[Senate Hearing 113-331]
[From the U.S. Government Publishing Office]
S. Hrg. 113-331
ENERGY DRINKS: EXPLORING CONCERNS
ABOUT MARKETING TO YOUTH
=======================================================================
HEARING
before the
COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
JULY 31, 2013
__________
Printed for the use of the Committee on Commerce, Science, and
Transportation
______
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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
JOHN D. ROCKEFELLER IV, West Virginia, Chairman
BARBARA BOXER, California JOHN THUNE, South Dakota, Ranking
BILL NELSON, Florida ROGER F. WICKER, Mississippi
MARIA CANTWELL, Washington ROY BLUNT, Missouri
MARK PRYOR, Arkansas MARCO RUBIO, Florida
CLAIRE McCASKILL, Missouri KELLY AYOTTE, New Hampshire
AMY KLOBUCHAR, Minnesota DEAN HELLER, Nevada
MARK WARNER, Virginia DAN COATS, Indiana
MARK BEGICH, Alaska TIM SCOTT, South Carolina
RICHARD BLUMENTHAL, Connecticut TED CRUZ, Texas
BRIAN SCHATZ, Hawaii DEB FISCHER, Nebraska
MARTIN HEINRICH, New Mexico RON JOHNSON, Wisconsin
EDWARD MARKEY, Massachusetts JEFF CHIESA, New Jersey
Ellen L. Doneski, Staff Director
James Reid, Deputy Staff Director
John Williams, General Counsel
David Schwietert, Republican Staff Director
Nick Rossi, Republican Deputy Staff Director
Rebecca Seidel, Republican General Counsel and Chief Investigator
C O N T E N T S
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Page
Hearing held on July 31, 2013.................................... 1
Statement of Senator Rockefeller................................. 1
Statement of Senator Thune....................................... 6
Statement of Senator Blumenthal.................................. 25
Statement of Senator Markey...................................... 26
Witnesses
Hon. Richard Durbin, U.S. Senator from Illionis.................. 3
Report dated April 10, 2013 entitled ''What's all the Buzz
about'' written by the staff of Congressman Edward J.
Markey (D-MA) in coordination with the staff of Senators
Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT)..... 8
Marcie Beth Schneider, MD, FAAP, on behalf of the American
Academy of Pediatrics.......................................... 27
Prepared statement........................................... 29
Jennifer L. Harris, Ph.D., MBA, Senior Research Scientist,
Director of Marketing Initiatives, Rudd Center for Food Policy
& Obesity, Yale University..................................... 45
Prepared statement........................................... 46
William R. Spencer, M.D., Suffolk County Legislator.............. 91
Prepared statement........................................... 92
Rodney Sacks, Chairman and Chief Executive Officer, Monster
Beverage Corporation........................................... 112
Prepared statement........................................... 113
Amy Taylor, Vice President and General Manager, Red Bull North
America, Inc................................................... 136
Letter dated July 30, 2013 to Hon. John D. Rockefeller IV and
Hon. John R. Thune from Stefan Kozak, Chief Executive
Officer, Red Bull North America, Inc....................... 137
Prepared statement........................................... 141
Janet Weiner, Chief Operations Officer and Chief Financial
Officer, Rockstar, Inc......................................... 144
Prepared statement........................................... 146
James R. Coughlin, Ph.D., President, Coughlin & Associates....... 200
Prepared statement........................................... 202
Letter dated March 13, 2013 to Hon. Edward Markey from Mark A.
Emmert, President, National Collegiate Athletic Association.... 224
Letter dated March 7, 2013 to Hon. Richard J. Durbin, Hon.
Richard Blumenthal, and Hon. Edward J. Markey from Robert B.
Gardner, Executive Director, National Federation of State High
School Associations............................................ 226
Appendix
Fact Sheet from the Council for Responsible Nutrition to the U.S.
Senate Committee on Commerce, Science, and Transportation...... 239
Recommended Guidelines from the Council for Responsible Nutrition
to the U.S. Senate Committee on Commerce, Science, and
Transportation................................................. 242
Red Bull North America's Statement Supplementing the Record of
the U.S. Senate Committee on Commerce, Science &
Transportation's July 31, 2013 Hearing on Energy Drinks:
Exploring Concerns About Marketing to Youth.................... 244
ENERGY DRINKS: EXPLORING CONCERNS ABOUT MARKETING TO YOUTH
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WEDNESDAY, JULY 31, 2013
U.S. Senate,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Committee met, pursuant to notice, at 2:55 p.m., in
Room SR-253, Russell Senate Office Building, Hon. John D.
Rockefeller IV, Chairman of the Committee, presiding.
OPENING STATEMENT OF HON. JOHN D. ROCKEFELLER IV,
U.S. SENATOR FROM WEST VIRGINIA
The Chairman. The Senate is the Senate. The person at the
witness table knows that better than anybody. Are you going to
do anything with those things? Is that an exhibition, or are
you going to show us your--you are? OK.
All right. Let me just explain to the witnesses and to the
faithful audience. It is hard to get people confirmed around
here, and so it always come down to--often comes down to when a
single member is missing or not findable that everything stops,
and the whole world tries to get that person, find that person.
And so, that is the situation we are in now.
If she is found and does vote, which I don't think will be
probable, then we will--I will have to go back and do another
vote, make your life even worse.
However, Senator Durbin is here, and Senator Blumenthal is
here, and Senator Markey is going to be here. And what I want
to do, because those three have been so incredible on this
whole subject, they put out a report, the three of them, which
is called ``What's All the Buzz About?'' And you understand
what I mean by ``buzz.'' I mean this is a different kind of
buzz.
And they did this some months ago. It is a fabulous report,
and it is all about targeting marketing to adolescents of
things which should not be targeted or marketed to them.
So what I am going to do is make my statement and then
listen to my leader, Richard Durbin, who has been working very,
very strongly, as I indicated, on this. And then I am going to
turn the gavel over to Senator Blumenthal. Not because I want
to, but because the thought of him having the gavel, presiding
over something in which he and Senator Markey have been so
committed and so dedicated for so long is the only proper thing
to do.
So I will fade into the distance, and you will forget that
you ever heard me or saw me.
[Laughter.]
The Chairman. So my statement. Today's hearing is going to
look at a product that it has been growing very rapidly in
popularity in the last few years. It is not the Congress,
actually, I am talking about. It is energy drinks, energy
drinks.
While energy drink companies have aggressively marketed
their products on television, social media, and event
sponsorship, public health experts have been raising some
serious, disturbing questions about these drinks. They are
asking whether we should be letting our children drink energy
drinks and whether energy drink companies should be able to
market their products to children and to teenagers, two fairly
basic questions.
In the meantime, if you watch TV, you just--every other TV
ad is either about a car, which is fine, or about one of these
drinks, which is less fine. I think these are important
questions, and I am going to be listening to those who are
asking some of them.
So here are just two facts about energy drinks. As energy
drink marketing and sales to children has increased, there has
been a surge in emergency room visits associated with energy
drinks. And in the first 6 months of this year, poison control
centers received 1,500 reports involving energy drinks, more
than half of which involved children under the age of 18.
So these are two frightening statistics. Pediatricians and
other medical experts have been saying that high levels of
caffeine found in many of these drinks may pose health risks to
young people, such as heart arrhythmias, increased blood
pressure, and dehydration. And again, that is scary stuff.
In fact, a recent clinical report published by the American
Academy of Pediatrics states, ``Rigorous review and analysis of
the literature reveal that caffeine and other stimulant
substances contained in energy drinks have no place in the diet
of children and adolescents.'' So that is what we are hearing
from pediatricians.
And just last month, the American Medical Association
approved a resolution endorsing a ban on marketing energy
drinks to children and teens. They don't do that often. They
did that on this.
That brings us to the question before us. How are companies
marketing energy drinks to younger people? What are their
techniques? And are energy drink companies listening to the
medical experts who are increasingly worried about what these
drinks may be doing to our kids? Is there any talk back and
forth?
Two members of this committee, Senators Blumenthal and
Markey, along with Senator Durbin, have been leading the way in
examining the marketing practices of major energy drink
companies for a long time. And I honor them for their work.
Their investigation found that while energy drink companies say
they do not market to children, adolescent consumer products
are frequent targets for energy drink marketing practices. We
know that.
Similarly, marketing experts at the Rudd Center on Food
Policy and Obesity at Yale University have raised concerns
about energy drink marketing practices that are reaching teens
in high percentages relative to adults. For example,
disturbingly, many energy drinks are now sold in large,
nonresealable containers holding two to three servings that
encourage high-volume consumption in one sitting. Clever, isn't
it? Helpful, it is not.
To explore the nature and extent of energy drink marketing
efforts reaching children and teens, the Committee recently
requested information from leading energy drink companies about
marketing practices that reach young audiences. The information
we received from these companies, along with publicly available
information, supports the findings of Senators Blumenthal,
Markey, and Durbin, as well as other marketing experts, that a
number of companies are using marketing techniques highly
appealing to teens, deliberately appealing to teens.
We know that some companies sponsor athletes as young as 13
or 14 years and make them a public face for the company. These
young athletes are featured wearing the logos of the company in
photos and videos on the company's Website and through social
media channels. The question I want us to get at in this
hearing is whether this is responsible corporate behavior.
Today, we will learn more about these issues from public
health and marketing experts as well as several leading energy
drink companies. In the next few weeks, I understand that the
Institute of Medicine, the Department of Health and Human
Services, and other leading health agencies are convening
public panels to review the health effects of these drinks. In
my judgment, this problem is crying out for that kind of
credible scientific review, and I am glad it is happening in
the immediate aftermath of this hearing.
Without further pause and with the permission of Senator
Blumenthal, I would like to call on Senator Richard Durbin from
Illinois.
STATEMENT OF HON. RICHARD DURBIN,
U.S. SENATOR FROM ILLINOIS
Senator Durbin. Thank you very much, Mr. Chairman.
I want to commend you, Chairman Rockefeller and Senator
Blumenthal, for your leadership in convening this hearing on
this important issue, and I want to thank you for allowing me
to make a statement.
Ten years ago, most of the people in this room would have
never heard of an energy drink. Well, times have changed. By
some estimates, the sale of energy drinks has risen by 60
percent over the past 5 years. Energy drinks are now a common
fixture in grocery stores, vending machines, and convenience
stores.
I would really challenge anybody in this room to go to
their favorite gas station and stand at the cash register, and
if you cannot reach an energy drink as you stand there, I will
be shocked. Throughout Illinois, whether it is Chicago or
Springfield, they are as close to the register, as close to the
consumer as possible.
And as the sale of energy drinks has grown, so has the
alarming evidence that they pose potential health risk, and the
energy drink market has grown to its current size because it is
marketing to children and adolescents. Scientific studies have
concluded that consuming large amounts of caffeine can have
serious health risks, such as seizures, heart arrhythmias, and
in some cases death.
In our audience today is Wendy Crossland. She is the mother
of a 14-year-old, Anais Fournier, who died in Maryland after
consuming two 24-ounce cans of Monster energy drink. I met with
Mrs. Crossland. It is a heartbreaking story.
Scientific studies have concluded that consuming these
drinks are dangerous. Organizations committed to the well-being
of children and adolescents, such as the American Academy of
Pediatrics, the American Medical Association, the National
Federation of State High School Associations, and the NCAA,
discourage kids from drinking energy drinks. In fact, the
American Academy of Pediatrics stated that energy drinks have
no place in the diet of children and adolescents.
A recent article in an official AAP journal said, ``Given
the unknown levels of caffeine and other poorly studied
additives in energy drinks, there is significant risk
associated with energy drink consumption and may outweigh the
benefits in the adolescent consumer.''
Warnings from AAP are echoed by a recent SAMHSA study,
which found that between 2007 and 2011 emergency room visits
related to the consumption of energy drinks doubled, from
10,000 to 20,000. In the first 6 months of this year, the
American Association of Poison Control Centers, in the first 6
months, have already received 1,575 reports related to energy
drinks; 988 of those reports--over half--involve children under
the age of 18.
Many of the health concerns about energy drinks are due to
their high levels of caffeine and ingredients that act as
stimulants. The FDA currently limits the level of caffeine in a
soda to no more than 71 milligrams of caffeine in a 12 ounce
can. Compare that to 240 milligrams of caffeine in a 24 ounce
can of Monster Energy.
But as we all know, most energy drinks are not sold in 12
ounce cans. They are sold in 16, 24, even 32 ounce containers.
These are two, Monster and Rockstar. Twenty-four ounce cans.
Just one of these cans contains 240 milligrams of caffeine.
These cans are sold in convenience stores right next to the
Gatorade and soft drinks, but just one of these cans contains
the same amount of caffeine as almost seven cans of soda, which
we have displayed here on the table. They each contain 35
milligrams apiece. They are restricted and regulated in terms
of what they can contain. But this one can contains more
caffeine and is for sale right next to them.
Keep in mind that some adolescents consume more than one
energy drink in a 24 hour period and that each of these drinks
contain not only caffeine, but additives and stimulants, such
as guarana and ginseng. I was reading the ingredients on this
Monster label while we were getting ready for this hearing. It
contains both of the things I just noted.
Although many of these ingredients have been used for
years, energy drinks combine them in new ways and at higher
doses. On top of that, energy drink companies urge people to
``chug down,'' ``throw it back,'' ``pound it down'' when it
comes to their products and to consume them before, during, or
after physical activity to enhance performance. As a result,
younger and younger people in America are exposed to higher and
higher levels of stimulants in a short window of time and in
new ways, compared to how people have traditionally consumed
caffeinated hot drinks or beverages.
Now let us get to the issue of marketing. Across the board,
makers of energy drinks say consistently that they do not
market their products to children, Senator. But then you hear
about the samples of energy drinks being distributed where
teens hang out--sporting events, concerts, local parks, even
SAT prep courses.
You can go to their websites and see that energy drink
makers sponsor athletes as young as 10 years of age. You can't
see this cover from where you are sitting, but this is a
publication up here called ``Red Bulletin'' put out by Red Bull
that makes some of these energy drinks. They are insisting to
us they don't market to children. Take a look at that cover.
That is a 12-year-old boy on that cover.
Enzo Lopes is a Motocross athlete. He has been signed by
Red Bull to promote their product. Do you think that he appeals
to older people? He appeals to kids his own age. That is what
it is all about.
Some of us--Senator Blumenthal, now Senator Markey, even
Senator Rockefeller--we were all veterans of the tobacco wars,
fought in different theaters, but we were fighting in that same
war. Remember when the tobacco companies used to tell us, oh,
we are not interested in kids? We knew better. We knew if they
could get them hooked early on, it would become an addiction
and one hard to break.
We are getting the same run-around from these energy drink
companies. They are openly, openly advertising to kids and
denying it. Companies use highly effective tools to reach
kids--video games on their websites, social media, flashy ads,
and claims to increase attention, stamina, and help with
hydration and building muscle.
Contrary to industry claims that they don't market to
children, we can see they do. And sadly, sadly, it is working.
According to a 2011 study, 35 percent--1 out of 3--eighth
graders recently consumed energy drinks, and 18 percent drank
more than 1 a day.
Here is a photo from an event sponsored by Monster Energy
as part of the Monster Army Recon Tour. I think you can see
that up there, which moves across the country to identify
talented athletes, including children under the age of 12. This
photo features kids as young as 7 years of age who won the
local competition that was sponsored by this company, this
Monster beverage company. It is hard to believe the claims of
Monster, Red Bull, and Rockstar that they don't market to
children and look at the obvious marketing that is going on
right now.
When energy drink makers say they don't market to children,
maybe they mean they don't market to kids under 12. This image
clearly suggests marketing to children, but I want to make a
separate point. I am also deeply concerned about marketing to
adolescents between the ages of 12 and 18.
I have been through this battle before. We talked about
tobacco. I have been through this battle with Ephedra. When a
16-year-old kid in Lincoln, Illinois, wanted to get ``powered
up'' for a high school football game, went to his local gas
station and bought some of these stimulant pills, energy pills,
poor kid died from just taking pills that you can buy over the
counter at a gas station that contained that chemical.
These companies know what they are doing. They have got
kids with disposable income who are swayed by advertising and
can get hooked on their product. Public health experts across
the country have stated concerns about the health risks of
highly caffeinated beverages for adolescents.
Last month, the AMA adopted a policy supporting a ban on
the marketing of energy drinks to adolescents under the age of
18. Now I have joined with Senators Blumenthal and Markey to
urge energy drink makers to adopt policies prohibiting
marketing to adolescents up to the age of 18.
This hearing provides an important opportunity to discuss
health and marketing when it comes to these energy drinks and
kids. I look forward to working with you and the public health
community and even the industry, the responsible elements in
this industry, to take the necessary steps to protect our
children and adolescents.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Durbin, for your totally
focused and intense presentation. You at your best.
Senator Durbin. Thanks.
The Chairman. Now I want to call on Senator Thune, and then
we will proceed as I indicated before.
STATEMENT OF HON. JOHN THUNE,
U.S. SENATOR FROM SOUTH DAKOTA
Senator Thune. Thank you, Mr. Chairman.
I want to thank you for holding this hearing and want to
extend a thank you to all the witnesses. I understand we are
going to have seven witnesses on the panel today. I am not sure
I remember a time when we have had seven witnesses on one
panel. So I am sure it will be informative and lively and, with
all the cans that are on the table, energetic, I would say,
too.
And let me just say that ensuring the health of our
children is a priority for all of us. And so, we all take that
responsibility very seriously.
The energy drink industry is remarkably fast growing, with
American sales of energy drinks reaching $8.6 billion in 2012,
which is about 12 times their level a decade ago, according to
a recent article in The Economist. This rapid growth, however,
has contributed to closer scrutiny of the industry and its
products.
Concerns about the levels of caffeine in energy drinks and
the possible effects on children and adolescents who consume
these products have prompted several studies and
investigations. And while it is entirely appropriate to examine
these issues, we should also consider the broader context
regarding caffeinated products.
Caffeine has been consumed for thousands of years, and I am
sure most of us on this committee and in the Senate take
advantage of it once in a while to get through our days. It is
found in beverages such as coffee, tea, soft drinks, and in
products containing cocoa and chocolate. But when I hear that
caffeine may now be added to products as diverse as potato
chips and marshmallows, I have to wonder whether our
fascination with caffeine has gone too far.
Some of our witnesses today will also note that certain
energy drinks may contain other stimulants in addition to their
caffeine content and that the combination raises additional
concerns. And so, I look forward to the witnesses' discussion
on this point as well.
The industry has shared with the Committee that most
commonly sold energy drinks contain about half the caffeine of
a similarly sized cup of coffeehouse coffee. For example, we
are told that a typical 16 ounce can of one energy drink
contains about 180 milligrams of caffeine. By comparison, my
understanding is that a typical 16 ounce cup of coffee from a
coffeehouse contains about 330 milligrams of caffeine.
According to the FDA, most healthy adults can safely
consume up to 400 milligrams of caffeine per day, but children
can safely only consume between 45 and 85 milligrams of
caffeine per day, depending on their weight.
Few would challenge the statement that children should not
be consuming highly caffeinated energy drinks. So I look
forward to hearing about the steps that the companies
represented here today are taking to ensure their products are
safe, as well as the efforts that they are undertaking to
ensure their products are marketed appropriately.
Protecting the health of our children is very important. I
believe it is also important to rely on good science, careful
investigation, and accurate evaluations when assessing the
possible health risks of energy drinks and other products.
Given the broader context regarding the safety of caffeine
and its sometimes significant use in non-energy drink
beverages, it also seems appropriate that any discussion of the
scientific determinations about safe levels of caffeine should
examine the consumption of caffeine from a variety of products,
not just energy drinks. I hope that the testimony and evidence
put forward today is examined thoughtfully and within that
larger context.
Mr. Chairman, thank you again for holding this hearing, and
I look forward to hearing from our witnesses.
I thank the Senator from Illinois for being here.
The Chairman. Thank you. Thank you very much, Senator
Thune.
I ask unanimous consent to place this [What's All the Buzz
About? A Survey of Popular Energy Drinks Finds Inconsistent
Labeling, Questionable Ingredients and Targeted Marketing to
Adolescents, A report written by the staff of Congressman
Edward J. Markey (D-MA) in coordination with the staff of
Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-
CT)] in the hearing record, and I don't hear any objections.
Nor would I have heard, were there to have been any.
[Laughter.]
``Whats all the Buzz About? A Survey of Popular Energy Drinks Finds
Inconsistent Labeling, Questionable Ingredients and Targeted Marketing
to Adolescents''--A report written by the staff of Congressman Edward
J. Markey (D-MA) in coordination with the staff of Senators Richard J.
Durbin (D-IL) and Richard Blumenthal (D-CT)
Table of Contents
Executive Summary
Findings in Brief
Recommendations
Background
Investigation
Findings
Finding #1
Finding #2
Finding #3
Finding #4
Finding #5
Conclusions and Recommendations
List of Tables and Figures
TABLE 1: Key differences between the Federal regulation of
dietary supplements and beverages
TABLE 2: Energy drinks, even those produced by the same
company, are represented inconsistently in the market as both
dietary supplements and regular beverages
TABLE 3: Energy drinks contain a varied amount of caffeine that
is inconsistently represented on the label
FIGURE 1: Comparison of similar sized energy drink caffeine
concentrations
TABLE 4: Company responses on marketing practices and warning
labels included on energy drink products
TABLE 5: Energy drinks make a range of advertising claims
relating to functional benefits
TABLE 6: Ingredients commonly used in energy drink products
______
Executive Summary
The term ``energy drinks'' generally represents a class of products
in liquid form that contains high levels of caffeine frequently
combined with other stimulants and specialty ingredients. The spike in
the number of energy drinks in the marketplace and the frequency in
which these products are marketed to children and teens raises serious
questions, both about the safety of this class of products and whether
they fulfill their claims to consumers.
Recently, the Food and Drug Administration (FDA) released a series
of adverse event reports of illness, injury and death allegedly linked
to the consumption of products marketed as energy drinks. The FDA also
is currently investigating energy drinks. The Department of Health and
Human Services recently issued a report that emergency room visits
related to energy drinks doubled from 10,000 to 20,000 visits between
2007 and 2011.
To address growing concerns over energy drinks, the marketing of
these products to children and provide more information about the
ingredients used in these products, Representative Edward J. Markey (D-
MA) and Senators Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT)
launched an investigation into the practices of fourteen commonly sold
energy drink brands. This report presents the information gathered in
response to this investigation and places it in the context of the
current regulatory structure for energy drink products.
Findings in Brief
Various marketing, labeling and ingredient disclosure
requirements are applied to energy drinks, sometimes
inconsistently. As a result, nearly identical energy drinks can
be marketed and represented to consumers differently, leading
to consumer confusion and a lack of transparency.
Four out of the 14 companies surveyed classify and
market one or more of its products as dietary supplements,
as opposed to conventional beverages.
The beverage company Arizona produces several energy
drink products, but although the products come in similar
sizes and caffeine concentrations, half of the products
disclose caffeine concentrations on the label, while the
other half do not.
Both Monster Beverage Corporation and Rockstar Inc.,
recently switched classification of their energy drinks
from dietary supplements to beverages, resulting in some
products being marketed, represented, regulated and labeled
as dietary supplements and some as conventional beverages
despite their identical compositions.
Energy products come in a range of sizes, with various
amounts of caffeine that exceed what has been previously
recognized as safe by the FDA for soda beverages (approximately
71 milligrams of caffeine per 12 ounces). Despite these
elevated levels, concentrations of caffeine are not uniformly
represented on the label of the brands evaluated.
Of the 14 companies, Coca-Cola's NOS energy drink
product contains the most caffeine at 260 milligrams per 16
ounce can, while Target's Archer Farms energy drink
contains just 70 milligrams in 16 ounces.
Monster's Worx Energy shot contains 200 milligrams of
caffeine in just 2 ounces, but the level of caffeine is not
disclosed on the label. In contrast, Arizona Energy Fast
shot contains 113 milligrams of caffeine in 2 ounces and
discloses the caffeine on the label.
Rockstar energy drink contains 240 milligrams of
caffeine in 16 ounces, but because the company is
undergoing a change in labeling practices, only some cans
currently on the market present the amount of caffeine on
the label.
All 14 companies stated that they do not market energy
drinks to children. However, there is clear evidence that
adolescent consumers are frequent targets for the marketing
pitches of energy drink companies. The use of unconventional
marketing practices combined with product design and placement
on store shelves assists in creating product images that appeal
to children and teens.
Companies such as Monster Beverage Corporation and
Rockstar Inc, focus on youth-oriented social media
advertising as well as sponsoring events and athletes that
cater to high school-aged students.
Monster Beverage Corporation produces a range of
products meant to mimic frequently consumed alcoholic
beverages and which appear to be intended for audiences
that are not old enough to consume alcohol legally.
Energy drink companies make a range of advertising claims
related to the functional benefits of their products that are
not generally evaluated or substantiated by the FDA. Some of
these claims appear to be targeted to young audiences or
student athletes. However, the National Collegiate Athletic
Association, National Federation of High Schools, and American
Academy of Pediatrics have all warned of the risks these
products play, particularly for children and student athletes.
PepsiCo's AMP Energy Boost claims that it will help
``energize and hydrate the body,'' while Coca-Cola's NOS
promises ``50 percent more focus''.
Monster energy pledges that its products will provide
a ``big, bad buzz.''
Dr. Pepper's Venom highlights its products ability to
improve ``up to the nanosecond performance.''
Red Bull claims ``increased concentration and reaction
speed'' and ``stimulated metabolism.''
In addition to caffeine, energy drinks contain a myriad of
specialty ingredients whose combinations and additive impacts
are not thoroughly evaluated or well understood. Companies can
and often do self-determine that ingredients are safe for use
in energy drinks, and there is no requirement for companies to
notify the FDA of this determination or the use of the
ingredient. Moreover, much like caffeine, companies can choose
whether they want to disclose the amount of these other
ingredients on the product label.
Nearly all energy drinks surveyed contain taurine, an
amino acid that has not been approved as a food additive by
the FDA, but has been self-determined by energy drink
companies to be safe for inclusion in its products.
In addition to caffeine, energy drinks combine other
stimulants such as ginseng, guarana, green tea and, less
frequently, methylated xanthine (as in 5-hour Energy), a
synthetic stimulant.
Recommendations
There are a number of steps that energy drink manufacturers should
take to improve transparency and representation of this class of
products as well as ensure that children and teens are adequately
protected from deceptive advertising practices. Energy drink
manufactures should immediately:
1. Label products with a clear description of the total amount of
caffeine (in milligrams) added to the product from all sources.
For products that are packaged in non-resealable containers
(such as pop-top cans), the label should include the amount of
caffeine from all sources in the entire container, not just one
serving.
2. For products that contain caffeine that has been intentionally
added to the product at levels above 200 parts per million
(approximately 71 milligrams per 12 fluid ounces), the level
affirmed as GRAS by the FDA, display a prominent precautionary
statement that at a minimum says, ``This product is not
intended for individuals under 18 years of age, pregnant or
nursing women or for those sensitive to caffeine. Consult with
your doctor before use if you are taking medication and/or have
a medical condition.''
3. Cease marketing of energy drink products to children and teens
under the age of 18. Marketing includes use of both traditional
media and social media as well as the sponsorship of events,
activities and individuals that are intended for an audience
comprised primarily of children or teens.
4. Report to the FDA the receipt of any serious adverse events
associated with energy drink use. Serious adverse events are
defined by the FDA, but reporting is currently only required by
the FDA for products that are represented as dietary
supplements.
Background
In the past few years, there has been an explosion in the
consumption of a class of beverage products, known collectively as
energy drinks, which carry a unique set of risks for adolescents.
Although the term ``energy drink'' is not defined by the Food and Drug
Administration (FDA), the primary entity responsible for the safety,
labeling and ingredients present in the food supply, it generally
represents a class of products in liquid form that contains high levels
of caffeine and, typically also includes, additional ingredients not
found in sodas and juice drinks.
Energy drinks have become a multibillion-dollar business, with
steadily increasing sales that rose 16 percent in 2012 alone, amounting
to a U.S. sales market worth more than $12.5 billion.\1\ Consumption of
energy drinks by children and teens has been a growing trend; a 2012
study of U.S. high school students revealed that energy drinks
represented 8.8 percent of the sugar-sweetened beverages they
consumed.\2\ Another U.S. study found that 31 percent of 12-17 year
olds regularly drink energy drinks, in comparison to 22 percent of 25-
35 year-olds.\3\
---------------------------------------------------------------------------
\1\ Energy Drinks and Shots: U.S. Market Trends, Packaged Facts,
Feb. 11, 2013
\2\ Park, S., Blanck, H.M., Sherry, B., Brener, N. and O'Toole, T.
(2012) Factors associated with sugar-sweetened beverage intake among
united states high school students. Journal of Nutrition 142(2): 306-
312
\3\ Simon, M. and Mosher, J. (2007) Alcohol, Energy Drinks, and
Youth: A Dangerous Mix. California: Marin Institute.
---------------------------------------------------------------------------
The proliferation of energy drinks is largely related to the
tailored marketing and claims made by these products, which promise
outcomes such as improved athletic performance, reaction time and
increased attention and alertness. Energy drink companies rely on added
sugars and caffeine in the effort to fulfill these promises. However,
both the high levels of caffeine and the mixture of other unique
ingredients, not typically found in other beverages, call into the
question the safety of these products, particularly for youth.
Furthermore, the high levels of sugar (typically double the amount of
soda) present serious health risks of obesity, diabetes and heart
disease.
The increasing consumption of energy drinks by children and
teenagers has emerged as a new public health threat for youth.
Frequently these products are marketed through youth-oriented media and
venues and use packaging and images that appeal to a young audience.\4\
The American Academy of Pediatrics (AAP) has stated that ``energy
drinks have no therapeutic benefit to children'' and that the
properties of the ingredients of these drinks ``may put some children
at risk for adverse health events.'' \5\ A recent survey by the U.S.
Department of Health and Human Services revealed that emergency room
visits related to energy drinks doubled from 10,000 to 20,000 visits
between 2007 and 2011.\6\ It has been previously reported that 11
percent of total emergency room visits related to energy drink
consumption involved youth aged 12-17 years.\7\
---------------------------------------------------------------------------
\4\ Pomeranz, J.L., Munsell, C.R. and Harris, J.L. (2013) Energy
drinks: An emerging public health hazard for youth. Journal of Public
Health Policy. Advance online publication 14 March 2013
\5\ See Energy Drinks Can Harm Children, Feb. 114, 2011 http://
www.aap.org/en-us/about-the-aap/aap-press-room/pages/Energy-Drinks-Can-
Harm-Children.aspx
\6\ Substance Abuse and Mental Health Services Administration,
Center for Behavioral Health Statistics and Quality. (January 10,
2013). The DAWN Report: Update on Emergency Department Visits Involving
Energy Drinks: A Continuing Public Health Concern. Rockville, MD.
\7\ Substance Abuse and Mental Health Services Administration,
Center for Behavioral Health Statistics and Quality. (November 22,
2011). The DAWN Report: Emergency Department Visits Involving Energy
Drinks. Rockville, MD. Data from between 2004 and 2008.
---------------------------------------------------------------------------
The FDA recently released injury report filings, also known as
adverse event reports, that were associated with several popular energy
drink brands including, Rockstar, Red Bull, Monster and 5-hour
Energy.\8\ These reports indicated serious or life threatening injuries
such as heart attacks, convulsions and, in a few instances, death. The
FDA is currently investigating these reports, as the mere filing of an
incident report with the FDA does not mean that a product was
responsible for a death or an injury. The FDA has also announced that
it intends to form a third party review panel to help determine whether
energy drinks pose particular risks to teenagers or people with
underlying health problems.
---------------------------------------------------------------------------
\8\ http://www.fda.gov/downloads/AboutFDA/CentersOffices/
OfficeofFoods/CFSAN/CFSAN
FOIAElectronicReadingRoom/UCM328270.pdf and http://www.fda.gov/
downloads/AboutFDA
/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/
UCM328525.pdf
---------------------------------------------------------------------------
For consumers interested in limiting their personal consumption of
caffeine or concerned about the ingredients used in energy drinks,
labels on the packaging of these products can be confusing or lack
necessary information regarding the quantity of caffeine and other
ingredients. Manufacturers of energy drinks currently are left to their
own discretion in deciding whether a product will be marketed and
labeled as a conventional food (beverage) or as a dietary supplement.
These two product types have different Federal requirements relating to
ingredient disclosure, labeling and other FDA responsibilities. As a
result, the information that is provided to consumers on a product
label is inconsistent within the category of energy drink products
depending on whether the product is classified as a beverage or dietary
supplement. In 2009, the FDA issued draft guidance to clarify when a
liquid energy drink product should be classified as a dietary
supplement or a beverage, but the guidance, which is non-binding, has
yet to be finalized by the agency.\9\
---------------------------------------------------------------------------
\9\ FDA Draft Guidance for Industry: Factors that Distinguish
Liquid Dietary Supplements from Beverages, Considerations Regarding
Novel Ingredients, and Labeling for Beverages and Other Conventional
Foods. (December 2009)
---------------------------------------------------------------------------
Investigation
To address the growing consumer concern over energy drinks, the
marketing of these products toward youth and to provide more
information about the ingredients used in these products,
Representative Edward J. Markey (D-Mass) and Senators Richard J. Durbin
(D-IL) and Richard Blumenthal (D-CT) launched an investigation into the
practices of fourteen commonly sold energy drink brands (See an example
of the letter in Appendix A).\10\ Each company was asked to respond to
a series of fourteen questions seeking information on:
---------------------------------------------------------------------------
\10\ An example of the letters sent to the companies can be found
here: http://markey.house.gov/press-release/markey-durbin-blumenthal-
quiz-energy-drink-makers-products
how the company determines whether its product should be
---------------------------------------------------------------------------
represented as a dietary supplement or a conventional food;
the ingredients used in the products;
the levels of caffeine and serving size of the products;
the studies performed to back up any claims made about the
benefits of the products; and
the marketing and advertising practices employed by the
companies to target youth audiences.
With the exception of Sambazon and 5-hour Energy, all companies
responded to the questions posed to them.\11\ In instances where
companies did not provide complete responses or simply did not respond
to a question, supplemental information was gathered from company
websites, contacting company consumer representatives through the
company's public contact telephone number, or through reviewing other
publically available information, including product labels. This report
presents the information gathered in response to this investigation.
---------------------------------------------------------------------------
\11\ Sambazon and 5-hour energy did not respond to the questions
asked. Sambazon requested to be removed from the investigation. 5-hour
energy provided a copy of its patent in lieu of responding to specific
questions.
---------------------------------------------------------------------------
Findings
FINDING #1: Various marketing, labeling and ingredient disclosure
requirements are applied to energy drinks, sometimes inconsistently. As
a result, nearly identical energy drinks can be marketed and
represented to consumers differently, leading to consumer confusion and
a lack of transparency.
While the FDA does have the authority to regulate both conventional
foods, referred to in this report as ``beverages,'' and dietary
supplements, the requirements for ingredients, manufacturing processes,
reporting of adverse events and labeling, differ depending on whether
the product is marketed as a beverage or as a supplement (See Table 1).
According to FDA, a manufacturer of a product in liquid form may choose
on its own whether or not to market its product as a beverage with the
required ``Nutrition Facts'' panel or as a liquid dietary supplement
with the required `Supplement Facts' panel.
Regardless of the category chosen by the manufacturer FDA is
responsible for ensuring that the manufacturer complies with the
requirements associated with beverages and dietary supplements,
including how the product is represented (i.e., marketed) to consumers.
TABLE 1: Key differences between the Federal regulation of dietary supplements and beverages
----------------------------------------------------------------------------------------------------------------
Conventional Food (Beverage) Dietary Supplements
----------------------------------------------------------------------------------------------------------------
New ingredients must be approved as a food additive by Only new ingredients not marketed in dietary
the FDA, unless the ingredient is generally recognized supplements in the U.S. prior to October 15, 1994
as safe (GRAS)* require FDA preapproval. Otherwise, FDA must determine
an ingredient is unsafe under conditions of use to
take the product off the market
----------------------------------------------------------------------------------------------------------------
Any reporting of serious adverse events is completely Required by law to report to the FDA any serious
voluntary adverse events
----------------------------------------------------------------------------------------------------------------
Includes a ``Nutrition Facts'' panel on the label, with Includes a ``Supplement Facts'' panel on the label,
information on amount of calories, total fat, with information on quantities of ingredients that
cholesterol, sodium, carbohydrates, protein, vitamin exceed standards or that are relevant to a product
A, vitamin C, calcium and iron claim
----------------------------------------------------------------------------------------------------------------
Listing of ingredients in descending order of List the quantity of each dietary ingredient, unless
predominance is required the ingredient is a part of a `proprietary blend', in
which case quantities are not required
----------------------------------------------------------------------------------------------------------------
Good Manufacturing Practices (GMP) focus on ensuring Good Manufacturing Practices (GMP) contain standards of
safe and sanitary processing conditions identity to help verify that the product is what it is
purported to be
----------------------------------------------------------------------------------------------------------------
* Manufacturers of a product are permitted to self-determine that an ingredient is generally recognized as safe
(GRAS) without FDA affirmation
In 2009, FDA attempted to clarify the agency's views on the
distinction between liquid dietary supplements and beverages by issuing
a guidance document that outlines some of the factors that may cause a
product to be represented as a beverage, instead of as a dietary
supplement.\12\ These items include the volume in which the product is
intended to be consumed, the labeling of the product, the recommended
conditions of use, and the packaging in bottles or cans that are
similar to packaging found in other beverages like soda and bottled
water. This guidance has yet to be finalized by the FDA, but the agency
has indicated that it hopes that once completed the guidance will more
clearly demarcate the line between beverages and liquid dietary
supplements.
---------------------------------------------------------------------------
\12\ FDA Draft Guidance for Industry: Factors that Distinguish
Liquid Dietary Supplements from Beverages, Considerations Regarding
Novel Ingredients, and Labeling for Beverages and Other Conventional
Foods. (December 2009)
TABLE 2: Energy drinks, even those produced by the same company, are represented inconsistently in the market as
both dietary supplements and regular beverages
----------------------------------------------------------------------------------------------------------------
Marketed as Dietary
Supplement or
Parent Company Brand Name Product Name Conventional Food
(Beverage)
----------------------------------------------------------------------------------------------------------------
Living Essentials 5-hour Energy 5-hour Energy Dietary Supplement
----------------------------------------------------------------------------------------------------------------
Celsius Celsius Celsius Dietary Supplement
----------------------------------------------------------------------------------------------------------------
Monster Beverage Worx Energy Worx Energy Dietary Supplement
Corporation
----------------------------------------------------------------------------------------------------------------
Monster Beverage Monster Monster Energy, Blue Conventional Food
Corporation Energy, Hansen's Energy (since March 2013)
----------------------------------------------------------------------------------------------------------------
Rockstar Inc. Rockstar Energy Drink Rockstar Conventional Food
(since January 2013)
----------------------------------------------------------------------------------------------------------------
PepsiCo AMP Energy Boost AMP Conventional Food
(since 2012)
----------------------------------------------------------------------------------------------------------------
Dr. Pepper Snapple Group Venom Venom Energy Conventional Food
----------------------------------------------------------------------------------------------------------------
Clif Bar and Company Clif Shot Clif Shot Gel Conventional Food
----------------------------------------------------------------------------------------------------------------
Red Bull Red Bull Red Bull Conventional Food
----------------------------------------------------------------------------------------------------------------
Coca Cola Full Throttle Fuze Conventional Food
----------------------------------------------------------------------------------------------------------------
Coca Cola NOS Nos Conventional Food
----------------------------------------------------------------------------------------------------------------
Nestle USA (until November Jamba Jamba Energy Conventional Food
2012)
----------------------------------------------------------------------------------------------------------------
Sambazon Sambazon Sambazon Conventional Food
----------------------------------------------------------------------------------------------------------------
Target Corp. made by thiArcher Farms Archer Farms Energy Drinks Conventional Food
party
----------------------------------------------------------------------------------------------------------------
AriZona Beverages Arizona AZ Energy, RX Energy Fast Dietary Supplement
Shot
----------------------------------------------------------------------------------------------------------------
AriZona Beverages Arizona Caution, Joltin Joe, Rx Conventional Food
Energy Herbal
----------------------------------------------------------------------------------------------------------------
The FDA has stated that energy drinks can be lawfully marketed as
either dietary supplements or as beverages as long as they satisfy the
requirements for the product category which they represent. Responses
from energy drink companies indicate that four of the fourteen
responding companies classify and market one or more of its products as
dietary supplements (See Table 2). These products include Celsius,
Monster's Worx, 5-hour Energy and approximately 50 percent of the
Arizona brand energy drinks (representing 5 products).
