinesses? If not, why was
this not considered?
Answer. FDA's estimate of the total cost of the proposed Nutrition
Facts Label and Serving Size rules is an aggregate measure of costs,
and captures relabeling costs associated with adding the added sugars
declaration and percent daily value to the Nutrition Facts Panel, and
reformulation costs associated with product reformulation aimed at
reducing added sugars content in products (e.g., substituting a high-
intensity, low-calorie sweetener for sugar). FDA did not explicitly
consider the potential economic impact to agriculture producers of
perennial crops like cranberries because the industry may reformulate
products to include less added sugars (by using other sweeteners, for
example, or using other juice blends).
Question 2b. It is my understanding that FDA has based the proposed
added sugar labeling requirements on the findings of the 2015 Dietary
Guidelines Committee Report which is currently still under review by
HHS and USDA. Is it correct that the Committee's findings do not agree
with the Institute of Medicine's (IOM) current recommendations for
upper limits on added sugar and that added sugar consumption is
declining to levels nearly 50% below the upper limit as recommend by
the IOM?
Answer. FDA considered the scientific evidence underpinning the
recommendations provided in the 2015 DGAC technical report in setting a
proposed Dietary Reference Value (DRV) for added sugars. The 2015 DGAC
report evaluated more recent scientific evidence than the evidence that
had been evaluated by the Institute of Medicine (IOM) when it issued
its 2002 report. In 2002, the IOM provided a suggested maximum intake
level of 25 percent or less of calories for added sugars based on data
that demonstrated decreased intakes of some micronutrients among
American subpopulations whose intake of added sugars exceeded this
level. This suggested maximum intake level, however, is not considered
an upper level of intake, which are set by the IOM for many other
nutrients. The 2015 DGAC recommended that ten percent or less of
calories should come from added sugars. The current average U.S. intake
of added sugars is approximately 13.4 percent of total calories, with
some subpopulations such as adolescents and young adults consuming
greater amounts. Added sugars intake has decreased for both males and
females across all age groups between 2001-2004 and 2007-2010, but
intakes still exceed the amount that can be consumed while meeting food
group and nutrient needs within the calorie levels. FDA will consider
the scientific evidence and all of the public comments received by the
Agency as it proceeds with this rulemaking process.
Questions Submitted by Hon. Ann Kirkpatrick, a Representative in
Congress from Arizona
Question 1. The Dietary Guidelines are aimed at general populations
based on age and gender. But, obesity on tribal land is especially
severe. How do the Dietary Guidelines help my tribal constituents eat
healthier? And will these guidelines be achievable for people of all
cultures and socioeconomic levels?
Answer. HHS and USDA are working together to finalize the 2015
Dietary Guidelines for Americans, which are expected to be completed in
December of this year. We are unable to comment on the final content of
the forthcoming edition of the Dietary Guidelines at this time, as they
are still under development. However, the review of the evidence
conducted by the Dietary Guidelines Advisory Committee (DGAC) included
obesity as an outcome on several research questions when applicable,
and thus there is evidence on obesity available in the Advisory Report
that the Departments are taking under consideration when updating the
Dietary Guidelines.
HHS and USDA recognize that many factors influence the diet and
physical activity choices individuals make. The United States is a
diverse nation, with people from many backgrounds, cultures, and
traditions with varied personal preferences. In addition, significant
health and food access disparities exist, with many U.S. households
having insufficient resources to acquire adequate food to meet their
needs. All of these factors can have a profound impact on choices. The
Dietary Guidelines are meant to provide a sound, healthy diet for the
general population, including those at increased risk for obesity and
obesity-related chronic diseases. It is not a rigid prescription, but
rather, an adaptable framework in which individuals can meet their
personal, cultural, and traditional food preferences and stay within
their budget, including those within tribes in the State of Washington.
Question 2. A typical serving of coffee, soda or an energy drink
all contain about the same amount of caffeine. The Dietary Guidelines
Advisory Committee recommends that you establish a guideline for
caffeine, for the first time, but then recommends that you classify
coffee as a `normal' caffeine drink and energy drinks--and only energy
drinks--as a `high' caffeine drink. What is the scientific
justification for this distinction?
Answer. The DGAC did not recommend that HHS and USDA classify
coffee as a ``normal'' caffeine drink or energy drinks as ``high''
caffeine drinks. Instead, the references the Committee made to
``coffee'' and ``high-caffeine energy drinks'' were to the evidence it
reviewed related to intake of these products and health outcomes. For
example, the literature that the Committee reviewed demonstrated the
highly variable amount of caffeine in energy drinks and shots; a table
in the article by Reissig, et al. (reference 122 in Part D, Chapter 5:
Food Sustainability and Safety) shows that many energy drinks are in
the same caffeine concentration range as coffee, although many have
serving sizes twice that of an 8 oz. coffee serving. The table also
lists ``higher caffeine energy drinks'' as well as ``high concentration
energy drinks,'' also known as energy shots. Much of the available
evidence on caffeine focuses on coffee intake. The Committee stated
that moderate coffee consumption (three to five 8 oz. cups/day, or
providing up to 400 mg/day of caffeine) can be incorporated into
healthy eating patterns. The Committee also noted that the limited
evidence in regard to high-caffeine energy drinks and health outcomes
shows mixed results.
Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department of
Health and Human Services
Question Submitted by Hon. John R. Moolenaar, a Representative in
Congress from Michigan
Question. In an 18 month process, spanning June 2013-December 2014,
the DGAC waited until September 2014 to form its Added Sugars Working
Group. This gave the Committee a mere 90 days to collect, review,
synthesize and formulate conclusions on the extensive body of
literature on sugars.
Considering the complexity and recent controversy around sugars
intake, why wasn't the review of the scientific evidence on sugars
initiated at the very beginning of the process?
Do you believe 90 days was a sufficient amount of time allocated
for stakeholders to review and provide comment on the scientific
evidence used, and conclusions made, by this DGAC regarding sugars
intake?
Answer. The work of the 2015 Dietary Guidelines Advisory Committee
(DGAC) on the topic of added sugars spanned its entire 19 months of
work, during which time the public was invited to submit comments to
the Advisory Committee. The process chosen by the Advisory Committee to
address the topic was comprehensive and consistent with the methodology
it applied across its Advisory Report. The Committee began its
discussion on added sugars at its first public meeting in June 2013
when it began developing the questions it wanted to examine. The
Science Review Subcommittee, which served as an executive subcommittee
to provide guidance to the full Committee to support its reviews of the
evidence, decided to form the Added Sugars Working Group in June 2014
based on extensive discussion that had already occurred within various
topic-specific subcommittees and at public meetings. These discussions
made it clear that an Added Sugars Working Group would be the most
efficient and consistent way to comprehensively address the topic. The
Added Sugars Working Group had its first meeting on July 16, 2014, not
in September 2014. After the Advisory Report was released in February
2015, a public comment period ending May 8, 2015 provided additional
time for the public to review this issue and submit comments to HHS and
USDA.
Response from Hon. Thomas ``Tom'' J. Vilsack, Secretary, U.S.
Department of Agriculture
Questions Submitted by Hon. Collin C. Peterson, a Representative in
Congress from Minnesota
Question 1. In an 18 month process, spanning June 2013-December
2014, the DGAC waited until September 2014 to form its Added Sugars
Working Group. This gave the Committee a mere 90 days to collect,
review, synthesize and formulate conclusions on the extensive body of
literature on sugars.
Considering all of the complexity and recent controversy around
sugars intake, why wasn't this review of the scientific evidence on
sugars initiated at the very beginning of this process?
Were fewer than 90 days a sufficient amount of time for
stakeholders to review and provide comment on the scientific evidence
used, and conclusions made, by this DGAC regarding sugars intake?
Answer. The work of the 2015 Dietary Guidelines Advisory Committee
(DGAC) on the topic of added sugars spanned its entire 19 months of
work, during which time the public was invited to submit comments to
the Advisory Committee. The process chosen by the Advisory Committee to
address the topic was comprehensive and consistent with the methodology
it applied across its Advisory Report. The Committee began its
discussion on added sugars at its first public meeting in June 2013
when it began developing the questions it wanted to examine. The
Science Review Subcommittee, which served as an executive subcommittee
to provide guidance to the full Committee to support its reviews of the
evidence, decided to form the Added Sugars Working Group in June 2014
based on extensive discussion that had already occurred within various
topic-specific subcommittees and at public meetings. These discussions
made it clear that an Added Sugars Working Group would be the most
efficient and consistent way to comprehensively address the topic. The
Added Sugars Working Group had its first meeting on July 16, 2014 not
in September 2014. After the Advisory Report was released in February
2015, a public comment period ending May 8, 2015 provided additional
time for the public to review this issue and submit comments to HHS and
USDA.
Question 2. The following chart was published on the National
Consumers League website during March 2015, National Nutrition Month,
along with an article entitled ``What's the Buzz on Caffeine?''.
Caffiene Equivalence
70-90 mg of Caffeine
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
http://www.nclnet.org/whats_the_buzz_on_caffeine.
If a typical serving of coffee, soda or an energy drink all contain
about the same amount of caffeine, do you think final dietary guidance
to consumers should be based upon recommendations that classify coffee
as `normal' caffeine, energy drinks--and only energy drinks--as `high'
caffeine and did not take tea or other common caffeine sources into
account whatsoever as far as contribution to daily caffeine intake of
Americans is concerned?
Answer. The DGAC did not recommend that HHS and USDA classify
coffee as a ``normal'' caffeine drink or energy drinks as ``high''
caffeine drinks. Instead, the references the Committee made to
``coffee'' and ``high-caffeine energy drinks'' were to the evidence it
reviewed related to intake of these products and health outcomes. For
example, the literature that the Committee reviewed demonstrated the
highly variable amount of caffeine in energy drinks and shots; a table
in the article by Reissig, et al. (reference 122 in Part D, Chapter 5:
Food Sustainability and Safety) shows that many energy drinks are in
the same caffeine concentration range as coffee although many have
serving sizes twice that of an 8 oz. coffee serving. The table also
lists ``higher caffeine energy drinks'' as well as ``high concentration
energy drinks'' also known as energy shots. Much of the available
evidence on caffeine focuses on coffee intake. The Committee stated
that moderate coffee consumption (three to five 8 oz. cups/day, or
providing up to 400 mg/day of caffeine) can be incorporated into
healthy eating patterns. The Committee also noted that the limited
evidence in regard to high-caffeine energy drinks and health outcomes
shows mixed results.
Question Submitted by Hon. Vicky Hartzler, a Representative in Congress
from Missouri
Question. Has the USDA considered moving the Nutrition Evidence
Library from CNPP to ARS to allow for more open access of the nutrition
science data for all government agencies?
Answer. The Nutrition Evidence Library (NEL) is unique in its
special focus on systematic reviews specifically in nutrition to help
inform Federal nutrition policies and programs--it requires the
expertise of the professionals at CNPP. Since its inception, the NEL
has been fully available and accessible to the public on NEL.gov, and
all government agencies have had access not only to its contents, but
also to its staff at CNPP. For example, USDA's Food and Nutrition
Service (FNS) utilized the NEL for a series of systematic reviews in
order to answer targeted nutrition education-related questions to
inform guidance, policy, and program development related to FNS-
administered nutrition education programs.
attachment 1
Appendix E-2.39a: Evidence Portfolio
Part D. Chapter 5: Food Sustainability and Safety
Usual Caffeine Consumption and Health
-------------------------------------------------------------------------
Systematic Review Question: Total Mortality
What is the relationship between usual caffeine consumption and
total mortality?
Conclusion Statement: Strong and consistent evidence shows that
consumption of coffee within the moderate range (3 to 5 cups/d or up to
400 mg/d caffeine) is not associated with increased risk of major
chronic diseases, such as cardiovascular disease (CVD) and cancer and
premature death in healthy adults.
DGAC Grade: Strong
------------------------------------------------------------------------
Key Findings
Coffee consumption was associated with reduced risk of total
mortality (3-4% lower mortality with 1 cup/day), especially
cardiovascular mortality.
Decaffeinated coffee consumption was associated with a lower
risk of death (5 studies only).
The limited number of studies on decaffeinated coffee
indicates that protective association of coffee consumption may
not be due to caffeine alone.
Description of the Evidence
Two systematic reviews and/or meta-analyses (SR/MAs) of 20 and 23
prospective cohort studies (Je, 2013 and Malerba, 2013, respectively).
Je, et al. examined total mortality and Malerba, et al., examined
total, CVD, and cancer mortality. Evidence suggests a significant
inverse relationship between coffee consumption of 1-4 cups/day with
total mortality, especially cardiovascular disease mortality. This
evidence is based on three meta-analyses of more than 20 prospective
cohort studies (Je, 2013; Malerba, 2013; Crippa, 2014). In general,
results were similar for men and women. The risk reduction associated
with each cup of coffee per day was between 3-4 percent. In addition,
Je (2013) found a significant inverse association between coffee
consumption and cardiovascular disease mortality. This association was
stronger in women (16% lower risk) than in men (8% lower risk).
However, no association was found for cancer mortality. Crippa, et al.,
found that the lowest risk was observed for 4 cups/d for all-cause
mortality (16%, 95% CI = 13-18) and 3 cups/d for CVD mortality (21%,
95% CI = 16-26),
-------------------------------------------------------------------------
Systematic Review Question: Cardiovascular Disease
What is the relationship between usual caffeine consumption and
cardiovascular disease?
Conclusion Statement: Consistent observational evidence indicates
that moderate coffee consumption is associated with reduced risk of
type 2 diabetes and cardiovascular disease in healthy adults. In
addition, consistent observational evidence indicates that regular
consumption of coffee is associated with reduced risk of cancer of the
liver and endometrium, and slightly inverse or null associations are
observed for other cancer sites.
DGAC Grade: Moderate
------------------------------------------------------------------------
Key Findings
CVD
Non-linear association between coffee intake and risk of CVD
Moderate coffee consumption was inversely associated with
CVD risk
Lowest risk at 3-5 cups/d
Heavy consumption was not associated with higher CVD risk
Stroke
Non-linear association between coffee intake and risk of
stroke
Moderate coffee consumption was inversely associated with
stroke
Lowest risk at 3-4 cups/d
Higher intakes were not associated with higher stroke risk
CHD
Moderate coffee consumption was associated with lower CHD
risk
Higher intakes were not associated with higher CHD risk
Heart Failure
Moderate (1-5 cups/d) coffee consumption was inversely
associated with risk of heart failure
The largest inverse association observed for 4 cups/d
Blood Pressure & Hypertension
No effect of coffee on long-term BP or risk of HTN
For habitual coffee consumption, consumption of >3 cups/d
was not associated with increased risk of HTN compared with <1
cup/d
There was a slightly elevated risk of HTN for light to
moderate consumption (1-3 cups/d)
In hypertensive individuals, caffeine intake produces an
acute increase in BP for %3 h, but there is no evidence of an
association between long-term coffee consumption and increased
BP
Regular caffeine intake (median 410 mg/d) increases BP in
short-term RCTs, although when ingested through coffee, BP
effect of caffeine was smaller but significant
Atrial Fibrillation
Caffeine was not associated with increased risk of atrial
fibrillation
Low-dose caffeine exposure (<350 mg) may have a protective
effect
Blood Lipids
Caffeinated, but not decaffeinated coffee, had significant
effect on serum lipids.
The effects were mostly found in unfiltered coffee.
Coffee consumption increased TC, LDL-C, and TG
Positive dose-response relation between coffee intake
and TC, LDL-C, and TG
Description of the Evidence
Twelve SR/MAs examined CVD (Ding, 2014; Caldiera, 2013; Cai, 2013;
Kim, 2012; Mostofsky, 2012; Steffen, 2012; Zhang, 2011; Mesas, 2011;
Larrson, 2011; Wu, 2009; Soffi, 2007; Noordjiz, 2005). Some SR/MAs
covered only RCTs (Cai, 2013). Others included only prospective cohort
studies (Larsson, 2011; Zhang, 2011; Kim, 2012; Mostofsky, 2012; Wu,
2009). Other SR/MAs covered RCTs and cohort studies (Steffen, 2012);
controlled trials (randomized and non-randomized) and cohort studies
(Mesas, 2011); prospective studies and case-control (Soffi, 2007);
prospective cohort studies, case-cohort, and nested case-control
studies (Ding, 2014); and RCT, prospective or retrospective cohorts and
case-control studies (Caldiera, 2013). The number of studies included
in the SR/MAs ranged from 5-36.
A large and current body of evidence directly addressed the
relationship between normal coffee consumption and risk of
cardiovascular disease (CVD). The evidence included 12 systematic
reviews with meta-analyses, all of which had high quality ratings
(AMSTAR scores 8/11-11/11). CVD incidence and mortality, as well as
coronary heart disease (CHD), stroke, heart failure, and hypertension
were assessed by meta-analyses that consisted primarily of prospective
cohort studies; intermediate outcomes such as blood pressure, blood
lipids, and blood glucose were assessed by meta-analyses of randomized
controlled trials.
CVD risk was assessed by a current meta-analysis of 36 prospective
cohort studies on long-term coffee consumption (Ding, 2014). This
analysis showed a non-linear association, such that the lowest risk of
CVD was seen with moderate coffee consumption (3-5 cups/day), but
higher intakes (>5 cups/day) were neither protective nor harmful.
Overall, moderate consumption of caffeinated, but not decaffeinated,
coffee was associated with a 12 percent lower risk of CVD.
Results from the assessment of CHD risk in three meta-analyses
(Ding, 2014; Wu, 2009; Sofi, 2007) were inconsistent. Ding (2014) found
10 percent lower CHD risk with moderate coffee consumption (3-5 cups/
day) in a meta-analysis of 30 prospective cohort studies, whereas Wu
(2009) and Sofi (2007) in meta-analyses of 21 and 10 prospective cohort
studies, respectively, found no association between coffee consumption
and CHD risk. However, in sub-group analysis, Wu (2009) found that
habitual moderate coffee consumption (1-4 cups/day) was associated with
an 18 percent lower risk among women. Overall, the meta-analyses of
Sofi (2007) and Wu (2009) were conducted with smaller bodies of
evidence and Ding (2014) assessed several more recent studies. One
reason for the inconsistent associations may be that coffee brewing
methods have changed over time and the filter method has become more
widely used, replacing unfiltered forms of coffee such as boiled coffee
that were more widely consumed by participants in earlier studies.
Risk of stroke was assessed in two systematic reviews with meta-
analyses of prospective cohort studies (Larsson, 2011; Kim, 2012) with
consistent findings. Kim (2012) found that coffee intake of 4 or more
cups/day had a protective effect on risk of stroke. Larsson (2011)
documented a non-linear association such that coffee consumption
ranging from 1 to 6 cups/day was associated with an 8 percent-13
percent lower risk of stroke, and higher intakes were not associated
with decreased or increased risk. The inverse associations were limited
to ischemic stroke and no association was seen with hemorrhagic stroke.
Regarding blood pressure, three meta-analyses evaluated the effect
of coffee and caffeine on systolic and diastolic blood pressure using
controlled trials (Steffen, 2012; Mesas, 2011; Noordzij, 2005). The
most recent meta-analysis of 10 randomized controlled trials by
Steffen, et al. (2012) showed no effect of coffee on either systolic or
diastolic blood pressure. Similarly, in another meta-analysis of 11
coffee trials and 5 caffeine trials, caffeine doses of <410 mg/day had
no effect on systolic and diastolic blood pressure while doses of 410
or more mg/day resulted in a net increase (Noordzij, 2005). A third
meta-analysis showed that among individuals with hypertension, 200-300
mg of caffeine (equivalent to 2-3 cups filtered coffee) resulted in an
acute increase of systolic and diastolic blood pressure (Mesas, 2011).
Additionally, two meta-analyses quantified the effect of coffee on
incidence of hypertension (Steffen, 2012; Zhang, 2011) and found no
association between habitual coffee consumption and risk of
hypertension. However, Zhang, et al. (2011) documented a slightly
elevated risk for light to moderate consumption (1-3 cups/day) of
coffee compared to less than 1 cup/day. Regarding blood lipids, in a
quantitative analysis of short-term randomized controlled trials, Cai,
et al. (2012) revealed that coffee consumption contributed
significantly to an increase in total cholesterol, LDL-cholesterol, and
triglycerides, and that unfiltered coffee had a greater effect than
filtered coffee. Interestingly, caffeinated, but not decaffeinated
(more likely to be filtered), coffee had this effect on serum lipids.
In a meta-analysis of observational study data, including
prospective, retrospective, and case-control studies, higher amounts of
coffee or caffeine had no association with risk of atrial fibrillation,
but low doses of caffeine (<350 mg/day) appeared to have a protective
effect (Caldeira, 2013). In contrast, coffee consumption of 1-5 cups/
day was found to be inversely associated with risk of heart failure in
a meta-analysis of 5 prospective studies (Mostofsky, 2012). A non-
linear association was documented and the lowest risk was observed for
4 cups/day (Mostofsky, 2012).
-------------------------------------------------------------------------
Systematic Review Question: Type 2 Diabetes
What is the relationship between usual caffeine consumption and
type 2 diabetes?
Conclusion Statement: Consistent observational evidence indicates
that moderate coffee consumption is associated with reduced risk of
type 2 diabetes and cardiovascular disease in healthy adults. In
addition, consistent observational evidence indicates that regular
consumption of coffee is associated with reduced risk of cancer of the
liver and endometrium, and slightly inverse or null associations are
observed for other cancer sites.
DGAC Grade: Moderate
------------------------------------------------------------------------
Key Findings
Coffee consumption was inversely associated with T2D risk in
a dose-response manner.
Both caffeinated and decaffeinated coffee were associated
with lower T2D risk.
Increased coffee consumption by 1 cup/d was associated with
7% lower T2D risk.
Similar associations were seen in men and women.
A smaller number of studies on decaffeinated coffee indicate
that protective association of coffee consumption is unlikely
to be due to caffeine alone.
In T2D individuals, ingestion of caffeine ( 200-500 mg)
significantly increased blood glucose, serum insulin, and
lowered insulin sensitivity in those with T2D in short-term
RCTs.
Description of the Evidence
Five SR/MAs examined T2D (Ding, 2014; Jiang, 2014; Whitehead, 2013;
Huxley, 2009; van Dam, 2005). One SR/MA covered controlled trials
(Whitehead, 2013) and two others covered only prospective cohort
studies (Jiang, 2014; Huxley, 2009). Other SR/MAs covered both
prospective cohort and nested case-control studies (Ding, 2014) or
prospective cohort and cross-sectional studies (van Dam, 2005). The
number of studies included in the SR/MAs ranged from 9-31.
Coffee consumption has consistently been associated with a reduced
risk of type 2 diabetes. In four meta-analyses of prospective cohort
studies (Ding, 2014; Jiang, 2014; Huxley, 2009; van Dam, 2005) and
cross-sectional studies (van Dam, 2005), coffee consumption was
inversely associated with risk of type 2 diabetes in a dose-response
manner. Risk for type 2 diabetes was 33 percent lower for those
consuming 6 cups/day in the analysis by Ding, et al. (2014) while the
risk was 37 percent lower for those consuming 10 cups/day in the
analysis by Jiang, et al. (2014). Using a sub-set of the prospective
cohorts in the Ding, et al. (2014) and Jiang, et al. (2014) meta-
analyses, Huxley (2009) documented that each cup of coffee was
associated with a 7 percent lower risk of type 2 diabetes. Similarly,
van Dam (2005) noted that consumption of %6 or %7 cups/day was
associated with a 35 percent lower risk of type 2 diabetes. Three meta-
analyses (Ding, 2014; Jiang, 2014; Huxley, 2009) found protective
associations for decaffeinated coffee. Moderate decaffeinated coffee
consumption (3-4 cups/day) was associated with a 36 percent lower risk
of type 2 diabetes (Huxley, 2009). Each cup of decaffeinated coffee was
associated with a 6 percent lower risk (Ding, 2014) while every 2 cups
were associated with a 11 percent lower risk (Jiang, 2014). Both
reports also documented a dose-response association between caffeine
and type 2 diabetes risk such that every 140 mg/day was associated with
an 8 percent lower risk in the Ding, et al. (2014) meta-analysis while
every 200 mg/day was associated with a 14 percent lower risk in the
analysis by Jiang, et al. (2014). However, it remains unclear if this
inverse association is independent of coffee consumption as Ding et al
(2014) indicated that none of the studies included in the caffeine
dose-response analysis adjusted for total coffee.
Only one systematic review of 9 randomized controlled trials
examined the effects of caffeine on blood glucose and insulin
concentrations among those with type 2 diabetes (Whitehead & White
2013). Ingestion of 200-500 mg of caffeine acutely increased blood
glucose concentrations by 16-28 percent of the area under the curve and
insulin secretions by 19-48 percent of the area under the curve when
taken prior to a glucose load. At the same time, these trials also
noted a decrease in insulin sensitivity by 14-37 percent. Although it
is not clear if the acute effects of caffeine on blood glucose and
insulin persist in the long term, evidence from prospective cohorts
indicate that caffeine may have no adverse effect on the risk of type 2
diabetes.