In addition, three energy drink brands, AMP Energy (owned by
PepsiCo), Rockstar and Monster energy drinks have only within the last
year shifted from marketing their products in the category of dietary
supplements to marketing and labeling their products as beverages.\13\
Until this market transition is complete, which in the case of Rockstar
may take a year, consumers can expect to find identical products by
Rockstar Inc., and Monster labeled with both Supplement Facts (as in
dietary supplements) and Nutrition Facts (as in beverages). According
to Monster Beverage Corporation, this decision was made for business
purposes as well as to avoid criticism that the company was marketing
their products as dietary supplements to avoid FDA oversight.
---------------------------------------------------------------------------
\13\ Monster Beverage Corp. indicated in its response that all
products, with the exception of Worx Energy would be transitioned to
beverages and labeled with a nutrition facts panel.
---------------------------------------------------------------------------
When the companies were asked to explain how they determine whether
a product should be marketed as a beverage or dietary supplement, the
responses indicated that the companies routinely review FDA laws and
regulations and in some instances cited warning letters issued by the
FDA to other companies. The companies indicated that the decisions are
made on a case-by-case basis dependent on the intention of the product.
For instance if the product is intended to primarily quench thirst, the
company markets it as a beverage, but if the product is intended to be
a supplement to the diet they would treat the product as a dietary
supplement.
Interestingly, Monster indicated in its response that it views its
products as intended to specifically supplement the diet with dietary
ingredients and ``not merely to be consumed ad libitum to provide
refreshment and good taste.'' Despite this declaration, the company
still transitioned its products (with the exception of Worx Energy)
from dietary supplements into the beverages category. Furthermore,
Arizona beverages produces several remarkably similarly packaged and
sized energy drink products with comparable claims and ingredients and
the company appears to arbitrarily select whether a product is
classified as a dietary supplement or beverage. The blurred distinction
between supplements and beverages is a source of confusion for
consumers. The FDA should expeditiously ensure that energy drink
manufacturers utilize a consistent approach to categorize their
products.
FINDING #2: Energy products come in a range of sizes, with various
amounts of caffeine that exceed what has been previously recognized as
safe by the FDA for soda beverages (approximately 71 milligrams of
caffeine per 12 ounces). Despite these elevated levels, concentrations
of caffeine are not uniformly represented on the label of the brands
evaluated.
The fourteen companies surveyed produce different types of energy
drink products (See Table 3). In the case of Clif Shot, the product is
an energy gel packaged in small squeezable packet and intended to be
consumed by athletes during endurance activities. Clif Shot is marketed
as a conventional food. Another product, Celsius, which is sold as a
single serving packet of powder to mix with water as well as ready to
drink cans and is marketed as the ``ultimate fitness partner'' is
classified as a dietary supplement. In the case of Celsius, the product
is intended to be consumed pre-exercise to help reduce body fat and
improve endurance. These two companies have remarkably similar uses,
but two different designations.
The remaining twelve companies produce two main energy product
types, which they refer to as ``drinks'' and ``shots'' (See Table 3).
The energy shots come in 2-ounce single serve containers. The energy
drinks are commonly sold in 8-32 ounce packaging, many of which are
packaged in large, non-resealable cans, despite the number of servings
listed on the container. For example, Monster Energy and Arizona AZ
Energy both produce a 24 fluid ounce canned product that contains 240
mg and 306 mg of caffeine, respectively, and more than 75 grams of
sugar per container. Both companies claim that the can represents 3
servings of the product, yet the carbonated beverage is provided in a
non-resealable can similar to a soda can, encouraging the product to be
consumed in one sitting. For comparison, this is 7-9 times more
caffeine and approximately twice as much sugar as a can of Coca-Cola
Classic. Monster produces a 32 ounce non-resealable can with
approximately 108 grams of sugar and 320 mg of caffeine.
The caffeine content varies widely between the energy products
surveyed, and in many cases is not disclosed on the product label. In
cases where it is disclosed, companies vary in the way they present
this information, sometimes impairing consumers' ability to make
informed decisions about caffeine levels in the products they are
purchasing. For example, some products only present the amount of
caffeine per recommended serving size rather than in the entire
container. For products packaged in large 24 or 32 ounce non-resealable
containers that are typically consumed all at once, this practice could
mislead consumers about the total amount caffeine and other ingredients
they are ingesting, as they may presume that there is no distinction
between the recommended serving size and the serving in the container
itself. While some companies provide caffeine concentration in
milligrams, other companies, including 5-hour Energy and some of the
Arizona energy drink products, disclose caffeine only in comparison to
other products, stating on the label that the product contains
``caffeine equivalent to 2 cups of coffee'' or ``contains caffeine
comparable to a cup of the leading premium coffee.'' The inconsistent
ways in which caffeine concentration is presented on the label may
further confuse consumers.
TABLE 3: Energy drinks contain a varied amount of caffeine that is inconsistently represented on the label
----------------------------------------------------------------------------------------------------------------
Total Caffeine Per
Product Name Product Container Size Container From All Caffeine Amount Declared On The
Type (fl.oz.) Sources (mg) Label
----------------------------------------------------------------------------------------------------------------
Rockstar Drink 24 360 or 240* Transitioning to labeling caffeine
on all products
----------------------------------------------------------------------------------------------------------------
Arizona AZ Energy Drink 23 265 Yes
Half&Half Iced
Tea Lemonade
----------------------------------------------------------------------------------------------------------------
NOS Drink 16 260 Yes
----------------------------------------------------------------------------------------------------------------
Rockstar Drink 16 240 or 160* Transitioning to labeling caffeine
on all products
----------------------------------------------------------------------------------------------------------------
Monster Energy Drink 24 240 Transitioning to labeling caffeine
on all products
----------------------------------------------------------------------------------------------------------------
Worx Energy Shot 2 200 No
----------------------------------------------------------------------------------------------------------------
Celsius Drink, 12 200 Yes
Powder
----------------------------------------------------------------------------------------------------------------
Full Throttle Drink 16 200 Yes
Fuze
----------------------------------------------------------------------------------------------------------------
Java Monster Drink 16 200 Yes
----------------------------------------------------------------------------------------------------------------
Arizona AZ Energy Drink 15 195 Yes
----------------------------------------------------------------------------------------------------------------
Venom Drink 16 160 Yes
----------------------------------------------------------------------------------------------------------------
Monster Energy Drink 16 160 Transitioning to labeling caffeine
on all products
----------------------------------------------------------------------------------------------------------------
Arizona Caution Drink 11.5 144 Yes
----------------------------------------------------------------------------------------------------------------
AMP Energy Boost Drink 16 142 Yes
----------------------------------------------------------------------------------------------------------------
Red Bull Drink 12 114 Yes
----------------------------------------------------------------------------------------------------------------
Arizona Rx Energy Shot 2 113 No
Fast Shot
----------------------------------------------------------------------------------------------------------------
Jamba Drink 8.4 80 Yes
----------------------------------------------------------------------------------------------------------------
Sambazon Drink 10.5 80 Yes
----------------------------------------------------------------------------------------------------------------
Target Archer Drink 12 70 Yes
Farms
----------------------------------------------------------------------------------------------------------------
Clif Shot Gel 34 grams 0, 25 mg, 50 mg, or 100 Yes
----------------------------------------------------------------------------------------------------------------
5-hour Energy Shot 2 did not answer No
----------------------------------------------------------------------------------------------------------------
* Caffeine amount depends on specific product.
Although FDA does not require caffeine disclosure for either
beverages or supplements, the American Beverage Association (ABA), the
trade association that represents the non-alcoholic beverage industry
in the U.S., recommends that all such energy products clearly label
their products with the amount of caffeine from all sources in the
product. However, not all energy products, abide by these voluntary
guidelines. For example, Arizona has several energy drink products with
labels that either do not disclose the level of caffeine at all or
provide a level of caffeine that is not representative of the actual
caffeine content from all sources. Living Essentials 5-hour Energy, not
a member of the ABA and marketed as a dietary supplement energy shot,
also does not provide the amount of caffeine on the label of its
product. Monster and Rockstar energy products are transitioning to
labels that disclose caffeine content from all sources, in compliance
with ABA's voluntary guidelines. Most caffeinated sodas also disclose
the concentration of caffeine present in the container from all
sources.
In general the caffeine concentration of the energy products
surveyed is much higher than that of sodas for which the FDA has
generally recognized as safe (GRAS) at a level of 200 parts per million
of caffeine (approximately 71 mg per 12 fl oz serving). In contrast,
popular energy drinks, such as NOS and Rockstar contain between 240 and
260 milligrams of caffeine per 16 ounce can and popular energy shots,
such as 5-hour energy and Worx contain between 200-242 milligrams of
caffeine \14\ per 2 ounce bottle (See Figure 1). For 5-hour Energy and
Worx, because these products are marketed as dietary supplements, there
is no requirement or voluntary guidance that the amount of caffeine be
listed on the product label or disclosed to the consumer in any way.
---------------------------------------------------------------------------
\14\ Information for 5 hour Energy provided by Consumer Report
Magazine (December 2012). The buzz on energy-drink caffeine.
---------------------------------------------------------------------------
FIGURE 1: Comparison of similar sized energy drink caffeine
concentrations
* Container size 15 fluids ounces
Caffeine toxicity is a concern, especially for children and
adolescents, who are the frequently targeted demographic for energy
drink companies. According to the American Academy of Pediatrics (AAP)
``caffeine can produce harmful health effects in adolescents, including
cardiovascular problems, anxiety, insomnia, digestive problems,
dehydration, and others.'' \15\ The American Academy of Pediatrics'
Committee on Nutrition and the Council on Sports Medicine and Fitness
recently concluded that, ``rigorous review and analysis of the
literature reveal that caffeine and other stimulant substances
contained in energy drinks have no place in the diet of children and
adolescents.\16\''
---------------------------------------------------------------------------
\15\ AAP, Energy Drinks Pose Health Risks to Adolescents Feb. 1,
2013.
\16\ Committee on Nutrition and the Council on Sports Medicine and
Fitness. Sports drinks and energy drinks for children and adolescents:
Are they appropriate? Pediatrics. 2011; 127(6):1182-1189.
---------------------------------------------------------------------------
Children and teens who consume energy drinks for the promise of
increased physical performance, before, during, or after physical
activity are exposed to a high dose of caffeine and other ingredients
in a short window of time. According to a recent study \17\,
``cardiovascular effects as a result of heavy caffeine use can be a
significant source of morbidity in athletes,'' and ``given the unknown
levels of caffeine and other poorly studied additives, there is
significant risk associated with energy drink consumption that may
outweigh the benefits in the adolescent consumer.''
---------------------------------------------------------------------------
\17\ Blankson, K., et al., Pediatrics in Review Vol. 34 No. 2
February 1, 2013 pp. 55-62
---------------------------------------------------------------------------
On average the U.S. population consumes approximately 300
milligrams of caffeine per day.\18\ For healthy adults, the FDA has
noted that consumption of 400 milligrams of caffeine (considered an
upper limit) in a day is not associated with adverse health effects.
However, the standard of `healthy adults' does not take into account
varying sensitivities to caffeine and varying capabilities of younger
consumers to metabolize this stimulant.\19\ Furthermore, statements
made by energy drinks such as ``chug it down'' and ``pound down'' \20\
encourage consumers to drink large quantities of these products
rapidly, which can decrease the clearance of caffeine from the body and
result in elevated caffeine blood concentrations for a sustained period
of time.\21\ This is especially risky for children and teen consumers,
as well as consumers who have pre-existing health conditions or who are
taking medications that may interfere or interact with caffeine
metabolism. As the FDA has stated, smaller individuals (adolescents)
are typically more sensitive to caffeine consumption. The FDA has also
warned that while caffeine and other stimulants may make one feel more
awake, ``judgment and reaction time can still be impaired.'' \22\
---------------------------------------------------------------------------
\18\ Caffeine Intake by the U.S. Population, September 2009, revd.
August 2010, by Laszlo P. Somogyi, Ph.D.
\19\ Letter from City Attorney of San Francisco Dennis Herrera to
FDA Commissioner Margaret Hamburg (March 19, 2013)
\20\ See for example: http://www.monsterenergy.com/ph/en/products/
and http://originalcap
sultimate.blogspot.com/2012/08/where-should-buy-8-pack-monster-
energy.html
\21\ Letter from City Attorney of San Francisco Dennis Herrera to
FDA Commissioner Margaret Hamburg (March 19, 2013)
\22\ http://www.fda.gov/Food/NewsEvents/ucm328536.htm
FINIDNG #3: Adolescent consumers are frequent targets for the marketing
pitches of energy drink companies. The use of unconventional marketing
practices combined with product design and placement on store shelves
assists in creating product images that appeal to children and teens.
In the course of this investigation, companies were asked whether
they market energy drink products to children or teenagers.
Unsurprisingly, all companies indicate that their products were not
directed toward children, and several products including Venom and Red
Bull, indicated that they follow the American Beverage Association
(ABA) voluntary guidance for the responsible labeling and Marketing of
Energy Drinks (See Table 4).\23\ Monster Beverage Corp. and Rockstar
indicated that the companies have recently joined the ABA. These ABA
guidelines indicate that energy drinks should be labeled with the
quantity of caffeine from all sources contained in the beverage, should
not promote mixing with alcohol, should not be marketed as sport
drinks, should contain an advisory statement \24\ and should not be
advertised to an audience that is comprised predominantly of children
less than 12 years of age.
---------------------------------------------------------------------------
\23\ See: http://www.ameribev.org/files/
339_Energy%20Drink%20Guidelines%20%28final%29
.pdf
\24\ According to ABA voluntary guidelines, labels of energy drinks
should include the statement ``Not (intended/recommended) for children,
pregnant or nursing women,(and/or persons/those) sensitive to
caffeine''
---------------------------------------------------------------------------
Not all energy drink companies adhere to ABA guidance. Furthermore,
while children 12 years of age and younger may not be targeted by some
companies, adolescents who are between the ages of 13 and 17 are
frequently the focus for energy drink marketing practices and this
population is also at risk for the detrimental impacts of energy drink
consumption. For example, Monster Energy and Rockstar Energy both
indicate that their target audience is young adults and as a result,
these companies frequently sponsor young athletes, such as Mitchie
Brusco, a skateboarder who has been sponsored by Rockstar since he was
at least 14 years old. Monster also has a practice of awarding
outstanding high school student athletes with the ``Monster Energy
Drink Player of the Game.'' As a part of this honor, photos of these
teen student athletes are taken with a package of Monster Energy in
each hand and other Monster paraphernalia.\25\ Red Bull also engages in
the sponsorship of high school sport events, including the ``Red Bull
Game Breakers'' and ``Red Bull Rookies Cup'' which includes adolescents
as young as 13 years old. While Monster Energy indicated in its
response that it does not conduct traditional advertising through
traditional media, the company, along with Rockstar Energy products,
relies heavily on an organized social media presence and the
sponsorship of music and sports events that target young audiences. As
Rockstar indicated in its response, teenagers do attend and participate
in these marketing initiatives.
---------------------------------------------------------------------------
\25\ Monster energy has indicated through conversations with staff
that were unaware of the routine awarding ``Monster Energy Player of
the Game'' and are investigating this practice.
---------------------------------------------------------------------------
Recently both the National Collegiate Athletic Association (NCAA)
and the National Federation of State High School Associations (NFHS)
have stated that energy drinks may pose a health and safety risk for
student-athletes and are particularly worrisome if consumed before or
during strenuous exercise. These organizations are making a concerted
effort to warn their student athletes of the risk of energy drink
consumption and in the case of NCAA to also restrict the marketing
advertising of these products to their athletes.
TABLE 4: Company responses on marketing practices and warning labels included on energy drink products
----------------------------------------------------------------------------------------------------------------
Company Name Marketing Practices Relating To Kids Precautionary Statements
----------------------------------------------------------------------------------------------------------------
5-hour Energy Marketed and intended for adults Do not take if you are pregnant or nursing, or
under 12 years of age. If you are taking
medication and/or have a medical condition,
consult your doctor before use.
----------------------------------------------------------------------------------------------------------------
AMP Energy Target demographic is the male consumer between Not recommended for children, pregnant women
the ages of 25 and 35 or people sensitive to caffeine
----------------------------------------------------------------------------------------------------------------
Arizona Company doesRecommended limits and precautionary
statements are provided on 7 out of 11 of the
company's energy products
----------------------------------------------------------------------------------------------------------------
Celsius Follows American Academy of Pediatrics Not recommended for people who are caffeine
guidelines for marketing dietary supplements sensitive, children under 12 or women pregnant
and does market to children or teens. Target or nursing
demographic is 25-54
----------------------------------------------------------------------------------------------------------------
Clif Shot Product is marketed to adult athletes. CompanyNot recommended for children, pregnant or
is aware that high schools occasionally offer nursing women, or people sensitive to caffeine
caffeinated products to teenage athletes
----------------------------------------------------------------------------------------------------------------
Full Throttle CompNot recommended for individuals under 18 years
Fuze over 18 years of age and buy advertising only of age, pregnant or nursing women or for those
when 65 percent of audience is above 18 years sensitive to caffeine. Daily caffeine
of age. consumption should be limited to 400 mg per
day from all sources, this package contains
200
----------------------------------------------------------------------------------------------------------------
Jamba Does not market to children or teenagers. The Not recommended for pregnant women, children
intended audience is 26-34. or people sensitive to caffeine
----------------------------------------------------------------------------------------------------------------
Monster Energy Target demographic is young adults (primarily Not recommended for children, people sensitive
males). Brand initiatives and brand image are to caffeine, pregnant women or women who are
directed toward this population. nursing.
----------------------------------------------------------------------------------------------------------------
NOS CompNot recommended for individuals under 18 years
over 18 years of age and buy advertising only of age, pregnant or nursing women or for those
when 65 percent of audience is above 18 years sensitive to caffeine. Daily caffeine
of age. consumption should be limited to 400 mg per
day from all sources, this package contains
260
----------------------------------------------------------------------------------------------------------------
Red Bull CompanyNot recommended for children, pregnant or
voluntary guidance nursing women, or people sensitive to caffeine
----------------------------------------------------------------------------------------------------------------
Rockstar Messaging is designed to be aspirational for Not recommended for children, pregnant or
young adults. Some teenagers do participate in nursing women, or people sensitive to caffeine
marketing initiatives or view them on TV or the
internet
----------------------------------------------------------------------------------------------------------------
Sambazon Not conventionally marketed to any groups None
(particularly teens and children)
----------------------------------------------------------------------------------------------------------------
Target Archer Not intended or marketed to children or teens. None
Farms Product is designed to appeal to adults with an
active lifestyle as an alternative to soda.
----------------------------------------------------------------------------------------------------------------
Venom Not marketed to children or teens. Follows Not recommended for children, pregnant or
American Beverage voluntary guidance nursing women, or people sensitive to caffeine
----------------------------------------------------------------------------------------------------------------
The combination of energy drinks with alcohol is a well-recognized
public health hazard, particularly for youth. In the past FDA has taken
enforcement action against caffeine containing alcoholic beverages,
because drinking them was considered to create risky, ``hazardous and
life-threatening situations.'' \26\ While caffeine containing alcoholic
beverages are no longer popularly sold, some energy drink companies
have sought to fill this market void by marketing products that
represent themselves similarly to commonly consumed alcoholic
beverages. For example, Monster Energy produces a product known as Cuba
Lima, which is compared on its website to the popular alcoholic
beverage Cuba-Libre.\27\ The company also makes a product with a
special ``brewing process'' and packaged in a bottle made to look
similar to a beer bottle. Monster additionally markets a product
compared to the alcohol infused whipped cream called `Whip-it' and for
which the company proudly states ``it will whip you good.'' \28\ It
appears that these products and their advertising and packaging
practices are intended to attract young audiences that are not of legal
age to consume alcohol.
---------------------------------------------------------------------------
\26\ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm234109.htm
\27\ http://www.monsterenergy.com/us/en/products/monster-energy/#!/
products%3Acuba-lima
\28\ Monster website see http://www.monsterenergy.com/us/en/
products/monster-energy/#!/products percent3Aubermonster and http://
www.monsterenergy.com/us/en/products/nitrous-2/#!/products
percent3Ablack-ice
---------------------------------------------------------------------------
With the exception of Sambazon, Target's Archer Farms Energy Drinks
and some of the Arizona brand energy drink products, the remaining
companies surveyed all include a precautionary statement in line with
ABA voluntary guidance, that the product is not recommended for
children, pregnant women or people who are sensitive to caffeine. Coca-
Cola's Nos and Full Throttle Fuze brand products include an additional
statement that the product is not recommended for those under the age
of 18. It would be helpful for consumers if all energy drinks contained
precautionary statements that were consistent across all products.
FINDING#4: Energy drink companies make a range of advertising claims
related to the functional benefits of their products that are not
generally evaluated or substantiated by the FDA. Some of these claims
appear to be targeted to young audiences or student athletes.
The FDA and the Federal Trade Commission (FTC) share jurisdiction
over health-and nutrient-related claims made by food and supplement
manufacturers. FDA oversees labeling requirements that prohibit, among
other things, food labeling that is false or misleading. FTC oversees
Federal consumer protection requirements that prohibit, among other
things, deceptive acts or practices in advertising, including food
advertising. Under a longstanding memorandum of understanding, the two
agencies agreed that FDA has primary responsibility for labeling of
food, including dietary supplements and beverages, while the FTC has
primary responsibility over the advertising of these products. FTC has
recently emphasized in the context of energy drinks that advertising
directed to youth, particularly advertising that raises safety
concerns, is a priority for the Commission.\29\
---------------------------------------------------------------------------
\29\ Letter from Chairman Jon Leibowitz to Congressman Edward J.
Markey (January 2, 2013). See: http://markey.house.gov/press-release/
markey-asks-ftc-investigate-advertising-claims-ener
gy-drinks
---------------------------------------------------------------------------
The FDA categorizes health-and nutrient-related claims as follows:
Health claims characterize the relationship of any substance
to a disease or health-related condition (e.g., diets low in
sodium may reduce the risk of high blood pressure).
Structure/function claims describe the role of, or
characterize the mechanism by which, a nutrient affects a body
structure or function (e.g., calcium helps build strong bones).
Nutrient content claims characterize the level of a nutrient
in a food (e.g., good source of vitamin C).
The survey of energy drink manufacturers found that these companies
routinely use structure/function claims to convey the health benefits
of their products (See Table 5). Of the 14 companies surveyed, 10 (71
percent) responded to the question that asked them to identify the
types of claims their product makes. Out of these ten respondents,
eight (80 percent) indicated that their product makes structure/
function claims. An additional two products, AMP energy and 5-hour
energy, did not answer the question regarding claim type, but do make
claims both on the product label and in advertising that would be
categorized as structure-function claims.
The way in which structure/function claims are validated and
governed depends on whether the product is represented as a dietary
supplement or beverage. If a dietary supplement includes a structure/
function claim, it must have a disclaimer on its label stating, ``This
statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any
disease.'' \30\ In addition, dietary supplements making a structure/
function claim must notify the FDA within 30 days of first making such
a claim. As a dietary supplement these claims have limitations and must
also be substantiated with data.\31\ However, the FDA has limited
resources for oversight of dietary supplements and generally has
limited information on the number and location of dietary supplement
firms, the types of products currently available in the marketplace,
and information about moderate and mild adverse events reported to
industry.\32\ As a result, many of the functional claims made about
dietary supplements are not evaluated by the FDA to ensure they perform
as advertised.
---------------------------------------------------------------------------
\30\ The Dietary Supplement Health and Education Act of 1994
\31\ Dietary supplement structure function claims must also either:
(1) claim a benefit related to a classical nutrient deficiency disease
and disclose the prevalence of such disease in the United States, (2)
describe the role of a nutrient or dietary ingredient intended to
affect the structure or function in humans, (3) characterize the
documented mechanism by which a nutrient or dietary ingredient acts to
maintain such structure or function, or (4) describe general well-being
from consumption of a nutrient or dietary ingredient
\32\ FDA Needs to Reassess Its Approach to Protecting Consumers
from False or Misleading Claims GAO-11-102, Jan 14, 2011
---------------------------------------------------------------------------
The limitations, disclaimers and other requirements that apply to
structure/function claims made by dietary supplements do not apply to
products that are classified as beverages. Instead, the structure/
function claims made by beverages are subject to FDA's overall
requirement that labeling not be false or misleading. However, as
indicated by a report released by the Government Accountability Office
\33\, the FDA has not provided guidance on the scientific support
needed to prevent false or misleading information for a structure/
function claim for food or beverages. The FDA also has not given its
inspectors instructions for identifying potentially false or misleading
information in such claims. Furthermore, unlike dietary supplements,
the FDA cannot compel food and beverage companies to turn over the data
and information used to substantiate product claims. As a result, the
claims made by these energy products have never been evaluated or
substantiated by the FDA, or any publically accountable body.
---------------------------------------------------------------------------
\33\ Ibid.
TABLE 5: Energy drinks make a range of advertising claims relating to functional benefits
----------------------------------------------------------------------------------------------------------------
Product Claim Type Examples Of Claims
----------------------------------------------------------------------------------------------------------------
Sambazon did not answer Wake up to the energizing powers of the rainforest. Made with all
organic and GMO free ingredients sustainably sourced in the
Brazilian Amazon, stimulate your body and mind
----------------------------------------------------------------------------------------------------------------
AMP Energy Boost did not answer Caffeine and B-vitamins, Help kick you in high gear, Helps
energize and hydrate the body
----------------------------------------------------------------------------------------------------------------
5-hour Energy did not answer Hours of energy, No crash, Helps you feel awake for hours, Power
through your day, Stay bright and alert
----------------------------------------------------------------------------------------------------------------
Jamba did not answer All Natural (removed as of November 2012), Natural caffeine for
mental alertness, A full serving of fruit per can
----------------------------------------------------------------------------------------------------------------
Celsius Health ClaimReduces body fat, Improves endurance, Increases metabolic rate,
Burn calories (based on six clinical studies of product)
----------------------------------------------------------------------------------------------------------------
Target Archer Farms Nutrient ConteSugar free, Low calorie, Energy enhancing properties of ginseng
----------------------------------------------------------------------------------------------------------------
Venom Structure/Function Free agent of energy, Up to the nanosecond performance for MVPs
and VIPs, Instant impact
----------------------------------------------------------------------------------------------------------------
Clif Structure/Function Performance enhancing caffeine, Helps with motivation and mental
alertness during activity, Clean essential energy and hydration,
Fast muscle recovery, Fast acting energy source, Essential
electrolytes
----------------------------------------------------------------------------------------------------------------
Red Bull Structure/Function Increases endurance, Increases concentration and reaction speed,
Improves performance during stress and strain, Gives you wings,
Improves vigilance, Stimulates metabolism, Makes you feel more
energetic and improves your overall well-being
----------------------------------------------------------------------------------------------------------------
Full Throttle Fuze Structure/Function Help you get the job done, Feel the energy at work, Easy drinking
energy
----------------------------------------------------------------------------------------------------------------
NOS Structure/Function Enhanced mental focus, High performance energy, Get focused, Get
50 percent more focused, React faster
----------------------------------------------------------------------------------------------------------------
Rockstar Structure/Function Bigger, faster, and stronger that other energy drinks, Provides
energy and hydration
----------------------------------------------------------------------------------------------------------------
Monster Energy Structure/Function Rehabilitate with a killer mix, Gives you hydration and energy you
need, Quenches thirst, Fires you up and brings you back after a
hard night, No 'whip it' but it will whip you good, Delivers a big
bad buzz, Unleash the beast, Packs a powerful punch
----------------------------------------------------------------------------------------------------------------
Arizona Structure/Function Extreme performance, Loaded with antioxidants, Lasts for hours,
and Nutrient Content Natural energy, Invigorating blend
----------------------------------------------------------------------------------------------------------------
FINDING #5: In addition to caffeine, energy drinks contain a myriad of
specialty ingredients whose combinations and additive impacts are not
thoroughly evaluated or well understood. Companies can and often do
self-determine that ingredients are safe for use in energy drinks, and
there is no requirement for companies to notify the FDA of this
determination or the use of the ingredient.
Caffeine and added carbohydrates (usually in the form of natural or
synthetic sugars) are the primary ingredients energy drinks rely on to
fuel claims of ``increased energy''. However, these drinks also contain
other ingredients for purported health benefits, most commonly high
levels of certain B-vitamins, ginseng, guarana, inositol, taurine, and
other amino acids (See Table 6). The combined health impacts of these
ingredients as well as some less commonly used exotic ingredients, such
as methylated xanthines (a stimulant), raise significant concerns for
consumers, particularly youth. With the exception of the B-vitamins,
the quantities of many of these other ingredients are not required to
be disclosed on the label. Similarly to caffeine, some companies \34\
choose to voluntarily disclose the amount of some of the more commonly
used ingredients, such as guarana and taurine. However, frequently
these ingredients are merely labeled without corresponding quantities.
---------------------------------------------------------------------------
\34\ See for example the label of AMP energy.
---------------------------------------------------------------------------
From a regulatory perspective, ingredients that are used in energy
drinks are treated differently dependent on whether the energy product
is represented as a dietary supplement or a beverage. If a dietary
supplement manufacturer opts to use a ``new dietary ingredient''--an
ingredient that was not marketed in the United States before October
15, 1994--the company may be required to notify the FDA before
marketing the product, depending on the history of use of the
ingredient. For the most part, FDA relies on post-market surveillance
efforts--such as monitoring adverse event reports it receives from
companies, health care practitioners, and individuals, as well as
reviewing consumer complaints and conducting facility inspections--to
identify potential safety concerns related to dietary supplements. Even
once a safety concern is identified, FDA must demonstrate that the
dietary supplement presents a significant or unreasonable risk under
its specified conditions of use--a high threshold to meet--before it
can remove the product from the market.\35\
---------------------------------------------------------------------------
\35\ FDA Needs to Reassess Its Approach to Protecting Consumers
from False or Misleading Claims GAO-11-102, Jan 14, 2011
---------------------------------------------------------------------------
For energy drinks classified as beverages, the FDA handles the
oversight of ingredients differently. Generally, an ingredient added in
a food product must either be generally recognized as safe (GRAS) or go
through FDA's review and approval process as a food additive.\36\ In
order for an ingredient to be considered GRAS there must be a
``reasonable certainty in the minds of competent scientists that the
substance is not harmful under the intended conditions of use.'' \37\
However, the burden to determine whether an ingredient is GRAS is
typically left to the manufacturer and a manufacturer can make this
determination on its own, and use the ingredient in a product, without
informing the FDA. As a result not only would the FDA potentially not
know when a company has made an unsupported or incorrect determination
about whether an ingredient is GRAS, the FDA would have no knowledge
whether an ingredient was even being used or the frequency of its use.
In the event that FDA was aware that an unapproved additive was being
used in a product and the ingredient was not GRAS for its intended use,
the FDA would consider this product to be adulterated, making marketing
or selling of the product illegal.
---------------------------------------------------------------------------
\36\ Substances that were in use prior to 1958 can be determined
GRAS based on its common use in food.
\37\ 21 C.F.R 170.3(i)
TABLE 6: Ingredients commonly used in energy drink products
----------------------------------------------------------------------------------------------------------------
Ingredients Related To Functional Claims Made* (not including natural or synthetic
Brand Name sugars)
----------------------------------------------------------------------------------------------------------------
Arizona Caffeine, guarana extract, L-carnitine, ginseng extract, eleuthero root, schisandara,
green tea extract, B-vitamins
----------------------------------------------------------------------------------------------------------------
Venom Caffeine, taurine, guarana, L-carnitine, ginseng extract, inositol, maltodextrin, B-
vitamins (niacinamide, B6, riboflavin, B12)
----------------------------------------------------------------------------------------------------------------
Clif Shot Caffeine, green tea extract, guarana, maltodextrin
----------------------------------------------------------------------------------------------------------------
Red Bull Caffeine, taurine, glucuronolactone, inositol, B-vitamins (niacinamide, B-12,
pantothenic acid, pyridoxine)
----------------------------------------------------------------------------------------------------------------
Full Throttle Fuze Caffeine, B-vitamins (niacinamide pantothenic acid, pyridoxine)
----------------------------------------------------------------------------------------------------------------
NOS Caffeine, guarana, taurine, L-theanine, B-vitamins (B6, B12)
----------------------------------------------------------------------------------------------------------------
Jamba Caffeine, green tea extract
----------------------------------------------------------------------------------------------------------------
Sambazon Caffeine, yerba matte, green tea extract, guarana
----------------------------------------------------------------------------------------------------------------
Target Archer Farms Caffeine, panax ginseng root, guarana, taurine, vitamin B6 and B12
----------------------------------------------------------------------------------------------------------------
AMP Energy Caffeine, choline, theanine, maltodextrin, panax ginseng root extract, L-carnitine,
guarana, taurine, B-vitamins (riboflavin, pantothenic acid, niacinamide)
----------------------------------------------------------------------------------------------------------------
Rockstar Caffeine, guarana, B-vitamin niacin B-12, pantothenic acid, B6) taurine, yerba mate,
green tea extract, L-carnitine, inositol
----------------------------------------------------------------------------------------------------------------
5-hour Energy Caffeine, citicoline, L-tyrosine, L-phenylalanine, malic acid, glucuronolactone,
taurine, B-vitamins (Niacinamide, pyridoxine,B12, folic acid), methylated xanthines
----------------------------------------------------------------------------------------------------------------
Celsius Caffeine, guarana, taurine, green tea extract, glucuronolactone, ginger extract, B-
vitamins (riboflavin, niacin, B6, B12, pantothenic acid)
----------------------------------------------------------------------------------------------------------------
Monster Energy Caffeine, taurine, L-carnitine, glucuronolactone, guarana, panax ginseng extract,
inositol, maltodextrin
----------------------------------------------------------------------------------------------------------------
* ingredients may vary dependent on product
The FDA has raised concerns that some ingredients that have been
present in the food supply for many years are now being added to energy
drinks at levels in excess of how they are traditionally used.\38\ This
trend raises questions regarding whether these higher levels and other
new conditions of use are safe. For example, guarana is a FDA approved
additive for flavor, but is commonly and intentionally added to energy
drinks as an extra source of caffeine stimulant, sometimes at higher
levels than what would be used if guarana was only being added for
flavor. Taurine, an amino acid, is another frequently added ingredient
in energy drinks. It has never been affirmed as GRAS by the FDA, nor
has it been approved as a food additive. However, taurine is considered
GRAS by the Flavor and Extract Manufacturers Association of the United
States for flavor use. The European Commission (EC), assessed the use
of taurine in energy drinks and couldn't conclude taurine
concentrations used in energy drinks are safe.\39\ Furthermore,
caffeine is universally added to energy drinks at levels that are far
beyond what has been affirmed as GRAS by the FDA for use in cola-type
beverages (approximately 71 mg per 12 ounces).\40\
---------------------------------------------------------------------------
\38\ FDA Draft Guidance for Industry: Factors that Distinguish
Liquid Dietary Supplements from Beverages, Considerations Regarding
Novel Ingredients, and Labeling for Beverages and Other Conventional
Foods. (December 2009)
\39\ http://ec.europa.eu/food/fs/sc/scf/out22_en.html
\40\ 21 CFR 182.1180
---------------------------------------------------------------------------
Recently, the City Attorney of San Francisco wrote a letter to FDA
Commissioner Margaret Hamburg, challenging the GRAS determination
energy drink companies have made to use levels of caffeine beyond what
is typically found in cola-type beverages. According to the city
attorney's letter, which was supported by 18 independent scientific
experts, the addition of caffeine in the amounts used in energy drinks
is not safe based on scientific evidence, and as such, the FDA should
enforce limits in energy drinks that are comparable to what is commonly
found in cola-type beverages. Historically, the FDA has not challenged
the use of caffeine in other beverages at levels that are comparable to
the GRAS level for cola beverages. However, the use of caffeine in
energy drinks far surpasses that which is found in common sodas. The
FDA should use its current authority to evaluate whether the levels of
caffeine and other ingredients commonly used in energy drinks is in
fact GRAS and revise its regulations accordingly. The FDA should also
set limits for the use of these ingredients for single serve
containers.
Conclusions and Recommendations
Energy drinks are a relatively new product category that is rapidly
growing in the marketplace and may serve as an emerging public health
risk, particularly for adolescents. Energy drinks universally contain
high levels of intentionally added caffeine, sugar and other novelty
ingredients that are often advertised and marketed toward young people
or presented in youth-oriented media and venues. The use of these
ingredients and their combinations have largely not been assessed for
safety by the FDA, but recent indications of adverse events and
increased hospitalizations that may be associated with consumption of
energy drinks call into question both the safety and the claims made by
these companies.
The inconsistency in the way these products are represented to
consumers, marketed, and labeled poses unique challenges to Federal
regulation and oversight. Furthermore, because of the way energy drinks
are regulated, ingredients are often not presented on the label in a
manner that enables consumers to make an informed decision about
quantities of caffeine and other ingredients they purchase and consume.
The lack of transparency in the labeling practices of energy drinks
combined with the inconsistent way in which they are presented in the
market and the advertising claims and marketing practices of these
companies have the capability of eroding consumer confidence in the
safety of all FDA-regulated products.
We call on all manufacturers of energy drink products, whether they
are marketed as dietary supplements or conventional foods (beverages)
to take the following steps to improve transparency and representation
of its products and ensure that children and teens are adequately
protected from deceptive advertising practices:
1. Label products with a clear description of the total amount of
caffeine (in milligrams) added to the product from all sources.
For products that are packaged in non-resealable containers
(such as pop-top cans), the label should include the amount of
caffeine from all sources in the entire container, not just one
serving.
2. For products that contain caffeine that has been intentionally
added to the product at levels above 200 parts per million
(approximately 71 milligrams per 12 fluid ounces), the level
affirmed as GRAS by the FDA, display a prominent precautionary
statement that at a minimum says, ``This product is not
intended for individuals under 18 years of age, pregnant or
nursing women or for those sensitive to caffeine. Consult with
your doctor before use if you are taking medication and/or have
a medical condition.''
3. Cease marketing of energy drink products to children and teens
under the age of 18. Marketing includes use of both traditional
media and social media as well as the sponsorship of events,
activities and individuals that are intended for an audience
comprised primarily of children or teens.
4. Report to the FDA the receipt of any serious adverse events
associated with energy drink use. Serious adverse events are
defined by the FDA, but reporting is currently only required by
the FDA for products that are represented as dietary
supplements.
______
The Chairman. Senator Blumenthal, would you come forward,
please, and chair? And the list of witnesses, you have. And I
am very proud of the work you have done.
Senator Durbin. Mr. Chairman, thank you very much for
allowing me to testify.
The Chairman. Thank you, Senator Durbin.
[Pause.]
STATEMENT OF HON. RICHARD BLUMENTHAL,
U.S. SENATOR FROM CONNECTICUT
Senator Blumenthal [presiding]. I would like the witnesses
to come forward, if you would, please?
Dr. Marcie Beth Schneider. Dr. Schneider is a Pediatrician
who is here on behalf of the American Academy of Pediatrics.
Dr. Jennifer Harris. Dr. Harris is from Yale University's
Rudd Center on Food Policy and Obesity.
Dr. William R. Spencer. Dr. Spencer is a Legislator from
Suffolk County, New York, and he is originally from Welch,
Virginia.
Mr. Rodney Sacks. Mr. Sacks is the Chairman and Chief
Executive Officer of Monster Beverage Corporation.
Ms. Amy E. Taylor. Ms. Taylor is Vice President and General
Manager of Red Bull North America.
Ms. Janet Weiner. Ms. Weiner is Chief Financial Officer and
Chief Operations Officer for Rockstar, Incorporated.
And Dr. James R. Coughlin. Dr. Coughlin is the President of
Coughlin & Associates Consultants in Food/Nutritional/Chemical
Toxicology and Safety.
We welcome you. We are very, very grateful to you each for
being here today. This hearing is another step in the efforts
that Senator Durbin, now Senator Markey, and I have led to call
attention to the health risks associated with energy drinks.
I began my own involvement with energy drinks that combined
alcohol with their product and, when I was Attorney General,
led a group of my colleagues to successfully urge the FDA to
ban alcoholic energy drinks for the obvious reasons that they
resulted essentially in energized drunks. The effort to call
attention to the potential health risks involves the marketing
practices. You have heard them described here. I will have
questions about them.
And clearly, we are concerned, and I know that the panel
will address, each of the witnesses will address these issues.
Not only the health risks that result from huge amounts of
caffeine in these drinks that endanger particularly young
people with problems ranging from cardiac arrest to liver and
kidney damage and result in the doubling of emergency room
visits that are related to energy drinks, but also the
marketing and promotion practices that involve, as you have
heard, the use of adolescent athletes and sometimes children in
promotions and pictures as well as Websites and social media,
making use of children, making use of video games and other
activities designed to appeal to children, as well as buses and
vans at SAT test preparation and a variety of activities that
seem very problematic.
And so, I am not going to go on at this point with what I
think the panel will be discussing, but simply to call
attention to a number of the areas that we think are important
and that are for this panel to assess. But I would just finish
this part of my statement by saying we really do appeal to the
more responsible elements in this industry, the more
responsible companies to set a model and provide an example
because voluntary compliance, for example, with the American
Beverage Association standards and practices would be a good
step. And if further action is necessary, certainly we would
consider it.
I want to thank both of my colleagues, Senator Durbin and
Senator Markey, for their work on this issue. And most
particularly, now Senator Markey for the report, ``What's All
the Buzz About?'' which has been entered into the record, a
very important and compelling document that we worked on
together.
And I want to ask Senator Markey if he has any remarks at
the opening of our hearing?
STATEMENT OF HON. EDWARD MARKEY,
U.S. SENATOR FROM MASSACHUSETTS
Senator Markey. Thank you, Senator, very much and thank you
for your work.
And I thank Senator Rockefeller and Senator Thune for
having this very important hearing here today.
Over the last few years, a class of caffeine-laced
beverages popular with teens and known collectively as ``energy
drinks'' has taken the marketplace by storm. These products
promise improved athletic performance, more energy, better
hydration, increased concentration, and enhanced alertness that
collectively ``zap the nap'' and make consumers better at life,
athletics, and performance.
But energy drinks have been linked to severe adverse health
effects. In fact, between 2007 and 2011, the number of
emergency room visits related to the consumption of energy
drinks has doubled. This data is particularly troubling when
examining the way energy drink companies market these
beverages, especially to teenagers.
Earlier this year, Senator Blumenthal, Senator Durbin, and
I held up this issue for examination. And we believe that the
spotlight belongs on this issue. Senator Blumenthal has
referred to this report, ``What's All the Buzz About?'' And
this goes right to the heart of this issue, this focus on
teenagers, focus on younger people.
Senator Durbin made reference to smoking. It is right on
the money. That is exactly what is happening, and we can't kid
ourselves about the direct correlation that exists between the
marketing practices and the increased use by younger people of
these beverages.
We surveyed the practices of the makers of 14 of the most
commonly sold energy drink brands, including the 3 companies
here today. Our report found that while many of these products
do not engage in traditional marketing through TV, print, and
radio, they are very active in social media and sponsorship of
sporting, music, and gaming events that promote brand
recognition in a way that clearly appeals to young people and
often promotes unhealthy and quick consumption.
These companies are adamant that their target market
consists of adults, but with their heavy use of promotion
through Facebook, Instagram, Twitter, and other teen favorites,
they are, in fact, marketing to every single teenager in this
country. That is what this hearing is all about.
Senator Blumenthal and Senator Durbin and I are going to
continue to focus on this issue because we do think that there
has to be a dramatic change in the marketing practices of this
industry, and I thank you, Senator.
Senator Blumenthal. Thank you, Senator Markey.
Let us begin with you, Dr. Schneider, and then we will just
go across the table.
STATEMENT OF MARCIE BETH SCHNEIDER, MD, FAAP, ON BEHALF OF THE
AMERICAN ACADEMY OF PEDIATRICS
Dr. Schneider. Good afternoon, Chairman Rockefeller,
Ranking Member Thune, Senator Blumenthal, and members of the
Senate Commerce Committee, and thank you so much for inviting
me to speak this afternoon.
My name is Dr. Marcie Schneider, and I am honored to
provide testimony on behalf of the 60,000 members of the
American Academy of Pediatrics, or the AAP. I am a physician
boarded in the specialty of pediatrics and in the subspecialty
of adolescent medicine in private practice in Greenwich,
Connecticut. I am an incoming Executive Committee member of the
AAP Section on Adolescent Health.
While serving on the Committee on Nutrition, I coauthored
the clinical report entitled ``Sports Drinks and Energy Drinks
for Children and Adolescents: Are They Appropriate?'' The AAP
published its 2011 report to raise awareness of the dangers of
energy drink consumption in children and adolescents by
educating pediatricians who could, in turn, educate parents and
kids about the risks of consuming energy drinks.
We also took action, recognizing widespread confusion
between energy drinks and sports drinks. After an extensive
review of the research and scientific data available, the
conclusion within the AAP's clinical report was, ``Energy
drinks have no place in the diets of children and
adolescents.'' Another area of concern was that marketing
played a significant role in the rising use and abuse of energy
drinks.
What distinguishes an energy drink is that they all contain
caffeine, an addictive stimulant with many side effects. These
include cardiac side effects--elevated heart rate, elevated
blood pressure, cardiac arrhythmias--sleep disturbances,
anxiety, irritability, restlessness, high speech rate, motor
activity, increased attentiveness. Stomachs secrete more fluid.
People get dehydrated, and temperatures rise.
Energy drinks have been implicated in seizures. We know
that stimulants restrict blood flow to the entire body,
including the heart, including the brain, and particularly the
impact of a developing neurological system of a child or a
teenager is of grave concern.
Children and adolescents are also at risk for physical
dependence and addiction, and in fact, in schoolchildren,
caffeine withdrawal has been shown to be associated with
decreased reaction and attention for up to a week after
cessation of caffeine use.
In addition to caffeine, energy drinks contain other
stimulant substances, such as the protein taurine and the plant
extract guarana, both of which make the caffeine more potent.
Other nonstimulant ingredients in energy drinks also have been
noted to have negative side effects. L-carnitine has been
associated with some nausea, vomiting, abdominal pain, and
diarrhea. Ginseng has been associated with vaginal bleeding,
headache, dizziness, mania, and yohimbine with a rapid
heartbeat.
The adverse health effects of energy drinks are
increasingly bringing consumers to the emergency room. From
2007 to 2011, SAMHSA reported an increase in those emergency
room visits involving energy drinks. They have doubled from
10,000--over 10,000 in 2007 to over 20,000 in 2011. And almost
half of those were among patients from 12 to 25 years old. In
addition, the Poison Control Exposure Report skyrocketed from
672 in 2010 to over 3,000 in 2011 and 2012.
Energy drinks are reportedly consumed by 30 to 50 percent
of young adults, and you have also heard this afternoon that 18
percent of eighth graders are using these, more than one energy
drink a day. The public needs to fully understand the potential
for addiction, overconsumption, intoxication, and death.
The marketing and labeling of energy drink products also
plays a significant role in increasing health risks for young
people. First, the marketing of these products aims to entice
young people through social media and entertainment without
appropriate information about the product's risks.
Second, labeling is very confusing. Some energy drink
labels delineate the amount of caffeine, taurine, and guarana.
Others simply lump the stimulants together under an umbrella of
an ``energy blend.''
Third, the association of energy drinks with sports and
physical activity results in confusion and poses great safety
risks. Sports drinks provide energy through carbohydrates,
through electrolytes, and are used to replace the fuel lost
during physical exertion. Stimulant substances have no
nutritive value and can put athletes at risk of overheating,
dehydrating, and having caffeine toxicity.
As an adolescent medicine specialist, I have encountered
numerous parents who inadvertently encouraged their teen
athletes to consume energy drinks and were shocked to learn of
the health risks. As I conclude, I would like to submit the
following five recommendations.
First, caffeine in energy drinks should be actively and
strongly discouraged for young people. Children and adolescents
are not little adults. Their bodies are growing. Their bodies
are developing. Their minds are growing and developing.
Sleep and a well-balanced diet are really all that young
bodies need to perform their daily tasks. This message really
needs to be reinforced and especially at physician visits.
Second, given the health risks, public education is
necessary. Caffeine, in combination with other stimulant
ingredients, is what makes these energy drinks a grave concern.
Third, energy drinks' ingredients should be clearly labeled
and should provide information on the cumulative total of all
caffeine and other stimulants.
Fourth, given the rise in adverse health effects associated
with energy drinks that include high doses of caffeine often in
combination with other stimulants with unknown safety profiles,
research is urgently needed.
And last, stronger Federal guidance is necessary. The AAP
is very pleased that the FDA took action in response to the
health concerns associated with other caffeinated products.
Ultimately, policymakers in the Federal Government should work
together to advance and address the rising health and safety
incidents associated with energy drinks.
Again, it is an honor to provide testimony today on behalf
of the AAP. I would be happy to answer any questions that you
might have.
Thank you.
[The prepared statement of Dr. Schneider follows:]
Prepared Statement of Marcie Beth Schneider, MD, FAAP, On behalf of the
American Academy of Pediatrics
Good afternoon Chairman Jay Rockefeller, Ranking Member John Thune
and members of the Senate Commerce Committee, thank you for inviting me
to speak this afternoon and for your leadership on this important
issue. My name is Dr. Marcie Schneider and I am honored to provide
testimony on behalf of the 60,000 primary care pediatricians, pediatric
medical subspecialists, and pediatric surgical specialists of the
American Academy of Pediatrics (AAP). The AAP is committed to the
health and well-being of all infants, children, adolescents, young
adults, and their families. I am a physician boarded in the specialty
of Pediatrics and in the subspecialty of Adolescent Medicine.
I was a member of the American Academy of Pediatrics Committee on
Nutrition from 2005--2011, am a current member of the Executive
Committee of the American Academy of Pediatrics Section on Adolescent
Health, and a private practitioner of adolescent medicine in Greenwich,
Connecticut. While on the Committee of Nutrition, I coauthored the
clinical report entitled ``Sports Drinks and Energy Drinks for Children
and Adolescents: Are They Appropriate?'' published in Pediatrics in
June 2011.
Concerns About Energy Drinks
The AAP published its clinical report on energy drinks and sports
drinks due to a persistent need to educate parents, physicians and the
public about these products. Many of our colleagues within the medical
field and numerous families we encountered in our practices were
confused about product usage, ingredients and most importantly, safety.
After extensive review of the research and scientific data on energy
drinks, our conclusion as was presented in the AAP's clinical report
was that ``Energy drinks have no place in the diet of children and
adolescents.'' I will summarize the data.
First, what distinguishes an energy drink from other sports
beverages is that they contain caffeine, a stimulant substance.
Stimulant substances have no nutritive value nor does the body have any
need for them in our diets. When consumed, caffeine has a stimulant
drug effect on the entire body, head to toe. When consumed frequently
or in large quantities, that effect is magnified and poses greater
risks.
Overall, the risks to children and adolescents from consuming
energy drinks include increased heart rate, increased blood pressure,
increased anxiety, sleep disturbances, physical dependence and
addiction to caffeine, effects on the developing neurologic system,
precipitation of arrhythmias (irregular heartbeats), and even death.
Because these drinks and beverage products are considered dietary
supplements, they are not strongly regulated by the Food and Drug
Administration (FDA), and there is no limit to their caffeine levels,
which produces additional risk for smaller sized, physiologically and
developmentally immature children and adolescents.
Health Risks of Energy Drinks
Caffeine is commonly consumed in the United States in beverages
including coffee, tea, and soft drinks and this has contributed to
confusion with the safety of energy drinks. However, there is growing
concern over caffeine consumed in the form of ``energy drinks.''
Although the term ``energy drink'' lacks a statutory definition, they
are generally accepted to include beverages and liquid dietary
supplements that are marketed to boost energy, decrease fatigue,
enhance concentration, and increase mental alertness. They typically
contain variable amounts of caffeine, and often contain one or more
additional stimulant substances (such as guarana and taurine). Energy
drink manufacturers are not required to disclose caffeine content on
drink labels, so it is difficult for consumers to identify how much
caffeine is being consumed. The total amount contained in some products
can exceed 500mg (equivalent to 14 cans of common, caffeinated soft
drinks).
There are many known physiologic effects of caffeine
consumption.\1\ Caffeine is absorbed by all body tissues, and can have
variable effects on the brain, heart, endocrine, gastrointestinal,
musculoskeletal, renal and other body systems.\2\ Even when consumed at
low levels, some effects of caffeine include increases in speech rate,
motor activity, attentiveness, gastric secretion, dehydration, and
temperature. It can cause sleep disturbances and can increase anxiety
in those with anxiety disorders. It can cause numerous cardiac effects
including elevated heart rate, blood pressure and cardiac arrhythmias
in susceptible individuals.\3\
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\1\ American Academy of Pediatrics, Committee on Nutrition and the
Council on Sports Medicine and Fitness. Clinical Report: Sports Drinks
and Energy Drinks for Children and Adolescents: Are They Appropriate?
Pediatrics. 2011 Jun; 127(6):1182-1189.
\2\ Kabagambe EK, Wellons MF. Benefits and risks of caffeine and
caffeinated beverages. In: UpToDate, Rose BD (Ed), UptoDate, Waltham,
MA, 2013.
\3\ Giardina EG. Cardiovascular effects of caffeine. In: UpToDate,
Rose BD (Ed), UpToDate, Waltham, MA, 2013.
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Additional concerns specific to caffeine use in children include
its effects on the developing neurologic and cardiovascular systems and
the risk of physical dependence and addiction. Symptoms of caffeine
withdrawal can include headache, fatigue, decreased alertness,
drowsiness, difficulty concentrating, irritability, depressed mood,
muscle pain or stiffness, and nausea or vomiting. In school age
children, caffeine withdrawal has been shown to be associated with
decreased reaction and attention for up to one week after cessation of
caffeine use.\4\
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\4\ Bernstein GA, Carroll ME, Dean NW, et al., Caffeine withdrawal
in normal school-age children. J Am Acad Child Adolesc Psychiatry 1998;
37:858-65.
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When consumed in higher doses, caffeine intoxication can occur.\5\
Heavy caffeine consumption has been reported to cause serious
consequences including seizures, mania, stroke, hallucinations,
increased intracranial pressure, cerebral edema, paralysis, altered
consciousness, arrhythmias, and even sudden death.\5\ Effects on
children are less well studied, but evidence is mounting that children
experience many similar and some unique adverse health impacts compared
to adults. Caffeine effects also are dose dependent so the same amount
of caffeine consumed by a child or adolescent who is smaller than the
average adult will lead to increased risk of toxicity.
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\5\ Seifert, S. M., Schaechter, J. L., Hershorin, E. R., &
Lipshultz, S. E. (2011). Health effects of energy drinks on children,
adolescents, and young adults. Pediatrics, 127(3), 511-528.
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Consumption of caffeine in the form of energy drinks by children
and adolescents is a growing public health problem. Energy drinks are
reportedly consumed by 30 percent to 50 percent of adolescents and
young adults.\5\ In addition to the negative health effects associated
with consuming large amounts of caffeine, young people are experiencing
additional adverse effects of energy drink consumption. Guarana, a
plant that naturally contains large amounts of caffeine, can boost the
effects of added caffeine. Taurine, an amino acid, potentiates the
effects of caffeine as it affects the heart in a similar fashion.
Ingredients in energy drinks other than caffeine have also been
associated with negative health effects, such as nausea, vomiting,
abdominal pain, and diarrhea (L-Carnitine); vaginal bleeding, headache,
vertigo, mania, hypertension, rash, insomnia, irritability (Ginseng);
and tachycardia (Yohimbine).\5\
The adverse health effects of energy drinks are increasingly
bringing consumers to the emergency room: from 2007 to 2011, the
Substance Abuse and Mental Health Services Administration (SAMHSA)
reports the number of emergency department visits involving energy
drinks doubled from 10,068 visits in 2007 to 20,783 visits in 2011.\6\
Over 7,000 visits were made by young adults aged 18 to 25 years in
2011; 1,499 visits were made by adolescents aged 12 to 17.
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\6\ Substance Abuse and Mental Health Services Administration,
Center for Behavioral Health Statistics and Quality. (January 10,
2013). The DAWN Report: Update on Emergency Department Visits Involving
Energy Drinks: A Continuing Public Health Concern. Rockville, MD.
---------------------------------------------------------------------------
In addition, the number of energy drink exposures reported to
poison control centers has skyrocketed from 672 reports in 2010 to over
3152 reports in 2011 and 2012.\7\. Clearly, energy drink use and abuse
is becoming a public health problem with significant costs and burdens
to the health care system.
---------------------------------------------------------------------------
\7\ American Association of Poison Control Centers, accessed online
at http://www.aapcc.org/alerts/energy-drinks/
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Energy drink consumption has also been linked to other unhealthy
behaviors in adolescents. Among college students, energy drink
consumption has been linked to marijuana use, sexual risk-taking,
fighting, smoking, drinking, and misuse of prescription
drugs.\8\,\9\
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\8\ Miller, K. E. (2008). Energy drinks, race, and problem
behaviors among college students. Journal of Adolescent Health, 43(5),
490-497.
\9\ Thombs, D. L., O'Mara, R. J., Tsukamoto, M., Rossheim, M. E.,
Weiler, R. M., Merves, M. L., & Goldberger, B. A. (2010). Event-level
analyses of energy drink consumption and alcohol intoxication in bar
patrons. Addictive Behaviors, 35(4), 325-330.
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Mixing Caffeine and Alcohol
Mixing caffeine and alcohol is dangerous and potentially life-
threatening, particularly for adolescents. In 2010, FDA took regulatory
action against caffeinated alcoholic beverages. The FDA outlined the
health concerns about dual use of caffeine and alcohol to include
behavioral effects, diminished motor coordination or slower visual
reaction times and reduced perception of intoxication. The agency also
highlighted concerns about the risk that consumption of pre-mixed
products containing added caffeine and alcohol may result in higher
amounts of alcohol consumed per drinking occasion, a situation that was
particularly dangerous for underage drinkers.\10\
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\10\ FDA: Background Information Caffeinated Alcoholic Beverages:
http://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/
UCM190372.pdf
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The American Academy of Pediatrics agreed with the concerns of the
FDA about the combined use of alcohol and caffeine. The agency's
actions also represented an example of effective governmental
intervention in response to demonstrated health and safety risks.
However, despite FDA's regulatory action, research has demonstrated the
continuing prevalence of alcohol and energy drink mixing behaviors by
adolescents.
Concerns About Energy Drink Marketing
Perhaps one of the AAP's greatest concerns during the course of our
research was the realization that marketing plays a significant role in
the rising use and abuse of energy drinks. It is increasingly clear
that children and adolescents are targets as well as victims of
marketing aimed to encourage frequent, repetitive use of energy drinks
without any attempt to provide education as to potential risks by the
beverage manufacturers.
The manner in which energy drinks are packaged, the sizes as well
as the poor product content labeling only serve to exacerbate the
health concerns associated with youth consumption of energy drinks.
While the AAP has concluded that stimulant containing energy drinks
have no place in the diet of children and adolescents, current energy
drink marketing significantly targets youth with considerable
effectiveness.
Industry marketing practices and inconsistent Federal guidelines
contribute to consumer confusion and a lack of information from which
to properly make informed decisions. Children and adolescents are
frequently exposed to advertising for these products, contributing to
the public health problem of youth energy drink consumption. One of our
recommendations to this committee is to support and advocate for
widespread education and detailed product labeling so that consumers
may be better informed as they make choices for beverage consumption.
The U.S. energy drink market has grown rapidly and in 2012, sales
rose 16 percent percent and totaled $12.5 billion.\11\ At the same
time, adolescents consume energy drinks more regularly than other
groups, with 31 percent of 12-17 year olds regularly consuming energy
drinks, compared with 22 percent of the 25-35 year old age range.
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\11\ Staff of Congressman Edward J. Markey (D-MA), in coordination
with the staff of Senators Richard J. Durbin (D-IL) and Richard
Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
Targeted Marketing to Adolescents. April 10, 2013.
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Much of the growth in adolescent consumption is attributable to
marketing, which frequently targets youth through youth-oriented media
and packaging and images geared toward a young audience. In 2010,
energy drink advertisements reached 18 percent more teens than adults
via television and 46 percent more teens than adults via radio.\12\
This marketing is increasing as well, as teens saw 20 percent more
television ads for energy drinks in 2010 than in 2008. The practices
energy drink manufacturers use to sell these products associate them
with sports and physical activity.\13\ Frequently, companies sponsor
young athletes and high school sporting events, and these
advertisements promise things such as improved athletic performance and
increased attention and alertness.\14\
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\12\ Harris, Jennifer et al., Yale Rudd Center for Food Policy and
Obesity. Sugary Drink F.A.C.T.S.: Evaluating Sugary Drink Nutrition and
Marketing to Youth. October 2011. Accessed July 17, 2013. http://
www.sugarydrinkfacts.org/resources/SugaryDrinkFACTS_Report.pdf
\13\ Pediatrics. 2011 Jun; 127(6):1182-1189.
\14\ Staff of Congressman Edward J. Markey (D-MA), in coordination
with the staff of Senators Richard J. Durbin (D-IL) and Richard
Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
Targeted Marketing to Adolescents. April 10, 2013.
---------------------------------------------------------------------------
Teen exposure to advertising for energy drinks is significant.
Recent research by the Yale Rudd Center for Food Policy and Obesity
found that in 2010, energy drinks ranked high in the list of sugar-
sweetened beverage advertisements viewed by teens. Out of the top 28
beverages by teen advertisement exposure, three were for energy drinks:
5-Hour Energy ranked number one overall, Red Bull ranked 9th, and
PepsiCo's Amp ranked 19th.
All three of these beverages had a ratio of teens to adults
targeted by the ad that were above 1.0.\15\ In addition, energy drink
companies target and reach an adolescent market through significant
social media marketing. Yale's Rudd Center found that in 2011, Red Bull
had over 150 million YouTube upload views and over 20 million Facebook
fans. Rockstar also had 11 million Facebook fans.\16\Young people
commonly use social media, with over half of all teens accessing social
media daily and 22 percent of teens visiting their favorite social
media site over 10 times per day.\17\ These tools reach a
disproportionately young audience, and we know that advertisements
influence the behavior of children and adolescents. A study has found
that the amount of time watching television correlates with requests
for specific foods and caloric intake, and children are more likely to
request high caloric foods with low nutritional values after viewing
commercials.\18\
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\15\ Harris, Jennifer et al., Yale Rudd Center for Food Policy and
Obesity. Sugary Drink F.A.C.T.S.: Evaluating Sugary Drink Nutrition and
Marketing to Youth. October 2011. Accessed July 17, 2013. http://
www.sugarydrinkfacts.org/resources/SugaryDrinkFACTS_Report.pdf
\16\ Ibid.
\17\ O'keefe, Gwenn Schurgin; Clarke, Kathleen; American Academy of
Pediatrics Council on Communications and Media. The Impact of Social
Media on Children, Adolescents, and Families. Pediatrics. 2011 March.
127(4): 800-804.
\18\ American Academy of Pediatrics, Committee on Communications.
Policy Statement: Children, Adolescents, and Advertising. Pediatrics.
2006 Jun; 118(6): 2563-2569.
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The claimed association of energy drinks and ergogenic and
performance enhancing effects of the stimulants in energy drinks has
not been adequately studied in adolescents, who are more susceptible to
the negative health effects and who do not need stimulants to support
physical activity.\19\ Notably, adolescents surveyed do not
differentiate between ``sports drinks'' and energy drinks, highlighting
the same benefits for both product categories.\20\
---------------------------------------------------------------------------
\19\ Ibid.
\20\ Pediatrics. 2011 Jun; 127(6):1182-1189.
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A ``sports drink'' is a beverage that helps young athletes
rehydrate and replenish carbohydrates, electrolytes, and water during
prolonged and vigorous activity. The ``energy'' from a sports drink is
from carbohydrates which the body needs. However, the body never needs
the ``energy'' in the form of a drug stimulant like caffeine.
Regardless, heavy marketing and the association of energy drinks with
sports and physical activity equates the two types of products and
results in confusion about their uses.\21\ After all who doesn't want
more ``energy''? Youth athletes are susceptible to these marketing
practices and are consuming larger quantities of energy drinks in
association with sports activities, putting them at risk for adverse
health outcomes.
---------------------------------------------------------------------------
\21\ Ibid.
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As an adolescent medicine specialist, I have encountered numerous
parents who inadvertently encouraged their teens to consume energy
drinks to enhance sports performance and were confused or surprised
when informed about the health risks. This is due in large part to
advertising practices that associate energy drinks with health,
nutrition and physical activity without appropriate information about
the products' effects. In addition, products that use the terms
``organic'' and ``all natural'' also appeal to many young people's
desire to embrace healthier lifestyle options.
Packaging and Discerning Stimulant Content
The marketing and packaging of energy drinks also makes it
difficult to discern products' caffeine and other stimulant content.
Nearly identical products are often marketed and represented
differently to consumers, based on the distinction of whether they are
categorized as beverages or dietary supplements. Because this is a
distinction companies choose, they are able to decide which regulatory
rules under FDA govern their products.\22\ These inconsistencies result
in a dearth of information for consumers to make informed choices about
how much caffeine and other stimulants they are consuming. While
products classified as beverages list caffeine content, supplements do
not have to, or can include vague quantities comparing the product to a
number of cups of coffee.\23\ Additionally, even when caffeine content
is listed, it can be per serving in a container containing multiple
servings and the stimulant effect of additional ingredients is not
quantified, providing an incomplete estimate of total stimulant
content.\24\
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\22\ Staff of Congressman Edward J. Markey (D-MA), in coordination
with the staff of Senators Richard J. Durbin (D-IL) and Richard
Blumenthal (D-CT). What's all the buzz about? A Survey of Popular
Energy Drinks Finds Inconsistent Labeling, Questionable Ingredients and
Targeted Marketing to Adolescents. April 10, 2013.
\23\ Ibid.
\24\ Pediatrics. 2011 Jun; 127(6):1182-1189.
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Regulation of Conventional Foods and Supplemental Products
Although soft drinks and energy drinks seem similar, the two
products are regulated in different manners. Soft drink beverages are
classified as a conventional ``beverage'' and, as such, are regulated
by the Federal Food, Drug, and Cosmetic Act (FFDCA), which limits the
amount of caffeine in soft drinks to no more than 71 mg per 12 fl.
oz.\25\
---------------------------------------------------------------------------
\25\ FDA GRAS Notices, http://www.accessdata.fda.gov/scripts/fcn/
gras_notices/grn000347
.pdf
---------------------------------------------------------------------------
Energy drinks can be categorized as either conventional
``beverages'' or ``dietary supplements.'' Many energy drink
manufacturers claim their products are ``dietary supplements,'' which
allows them to fall under regulation by the 1994 Dietary Supplement
Health and Education Act (DSHEA) instead of the FFDCA. DSHEA allows
herbal or other natural products to be classified as dietary
supplements rather than food or drugs, and does not place limits on the
amount of caffeine that can be included in products.\26\
---------------------------------------------------------------------------
\26\ FDA, http://www.fda.gov/RegulatoryInformation/Legislation/
FederalFoodDrugandCosme
ticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148003.htm
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The requirements related to caffeine labeling for conventional
beverages and dietary supplements are also different. Beverages
containing caffeine must include the included amount on the product
label; dietary supplements must include caffeine in the list of
ingredients, but there is no requirement that the amount of caffeine be
listed.
Caffeine is considered by the FDA as a Substance Generally
Recognized as Safe (GRAS), which allows it to be added to conventional
foods and beverages without preapproval from the FDA. In the case of
dietary supplements, caffeine is considered to be a ``dietary
ingredient,'' which allows it to similarly be used without FDA
preapproval. This means in both beverages and dietary supplements,
manufacturers can add caffeine to their products without FDA approval.
Adverse events associated with use of dietary supplements are
required to be reported to the FDA by the 2006 Dietary Supplement and
Nonprescription Drug Consumer Protection Act.\27\ Specifically, dietary
supplement manufacturers, packers, and distributors must notify FDA if
they receive reports about serious adverse events in connection with
the use of their products. This law defines a serious adverse event as
an adverse health-related event that is associated with the use of a
dietary supplement and that results in death, a life threatening
experience, inpatient hospitalization, a persistent or significant
disability or incapacity, a congenital anomaly or birth defect, or that
requires, based on reasonable medical judgment, a medical or surgical
intervention to prevent one of those outcomes. The requirement to
report serious adverse events to FDA applies only to dietary
supplements and not to conventional beverages, other conventional
foods, or cosmetics.
---------------------------------------------------------------------------
\27\ FDA, ``Energy Drinks'' and Supplements: Investigation into
Adverse Event Reports, http://www.fda.gov/Food/NewsEvents/ucm328536.htm
---------------------------------------------------------------------------
FDA has prepared draft guidance on the subject of differentiating
between whether a product ought to be classified as a beverage or a
dietary supplement.\28\ First prepared in December 2009, this guidance
would provide significant clarity to manufacturers about precisely the
standards a product should meet to be classified as one category or the
other. Additionally, this guidance would outline standards for the use
of novel ingredients or novel quantities of previously used
ingredients, to ensure that they meet GRAS and those consumers,
particularly children, who are more susceptible to the effects of
caffeine and other stimulants, are not exposed to unsafe products.
---------------------------------------------------------------------------
\28\ FDA: Guidance Document http://www.fda.gov/Food/
GuidanceRegulation/GuidanceDocu
mentsRegulatoryInformation/DietarySupplements/ucm196903.htm
---------------------------------------------------------------------------
In addition, proposals have been introduced in Congress to
establish FDA authority to regulate or mandate new labeling for energy
drinks, including a mandatory warning label requirements for dietary
supplement ingredients that the Secretary determines to cause
potentially serious adverse events, drug interactions,
contraindications, or potential risks to subgroups to subgroups such as
children and pregnant or breastfeeding women.
Recommendations
The American Academy of Pediatrics submits the following
recommendations for consideration by the Committee:
Caffeine and Energy Drinks Should Be Actively and Strongly
Discouraged for Young People. Due to the potentially harmful
health effects of caffeine, dietary intake should be
discouraged for all children. Because the actual stimulant
content of energy drinks is hard to determine, energy drinks
pose an even greater health risk than simple caffeine.
Therefore, energy drinks are not appropriate for children and
adolescents and should never be consumed.
Public Education is Necessary. Parents should be advised on
nutrition and sleep needs of children and adolescents to reduce
the need for stimulant seeking behaviors. Also, parents and
adolescents should understand the risks of consumption and
overconsumption of caffeinated beverages and energy drinks as
well as the dangers of consuming alcohol with energy drinks.
The health risks of these products also reinforce the need for
increased media literacy as recommended by the AAP.\29\
---------------------------------------------------------------------------
\29\ Pediatrics, Vol. 118 No. 6 December 2006, pp 2563-2569
Voluntary Consumer Product Labeling Would Benefit the
Public. Energy drink packaging should provide information on
the cumulative total of all caffeine and other stimulants, and
it should be per package for non-resealable packaging. In the
absence of strong voluntary standards, mandatory requirements
would help consumers make informed choices and better protect
---------------------------------------------------------------------------
public health and safety.
More Research Is Needed. Given the health effects of energy
drinks due to the high doses of caffeine, often in combination
with other stimulant ingredients with unknown safety profiles,
research on energy drinks and the ingredients they contain, is
urgently needed. Additional poison control data would certainly
be helpful in identifying areas of concern.
Stronger Federal Guidance is Necessary. The AAP is pleased
the FDA took action to protect public health and safety in
response to concerns and adverse incidences regarding
caffeinated alcoholic beverages, inhalable caffeine products
and the introduction of caffeinated gum and processed foods.
The FDA should finalize its 2009 guidance for industry to
ensure that beverage products are classified appropriately
based on their composition and intended use. Furthermore,
additional efforts are needed to examine potential safety
standards for GRAS ingredients that are generally regarded as
safe but with demonstrated health and safety risks for children
or other vulnerable populations or when consumed in excess
amounts. Finally, Congress should eliminate all unnecessary
requirements that delay or inhibit the work of the Interagency
Working Group on Food Marketed to Children.
Conclusion
It is an honor to provide testimony on behalf of myself and the
over 60,000 primary care pediatricians, pediatric medical
subspecialists, and pediatric surgical specialists of the American
Academy of Pediatrics. I appreciate the opportunity to discuss this
very important national issue and would be happy to answer your
questions.
The online version of this article, along with updated information and
services, is located on the World Wide Web at: http://
pediatrics.aappublications.org/content/early/2011/05/25/peds.2011-0965
Senator Blumenthal. Thank you, Dr. Schneider.
Dr. Harris?
STATEMENT OF JENNIFER L. HARRIS, Ph.D., MBA,
SENIOR RESEARCH SCIENTIST, DIRECTOR OF MARKETING
INITIATIVES, RUDD CENTER FOR FOOD POLICY & OBESITY,
YALE UNIVERSITY
Dr. Harris. Thank you, Senator Blumenthal, Chairman
Rockefeller, and members of the Committee, for inviting me to
participate in this important hearing on energy drinks and
youth.
My name is Dr. Jennifer Harris, and I am Senior Research
Scientist and Director of Marketing Initiatives at the Rudd
Center for Food Policy and Obesity at Yale University. I have
been studying food marketing to children and teens for the past
10 years, and I also have an MBA and 20 years of experience as
a marketing executive and consultant.
Today, I will describe how energy drink companies reach and
target teens, why beverage industry marketing guidelines do not
address public health concerns, and how companies could protect
minors from the harm caused by their products. I would also
like to refer you to my extensive written testimony.
In 2010, we began to study youth-targeted marketing of
soda, fruit drinks, and other sugary drinks. But what we
learned about energy drinks stunned us. Energy drink brands,
such as 5-Hour Energy shots and Red Bull, spend more on
advertising than any other category of sugary drinks except
soda, and their TV ads often appear on teen-targeted networks,
like MTV and Adult Swim.
In fact, teens see more energy drink ads than adults do on
TV. All brands are active in social media that teens share
virally with their friends, including Facebook, Twitter, and
YouTube. Red Bull and Monster Energy are the number 5 and the
number 12 most popular brands on Facebook.
Energy drink brands often promote teen athletes and
musicians and sponsor local events, where they provide free
samples, including to minors. And most energy drinks are sold
in convenience stores, where special displays encourage impulse
purchases, and minors can easily buy them without parents'
consent.
We recently updated our marketing analysis and found that
these practices continue unabated and have become worse. New
products are being advertised. Several brands doubled their
advertising spending in 2 years, and social media fans
increased by 2 to 10 times.
And this marketing is very effective. While sales of most
other beverage categories have declined, energy drink sales
increased by 19 percent in 2012, reaching $8 billion. You have
heard that pediatricians are concerned, and so are parents.
Three quarters of parents agree that energy drinks should not
be marketed or sold to teens under 18.
The American Beverage Association and energy drink
manufacturers have responded to these concerns. Today, you will
probably hear from members of the panel that caffeine is safe
for all ages and that manufacturers comply with ABA guidelines
for responsible labeling and marketing of energy drinks.
But many energy drink manufacturers do not belong to the
ABA, and not all members comply with these guidelines. Further,
the FDA has not determined that the concentration of caffeine
and the other stimulants in most energy drinks and shots are
safe for the food supply.
You will probably also hear that these companies do not
market their products to children. But the only marketing the
ABA guidelines specifically prohibit is advertising on
children's television programs like Nickelodeon and marketing
in elementary schools. The policy does not address advertising
to children 12 years and older or most common types of energy
drink marketing, including social media and sponsorships.
The ABA also suggests that energy drinks not be marketed as
sports drinks. But companies continue to sponsor sporting
events and high school athletics, hire athletes as brand
Ambassadors, and explicitly encourage use during physical
activity.
Clearly, more needs to be done to protect teens. At a
minimum, energy drink manufacturers should not advertise in
media that are more likely to be seen by teens than by adults,
and they should establish age requirements to access digital
content whenever possible. They should not engage in marketing,
including YouTube videos and smartphone apps, which
disproportionately appeal to teens. They should not distribute
free samples to minors, and they should comply with their own
guidelines to not market energy drinks as sports drinks.
But teens represent a significant growth opportunity for
energy drink companies. Teens are highly vulnerable to
marketing influence, especially when it exploits their peer
relationships and their desire to appear cool, daring, and
grown-up, making them an easy target.
If energy drink manufacturers continue to evade the issue
of marketing to teens, the FDA, the FTC, policymakers, and
attorneys general have the authority to establish and enforce
restrictions on energy drink ingredients, labeling, retail
placement, and sales to minors. Such regulations would be
widely supported by parents, the medical community, and others
who advocate for children's health.
Thank you, and I look forward to answering your questions.
[The prepared statement of Dr. Harris follows:]
Prepared Statement of Jennifer L. Harris, Ph.D., MBA, Senior Research
Scientist, Director of Marketing Initiatives, Rudd Center for Food
Policy & Obesity, Yale University
Thank you for the opportunity to address this committee. I am
Jennifer Harris, Director of Marketing Initiatives and Senior Research
Scientist at the Rudd Center for Food Policy and Obesity at Yale
University. I also have twenty years experience as a marketing
executive and consultant. The Rudd Center seeks to improve the world's
diet, prevent obesity, and reduce weight stigma by establishing
creative connections between science and public policy, carrying out
research that addresses key questions in nutrition policy, and serving
as an information resource to leaders around the world on matters of
food and nutrition. For the past five years, I have been conducting
research to document the amount and impact of food marketing to
children and teens and identify opportunities to reduce its harmful
effects on children's diets and health.
In 2011, I led a team of researchers at the Rudd Center to evaluate
the nutritional quality and marketing of sugary drinks, including
energy drinks, to children and teens. Soda and fruit drinks were our
primary concern when we started. Numerous research studies have shown
that young people consume these products in large quantities,
contributing to obesity and other diet-related diseases, such as type 2
diabetes and cardiovascular disease. However, as we gathered our data,
we soon became alarmed by what we were learning about energy drink
products--including energy drinks such as Red Bull and Monster Energy,
and energy shots such as 5-Hour Energy--and how they are marketed. Key
findings include:
Most energy drinks contain unhealthy levels of sugar,
sodium, and caffeine for young people. \1\ Sugar and calories
in energy drinks are comparable to sugar-sweetened sodas, but
sodium levels are three times as high. The median amount of
caffeine in energy drinks is 80 mg per 8 ounces--comparable to
one cup of coffee. However, energy drinks often come in large,
non-resealable cans (that must be consumed at one time), which
contain up to 325 mg of caffeine,\2\ while energy shots contain
as much as 280 mg of caffeine per 2.5-ounce bottle.\3\ These
amounts are six to seven times the caffeine in a can of cola.