-------------------------------------------------------------------------
Systematic Review Question: Cancer
What is the relationship between usual caffeine consumption and
cancer?
Conclusion Statement: Consistent observational evidence indicates
that moderate coffee consumption is associated with reduced risk of
type 2 diabetes and cardiovascular disease in healthy adults. In
addition, consistent observational evidence indicates that regular
consumption of coffee is associated with reduced risk of cancer of the
liver and endometrium, and slightly inverse or null associations are
observed for other cancer sites.
DGAC Grade: Moderate
------------------------------------------------------------------------
Key Findings
Total Cancer
Total Cancer Coffee drinkers had a modestly lower total
cancer incidence compared to nondrinkers or those with the
lowest intakes.
Lung Cancer
Coffee consumption was associated with higher risk of lung
cancer, but the association was mainly explained by smoking. An
association was not founder among nonsmokers.
Liver Cancer
Significant inverse association between coffee consumption
and liver cancer risk seen in both case-control and cohort
studies (after adjustment for existing liver disease).
Risk of hepatocelluar carcinoma was reduced by 40% for any
coffee consumption versus no coffee consumption.
Breast Cancer
No association between caffeine, coffee, or decaffeinated
coffee and breast cancer risk.
An inverse association was seen in postmenopausal
women and a strong inverse association seen in BRCA1
mutation carriers.
Borderline lower risk for highest versus lowest coffee
consumption.
For all studies together, an increase of 2 cups of
coffee per day was associated with a 2% marginally lower
breast cancer risk.
Prostate Cancer
Regular coffee consumption associated with modestly lower
risk of prostate cancer.
Significant inverse association documented for cohort
studies. For case-control studies, a 2 cup increment was
associated with a higher risk of prostate cancer.
Dose-response meta-analysis of coffee consumption showed
inverse association with prostate cancer mortality, but not
incidence.
Ovarian Cancer
No association between coffee consumption and ovarian cancer
risk in high versus low or dose-response meta-analysis.
Endometrial Cancer
Increased coffee intake was associated with a reduced risk
of endometrial cancer in both cohort and case-control studies.
A reduction of 20% in endometrial cancer risk among coffee
drinkers; >20% and >30% reduction in risk among low to mod and
heavy drinkers, respectively.
Bladder Cancer
Data from case-control studies suggest that consumption of
coffee is associated with an increased risk for bladder cancer,
but no significant association was seen in prospective cohort
studies.
Pancreatic Cancer
Meta-analysis of prospective cohort studies showed that
coffee drinking was inversely associated with pancreatic cancer
risk (in sub-group analyses, there was a reduced risk in men
but not women).
A positive association was found between coffee intake and
pancreatic cancer in case-control studies that did not adjust
for smoking. An inverse association was found in prospective
cohort studies.
Upper Digestive & Respiratory Cancer
Coffee drinking was inversely related to oral/pharyngeal
cancer risk while there was no relation with laryngeal cancer,
ESCC, and EAC.
Gastro-esophageal Cancer
Coffee consumption was inversely, but non-significantly,
associated with risk of esophageal cancer.
No association between coffee consumption and gastric cancer
risk in cohort or case-control studies.
Colorectal Cancer
Case-control studies suggest coffee consumption decreases
risk of colorectal and colon cancer, especially in women; the
association was inverse, but marginally non-significant, for
cohort studies for colorectal and colon cancer.
Prospective cohort studies showed no association between
coffee consumption on colorectal cancer risk (a suggestive
inverse association was slightly stronger in studies that
adjusted for smoking and alcohol).
Description of the Evidence
A large number of SR/MAs addressed cancer, including total cancer
(Yu, 2011), lung cancer (Tang, 2010), liver cancer (Sang, 2013; Bravi,
2013), breast cancer (Jiang, 2013; Li, 2013; Tang 2009), prostate
cancer (Cao, 2014; Zhong, 2013; Discacciati, 2013; Park, 2010), ovarian
cancer (Braem, 2012), endometrial cancer (Je, 2012; Bravi, 2009),
bladder cancer (Zhou, 2012), pancreatic cancer (Turati, 2011; Dong,
2011), upper digestive and respiratory tract cancer (Turati, 2011),
esophageal cancer (Zheng, 2013), gastric cancer (Botelho, 2006), and
colorectal cancer (Li, 2012; Galeone, 2010; Je, 2009). The majority of
the studies included cohort and cross-sectional studies, although some
covered only prospective cohort studies or case-control studies. The
number of studies included in the SR/MAs ranged from 3-54.
Several systematic reviews and meta-analyses examined the
association between coffee consumption and risk of cancer. Types of
cancer examined by the Committee included total cancer, cancers of the
lung, liver, breast, prostate, ovaries, endometrium, bladder, pancreas,
upper digestive and respiratory tract, esophagus, stomach, colon, and
rectum.
In a quantitative summary of 40 prospective cohort studies with an
average follow-up of 14.3 years, Yu (2011) found a 13 percent lower
risk of total cancer among coffee drinkers compared to non-drinkers or
those with lowest intakes. Risk estimates were similar for men and
women. In sub-group analyses, the authors noted that coffee drinking
was associated with a reduced risk of bladder, breast, buccal and
pharyngeal, colorectal, endometrial, esophageal, hepatocellular,
leukemic, pancreatic, and prostate cancers.
Tang, et al. (2010) evaluated 5 prospective cohorts and 8 case-
control studies and found that overall those with the highest levels of
coffee consumption had a 27 percent higher risk for lung cancer
compared to never drinkers or those with least consumption. An increase
in coffee consumption of 2 cups/day was associated with a 14 percent
higher risk of developing lung cancer. However, because smoking is an
important confounder, when analyses were stratified by smoking status,
coffee consumption was marginally protective in non-smokers and was not
associated with lung cancer among smokers. When estimates from 2
studies that examined decaffeinated coffee were summarized, there was a
protective association with lung cancer. No association was seen with
lung cancer when only case-control studies were considered.
Results from two meta-analyses indicate the coffee consumption is
associated with a 50 percent lower risk of liver cancer (Sang, 2013)
and a 40 percent lower risk of hepatocellular carcinoma (Bravi, 2013)
when considering both cohort and case-control studies. Associations
were significant in men but not in women (Sang, 2013).
Three meta-analyses of observational studies found no association
between coffee consumption (Jiang, 2013; Li, 2013; Tang, 2013),
caffeine consumption (Jiang, 2013), or decaffeinated coffee consumption
(Jiang, 2013) and risk of breast cancer. In all 3 reports, each 2 cup/
day of coffee was marginally associated with a 2 percent lower risk of
breast cancer. However, in sub-group analyses, coffee consumption was
protective against breast cancer risk in postmenopausal women (Jiang,
2013), BRCA1 mutation carriers (Jiang, 2013), and women with estrogen
receptor negative status (Li, 2013).
The association between coffee consumption and risk of prostate
cancer was mixed. Cao (2014) and Zhong (2013) found that regular or
high coffee consumption, compared to non- or lowest levels of
consumption, was associated with a 12 percent-17 percent lower risk of
prostate cancer in prospective cohort studies. Further, each 2 cups of
coffee per day was associated with a 7% lower risk of prostate cancer.
However, no associations were seen with case-control data alone or when
these studies were examined together with prospective cohort studies.
Using a combination of both prospective cohort and case-control data,
Discacciati (2013) found that each 3 cups/day of coffee was associated
with a 3% lower risk of localized prostate cancer and an 11% lower risk
of mortality from prostate cancer. On the other hand, after summarizing
data from 12 prospective cohort and case-control studies, Park (2010)
found a 16% higher risk of prostate cancer. However, in sub-group
analyses by study design, the higher risk was observed in case-control
but not in cohort studies.
Consumption of coffee was not associated with risk of ovarian
cancer in a meta-analysis of 7 prospective cohort studies with over
640,000 participants (Braem, 2012).
Two meta-analyses confirmed an inverse association between coffee
consumption and risk of endometrial cancer (Je, 2012; Bravi, 2009). In
the most recent and updated meta-analysis of prospective cohort and
case-control studies, compared to those in the lowest category of
coffee consumption, those with the highest intakes of coffee had a 29%
lower risk of endometrial cancer (Je, 2012). Each cup of coffee per day
was associated with an 8% lower risk of endometrial cancer. Similar
results were found in the meta-analysis by Bravi (2009) that included a
sub-set of the studies in Je (2012) and documented a 20% lower risk of
endometrial cancer overall, and a 7% decrease for each cup of coffee
per day. However, the association was significant only in case-control
studies but not in cohort studies, most likely due to lower statistical
power.
A recent meta-analysis of 23 case-control studies by Zhou (2012)
found coffee was a risk factor for bladder cancer. There was a smoking-
adjusted increased risk of bladder cancer for those in the highest
(45%), second highest, (21%), and third highest (8%) groups of coffee
consumption, compared to those in the lowest group. No association was,
however, seen in cohort studies.
Two meta-analyses of coffee consumption and pancreatic cancer risk
provided mixed results (Turati, 2011; Dong, 2011). Using both
prospective cohort and case-control studies, Turati (2011) found that
coffee consumption was not associated with risk of pancreatic cancer.
However, an increased risk was seen in case-control studies that did
not adjust for smoking. Using a sub-set of prospective cohorts included
in the Turati (2011) meta-analysis, Dong (2011) found that coffee
drinking was inversely associated with pancreatic cancer risk but did
not separate studies based on their adjustment for smoking status. Sub-
group analyses revealed a protective association in men, but not in
women.
Turati (2011) quantified the association between coffee consumption
and various upper digestive and respiratory tract cancers using data
from observational studies. Coffee consumption was associated with a
36% lower risk of oral and pharyngeal cancer but not with risk of
laryngeal cancer, esophageal squamous cell carcinoma, or esophageal
adenocarcinoma. In a meta-analysis of prospective cohort and case-
control studies, Zheng (2013) noted that coffee was inversely, but non-
significantly, associated with risk of esophageal cancer. Regarding
gastric cancer, no association between coffee consumption and risk was
seen in a meta-analysis of observational studies by Botelho (2006).
Three meta-analyses on the association between coffee consumption
and colorectal cancer risk (Li, 2012; Galeone, 2012; Je, 2009) have
yielded mixed findings. Results from case-control studies suggested
coffee consumption was associated with lower risk of colorectal (15%
lower) and colon cancer (21% lower), especially in women. However, this
inverse association was non-significant for cohort studies. Using all
but one of the case-control studies, Galeone (2012) arrived at similar
conclusions as the Li (2012) analysis although associations were in
general stronger. Galeone (2012) also provided suggestive evidence for
a dose-response relationship between coffee and colorectal cancer such
that each cup of coffee was associated with a 6% lower risk of
colorectal cancer, 5% lower risk of colon cancer, and 3% lower risk of
rectal cancer. Using several prospective cohort studies as in the Li
(2012) meta-analysis, Je (2009) found no significant association of
coffee consumption with risk of colorectal cancer. Interestingly, no
differences were seen by sex but the suggestive inverse associations
were slightly stronger in studies that adjusted for smoking and
alcohol.
-------------------------------------------------------------------------
Systematic Review Question: Cognitive Function
What is the relationship between usual caffeine consumption and
cognitive function?
Conclusion Statement: Limited evidence indicates that caffeine
consumption is associated with a modestly lower risk of cognitive
decline or impairment and lower risk of Alzheimer's disease.
DGAC Grade: Limited
------------------------------------------------------------------------
Key Findings:
There was a trend toward a protective effect of caffeine
from different sourcesand cognitive impairment/dementia.
Description of the Evidence
Two systematic reviews (Arab, 2013; Santos, 2010) and one meta-
analysis (Santos, 2010) examined the effects of caffeine from various
sources, including coffee, tea, chocolate, on cognitive outcomes. Arab
(2013) systematically reviewed six longitudinal cohort studies
evaluating the effect of caffeine or caffeine-rich beverages on
cognitive decline. Most studies in this review used the Mini Mental
State Examination Score as a global measure of cognitive decline. The
review concluded that estimates of cognitive decline were lower among
consumers, although there was no clear dose-response relationship.