---------------------------------------------------------------------------
\1\ Harris JL, Schwartz MB, Brownell KD, et al., (2011). Sugary
Drink FACTS: Evaluating fast food nutrition and marketing to youth.
Retrieved from http://www.sugarydrinkfacts.org/resources/
SugaryDrinkFACTS_Report.pdf.
\2\ Harris et al., (2011).
\3\ SKEnergyShots.com
Information about caffeine content and other ingredients in
energy drinks can be difficult to find.\4\ Just over half of
products fully disclosed caffeine and other ingredients on the
labels. Even after repeated calls to company customer
helplines, researchers were unable to obtain caffeine content
for 46 percent of energy drinks, including 5-Hour Energy and
Monster products.
---------------------------------------------------------------------------
\4\ Harris et al., (2011).
Energy drink brands spent more on media advertising in 2010
than all other sugary drink brands except soda.\5\ Spending on
media advertising for energy drinks and shots, including 5-Hour
Energy, Red Bull, and Amp, totaled $165 million, an increase of
36 percent from 2008 and comparable to the $189 million spent
on fruit juices.
---------------------------------------------------------------------------
\5\ Ibid.
Both children and teens often are often exposed to energy
drink advertising on TV. In 2010, all children (ages 6-11) in
the United States viewed on average more than one energy drink
advertisement per week.\6\ They saw more ads for 5-Hour Energy
than for any brand of sugary drink, except Capri Sun children's
fruit drink. And teens (defined by advertisers as 12- to 17-
year-olds) see even more. They viewed 124 energy drink ads on
average in 2010--more ads than any other drink category
including soda, fruit drinks, and sports drinks.
---------------------------------------------------------------------------
\6\ Ibid.
While sales of most other categories of sugary drinks are
decreasing, sales of energy drinks continue to grow. From 2007
to 2012, gallon sales of energy drinks increased by 53 percent,
compared with a decline of 9 percent for carbonated soft
drinks.\7\ In 2010, U.S. energy drink sales equaled
approximately $20 per capita, surpassing sales of both sports
and fruit drinks and approximately half of sugar-sweetened soda
sales.\8\ Total sales of energy drinks reached $6.9 billion in
2012, an increase of 19 percent over the previous year, and
sales of energy shots increased by 9 percent to reach $1.1
billion.\9\
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\7\ Beverage World (2013, June 7). State of the Beverage Market.
Webcast.
\8\ Harris et al., (2011).
\9\ BeverageIndustry.com. (2012, July 18). 2012 State of the
Industry: Energy Drinks. Retrieved from www.bevindustry.com/articles/
85655-consumers-seek-out-energy-boosts.
Despite risks and concerns about energy drink consumption by
youth under age 18, teens appear to be an important target
market for many energy drink brands. Our research shows that
many energy drink brands reach teens through targeted media and
marketing messages that disproportionately appeal to this age
group.\10\
---------------------------------------------------------------------------
\10\ Harris et al., (2011).
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Targeted marketing of energy drinks to teens
Our research utilizes syndicated market research data (including
Nielsen and comScore) and other publicly available information to
measure where companies place their advertising, as well as age and
other demographic information about individuals who see or hear this
advertising. Advertisers use these same data to measure the
effectiveness of their own campaigns and monitor those of their
competitors. While our analysis did not include proprietary industry
documents detailing companies' marketing strategies, our findings are
comparable to results of a recent Congressional investigation.\11\
Responses by fourteen energy drink companies confirmed that adolescents
are frequent targets of their marketing efforts.
---------------------------------------------------------------------------
\11\ Markey EJ, Durbin RJ, Blumenthal R. (2013). What's all the
buzz about? A survey of popular energy drinks finds inconsistent
labeling, questionable ingredients and targeted marketing to
adolescents. Retrieved from clerk.house.gov/member_info/
vacancies_pr.aspx?pr=house&
vid=83
---------------------------------------------------------------------------
The following summarizes our findings on teen-targeted marketing by
energy drink brands in 2010,\12\ and Exhibit 1 provides examples of
their marketing communications.
---------------------------------------------------------------------------
\12\ Harris et al., (2011).
Energy drink ads frequently appeared on cable networks with
more teen viewers than adults, including Adult Swim (80-90
percent more teen viewers), MTV and MTV2 (88-199 percent more
teen viewers), and Comedy Central (20-30 percent more teen
viewers).\13\ Overall, teens viewed 18 percent more TV ads for
energy drinks than adults viewed, even though they spend 25
percent less time watching TV.\14\
---------------------------------------------------------------------------
\13\ Yale Rudd Center for Food Policy and Obesity (2012).
Adolescent-targeted television advertising for energy drinks. Retrieved
from yaleruddcenter.org/resources/upload/docs/what/
advertising/TVAdvertising_EnergyDrinks_2010.pdf
\14\ Harris et al., (2011).
Energy drink brands have been early adopters of social media
marketing, with a strong presence on Facebook, Twitter, and
YouTube.\15\ Red Bull had more than 20 million Facebook fans in
2011 and Monster had 11 million; Coca-Cola was the only sugary-
drink brand with a larger fan base (31 million). Teens
comprised 38 percent of unique visitors to Monster's Facebook
page and 11 percent of Red Bull's visitors.\16\ 5-Hour Energy
and Red Bull tweeted more frequently than any other sugary
drink brand: 42.1 and 32.5 times per week, respectively. Red
Bull posted an astounding 447 videos to its YouTube channel in
2010 and received 158 million views by June 2011. Monster
Energy's YouTube channel was also popular with 121 videos
uploaded and almost 11 million views. Teens and even children
under age 12 are frequent users of these social media.\17\
---------------------------------------------------------------------------
\15\ Ibid.
\16\ Pomeranz, JL, Munsell CR, and Harris JL (2013).Energy drinks:
an emerging public health hazard for youth. J. PublicHealthPolicy, 34,
254-271.
\17\ Harris et al., (2011); Harris JL (2013). The new hidden
persuaders: The digital world of food marketing to children and teens.
In A Place at the Table, 106-P Pringle (Ed), 106-122, Public Affairs:
NY.
Energy drink brands offered popular smartphone applications
and advertised on mobile websites. \18\ Red Bull offered 18
different smartphone apps, primarily games and music, and teens
under 18 represented 25 percent to 41 percent of individuals
who downloaded three of these apps. Amp was a frequent
advertiser on mobile websites, including VH1 Mobile and MTV
Mobile.
---------------------------------------------------------------------------
\18\ Harris et al., (2011).
Energy drink brands were active sponsors of local events,
primarily music concerts and extreme sports, such as Monster
Energy AMA Supercross, AMP World Extreme Cagefighting, and Red
Bull rallycar jumping.\19\ Monster Energy, Rockstar, Red Bull
and Amp all aired advertising on local television to support
their sponsorships, and sponsorships were featured prominently
on company websites and YouTube videos. Of note, there are
typically no age restrictions on who may attend these events
and energy drink sponsors often provide free samples to
spectators.
---------------------------------------------------------------------------
\19\ Harris et al., (2011).
Messages on energy drink websites frequently targeted young
males and often contained highly questionable messages.\20\ For
example, MonsterEnergy.com included references to extreme
sports, alcohol and drug use, and sexual objectification of
women, and Rockstar69.com featured scantily clad women in
sexually suggestive poses. RedBull.com focused on extreme
sports and youth culture. MonsterEnergy.com had the most teen
visitors (averaging 23,300 per month), followed by
5HourEnergy.com (13,200) and RedBull.com (11,800). Teens were
2.5 times more likely to visit MonsterEnergy.com than adults
and 1.7 times more likely to visit Rockstar69.com.
---------------------------------------------------------------------------
\20\ Ibid.
Retail practices encourage impulse purchases and provide
easy access for minors. The majority of energy drinks (79
percent) are sold in convenience stores.\21\ They typically are
stocked in coolers together with sugary drinks or alcoholic
beverages. This placement implies that these products are
similar to sodas and other non-alcoholic beverages and may
encourage their consumption with alcohol. Energy shots often
are featured in free-standing displays near the checkout
counter, and 79 percent of sales occurred in stores with
special displays of these products.
---------------------------------------------------------------------------
\21\ Ibid.
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Why energy drinks should not be marketed to teens
Increasing consumption of high-sugar energy drinks and potential
effects on obesity and other diet-related diseases in young people is
an obvious concern. However, concerns extend far beyond excess sugar
consumption, as evidence of severe immediate adverse effects of energy
drink consumption by minors grows. Emergency room visits involving
energy drinks increased tenfold from 2005 to 2009, and 11 percent of ER
visits related to energy drink consumption involved 12-to 17-year-olds,
mostly due to energy drink intake alone.\22\ The U.S. Food and Drug
Administration (FDA) is investigating adverse effects related to the
intake of energy drinks and shots, including deaths.\23\
---------------------------------------------------------------------------
\22\ Substance Abuse and Mental Health Services Administration,
Center for Behavioral Health Statistics and Quality (2011, November
22). The DAWN Report: Emergency Department Visits Involving Energy
Drinks. Rockville, MD.
\23\ Food and Drug Administration [FDA] (2012, November 16). Energy
``drinks'' and supplements: Investigations of adverse event reports.
Retrieved from www.fda.gov/Food/NewsEvents/ucm328536.htm.
---------------------------------------------------------------------------
The medical community and parents do not believe that children
under 18 should consume these products.
In 2008, 100 scientists and physicians wrote a letter to the
FDA requesting increased regulation of energy drinks due to the
risk of caffeine intoxication and alcohol-related injuries when
consumed by youth.\24\
---------------------------------------------------------------------------
\24\ Weise E (2008, October 22). Petition calls for FDA to regulate
energy drinks. USA Today. Retrieved from Usatoday30.usatoday.com/news/
health/2008-10-21-energy-drinks_N.htm.
The American Academy of Pediatrics (AAP) concluded in 2011
that ``energy drinks have no place in the diet of children and
adolescents'' due to their ``stimulant content.'' \25\ An
article in Pediatrics in Review counsels pediatricians to
screen teenagers for energy drink use and provide appropriate
counseling due to heavy energy drink consumption among some
patients that can cause significant morbidity.\26\
---------------------------------------------------------------------------
\25\ American Academy of Pediatrics [AAP]. (2011). Sports drinks
and energy drinks for children and adolescents: Are they appropriate?
Pediatrics, 127(6), 1182-1189.
\26\ Blankson KL, Thompson AM, Ahrendt DM, Patrick V (2013). Energy
drinks: What teenagers (and their doctors) should know. Pediatrics in
Review, 34(2),55-62.
The American Medical Association (AMA) adopted a policy to
support a ban on the marketing of energy drinks and shots to
adolescents under age 18. According to an AMA board member,
``Energy drinks contain massive and excessive amounts of
caffeine that may lead to a host of health problems in young
people, including heart problems, and banning companies from
marketing these products to adolescents is a common sense
action that we can take to protect the health of American
kids.'' \27\
---------------------------------------------------------------------------
\27\ American Medical Association [AMA]. (2013, June 18). AMA
adopts new policies on second day of voting at annual meeting. Press
release. Retrieved from www.ama-assn.org/ama/pub/news/news/2013/2013-
06-18-new-ama-policies-annual-meeting.page
The Institute of Medicine (IOM) will hold a two-day workshop
next month to ``examine cardiovascular and central nervous
system (CNS) effects and other important health hazards of
caffeine that may arise in at-risk populations consuming varied
amounts of caffeine'' including in dietary supplements or
conventional foods, ``alone or in combination with other
substances in products commonly referred to as `energy
products.' '' \28\
---------------------------------------------------------------------------
\28\ Institite of Medicine, National Academies of Sciences (2013).
Planning committee for a workshop on potential health hazards
associated with consumption of caffeine in food and dietary
supplements. www.iom.edu/Activities/Nutrition/
PotentialHazardsCaffeineSupplements
.aspx.
The Rudd Center conducted a survey of 985 parents of
children under age 18 in 2011.\29\ The majority of parents
agreed that energy drinks should not be marketed or sold to
children and adolescents (78 percent and 74 percent,
respectively). In addition, 86 percent supported caffeine
disclosures and 85 percent supported warnings on labels about
potential adverse effects. Almost half of parents (48 percent)
agreed that youth under 18 should not be allowed to consume
energy drinks.
---------------------------------------------------------------------------
\29\ Yale Rudd Center for Food Policy & Obesity. (2012) Parents'
attitudes about energy drinks. Retrieved from www.yaleruddcenter.org/
resources/upload/docs/what/policy/SSBtaxes/SSB_
Parent_Attitudes_Energy_Drinks.pdf
---------------------------------------------------------------------------
How energy drink companies have responded
Energy drink manufacturers and the American Beverage Association
(ABA) have responded to the AAP, the Rudd Center, and others who have
raised concerns about their products with statements such as ``We do
not market our products to children and other caffeine sensitive
people'' (Red Bull, June 2011)\30\ or ``Caffeine is safe for all ages
and is among the most studied ingredients in the food supply today''
(ABA, October 2011).\31\ The ABA has produced guidelines for its
members on the responsible labeling and marketing of energy drinks.\32\
In its guidance document, the ABA encourages its members who produce
and market energy drinks to disclose caffeine content and include a
warning, ``Not (intended/recommended) for children, pregnant or nursing
women (and/or persons/those) sensitive to caffeine'' on product labels.
It also encourages members to not market energy drinks as sports drinks
and not market them to children ``as set forth in ABA's commitment to
the Global Policy on Marketing to Children.''
---------------------------------------------------------------------------
\30\ BeverageDaily.com (2011, June). Red Bull denies child
marketing claims in new study. Retrieved from http://
www.beveragedaily.com/Regulation-Safety/Red-Bull-denies-child-marketing
-claims-in-new-study.
\31\ American Beverage Association. (2011, October 31). Beverage
Industry Responds to Latest Rudd Report. Press release. Retrieved from
www.ameribev.org/files/news/253_ABA%20
Responds%20to%20Rudd%20Report.pdf.
\32\ American Beverage Association. ABA Guidance for the
Responsible Labeling and Marketing of Energy Drinks. Retrieved from
www.ameribev.org/files/339_Energy%20Drink%20Guide
lines%20%28final%29.pdf
---------------------------------------------------------------------------
However, these statements fail to address most concerns about
energy drink products and their marketing practices.
Not all energy drink companies belong to the ABA, and all
products on the market do not abide by their guidelines.
Labeling across energy drinks is inconsistent,\33\ and products
labeled as supplements (including energy shots) are not subject
to these requirements.\34\ In Presently, Coca-Cola, PepsiCo, Dr
Pepper Snapple Group, Red Bull, Monster, and Rockstar are ABA
members.\35\
---------------------------------------------------------------------------
\33\ Harris et al., (2011).
\34\ Pomeranz et al., (2013).
\35\ American Beverage Assocation. Active Members. Retrieved from
www.ameribev.org/members/active-members/.
Most energy drinks contain caffeine in higher concentrations
than has been determined to be safe. In 1977, the FDA
determined that caffeine is Generally Recognized as Safe (GRAS)
for ``cola-type beverages'' in quantities up to .02 percent (71
mg per 12 ounces),\36\ significantly less caffeine than
contained in most energy drinks.\37\ Caffeine's GRAS status was
granted 40 years ago at a time when the food supply was very
different, and energy drinks did not exist in the marketplace.
---------------------------------------------------------------------------
\36\ Food and Drug Administration [FDA] (2003). Substances
generally recognized as safe. Code of Federal Regulations. Title 21
volume 3, Sec. 182.1180. Retrieved from www.access
data.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.1.
\37\ Reissig CJ, Strain EC, and Griffiths RR. (2009). Caffeinated
energy drinks--A growing problem. Drug and Alcohol Dependence, 99(1-3),
1-10; Markey et al. (2013).
Energy drinks often contain ingredients, such as guarana and
taurine, which energy drink companies have self-determined to
be safe. \38\ If an ingredient added to beverages has not been
designated as GRAS by the FDAs, companies may self-determine
its GRAS status, as long as the FDA is notified.\39\ Further,
beverages are not required to disclose the amount of these
ingredients on product packages.
---------------------------------------------------------------------------
\38\ Pomeranz, Munsell, & Harris (2013); Markey, Durbin, &
Blumenthal (2013).
\39\ Markey, Durbin, & Blumenthal (2013).
The ABA's policy on marketing to children does not address
marketing to children 12 years and older. The International
Food & Beverage Alliance (IFBA) Global Policy on Marketing and
Advertising to Children, to which the ABA guidance document
refers, only limits advertising to children under 12 years old
and commercial communication to students in primary
schools.\40\ IFBA defines advertising to children as
``advertising to media audiences with a majority of children
under 12 years.'' In effect, the only marketing guidance the
ABA has provided its members is to encourage them not to
advertise on children's television programs (e.g., Nickelodeon,
Cartoon Network) or in elementary schools. These guidelines do
not even cover children's websites (including Nickelodeon.com
and CartoonNetwork.com)\41\ or most food-company child-targeted
websites (including HappyMeal.com and FrootLoops.com) because
their audiences consist of 30 percent or fewer children under
12.\42\ Further, marketing that occurs in non-measured media--
including social media, mobile devices, local events and
signage, retail displays and product packaging--are not covered
by the IFBA policy.
---------------------------------------------------------------------------
\40\ International Food and Beverage Alliance. (2010). IFBA Global
Policy on Marketing and Advertising to Children. Retrieved from
www.ifballiance.org/sites/default/files/IFBA%20Global%
20Policy%20on%20Marketing%20and%20Advertising%20to%20Children%20%28June%
202010%
29.pdf.
\41\ Harris JL, Speers SE, Schwartz MB, Brownell KD. (2012). U.S.
food company branded advergames on the internet: Children's exposure
and effects on snack consumption. Journal of Children and Media, 6(1),
51-68.
\42\ Ustjanauskas AE, Harris JL, Schwartz MB (2013). Food and
beverage advertising on children's websites. Pediatric Obesity.
[published online ahead of print]. Retrieved from http://
onlinelibrary.wiley.com/doi/10.1111/j.2047-6310.2013.00185.x/pdf.
Despite ABA guidelines, marketing for many energy drinks
implies that they are appropriate for use in connection with
sports.\43\ For example, companies commonly feature sports
themes in advertising, sponsor sporting events and high school
athletics, hire professional athletes as brand ambassadors, and
explicitly encourage consumption during physical activity.\44\
One Coca-Cola brand (NOS) recently introduced an energy drink
sub-brand called ``Active'' which resembles a traditional
sports drink in packaging and presentation.\45\ Apparently many
energy drink companies have chosen not to comply with the ABA's
``encouragement'' in this regard.
---------------------------------------------------------------------------
\43\ Harris et al (2013); Markey, Durbin, & Blumenthal (2013).
\44\ Red Bull. Q&A. Retrieved from http://energydrink.redbull.com/
when-to-consume.
\45\ NOS. Energy Drink Products. Retrieved from http://
www.drinknos.com/products.do.
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Recent developments in energy drink marketing to teens
We recently updated our data on energy drink marketing practices
from 2011 through early 2013 to evaluate how energy drink
manufacturers' marketing practices have changed following increased
attention to potential dangers of their products. Exhibit 2 (Rudd
Report, Energy Drink Marketing to Teens: 2010 to 2103) details many of
these findings.\46\
---------------------------------------------------------------------------
\46\ Rudd Report (2013). Energy drink marketing to teens: 2010 to
2013. Available at yaleruddcenter.org/energydrinks.
---------------------------------------------------------------------------
We found a few positive developments.
ABA-member energy drinks now disclose caffeine content on
product labels. Visits to convenience stores and other retail
outlets indicate that all ABA companies also are compliant with
the guideline to include warning labels on cans. However, the
problem of inadequate disclosure and inconsistent labeling from
non-ABA companies, including 5-Hour Energy and smaller energy
drink brands, remains.
A few brands significantly reduced marketing in 2012.\47\
Two products, Venom (Dr Pepper Snapple Group), and Full
Throttle (Coca-Cola), appear to have stopped most marketing
practices observed in 2010. In addition, Amp (PepsiCo) reduced
traditional advertising, although the brand remains active on
social media.
---------------------------------------------------------------------------
\47\ Ibid..
However, we found significantly more cause for continued concern.
Two new energy products have been introduced since 2010 that present
---------------------------------------------------------------------------
significant risks for youth consumption.
Street King Energy ``was founded to fight childhood hunger,
using the SK Energy Shots brand as a launch pad to unite the
world's best athletes and performers and prove that energy,
health, and philanthropy can exist in one amazing package.''
\48\ SK Energy is promoted by sports figures, such as Erin
Andrews (Fox Sportscaster) and pro football and basketball
players. The company spent $6 million on advertising in 2012
and also maintains Facebook, Twitter, and YouTube pages. The
product is touted as ``a better source of energy'' because it
does not contain ``controversial industry ingredients like
taurine, guarana and ginseng'' and because ``We added in
beneficial ingredients like antioxidants and Vitamins A, B6,
B12, C and E.'' However, the product also contains a very high
280 mg of caffeine in one 2.5-oz shot and directly claims to
help improve sports performance.
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\48\ SK Energy. Retrieved from www.skenergyshots.com.
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Kraft Foods introduced Mio Energy ``drops'' as part of its
Mio drink mix line to be added to other beverages.\49\ The
company spent $16 million to advertise in 2012. Consumers are
instructed to use one ``squirt'' of Mio in 8 ounces of liquid.
Although one drop contains a relatively small amount of
caffeine (60 mg), each bottle contains 18 servings totaling
1,080 mg of caffeine, and consumers may purposely or
inadvertently use more than one drop. The product also contains
B vitamins, taurine, guarana, and ginseng. Further, Mio Energy
is stocked in the drink mix aisle with non-caffeinated Mio
products--together with Kool-Aid, lemonade, and iced tea
mixes--creating the risk of consumer confusion and inadvertent
caffeine intake.
---------------------------------------------------------------------------
\49\ MiO Liquid Water Enhancer. MiO Energy. Retrieved from
www.makeitmio.com/mio-energy.
---------------------------------------------------------------------------
Further, most leading energy drink manufacturers have not taken any
actions to reduce teens' exposure to their marketing messages. On the
contrary, they appear to have increased marketing in venues where young
people are highly likely to view them.
Advertising spending on all energy drink brands combined
totaled $282 million in 2012, an increase of 71 percent versus
2010 and 2.5 times 2008 spending. \50\ Three existing brands
increased advertising spending in 2012 over 2010 levels.
Spending on 5-Hour Energy reached $194 million, an increase of
82 percent versus 2010 and almost 4 times the amount spent in
2008. Red Bull spent $56 million, more than twice its spending
in 2010. NOS spent significantly less than the others ($5.2
million), but this was twice the amount spent in 2010.
---------------------------------------------------------------------------
\50\ Rudd Report (2013).
Teens' exposure to energy drink advertising on TV increased
by 33 percent in 2012 compared with 2010.\51\ In addition to TV
advertising for new products, teens viewed 8 percent more ads
for 5-Hour Energy, twice as many ads for Red Bull, and three
times as many NOS ads in 2012 than they had in 2010. Teens also
saw 31 percent more ads for Red Bull than adults saw and 44
percent more ads for Street King. Examination of the networks
where these ads appeared confirms that 5-Hour Energy, Red Bull,
and Street King placed a high proportion of advertising on
programs viewed significantly more often by teens than adults.
---------------------------------------------------------------------------
\51\ Ibid.
Some brands increased teen-targeted marketing on the
internet.\52\ Average monthly teen visitors to 5HourEnergy.com
and RedBull.com increased by 47 percent and 7 percent,
respectively. Teen visitors to DrinkNOS.com increased 4.5-fold,
and teens were 50 percent more likely to visit the site
compared with adults. Three brands that had not used display
advertising in 2010 began to advertise on other websites,
including NOS, Monster, and Street King; Facebook was the most
common site where these ads appeared. Although Full Throttle
reduced display advertising in 2012, 27 percent of these ads
were placed on youth-targeted websites.
---------------------------------------------------------------------------
\52\ Ibid.
But most energy drink brands shifted their Internet
marketing focus to social media, evidenced by enormous growth
in Facebook, Twitter, and YouTube reach across the board.\53\
For example, the number of Facebook likes for Red Bull and
Monster doubled to 39 million and 23 million, respectively.
These two brands rank #5 and #12 in number of likes for
corporate brands on Facebook.\54\ Red Bull and Monster also
have approximately 1 million followers on Twitter. Red Bull
tweets 68 times per day and 53 percent of tweets are retweeted
by its followers. These numbers are comparable to Twitter
followers of Coca-Cola (1.2 million) and McDonald's and Subway
(1.4 million each). Red Bull dominates corporate-sponsored
videos on YouTube. Its videos have been viewed on YouTube 598.6
million times; this number does not include videos viewed on
other websites. One Red Bull video, ``Felix Baumgartner's
supersonic freefall from 128k','' has been viewed 34.5 million
times since it was posted in October 2012. The company posted
520 new videos to its YouTube channel from January to July
2013.
---------------------------------------------------------------------------
\53\ Ibid.
\54\ Fan Page List. Top Corporate Brands on Facebook. Retrieved
from Fanpagelist.com/category/corporate_brands/.
Energy drink brands continued to be active sponsors of
extreme sports and music events in many local markets. Events
with teenage athletes include Street League 2013 Skateboarding
World Tour (Monster Energy), 27th Annual U.S. Open Snowboarding
Championships (Amp Energy), and Vans U.S. Open Surfing and X
Games (Red Bull). One Rockstar-sponsored event, Nautique WWA
Wakeboard National Championships, has a junior competition for
---------------------------------------------------------------------------
boys aged 9 and under.
Red Bull introduced eleven new smartphone apps since 2010
and Rockstar introduced five. One Red Bull game app (Kart
Fighter) includes a parental advisory: ``This game has cool
stuff to purchase with your iTunes account.'' Rockstar apps
include one for its Mayhem Festival and three Grand Theft Auto
apps with ratings asking users to be 17 to download. 5-Hour
Energy introduced one app that asks users to confirm that they
are 17 before downloading.
Regulating energy drinks marketed and sold to youth
Recent developments in energy drink marketing practices clearly
indicate that current industry self-regulatory guidelines are
inadequate to protect teens from exposure to marketing of these
potentially dangerous products. We support recommendations by
Congressman Markey and Senators Durbin and Blumenthal that energy drink
manufactures immediately take steps to provide additional information
and warnings on product labels, report all serious adverse events to
the U.S. Food and Drug Administration (FDA) (which is not currently
required for products labeled as beverages), and cease marketing to
teens under age 18.\55\
---------------------------------------------------------------------------
\55\ Markey, Durbin, & Blumenthal (2013).
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Effective self-regulation of energy drink marketing would require
manufacturers to acknowledge that energy drink consumption by children
under 18 is much more dangerous than consumption of soda. There are
many options to substantially reduce energy drink marketing to teens,
with minimal effects on brands' access to adult consumers.
Discontinue advertising in teen-targeted media. At a
minimum, energy drink manufacturers should not advertise in
media with an audience of 30 percent or more children and teens
(approximately 50 percent more youth viewers than the average
television and Internet audience) or with large audiences of
children and teens. Alcohol industry self-regulation does not
allow advertising in media with an audience comprising more
than 30 percent minors under 21.\56\ The National Research
Council (NRC) and IOM,\57\ and 19 state attorneys general \58\
have recommended tighter regulatory standards for the alcohol
industry, but these standards are significantly more
restrictive than ABA guidelines that limit energy drink
advertising only in media where the majority of the audience
(i.e., >50 percent) is children under 12.
---------------------------------------------------------------------------
\56\ Federal Trade Commission [FTC] (2008). Marketing Food to
Children and Adolescents. A Review of Industry Expenditures,
Activities, and Self-Regulation. A report to Congress. Retrieved from
www.ftc.gov.
\57\ National Research Council [NRC] & Institute of Medicine [IOM].
(2004). Reducing Underage Drinking: A Collective Responsibility. R.J.
Bonnie and M.E. O'Connell, eds. (Washington, D.C.: The National
Academies Press.
\58\ National Association of Attorneys General Youth Access to
Alcohol Committee. (2006, May 8). RE: Alcohol reports: Paperwork
comment RE: FTC file no. P064505. Washington, D.C.: Federal Trade
Commission. Retrieved from http://www.ftc.gov/os/comments/
alcoholmanufac
adstudy/522852-01287.pdf
Discontinue other marketing practices that
disproportionately appeal to children under 18. For example,
energy drink companies could block Facebook users under 18 from
accessing energy drink pages. Cap'n Crunch currently does this,
and alcohol manufactures do so for minors under 21. They could
require age verification for visitors to energy drink websites
and downloads of mobile apps. They also could cease sponsorship
---------------------------------------------------------------------------
of athletic events that include teenage participants.
Comply with ABA guidelines to not market energy drinks as
sports drinks, including ABA members and non-members.
Agree to independent review of marketing practices. The NRC
and IOM have recommended establishing an independent review
board to monitor alcohol marketing practices.\59\ Independent
review would verify that energy drink marketing does not
encourage consumption of energy drinks by children under 18.
---------------------------------------------------------------------------
\59\ NRC & IOM (2004).
Given that effective limits on teen-targeted marketing of energy
drinks would restrict a successful strategy for continued sales growth
and conflict with companies' obligations to shareholders and private
owners, government regulation may be required. My colleagues and I
recently examined the regulatory structure for energy drinks in the
United States and present a number of possible strategies to protect
young consumers from these potentially dangerous products (see Exhibit
3).\60\ Following is a summary of our recommendations.
---------------------------------------------------------------------------
\60\ Pomeranz, Munsell, & Harris (2013).
Revise GRAS. The FDA should reevaluate GRAS standards, add
limitations on problematic ingredients in energy drinks, and
take enforcement action against manufacturers that add
---------------------------------------------------------------------------
unapproved ingredients.
Update labeling. The FDA should update regulations for the
Nutrition Facts Label. The update should include establishing
daily reference values for caffeine and added sugar and
disclosures of caffeine, added sugar, and novel ingredients
(e.g., taurine, guarana) on all energy drinks and shots. In
addition, FDA should mandate labeling for all energy products,
requiring more explicit warnings on labels and compliance with
the Nutrition Labeling and Education Act of 1990 (NLEA), and
taking enforcement action against products mislabeled as
dietary supplements.
Enforce marketing regulations. The Federal Trade Commission
(FTC) could take enforcement action against marketing of
mislabeled products or products with false or deceptive claims.
Establish age limits. The U.S. Congress, state or local
governments could require age limits for purchase of energy
products and establish excise taxes on products with sugar and/
or caffeine.
Establish sales restrictions. State and local governments
could restrict where energy products may be located in retail
establishments (e.g., separated from other alcoholic and non-
alcoholic beverages or behind the counter) and prohibit the
sale of the most problematic products.
Enforce consumer protections. Attorneys general also could
take many of these actions under state consumer protection
laws.
Establish monitoring of energy drink consumption among youth
to provide the public health community with the necessary tools
to address this crisis. For example, the U.S. Centers for
Disease Control and Prevention (CDC) could include consumption
of energy drinks and shots in its Youth Risk Behavior
Surveillance System \61\ and obtain separate results for energy
drink consumption in the National Health and Nutrition
Examination Survey (NHANES).\62\ Current NHANES questionnaires
combine sports drinks and energy drinks in the ``Energy
drinks'' category.
---------------------------------------------------------------------------
\61\ Centers for Disease Control and Prevention [CDC]. Adolescent
and School Health: Youth Risk Behavior Surveillance System. Retrieved
from www.cdc.gov/HealthyYouth/yrbs/index.htm.
\62\ Centers for Disease Control and Prevention [CDC]. National
Health and Nutrition Examination Survey. Retrieved from www.cdc.gov/
nchs/nhanes.htm.
---------------------------------------------------------------------------
In conclusion
Energy drink products are dangerous for children and teens to
consume, but many manufacturers continue to aggressively market these
products to teens, and sales are growing rapidly. While the industry
has initiated some modest improvements in product labeling, they have
evaded the issue of marketing to teens and in fact seem to be
increasing teen-targeted marketing. It is clear that the current self-
regulatory efforts on the part of energy drink companies are
insufficient. Unless such efforts are strengthened, federal, state, and
local government efforts aimed at limiting the sales and marketing of
energy drinks to children under 18 may be warranted. And such oversight
would be supported by parents, the medical community, and others who
advocate for children's health.
I thank the Committee for this opportunity to share our research
and increase awareness of the dangers posed by continued aggressive
marketing of energy drinks to children. I also would like to thank my
colleagues at the Rudd Center and Berkeley Media Studies Group who
conducted much of this research and the Robert Wood Johnson Foundation
and the Rudd Foundation for their funding of our research.
Exhibit 1
Exhibit 2
``Energy Drink Marketing to Teens: 2010-2010''
A report submitted by Yale Rudd Center
Exhibit 3
Senator Blumenthal. Thank you.
Dr. Spencer?
STATEMENT OF WILLIAM R. SPENCER, M.D.,
SUFFOLK COUNTY LEGISLATOR
Dr. Spencer. Thank you.
Good afternoon, Honorable Senators, members of the
Committee, ladies and gentlemen. Thank you for allowing me this
opportunity to testify on the marketing and sale of energy
drinks.
I am Suffolk County legislator Dr. William Spencer, a
pediatric otolaryngologist from Huntington, New York. I was
elected to the legislature in 2011, and I am part of a
legislative body that represents 1.5 million people. I
currently serve as Chair of the legislature's Health Committee
and am a Member of the Suffolk County Board of Health.
The powerful energy drink industry generates over $7
billion of revenue a year and spends over $100 million per year
in advertising here in the United States. Due to the growing
reports of adverse effects in our county related to energy
drinks, the board requested that I look for potential avenues
of legislative action.
A poor public health message has become pervasive. Recent
ads that you mentioned earlier include the catch phrase ``zap
the nap.'' The message to children, who are frequently
overscheduled and under constant pressure to succeed, is to
ignore the body's natural signals of fatigue and hunger and use
a stimulant instead. These beverages are marketed as a quick
and easy way to relieve fatigue and improve performance. Their
illusion of energy is high-dose caffeine acting as a stimulant
to the central nervous system.
These marketing tactics and messages are embedded
throughout our children's lives, even in the early Sunday
morning cartoons. Over the years, we have seen that marketing
has doubled recently, as indicated by the Yale Rudd report.
In our 24/7 social media world, commercials, sampling
directed at children have taken the power of control away from
parents and made our children vulnerable to an industry with a
cool, seductive message. I discovered that an unlevel playing
field existed and most parents did not know about the dangers
associated with ingesting energy drinks.
In fact, many parents think energy drinks are akin to
sports drinks. I have personally witnessed a parent dispensing
an energy drink to her 10-year-old child at a swim meet, and
she had assumed incorrectly that she was helping her child to
hydrate.
There has been a lot of action around the country, as you
have indicated. We know in 2012, Manatee County, Florida,
banned the sale of energy drinks in its schools, indicating
that the drinks made the children restless and unable to
concentrate in class.
It also has been reported by some of the other members that
there has been a dramatic increase in emergency room visits. So
far, what I have reported is what I have read and heard, but I
would like to share with you what I have personally seen in
Suffolk County.
Energy drink companies sponsor local events for children as
young as 10 years old. Samples are being distributed to local
theaters in my legislative district to children standing in
line as young as 12. Energy drink displays are positioned next
to video games in local department stores. And most recently,
along Memorial Day, after our legislation was passed, we saw
energy drinks being distributed at a parade in Sayville, New
York.
Finally and probably the most egregious act was that direct
mail of an energy drink with a sample packet was sent to one of
my colleagues on the legislature's 16-year-old child.
I believe we have a responsibility to protect the public
and our vulnerable children. I believe in the importance of
free commerce and the right of businesses to conduct business
in an unfettered way, but they cannot be allowed to imperil the
public, especially our most vulnerable, children.
After an exhaustive effort in Suffolk County, we passed the
first in the Nation modest regulations prohibiting the
marketing and advertising of stimulant drinks to minors,
prohibiting the distribution of stimulant drinks to minors in
our county parks, and also embarked upon an educational
campaign. This, for me, is about protecting our children. Some
children, as many as 1 in 100, have underlying heart defects
that may make them susceptible to life-threatening conditions
when exposed to even a recommended sample of energy drink.
There are responsible members of the industry that I have
met with. But in conclusion, although they may be responsible,
there are a lot of members who are not part of the American
Beverage Association that may act on their own.
What I am asking today is that if the products are labeled
not recommended for use in children, then we should not allow
them to be marketed to children. Please consider restricting
the marketing to children under 18 years old and until we can
find that these drinks are safe and not habit forming.
Thank you for this opportunity.
[The prepared statement of Dr. Spencer follows:]
Prepared Statement of William R. Spencer, M.D., Suffolk County
Legislator
Good afternoon ladies and gentlemen. Thank you for allowing me the
opportunity to testify today on the marketing and sale of energy drinks
to children.
I am Suffolk County Legislator William Spencer from New York. I am
also a board-certified, fellowship-trained, pediatric otolaryngologist
in Huntington, New York. I am currently the Vice President for the
Suffolk County Medical Society, a delegate to the New York State
Medical Society, and a member of the AMA. I have attached my CV for
your review.
For the purposes of this presentation I will be referring to the
products as ``energy drinks.'' I want you to know that I disagree with
the characterization of these products as ``energy drinks'' and in
fact, in my legislation, I refer to them as ``stimulant drinks''
because they do not provide energy, they stimulate.
In November 2011, I was elected to the Suffolk County Legislature.
I am one of 18 legislators in the County's legislative body that
represent over 1.5 million people. As the first physician to serve on
the Suffolk County Legislature, I was appointed to serve as Chairman of
the County's Health Committee and to serve on the County Board of
Health. The Board of Health is charged with formulating public health
policy and administering the sanitary code.
Suffolk County has a proud history of passing consumer protecting,
visionary legislation that have gone on to be adopted at both the state
and Federal levels. Prohibiting the use of cell phones while driving
and most recently the ban on the use of the carcinogen bisphenol A
(BPA) are resolutions that began as Suffolk County resolutions.
In 2010, my colleague Legislator Lynn Nowick introduced two
resolutions regarding energy drinks, one to alert customers to the
health risks associated with energy drinks and the other that would
have banned the sale of energy drinks to minors in our county. Her
efforts received national and even worldwide attention. Lobbyists and
industry representatives opposed any restrictions on their products
claiming they were safe. They believed the legislation was misguided
and that any bans would hurt commerce.
The powerful energy drink industry generates over 7 billion dollars
per year in revenue, and spends hundreds of millions of dollars per
year in marketing and advertising here in the United States.
Eventually, under pressure from the industry, Legislator Nowick was
able to fashion a compromise. Some major manufacturers of energy drinks
and the American Beverage Association agreed to include a warning on
their labels that stated ``these products are not intended for
children, pregnant or nursing women or those sensitive to caffeine.''
In addition, they agreed to disclose the total caffeine content on the
product label. Additionally, funding was promised for an educational
campaign to teach youth about the risks of excessive caffeine
ingestion.
With this compromise in hand, Legislator Nowick allowed her
resolutions to expire without any further action being taken. In light
of the enormous lobbying effort against her position, my colleague's
efforts were considered by most a huge win against a powerful industry
and a victory for protecting our children's public health.
Two years later, I was elected and started my tenure on the Board
of Health. Due to the growing reports of adverse incidents related to
energy drinks, the board requested that I revisit the issue for
potential legislative action. During the summer of 2012, I began to
research and discuss the issue with my colleagues and peers in the
medical field.
Much had changed since the compromise with Legislator Nowick.