Studies also showed stronger effects among women than men. In a
metaanalysis of nine cohort and two case-control studies, caffeine
intake from various sources was associated with a 16% lower risk of
various measures of cognitive impairment/decline. Specifically, data
from four studies indicate that caffeine is associated with a 38% lower
risk of Alzheimer's disease.
-------------------------------------------------------------------------
Systematic Review Question: Parkinson's Disease
What is the relationship between usual caffeine consumption and
Parkinson's disease?
Conclusion Statement: Consistent evidence indicates an inverse
association between caffeine intake and risk of Parkinson's disease.
DGAC Grade: Moderate
------------------------------------------------------------------------
Key Findings
There was a non-linear inverse association between coffee
and Parkinson's disease risk with maximum protection at 3
cups/d (adjusted for smoking).
For caffeine consumption, a linear inverse association was
found (adjusted for smoking); every 300 mg/day was associated
with a 24% lower risk of Parkinson's disease.
Description of the Evidence
Evidence from two systematic reviews (Ishihara, 2005; Costa, 2010)
and one quantitative meta-analysis (Qi, 2013) confirmed an inverse
association between coffee, caffeine, and risk of Parkinson's disease.
Qi (2013) evaluated six case-control studies and seven prospective
articles and documented a non-linear relationship between coffee and
risk of Parkinson's disease, overall. The lowest risk was observed at
3 cups/day (smoking-adjusted risk reduction was 28%). For caffeine, a
linear dose-response was found and every 200 mg/day increment in
caffeine intake was associated with a 17% lower risk of Parkinson's
disease. Using a combination of cohort, case-control, and cross-
sectional data, Costa (2010) summarized that the risk of Parkinson's
disease was 25% lower among those consuming the highest versus lowest
amounts of caffeine. Like Qi (2013), Costa documented a linear dose-
response with caffeine intake such that every 300 mg/day was associated
with a 24% lower risk of Parkinson's disease. In both reports,
associations were weaker among women than in men.
-------------------------------------------------------------------------
Systematic Review Question: Pregnancy outcomes
What is the relationship between usual caffeine consumption and
pregnancy outcomes?
Conclusion Statement: Consistent evidence from observational studies
indicates that caffeine intake in pregnant women is not associated with
risk of preterm delivery. Higher caffeine intake (especially >=300 mg/
day ) is associated with a small increased risk of miscarriage,
stillbirth, low birth weight, and small for gestational age (SGA)
births. However, these data should be interpreted cautiously due to
potential recall bias in the case-control studies and confounding by
smoking and pregnancy signal symptoms.
DGAC Grade: Moderate
------------------------------------------------------------------------
Key Findings
No important association between caffeine intake during
pregnancy and risk of pre-term birth were observed in either
cohort or case-control studies.
Consumption of caffeine from various sources was associated
with a significantly increased risk of spontaneous abortion and
low birth weight. Control for confounders such as maternal age,
smoking, and ethanol use was not possible.
Description of the Evidence
Two SR/MAs assessed observational studies on the association of
caffeine intake with adverse pregnancy outcomes (Greenwood, 2014;
Maslova, 2010). The pregnancy outcomes included miscarriage, pre-term
birth, stillbirth, small for gestational age (SGA), and low birth-
weight. The most recent SR/MA by Greenwood, et al., quantified the
association between caffeine intake and adverse pregnancy outcomes from
60 publications from 53 separate cohort (26) and case-control (27)
studies. The evidence covered a variety of countries with caffeine
intake categories that ranged from non-consumers to those consuming
>1,000mg/day. They found that an increment of 100 mg caffeine was
associated with a 14% increased risk of miscarriage, 19% increased risk
of stillbirth, 10% increased risk of SGA, and 7% increased risk of low
birth weight. There was no significant increase in risk of preterm
delivery. The magnitude of these associations was relatively small
within the range of caffeine intakes of the majority women in the study
populations, and the associations became more pronounced at higher
range (>=300 mg/day). The authors also note the substantial
heterogeneity observed in the meta-analyses shows that interpretation
of the results should be cautious. In addition, the results from
prospective cohort studies and case-control studies were mixed
together. Since coffee consumption is positively correlated with
smoking, residual confounding by smoking may have biased the results
toward a positive direction.
The other SR/MAs did not cover all of the above pregnancy outcomes,
but for those adverse outcomes covered, the results were in agreement
with Greenwood, et al., Maslova (2010) reviewed 22 studies (15 cohort
and 7 case-control studies) and found no significant association
between caffeine intake and risk of pre-term birth in either
casecontrol or cohort studies. For all of the observational studies
assessed across the three SR/MAs, most studies did not adequately
adjust for the pregnancy signal phenomenon, i.e., that nausea,
vomiting, and other adverse symptoms are associated with a healthy
pregnancy that results in a live birth, whereas pregnancy signal
symptoms occur less frequently when the result is miscarriage. Coffee
consumption decreases with increasing pregnancy signal symptoms,
typically during the early weeks of pregnancy, and this confounds the
association (Peck, et al. 2010). Greenwood, et al., state that this
potential bias is the most prominent argument against a causal role for
caffeine in adverse pregnancy outcomes. Only one randomized controlled
trial of caffeine/coffee reduction during pregnancy has been conducted
to date (Bech, 2007). The study found that a reduction of 200 mg of
caffeine intake per day did not significantly influence birth weight or
length of gestation. The trial did not examine other outcomes.
Research Recommendations
1. Evaluate the effects of coffee on health outcomes in vulnerable
populations, such as women who are pregnant (premature
birth, low birth weight, spontaneous abortion).
2. Examine the effects of coffee on sleep patterns, quality of life,
and dependency and addiction.
3. Evaluate the prospective association between coffee/caffeine
consumption and cancer at different sites.
4. Examine prospectively the effects of coffee/caffeine on cognitive
decline, neurodegenerative diseases, and depression.
5. Understand the mechanisms underlying the protective effects of
coffee on diabetes and CVD.
6. Understand the association between coffee and health outcomes in
individuals with existing CVD, diabetes, cancer,
neurodegenerative diseases, or depressive symptoms.
References
1. Crippa A., Discacciati A., Larsson S.C., Wolk A., Orsini N.
Coffee consumption and mortality from all causes, cardiovascular
disease, and cancer: a dose-response meta-analysis. Am. J. Epidemiol.
2014; 180(8):763-75. PMID: 25156996. http://www.ncbi.nlm.nih.gov/pubmed/
25156996.
2. Je Y., Giovannucci E. Coffee consumption and total mortality: a
meta-analysis of twenty prospective cohort studies. Br. J. Nutr.
2014;111(7):1162-73. PMID: 24279995. http://www.ncbi.nlm.nih.gov/pubmed/
24279995.
3. Malerba S., Turati F., Galeone C., Pelucchi C., Verga F., La
Vecchia C., et al. A meta-analysis of prospective studies of coffee
consumption and mortality for all causes, cancers and cardiovascular
diseases. Eur. J. Epidemiol. 2013; 28(7):527-39. PMID: 23934579. http://
www.ncbi.nlm.nih.gov/pubmed/23934579.
4. Ding M., Bhupathiraju S.N., Satija A., van Dam R.M., Hu F.B. Long-
term coffee consumptionand risk of cardiovascular disease: a systematic
review and a dose-response metaanalysisof prospective cohort studies.
Circulation. 2014; 129(6):643-59. PMID: 24201300. http://
www.ncbi.nlm.nih.gov/pubmed/24201300.
5. Sofi F., Conti A.A., Gori A.M., Eliana Luisi M.L., Casini A.,
Abbate R., et al. Coffee consumption and risk of coronary heart
disease: a meta-analysis. Nutr. Metab. Cardiovasc. Dis. 2007; 17(3):209-
23. PMID: 17156982. http://www.ncbi.nlm.nih.gov/pubmed/17156982.
6. Wu J.N., Ho S.C., Zhou C., Ling W.H., Chen W.Q., Wang C.L., et
al. Coffee consumption and risk of coronary heart diseases: a meta-
analysis of 21 prospective cohort studies. Int. J. Cardiol. 2009;
137(3):216-25. PMID: 18707777. http://www.ncbi.nlm.nih.gov/pubmed/
18707777.
7. Kim B., Nam Y., Kim J., Choi H., Won C. Coffee Consumption and
Stroke Risk: A Meta-analysis of Epidemiologic Studies. Korean J. Fam.
Med. 2012; 33(6):356-65. PMID: 23267421. http://www.ncbi.nlm.nih.gov/
pubmed/23267421.
8. Larsson S.C., Orsini N. Coffee consumption and risk of stroke: a
dose-response meta-analysis of prospective studies. Am. J. Epidemiol.
2011; 174(9):993-1001. PMID: 21920945. http://www.ncbi.nlm.nih.gov/
pubmed/21920945.
9. Mesas A.E., Leon-Munoz L.M., Rodriguez-Artalejo F., Lopez-Garcia
E. The effect of coffee on blood pressure and cardiovascular disease in
hypertensive individuals: a systematic review and meta-analysis. Am. J.
Clin. Nutr. 2011; 94(4):1113-26. PMID: 21880846. http://
www.ncbi.nlm.nih.gov/pubmed/21880846.
10. Noordzij M., Uiterwaal C.S., Arends L.R., Kok F.J., Grobbee
D.E., Geleijnse J.M. Blood pressure response to chronic intake of
coffee and caffeine: a meta-analysis of randomizedcontrolled trials. J.
Hypertens. 2005; 23(5):921-8. PMID: 15834273. http://
www.ncbi.nlm.nih.gov/pubmed/15834273.
11. Steffen M., Kuhle C., Hensrud D., Erwin P.J., Murad M.H. The
effect of coffee consumption on blood pressure and the development of
hypertension: a systematic review and metaanalysis. J. Hypertens. 2012;
30(12):2245-54. PMID: 23032138. http://www.ncbi.nlm.nih.gov/pubmed/
23032138.
12. Zhang Z., Hu G., Caballero B., Appel L., Chen L. Habitual coffee
consumption and risk of hypertension: a systematic review and meta-
analysis of prospective observational studies. Am. J. Clin. Nutr. 2011;
93(6):1212-9. PMID: 21450934. http://www.ncbi.nlm.nih.gov/pubmed/
21450934.
13. Cai L., Ma D., Zhang Y., Liu Z., Wang P. The effect of coffee
consumption on serum lipids: a meta-analysis of randomized controlled
trials. Eur. J. Clin. Nutr. 2012; 66(8):872-7. PMID: 22713771. http://
www.ncbi.nlm.nih.gov/pubmed/22713771.
14. Jee S.H., He J., Appel L.J., Whelton P.K., Suh I., Klag M.J.
Coffee consumption and serum lipids: a meta-analysis of randomized
controlled clinical trials. Am. J. Epidemiol. 2001; 153(4):353-62.
PMID: 11207153. http://www.ncbi.nlm.nih.gov/pubmed/11207153.
15. Caldeira D., Martins C., Alves L.B., Pereira H., Ferreira J.J.,
Costa J. Caffeine does not increase the risk of atrial fibrillation: a
systematic review and meta-analysis of observational studies. Heart.
2013; 99(19):1383-9. PMID: 24009307. http://www.ncbi.nlm.nih.gov/pubmed/
24009307.
16. Mostofsky E., Rice M.S., Levitan E.B., Mittleman M.A. Habitual
coffee consumption and risk of heart failure: a dose-response meta-
analysis. Circ Heart Fail. 2012;5(4):401-5. PMID: 22740040. http://
www.ncbi.nlm.nih.gov/pubmed/22740040.
17. Ding M., Bhupathiraju S.N., Chen M., van Dam R.M., Hu F.B.
Caffeinated and decaffeinated coffee consumption and risk of type 2
diabetes: a systematic review and a dose-response meta-analysis.
Diabetes Care. 2014; 37(2):569-86. PMID: 24459154. http://
www.ncbi.nlm.nih.gov/pubmed/24459154.
18. Huxley R., Lee C.M., Barzi F., Timmermeister L., Czernichow S.,
Perkovic V., et al. Coffee, decaffeinated coffee, and tea consumption
in relation to incident type 2 diabetes mellitus: a systematic review
with meta-analysis. Arch. Intern. Med. 2009; 169(22):2053-63. PMID:
20008687. http://www.ncbi.nlm.nih.gov/pubmed/20008687.
19. Jiang X., Zhang D., Jiang W. Coffee and caffeine intake and
incidence of type 2 diabetesmellitus: a meta-analysis of prospective
studies. Eur. J. Nutr. 2014; 53(1):25-38. PMID: 24150256. http://
www.ncbi.nlm.nih.gov/pubmed/24150256.