A poor public health message had become pervasive. The idea
delivered in advertisements was that if you are tired, just drink an
energy drink. Recent ads included the catch phrase ``zap the nap''. The
message to our children, who are frequently over scheduled and under
constant pressure to succeed, is to ignore your body's natural signals
of fatigue or hunger and override those signals with stimulants. These
beverages are marketed as a quick and easy way to relieve fatigue and
improve performance. Their illusion of energy is high-dose caffeine
acting as a stimulant to the central nervous system.
These deceptive marketing tactics and messages are imbedded
throughout our children's lives, supported by popular stars,
influential athletes and are directed at the very young, even in early
morning cartoons. Recent data reveals that the marketing of these
products to children and young people has doubled in recent years.
A Yale Rudd Center for Food Policy and Obesity study showed that
``on average, preschoolers viewed 44 energy drink ads per year in 2010,
children viewed 54 ads, and adolescents viewed 124 ads. From 2008 to
2010, exposure increased 47 percent among preschoolers, 23 percent
among children, and 22 percent among adolescents. In 2010, adolescents
viewed 18 percent more ads for energy drinks compared to adults.''
In our 24/7, high tech social media world, a shift of influence has
occurred away from parents. Commercials, sponsorships and sampling
directed at our children have taken the power of control away from
parents and made our children vulnerable to an industry with a cool
seductive message. I discovered that an un-level playing field existed
and that most parents did not know about the dangers associated with
ingesting energy drinks or the enticing advertising their children had
been exposed to as they watched television, played video games, and
even competed on their local soccer field. In fact, many parents think
energy drinks were akin to sports drinks.
I have personally witnessed a parent dispensing an energy drink to
her 10-year-old child at a swim meet. She had assumed incorrectly that
she was helping her child hydrate and that the caffeine would boost her
child's performance. Other parents I have spoken with have witnessed
their peers supplying their children with energy drinks before track,
soccer and lacrosse meets.
While I was contemplating this issue, others were starting to
express concern as well:
In April 2012, The Honorable Senator Durbin sent a letter to
the FDA ``expressing concern about the potential safety issues
associated with the consumption of so-called ``energy drinks
and requested they take certain actions in response to these
issues . . .'' Most of his issues dealt with how the industry
defines their product.
In July 2012, the School Board of Manatee County in Florida
banned the sale of energy drinks in its schools and would no
longer allow students to bring them from home, citing the
drinks make students to restless to concentrate in class. The
director of elementary schools, Joe Stokes was quoted as saying
``we know a significant number of students who have increased
energy followed by decreased energy can have agitation.
Caffeine affects how the brain works.''
In August 2012, closer to my home, NYS Attorney General
Schneiderman began investigating energy drinks, specifically
whether the multibillion-dollar energy drink industry is
deceiving consumers with misstatements about the ingredients
and health value of its products. According to reports, the
subpoenas asked for ``information on the companies' marketing
and advertising practices.''
In October 2012, strict new regulations and taxes were imposed
on the sale of energy drinks in Mexico to deter new brands from
entering the market. The Mexican Senate eventually banned the
sale of energy drinks to anyone under the age of 18.
In November 2012, the FDA announced that it was investigating
reports of five deaths that may have been associated with
Monster Energy Drink since 2009. The family of Anais Fournier,
a 14-year-old girl with a heart condition who died after
drinking two cans of it's Monster Energy Drink in a 24-hour
period had recently filed its lawsuit against the company.
It was also reported during that same time that emergency room
visits attributed to caffeine toxicity had risen 10-fold
between the years 2005-2008. According to a 2012 report by the
Substance Abuse and Mental Health Services Administration,
there were 1,128 visits to an E.R. as a result of caffeine
overdoses in 2005. That number went up to 16,053 in 2008.
One last example of the changing tide, was in late October
2012, Dennis J. Herrera, the city attorney of San Francisco
sent a letter to Monster Beverage, asking them to substantiate
its claim that large daily quantities of Monster were safe for
adolescents and adults. According to reports, Mr. Herrera cited
a section of California law that makes it illegal for a company
to make false or misleading advertising claims that purport to
be based on fact or clinical data.
Similar conversations were taking place in Canada where Mr.
James Shepherd, who lost his 15-year-old son due to an
``unexplained arrhythmia'' on January 6, 2008, has become a
huge advocate for regulation and change in Canada. Claims are
that his son was supplied an energy drink sample during a free
hand out by Red Bull company representatives and several hours
later collapsed and died. Canadian government officials have
made strides to create a caffeine cap on these products and are
working on further regulations.
Schools, colleges, cities, states, countries and even branches of
the military have started to address increasing use and abuse of these
products. The issue is studied and a variety of actions including
banning the sale, use and marketing of the products have been taken to
product consumers.
So far I have reported about what I have read, heard and
researched, but this is what we have seen in Suffolk County which led
my colleagues to support my three point plan to educate, protect and
empower residents.
1. I heard first hand from residents and colleagues that energy
drink companies were sponsoring local sporting events/lacrosse
and soccer tournaments. Coupons and products with the company's
logo were distributed.
2. Samples of Monster Energy Drink were distributed on several
occasions out of the back of a Monster Energy truck to concert
attendees, ranging from approximately 12 years old to adult, in
front of the Paramount in Huntington Village. Concert attendees
were give samples of the product as they waited on line for the
concerts to begin. The Paramount is a very popular concert and
performance venue.
3. Energy Drink marketing displays are positioned next to video
games in local department stores. I heard testimony that energy
drink manufacturers imbed logos or references to their products
in video games and cartoons. One drink even ``gives you wings .
. .'' which are particularly attractive to children when they
are playing in a competitive arena.
4. One of my colleagues called to report that energy drink samples
were handed out at a traditional small town Memorial Day parade
in Sayville, Long Island. Apparently, there was an energy drink
truck with company representatives handing out products with
their logo and coupons to parade attendees and there were no
obvious attempts at ensuring that children didn't receive these
samples. This activity took place a month after Suffolk made it
illegal to do so.
5. Finally and probably the most egregious was that a direct-mail
sample packet was sent to one of my colleague's 16-year-old son
at his home. The product was clearly marked not for use by
anyone under 18 but was sent directly to a 16-year-old who had
come home from school hours before his parents, and could have
added the small packet to water and ingested it, without his
parent's knowledge.
I believe the government has a responsibility to protect the
public, particularly the most vulnerable, our children. I also believe
in the importance of free commerce, capitalism and the right of
businesses to conduct business in an unfettered way. But they cannot be
allowed to imperil the public, especially our most vulnerable.
In the fall of 2012, I began meeting with industry leaders, health
officials and educators, constituents and my colleagues. Rather than
implementing an outright ban on the sale of the products in Suffolk
County as our Board of Health advocated, I worked to create a balanced,
comprehensive plan.
After getting word that the minor son of my colleague received a
sample and coupons in the mail from a local energy drink company, I
filed IR 1085-2013, A Local Law to Protect Minors From Direct Mail
Stimulant Drink Advertising and Samples. The product that was clearly
marked ``Not for Use by Children'' was sent directly to a minor through
the mail. Despite vehement claims by the industry that they didn't
market to children, there was enormous proof to the contrary.
To address the concerns expressed by the Suffolk County Board of
Health, my colleagues supported the compromise position stated in my IR
1086-2013, A Local Law to Prohibit the Sales and Distribution of
Stimulant Drinks to Minors in County Parks. If the County Board of
Health, supported by much research and reliable data, was concerned
about the harmful effects of energy drinks on children, then we should
not be allowing those products to be sold or distributed on County
property.
Finally, but actually the first and most widely supported
resolution was IR 1920-2012, Establishing ``The Truth About Stimulant
Drinks'' Public Education Campaign to Increase Awareness of the Side
Effects Associated with Stimulant Drink Consumption. This campaign
would educate junior high and high school students about stimulant
drinks and encourages their participation in a public safety
announcement (PSA) competition. The winning PSA would be aired on local
cable television to strengthen awareness about these drinks annually.
We have begun to meet with the Department of Health and school
officials to get this program off the ground and have met with
excitement and support.
In April 2013, after an exhaustive effort, Suffolk County became
the first municipality in the United States to pass legislation that
would modestly regulate the industry and educate consumers. We had
fashioned a comprehensive energy/stimulant education and protection
plan to address the health risks associated with energy/stimulant
drinks. Again, this historic three-pronged approach included:
Prohibiting the marketing and advertising of stimulant
drinks to minors.
Prohibiting the distribution and sale of stimulant drinks to
minors in County parks.
Educating Suffolk's youth about the health risks associated
with stimulant drinks.
This plan addresses the issue from an educational, medical and
practical way without stifling business or infringing on anyone's
constitutional rights.
These bills were approved, in spite of the industry's efforts to
stop any legislation which included constant lobbying, letters,
repeated phone calls. Political pressure was placed on legislators by
calls to other elected officials, county leaders and even calls to the
NYS governor's staff to stop the legislation.
Most of the industry's arguments against legislation were well-worn
and repetitive. The same players showed up to testify, using the
arguments as they had when the Suffolk County Legislature debated
Legislator Nowick's resolutions in 2010. Their arguments against
legislation include the following points with responses as numbered
below include:
1. ``Caffeine is a natural substance. It is safe. Why try to
regulate it?'' Poppies use to make heroin are also a natural
substance but that does not make their use safe.
2. ``FDA fully regulates energy drinks, their ingredients and
labeling.'' Substances designated as ``Food'' products, have to
list their exact ingredients but don't have to report adverse
reactions or side effects. But dietary supplements don't have
to list exact ingredients but must report adverse reactions.
Most energy drinks are now regulated as foods.
3. ``Some caffeine is safe for children, why limit their access to
it.'' Although children can tolerate some caffeine there is no
benefit to caffeine in a child's diet.
4. Many energy drinks contain as much caffeine as much as large cups
of coffee why not ban or restrict coffee? Coffee has a
considerably higher volume and is hot which slows the ingestion
of caffeine.
5. Industry leaders insist repeatedly that they do not market their
products to children and teens. When in fact, according to one
pediatrician, Dr. Kwabena Blankson, ``They market in places
kids like to go--on their X-boxes, at the X-games . . .'' This
point can be broadened. Energy drink manufacturers market to
children during cartoons, during sporting events, in video
games and movies. Products are available everywhere children
go, except for school but that change was recent and not
welcomed by the industry. They send samples to minors using
team rosters and market research. They hand out coupons and
samples at concert venues. They sponsor teams, athletes, and
popular video gamers. They give drinks trendy, cool names, put
them in attractive packaging and offer appealing, desirable
performance enhancement abilities. There is overwhelming proof
that there is direct marketing to children and adolescents.
6. ``Ingredients are considered safe.'' Yes, this may be the case
when they are consumed individually but what they cannot prove
is that their ingredients in combination are safe. Energy
drinks often include, vitamins, supplements (Guarine, Taurine,
Guarana) and other ingredients that potentiate stimulating
effects of caffeine. If multiple drinks are consumed, the
effects are multiplied. The AMA, with members across the Nation
have expressed concern that these ingredients, taken together
may not be safe for children under 19.
7. ``There are warnings on the bottles or cans . . .'' This labeling
had been part of the compromise originally negotiated by my
colleague two years prior!! If the industry agrees that their
``products are not intended for children, pregnant or nursing
women or those sensitive to caffeine'' then why allow them to
market to children?
Important Points to Consider
Potentially as many as 1 out of 100 children have underlying
congenital heart anomalies that may go undetected but under the right
circumstances in combination with stimulants and extreme physical
activity like competing in a sport event, running or etc. may
potentially cause heart arrhythmias or possibly death possibly after
one ingestion of a normal serving of a energy drink.
Currently without caffeine caps of guidelines new products are
being introduced to the market place upping the ante including highly
concentrated caffeinated products like gum, patches, tongue tabs
electronic cigarettes with no limits to caffeine concentration.
Energy/stimulant drinks can be a gateway to addiction to alcohol
and drugs by altering vulnerable chemistry of the brain by starting a
cycle of dependence.
There are some responsible members of the industry who do not do
all of the above but do allow marketing divisions broad discretion to
get their message out.
With the support of my colleagues in the Suffolk County Medical
Society, I brought my resolution to annual convention of the New York
State House of Delegates of the Medical Society of the State of New
York. The bill was to temporarily ban the marketing of energy drinks to
children until the FDA could investigate the products and deem them
safe. It was approved overwhelmingly. A delegation from MSSNY brought
the same resolution before the American Medical Association, where it
was strengthened, changes were made and it was also approved.
In conclusion, my desire is to protect our kids. That is what this
is about. I am going to paraphrase my colleague Legislator Lou D'Amaro,
who summed up our debate so eloquently. . . . Our kids are bombarded by
all kinds of advertising. Some things are worse than others. There is
always a matter of degree, but the fact of the matter is that energy
drinks, just by the name alone, are a misnomer because they don't give
you energy. But, yet, that is the message that's being directed at our
children, telling them that as we live in a more and more hectic world,
and it becomes more and more difficult to find the time to do
everything you want to do in a day, here's the quick solution. Have an
energy drink, you'll feel great and you'll just keep on going.
It is even more egregious for athletes, kids in schools, kids that
are in school playing, maybe even high school sports, to believe that
energy drinks somehow will make you a better athlete, because they will
not. But, yet, this industry insists on calling their products energy
drinks. They are not energy drinks. They give you a caffeine high and a
sugar high and then you crash. They reduce your performance and add to
fatigue. We are talking about children. They should not be drinking
caffeine no matter if the amount is equivalent to a cup of coffee. I
will not advise any parents to give their child one cup of coffee, and
never multiple cups. This is about telling our children at a very young
age that it's okay to drink these products because you're going to feel
great. These seemingly benign stimulants can be a precursor and gateway
to using other drugs and alcohol as teenagers look for that next and
better high. For the vulnerable person, the jolt from caffeine or an
energy complex, changes the chemistry, tricks the brain and leaves it
seeking more chemical stimulation. If caffeine is stopped, the body and
brain do experience withdrawal symptoms, no matter the quantity
ingested. Hundreds of thousands of physicians across this nation, as
indicated by the AMA resolution, agree that these products have the
potential to harm our children. The deceptive marketing practices of
the industry are placing children in peril, contributing to addiction
cycles of those who are vulnerable and taking away parents' power to
make educated decisions about what their children should and can
ingest.
Please, consider restricting the marketing to children under 18
unless or until the products are proven to be safe and not habit
forming. Also, let's embark on an education campaign to empower parents
to make educated decisions for their children and even teach adults
about the potential side effects they may experience as a result of
choosing to indulge in these products.
Thank you for your time and attention to this matter. I am honored
to have been given this opportunity. Thank you again.
______
Biography of William Robert Spencer, Jr.
Dr. William Robert Spencer, Jr. received his early education in
Welch, West Virginia, a small town near Charleston. He was named a
``West Virginia Scholar'', graduated with honors from high school and
went on to receive his higher education at Wesleyan University,
Middletown, CT; Connecticut Missionary Baptist Association; and
University of Connecticut School of Medicine, Farmington, CT. He moved
on to St. Vincent's Hospital and Medical Center, New York City where he
completed his Internship and Residency in Surgery. His residency in
Otolaryngology was completed at New York Eye and Ear Infirmary, New
York City and he studied at the University of Miami in Miami, FL under
a Fellowship in Pediatric Otolaryngology in 1999-2000.
He is a Diplomate of the American Board of Otolaryngology, a
Diplomate of the National Board of Medical Examiners, a Fellow of the
American Academy of Pediatrics, and a Fellow of The American Academy of
Otolaryngology Head and Surgery. He is a member of the Suffolk County
Medical Society, and the American Medical Association and is licensed
to practice in the State of Florida and the State of New York. In 2000
he started his own private practice, Long Island Otolaryngology &
Pediatric Airway, P.C. at 25 E. Carver Street, Huntington, NY.
Dr. Spencer has been involved in research in various areas of his
field at the University of Miami; New York Medical College in Valhalla,
NY; New York Eye and Ear Infirmary in New York City; Wesleyan
University, Middletown, CT; University of Connecticut Department of
Pulmonology in Farmington, CT; and New England Nuclear Medicine Society
where he was granted a fellowship for research in a particular area.
Dr. Spencer has at least 16 articles to his credit that have been
published in Journals pertaining to his area of specialty, as well as
chapters that have been contributed to books on the subject. He has
made oral presentations in Texas; Washington, D.C.; Florida; New York;
Ohio; Connecticut; and in Paris, France and Cancun, Mexico.
Academic Appointments include Stony Brook University, Department of
Otolaryngology, Assistant Professor Voluntary Clinical Faculty; New
York Eye and Ear Infirmary, Department of Otolaryngology, Associate
Adjunct; Huntington Hospital, Department of Surgery/Otolaryngology,
Attending Staff; Otolaryngology--Head and Neck Surgery Journal, San
Antonio, TX, Editorial Review Panel; University of Miami, Department of
Otolaryngology, Miami, FL, Clinical Instructor; Jackson Memorial,
Department of Otolaryngology, Miami, FL, Attending Staff; Bascom Palmer
Eye Institute, Department of Surgery, Miami, FL, Attending Staff.
In addition to being a West Virginia Scholar his awards and honors
include West Virginia Bar Association Award, Leadership and Academic
Excellence; Psi Upsilon Achievement Prize, Outstanding Community
Service; University of Connecticut Surgical Scholar; Sigma Xi Research
Honor Society, Outstanding Medical Research; J. Swift Hanley Award, New
York Eye and Ear Infirmary, Excellence in Resident Research.
During his school years Dr. Spencer served as a Residential Health
Advisor at Wesleyan University; Steward of Psi Upsilon Fraternity;
Chemistry and Physics Laboratory Instructor; Medical/Dental Student
Government President; and an Anatomy Teaching Assistant. He also taught
at the University of Miami
With his father, Rev. William Robert Spencer, Sr., as his role
model Rev. Spencer, Jr. has been serving God since he was a youngster.
At St. James Missionary Baptist Church where his father was Pastor, he
served as Superintendent of Sunday School from 1978-1989 and also as
Jr. Deacon and Lay Minister. It was there that he became a Licensed
Minister in 1986. At Shiloh Missionary Baptist Church in Middletown, CT
he served as their first Youth Pastor and expanded the Youth Ministry
from 6 to 75 children. He served also as Assistant Pastor from 1986-
1993. It was there that he became an Ordained Minister in 1993 and was
accepted as such by The Connecticut Missionary Baptist Association. At
Metropolitan Duane Methodist Church in New York City he attended
services as Lay Minister and delivered the Sunday morning message
periodically from 1995-2000. He has served as an Evangelist preaching
at various worship services and revivals throughout the East Coast, by
invitation, from 1986 to the present.
Rev. Spencer is a Licensed Private Pilot, having achieved that goal
after his first year of college. In l987, combining his interest in
flying and his compassion for children, he received some first-hand
missionary experience when he flew, seated in the cockpit with the
commercial pilot, to Haiti to deliver medicine, supplies, and food to
the children of that country. There he donned the traditional red and
white suit and played Papa Noel to thousands of children in streets,
schools, and hospitals for the five days that he was there.
In 1997 Rev. Spencer began his affiliation with Huntington Hospital
and when he asked employees there about a church that he might visit,
he was referred to the little white church across the street, up on the
hill. Once he visited Bethel, he decided to make it his church home. He
was a member at Bethel for many years taking part regularly in morning
Worship Services. He delivered the Sunday morning message periodically
and was of great assistance to the pastor in whatever capacity he has
been called upon to serve. Once a month there is a time devoted to
``Children's Talk'' and Rev. Spencer was called upon periodically to
deliver that message, as well. He loves working with the children and
has spoken to our YPD and also arranged for them to add Huntington
Hospital to their Christmas caroling list last year.
He attended the A.M.E. Ministers' Institute, and completed his
studies to become an Itinerant Elder in the African Methodist Episcopal
Church. He conducts services in his home regularly and continues to
minister to a modest congregation of the faithful.
Legislator William R. Spencer
This multi-talented gentleman now lives with his wife, Rachel, and
three young children, Robbie and Hannah, and Ava in Centerport. He is
committed to bettering the community in which he lives and has,
accordingly, become active in the Town's political structure. He was
elected to serve as the Suffolk County Legislator in the 18th
Legislative District and is serving the second of his two-year term.
His freshman-year accomplishments are impressive. As the first
physician to serve in the Suffolk County Legislature since its
inception in 1960, he was selected to serve as the chairman of the
Legislature's Health Committee. Working closely Commissioner James
Tomarken of the Health Department, Legislator Spencer helped to
streamline the department with a priority on maintaining good public
health for all County residents.
Since January, 2012, Legislator Spencer sponsored more than 35
resolutions with almost 1/3 of them related to health and safety
issues. One of the first was a request for money from a dedicated fund
to improve the Wastewater Treatment Collection System in Northport thus
ensuring that the beaches, harbors and fisheries become healthy again.
Trying to find new and more efficient sewage treatment technologies has
become another priority of his in an effort to protect our drinking
water and health.
Over the years, it has been proven that the effects of secondhand
smoke pose a serious threat to the health, safety and welfare of all
citizens. It was difficult to understand why our County parks and
beaches, which provide our residents with easy access to the beauty of
nature and recreational activities, permitted smoking. Fortunately, a
majority of his colleagues in the Legislature agreed and as a result of
his sponsored resolution, smoking is no longer permitted there.
Legislator Spencer believes public education campaigns are also an
effective vehicle for getting important messages out to our most
vulnerable residents. Working with AT&T and Harborfields School
District, he declared 9/19 ``Don't Text and Drive Awareness Day'' in
Suffolk County and developed an assembly program to teach students that
no text is worth dying for--``It can Wait!'' Furthermore, he also
introduced legislation recently to establish ``The Truth About Energy
Drinks'' public education campaign to increase awareness of the
potentially dangerous side effects associated with caffeine toxicity.
Opiate addiction has become an epidemic among our young people on
Long Island and overdoses are on the rise. Some estimates say we lose
one resident per day to the horrendous effects of drug use. Narcan is a
narcotic antagonist which prevents or reverses the effects of narcotics
within minutes of being administered. Earlier this year, another
legislator introduced legislation to pilot a Narcan program in three of
our Suffolk County Police Precincts. This pilot program has already
saved 42 lives. Seeing the abundant results of the trial program, he
proposed a resolution to expand it to all of our precincts which passed
unanimously. Narcan is now available to police emergency responders in
the Second Precinct.
Super Storm Sandy, the looming fiscal cliff, and the bleak economy,
have added dramatically to the burdens Suffolk County residents face.
In his first year, he fought hard to hold the line on no tax increase
in the General Fund and he continues to ensure taxpayers get the
services they need and are paying for.
William R. Spencer, Jr. is a rare combination of scholar, medical
doctor, active Reverend and Suffolk County Legislator and he allows
these components to interact in his own life and in the lives of others
with whom he comes in contact.
______
Attachment 1
Intro. Res. No. 1920-2012 Laid on Table 9/13/2012
Introduced by Legislators Spencer and Anker
RESOLUTION NO. 187-2013, ESTABLISHING ``THE TRUTH ABOUT
STIMULANT DRINKS'' PUBLIC EDUCATION CAMPAIGN TO INCREASE
AWARENESS OF SIDE EFFECTS ASSOCIATED WITH STIMULANT DRINK
CONSUMPTION
WHEREAS, stimulant drinks are increasingly popular beverages,
particularly among young people; and
WHEREAS, caffeine is not a source of energy but a stimulant and
therefore subsequent reference will be made to ``stimulant'' drinks and
not ``energy'' drinks.
WHEREAS, stimulant drinks can contain up to 800 milligrams of
caffeine, the equivalent of eight cups of coffee, but manufacturers are
not obligated to disclose such amounts to consumers; and
WHEREAS, stimulant drinks also contain a number of herbal
supplements, including, but not limited to, ginkgo, guarana, taurine
and St. John's Wort, with no requirement for manufacturers to report a
drink's exact contents; and
WHEREAS, consumption of stimulant drinks has been associated with
significant adverse health effects, including aggravating heart
conditions, headaches, rapid heartbeat, nervousness, irritability,
sleeplessness, dehydration, abnormal heart rhythms, and stomach upset;
and
WHEREAS, the County of Suffolk should take all possible steps to
increase public awareness of the health effects associated with
consuming stimulant drinks; now, therefore be it
1st RESOLVED, that the Office of the Presiding Officer of the
County Legislature shall conduct an annual ``The Truth About Stimulant
Drinks'' campaign in high schools throughout the County of Suffolk,
inviting students to participate in a contest creating a video public
service announcement incorporating the student's interpretation on the
negative health effects associated with consuming stimulant drinks; and
be it further
2nd RESOLVED, that each Legislator shall send letters and a copy
of the stimulant drink effects pamphlet, published pursuant to the 5th
RESOLVED clause of this Resolution, to the Superintendents of public
school districts, located within their pertinent legislative district,
advising the school as to the contest; and be it further
3rd RESOLVED, that each Legislator shall judge entries made by
high schools and recommend one (1) winner from each school as a
finalist. A Legislator from each district shall then recommend to the
Presiding Officer of the County Legislature one (1) public service
announcement to represent their legislative district; and be it further
4th RESOLVED, that the deadline for submitting eligible public
service announcements shall be May 1st of each year beginning with the
year 2013; the Legislative Office of Budget Review shall then select
the winning public service announcement, which shall be announced by
the Presiding Officer at the first regularly scheduled meeting of the
Legislature in June each year; and be it further
5th RESOLVED, that any student requesting to participate in said
contest shall be furnished with a pamphlet from the Suffolk County
Department of Health Services regarding energy drinks and the health
effects of consuming same, as well as information from any other
relevant organization dedicated to reducing the use of energy drinks by
minors; and be it further
6th RESOLVED, that said pamphlet shall be disseminated by the
County Department of Health Services no later than January 31st each
year; and be it further
7th RESOLVED, that this Legislature, being the State Environmental
Quality Review Act (SEQRA) lead agency, hereby finds and determines
that this resolution constitutes a Type II action pursuant to Section
617.5(c)(20), (21) and (27) of Title 6 of the NEW YORK CODE OF RULES
AND REGULATIONS (6 NYCRR) and within the meaning of Section 8-0109(2)
of the NEW YORK ENVIRONMENTAL CONSERVATION LAW as a promulgation of
regulations, rules, policies, procedures, and legislative decisions in
connection with continuing agency administration, management and
information collection, and the Suffolk County Council on Environmental
Quality (CEQ) is hereby directed to circulate any appropriate SEQRA
notices of determination of non-applicability or non-significance in
accordance with this resolution.
DATED: March 19, 2013
APPROVED BY:
/s/ Dennis M. Cohen
Chief Deputy County Executive of Suffolk County
Date: April 4, 2013
______
Attachment 2
Intro. Res. No. 1085-2013 Laid on Table 2/5/2013
Introduced by Legislators Spencer and Anker
RESOLUTION NO. 188-2013, ADOPTING LOCAL LAW NO. 16-2013, A
LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT DRINK
ADVERTISING AND SAMPLES
WHEREAS, there was duly presented and introduced to this County
Legislature at a meeting held on February 5, 2013, a proposed local law
entitled, ``A LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT
DRINK ADVERTISING AND SAMPLES''; now, therefore be it
RESOLVED, that said local law be enacted in form as follows:
LOCAL LAW NO. 16-2013, SUFFOLK COUNTY, NEW YORK
A LOCAL LAW TO PROTECT MINORS FROM DIRECT MAIL STIMULANT DRINK
ADVERTISING AND SAMPLES
BE IT ENACTED BY THE COUNTY LEGISLATURE OF THE COUNTY OF SUFFOLK,
as follows:
Section 1. Legislative Intent.
This Legislature hereby finds and determines that so-called
``energy drinks'' are very popular, particularly among young people.
This Legislature also finds that these drinks contain very high
amounts of caffeine, though the exact amounts are not disclosed by
their makers as nutrition information.
This Legislature finds that caffeine is not a source of energy but
a stimulant and, therefore, these beverages are more accurately
described as ``stimulant drinks'' and are referred to as such in this
law.
This Legislature finds that stimulant drinks also contain herbal
supplements, vitamins and amino acids, including, but not limited to,
guarana, taurine, vitamins B6 and B12, yerba mate, bitter orange,
ginkgo, St. John's Wort and ginseng. The exact blend of these
ingredients is not disclosed by manufacturers.
This Legislature determines that consumption of stimulant drinks by
minors has been associated with hyperactivity, lack of concentration,
poor nutrition and dental problems. Consumption of stimulant drinks can
also cause significant adverse health effects, including: aggravating
heart conditions, headaches, rapid heartbeat, nervousness,
irritability, sleeplessness, dehydration, abnormal heart rhythms, and
stomach upset. These effects may be exacerbated in minors and occur
after consuming smaller quantities of caffeine or other stimulants.
This Legislature notes that many stimulant drinks are labeled by
their own manufacturers as ``Not Recommended for Children''.
This Legislature also finds that although there is general
consensus that it is not advisable for minors to consume stimulant
drinks, some manufacturers and distributors of stimulant drinks
advertise their products at extreme sporting events, concerts, and in
video games and gaming networks, all of which are popular with
adolescents.
This Legislature further determines that some stimulant drink
manufacturers provide free samples of their products at public events
that attract young people; mail free samples of liquid and powdered
stimulant drinks to minors at their homes; and provide coupons to
minors for free or discounted samples of stimulant drinks.
This Legislature concludes that given the health risks associated
with consumption of stimulant drinks by minors, it is reasonable and
appropriate for the County of Suffolk to exercise its police powers to
prohibit certain advertising and marketing practices that put stimulant
drinks in the hands of minors.
Therefore, the purpose of this law is to prohibit the distribution
of free samples of stimulant drinks or coupons for free or discounted
stimulant drinks to minors within the County of Suffolk.
Section 2. Definitions.
As used in this law, the following terms shall have the meanings
indicated:
``STIMULANT DRINK'' shall mean a beverage or powdered drink mix
that contains 75 or more milligrams of caffeine per 8 fluid
ounces and generally includes a combination of other
supplements such as methylxanthines, B vitamins, herbal
ingredients and other ingredients which are advertised as being
specifically designed to provide or improve energy.
``PERSON'' shall mean any natural person, individual,
corporation, unincorporated association, proprietorship, firm,
partnership, joint venture, joint stock association or other
entity or business organization of any kind.
Section 3. Prohibitions.
No person shall provide free samples of stimulant drinks or coupons
for free or discounted stimulant drinks to any individual under the age
of eighteen (18) in the County of Suffolk. This prohibition shall apply
to the direct mailing of free samples or coupons for free or discounted
stimulant drinks to County residents under the age of eighteen (18).
Section 4. Penalties.
A. Violation of this law shall be punishable by a civil fine of up to
five hundred dollars ($500.00) for a first violation, with
subsequent violations punishable by a fine of up to one
thousand dollars ($1,000.00).
B. A civil penalty shall only be assessed by the Commissioner of the
Department of Health Services following a hearing at which an
alleged violator has the opportunity to be heard.
Section 5. Enforcement.
A. This law shall be enforced by the Department of Health Services.
Section 6. Authority to Promulgate Rules and Regulations.
The Commissioner of the Department of Health Services is hereby
authorized and empowered to promulgate such rules and regulations as he
or she deems necessary to implement this law.
Section 7. Applicability.
This law shall apply to actions occurring on or after the effective
date of this law.
Section 8. Severability.
If any clause, sentence, paragraph, subdivision, section, or part
of this law or the application thereof to any person, individual,
corporation, firm, partnership, entity, or circumstance shall be
adjudged by any court of competent jurisdiction to be invalid or
unconstitutional, such order or judgment shall not affect, impair, or
invalidate the remainder thereof, but shall be confined in its
operation to the clause, sentence, paragraph, subdivision, section, or
part of this law, or in its application to the person, individual,
corporation, firm, partnership, entity, or circumstance directly
involved in the controversy in which such order or judgment shall be
rendered.
Section 9. SEQRA Determination.
This Legislature, being the State Environmental Quality Review Act
(SEQRA) lead agency, hereby finds and determines that this law
constitutes a Type II action pursuant to Section 617.5(c)(20), (21),
and/or (27) of Title 6 of the NEW YORK CODE OF RULES AND REGULATIONS (6
NYCRR) and within the meaning of Section 8-0109(2) of the NEW YORK
ENVIRONMENTAL CONSERVATION LAW as a promulgation of regulations, rules,
policies, procedures, and legislative decisions in connection with
continuing agency administration, management and information
collection. The Suffolk County Council on Environmental Quality (CEQ)
is hereby directed to circulate any appropriate SEQRA notices of
determination of non-applicability or non-significance in accordance
with this law.
Section 10. Effective Date.
This law shall take effect on the sixtieth (60) day upon filing in
the Office of the Secretary of State.
DATED: March 19, 2013
APPROVED BY:
/s/ Steven Bellone
County Executive of Suffolk County
Date: April 19, 2013
After a public hearing duly held on April 2, 2013
Filed with the Secretary of State on May 3, 2013
______
Attachment 3
Intro. Res. No. 1086-2013 Laid on Table 2/5/2013
Introduced by Legislators Spencer and Anker
RESOLUTION NO. 189-2013, ADOPTING LOCAL LAW NO. 17-2013, A
LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF STIMULANT
DRINKS TO MINORS IN COUNTY PARKS
WHEREAS, there was duly presented and introduced to this County
Legislature at a meeting held on February 5, 2013, a proposed local law
entitled, ``A LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF
STIMULANT DRINKS TO MINORS IN COUNTY PARKS''; now, therefore be it
RESOLVED, that said local law be enacted in form as follows:
LOCAL LAW NO. 17-2013, SUFFOLK COUNTY, NEW YORK
A LOCAL LAW TO PROHIBIT THE SALE AND DISTRIBUTION OF STIMULANT
DRINKS TO MINORS IN COUNTY PARKS
BE IT ENACTED BY THE COUNTY LEGISLATURE OF THE COUNTY OF SUFFOLK,
as follows:
Section 1. Legislative Intent.
This Legislature hereby finds and determines that the County of
Suffolk is dedicated to protecting the health and safety of its
residents, and pays special attention to children's health.
This Legislature further finds and determines that so-called
``energy drinks'' are very popular, particularly among young people.
This Legislature finds that these drinks contain very high levels
of caffeine, though the exact amounts are not disclosed by their makers
as nutrition information.
This Legislature finds that caffeine is not a source of energy but
a stimulant and, therefore, these beverages are more accurately
described as ``stimulant drinks'' and shall be referred to as such in
this law.
This Legislature finds that in addition to caffeine stimulant
drinks contain a variety of herbal supplements, vitamins and amino
acids, such as guarana, taurine, vitamins B6 and B12, yerba mate,
bitter orange, ginger, ginkgo, St. Johns Wort and ginseng.
This Legislature determines that consumption of stimulant drinks
can cause significant adverse health effects: aggravating heart
conditions, headaches, rapid heartbeat, nervousness, irritability,
sleeplessness, dehydration, abnormal heart rhythms and stomach upset.
This Legislature also finds that consuming stimulant drinks can be
particularly harmful to young people. Consumption of stimulant drinks
may interfere with medications prescribed for certain conditions,
including attention deficit disorder, allergies, asthma, and birth
control pills.
This Legislature notes that many stimulant drinks are labeled by
their own manufacturers as ``Not Recommended for Children''.
This Legislature further finds that given the health risks
associated with the consumption of stimulant drinks by minors, it is
reasonable and appropriate for the County of Suffolk to exercise its
police powers to prohibit the sale and distribution of stimulant drink
products at its own parks and beaches..
Therefore, the purpose of this law is to prohibit the sale or
distribution of stimulant drinks to minors in County parks.
Section 2. Amendments.
Chapter 643 of the SUFFOLK COUNTY CODE is hereby amended as
follows:
Chapter 643. PARKS AND PARK FACILITIES.
ARTICLE I. Rules and Regulations.
****
Sec. 643-2. Definitions.
As used in this article, the following terms shall have the
meanings indicated:
****
PERSON--Any person, firm, partnership, association, corporation,
company or organization of any kind.
STIMULANT DRINK--a beverage that contains 75 or more milligrams of
caffeine per 8 fluid ounces and generally includes a combination of
other supplements such as methylxanthines, B vitamins, herbal
ingredients and other ingredients which are advertised as being
specifically designed to provide or improve energy.
****
Sec. 643-4. Prohibited acts.
A. No person in a County park shall:
****
(25) sell or offer for sale, provide or otherwise distribute
stimulant drinks to persons under the age of eighteen.
****
Section 3. Exemptions.
(A) This prohibition shall not apply to individuals who bring
stimulant drinks into a County park solely for personal
consumption.
(B) This law shall not apply to persons operating a concession in a
County park who are expressly authorized by their agreement
with the County of Suffolk to sell or distribute stimulant
drinks.
Section 4. Future Concession Licenses
All concession licenses and license renewals entered into by the
Suffolk County Department of Parks, Recreation and Conservation on or
after the effective date of this law shall contain a provision barring
the sale or distribution of stimulant drinks to persons under the age
of eighteen.
Section 5. Applicability.
This law shall apply to all actions occurring on or after the
effective date of this law.
Section 6. Severability.
If any clause, sentence, paragraph, subdivision, section, or part
of this law or the application thereof to any person, individual,
corporation, firm, partnership, entity, or circumstance shall be
adjudged by any court of competent jurisdiction to be invalid or
unconstitutional, such order or judgment shall not affect, impair, or
invalidate the remainder thereof, but shall be confined in its
operation to the clause, sentence, paragraph, subdivision, section, or
part of this law, or in its application to the person, individual,
corporation, firm, partnership, entity, or circumstance directly
involved in the controversy in which such order or judgment shall be
rendered.
Section 7. SEQRA Determination.
This Legislature, being the State Environmental Quality Review Act
(SEQRA) lead agency, hereby finds and determines that this law
constitutes a Type II action pursuant to Section 617.5(c)(20), (21),
and/or (27) of Title 6 of the NEW YORK CODE OF RULES AND REGULATIONS (6
NYCRR) and within the meaning of Section 8-0109(2) of the NEW YORK
ENVIRONMENTAL CONSERVATION LAW as a promulgation of regulations, rules,
policies, procedures, and legislative decisions in connection with
continuing agency administration, management and information
collection. The Suffolk County Council on Environmental Quality (CEQ)
is hereby directed to circulate any appropriate SEQRA notices of
determination of non-applicability or non-significance in accordance
with this law.
Section 8. Effective Date.
This law shall take effect on the sixtieth (60th) day following its
filing in the Office of the Secretary of State.
____ Underlining denotes addition of new language
DATED: March 19, 2013
APPROVED BY:
/s/ Steven Bellone
County Executive of Suffolk County
Date: April 19, 2013
After a public hearing duly held on April 2, 2013
Filed with the Secretary of State on May 3, 2013
______
Attachment 4
Copy of envelope and sample sent to
Legislator Sarah Anker's 16-year-old son
Suffolk County Department of Health Services Brochure
______
______
Attachment 5
County of Suffolk--Department of Health Services
Great River, NY, December 3, 2012
Hon. Presiding Officer William J. Lindsay,
Suffolk County Legislature,
Hauppauge, NY.
Dear Presiding Officer,
The Suffolk County Board of Health has been concerned about energy
drinks for the past two years beginning when the Suffolk County
Legislature requested the Board of Health to review proposed
legislation regarding limiting the sale of energy drinks and promoting
educational activities. In 2011, recommendations were made to the you
as Presiding Officer of the Suffolk County Legislature.
Since 2011, the energy drink industry has continued and expanded
its marketing of its products to young adults and children. Recent
alleged associations of deaths related to energy drinks and the
increase in emergency room visits due to illnesses attributed to these
beverages has added to the concerns of the Board.
The use of energy drinks for children and young adults sends a
negative nutritional message to this population. The use of these
supplements to compensate for fatigue, lack of energy and to experience
higher levels of physical and mental functioning is not only
inappropriate for this population but may be dangerous to their health.