20. van Dam R.M., Hu F.B. Coffee consumption and risk of type 2
diabetes: a systematic review. JAMA. 2005; 294(1):97-104. PMID:
15998896. http://www.ncbi.nlm.nih.gov/pubmed/15998896.
21. Whitehead N., White H. Systematic review of randomised
controlled trials of the effects of caffeine or caffeinated drinks on
blood glucose concentrations and insulin sensitivity in people with
diabetes mellitus. J. Hum. Nutr. Diet. 2013; 26(2):111-25. PMID:
23331476. http://www.ncbi.nlm.nih.gov/pubmed/23331476.
22. Yu X., Bao Z., Zou J., Dong J. Coffee consumption and risk of
cancers: a meta-analysis of cohort studies. BMC Cancer. 2011; 11:96.
PMID: 21406107. http://www.ncbi.nlm.nih.gov/pubmed/21406107.
23. Tang N., Wu Y., Ma J., Wang B., Yu R. Coffee consumption and
risk of lung cancer: a meta-analysis. Lung Cancer. 2010; 67(1):17-22.
PMID: 19362749. http://www.ncbi.nlm.nih.gov/pubmed/19362749.
24. Sang L.X., Chang B., Li X.H., Jiang M. Consumption of coffee
associated with reduced risk of liver cancer: a meta-analysis. BMC
Gastroenterol. 2013; 13:34. PMID: 23433483. http://www.ncbi.nlm.nih.gov/
pubmed/23433483.
25. Bravi F., Bosetti C., Tavani A., Gallus S., La Vecchia C. Coffee
reduces risk for hepato-cellular carcinoma: an updated meta-analysis.
Clin. Gastroenterol. Hepatol. 2013; 11(11):1413-21.e1. PMID: 23660416.
http://www.ncbi.nlm.nih.gov/pubmed/23660416.
26. Jiang W., Wu Y., Jiang X. Coffee and caffeine intake and breast
cancer risk: an updated dose-response meta-analysis of 37 published
studies. Gynecol. Oncol. 2013; 129(3):620-9. PMID: 23535278. http://
www.ncbi.nlm.nih.gov/pubmed/23535278.
27. Li X.J., Ren Z.J., Qin J.W., Zhao J.H., Tang J.H., Ji M.H., et
al. Coffee consumption and risk of breast cancer: an up-to-date meta-
analysis. PLoS One. 2013; 8(1):e52681. PMID: 23308117. http://
www.ncbi.nlm.nih.gov/pubmed/23308117.
28. Tang N., Zhou B., Wang B., Yu R. Coffee consumption and risk of
breast cancer: a meta-analysis. Am. J. Obstet. Gynecol. 2009;
200(3):290.e1-9. PMID: 19114275. http://www.ncbi.nlm.nih.gov/pubmed/
19114275.
29. Cao S., Liu L., Yin X., Wang Y., Liu J., Lu Z. Coffee
consumption and risk of prostate cancer: a meta-analysis of prospective
cohort studies. Carcinogenesis. 2014; 35(2):256-61. PMID: 24343360.
http://www.ncbi.nlm.nih.gov/pubmed/24343360.
30. Zhong S., Chen W., Yu X., Chen Z., Hu Q., Zhao J. Coffee
consumption and risk of prostate cancer: an up-to-date meta-analysis.
Eur. J. Clin. Nutr. 2014; 68(3):330-7. PMID: 24300907. http://
www.ncbi.nlm.nih.gov/pubmed/24300907.
31. Discacciati A., Orsini N., Wolk A. Coffee consumption and risk
of nonaggressive, aggressive and fatal prostate cancer--a dose-response
meta-analysis. Ann. Oncol. 2014; 25(3):584-91. PMID: 24276028. http://
www.ncbi.nlm.nih.gov/pubmed/24276028.
32. Park C.H., Myung S.K., Kim T.Y., Seo H.G., Jeon Y.J., Kim Y.
Coffee consumption and risk of prostate cancer: a meta-analysis of
epidemiological studies. BJU Int. 2010; 106(6):762-9. PMID: 20590551.
http://www.ncbi.nlm.nih.gov/pubmed/20590551.
33. Braem M.G., Onland-Moret N.C., Schouten L.J., Tjonneland A.,
Hansen L., Dahm C.C., et al. Coffee and tea consumption and the risk of
ovarian cancer: a prospective cohort study and updated meta-analysis.
Am. J. Clin. Nutr. 2012; 95(5):1172-81. PMID: 22440851. http://
www.ncbi.nlm.nih.gov/pubmed/22440851.
34. Bravi F., Scotti L., Bosetti C., Gallus S., Negri E., La Vecchia
C., et al. Coffee drinking and endometrial cancer risk: a metaanalysis
of observational studies. Am. J. Obstet. Gynecol. 2009; 200(2):130-5.
PMID: 19110217. http://www.ncbi.nlm.nih.gov/pubmed/19110217.
35. Je Y., Giovannucci E. Coffee consumption and risk of endometrial
cancer: findings from alarge up-to-date meta-analysis. Int. J. Cancer.
2012; 131(7):1700-10. PMID: 22190017. http://www.ncbi.nlm.nih.gov/
pubmed/22190017.
36. Zhou Y., Tian C., Jia C. A dose-response meta-analysis of coffee
consumption and bladder cancer. Prev. Med. 2012; 55(1):14-22. PMID:
22564775. http://www.ncbi.nlm.nih.gov/pubmed/22564775.
37. Turati F., Galeone C., Edefonti V., Ferraroni M., Lagiou P., La
Vecchia C., et al. A meta-analysis of coffee consumption and pancreatic
cancer. Ann. Oncol. 2012; 23(2):311-8. PMID: 21746805. http://
www.ncbi.nlm.nih.gov/pubmed/21746805.
38. Dong J., Zou J., Yu X.F. Coffee drinking and pancreatic cancer
risk: a meta-analysis of cohort studies. World J. Gastroenterol. 2011;
17(9):1204-10. PMID: 21448427. http://www.ncbi.nlm.nih.gov/pubmed/
21448427.
39. Turati F., Galeone C., La Vecchia C., Garavello W., Tavani A.
Coffee and cancers of the upper digestive and respiratory tracts: meta-
analyses of observational studies. Ann. Oncol. 2011; 22(3):536-44.
PMID: 20943597. http://www.ncbi.nlm.nih.gov/pubmed/20943597.
40. Zheng J.S., Yang J., Fu Y.Q., Huang T., Huang Y.J., Li D.
Effects of green tea, black tea, and coffee consumption on the risk of
esophageal cancer: a systematic review and meta-analysis of
observational studies. Nutr. Cancer. 2013; 65(1):1-16. PMID: 23368908.
http://www.ncbi.nlm.nih.gov/pubmed/23368908.
41. Botelho F., Lunet N., Barros H. Coffee and gastric cancer:
systematic review and meta-analysis. Cad. Saude. Publica. 2006;
22(5):889-900. PMID: 16680342. http://www.ncbi.nlm.nih.gov/pubmed/
16680342.
42. Galeone C., Turati F., La Vecchia C., Tavani A. Coffee
consumption and risk of colorectal cancer: a meta-analysis of case-
control studies. Cancer Causes Control. 2010; 21(11):1949-59. PMID:
20680435. http://www.ncbi.nlm.nih.gov/pubmed/20680435.
43. Je Y., Liu W., Giovannucci E. Coffee consumption and risk of
colorectal cancer: a systematic review and meta-analysis of prospective
cohort studies. Int. J. Cancer. 2009; 124(7):1662-8. PMID: 19115212.
http://www.ncbi.nlm.nih.gov/pubmed/19115212.
44. Li G., Ma D., Zhang Y., Zheng W., Wang P. Coffee consumption and
risk of colorectal cancer: a meta-analysis of observational studies.
Public Health Nutr. 2013; 16(2):346-57. PMID: 22694939. http://
www.ncbi.nlm.nih.gov/pubmed/22694939.
45. Costa J., Lunet N., Santos C., Santos J., Vaz-Carneiro A.
Caffeine exposure and the risk of Parkinson's disease: a systematic
review and meta-analysis of observational studies. J. Alzheimers Dis.
2010;20 Suppl 1:S221-38. PMID: 20182023. http://www.ncbi.nlm.nih.gov/
pubmed/20182023.
46. Ishihara L., Brayne C. A systematic review of nutritional risk
factors of Parkinson's disease. Nutr. Res. Rev. 2005; 18(2):259-82.
PMID: 19079910. http://www.ncbi.nlm.nih.gov/pubmed/19079910.
47. Qi H., Li S. Dose-response meta-analysis on coffee, tea and
caffeine consumption with risk of Parkinson's disease. Geriatr.
Gerontol. Int. 2014; 14(2):430-9. PMID: 23879665. http://
www.ncbi.nlm.nih.gov/pubmed/23879665.
48. Arab L., Khan F., Lam H. Epidemiologic evidence of a
relationship between tea, coffee, or caffeine consumption and cognitive
decline. Adv. Nutr. 2013; 4(1):115-22. PMID: 23319129. http://
www.ncbi.nlm.nih.gov/pubmed/23319129.
49. Santos C., Costa J., Santos J., Vaz-Carneiro A., Lunet N.
Caffeine intake and dementia: systematic review and meta-analysis. J.
Alzheimers Dis. 2010; 20 Suppl. 1:S187-204. PMID: 20182026. http://
www.ncbi.nlm.nih.gov/pubmed/20182026.
50. Greenwood D.C., Thatcher N.J., Ye J., Garrard L., Keogh G., King
L.G., et al. Caffeine intake during pregnancy and adverse birth
outcomes: a systematic review and dose-response meta-analysis. Eur. J.
Epidemiol. 2014; 29(10):725-34. PMID: 25179792. http://
www.ncbi.nlm.nih.gov/pubmed/25179792.
51. Maslova E., Bhattacharya S., Lin S.W., Michels K.B. Caffeine
consumption during pregnancy and risk of preterm birth: a meta-
analysis. Am. J. Clin. Nutr. 2010; 92(5):1120-32. PMID: 20844077. http:/
/www.ncbi.nlm.nih.gov/pubmed/20844077.
Analytical Framework
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Inclusion Criteria
PubMed was searched for original research articles published in
English in peer-reviewed journals. Studies published since January 2000
with subjects who were healthy or at elevated chronic disease risk from
countries with high or very high human development were considered.
Study design was limited to systematic reviews or systematic reviews
with meta-analyses. All other study designs were excluded. Studies were
required to specify level of caffeine and included caffeine from any
source. Both short- and long-term health outcomes were included.
Studies that examined low-calorie diets and other treatment diets were
excluded. Finally, studies were required to include a description of
the dietary pattern along with sustainability or food security
outcomes.
Search Results
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
attachment 2
The Federal Advisory Committee Act (FACA) Brochure
An Overview
U.S. General Services Administration,
Office of Governmentwide Policy,
Committee Management Secretariat,
Washington, D.C. 20417
Advisory committees have played an important role in shaping
programs and policies of the Federal Government from the earliest days
of the Republic. Since President George Washington sought the advice of
such a committee during the Whiskey Rebellion of 1794, the
contributions made by these groups have been impressive and diverse.
Today, an average of 1,000 advisory committees with more than
60,000 members advise the President and the Executive Branch on such
issues as the disposal of high-level nuclear waste, the depletion of
atmospheric ozone, the national fight against Acquired Immune
Deficiency Syndrome (AIDS), efforts to rid the nation of illegal drugs,
to improve schools, highways, and housing, and on other major programs.
Through enactment of the Federal Advisory Committee Act (FACA) of
1972 (Public Law 92-463), the U.S. Congress formally recognized the
merits of seeking the advice and assistance of our nation's citizens.
At the same time, the Congress also sought to assure that advisory
committees:
Provide advice that is relevant, objective, and open to the
public;
Act promptly to complete their work; and
Comply with reasonable cost controls and record keeping
requirements.
Role of Federal Advisory Committees
With the expertise from advisory committee members, federal
officials and the nation have access to information and advice on a
broad range of issues affecting federal policies and programs. The
public, in return, is afforded an opportunity to provide input into a
process that may form the basis for government decisions.
Federal Agency Responsibility
Each Federal agency that sponsors advisory committees must adhere
to the requirements established by the FACA, as well as regulations
promulgated by the U.S. General Services Administration's (GSA)
Committee Management Secretariat. GSA has had the responsibility for
overseeing the FACA since 1977.
GSA's Role Under the FACA
With approximately 1,000 advisory committees in existence at any
given time, special attention is required to assure compliance with the
FACA, the Freedom of Information Act, and related regulations, as well
as to encourage effective and efficient use of committee resources.