As a result, the Board recommends the following:
1. Regulation at the Federal level to limit the access to energy
drinks by restricting the sale to individuals less than 19
years of age.
2. Regulation at the county (Suffolk) level to limit the access to
energy drinks by restricting the sale to individuals less than
19 years of age.
3. Promote a multi-component educational program for the schools,
the general public and especially parents so they are aware of
the ingredients in energy drinks and their potential dangers,
including the total caffeine content from all sources.
4. Labeling of all the ingredients in energy drinks and their
components, in milligrams per container (mg/container), should
be required on the packages. The label should be on the front
of the can, easily visible by consumers, utilizing a color that
stands out and a font size that is easily distinguishable.
5. Consideration should be given to the placement of energy drinks
in commercial establishments.
6. Propose a local law requiring that a WARNING sign be posted at
the point of sale of energy drinks in all establishments in
Suffolk County.
The warning is the following:
ENERGY DRINKS WARNING
CONSUMPTION OF ENERGY DRINKS MAY BE HARMFUL TO CHILDREN,
PREGNANT WOMEN AND PEOPLE SENSITIVE TO CAFFEINE. ENERGY DRINKS
MAY AGGRAVATE HEART CONDITIONS, CAUSE HEADACHES, RAPID
HEARTBEAT, DEHYDRATION, DISRUPTION OF SLEEP PATTERNS AND
CONCENTRATION, AND IN RARE CASES, DEATH. THESE EFFECTS MAY BE
MAGNIFIED IN CHILDREN UNDER AGE 19. ENERGY DRINKS MAY CONTAIN
LARGE QUANTITIES OF CAFFEINE AND OTHER INGREDIENTS, INCLUDING
HERBAL SUPPLEMENTS, AMINO ACIDS AND VITAMINS. THE INGREDIENTS
IN THESE DRINKS MAY INTERFERE WITH CERTAIN PRESCRIPTION
MEDICATIONS FOR ATTENTION DEFICIT DISORDER, ASTHMA, ALLERGIES,
BIRTH CONTROL AND OTHER CONDITIONS. MIXING ENERGY DRINKS WITH
ALCOHOL OR OTHER DRUGS MAY POSE ADDITIONAL HEALTH RISKS.
7. Ban the distribution of samples of energy drinks in Suffolk
County to individuals less than 19 years of age.
Respectfully submitted,
James L. Tomarken, MD,
MPH, MBA, MSW, FRCPC, FACP,
Commissioner & Chair Health Committee.
cc: Honorable William Spencer, MD, Chair, Health Committee, Suffolk
County Legislature
______
Attachment 6
MEDICAL SOCIETY OF THE STATE OF NEW YORK 2013 HOUSE OF
DELEGATES
Report of: Reference Committee on Public Health and Education
Presented by: Daniel Young, MD, Chair
_______________________________________________________________________
Mister Speaker and Members of the House of Delegates:
Your Reference Committee recommends the following consent calendar for
acceptance:
RECOMMENDED FOR ADOPTION
(1) Resolution 154--Require Third Party Payer Coverage of Follow Up
Exams for Patients with Dense Breast Tissue
(2) Resolution 163--Committees of Specialty Societies to Eliminate
Health Care Disparities
(3) 2013 Public Health & Education Sunset Report
RECOMMENDED FOR ADOPTION AS AMENDED OR SUBSTITUTED
(4) Resolution 152--Violent Acts of Youth and Violent Acts Upon Youth
(5) Resolution 153--Immunization in Hamilton County Children
(6) Resolution 155--Legislation Requiring 90 day Supply of all Chronic
Medications
(7) Resolution 157--Oppose Legislature Approval of Smoked Medical
Marijuana
(8) Resolution 158--Farm Use of Antibiotics
(9) Resolution 159--Regulation of Tattoo Procedures
(10) Resolution 160--Statewide ``Don't Text and Drive Initiative''
[[(11) Resolution 161--Banning Marketing and Sale of ``High-Energy/
Stimulant Drinks'' to Children Under the Age of 19]]
(12) Resolution 162--STI Elevation Myocardial Infarction
(13) Resolution 165--Opposition to Mandatory Maintenance of
Certification
And
Resolution 168--Opposition of Mandatory Maintenance of Certification
(MOC)
(14) Resolution 166--Opposition to Maintenance of Licensure
And
Resolution 167--Opposition to Maintenance of Licensure
(15) Resolution 169--Transparency and Accountability for Specialty
Boards and MOC
(16) Resolution 170--Expanding Participation of Asthmatic Children in
Physical Education Or Exercise Programs
(17) Resolution 171--Public Health Implications of Natural Gas
Extraction Using Hydraulic Fracturing
(18) Resolution 172--Partner Delivered Therapy for STIs
(19) Resolution 173--Sudden Closure of Residency Programs
RECOMMENDED NOT FOR ADOPTION
(20) Resolution 150--Pathology Specimen
Reference Committee agrees with the intent of the sponsor, but did
believe it was more appropriate for MSSNY to encourage that the county
medical societies become involved in these types of initiatives.
Additionally, your Reference Committee offered up the substitute
resolution to more accurately reflect the current status of the
federal, state and local efforts on this matter. Your Reference
Committee recommends adoption of the substitute resolution.
(11) Resolution 161 Banning Marketing and Sale
of ``High-Energy/
Stimulant Drinks'' to
Children Under the Age of
19
RECOMMENDATION A:
Mr. Speaker, your Reference Committee recommends that
the FOLLOWING SUBSTITUTE RESOLUTION 161 BE ADOPTED IN
LIEU OF RESOLUTION 161:
RESOLVED, that the Medical Society of the State of New
York support a temporary ban on the marketing of ``high
stimulant/caffeine drinks'' to children/adolescents
under the age of 18; and be it further
RESOLVED, that the temporary marketing ban for
children/adolescents under age 18 be kept in place
until such time as the scientific evidence regarding
the possible adverse medical affects that stimulant
drinks may have on children and adolescents is
determined; and be it further
RESOLVED, that a copy of this resolution be forwarded
to the American Medical Association for consideration
at its next House of Delegates meeting.
RECOMMENDATION B:
Mister Speaker, your Reference Committee recommends
that A TITLE CHANGE BE MADE TO RESOLUTION 161 TO READ
AS FOLLOWS;
Banning Marketing and Sale of ``High-Energy/Stimulant
Drinks'' to Children/Adolescents Under the Age of 18
Resolution 161 says that in recognizing the adverse health effects
which ``stimulant'' drinks can have on children and adolescents,
including but not limited to insomnia, agitation, anxiety, cardiac
arrhythmias, and even death, that the Medical Society of the State of
New York support legislation or regulation to place a temporary ban on
the marketing of these ``high stimulant/caffeine drinks'' at youth-
related sporting activities, as well as prohibiting the sale and direct
distribution by industry of these stimulant drinks to children under
the age of 19; and that the above ban, sales, and direct distribution
prohibition be kept in place until such time as the scientific evidence
regarding the adverse medical affects these stimulant drinks have on
children and adolescents have been disproven.
Your Reference Committee heard testimony in support of this resolution.
Your Reference Committee applauds the effort of Suffolk County
physician and county legislator, Dr. William Spencer, in bringing this
matter forward to the House of Delegates. Your Reference Committee
agreed that this resolution is meritorious, but felt that the
substitute resolution more clearly defined a more balanced approach
until such time as the FDA acts on these drinks. The FDA is currently
investigating the health consequences of energy drinks. The substitute
also provides MSSNY with a position should such legislation come before
the NYS Legislature for action. There were some questions received in
testimony regarding the age, and your Reference Committee agrees that
18 is the appropriate age for the temporary marketing ban. The
resolution also request that a copy of the resolution be forwarded to
the AMA for its consideration as this is also a Federal issue as the
FDA is involved. Your Reference Committee believes the substitute
creates an appropriate balance and urges adoption.
Your Chairperson is grateful to the Committee members, namely David M.
Jakubowicz, MD; Sonya Sidhu-Izzo, MD; Brian Meagher, MD; David Y.
Zhang, MD and Stephen Coccaro, MD.
Your Reference Committee Chairman also wishes to express his
appreciation Pat Clancy, Barbara K. Ellman, and Terri Holmes for their
help in preparation of this report.
Respectfully submitted,
Daniel Young, MD, Chair; David M. Jakubowicz, MD, Bronx County; Sonya
Sidhu-Izzo, MD, Schenectady County; Brian Meagher, MD, Cautauqua
County; David Y. Zhang, MD, Queens County; Stephen Coccaro, MD, Suffolk
County
Attachment 7
______
Attachment 8
Attachment 9
Monster Energy Drink Store Display
Senator Blumenthal. Mr. Sacks?
Thank you.
STATEMENT OF RODNEY SACKS, CHAIRMAN AND CHIEF EXECUTIVE
OFFICER, MONSTER BEVERAGE CORPORATION
Mr. Sacks. Thank you.
Good afternoon, Mr. Chairman, Ranking Member Thune, and
members of the Committee. My name is Rodney Sacks, and I am the
Chairman and Chief Executive Officer of Monster Beverage
Corporation.
Monster is and has always been committed to ensuring that
all of the ingredients in its energy drinks, including
caffeine, are safe and in regulatory compliance for their
intended use. The formulations of our energy drink line have
been and continue to be overseen by our chief scientific
officer, a professor of pharmacology at a major university who
has been part of our team from the outset.
Indeed, we have extensively and continually analyzed the
scientific and medical literature relating to the safety of
caffeine and other ingredients in our products. Since 2002,
more than 9 billion cans of Monster energy drinks have been
sold and safely consumed worldwide, including 8 billion in the
United States.
The safety of caffeine and other ingredients in Monster
energy drinks is well established by an overwhelming body of
generally accepted scientific literature published by reputable
third parties, including major governmental and other
authoritative, scientific, and medical bodies.
Mr. Chairman, the level of caffeine in Monster energy
drinks is about half the caffeine per ounce of coffeehouse-
brewed coffee. Monster Energy's 16-ounce cans, which represent
more than 80 percent of Monster energy drinks sold, contain
approximately 160 milligrams of caffeine from all sources per
can.
A 16-ounce medium cup of coffee from Starbucks contains
approximately 330 milligrams of caffeine, more than twice as
much. Dunkin' Donuts, Caribou, Pete's, Seattle's Best, all have
more caffeine per ounce than Monster, as do many iced coffees
and other cold coffee beverages.
The presence of energy drinks in the U.S. marketplace has
not increased the consumption of caffeine by teenagers and
young adults. Consumption data from the USDA shows that
caffeine consumption in the U.S. has remained relatively stable
over the past decade, despite the introduction of energy
drinks.
These conclusions have been confirmed by subsequent
research, including a study commissioned by the FDA in 2009-
2010, which showed that teens and young adults, ages 14 to 21,
do not consume high amounts of caffeine and that their source
of caffeine is mainly from coffee, soft drinks, and tea. The
FDA study noted a prior survey that concluded that only about
0.9 percent of 14-to 21-year-olds are regular energy drinkers.
A study released this year by researchers at Penn State
University further confirmed that coffee, tea, and soft drinks
are the most significant caffeine sources in younger age
groups, not energy drinks.
While the company believes that its products are safe for
all consumers, the company does not market Monster to children
and has never done so. From Monster's introduction in 2002, the
company has included an advisory statement on every can that
Monster is not recommended for children. Monster was the first
energy drink company to ever include such an advisory statement
in its labeling.
Monster considers the primary demographic of consumers of
its energy drinks to be young adults, primarily males. And its
brand initiatives and brand image are directed towards this
population. The company does not focus its brand initiatives on
young teenagers. To do so would undermine the credibility of
the brand image in the eyes of young adults.
It has long been the company's policy not to sample Monster
at K through 12 schools. The company has also told its network
of independent distributors to refrain from any marketing
activities for Monster that target children or K through 12
schools.
The company sponsors a variety of athletes, music artists,
events, tours, and shows to promote Monster. The company's
primary marketing involves motor sports that are aligned with
Monster's brand image, such as NASCAR, Supercross, Motocross,
MotoGP, off-road truck racing, Formula 1, and the Dakar Rally.
The primary demographic for such motor sports is adults, not
children or young teenagers.
For 2012, one of the company's most significant marketing
commitments was to NASCAR, which has a median viewership age of
over 50. Other sponsorships include smaller commitments to
action sports, such as athletes who compete in events like the
X Games. The average age of X Games viewers is in the early
30s.
The company shares your commitment to protecting the health
and safety of consumers, including children and teenagers. The
company strives to be a responsible corporate citizen, and we
believe that our marketing practices reflect that.
I appreciate the opportunity to appear before you today to
discuss the safety and marketing of our products.
Thank you. I look forward to any questions you may have.
[The prepared statement of Mr. Sacks follows:]
Prepared Statement of Rodney Sacks, Chairman And Chief Executive
Officer, Monster Beverage Corporation
Good afternoon, Mr. Chairman, Ranking Member Thune, and members of
the Committee. My name is Rodney Sacks, and I am the Chairman and Chief
Executive Officer of Monster Beverage Corporation. Based in Corona,
California, Monster Beverage Corporation and its subsidiaries is a
leading marketer and distributor of alternative beverages and energy
drinks, including Monster Energy (``Monster''). I appreciate the
opportunity to appear before you today to discuss the safety of our
products and our marketing practices.
Monster Beverage Corporation traces its origins to the 1930s, when
it was founded as a business selling fresh juices under the brand name
Hansen's in Los Angeles. In 1992, a group headed by my co-founder
Hilton Schlosberg and I acquired the struggling Hansen's brand. We
have worked hard to grow the business, and we are proud of what the
Company has accomplished. Today the Company employs more than 2,100
people, including more than 1,200 full-time workers, and supports the
employment of tens of thousands more at packaging plants, warehouses,
distributors and retailers all across the country. Forbes magazine has
named us the ``Best Small Company'' in America and the Company has
similarly been recognized by other prestigious publications and
institutions over the years.
Monster is, and has always been, committed to ensuring that all of
the ingredients in its energy drinks (including caffeine) are safe and
in regulatory compliance for their intended use. The formulations of
our energy drink line have been and continue to be overseen by our
chief scientific officer, a professor of pharmacology at a major
university who has been part of our team from the outset. Indeed, we
have extensively and continually analyzed the scientific and medical
literature relating to the safety of caffeine and other ingredients in
our products.
Since 2002, more than 9 billion cans of Monster energy drinks have
been sold and safely consumed worldwide, including 8 billion in the
United States. The safety of caffeine and other ingredients in Monster
energy drinks is well established by an overwhelming body of generally
accepted scientific literature published by reputable third parties,
including major governmental and other authoritative scientific and
medical bodies. This body of literature includes literally hundreds of
studies on caffeine over many decades, as caffeine is one of the most
widely studied ingredients in the food supply. Attached to this
statement is a letter submitted to the FDA on behalf of the Company
discussing the relevant scientific literature and the safety of Monster
energy drinks.
The level of caffeine in Monster energy drinks is about half the
caffeine per ounce of coffeehouse brewed coffee. Monster Energy's 16-
ounce cans, which represent more than 80 percent of Monster energy
drinks sold, contain approximately 160 mg of caffeine from all sources
per can. A 16-ounce medium cup of coffee from Starbucks contains
approximately 330 mg of caffeine--more than twice as much. See
Attachment 1. Dunkin' Donuts, Caribou, Peet's, Seattle's Best--all have
more caffeine per ounce than Monster, as do many iced coffees and other
cold coffee beverages. See Attachments 2-3.
The presence of energy drinks in the U.S. marketplace has not
increased the consumption of caffeine by teenagers and young adults.
Consumption data from the USDA shows that caffeine consumption in the
U.S. has remained relatively stable over the past decade, despite the
introduction of energy drinks. These conclusions have been confirmed by
subsequent research, including a study commissioned by the FDA in 2009-
2010, which showed that teens and young adults (ages 14-21) do not
consume high amounts of caffeine and that their source of caffeine is
mainly from coffee, soft drinks and tea. The FDA study noted a prior
survey that concluded that only about 0.9 percent of 14-21 year olds
are regular energy drink consumers. A study released this year by
researchers at Penn State University on behalf of International Life
Sciences Institute of North America (ILSI) further confirmed that
coffee, tea, and soft drinks are the most significant caffeine sources
in younger age groups--not energy drinks. The study also concluded that
the percentage of energy drink users is low (less than 10 percent) and
that these energy drinks are minor contributors to overall caffeine
intakes in all age groups.
While the Company believes that its products are safe for all
consumers, I would like to emphasize that the Company does not market
Monster to children, and has never done so. From the time that Monster
was first introduced into the marketplace in 2002, the Company has
included an advisory statement on every can that Monster is not
recommended for children. The label currently states: ``CONSUME
RESPONSIBLY: Not recommended for children, people sensitive to
caffeine, pregnant women or women who are nursing.'' \1\ Monster was
the first energy drink company to ever include such an advisory
statement in its labeling, and years later, many peer companies have
done the same.
---------------------------------------------------------------------------
\1\ The original label was amended a few years ago to include the
reference to women who are nursing.
---------------------------------------------------------------------------
Monster considers the primary demographic of consumers of its
energy drinks to be young adults (primarily males), and its brand
initiatives and brand image are directed toward this population. The
Company does not focus its brand initiatives on young teenagers. To do
so would undermine the credibility of the brand image in the eyes of
young adults. It has long been the Company's policy not to sample
Monster at K-12 schools. The Company has also told its network of
independent distributors to refrain from any marketing activities for
Monster that target children or K-12 schools.
Like many other popular food and beverage companies, the Company
sponsors a variety of athletes, music artists, events, tours, and shows
to promote Monster. The Company's primary marketing involves motor
sports that are aligned with Monster's brand image, such as NASCAR,
Supercross, Motocross, MotoGP, off-road truck racing, Formula 1 racing,
and the Dakar Rally. The primary demographic for such motor sports is
young adults over the age of 18, not children or young teenagers. For
2012, one of the Company's most significant marketing commitments was
to NASCAR, which typically attracts an older population of viewers and
attendees, by sponsoring one of its leading teams. Other sponsorships
include smaller commitments to action sports, such as athletes who
compete in events like the X Games. The X Games is open to athletes and
spectators that span a broad range of ages, but is primarily attended
or watched by persons who are 18 years of age or older. As reported by
Nielsen, the average age of X Games viewers is in the early thirties.
The Company shares your commitment to protecting the health and
safety of consumers, including children and teenagers. The Company
strives to be a responsible corporate citizen, and we believe that our
marketing practices reflect that. I appreciate the opportunity to
appear before you today to discuss the safety and marketing of our
products, and also your willingness to review objectively and in an
evidence-based manner the body of scientific literature and other
information we have provided to the Committee.
Thank you. I look forward to any questions you may have.
Attachment 1
Attachment 2
Attachment 3
______
Attachment 4
Covington & Burling LLP
Washington, DC, July 29, 2013
Margaret A. Hamburg, MD
Commissioner of Food and Drugs,
Food and Drug Administration,
Silver Spring, MD.
Re: Monster Beverage Corporation Response to the Letter by Arria,
et al.
Dear Dr. Hamburg:
This letter reflects the response of Monster Beverage Corporation
(Monster or the Company) to the March 19, 2013, letter (the Letter) to
you from 18 healthcare professionals and researchers of various
backgrounds (the Authors) concerning the safety of caffeine as an
ingredient in energy drinks.\1\ Monster fully endorses the American
Beverage Association's (ABA's) response to the Letter but has also
prepared its own response to provide additional information specific to
the Company's products, to address some of the points in greater
detail, and to reinforce the evidence-based response of the ABA
documenting the safety and regulatory compliance of caffeine in energy
drinks. We hope this information is useful to FDA as the agency
considers the evidence regarding the safety of energy drinks and other
caffeinated foods and beverages.
---------------------------------------------------------------------------
\1\ Letter from Amelia M. Arria, Ph.D., et al., to the Honorable
Margaret A. Hamburg, M.D., Commissioner, FDA at 1 (Mar. 19, 2013)
(Letter).
---------------------------------------------------------------------------
I. Introduction
Monster is committed to ensuring that the caffeine and all
ingredients in its energy drinks are safe and in regulatory compliance
for their intended use. Indeed, Monster has extensively analyzed and
continues to analyze the scientific and medical literature relating to
the safety of caffeine and other ingredients in its products, and has
done so since prior to the formulation and initial marketing of Monster
Energy Drinks. Contrary to the assertion of the Authors that ``the
best available scientific evidence demonstrates a robust correlation
between the caffeine levels in energy drinks and adverse health and
safety consequences, particularly among children, adolescents, and
young adults,'' \2\ the wealth of peer-reviewed published scientific
and medical literature, including studies conducted by governmental and
other authoritative bodies and data on consumption of caffeine from
energy drinks and other sources, establishes that caffeine in energy
drinks is both safe and generally recognized as safe (GRAS) for its
intended use in energy drinks.
---------------------------------------------------------------------------
\2\ Id.
---------------------------------------------------------------------------
This body of literature includes literally hundreds of studies on
caffeine over many decades, as caffeine is one of the most widely
studied ingredients in the food supply and is certainly not new, novel,
or unknown. Regrettably, the Authors appear to have focused primarily
on their own research in characterizing the ``best available scientific
evidence,'' rather than on this overarching body of well-established
literature, as nearly a third of the articles cited in the Letter were
drafted by the Authors themselves.\3\ The articles cited by the Authors
stand at odds with the large and reputable body of scientific and
medical literature confirming the safety of caffeine at the level at
which it is used in Monster Energy Drinks (and most other energy drink
brands). Monster therefore takes this opportunity to summarize that
full body of reliable scientific and medical literature establishing
the safety and GRAS status of caffeine in its energy drinks.
---------------------------------------------------------------------------
\3\ A significant limitation of the Letter is the fact that the
greater part of the Authors' expertise, as evidenced by their
professional biographies and peer-reviewed publications, lies in
behavioral-related aspects of consumption of caffeine/energy drinks
combined with alcohol (such as addiction and risk-taking) and in
prevention of childhood obesity. The Authors with cardiology expertise
do not appear to have expertise (i.e., few if any studies or
publications) on the cardiovascular effects of caffeine/energy drink
consumption.
---------------------------------------------------------------------------
It is also helpful to put these issues into context. Energy drinks
are not new, nor have they suddenly emerged on the marketplace. Tens of
billions of energy drinks have been sold and safely consumed worldwide
for more than 25 years, and have been marketed in the United States
since 1997. Since 2002, more than 9 billion cans of Monster Energy
products alone have been sold globally, of which more than 8 billion
have been sold in the United States. Moreover, energy drinks are
subject to ample regulatory oversight and review. Food safety
authorities in Europe, where energy drinks were first marketed in 1987,
have evaluated the safety of energy drinks on numerous occasions over
the course of more than a decade and concluded they are safe. The FDA
has likewise been actively evaluating the safety of energy drinks for a
number of years and has not identified evidence establishing a cause
for concern. This significant history of safe consumption of so many
billions of servings of energy drinks, in conjunction with the wealth
of scientific evidence supporting the safety of caffeine at the levels
used in these products, negates speculative allegations of potential
harm from energy drinks.
II. Monster Energy Drinks Are Not ``High'' in Caffeine, and Contain
Half The Caffeine of Starbucks Coffee
At the outset, it is important to clarify that Monster Energy
Drinks are not ``high'' in caffeine, contrary to the assertion in the
Letter that energy drinks contain ``high levels of added caffeine.''
\4\ The amount of caffeine in Monster Energy Drinks is comparable to
standard brewed coffee and other foods, and is about half the amount of
caffeine found in the same volume of premium coffee such as Starbucks
(Table 1 and Figure 1). Monster Energy Drinks sold in cans 8 ounces or
larger generally contain approximately 10 mg of caffeine (from all
sources) per ounce. The typical 16-ounce Monster Energy can, which
represents more than 80 percent of Monster Energy Drinks sold, contains
approximately 160 mg of caffeine from all sources (including guarana,
which contributes only approximately 2 mg caffeine per 16-ounces)--half
the caffeine contained in a medium cup of Starbucks coffee. This amount
is comparable to, and in some cases, lower than, the caffeine in other
major energy drink brands (Table 2).
---------------------------------------------------------------------------
\4\ See, e.g., Letter at 1.
Table 1.--Caffeine Content of Select Foods Available in the U.S.
----------------------------------------------------------------------------------------------------------------
Caffeine (mg) per fl.
Product Amount Caffeine (mg) \5\ oz. or per oz.
----------------------------------------------------------------------------------------------------------------
Caribou Depth Charge 16 fl. oz. 370 23.1
----------------------------------------------------------------------------------------------------------------
Dunkin' Donuts with Turbo Shots 20 fl. oz. 436 21.8
----------------------------------------------------------------------------------------------------------------
Starbucks Coffee (Grande/Medium) 16 fl. oz. 330 20.6
----------------------------------------------------------------------------------------------------------------
Caribou Coffee of the Day 16 fl. oz. 305 19.1
----------------------------------------------------------------------------------------------------------------
Panera Frozen Mocha 16.5 oz. 267 16.2
----------------------------------------------------------------------------------------------------------------
Dunkin' Donuts Coffee (Medium) 14 fl. oz. 178 12.7
----------------------------------------------------------------------------------------------------------------
Starbucks Iced Coffee 16 fl. oz. 165 10.3
----------------------------------------------------------------------------------------------------------------
Pepsi Max 12 fl. oz. 69 5.8
----------------------------------------------------------------------------------------------------------------
Mountain Dew (Regular or Diet) 12 fl. oz. 54 4.5
----------------------------------------------------------------------------------------------------------------
Mountain Dew Big Gulp 52 fl. oz. 234 4.5
----------------------------------------------------------------------------------------------------------------
Brewed tea 8 fl. oz. 30-80 3.75
----------------------------------------------------------------------------------------------------------------
Coca-Cola, Coke Zero, or Diet Pepsi 12 oz. 35 2.9
----------------------------------------------------------------------------------------------------------------
Mio (by Kraft) 1 squirt (1/2 tsp.) 60 per serving; 1080
per 1.62 fl. oz. bottle
----------------------------------------------------------------------------------------------------------------
Hershey's Special Dark Chocolate Bar 1.45 oz. 31 21.4
----------------------------------------------------------------------------------------------------------------
Ben & Jerry's Coffee Heath Bar Crunch 8 oz. 84 10.5
Ice Cream
----------------------------------------------------------------------------------------------------------------
Ben & Jerry's Coffee Flavored Ice 8 oz. 68 8.5
Cream
----------------------------------------------------------------------------------------------------------------
Table 2.--Caffeine Content of Energy Drinks Available in the U.S.
----------------------------------------------------------------------------------------------------------------
Caffeine Per
Energy Drink Can Size (oz.) Caffeine Per Container (mg) Caffeine (mg)
Serving (mg) \6\ per oz.
----------------------------------------------------------------------------------------------------------------
Amp Energy (by Pepsi) 16 71 142 8.9
----------------------------------------------------------------------------------------------------------------
Red Bull 8.4 80-83 80-83 9.5-9.9
----------------------------------------------------------------------------------------------------------------
Monster Energy 16 80 160 10
----------------------------------------------------------------------------------------------------------------
Rockstar 16 80 160 10
----------------------------------------------------------------------------------------------------------------
Full Throttle (by Coca-Cola) 16 100 200 12.5
----------------------------------------------------------------------------------------------------------------
NOS Energy (by Coca-Cola) 16 112 224 14
----------------------------------------------------------------------------------------------------------------
As shown in Table 1 and Figure 1, numerous foods and beverages
contain caffeine at levels comparable to or greater than that in
Monster Energy Drinks (and many other brands). These foods have a long
history of safe consumption in the U.S. and globally by persons of all
age groups. It is therefore clear that energy drinks do not introduce
new or alarming levels of caffeine into American diets. While the
Letter states that ``many energy drinks and related products containing
added caffeine exceed the caffeine concentration of even the most
highly caffeinated coffee,'' \7\ the data in Table 1 and Figure 1,
showing the caffeine content of coffee, and in Table 2, which reflects
approximately 95 percent of the range of caffeine content in the energy
drink category, make clear that this statement is not correct.
---------------------------------------------------------------------------
\5\ Source: Caffeine Content of Food & Drugs, Center for Science in
the Public Interest (``CSPI'') (Dec. 2012), http://www.cspinet.org/new/
cafchart.htm, and public industry information including
www.cariboucoffee.com. This chart includes values from the CSPI chart
currently on the website, as well as previous versions of the page.
\6\ Source: The Buzz on Energy-Drink Caffeine, ConsumerReports.org
(Dec. 2012), http://www.consumerreports.org/cro/magazine/2012/12/the-
buzz-on-energy-drink-caffeine/index.htm; Caffeine Content of Food &
Drugs, Center for Science in the Public Interest (CSPI) (Dec. 2012),
http://www.cspinet.org/new/cafchart.htm; and public industry
information.
\7\ Letter at 2.
---------------------------------------------------------------------------
To provide consumers with additional information about caffeine
content and to dispel false assertions that Monster Energy Drinks are
``high'' in caffeine, Monster Energy Drink labels produced beginning in
the spring of 2013 declare the total caffeine content from all sources.
Contrary to the Letter's assertion that energy drinks fail to disclose
caffeine content, most energy drink brands now bear a declaration of
caffeine content on their labels, on both a per-serving and a per-
container basis. This caffeine declaration is in addition to the
advisory statements that have appeared for years on Monster Energy
Drinks directing consumers to consume the drinks responsibly and
advising that the products are not recommended for children, pregnant
or nursing women, or people sensitive to caffeine. These advisory
statements convey meaningful information to help consumers enjoy
Monster Energy Drinks safely and responsibly. In contrast, coffee
marketers generally include no such advisories regarding consumption on
their products.
The Authors of the Letter suggest a distinction between ``naturally
occurring'' caffeine in coffee and ``added'' caffeine, implying that
``added'' caffeine is somehow different and more problematic.\8\ There
is no scientific basis for this assertion. The caffeine molecules of
``added'' caffeine and ``naturally occurring'' caffeine are chemically
identical, and the body metabolizes ``added'' caffeine, from any
source, in the same way that it metabolizes ``naturally occurring''
caffeine in foods and beverages. Moreover, Monster's leading products
contain 100 percent natural caffeine derived from coffee beans.
---------------------------------------------------------------------------
\8\ See Letter at 2.
---------------------------------------------------------------------------
Importantly, food manufacturers like Monster who add caffeine to
their products can control the caffeine content of their foods to a far
greater extent than producers or marketers of food in which caffeine is
``naturally occurring.'' Monster can ensure with a high degree of
precision that its products contain the amount of caffeine declared on
their labels. By contrast, the caffeine content of coffee products
varies widely due to many factors, such as brewing method, origin and
growing conditions of the bean, degree of roasting, and other
attributes. Indeed, one study found that the caffeine content of one
specific coffee (Starbucks Breakfast Blend) at a single coffee shop
varied by hundreds of milligrams (from 259 to 564 mg in a 16-oz cup)
over the course of six consecutive days.\9\
---------------------------------------------------------------------------
\9\ R.R. McCusker et al., Caffeine Content of Specialty Coffees, 27
J. Analytical Toxicology 520, 522 (2003).
---------------------------------------------------------------------------
The Authors also distinguish energy drinks from coffee by saying
that ``coffee is typically served hot, tastes bitter, and is consumed
slowly by sipping. By contrast, energy drinks are typically carbonated,
sweetened drinks that are served cold and consumed more rapidly.'' \10\
No data are offered to support these statements, which are selective
characterizations that fail to account for the fact that many, if not
most, consumers sweeten their coffee and add milk and drink it quickly
enough to avoid it becoming cold. Perhaps even more relevant in the
context of the Authors' focus on children and adolescents, these
statements do not account for cold or iced coffee beverages, which are
typically sweetened and are quite popular among younger consumers. The
volume of liquid in energy drinks is also self-limiting. With energy
drinks containing about half the caffeine content of premium coffee on
a mg/oz basis (see Table 1 and Figure 1), even if a consumer took twice
as long to drink coffee as he or she takes to drink an energy drink,
the amount of caffeine delivered in a given time period would be the
same.
---------------------------------------------------------------------------
\10\ Letter at 2.
---------------------------------------------------------------------------
Moreover, the unproven assumption that energy drinks are consumed
in a considerably shorter time than coffee is not clinically
significant. Given the pharmacokinetic parameters of caffeine, oral
administration of equal doses of caffeine over a short window (five
minutes, for example) as opposed to a longer window (15 minutes, for
example) would have a negligible effect on serum levels.\11\ Further,
the human body absorbs, distributes, metabolizes and excretes (ADME)
caffeine in the same manner whether it is delivered to the stomach cold
or hot.\12\ For example, one study conducted specifically to examine
any differences in the absorption and subjective effects of caffeine
from coffee vs. cold cola found no such effects.\13\ This randomized,
double-blind, placebo-controlled within-subjects study compared the
absorption and subjective effects of 400 mg caffeine from coffee and
cola (as well as capsules) and found no differences in peak caffeine
absorption, time to peak absorption, and subjective effects of caffeine
from the cola vs. coffee vehicle. This study confirms earlier research
concluding that temperature does not influence caffeine absorption.
---------------------------------------------------------------------------
\11\ See M. Arnaud, Pharmacokinetics and Metabolism of Natural
Methylxanthines in Animal and Man, Methylxanthines, 200 Handbook of
Experimental Pharmacology 33, 35-41 (B. Fredholm ed., 2011).
\12\ M.J. Arnaud, The Pharmacology of Caffeine, 31 Progress in Drug
Research 273, 276-77 (1987).
\13\ A. Liguori et al., Absorption and Subjective Effects of
Caffeine from Coffee, Cola and Capsules, 58 Pharmacology Biochemistry
and Behavior 721 (1997).
---------------------------------------------------------------------------
In sum, the foregoing data and information document that Monster
Energy Drinks are not ``high'' in caffeine content, and there is no
meaningful difference between the caffeine in coffee or other foods and
the caffeine in energy drinks.
III. Consumption Data Confirm that Children and Adolescents Are Not
Frequent Consumers of Energy Drinks or Caffeine
Having established that Monster Energy Drinks are not ``high'' in
caffeine content and do not expose consumers to caffeine in a manner
that is meaningfully different from coffee, we next discuss the
consumption data demonstrating the relative contribution of energy
drinks to the total caffeine intake of children, adolescents, and
adults. These consumption data, including from studies performed or
sponsored by the U.S. government, show that consumption of energy
drinks by younger consumers is low and has not increased their overall
caffeine intake. Therefore, the availability of energy drinks and the
limited consumption of these food products by younger people is simply
not a cause for alarm.
U.S. caffeine consumption data obtained from the United States
Department of Agriculture (USDA) National Health and Nutrition
Examination (NHANES) surveys shows that caffeine consumption in the
U.S. has remained essentially stable over the past decade. Data from
NHANES show that caffeine intake remained steady across all age groups
from 2001-2010 despite the growth of the market for energy drinks and
caffeinated water during this time. In direct contrast to the
allegations of the Authors, the level of caffeine consumption for
children and young adults has remained stable or decreased between
2001-2010, despite the availability of energy drinks (Table 3 and
Figure 2).
Table 3.--Caffeine Intakes From Beverages and Foods (NHANES 2001-2010) *
----------------------------------------------------------------------------------------------------------------
Caffeine (mg)/person
Age (years) ---------------------------------------------------------------------------------------
2001-2002 \1\ 2005-2006 \2\ 2007-2008 \3\ 2009-2010 \4\
----------------------------------------------------------------------------------------------------------------
Males
----------------------------------------------------------------------------------------------------------------
2-5 15.2 8.4 7.8 6.0
0.72 0.80 0.70
6-11 26.1 19.7 29.9 18.2
2.74 3.59 1.78
12-19 74.3 69.5 73.6 66.3
6.70 10.18 11.12
20-29 151.9 133.4 139.6 124.0
14.46 14.39 13.82
30-39 215.0 201.1 187.8 187.9
12.21 18.29 18.79
40-49 240.1 263.6 259.6 253.3
14.78 20.99 22.34
50-59 243.0 295.6 273.4 282.0
26.51 22.40 19.41
60-69 203.8 228.0 228.3 220.5
16.17 17.81 15.75
70 and over 160.1 156.9 162.7 174.8
12.81 8.23 15.93
20 and over 207.7 216.1 211.0 208.6
8.23 10.78 10.70
----------------------------------------------------------------------------------------------------------------
Females
----------------------------------------------------------------------------------------------------------------
2-5 12.3 6.9 8.9 5.7
0.90 1.63 0.56
6-11 23.0 17.0 19.0 16.1
1.26 3.29 0.99
12-19 49.1 46 6 60.4 48.4
4.18 4.40 4.28
20-29 91.4 82.2 105.8 107.6
8.14 13.35 7.62
30-39 168.9 165.2 153.5 155.8
19.3 15.04 12.22
40-49 190.0 219.8 194.4 168.8
10.24 11.96 12.22
50-59 190.6 225.3 207.2 186.1
15.33 32.17 15.95
60-69 153.0 163.7 180.7 166.8
19.05 17.96 14.61
70 and over 118.5 120.8 139.1 121.9
7.61 10.39 11.93
20 and over 153.4 165.3 163.8 152.2
4.91 8.51 7.79
----------------------------------------------------------------------------------------------------------------
Males and females
----------------------------------------------------------------------------------------------------------------
2 and over 142.1 149.8 148.8 142.2
5.27 7.44 6.33
----------------------------------------------------------------------------------------------------------------
* Data are reported as mean error per individual (per capita) by gender and age in United States people 2 years
and over (excluding breast-fed children) unless indicated otherwise.
\1\ No standard errors were reported. Does not include separate food codes for energy drinks.
\2\ Includes separate food codes for one brand of energy drinks and a general food code for ``Energy Drink''.
\3\ Includes separate food codes for ten different brands of energy drinks and a general food code for ``Energy
Drink''.
\4\ Includes separate food codes for ten different brands of energy drinks and a general food code for ``Energy
Drink''.
In addition, the results of a study commissioned by FDA (the
Somogyi study) confirm the NHANES consumption data. The Somogyi study
results show that caffeine consumption in the U.S. has remained
``relatively stable at approximately 300 milligrams per person per day
(mg/p/d), despite the entry of `energy drinks' into the market place.''
\14\ The study results also confirm that U.S. consumers have not
significantly modified their caffeine consumption patterns since the
appearance of energy drinks on the market. As an FDA representative
commented, ``In response to the emergence of energy drinks as a new
class of caffeinated products, FDA completed an updated assessment of
the amount of caffeine that people in the United States ingest from all
sources. The results show that, even when the consumption of energy
drinks is considered, most of the caffeine consumed comes from what is
naturally present in coffee and tea.'' \15\
---------------------------------------------------------------------------
\14\ Letter from Michele Mital, Acting Associate Commissioner for
Legislation, FDA, to the Honorable Richard J. Durbin, United States
Senate at 4 (Nov. 21, 2012) (``FDA November 2012 letter''), citing L.
Somogyi, Caffeine Intake By The U.S. Population (September 2009, rev'd
Aug. 2010) (``Somogyi'').
\15\ Letter from Jeanne Ireland, Assistant Commissioner for
Legislation, FDA, to the Honorable Richard J. Durbin, United States
Senate, at 2 (Aug. 10, 2012) (``FDA August 2012 letter'').
---------------------------------------------------------------------------
Based on the Federal data, it is clear that adolescents do not
consume high amounts of caffeine. The Somogyi study reported that
``teens and young adults (14-21 years of age) consume, at the mean,
approximately one-third (or about 100 mg/p/d) the amount of caffeine as
adults, and that their caffeine consumption is mainly from coffee, soft
drinks, and tea.'' \16\ Adolescent caffeine consumption also has
remained relatively stable since 2001, i.e., before Monster Energy
Drinks were marketed.\17\ FDA therefore concluded that `` `energy
drinks' contribute a small portion of the caffeine consumed, even for
teens.'' \18\
---------------------------------------------------------------------------
\16\ FDA November 2012 letter at 4, citing Somogyi, supra note 14.