While Executive Branch departments and agencies are responsible for
continually reviewing committee performance and compliance in these
areas, the General Services Administration was designated by the
President in 1977 to monitor committee activities government-wide. As
part of this responsibility, GSA:
Conducts annual reviews of advisory committee activities and
accomplishments;
Responds to requests from agencies on establishing new
committees or the renewal of existing groups; and
Maintains a FACA database on the internet from which
advisory committee information may be obtained.
Together, GSA and the Federal community work to eliminate the
overlap or duplication of advisory bodies, terminate unnecessary or
inactive committees, and develop committee management regulations,
guidelines, and training in response to requirements of the Executive
Branch and Congress.
Complying with FACA
Any advisory group, with limited exceptions, that is established or
utilized by a federal agency and that has at least one member who is
not a Federal employee, must comply with the FACA. To find out if a
group comes under the FACA, contact the sponsoring agency's Committee
Management Officer. The GSA Committee Management Secretariat is an
additional resource (see the last section ``For More Information . .
.'').
Requirements for Establishing and Managing Advisory Committees
Under the Federal Advisory Committee Act, advisory committees can
be created only when they are essential to the performance of a duty or
responsibility conveyed upon the Executive Branch by law or
Presidential Directive. Before committees can be set up, high-level
officials within the sponsoring agency must review and approve the
request. Once a committee is approved, a charter is prepared outlining
the committee's mission and specific duties and forwarded to GSA's
Committee Management Secretariat for final review. Following a required
public notification period, and the filing of the charter with
Congress, the committee may begin operation.
Committee Management Officer and Designated Federal Officer
The Federal Advisory Committee Act also provides that each agency
sponsoring a federal advisory committee must appoint a Committee
Management Officer to oversee the administration of the Act's
requirements.
In addition, a Designated Federal Officer must be assigned to each
committee to:
Ensure compliance with FACA, and any other applicable laws
and regulations;
Call, attend, and adjourn committee meetings;
Approve agendas;
Maintain required records on costs and membership;
Ensure efficient operations;
Maintain records for availability to the public; and
Provide copies of committee reports to the Committee
Management Officer for forwarding to the Library of Congress.
Expiration of a Committee's Charter
Unless the renewal of a committee charter is justified under the
FACA, the charter automatically expires after a 2 year period (or as
otherwise provided by law).
Advisory Committee Members
Federal advisory committee members are drawn from nearly every
occupational and industry group and geographical section of the United
States and its territories. The FACA requires that committee
memberships be ``fairly balanced in terms of the points of view
represented and the functions to be performed.''
As a result, members of specific committees often have both the
expertise and professional skills that parallel the program
responsibilities of their sponsoring agencies. In balancing committee
memberships, agencies are expected to consider a cross-section of those
directly affected, interested, and qualified, as appropriate to the
nature and function of the advisory committee.
Appointing Committee Members
Agency officials, Members of Congress, the general public, or
professional societies or current and former committee members may
nominate potential candidates for membership on a committee.
Selection of committee members is made based on the FACA's
requirements and the potential member's background and qualifications.
Final selection is made by the president or heads of departments or
agencies.
Prior to accepting an appointment with a Federal advisory
committee, each prospective member should clarify his/her role,
obligations, duties, allowable expenses, compensation limitations, and
any ethics requirements with their committee's Designated Federal
Officer and/or Committee Management Officer, as appropriate.
Federal Ethics and Conflict of Interest Laws
Agency officials must provide prospective advisory committee
members with information regarding any applicable standards of
conduct--including those imposed by federal conflict of interest
statutes. In some instances, members may be subject to special
limitations during the course of their service on an advisory
committee. For some members, these restrictions also may apply (for
limited periods) after their committee assignments have ended.
Some agencies may impose additional administrative requirements as
well. To avoid potential conflicts, each advisory committee member
should assure that he or she receives adequate information from the
sponsoring agency and completes any required appointment papers and
disclosure forms prior to service on a committee.
Oral briefings and other explanatory material may be obtained
through the sponsoring agency's Committee Management Officer,
Designated Agency Ethics Official, or from the Office of Government
Ethics, which has government-wide jurisdiction on federal ethics
issues.
Limits on Membership Terms
Each agency may set limits (unless provided by law or Presidential
Directive) on the lengths of terms for serving on advisory committees
to allow for new membership.
Open Access to Committee Meetings and Operations
Under the provisions of the Federal Advisory Committee Act, Federal
agencies sponsoring advisory committees must:
Arrange meetings that are reasonably accessible and at
convenient locations and times;
Publish adequate advance notice of meetings in the Federal
Register;
Open advisory committee meetings to the public (with some
exceptions--see the section on ``Government in the Sunshine
Act'' below);
Make available for public inspection, subject to the Freedom
of Information Act, papers and records, including detailed
minutes of each meeting; and
Maintain records of expenditures.
Government in the Sunshine Act
Advisory committee meetings may be closed or partially closed to
the public based upon provisions of the Government in the Sunshine Act
of 1976 (Public Law 94-409). Examples of meetings that may be closed
under the FACA are:
Those including discussions of classified information;
Reviews of proprietary data submitted in support of Federal
grant applications; and
Deliberations involving considerations of personnel privacy.
For More Information . . .
For more information on the requirements of the Federal Advisory
Committee Act, contact the General Services Administration's Committee
Management Secretariat at [email protected] or via the internet at:
http://www.gsa.gov/faca; or
http://www.gsa.gov/committeemanagement
Examples of materials available on the Committee Management
Secretariat website are:
Federal Advisory Committee Act (http://www.gsa.gov/portal/
content/100916)
GSA Final Rule on Federal Advisory Committee Management
(http://www.gsa.gov/portal/content/104034)
Guidance documents
Access to the Federal Advisory Committee Act database
(http://www.facadatabase.gov/)
Information on the Federal Advisory Committee Act Training
course (http://www.gsa.gov/portal/content/162635).
Other materials, such as samples of nominating letters and
committee reports, are available from each sponsoring agency.
(Accessed December 10, 2015.)
attachment 3
Office of the General Counsel Ethics Division
Revised October 2004 (Previous Editions Obsolete)
Ethics Rules for Advisory Committee Members and Other Individuals
Appointed as Special Government Employees (SGEs)
Introduction
This summary has been prepared primarily for individuals appointed
to serve as ``special Government employees'' (SGEs) on Department of
Health and Human Services (HHS) advisory committees or Presidential
boards, councils, or commissions that are attached to HHS for purposes
of administration. The information also will be useful to other SGEs
without advisory committee responsibilities, such as ``experts or
consultants'' or ``personal services contractors.''
New appointees, especially those that provide temporary,
intermittent services only a few days a year, often are surprised by,
or even resentful of, the complexity of the rules governing Federal
employees. The ethics rules do not appear to many people to be logical,
intuitive, or even, fair. Ignoring these rules, however, can result in
serious consequences or embarrassment, both personally and for the
Department. Criminal conflict of interest violations are ``strict
liability'' offenses, and even an inadvertent, ``technical'' violation
will require the initiation of an Inspector General investigation and
possible referral to the Department of Justice. Moreover, the entire
matter in which a violator participates may be considered so
compromised that the Department may have to nullify, cancel, or retract
any agency action that is perceived as tainted by the conflict.
Therefore, if you have questions on any of the topics covered in this
guidance, you should consult with the Designated Federal Official
responsible for your committee or the Deputy Ethics Counselor assigned
to your operating or staff division.
Definition of a Special Government Employee (SGE)
A ``special Government employee'' is an officer or employee in the
Executive Branch of the Federal Government who is appointed to perform
temporary duties, with or without compensation, for a period not to
exceed 130 days during any period of 365 consecutive days. 18 U.S.C.
202(a). This status is important because the ethics rules for SGEs are
somewhat less restrictive than the rules for other Federal employees
and officials. Some members of advisory committees are appointed for a
multi-year term. During each year of their term of appointment,
committee members generally will not be expected to perform work for
HHS in excess of 130 days during any period of 365 consecutive days.
Thus, most committee members will be considered ``SGEs.''
In addition, individuals who provide advice as an ``expert or
consultant'' or render assistance under a ``personal services
contract'' for a period that is not expected to exceed 130 days do so
as the functional equivalent of an employee and thus are treated as
SGEs for ethics purposes. Only ``true'' independent contractors are
excluded from the definition. Although several factors are evaluated to
determine independent contractor status, this category, for the most
part, comprises individuals who produce a defined ``end product'' or
``deliverable'' without detailed supervision by a Federal employee.
Financial Disclosure Reporting Requirements
HHS advisory committee members appointed as SGEs are required under
the Ethics in Government Act, as amended by the Ethics Reform Act of
1989, and 5 CFR Part 2634, to file a financial disclosure report when
first appointed and annually thereafter on the anniversary date of
their appointment. Committee members also may be required to update the
information on the report before each meeting throughout their term of
appointment. (Certain committee members are permitted to utilize an
alternative reporting system, e.g., FDA Form 3410, that focuses solely
on each filer's assets and associational interests that are directly
implicated by the subjects on the meeting agenda.) The information
reported is used to determine the matters for which a committee member
must be disqualified under the criminal financial conflict of interest
statute, 18 U.S.C. 208(a), and the matters for which a committee
member may be granted a waiver under 18 U.S.C. 208(b).
Complete reporting is essential to protect the committee member
from inadvertently violating any of the criminal conflict of interest
statutes, and to assure the public that the advice provided by an HHS
advisory committee is free from any real, or perceived, conflicts of
interest. The information reported by committee members is confidential
and may not be released except under the limited circumstances
described in the Privacy Act notice provided with the report or by
order of a Federal court. (SGEs who serve more than 60 days in any
period of 365 consecutive days and who are compensated at certain pay
levels may be required to file a publicly available financial
disclosure report.)
Criminal Conflict of Interest Statutes
The following criminal conflict of interest statutes apply to SGEs:
18 U.S.C 201. Section 201, commonly known as the ``bribery and
illegal gratuities'' statute, prohibits Federal employees, including
SGEs, from seeking, accepting, or agreeing to receive anything of value
in return for being influenced in the performance of an official act.
18 U.S.C. 203. Section 203 prohibits an SGE from receiving
compensation for representational services rendered by the employee or
another person before HHS or another Federal agency or other specified
entity (such as a court or commission) in any particular matter
involving a specific party (i) in which the SGE has participated
personally and substantially as a government employee, or (ii) which is
pending in the government agency in which the SGE is serving if the SGE
has served for more than 60 days during the immediately preceding 365
days.
Exempted from this rule are representations required in the proper
discharge of official duties. Also exempted are representations
determined by the head of the agency to be required in the performance
of work under a grant, contract or other agreement with or for the
benefit of the government.
A particular matter involving specific parties is a matter that is
focused upon the interests of identified persons in a specific
proceeding or an isolatable transaction or related set of transactions.
Examples include, but are not limited to, reviews of grant proposals or
contract applications, or similar funding decisions; recommendations or
approvals of scientific studies, projects, clinical trials, new drug
applications; and other actions that involve deliberation, decision, or
action affecting the legal rights of identified parties.
In contrast, a particular matter of general applicability is a
matter that is focused on the interests of a discrete and identifiable
class of persons or entities, but does not involve specific parties.
Examples include recommendations or consideration of legislative
proposals, regulatory initiatives, or policy development that affect an
industry, group of manufacturers, or health care providers.
Pay close attention to which type of particular matter is involved
in your assignment because the ethics rules may differ depending upon
whether a ``specific party matter'' or a ``general policy matter'' is
involved. The terms ``matter'' or ``particular matter,'' without more
description, are deemed to encompass both types.
Representational services include communications (written or oral)
and appearances made on behalf of someone else, generally with the
intent to influence or persuade the government. An inquiry as to the
status of a pending matter is not necessarily a representation,
although depending upon the context of the inquiry, it could give rise
to the appearance of a prohibited representation.
To avoid appearance problems, during the period in which a
committee is in session, committee members are advised not to contact
Department staff concerning any matters pending before the agency, or
as to which the agency has an interest. Such matters would include, for
example, applications for Federal funding, progress reports regarding
Cooperative Research and Development Agreements (CRADAS) or clinical
trials, and pending drug investigations or applications.
18 U.S.C. 205. Section 205 prohibits an SGE from representing a
party, with or without compensation, before HHS or another Federal
agency or other specified entity (such as a court or commission) in any
particular matter involving a specific party in which the United States
is a party or has a direct and substantial interest: (i) that the SGE
participated in personally and substantially as a government employee;
or (ii) which is pending in the agency in which the SGE is serving, if
the SGE has served for more than 60 days during the immediately
preceding 365 days.
18 U.S.C. 207. Section 207, the ``post-employment'' statute,
imposes a lifetime ban on a former SGE from representing another person
or entity to HHS or another Federal agency or other specified entity
(such as a court or commission) in any particular matter involving a
specific party in which the former SGE participated personally and
substantially while serving in the government. In addition, for two
years after terminating Federal employment, an SGE may not make such
representational communications to the government regarding specific
party matters that were pending under his or her official
responsibility during the last year of government service. Moreover,
``senior employees,'' those paid at an annual rate equivalent to level
ES-5 in the Senior Executive Service, are subject to a one-year
``cooling-off'' period which precludes any contacts with their former
agency on any matter for which official action is sought, even if the
former employee had no involvement with the matter while in government
service. For SGEs, this one-year ``cooling-off'' period does not apply
if the SGE served less than 60 days in the one-year period prior to
termination of senior employee status.
18 U.S.C. 208. Section 208(a), the main conflict of interest
statute, prohibits an SGE from participating personally and
substantially in any particular matter that could affect the financial
interests of the SGE, the SGE's spouse, minor child, general partner,
an organization in which the SGE serves as an officer, director,
trustee, general partner, or employee, or an organization with which
the SGE is negotiating or with which the SGE has an arrangement for
prospective employment.
Under this statute, for example, an SGE would be prohibited from
reviewing a grant application submitted by a researcher from the same
university in which the SGE is employed, or a contract proposal from an
association for which the SGE serves as a member of the board of
directors. In these instances, the SGE would be required to recuse from
participation in the reviews.
Section 208 might also prohibit the SGE from participating in
setting standards for grantees or contractors in general, to the extent
that the SGE's university (or any organization with which the SGE is
affiliated as an officer or board member) would be affected by those
standards. (Under this scenario, however, a waiver could be issued to
permit the SGE to participate in such general policy matters. Also, a
regulatory waiver might apply to this situation. See discussion below.)
A waiver for advisory committee members may be granted under 18
U.S.C. 208(b)(3). Section 208(b)(3) authorizes issuance of a waiver
to an SGE who serves on a committee subject to the Federal Advisory
Committee Act if the official responsible for the individual's
appointment certifies in writing that the need for the individual's
services outweighs the potential for a conflict of interest created by
the particular financial interest involved. The waiver granted is
considered a ``general'' waiver, in that it allows participation in
matters that affect all institutions, or types of institutions,
similarly. Even with a general waiver, however, SGEs must disqualify
themselves from participation in all matters that specifically and
uniquely affect their financial interests.
The Designated Federal Official responsible for a committee will
explain the procedures for disqualification. SGEs who do not serve on
advisory committees are subject to more exacting waiver requirements in
18 U.S.C. 208(b)(1), and a Deputy Ethics Counselor should be
consulted.
In addition, under regulations issued by the Office of Government
Ethics, a regulatory (i.e., automatic) waiver of the disqualification
requirement of 18 U.S.C. 208 is available under certain
circumstances, including instances involving the following classes of
financial interests:
interests held in broadly diversified investment funds;
publicly traded securities of $15,000 or less;
publicly traded securities of $25,000 or less if the matter
is a general policy matter and the total value of all
investments in the affected industry sector is no more than
$50,000;
employment in one campus of a multi-campus state university
if the matter affects only another campus and the employee does
not have multi-campus responsibilities.
In addition, there is an automatic exemption which allows SGEs
serving on Federal advisory committees to participate in particular
matters of general applicability where the otherwise disqualifying
financial interest arises solely from the committee member's non-
Federal employment or prospective employment, provided that the matter
will not have a special or distinct effect on the employee or employer
other than as part of a class. This exemption is unavailable if the
employee (or those persons whose interests are imputed to the employee)
owns stock, stock options, or has some other financial interest in the
employer other than his or her employment interest.
18 U.S.C 219. Section 219 prohibits an SGE from acting as an
``agent of a foreign principal'' as defined under the Foreign Agents
Registration Act (FARA) or a ``lobbyist'' on behalf of a foreign entity
that is required to register under the Lobbying Disclosure Act of 1995
(LDA).
The ban on participating in foreign agent activities covered by
FARA prohibits representation of foreign governments or foreign
political parties before the United States Government, as well as a
number of other activities conducted within the United States on behalf
of such entities: (1) political activities; (2) public relations
counseling; (3) publicity agent activities; (4) information services;
(5) political consulting; and (6) solicitation or disbursement of
contributions, loans, money, or other things of value; where such
services are rendered with the intent to influence the American public
or the government, with reference to formulating the domestic or
foreign policies of the United States, or with reference to the
political or public interests, policies or relations of a government of
a foreign country or a foreign political party.
There are certain FARA exceptions related to trade or commerce,
legal representation, humanitarian fundraising, and religious,
scholastic, or scientific pursuits. The head of an agency may authorize
the employment of an agent for a foreign entity as a special government
employee upon a certification that such action is in the national
interest. The LDA ban prohibits certain lobbying of covered legislative
and executive branch officials on behalf of foreign corporations,
associations, or other organizations.
Standards of Ethical Conduct
In addition to criminal statutes, the conduct of SGEs is governed
by a series of ethics rules that apply 24 hours per day and even on
days during which the SGE provides no Federal services. The following
are some of the major Standards of Ethical Conduct regulations (5 CFR
Part 2635) that pertain to HHS SGE advisory committee members during
the term of their appointment:
I. Teaching, Speaking and Writing in a Personal Capacity (i.e., Other
Than as a Government Employee)
Generally, during their term of appointment, committee members may
continue to receive fees, honoraria, and other compensation for
teaching, speaking and writing undertaken in their personal or non-
governmental capacities. However, there are some limitations:
(A) An SGE is prohibited from receiving compensation for
teaching, speaking, and writing that ``relates to the
employee's official duties.'' 5 CFR 2635.807. The
``relatedness'' test is met for an SGE if:
(1) the activity is undertaken as an official
government duty;
(2) the circumstances indicate that the invitation to
engage in the activity was extended to the SGE
primarily because of the employee's position in the
government rather than the employee's expertise in the
particular subject matter;
(3) the invitation to engage in the activity or the
offer of compensation for the activity was extended to
the employee, directly or indirectly, by a person who
has interests that may be affected substantially by the
performance or nonperformance of the employee's
official duties; or
(4) the information conveyed through the activity
draws substantially on ideas or official data that are
confidential or not publicly-available.
(B) Additionally, if a committee member serves for 60 days or
less during a one-year period, the SGE may not accept
compensation for teaching, speaking, and writing if the subject
matter of the teaching, speaking or writing concerns a
particular matter involving specific parties in which the SGE
participated or is participating personally and substantially
as a government employee.
For example, an AIDS researcher has been appointed to a 4
year term as a member of an advisory committee established for
the purpose of surveying and recommending modification of
procedures that deter the development of treatments for HIV
infection and HIV-related diseases. The committee member is not
expected to serve more than 60 days each year during her 4 year
term of appointment.
The committee member may accept compensation for an article
or speech about the deterrent effect of certain procedures
required for clinical investigations and trial designs even
though such issues are being discussed by the advisory
committee. Clinical procedures in general are not a particular
matter involving specific parties. The committee member could
not accept compensation for an article or speech which recounts
committee deliberations that took place in a closed meeting, or
which relies upon other, non-public information. In addition,
the committee member could not accept compensation for an
article or speech about specific collaborations in the HIV drug
development process which were discussed by the committee,
since the collaborations are considered a particular matter
involving specific parties.
(C) If a committee member serves for more than 60 days, the
SGE is additionally prohibited from receiving compensation for
teaching, speaking, and writing if the subject of the activity
deals in significant part with any matter to which the SGE is
presently assigned or was assigned during the previous one-year
period.
Exceptions:
1. This rule does not preclude a committee member from receiving
compensation for teaching, speaking, or writing on a
subject within the committee member's discipline or
inherent area of expertise based on the SGE's educational
background or experience. The outside activity must not be
about or distinctly related to the work the SGE is
providing to the government.
2. These restrictions also do not apply to teaching a course
requiring multiple presentations that is part of the
regularly established curriculum of an institution of
higher education, an elementary or secondary school, or a
program of education or training sponsored and funded by
the Federal, State, or local government.
II. Gifts
Any gift given to a committee member because of the member's
service on an HHS advisory committee would raise concerns. The
Designated Federal Official responsible for the committee should be
consulted should this situation arise. Gifts given to an SGE because of
the SGE's position or achievements in the private (non-government)
sector generally are not problematic.
III. Charitable Fundraising
A committee member may engage in charitable fundraising in a
personal capacity as long as the committee member does not personally
solicit funds or other support from any person or entity known to the
committee member to be a person or entity whose interests may be
substantially affected by the performance or nonperformance of the
committee member's Federal duties. 5 CFR 2635.808. If specific
questions concerning particular fundraising events or activities should
arise, the Designated Federal Official responsible for the committee
should be consulted.
IV. Expert Witness
A committee member cannot serve as an expert witness, in a
proceeding before a United States court or agency in which the United
States is a party or has a direct and substantial interest, except on
behalf of the United States, if the committee member participated,
while a Federal employee, in the particular proceeding, unless
authorized by the HHS Designated Agency Ethics Official (DAEO), who can
be reached at (202) 690-7258.
In addition, a committee member who was appointed by the President,
serves on a commission established by statute, or has served or is
expected to serve for more than 60 days in a period of 365 consecutive
days, cannot serve, other than on behalf of the United States, as an
expert witness, with or without compensation, in any proceeding before
a United States court or agency in which the committee members's
employing agency is a party or has a direct and substantial interest
unless authorized by the DAEO. 5 CFR 2635.805.
V. Impartiality
Although committee members are prohibited under 18 U.S.C. 208(a)
from participating in matters in which they have a financial interest,
there may be other circumstances in which a committee member's
participation in a particular matter involving specific parties would
raise a question regarding the member's impartiality in the matter. For
example, a committee member asked to review a grant application
submitted by the SGE's mentor, or someone with whom the SGE has a close
personal or professional relationship, would raise a concern about the
committee member's impartiality in the review. In such circumstances,
the committee member should discuss the relationship with the
Designated Federal Official responsible for the committee and a
determination will be made as to whether the member should be
disqualified from participation in the specific party matter, or should
be granted an ``authorization'' to permit the member to participate in
such matter. 5 CFR 2635.502.
VI. Misuse of Position
Committee members are subject to a number of prohibitions intended
to address the use, or appearance of use, of ``public office for
private gain.'' 5 CFR Part 2635, Subpart G. These prohibitions include:
(A) Using their HHS titles or referring to their government
positions for their own private gain, the private gain of
friends, relatives, or anyone with whom they are affiliated
in a non-governmental capacity (including nonprofit
organizations which they serve as officers, members,
employees, or in any other business relationship), or for
the endorsement of any product, service, or enterprise.
(B) Using their HHS titles or government positions to coerce or
induce another person to provide any benefit to themselves
or another person.
(C) Using non-public government information in a financial
transaction to further their private interests or those of
another, or disclosing confidential or non-public
information without authorization.
(D) Using government property for unauthorized purposes.
Employment by, or Gifts from, Foreign Governments
The Constitution prohibits a committee member's employment by a
foreign government, including political subdivisions of a foreign
government. For SGEs, this provision has particular relevance to
positions with foreign universities that are government-operated, as
opposed to private institutions. United States Constitution, art. I
9, cl. 8. There are also statutory provisions restricting acceptance of
gifts from foreign governments. 5 U.S.C. 7342. Committee members
should consult with the Designated Federal Official responsible for
their committee for details about these restrictions. Employment or
consultation with a foreign entity for the purpose of providing foreign
agent representation or lobbying is barred by a criminal statute; see
the discussion above concerning 18 U.S.C. 219. All SGEs are required
to complete HHS Form 697, Foreign Activities Questionnaire, for the
purpose of determining whether a committee member's foreign connections
are incompatible with Federal service.
Lobbying Activities
In their official capacities or as a group, committee members are
prohibited from engaging in any activity which directly or indirectly
encourages or directs any person or organization to lobby one or more
members of Congress. 18 U.S.C. 1913. When authorized, committee
members may appear before any individual or group for the purpose of
informing or educating the public about a particular policy or
legislative proposal. Committee members also may communicate to Members
of Congress at the request of any Representative or Senator.