\17\ Somogyi, supra note 14, at 48, Table 26; see also Figure 2.
\18\ FDA November 2012 letter at 4.
---------------------------------------------------------------------------
With regard to adolescent and young adult energy drink consumption,
the Somogyi study cited a survey ending in February 2010 of 2,000
nationally representative households, which concluded that 0.9 percent
of 14-21 year old individuals are ``regular energy drinkers.'' \19\
Somogyi assumed that 2 percent of the entire population older than 10
years of age are ``regular consumers'' of energy drinks, though
``regular consumers'' was not defined. Somogyi suggested that
``[r]eliable consumption data for habitual energy drinkers are
unavailable'' for any age group.\20\ The study assumed that the 2
percent of the general population estimated to consume energy drinks
consume about 1.55-16 fluid oz. servings per day (or approximately 24.8
fluid oz. per day).\21\ This amount would yield caffeine exposures that
are well within those accepted as safe in the published scientific
literature and in statements of governmental and other authoritative
bodies, as discussed herein.
---------------------------------------------------------------------------
\19\ Somogyi, supra note 14, at 61; Somogyi assumed that 2 percent
of the entire population older than 10 are ``regular consumers'' of
energy drinks, though ``regular consumers'' was not defined.
\20\ Id. at 2.
\21\ Somogyi, supra note 14, at 61.
---------------------------------------------------------------------------
These consumption data have been further confirmed by additional
recent studies examining caffeine consumption in the U.S. and Canada.
Researchers at Penn State University conducted a large study (over
37,000 participants) examining beverage caffeine intake across the U.S.
on behalf of the International Life Sciences Institute of North America
(ILSI).\22\ Like NHANES and Somogyi, the researchers found that
Americans consume the bulk of their caffeine from coffee and soft
drinks, rather than from energy drinks. They concluded, ``Coffee was
the primary contributor to caffeine intakes in all age groups combined,
but a more significant contributor in adults (>18 yrs.).'' \23\ The
study further observed, ``Carbonated soft drinks and tea beverages were
also significant caffeine sources, particularly in the younger age
groups.'' \24\ Specifically with respect to energy drinks, the
researchers determined, ``The percentage of energy drink users was low
(<10 percent) and these beverages were minor contributors to overall
caffeine intakes in all age groups.'' \25\ The researchers found that
out of all caffeine consumers, coffee drinkers consume the most
caffeine, with the highest daily mean average ingested by adults aged
50 to 64 years (223 mg/day). Only 4 percent of caffeine consumers
reported consuming energy drinks. Teenagers (ages 13 to 17) in the 90th
percentile of caffeine consumption ingest their caffeine from coffee at
a far greater level than they do from energy drinks--132.9 milligrams/
day from energy drinks versus 223.7 milligrams/day from coffee. This
survey, like the NHANES data and Somogyi report, confirms that coffee
is the primary source of caffeine in the U.S. for consumers of all
ages, not energy drinks. As discussed above, caffeine from energy
drinks presents no new or different effects from caffeine in coffee.
---------------------------------------------------------------------------
\22\ D.C. Mitchell et al., Beverage Caffeine Intakes in the U.S.,
Presented at Experimental Biology, American Society for Nutrition
Meeting (Apr. 22, 2013).
\23\ Id (emphasis added).
\24\ Id.
\25\ Id (emphasis added).
---------------------------------------------------------------------------
Researchers have found similar results when studying Canadian
consumption patterns. A 2010 through 2011 survey of more than 60,000
Quebecois teens, aged 13 to 17, found 83.8 percent of teens aged 13 to
17 rarely or never consumed energy drinks, with only 1.5 percent
consuming them daily (Figure 3).\26\ A 2012 study in Quebec, Canada
further confirms these trends, as it found that out of 10,000 teenagers
(aged 12 to 17) surveyed, 93 percent reported that they rarely or never
consumed energy drinks as compared to only 1 percent of participants
who consumed them daily.\27\
---------------------------------------------------------------------------
\26\ See L. Pica et al., Institut De La Statistique Du Quebec,
L'Enquete Quebecoise Sur La Sante Des Jeunes Du Secondaire 2010-2011,
Volume 1 (2012), http://www.stat
.gouv.qc.ca/publications/sante/pdf2012/EQSJS_tome1.pdf.
\27\ J. H., Reseau Du Sport Etudiant Du Quebec, Junk Food Marketing
Survey: 10,000 Quebec Teenagers Speak Out (2012), http://rseq.ca/media/
27863/rapport_d_enquete-anglais
_final.pdf.
A 2012 study conducted at the request of the European Food Safety
Authority (``EFSA Study'') observed similar trends in children and
adolescents in the European Union (``EU''), where energy drinks have
been marketed for at least a decade longer than in the United
States.\28\ The EFSA Study found that 68 percent of adolescents
(defined as consumers ages 10-18) consumed at least one energy drink in
2012, although energy drink contribution to their total caffeine
exposure was limited. For adolescents who identified themselves as
energy drink consumers, just 23.5 mg, or 12.7 percent, of their total
average daily caffeine intake came from energy drinks; with ``high
chronic energy drink consumers,'' this level rose to only 75.08 mg
caffeine, or 15.7 percent of the total daily caffeine intake.
---------------------------------------------------------------------------
\28\ S. Zucconi et al, External Scientific Report: Gathering
Consumption Data on Specific Consumer Groups of Energy Drinks (European
Food Safety Authority (EFSA) Supporting Publications 2013).
---------------------------------------------------------------------------
For children (defined as consumers ages 3-10) who were energy drink
consumers, mean total caffeine exposure from all sources for energy
drink consumers and high chronic energy drink consumers was 51.38
milligrams/day and 90.24 milligrams/day respectively. For each group,
their total caffeine intake was primarily from sources other than
energy drinks. Accordingly, as in the United States, children and
adolescents in the EU receive the majority of their daily caffeine from
a source other than energy drinks, and their total daily caffeine
intakes remain within levels accepted as safe.
These robust and recent consumption data from governmental and
other sources, reflecting tens of thousands of consumers surveyed,
belie the allegations of the Authors suggesting that adolescents are
regular consumers of high amounts of energy drinks. First, the Authors
conflate consumption by adolescents and young adults, stating, for
example, that ``65 percent of energy drink consumers are 13- to 35-
year-olds'' and that ``[M]ore recent reports show that 30 to 50 percent
of adolescents and young adults consume energy drinks.'' \29\ Such
statistics provide no information about consumption by adolescents
alone, while the NHANES, Somogyi, and ILSI data specifically document
that adolescents' caffeine consumption from energy drinks is low. The
Authors' statement that ``35 percent of eighth graders and 29 percent
of both tenth and twelfth graders consumed an energy drink during the
past year'' \30\ reflects, at most, only that such consumers tried an
energy drink and says nothing about caffeine exposure from energy
drinks among this population. The Authors' statement that ``18 percent
of eighth graders reported using one or more energy drinks every day''
\31\ is simply at odds with the rest of the survey literature and it is
unclear how the cited survey defined ``energy drinks'' for the young
survey respondents,\32\ if the term ``energy drinks'' was defined at
all.
---------------------------------------------------------------------------
\29\ Letter at 1-2. The Authors cite one of their own articles to
suggest that 30 percent to 50 percent of adolescents and young adults
consume energy drinks. S. Seifert et al., Health Effects of Energy
Drinks on Children, Adolescents, and Young Adults, 127 Pediatrics 511
(2011). The levels of consumption cited in that report do not provide
any insight, however, into regular consumption. One 2007 report cited
by Seifert found that 28 percent to 34 percent of teens and young
adults reported ``regularly consuming'' energy drinks but did not
define ``regular consumption.'' Another, a German study published in
1996, referred to consumption ``regularly but at a rate of < 1 can per
week.'' Id. That study also found that 53 percent of adolescents had
``tasted'' energy drinks, 24 percent drank <1 8 oz. can per week, and 3
percent drank 1 to 7 such cans per week. Id. at 514. That study
concluded that all young people in Germany knew about energy drinks but
actually consume them moderately, and prefer cola drinks. B. Viell et
al., New Caffeinated Beverages: A Pilot Survey of Familiarity and
Consumption by Adolescents in North-Rhine Westphalia and Berlin and
Considerations of Consumer Protection [in German], 35 Z. Ernahrungswiss
378-386 (1996). While Seifert asserts that ``[m]ost children in the
study consumed energy drinks in moderation but a small group consumed
extreme amounts,'' that ``small group'' appears to have been comprised
of just three out of 1265 survey participants who said they consumed 32
oz. of energy drinks a day, for a total of 320 mg of caffeine, which is
not ``extreme amounts.'' Seifert at 514-15. In sum, these data provide
little insight into current patterns of energy drink consumption in the
U.S., and are far less relevant than the recent U.S. consumption
figures recorded in the study commissioned by the FDA.
\30\ Letter at 2.
\31\ Id.
\32\ See the December 14, 2011 Monitoring the Future survey report
at 8 (quoting the survey question as, ``About how many [energy drinks]
do you drink per day on average?'' (brackets in original)), available
at: http://www.monitoringthefuture.org/pressreleases/11drugpr_complete
.pdf (accessed July 23, 2013).
---------------------------------------------------------------------------
In sum, the consumption data, including from studies performed or
sponsored by the U.S. government, show that consumption of energy
drinks by younger consumers is low and has not meaningfully increased
their overall caffeine intake. The caffeine contributed to the diet by
energy drinks does not push consumption of caffeine above the levels
documented to be safe in the wealth of scientific and medical
literature, as addressed below.
IV. The Wealth of Published, Peer-Reviewed Scientific and Medical
Literature Establishes the Safety of Caffeine at Levels
Delivered by
Energy Drinks
Caffeine is one of the most widely studied ingredients in the food
supply, and has been the subject of clinical and other research for
decades. Caffeine levels significantly higher than those reasonably
contributed by Monster Energy Drinks have been documented to be safe in
the published literature, including up to 600 mg per day in the
Institute of Medicine (IOM) study described below.\33\ Specifically,
the weight of the scientific and medical literature demonstrates,
contrary to the Authors' assertions in the Letter, that caffeine does
not cause cardiovascular complications or seizures in healthy people,
and that it is virtually impossible for a healthy person to consume a
fatal dose of caffeine from food or beverages.
---------------------------------------------------------------------------
\33\ IOM, Caffeine for the Sustainment of Mental Task Performance:
Formulations for Military Operations (2001).
---------------------------------------------------------------------------
A. Cardiovascular Effects
The Authors allege that several adverse cardiac effects are
associated with consumption of energy drinks, such as elevated blood
pressure, altered heart rates, and severe cardiac events. In support of
their conclusions, the Authors cite only eight studies, five of which
were authored by the Authors, one of which concluded only that
consumption of energy drinks before or during exercise ``might be
linked'' to an increased risk for myocardial ischemia.\34\
---------------------------------------------------------------------------
\34\ J.P. Higgins and K.M. Babu, Caffeine Reduces Myocardial Blood
Flow During Exercise, 126 Am. J. Med. 730 (2013).
---------------------------------------------------------------------------
In stark contrast, several renowned, peer-reviewed studies and a
number of substantial reviews of the scientific literature on caffeine
and cardiac effects conducted by governmental and other authoritative
organizations and reputable scientific experts find no scientifically
valid relationship between caffeine consumption at the levels reported
in the consumption data discussed above and heart disease or cardiac
arrhythmias, nor does the evidence document significant or long-term
effects on blood pressure. Representative peer-reviewed scientific
studies are summarized below:
In perhaps the best clinical study of its kind, the
Framingham Study (a landmark longitudinal study initiated in
1948 to identify cardiovascular risk factors) examined whether
there was any relationship between various dietary factors,
including caffeine, and the incidence of atrial fibrillation,
the most commonly encountered cardiac arrhythmia in clinical
practice.\35\ The well-known Framingham Study included 4526
individuals who had undergone 9640 clinical examinations and
were prospectively followed for four years. A multivariate
analysis was performed to account for nine important
confounding factors including age, gender, and body-mass index.
Individuals were divided into four quartiles based on daily
caffeine intake. Compared to individuals with the lowest daily
caffeine intake (median 23 mg/day, range 0 to 82 mg/day), the
individuals with the highest daily caffeine intake (median 452
mg/day, range 366 to 1203 mg/day) were at no higher risk for
atrial fibrillation (hazard ratio: 0.98, 95 percent confidence
interval: 0.70-1.39).\36\ The authors concluded that
consumption of caffeine ``was not significantly associated with
[atrial fibrillation] risk.'' \37\
---------------------------------------------------------------------------
\35\ J. Shen, Dietary Factors and Incident Atrial Fibrillation: the
Framingham Heart Study, 93 Am. J. Clin. Nutrition 261, 261 (2011)
(``Framingham Study'').
\36\ Id at 264.
\37\ Id. at 261, 265.
The 2001 IOM study of caffeine for the military concluded:
``The preponderance of evidence indicates that the use of
caffeine by the military would not place personnel at increased
risk of cardiovascular disease.'' \38\ That report stated
further that, ``[d]espite numerous studies attempting to show a
relationship between caffeine and serum lipoproteins, blood
pressure, cardiac arrhythmias, and risk of coronary heart
disease, results have failed to show a consistent adverse
effect of ingestion of moderate amounts of caffeine.'' \39\ The
IOM characterized up to 600 mg/day as moderate caffeine
consumption.\40\ Additional independent studies support the IOM
conclusion that 600 mg or more caffeine per day (bolus or
acute) is safe.\41\
---------------------------------------------------------------------------
\38\ IOM Report on Caffeine, supra note 33 at 12, 59.
\39\ Id. at 51.
\40\ Id. at 55.
\41\ See, e.g., W. Killgore, Effects of Dextroamphetamine, Caffeine
and Modafinil on Psychomotor Vigilance Test Performance After 44 H of
Continuous Wakefulness, 17 J. Sleep Res. 309 (2008); W. Pasman et al.,
The Effect of Different Dosages of Caffeine on Endurance Performance
Time, 16 Int. J. Sports Med. 225 (1995); L. Spriet, Caffeine and
Performance, 5 Int. J. Sport Nutr. S84 (1995); and N. Wesensten et al.,
Performance and Alertness Effects of Caffeine, Dextroamphetamine, and
Modafinil During Sleep Deprivation, 14 J. Sleep Res. 255 (2005).
The Organisation for Economic Co-operation and Development
(OECD) reported in 2002: ``Though consumption of caffeine
(eight cups of regular coffee corresponding to 500 mg caffeine
per day) may exhibit acute increases in blood pressure, the
long-term effects appear to be minimal. After one to four days
of regular consumption a tolerance develops, with blood
pressure returning to previous levels.'' \42\ The OECD also
cites several studies demonstrating that ``caffeine doses up to
500 mg/day do not affect cardiac rhythm in normal subjects and
patients.'' \43\ The 2002 OECD report also concludes that
although studies before the mid-1970s suggested an association
between consumption of more than six cups of coffee and
coronary heart disease, retrospective and prospective studies
conducted since have consistently failed to demonstrate an
association between caffeine and heart disease.\44\ It also
cites repeated dose toxicity rodent studies of caffeine that
showed the average No Observable Adverse Effect Levels (NOAELs)
were 160 mg for each kilogram of body weight of the rat per day
and 170 mg/kg bw/day (highest dose tested) in mice.\45\
---------------------------------------------------------------------------
\42\ OECD, Caffeine 16 (2002).
\43\ Id. at 16.
\44\ Id. at 15.
\45\ Id. at 24.
A thorough review of the scientific literature on caffeine
consumption examining the supposed causal connection between
caffeine and heart disease concludes that the body of relevant
scientific literature fails to show that the consumption of
caffeine in moderate quantities results in an increased risk of
coronary heart disease or arrhythmias. In particular, the
review notes that more recent and better-conducted research
undermines earlier erroneous assumptions that caffeine
consumption has a significant, long-term impact on
cardiovascular health.\46\ With respect to cardiac arrhythmias,
the authors conclude that ``moderate ingestion of caffeine does
not increase the frequency or severity of cardiac
arrhythmias.'' \47\ The authors of this review conclude,
``Contrary to common belief, the published literature provides
little evidence that coffee and/or caffeine in typical dosages
increases the risk of infarction, sudden death or arrhythmia.''
\48\ While this review was published in 1994, more recent
evidence (see, for instance, the discussion immediately below)
supports the paper's basic conclusions.
---------------------------------------------------------------------------
\46\ T. Chou and N. Benowitz, Caffeine and Coffee: Effects on
Health and Cardiovascular Disease, 109 Comp. Biochem. Physiol. 173,
185-186 (1994).
\47\ Id. at 185.
\48\ Id. at 173.
A 2011 article by researchers at Northwestern University
examined eleven clinical studies that were performed to
investigate whether caffeine had any effect on cardiac
arrhythmias.\49\ The researchers concluded that human studies
examining the effect of caffeine on cardiovascular endpoints
are consistent in finding ``minimal to no effect of caffeine on
coronary artery disease or stroke.'' \50\ With respect to
cardiac arrhythmias, the researchers found that even studies on
men with heart disease or known arrhythmias show no effect up
to 450 mg/day caffeine on heart rhythm, and concluded ``that in
most patients, even those with known or suspected arrhythmia,
caffeine in moderate doses is well tolerated and there is
therefore no reason to restrict ingestion of caffeine.'' \51\
---------------------------------------------------------------------------
\49\ D. Pelchovitz and J. Goldberger, Caffeine and Cardiac
Arrhythmias: a Review of the Evidence, 124 Am. J. Med. 284, 286 (2011).
\50\ Id. at 285.
\51\ Id. at 288.
A 2010 article on a prospective study of caffeine
consumption by women concluded that increased consumption was
not associated with an increased risk of atrial
fibrillation.\52\ The study was part of the large Women's
Health Study, with 33,638 women followed prospectively for
incident atrial fibrillation between 1993 and March 2,
2009.\53\ Multivariable analyses were performed to account for
potential confounding factors such as age, body-mass index,
smoking, and history of diabetes.\54\ In follow-up
observations, participants in the study comprising the highest
quintile of caffeine consumption (median daily caffeine intake:
656 mg/day, range: 561-778 mg/day) were found to have a risk of
incident atrial fibrillation similar to their counterparts in
the lowest quintile (median daily caffeine intake: 22 mg/day,
range: 9-44 mg/day) of caffeine consumption (multivariable-
adjusted relative risk: 0.89, 95 percent confidence interval:
0.73-1.09).\55\ The researchers discovered that women in the
third quintile of caffeine consumption (median daily caffeine
intake: 285 mg/day, range: 217-326 mg/day) were found to have a
significantly lower risk of incident atrial fibrillation
(multivariable-adjusted relative risk: 0.78, 95 percent
confidence interval: 0.64-0.95), which possibly ``suggested
that the consumption of small to moderate amounts of caffeine
may even be beneficial,'' and may have a ``small but
significant protective effect on the occurrence of [atrial
fibrillation].'' \56\
---------------------------------------------------------------------------
\52\ D. Conen et al., Caffeine Consumption and Incident Atrial
Fibrillation in Women, 92 Am. J. Clin. Nutr. 509, 512 (2010).
\53\ Id. at 509-10.
\54\ Id. at 511, Table 2.
\55\ Id. at 511-12, Table 2.
\56\ Id. at 511, 513, Table 2.
A meta-analysis of eleven prospective, longitudinal cohort
studies was performed to investigate whether there was any
association between coffee consumption and coronary heart
disease.\57\ The investigators concluded, ``No association
between increasing coffee consumption and the development of
[coronary heart disease] was evident.'' \58\ Compared to
consumption of 1 cup of coffee per day or less, the consumption
of 6 or more cups of coffee per day did not result in a
significantly different risk of coronary heart disease (odds
ratio: 1.09, 95 percent confidence interval: 0.97-1.22).\59\
---------------------------------------------------------------------------
\57\ M. Myers and A. Basinski, Coffee and Coronary Heart Disease,
152 Arch Intern. Med. 1767 (1992).
\58\ Id. at 1769.
\59\ Id.
A prospective cohort study--part of the well-known Nurses'
Health Study (NHS)--that followed 85,747 U.S. women for ten
years found no association between coffee and caffeine
consumption and the risk of subsequent coronary heart
disease.\60\ Multivariate analyses were performed to account
for potential confounding factors such as body-mass index and
smoking history.\61\ Compared to individuals who consumed 0
cups of coffee a day, those who consumed 6 or more cups of
coffee per day did not have a significantly different risk for
coronary heart disease (multivariate-adjusted relative risk:
0.95, 95 percent confidence interval: 0.73-1.26). Similarly,
when the highest quintile of total caffeine intake from all
sources (median daily caffeine intake: 816 mg/day) was compared
to the lowest quintile of total caffeine intake (median daily
caffeine intake: 51 mg/day), there was no significant
difference in the relative risk of coronary heart disease.\62\
---------------------------------------------------------------------------
\60\ W. Willett et al., Coffee Consumption and Coronary Heart
Disease in Women: a Ten-Year Follow-Up, 275 JAMA 458 (1996).
\61\ Id. at 460.
\62\ Id. at 461, Figure 1.
More than a decade later, Lopez-Garcia and colleagues
followed up with women from the NHS as well as men from the
Health Professionals Follow-Up Study and again found no
evidence that coffee consumption increases the risk of coronary
heart disease or mortality rate.\63\ In addition, based on
eighteen years of follow up with 41,736 men and twenty-four
years of follow up with 86,214 women, the authors concluded
that there may even be a positive benefit of coffee consumption
on all-cause and cardiovascular disease mortality.\64\
---------------------------------------------------------------------------
\63\ Lopez-Garcia et al., Coffee Consumption and Coronary Heart
Disease in Men and Women: a Prospective Cohort Study, 113 Circulation
2045 (2006); Lopez-Garcia et al., The Relationship of Coffee
Consumption With Mortality, 148 Annals Internal Med. 904 (2008).
\64\ Lopez-Garcia et al., (2008), supra note 63.
In addition to showing that coffee consumption is not a risk
factor for heart disease, the NHS has also revealed that coffee
consumption is not associated with increased risk of stroke,
another disease involving the cardiovascular system. A study of
83,076 thousand women over twenty-four years revealed that
long-term coffee consumption is not associated with an
increased risk of stroke in women.\65\
---------------------------------------------------------------------------
\65\ Lopez-Garcia et al., Coffee Consumption and Risk of Stroke in
Women, 119 Circulation 1116 (2009).
One recent meta-analysis study examined 13 retrospective
case-control studies and 10 prospective cohort studies for
evidence of an association between coffee consumption and
coronary heart disease. Interestingly, while a significant
association was found among the retrospective case-control
studies, no significant associations emerged from the long-term
follow-up prospective studies. This difference was attributed,
in part, to the greater vulnerability of retrospective studies
to bias and confounding, especially recall bias.\66\
---------------------------------------------------------------------------
\66\ F. Sofi et al, Coffee Consumption and Risk of Coronary Heart
Disease: a Meta-Analysis, 17 Nutr. Metab. Cardiovas. 209 (2007).
The findings from these large and long-term studies in the
United States have been replicated in similar studies conducted
in countries with traditionally high levels of caffeine
exposure. For example, a 2005 study of 47,979 Danish men and
women, showed that caffeine consumption is not associated with
risk of atrial fibrillation or ventricular arrhythmias.\67\ A
nine-year follow-up study of 37,315 Swedish men found that high
coffee consumption is not associated with increased rates of
heart failure hospitalization.\68\ A prospective cohort study
of 59,490 Finnish men and women found that coffee consumption
does not increase the risk of heart failure in men or women,
and that with women there is an inverse association between
moderate coffee consumption and the risk of heart failure.\69\
A prospective cohort study in Italy, involving 11,231 Italian
patients with a recent myocardial infarction found no
association with coffee consumption and cardiovascular events
in post-myocardial infarction patients.\70\
---------------------------------------------------------------------------
\67\ L. Frost and P. Vestergaard, Caffeine and Risk of Atrial
Fibrillation or Flutter: the Danish Diet, Cancer, and Health Study, 18
Am. J. Clinical Nutrition 578 (2005).
\68\ H.N Ahmed et al., Coffee Consumption and Risk of Heart Failure
in Men: an Analysis from the Cohort of Swedish Men, 158 Am. Heart J.
158 (2009).
\69\ Y. Wang et al., Coffee Consumption and the Risk of Heart
Failure in Finnish Men and Women, 97 Heart 44 (2011)
\70\ M.G. Silletta et al., Coffee Consumption and Risk of
Cardiovascular Events After Acute Myocardial Infarction: Results from
the GISSI (Gruppo Italiano per lo Studio della Sopravvivenza
nell'Infarto miocardico)-Prevenzione Trial, 116 Circulation 2944
(2007).
The foregoing summary clearly demonstrates that the Authors'
allegations of harmful cardiac effects from caffeine consumption are
largely speculative and unsupported by the best available medical and
scientific evidence.
B. Seizures
In support of their conclusion that seizures have been ``attributed
to energy drink consumption,'' the Authors cite a handful of individual
case reports.\71\ The Authors do not cite any human clinical studies or
animal studies. Case reports are inherently anecdotal and have
significant limitations that do not permit the establishment of any
causal link between seizures and the consumption of energy drinks. Most
of the patients had a past history of seizures, had consumed other high
caffeine sources such as diet pills, had a past history of stroke, or
had neurological or other disorders.\72\ For example, in one case
report the patient had a history of prior stroke, past heroin and
cocaine consumption, and an abnormal CAT scan revealing chronic
vascular encephalopathy with subcortical atrophy but no acute
cerebrovascular lesions.\73\ In another case report, the patient
reported she only had seizures when she consumed both an energy drink
along with diet pills, but the patient was uncertain as to the
ingredients in the diet pills, and the case report does not include the
quantity of diet pills the patient consumed.\74\
---------------------------------------------------------------------------
\71\ Letter at 5.
\72\ See, e.g., S. Iyadurai and S. Chung, New-Onset Seizures in
Adults: Possible Association With Consumption of Popular Energy Drinks,
10 Epilepsy Behav. 504-508 (2007); D. Trabulo et al., Caffeinated
Energy Drink Intoxication, 28 BMJ Case Rep. 712-714 (2011).
\73\ See D. Trabulo et al., supra note 72, at 712-714.
\74\ See S. Iyadurai and S. Chung, supra note 72, at 504-508.
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In contrast to the anecdotal reports cited by the Authors, the
largest and best study on this subject found that moderate-to-high
intake of caffeine was not associated with risk of seizures or
epilepsy.\75\ For its analysis of caffeine, the Nurses' Health Study
followed 105,941 study participants for a total of 1,440,850 person-
years of follow up. A multivariate analysis was performed to take into
account important potential confounding factors. Compared to
individuals with a long-term average caffeine intake of < 200 mg/day,
individuals with a long-term average caffeine intake of ≥ 400 mg/day
did not have a greater risk of seizures or epilepsy (seizure relative
risk: 0.77, 95 percent confidence interval: 0.41-1.47; epilepsy
relative risk: 0.97, 95 percent confidence interval: 0.57-1.67). In
addition, there was no linear relationship between increasing caffeine
intake and seizure or epilepsy risk (seizure relative risk: 0.95, 95
percent confidence interval: 0.80-1.11, p = 0.5; epilepsy relative
risk: 0.97, 95 percent confidence interval: 0.85-1.11, p = 0.6).\76\
---------------------------------------------------------------------------
\75\ B. Dworetzky et al., A Prospective Study of Smoking, Caffeine,
and Alcohol as Risk Factors for Seizures or Epilepsy in Young Adult
Women: Data from the Nurses' Health Study II, 51 Epilepsia 198 (2009).
\76\ Id.
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The weight of the evidence clearly establishes that caffeine in the
amounts delivered by energy drinks does not cause seizures.
C. Caffeine ``Overdose''
The Authors state that there is a ``risk for energy drink
overdose'' due to marketing activities of energy drink companies.\77\ A
fatal acute dose of caffeine in adult humans is estimated to be between
10 and 14 g (between 142 and 200 mg per kg body weight).\78\ In
children, 3 g of caffeine (183 mg caffeine/kg body weight) was shown to
be fatal for a 16.4 kg child.\79\ An adult would need to consume over
62.5 16-ounce cans (7.8 gallons of fluid) and a small child would need
to consume over 18 16-oz cans (2.3 gallons of fluid) of Monster Energy
Drinks acutely, i.e., in a single sitting, to ingest a lethal dose of
caffeine. This volume is in gross excess of what can reasonably be
consumed, even for individuals with high consumption patterns.
Accordingly, a caffeine ``overdose'' is impossible to achieve through
beverage sources of caffeine.
---------------------------------------------------------------------------
\77\ Letter at 2.
\78\ IOM, supra note 33, at 5.
\79\ V.J.M. Dimaio and J.C. Garriott, Lethal Caffeine Poisoning in
a Child, 275 Forensic Science 275 (1974).
---------------------------------------------------------------------------
D. Alleged Fatalities and Injuries
In support of their conclusion that energy drinks are the cause of
fatalities and injuries, especially in children, the Authors reference
several adverse event reports (AERs) submitted to FDA that cite energy
drinks. FDA has repeatedly emphasized that AERs associated with a
consumer product are not reports by FDA and do not establish any causal
link between a product and the reported event.\80\ In a recent
interview, FDA Commissioner Margaret Hamburg stressed that AERs related
to energy drinks do not suggest a causal effect: ``Frankly, many of the
reports, when examined with a real look at the science and the
potential for a causal relationship, are not very compelling.'' \81\
---------------------------------------------------------------------------
\80\ FDA, Energy ``Drinks'' And Supplements: Investigations Of
Adverse Event Reports (Nov. 16, 2012), http://www.fda.gov/Food/
NewsEvents/ucm328536.htm. In a statement that accompanied FDA's
November 16, 2012 release of AERs pertaining to energy drinks, FDA
explained, ``The existence of an adverse event report does not
necessarily mean that the product identified in the report actually
caused the adverse event. FDA assesses the relationship, if any,
between a product or ingredient and the reported adverse event.''
\81\ C. Choi and M. Jalonick, Monster Hits Back at Lawsuit Over
Teenager's Death, Yahoo! News (Mar. 4, 2013), http://news.yahoo.com/
monster-hits-back-lawsuit-over-160836281.html.
---------------------------------------------------------------------------
The Authors identify the case of 14-year-old Anais Fournier who
died of a cardiac arrhythmia to try and establish a link between
Monster Energy Drinks and the fatality. Ms. Fournier's medical records,
however, establish that Ms. Fournier had a known, pre-existing heart
condition, which was most likely the cause of her death. It is alleged
that Ms. Fournier consumed two 24-ounce cans of Monster Energy Drink 24
hours apart. She drank the first can without incident. According to the
body of scientific and medical literature on normal caffeine
metabolism, the caffeine from the first beverage would have dissipated
by the time she drank the second beverage 24 hours later. The medical
records reflect that no caffeine blood level test was performed at the
hospital. The Maryland Medical Examiner who performed the autopsy on
Ms. Fournier conducted a toxicology test and the results came back
negative for caffeine.
Despite reference to ``caffeine toxicity'' in her autopsy report,
the Maryland Medical Examiner testified under oath that there is no
evidence Ms. Fournier had any caffeine in her body at the time of her
cardiac arrest. She further testified that there is no medical or
scientific evidence that Ms. Fournier's cardiac arrest was due to
caffeine. The Maryland Medical Examiner also testified that she could
not say to a reasonable degree of medical certainty that Ms. Fournier's
cardiac arrest was due to her consumption of a Monster Energy Drink.
The Maryland Medical Examiner requested the expertise of a world-
renowned cardiac pathologist, Dr. Renu Virmani of CV Path Institute, in
analyzing Ms. Fournier's heart. Following a microscopic analysis of Ms.
Fournier's heart tissue, Dr. Virmani found that Ms. Fournier's heart
had several structural abnormalities, including (1) mitral valve
prolapse; (2) cardiomegaly (enlarged heart); (3) fibrosis (scarring);
and (4) inflammation. Dr. Virmani testified under oath that each of Ms.
Fournier's heart conditions is known causes of cardiac arrhythmia and
sudden death. Although Dr. Virmani had been told Ms. Fournier drank a
Monster Energy Drink three hours before her cardiac arrest, Dr. Virmani
did not find that Ms. Fournier's cardiac arrest was due to caffeine and
made no reference to caffeine in her final diagnosis.
Dr. Virmani testified that she is not aware of any evidence that
Ms. Fournier had any caffeine in her system at the time of her cardiac
arrest. She further testified that she cannot say to a reasonable
degree of medical certainty that Ms. Fournier's cardiac arrest was due
to caffeine or due to consuming a Monster Energy Drink. Instead, Dr.
Virmani testified that it was very plain and clear that Ms. Fournier
had mitral valve prolapse, and that condition, along with the scarring
(fibrosis), were the likely causes of Ms. Fournier's cardiac arrest.
The Authors also reference a paper, of which one of the Authors was
a co-author, in support of the conclusion that there has been a greater
incidence of accidental ingestion of caffeine from energy drinks than
other forms of caffeine in children under 6 years of age.\82\
Certainly, no one has ever recommended that children under 6 years of
age consume energy drinks. To the contrary, all major energy drink
marketers label their products as not recommended for children and
highlight the caffeine content in the products, so parents and
caregivers can ensure that children do not consume them. The accidental
ingestion of substances by young children is not grounds for concluding
that the substances themselves are unsafe for their intended use.
---------------------------------------------------------------------------
\82\ S.M. Seifert et al., Energy Drink Exposures in the American
Association of Poison Control Centers (AAPCC) National Poison Data
System (NPDS) Database. Paper presented at: Annual Meeting of the North
American Congress of Clinical Toxicology; 2012; Las Vegas, NV.
---------------------------------------------------------------------------
E. Emergency Room Visits
The Authors cite to the oft-mischaracterized report on so-called
energy drink-related emergency room (ER) visits (the Drug Abuse Warning
Network (DAWN) report) \83\ in an attempt to establish an increase in
energy-drink related ER visits. The DAWN report, however, has many
limitations, and therefore does not establish an association between
energy drink consumption and ER visits.\84\
---------------------------------------------------------------------------
\83\ See Substance and Abuse Mental Health. Servs. Admin., Ctr. for
Behavioral Health. Statistics and Quality, The DAWN Report Update on
Emergency Department Visits Involving Energy Drinks (Jan 10, 2013).
\84\ An analysis of the DAWN public use data also reflects that the
number of emergency room visits related to numerous other products,
including infant formula, vitamins and laxatives, substantially
exceeded those where energy drink consumption was reported.
---------------------------------------------------------------------------
For example, the report did not track the energy drinks brands
consumed or provide estimates of amounts of caffeine consumption. The
report is based on ER visits involving use of drugs, where drugs are
defined as alcohol, cocaine, heroin, marijuana, pharmaceuticals,
nutritional supplements, vitamins, and caffeine products. In more than
half of the visits in which energy drinks were reportedly consumed by
18- to 25-year olds, the subjects also reported using alcohol and other
drugs (and this figure is likely an underestimate given that alcohol
and drug use was self-reported and thus likely underreported). The DAWN
report did not provide patient outcomes. Where energy drink consumption
was reported, the report did not include the amount of energy drink
consumed or the amount of other sources of caffeine consumed. The DAWN
report, therefore, does not contain sufficient information to determine
the nature of patients' complaints, the amount of caffeine consumed
from all sources (including coffee, sodas, etc., either independently
of or in conjunction with energy drinks), or whether there was any
causal connection between the complaints and the consumption of energy
drinks. Moreover, the report concludes that while ER visits doubled,
``[v]isits among adolescents aged 12 to 17 remained stable'' during a
period in which energy drink consumption increased substantially.\85\
---------------------------------------------------------------------------
\85\ DAWN Report at 3.
---------------------------------------------------------------------------
In contrast to the limitations of the DAWN Report, the
International Society of Sports Nutrition's (ISSN's) 2013 position
statement on energy drinks, which is based on a thorough review of the
scientific literature and 224 medical and clinical studies, states,
``the rate of adverse events [associated with energy drinks] appears
low in the population of consumers'' and the current evidence
``suggests that consumption of [energy drinks] and [energy shots] are
safe in healthy populations and similar to ingesting other foods and
beverages containing caffeine.'' \86\ In fact, the ISSN concluded,
based on its extensive comprehensive literature search, that consuming
an energy drink 10-60 minutes before exercise can improve mental focus,
alertness, aerobic performance, and/or endurance performance.\87\
---------------------------------------------------------------------------
\86\ B. Campbell et al., International Society of Sports Nutrition
Position Stand: Energy Drinks, 10 J. Int'l Soc. Sports Nutr. 1, 10
(2013).
\87\ Id. at 1.
---------------------------------------------------------------------------
F. Caffeine Metabolism
The Authors express concern that metabolism of caffeine appears to
be non-linear at ``high doses,'' selectively quoting from or
interpreting the study by Kaplan, et al.\88\ The Authors cite the
Kaplan study for the proposition that metabolism of caffeine at high
doses (500 mg) was non-linear as compared to a 250 mg dose. While the
understanding that caffeine does not follow linear kinetics at high
concentrations has been documented since at least 1990, this very
property of non-linearity kinetics may play a role in the self-
regulating nature of caffeine. The Authors do not address the fact that
the Kaplan study cites cognitive and performance improvement at the 250
mg dose with some unpleasant effects at the higher dose. Importantly,
Kaplan and colleagues conclude that ``the unfavorable and somatic
effects, as well as performance disruption, from high doses of caffeine
may intrinsically limit the doses of caffeine used in the general
population.'' \89\ The Kaplan study thus reflects what caffeine
consumers know from their consumption experience: caffeine in low to
intermediate doses produces favorable effects, while higher doses may
produce some unpleasant effects and are not associated with consistent
enhancement of performance which, in turn, results in self-regulation
of intake. The Authors did not acknowledge the Kaplan study's comments
on this self-limiting effect of higher amounts of caffeine.
---------------------------------------------------------------------------
\88\ Letter at 3, citing G.B. Kaplan et al., Dose-Dependent
Pharmacokinetics and Psychomotor Effects of Caffeine in Humans, 37 J
Clin. Pharmcol 693 (1997).
\89\ Kaplan, supra note 88, at 693.
---------------------------------------------------------------------------
The Letter also asserts that the accumulation of caffeine
metabolites could compound the ``negative effects of caffeine at high
blood levels.'' \90\ This would only be the case in situations of overt
caffeine overdose (for example, purposeful caffeine tablet overdose).
Caffeine is known not to accumulate in any body tissues. Additionally,
accumulation of metabolites has not been demonstrated under normal
metabolic conditions, as the three primary metabolites paraxanthine,
theobromine, and theophylline are themselves metabolized and excreted
via multiple pathways. The Letter also describes the metabolites as
stimulants themselves. With normal caffeine ingestion, the metabolites
are present at small levels, and do not accumulate. While they may have
stimulant properties similar to caffeine, they are not the source of
the primary stimulant effect of caffeine-containing beverages.\91\
---------------------------------------------------------------------------
\90\ Letter at 3.
\91\ M. Arnaud, supra note 11, at 35-36.
---------------------------------------------------------------------------
G. Combining Energy Drinks with Alcohol
The Letter concludes that energy drinks, when mixed with alcohol,
pose unique dangers. Monster does not market or recommend its energy
drinks for use with alcohol. Any such abuse by consumers does not mean
that energy drinks themselves are unsafe. Monster supports education of
consumers about the appropriate and responsible consumption of energy
drinks.