Communications to Members of Congress initiated by committee members,
in their official capacity as members of the committee, should be
coordinated through the Office of the Assistant Secretary for
Legislation.
As private citizens, committee members may express their personal
views (but not the views of the committee as a whole or the opinions of
HHS) to anyone. In doing so, committee members may state their
affiliation with the committee, may factually state the committee's
official position on the matter (to the extent that non-public
information is not used), but may not take new positions and represent
those views as the committee's position on the matter. Moreover, in
expressing their private views, as with all other personal (non-
governmental) activities, committee members are not permitted to use
government computers, copiers, telephones, letterhead, staff resources,
or other appropriated funds. All personal activities must occur ``off
duty time.''
Committee members are prohibited in their personal capacities from
making representations on behalf of others, to the government, on
particular matters involving specific parties in which they were
involved as Federal employees. (See discussion above under 18 U.S.C.
203 and 205.)
Political Activities
The Hatch Act (5 U.S.C. 7321-7326) prescribes the restrictions
on certain political activities of Federal employees (see the
explanatory chart on the following page). Unlike the criminal conflict
of interest statutes and the ethics rules which are fully applicable to
an SGE throughout the SGE's entire term of appointment, the Hatch Act
restrictions apply only during the period of any day in which the SGE
actually is performing government business. For example, if an SGE
attends an advisory committee meeting from 8:00 a.m.-1:00 p.m., the SGE
could attend a political fund raiser at 3:00 p.m. and even solicit
political contributions from the attendees.
A series of criminal political statutes (18 U.S.C. 595, 600-603,
606-607, 610) applies to SGEs even on non-duty hours. These sections,
which focus on patronage crimes and election offenses, prohibit
coercive ``political shakedowns,'' intimidation regarding political
activities, campaign fundraising on Federal property, and the use of
public office or authority for the purpose of affecting the outcome of
an election.
Hatch Act Political Activity Restrictions
------------------------------------------------------------------------
Prohibited Activities (while on
Permissible Activities duty)
------------------------------------------------------------------------
May be candidates for May not use their
public office in nonpartisan official authority to interfere
elections with an election.
May register and vote as May not collect political
they choose. contributions, unless both
May assist in voter individuals are members of the
registration drives. same Federal labor organization
May express opinions about and the one solicited is not a
candidates and issues. subordinate employee.
May contribute money to
political organizations.
May attend and be active at May not knowingly solicit
political rallies and meetings. or discourage the political
May attend political fund activity of any person who has
raising functions. business before the agency.
May join and be an active May not engage in
member of a political party or political activity while on duty.
club. May not engage in
May sign nominating political activity in any
petitions. government office.
May campaign for or against May not engage in
referendum questions, political activity while wearing
constitutional amendments, an official uniform.
municipal ordinances.
May campaign for or against May not engage in
candidates in partisan elections. political activity while using a
government vehicle.
May distribute campaign May not solicit political
literature in partisan elections. contributions from the general
public.
May hold office in May not actively
political clubs or parties (except participate as a candidate for
Treasurer). public office in a partisan
election.
------------------------------------------------------------------------
attachment 4
Initial Meeting Materials
Charge to the 2015 Dietary Guidelines Advisory Committee
The Dietary Guidelines for Americans provide science-based advice
on how nutrition and physical activity can help promote health and
reduce the risk for major chronic diseases. The Guidelines form the
basis of Federal nutrition policy, standards, programs, and education
for the general public. The Dietary Guidelines are published jointly by
the U.S. Department of Health and Human Services and the U.S.
Department of Agriculture every 5 years.
The Dietary Guidelines Advisory Committee (DGAC), whose duties are
time-limited and solely advisory in nature, will:
Examine the Dietary Guidelines for Americans, 2010 and
determine topics for which new scientific evidence is likely to
be available that may inform revisions to the current guidance
or suggest new guidance.
Place its primary focus on the systematic review and
analysis of the evidence published since the last DGAC
deliberations.
Place its primary emphasis on the development of food-based
recommendations that are of public health importance for
Americans ages 2 years and older.
Prepare and submit to the Secretary of Health and Human
Services and the Secretary of Agriculture a report of technical
recommendations, with rationales, to inform the development of
the 2015 Dietary Guidelines for Americans. DGAC
responsibilities include providing authorship for this report;
however, responsibilities do not include translating the
recommendations into policy or into communication and outreach
documents or programs.
Disband upon the submittal of the Committee's
recommendations via the Report of the Dietary Guidelines
Advisory Committee on the Dietary Guidelines for Americans,
2015 to the Secretaries.
Complete all work within the required 2 year charter time
frame.
(Accessed December 10, 2015.)
attachment 5
Charter
2015 Dietary Guidelines Advisory Committee Authority
The 2015 Dietary Guidelines Advisory Committee (the Committee or
2015 DGAC) is authorized under 42 U.S.C. 217a, Section 222 of the
Public Health Service Act, as amended. The Committee is governed by
provisions of the Federal Advisory Committee Act (FACA), Public Law 92-
463, as amended (5 U.S.C., App.), which sets forth standards for the
formation and use of advisory committees.
Objectives and Scope of Activities
Under Section 301 of Public Law 101-445 (7 U.S.C. 5341, the
National Nutrition Monitoring and Related Research Act of 1990, Title
III) the Secretaries of Health and Human Services (HHS) and Agriculture
(USDA) are directed to jointly issue at least every 5 years a report
entitled Dietary Guidelines for Americans. The law instructs that this
publication shall contain nutritional and dietary information and
guidelines for the general public, shall be based on the preponderance
of scientific and medical knowledge current at the time of publication,
and shall be promoted by each Federal agency in carrying out any
Federal food, nutrition, or health program. The Dietary Guidelines for
Americans was issued voluntarily by HHS and USDA in 1980, 1985, and
1990; the 1995 edition was the first statutorily mandated report,
followed by subsequent editions at the appropriate intervals.
The 2015 DGAC is established to provide independent, science-based
advice and recommendations for development of the Dietary Guidelines
for Americans, 2015, which forms the basis of Federal nutrition
programs, nutrition standards, and nutrition education for the general
public. A variety of services and tools will be made available to the
Committee to support development of recommendations that promote health
and reduce chronic disease risk for Americans. The USDA Nutrition
Evidence Library will assist the Committee in conducting and creating a
transparent database of systematic reviews reflecting the most current
research available on a wide range of food and nutrition-related topics
to inform its recommendations.
Description of Duties
The work of the Committee will be solely advisory in nature and
time-limited. The Committee will examine the current Dietary Guidelines
for Americans, take into consideration new scientific evidence and
current resource documents, and then develop a report to be submitted
to the Secretaries that outlines its science-based recommendations and
rationale which will serve as a basis for developing the eighth edition
of Dietary Guidelines for Americans.
Agencies or Officials to Whom the Committee Reports
The HHS Assistant Secretary for Health and USDA Under Secretaries
of the Food, Nutrition, and Consumer Services (FNCS) and Research,
Education and Economics (REE) will provide guidance and oversight for
the Committee's function and activities.
Support
Management and support services for the 2015 DGAC primarily will be
provided by the Office of Disease Prevention and Health Promotion
(ODPHP) within the Department of Health and Human Services. The ODPHP
is a program office within Office of the Assistant Secretary for Health
(OASH), which is a staff division in HHS Office of the Secretary.
Responsibility for administrative services will be shared with staffs
of the USDA FNCS and REE. USDA administrative leadership and Nutrition
Evidence Library support will come from the Center for Nutrition Policy
and Promotion within FNCS. REE agencies will provide administrative and
data analysis support.
Estimated Annual Operating Costs and Staff Years
The estimated annual HHS cost for operating the DGAC, including
travel and per diem expenses for members, but excluding staff support
is $400,000. It is estimated that the annual person-years of HHS staff
support required is 4.4 FTEs, at an estimated cost of $430,000.
Designated Federal Officer
The HHS Assistant Secretary for Health will appoint two Co-
Executive Secretaries from HHS, one of whom will serve as the
Designated Federal Officer (DFO). USDA Under Secretaries of FNCS and
REE will appoint two Co-Executive Secretaries from USDA, one from the
Center for Nutrition Policy and Promotion, who will serve as the lead
for USDA, and the other from the Agricultural Research Service.
Since HHS has responsibility for providing management support for
the 2015 DGAC, the HHS Co-Executive Secretaries will, in collaboration
with the USDA Co-Executive Secretaries, schedule and approve all
meetings of the 2015 DGAC, and make logistical arrangements that are
necessary for public meetings of the 2015 DGAC, including meetings of
any established subgroups. The DFO, in collaboration with the USDA Co-
Executive Secretaries, will prepare and approve all meeting agendas;
development of the meeting agenda also can include consultation with
the Committee Chair.
The DFO or other official to whom the authority has been delegated
will be present at all meetings of the full Committee and any subgroups
that have been established to assist the Committee. The DFO has
authority to adjourn meetings, when it is determined to be in the
public interest, and may also chair the committee meetings when
directed to do so by the Assistant Secretary for Health and/or other
authorized official.
Estimated Number and Frequency of Meetings
It is estimated that the 2015 DGAC will meet approximately five
times during the projected period for its operation. More meetings will
be held if it is necessary to accomplish the mission of the Committee
and funds are available to support additional meetings. It is required
that \2/3\ of the appointed members be present for the Committee to
meet to conduct business. Meetings will be open to the public, except
as determined otherwise by the Secretaries of HHS and USDA or other
official to whom this authority has been delegated, in accordance with
guidelines under Government in the Sunshine Act at 5 U.S.C. 552b(c) and
the FACA. Notice of all meetings will be provided to the public.
Meetings will be conducted and records of the proceedings will be kept,
as required by applicable laws and Departmental policies.
Duration
The 2015 DGAC is established to accomplish a single, time-limited
task. It is expected that the Committee will complete the mission for
which it was established within two years from the date this charter is
filed.
Termination
Unless renewed by appropriate action prior to its expiration, the
2015 DGAC will terminate after delivery of its final report to the
Secretaries of HHS and USDA or 2 years from the date this charter is
filed, whichever comes first.
Membership and Designation
The 2015 DGAC will consist of not more than 17 members, with the
minimum number being 13; one or more members will be selected to serve
as the Chair, Vice Chair, and/or Co-Chairs. Individuals will be
selected to serve as members of the Committee who are familiar with
current scientific knowledge in the field of human nutrition and
chronic disease. Expertise will be sought in specific specialty areas
that may include but are not limited to cardiovascular disease; type 2
diabetes; overweight and obesity; osteoporosis; cancer; pediatrics;
gerontology; maternal/gestational nutrition; epidemiology; general
medicine; energy balance, which includes physical activity; nutrient
bioavailability; nutrition biochemistry and physiology; food processing
science, safety and technology; public health; nutrition education and
behavior change; and/or nutrition-related systematic review
methodology.
Members will be invited to serve for the duration of the Committee.
Individuals who are appointed to serve as members of the Committee will
be jointly agreed upon by the Secretaries of HHS and USDA. All
appointed members of the 2015 DGAC will be classified as special
government employees (SGEs).
Pursuant to an advance written agreement, the appointed members
will receive no compensation for the advisory service they render
during their tenure on the 2015 DGAC. However, as authorized by law and
in accordance with Federal travel regulations, members of the 2015 DGAC
will receive per diem and reimbursement for travel expenses incurred
while performing duties and/or conducting business related to the
Committee.
Subcommittees/Working Groups
To accomplish its mission, and with approval of the official to
whom authority has been given, the 2015 DGAC may establish
subcommittees and/or working groups that are composed of members of the
parent committee and non-member special consultants and/or individuals
with demonstrated expertise in the specialty areas designated for the
Committee membership.
The established subgroups will provide advice and/or make
recommendations to the parent committee. All reports and
recommendations developed by an established subgroup of the 2015 DGAC
must be submitted to the parent committee for the appropriate action to
be taken. An established subgroup may not report its findings to any
Federal official unless there is specific statutory authority for such
reporting.
The Department Committee Management Officer will be notified if any
subgroup is established for the 2015 DGAC, and will be provided
information regarding the name of the subgroup, function, membership,
and estimated frequency of meetings.
Recordkeeping
Records of the Committee and any established subgroup will be
handled in accordance with General Records Schedule 26, Item 2 or other
approved agency records disposition schedule. These records will be
made available to the public for inspection and copying, subject to the
Freedom of Information Act, 5 U.S.C. 552.
Filing Date: February 19, 2013
Approved
January 9, 2013 //s//
Date Kathleen Sebelius