V. Children and Adolescents Are Not at a Unique Risk for Health Effects
From Energy Drink or Caffeine Consumption
The majority of the Letter discusses the alleged ``health
complications associated with the consumption of energy drinks'' \92\
by children and adolescents. As detailed herein, the wealth of relevant
scientific literature does not substantiate the alleged correlation
between caffeine levels in energy drinks and adverse health effects,
nor does it show that children and adolescents are more susceptible to
caffeine effects. To the contrary, the weight of the evidence supports
the conclusion that consumption of caffeine from Monster Energy Drinks
is not associated with such health risks and that children and
adolescents experience no unique effects from caffeine.
---------------------------------------------------------------------------
\92\ Letter at 3.
---------------------------------------------------------------------------
Perhaps most notably, FDA itself confirmed the safety of caffeine
for teenagers at levels even higher than those in Monster Energy Drinks
in approving caffeine as safe for use in over-the-counter (OTC) drug
products at levels up to 200 mg caffeine every 3 to 4 hours for
consumers ages 12 and older.\93\ The agency made no distinction between
adolescents and adults and concluded that these acute and repeated
caffeine consumption levels were safe for both age groups. These levels
of caffeine are comparable to or higher than that found in Monster
Energy Drinks. FDA's conclusions in this monograph (which went through
a 1975 proposed rule, 1978 tentative final order, and 1988 final rule,
all published in the Federal Register allowing for public comment)
establish that caffeine at the levels present in Monster Energy Drinks
is safe for adolescents as well as adults.
---------------------------------------------------------------------------
\93\ 21 C.F.R. Sec. 340.50. FDA's approved OTC monograph for
stimulant drug products includes the following directions for use:
``Adults and children 12 years of age and over: Oral dosage is 100 to
200 milligrams not more often than every 3 to 4 hours.'' Id.
Sec. 350.50(d). FDA noted that caffeine from other sources should be
taken into account. Id. Sec. 350.50(c)(1).
---------------------------------------------------------------------------
European food safety authorities have likewise confirmed the safety
of caffeine in energy drinks for younger consumers. As noted above,
energy drinks have been reviewed by European food safety authorities on
three occasions spanning a decade, and have been found to be safe,
including for young consumers. In a 1999 opinion, the European
Commission Scientific Committee on Food (SCF) expressed no safety
concerns with consumption of energy drinks formulated with a caffeine
content comparable to that in Monster Energy Drinks.\94\ SCF also
addressed consumption of energy drinks by children and reported no
safety concerns from the exposure of young people to the caffeine in
these products. SCF revisited energy drinks again in 2003 and estimated
mean chronic, high chronic, and acute consumption of energy drinks by
regular consumers of such drinks to be 125, 350, and 750 ml/day,
respectively, concluding that its 1999 opinion on the safety of
caffeine and energy drinks remained unchanged.\95\ In 2009, the
European Food Safety Authority (EFSA), SCF's successor entity,
evaluated new data on taurine and glucuronolactone in caffeinated
energy drinks and did not identify any safety concerns.\96\
---------------------------------------------------------------------------
\94\ See SCF, Opinion on Caffeine, Taurine, and D-Glucurono-
γ-Lactone as Constituents of So-Called ``Energy'' Drinks (1999),
available at http://ec.europa.eu/food/fs/sc/scf/out22
_en.html.
\95\ SCF, Opinion Of The Scientific Committee On Food On Additional
Information On ``Energy'' Drinks at 2-3, 12 (2003).
\96\ EFSA, The Use of Taurine and D-Glucurono-g-Lactone as
Constituents of the So-Called ``Energy'' Drinks, 935 The EFSA Journal
1, 23 (2009).
---------------------------------------------------------------------------
A. No Unique Effects of Caffeine on Children and Adolescents
The substantial body of scientific and medical literature
demonstrates that children and adolescents experience no particular or
unique safety effects from caffeine, that dose response is a function
of body weight (mg/kg), not age, and that any behavioral or other
effects that children and adolescents may experience from caffeine are
the same as those experienced by adults.\97\ For these reasons, many of
the analyses in the scientific literature refer to safe levels of
caffeine in terms of mg/kg body weight per day, either in addition to
or instead of an absolute amount.
---------------------------------------------------------------------------
\97\ A. Leviton, Behavioral Correlates of Caffeine Consumption by
Children, 31 Clin. Pediatr. 742, 743 (1992). See also M. Arnaud, supra
note 11, at 35.
---------------------------------------------------------------------------
Dr. Alan Leviton, of Harvard Medical School and Children's Hospital
in Boston, Massachusetts published a paper, which he also presented at
the Annual Meeting of the American Academy of Pediatrics (AAP),
documenting the finding that after infancy, neither caffeine's
absorption, its excretion, nor its half-life are age-dependent.\98\ In
addition, articles reviewing the relative caffeine amounts in
particular bodily fluids or tissues reflected no appreciable
differences in children's and adults' caffeine pharmacokinetics.\99\
``A mean distribution volume of 0.7 L/kg (0.5-0.8 L/kg) was found in
newborn infants, adult subjects, or aged subjects. The pharmacokinetics
of caffeine in healthy young men aged 20.5 2.0 years and
in healthy elderly men aged 71.2 3.9 years showed that
Tmax, Cmax, and caffeine bioavailability were essentially identical.''
\100\ Therefore, as in adults, the amounts of caffeine that distribute
to a child's or adolescent's tissues appear to be a result of the
individual's caffeine intake in relation to his or her weight, rather
than of any differences in the rate and extent of children's and
adults' caffeine metabolism.
---------------------------------------------------------------------------
\98\ Leviton, supra note 97.
\99\ M. Arnaud, supra note 11 at 36-37.
\100\ Id. at 45.
---------------------------------------------------------------------------
Accordingly, there are no scientific grounds for safety concerns
about consumption of caffeine or energy drinks simply based upon the
consumer's chronological age, as caffeine effects are a function of
body weight. For example, the term ``teenagers'' captures 13- to 19-
year-olds, yet a 13-year-old typically weighs considerably less than a
19-year-old. Recent data (2007-2010) reported by the Centers for
Disease Control and Prevention (CDC) reveal that for adolescent males,
mean weight ranges from 59.2 kg for 13-year-olds to 79.5 kg for 19-
year-olds.\101\ For adolescent females, mean weight ranges from 56.8 kg
for 13-year-olds to 68.0 kg for 19-year-olds.\102\ These data also
reveal that even the youngest teenagers are, on average, not
particularly small.
---------------------------------------------------------------------------
\101\ Centers for Disease Control and Prevention, Anthropometric
Reference Data for Children and Adults: United States, 2007-2010, 11
Vital Health Stat. 1, 7-9 (2012).
\102\ Id.
---------------------------------------------------------------------------
In support of their conclusion that energy drinks should not be
consumed by adolescents, the Authors reference statements in a review
article by the American Academy of Pediatrics' Committee on Nutrition
and the Council of Sports Medicine and Fitness, which states that
``caffeine and other stimulant substances contained in energy drinks
have no place in the diet of children and adolescents'' and ``are not
appropriate for children and adolescents and should never be
consumed.'' \103\ At the outset, we note that the authors of that
article expressed concern about ``large and varied amounts of
caffeine'' in energy drinks stating that the ``total amount of caffeine
contained in some cans or bottles of energy drinks can exceed 500 mg
(equivalent to 14 cans of common caffeinated soft drinks).'' \104\ As
noted in Table 2, above, reflecting approximately 95 percent of the
energy drink category, virtually all energy drinks have less than half
this amount. Thus, it appears the view of these authors may have been
skewed by a misperception of the caffeine content of typical energy
drinks.
---------------------------------------------------------------------------
\103\ Committee on Nutrition and the Council on Sports Medicine and
Fitness, Sports Drinks and Energy Drinks for Children and Adolescents:
Are They Appropriate? Pediatrics 1185 (2011).
\104\ Pediatrics 2011, supra note 103, at 1185.
---------------------------------------------------------------------------
The first statement in the AAP Committee article quoted above cites
to a 2007 IOM report on nutrition standards for foods in schools in
support.\105\ That 2007 IOM report concluded that ``[a]lthough there
may be some benefits associated with caffeine consumption among
adults,'' the IOM Committee on Nutrition Standards for Foods in Schools
did not support offering caffeinated beverages in schools because of
the potential for effects such as physical dependency and
withdrawal.\106\ This recommendation related to all caffeinated
beverages except those with trace amounts of naturally occurring
caffeine substances. That is, this recommendation applied to coffee,
tea, and caffeinated sodas, and not solely to energy drinks. Further,
the potential effects described, such as physical dependence and
withdrawal, were not unique to children and adolescents but were the
same as those experienced by adults. Thus, this citation does not
establish any unique health effects of caffeine on youth.
---------------------------------------------------------------------------
\105\ IOM, Nutrition Standards For Foods In Schools: Leading The
Way Toward Healthier Youth (2007).
\106\ Id. at 134.
---------------------------------------------------------------------------
The second statement is not associated with a particular citation,
but is reflective of an overall cautious tone, which, while not
inappropriate for the AAP Committee, does not reflect evidence of a
different effect of caffeine on children and adolescents. Notably, the
authors of that article acknowledge that caffeine has been shown to
enhance physical performance in adults by increasing aerobic endurance
and strength, improving reaction time, and delaying fatigue, though
they state that these effects have not been studied in children and
adolescents.\107\ They note a number of effects of caffeine that have
been addressed herein, such as increases in blood pressure, increases
in attentiveness, withdrawal effects and sleep disturbances, but these
effects are neither unique to children nor documented to pose genuine
health risks. The AAP Committee article states that caffeine is ``known
also to play a role in triggering arrhythmias,'' but relies for this
proposition only on an experimental study in dogs with a review of the
literature,\108\ which stands at odds with the comprehensive analyses
discussed above refuting the alleged association of caffeine and
arrhythmias.
---------------------------------------------------------------------------
\107\ Pediatrics 2011, supra note 103, at 1185.
\108\ Id., citing A. Mehta, et al., Caffeine and Cardiac
Arrhythmias: an Experimental Study in Dogs With Review of the
Literature, 52 Acta Cariol. 273 (1997).
---------------------------------------------------------------------------
The AAP Committee discourages dietary intake of caffeine by
children--from all sources, not just energy drinks--``[b]ecause of the
potentially harmful adverse effects and developmental effects of
caffeine.'' \109\ Such potential developmental effects are the only
effects alleged to be particular to children, but the apparent source
cited in support is equally cautious and speculative. That source, a
review article by Nawrot, et al., noted behavioral effects of caffeine
in children and adolescents comparable to those discussed below, as
well as reports of beneficial effects such as improvements in
attention.\110\ The review included discussion of some studies that did
not reveal any deleterious effects, including a meta-analysis of nine
studies showing ``no significant deleterious acute effects on behavior
or cognition in children.'' \111\ Nawrot et al. acknowledged the mixed
evidence in children by stating, ``In conclusion, it is unknown if
long-term daily consumption of caffeine would produce effects similar
to those observed in the studies reviewed above.'' \112\ Nawrot et al.
later opine that, ``[o]wing to these findings [of behavioral effects],
as well as the fact that the nervous system in children is continually
developing and the lack of available information on the longer-term
effects of caffeine in this population, a cautious approach is
warranted.'' \113\ Thus, the reference to potential developmental
effects is a cautionary one--not one grounded in definitive evidence of
such an effect or conclusive evidence of an impact of caffeine on
children that is qualitatively different from that on adults.
---------------------------------------------------------------------------
\109\ Pediatrics 2011, supra note 103, at 1185.
\110\ P. Nawrot et al., Effects of Caffeine on Human Health, 20
Food Addit Contam. 1 (2003).
\111\ Id. at 10 (discussing a study by Stein et al.).
\112\ Id. at 10.
\113\ Id. at 23.
---------------------------------------------------------------------------
Relevant to the question of the theoretical potential of caffeine
to affect neurodevelopment in children and adolescents is the fact that
caffeine, and other methylxanthine derivatives such as theophylline and
theobromine, have a long-history of safe use for pediatric treatment of
apnea and attention deficit disorder in children and infants. Under
placebo controlled settings, the administration of caffeine (5 to 10
mg/kg body weight) to infants within the first 10 days of life for a
median duration of 37 days, for treatment of apnea of prematurity, did
not affect motor function, cognition, behavior, general health or other
developmental measures (e.g., deafness, blindness) during a 5-year
follow-up period.\114\ Meta-analyses of controlled studies (21 studies)
evaluating the effects of caffeine on development and behavior in
children and adolescents administered caffeine, or the structurally
similar methylxanthine theophylline, for treatment of asthma or
attention-deficit hyperactivity disorder, do not support an association
between methylxanthine use and adverse effects on cognition or behavior
in these individuals.\115\ Accordingly, the actual relevant evidence
strongly supports the conclusion that dietary exposure to caffeine is
not a risk for potential adverse effects on neurodevelopment in
children. Similarly, there is no evidence within the scientific and
medical literature to suggest that dietary exposure to caffeine in
energy drinks among adolescents has the potential to adversely affect
neurodevelopment in this population.
---------------------------------------------------------------------------
\114\ B. Schmidt et al., Caffeine Therapy for Apnea of Prematurity,
254 New England J. Med. 2112 (2006); B. Schmidt et al., Long-Term
Effects of Caffeine Therapy for Apnea of Prematurity [Caffeine for
Apnea of Prematurity Trial Group], 357 New England J. Med. 1893 (2007);
B. Schmidt et al., Survival Without Disability to Age 5 Years After
Neonatal Caffeine Therapy for Apnea of Prematurity [Caffeine for Apnea
of Prematurity (CAP) Trial Investigators], 307 J. Am. Med. Ass'n, 275
(2012).
\115\ S. Lindgren et al., Does Asthma or Treatment With
Theophylline Limit Children's Academic Performance?, 327 New England J.
Med. 926 (1992); Stein et al., Behavioral and Cognitive Effects of
Methylxanthines: a Meta-Analysis of Theophylline and Caffeine, 150
Arch. Pediatrics and Adolescent Med. 284 (1996).
---------------------------------------------------------------------------
B. Childhood Obesity
The Authors state that energy drinks ``have [ ] been shown to
contribute to youth obesity due to their high calorie and sugar
content'' and cite to the AAP Committee article discussed above to
conclude that ``the consumption of excessive carbohydrate calories from
energy drinks increases risk for pediatric overweight.'' \116\
Certainly, ``excessive'' consumption of calories from any food or
beverage increases the risk of obesity for any person, and
``excessive'' consumption of sugary foods in general should be avoided.
Monster produces and sells many energy drinks that have no sugar or are
low in sugar. In fact, almost half of Monster Energy Drink sales come
from these products.
---------------------------------------------------------------------------
\116\ Letter at 5.
---------------------------------------------------------------------------
C. Behavioral Effects
The Authors assert that caffeine consumption is associated with
several negative behavioral effects in ``youth.'' \117\ The evidence,
however, establishes that caffeine effects on behavior are largely
dependent upon the amount of caffeine a person normally consumes, and
are not unique for young consumers. This body of evidence includes the
work of Judith L. Rapoport, M.D., Chief, Child Psychiatry Branch, and
colleagues at the National Institute of Mental Health, National
Institutes of Health. As early as 1984, their review of the literature
led to the conclusion that ``[t]here is no clear behavioral toxicity
from caffeine in normal children. Those self-selecting high caffeine
diets generally do not seem to get negative effects.'' \118\ An earlier
study by Rapoport even found no negative outcomes when 19 children were
given 3 mg/kg or 10 mg/kg caffeine (500 mg for a 110-pound child).\119\
Rapoport and another NIH colleague reviewed the literature again in
2002, and described the results of seven studies performed with
hyperactive children and eight in normal children.\120\ The authors
concluded that ``[t]he effects of caffeine in children seem to be
modest and generally innocuous.'' \121\ Notably, the authors reported
that the administration to children habituated to caffeine of 10 mg/kg
bw/day produced no significant behavioral effects.\122\ The review
concludes that in children (as with adults), the amount of caffeine a
person normally consumes is very important in determining their
behavioral response to caffeine. The behavioral effects that were
observed in children not habituated to caffeine were the same as those
observed in adults, thereby indicating no unique effects on children.
Similar conclusions have been reached by medical researchers studying
the effects of caffeine on a wide range of children.\123\
---------------------------------------------------------------------------
\117\ Id.
\118\ J. Rapoport and M. Kruesi, Behavior and Nutrition: A Mini
Review, 51 J. Dent. Child. 451 (1984). See also J. Rapoport et al.,
Behavioral Effects of Caffeine in Children, 41 Arch. Gen. Psychiatry
1073 (1984); T. Zahn and J. Rapoport, Acute Autonomic Nervous System
Effects of Caffeine in Prepubertal Boys, 91 Psychopharmacology (Berl.)
40 (1987).
\119\ J. Rapoport et al., Behavioral and Autonomic Effects of
Caffeine in Normal Boys, 3 Dev. Pharmacol. Ther. 74 (1981).
\120\ F. Castellanos and J. Rapoport, Effects of Caffeine on
Development and Behavior in Infancy and Childhood: a Review of the
Published Literature, 40 Food Chem. Toxicol. 1235 (2002).
\121\ Id. at 1242.
\122\ Id. at 1241.
\123\ See, e.g., G. Bernstein et al., Caffeine Effects on Learning,
Performance, and Anxiety in Normal School-Age Children, 33 J. Am. Acad.
Child Adolesc. Psychiatry 407 (1994); H. Barr and A. Streissguth,
Caffeine Use During Pregnancy and Child Outcome: a 7-Year Prospective
Study, 13 Neurotoxicol. Teratol. 441 (1991); R. Baer, Effects of
Caffeine on Classroom Behavior, Sustained Attention, and a Memory Task
in Preschool Children, 20 J. Appl. Behav. Anal. 225 (1987); R. Elkins
et al., Acute Effects of Caffeine in Normal Prepubertal Boys, 138 Am.
J. Psychiatry 178 (1981).
---------------------------------------------------------------------------
VI. Concerns About ``Sensitive Consumers'' Are A Matter of Labeling,
Not General Safety or GRAS Status
The Authors assert that a safety standard for caffeine should take
into consideration that ``individuals have varying sensitivities to
caffeine,'' rather than be based on only ``healthy'' individuals.\124\
Further, the Authors state that the consumption of ``highly
caffeinated'' energy drinks is associated with adverse cardiac events
``especially [for] those with underlying cardiovascular diseases.''
\125\ Many of the studies addressed above found no increased risks from
caffeine consumption by consumers with underlying cardiovascular
diseases or conditions, such as preexisting arrhythmias or prior
myocardial infarctions,\126\ but in any case, the sensitivity of
consumers with underlying diseases or conditions to a particular food
ingredient does not detract from the GRAS status of that ingredient.
Such sensitivities are typically addressed through labeling. For
example, commonly consumed foods such as milk, wheat, and peanuts are
highly dangerous, and even fatal, to consumers who are allergic or
sensitive to them, but these foods are not deemed unsafe. Rather, the
issue is addressed through labeling. Congress enacted the Food Allergen
Labeling and Consumer Protection Act of 2004, requiring the clear label
declaration of the eight major food allergens, after finding that
``each year, roughly 30,000 individuals require emergency room
treatment and 150 individuals die because of allergic reactions to
food.'' \127\ Likewise, sulfites, to which sensitive consumers may have
serious, and even fatal reactions, are not deemed unsafe food additives
but rather are required to be disclosed in labeling where present over
10 ppm.\128\
---------------------------------------------------------------------------
\124\ Letter at 3.
\125\ Letter at 4.
\126\ See, e.g., Pelchovitz and Goldberger, supra note 49; Silletta
et al., supra note 70. See also T.B. Graboys et al., The Effect of
Caffeine on Ventricular Ectopic Activity in Patients With Malignant
Ventricular Arrhythmia, 149 Arch. Int'l Med. 637 (1989) (study of 50
patients with malignant arrhythmia found no evidence that caffeine is
arrhythmogenic, even among patients with life-threatening arrhythmia).
\127\ Food Allergen Labeling and Consumer Protection Act of 2004,
21 U.S.C. 343 note (1)(B).
\128\ 21 C.F.R. Sec. 101.100(a)(4).
---------------------------------------------------------------------------
Similarly, the fact that some consumers may be sensitive to
caffeine does not render caffeine unsafe or not GRAS for use in energy
drinks. Rather, these concerns should be addressed through labeling,
consistent with FDA's approach to other foods to which some consumers
may be sensitive. Monster has done so by labeling its energy drinks
with the caffeine content (per-serving and per can) and with the
statement, ``Not recommended for children, people sensitive to
caffeine, pregnant women or women who are nursing.''
VII. Conclusion
The scientific and medical literature clearly refutes the Letter's
ultimate conclusion that there is no general consensus among qualified
experts that the addition of caffeine in the amounts used in energy
drinks is safe under its conditions of intended use. As plainly and
thoroughly set forth above, the body of scientific and medical evidence
and actual consumption data establishes that caffeine effects are a
function of body weight and habituation, not age, and that caffeine
levels such as those delivered by Monster Energy Drinks are safe for
children, adolescents, and adults.
FDA has made clear, and courts have confirmed, that the consensus
of expert opinion needed to establish GRAS status does not require
unanimity among qualified experts,\129\ and that ``mere conflict among
experts is not enough to preclude a finding of general recognition.''
\130\ The conclusions of the Authors and selective citations in their
Letter--including in large part to their own work--do not undermine the
GRAS status of caffeine for use in Monster Energy Drinks. Rather, the
great weight of the scientific and medical literature, including that
by governmental and other authoritative bodies, establishes the safety
and GRAS status of caffeine as used in Monster Energy Drinks.
---------------------------------------------------------------------------
\129\ FDA Proposed Rule, ``Substances Generally Recognized as
Safe,'' 62 Fed. Reg. 18938, 18939 (April 17, 1997) (``Unanimity among
experts regarding safety of a substance is not required.'') (citing
United States v. Articles of Drug * * * 5,906 boxes, 745 F.2d 105, 119
n. 22 (1st Cir. 1984); United States v. An Article of Drug * * * 4,680
Pails, 725 F.2d 976, 990 (5th Cir. 1984); Coli-Trol 80, 518 F.2d 743,
745 (5th Cir. 1975); Promise Toothpaste, 624 F.Supp. 776, 782 (N.D.
Ill. 1985).
\130\ 62 Fed. Reg. at 18939 (citing Coli-Trol 80, supra note 129,
at 745).
---------------------------------------------------------------------------
Very truly yours,
/s/ Miriam J. Guggenheim,
Counsel to Monster Beverage Corporation.
cc: Michael Taylor
Michael Landa
______
Senator Blumenthal. Thank you, Mr. Sacks.
Ms. Taylor?
STATEMENT OF AMY TAYLOR, VICE PRESIDENT AND GENERAL MANAGER,
RED BULL NORTH AMERICA, INC.
Ms. Taylor. Mr. Chairman, Ranking Member Thune, and members
of the Committee, my name is Amy Taylor. I have been with Red
Bull for 14 years and responsible for Red Bull's marketing
strategy and initiatives in North America for much of that
time.
Let me thank the Committee for the chance to appear and
testify today on behalf of Red Bull North America about our
marketing policies and practices.
First, let me say something about our company and product.
Red Bull created the modern energy drink category in Europe in
1987 and launched it in the U.S. in 1997. Red Bull is now sold
in more than 165 countries. Health and regulatory bodies all
over the world have concluded that Red Bull is safe to consume.
It is worth noting that our 8.4-ounce can of Red Bull
contains 80 milligrams of caffeine, which, despite perceptions,
is about the same amount that a cup of coffee has in a home-
brewed situation and half as much of that of a typical
coffeehouse coffee. Red Bull is the small can product in the
energy drink category, with 85 percent of our business
comprised of the sale of 8 and 12 ounce cans, making us unique
within the category.
We have a long history of cooperation with legislative and
regulatory bodies in order to ensure the lawful marketing and
safe consumption of our products. We are pleased that the FDA
is looking into the safety of caffeine, as did health
authorities, for example, in Canada, Europe, Australia, and New
Zealand. We are participating in the FDA process and confident
that it will confirm caffeine is safe for consumption, even for
teens.
But we have always marketed ourselves as the adult premium
product in the category. Our marketing policies and practices
have evolved in the U.S. for strategic reasons. As an example,
we made the decision in 2011 to focus our marketing even more
narrowly at the core demographic of 18 to 34-year-olds to
leverage our strengths versus our competition.
Our positioning is reflected in our can design, packaging,
pricing, and core marketing messages, as well as the content,
timing, and placement of our advertising and communications.
While we focus on adults, no company can ensure that its
marketing materials will only reach a particular audience, and
people of all ages and demographics may be attracted to them.
Yesterday, we submitted a letter to this committee, which
we will now respectfully ask you to include in the record.
Senator Blumenthal. Without objection.
[The information referred to follows:]
Red Bull
July 30, 2013
BY HAND DELIVERY
Hon. John D. Rockefeller IV,
Chairman
Committee on Commerce, Science, and Transportation,
United States Senate,
Washington, DC.
Hon. John R. Thune,
Ranking Member,
Committee on Commerce, Science, and Transportation,
United States Senate,
Washington, DC.
Re: Voluntary Commitments Regarding Labeling and Marketing
Dear Chairman Rockefeller and Ranking Member Thune:
Red Bull North America, Inc. (RBNA) welcomes the opportunity to
participate in the Committee's investigation of the marketing and
promotional practices of energy drink manufacturers. RBNA and its
parent company, Red Bull GmbH (Fuschl am See, Austria), have a long
history of cooperation with legislative and regulatory authorities in
order to ensure the lawful marketing and safe consumption of our
products. In addition, we recognize the particular concerns of the
Committee and hope to be a partner in crafting a solution that
sufficiently and appropriately addresses these concerns. In that
spirit, RBNA is pleased to announce that it is undertaking a number of
voluntary commitments relating to the labeling and marketing of its
products in the United States.
Red Bull GmbH created the ``modem'' energy drink category, first in
Europe in 1987, and then launched in the United States in 1997 through
its U.S. subsidiary RBNA. Today, Red Bull products are sold in more
than 165 countries. Health authorities around the world, including Food
Standards Australia New Zealand (FSANZ), Health Canada, and European
Food Safety Authority (EFSA), have concluded that Red Bull Energy
Drink is safe to consume. Indeed, since 1987, over 40 billion cans of
Red Bull products have been safely consumed and enjoyed worldwide.
We cite these facts and statistics to show that Red Bull products
are safe. An 8.4 fl. oz. can of Red Bull Energy Drink contains about
the same amount of caffeine as a cup of home-brewed coffee, and about
half as much caffeine as contained in many coffee house coffees.
Caffeine, a key ingredient in Red Bull products, has been safely
consumed for hundreds of years. In fact, caffeine is one of the most
researched and widely consumed food ingredients throughout the world.
The vast body of science and historical use of caffeine supports
the conclusion that when a teenager begins to drink coffee, tea, and
caffeine-containing sodas, he/she also can consume equivalent amounts
of caffeine through energy drinks. However, as a general proposition,
children (12 and under) should consume less caffeine than adults and
teenagers due to their lower body weight, which is why the Company does
not market its products to children and does not recommend its products
for consumption by children. In fact, Red Bull product labels
specifically state that the product is not intended for consumption by
children.
As you may know, the Food and Drug Administration (FDA) is in the
process of considering current safety data on caffeine, including data
relating to caffeine-containing energy drinks. We are confident that
the FDA will agree that the data support the safe use of caffeine. RBNA
is supporting the FDA's evaluation by providing the FDA with Red Bull
product safety information. Beyond the FDA review, and as explained
further below, in order to support public confidence in our products
and the public's consumption decisions, RBNA will include additional
information on its label.
Despite the safety of Red Bull products, we recognize the public
health debate surrounding caffeinated soft drink consumption. Recent
public health discussions have focused on sugar-and caffeine-containing
beverages and possible links to childhood and teen obesity rates, as
well as excessive consumption of caffeine by teenagers. Teaching
children and teenagers moderation in their consumption habits and the
importance of proper exercise is an important public health goal.
Finding the ideal balance is not easy, but it is the responsibility of
parents to set those limits. We respect parents' choices about their
children's diets and do not interfere with that control.
Since its inception in 1987 and launch in the United States in
1997, Red Bull has always been and remains an aspirational, adult
brand and a premium product positioned for and marketed to adults. This
is reflected through our can design, pricing, core marketing messages,
as well as the content, timing, and placement of our advertising. Over
time, RBNA's marketing strategy evolved and its investments became more
focused. In 2011, the Company made a strategic decision to refine its
marketing activities even further to focus on adults 18-34 years of
age, which always has been the Company's primary target demographic.
This allowed us to leverage our positioning--our premium package
design, package sizes, and pricing--and play to our strengths via
differentiation from our competition within the energy drink category.
Since 2012, RBNA has continued to sharpen our marketing communications
and investments to reach this target demographic, recognizing, however,
that no company can ensure that its marketing materials will only reach
a particular audience, as people of all ages and demographics may be
attracted to them.
We recognize our responsibility, along with other food and beverage
companies, to play a positive role in the public health debate
surrounding consumption of calories and caffeine. RBNA is committed to
promoting active and healthy lifestyle choices. RBNA has supported
various industry anti-obesity initiatives. Notably, Red Bull Energy
Drink contains 110 calories/8.4 fl. oz. In addition, we also are
focused on supporting consumers by offering beverage choices that
provide low/no sugar and low/no calorie options. Following the launch
of Red Bull Energy Drink in the United States in 1997, we introduced
Red Bull Sugarfree and Red Bull Total Zero. Moreover, as a member of
the American Beverage Association (ABA), RBNA led the energy drink
sector in adopting the ABA 's Guidance for the Labeling and Marketing
of Energy Drinks, as well as similar industry codes in other parts of
the world.
In this spirit of providing adequate consumer information and in
light of our focus on adult marketing, RBNA undertakes the following
voluntary commitments and urges all producers of caffeine-and sugar-
containing beverages to make the same commitments.
PRODUCT LABELING AND FORMULATION:
Red Bull energy drink products will be labeled as
conventional foods/beverages and not as dietary supplements.
Red Bull energy drink products will declare the total
caffeine content per can on the product label.
As used herein, ``target'' is defined as the population for whom
communications/products are designed and broadcast. Marketing
communications are developed to appeal specifically to the target, and
are broadcast through channels most likely to reach the target.
RBNA will not sell energy drinks with a caffeine
concentration in excess of 80 mg/8.4 fl. oz.
RBNA will not sell energy drinks with a calorie content in
excess of 110 calories/8.4 fl. oz.
CLAIMS AND PROMOTION:
RBNA's marketing will not encourage or condone excessive or
rapid consumption of energy drinks.
RBNA's marketing will not say that larger sizes, more
caffeine, or higher concentrations of caffeine are better or
have a better/stronger effect.
RBNA's labeling and marketing will not make claims using
language specifically targeted to those under 18.
RBNA will not buy advertising directly targeted at audiences
that are more than 35 percent under 18 years of age. This
applies to TV, radio, print, and where data is available, to
the Internet and mobile devices. The media buying target age
for all RBNA advertising media will be 18-34.
RBNA will not feature child-or teen-oriented animated or
licensed characters in advertising or any other promotional
activities.
RBNA will not market its energy drink products in K-12
schools or any other institutions responsible for this age
group. This commitment includes school related events or
activities.
RBNA will not sell (including in automated vending machines)
its energy drink products in K-12 schools or any other
institutions responsible for this age group. This commitment
includes school-related events or activities.
RBNA will not sample energy drink products in or within the
immediate vicinity of K-12 schools or other institutions
responsible for this age group. The RBNA sampling target will
continue to be 18-34 year olds, with a focus on college,
military, and members of the workforce.
To further promote balanced nutrition and consumer awareness, we
remain open to discussing changes for the entire beverage industry. We
believe that any comprehensive effort regarding child and teen
nutrition should include all sugar-and caffeine-containing beverages
(e.g., caffeinated soft drinks, coffee, and tea). A recent caffeine
consumption survey shows that within each age group (including children
and teenagers), 90 percent or more do not consume energy drinks at all,
and more than 93 percent of the caffeine consumption within each age
group comes from sources other than energy drinks, such as caffeinated
soda, coffee, and tea. This survey is consistent with an FDA-sponsored
consumption survey and demonstrates that the majority of caffeine
intake comes from coffee, soft drinks, and tea. Soft drinks contain
about the same amount of sugar as energy drinks, but are consumed more
frequently and in larger volumes. In addition, energy drinks represent
only 2 percent of the total soft drink market. RBNA is ready to further
advance discussions about this topic, and believes the entire industry
should be engaged to make meaningful progress.
Therefore, RBNA puts forth the following voluntary commitments that
it will adopt, provided other producers of sugar-and caffeine-
containing beverages do the same:
CONTAINER SIZE:
RBNA will not sell products in containers larger than 12 fl.
oz. if other producers of sugar-and caffeine-containing
beverages agree to abide by the same limitation.
ADVERSE EVENT REPORTING:
RBNA is willing to report to FDA any serious adverse events
(reported to the Company by consumers) that are alleged to be
associated with consumption of Red Bull energy drink products,
provided that other producers of caffeine-containing beverages
do the same. The Company believes that any analysis of serious
adverse events suspected to be linked to caffeine, should
contain a review of all caffeine-containing beverages. The
Company would provide the reports in a manner consistent with
the serious adverse event reporting requirements applicable to
dietary supplements pursuant to the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.
*****
These commitments are separate from (and do not affect) RBNA's long
standing support of developing athletic talent. In ``giving wings to
people and ideas,'' RBNA supports up and coming and top potential
athletes under the age of 18. Additionally, RBNA hosts and sponsors
various events that are typically open to the public, and that provide
a platform for skilled individuals, some under 18 years of age, to
compete or perform. Finally, separate Red Bull affiliates operate
independent businesses, including professional motorsports and athletic
sports teams, which maintain their own marketing practices.
RBNA will regularly monitor its marketing practices to ensure it
honors the commitments contained herein. Further, RBNA shall establish
and conduct a recurring training program for employees and third-party
contractors and consultants involved in the marketing of Red Bull
products to ensure awareness of and compliance with these commitments.
These voluntary commitments shall not constitute nor be construed as an
admission of any kind regarding RBNA's prior practices.
Sincerely yours,
Stefan Kozak,
Chief Executive Officer,
Red Bull North America, Inc.
cc: Hon. Barbara Boxer
Hon. Bill Nelson
Hon. Maria Cantwell
Hon. Mark Pryor
Hon. Claire McCaskill
Hon. Amy Klobuchar
Hon. Mark Warner
Hon. Mark Begich
Hon. Richard Blumenthal
Hon. Brian Schatz
Hon. Martin Heinrich
Hon. Edward Markey
Hon. Roger Wicker
Hon. Roy Blunt
Hon. Marco Rubio
Hon. Kelly Ayotte
Hon. Dean Heller
Hon. Daniel Coats
Hon. Timothy Scott
Hon. Ted Cruz
Hon. Debra Fischer
Hon. Ronald H. Johnson
Hon. Jeff Chiesa
Hon. Richard Durbin
Ms. Taylor. Thank you.
We are publicly announcing for the first time voluntary
commitments relating to the labeling and marketing of our
product. We make these commitments to provide more information
to consumers so that they can make informed choices and to
further differentiate our product as the premium adult energy
drink.
Our commitments are as follows. Red Bull will continue to
label its energy drinks as conventional foods, rather than
dietary supplements. We will also declare the total caffeine
content per can on our product label. We will not sell energy
drinks with a caffeine concentration in excess of 80 milligrams
per 8.4 ounces or with more than 110 calories per 8.4 ounces.
Red Bull will not encourage or condone the excessive or
rapid consumption of its energy drinks. Our marketing will not
say that more caffeine or larger sizes or higher concentrations
of caffeine have a better or stronger effect. We will not make
claims using language specifically targeted to those under 18,
nor will we buy advertising targeted at audiences where more
than 35 percent of viewers are under the age of 18.
We will not feature child or teen-oriented characters in
our advertising and promotional activities. Red Bull will not
market or sell its energy drink products in K through 12
schools or other institutions responsible for this group. And
we will not sample in or within the immediate vicinity of such
places.
Red Bull is also prepared to adopt two additional
commitments if producers of other sugar and caffeine-containing
beverages are willing to do the same. We will agree not to sell
containers larger than 12 ounces, and we will agree to report
to the FDA any adverse events reported to us by consumers that
are alleged to be associated with the consumption of our
product.
We understand that childhood and teen obesity is a major
public health challenge and attracting more and more attention.
To the extent that sugar and caffeine are viewed as
contributors to this problem, we are interested in being a part
of the solution, which includes the entire industry. The energy
drink sector is only a small part of a much larger universe of
caffeine and sugar-containing drinks that must be a part of any
solution.
We believe that large can sizes are a primary contributor
to the problem, and we think this is an area where we, together
with the industry, can play a constructive role. And in
closing, it is relevant to note that in every age category,
including teens and children, 93 percent of caffeine
consumption comes from sources other than energy drinks.
Still, we are pleased to be here to participate in these
discussions. Red Bull is proud of its commitments that it is
making today. They enable consumers to make informed choices,
and they differentiate our product as the premium adult energy
drink.
Thank you, and I would be pleased to answer any questions
you may have.
[The prepared statement of Ms. Taylor follows:]
Prepared Statement of Amy Taylor, Vice President and General Manager,
Red Bull North America, Inc.
My name is Amy Taylor. I have been employed by Red Bull North
America, Inc. (RBNA) for the last 14 years. I currently serve as RBNA's
Vice President & General Manager, a position I have held since November
2012. In that capacity, I am responsible for the brand's overall
strategic marketing, sales and distribution throughout the eastern
region. Prior to this position, I served as RBNA's Vice President of
Marketing from 2008 to 2012, and led brand marketing, sports and
culture marketing, digital marketing, and communications.
Company Background
Founded in 1984 by Dietrich Mateschitz, Red Bull GmbH (Fuschl am
See, Austria) created the ``modern'' energy drink category with the
launch of its Red Bull Energy Drink, first in Europe in 1987, and then
in the United States in 1997 through its U.S. subsidiary RBNA. Red
Bull Sugarfree was launched in 2003, followed by Red Bull Total Zero
in 2012, and Red Bull Editions in 2013.
Today, Red Bull products are sold in more than 165 countries.
Health authorities around the world, including Food Standards Australia
New Zealand (FSANZ), Health Canada, and the European Food Safety
Authority (EFSA), have concluded that Red Bull Energy Drink is safe to
consume. Indeed, since 1987, over 40 billion cans of Red Bull products
have been safely consumed and enjoyed worldwide.
RBNA's vision is to ``give wings to people and ideas,'' and our
brand is built on supporting the dreams and ideas of innovative
individuals across sports, culture, science and technology. Red Bull
is a sophisticated, adult, aspirational brand that aims to communicate
with consumers in a manner that is witty, progressive and often
complex. We are the premium product in the energy drink category--as
evident in our packaging, pricing, messaging, and the demographics of
our consumer base.
Corporate Responsibility
RBNA always has taken an active leadership role in the public
health debate surrounding the consumption of caffeinated soft drinks,
including energy drinks. We recognize our responsibility, along with
other food and beverage companies, to play a positive role in this
discussion. RBNA is committed to promoting active and healthy lifestyle
choices. We believe that teaching children and teenagers moderation in
consumption habits and the importance of proper exercise is an
important public health goal. Finding the ideal balance is not easy,
but it is the responsibility of parents to set those limits. We respect
parents' choices about their children's diets and do not interfere with
that control.
We are committed to working with regulators such as the Food and
Drug Administration (FDA) to ensure that there is no question about the
safety of Red Bull products. RBNA is confident that our products are
just as safe to consume as the many other caffeine containing
beverages, regardless whether the caffeine is naturally occurring or
added. Accordingly, we remain open to discussing changes for the entire
beverage industry, and believe that any comprehensive effort regarding
child and teen nutrition must include all sugar-and caffeine-containing
beverages (e.g., caffeinated soft drinks, coffee, and tea).
Safety of Red Bull Products
As noted above, health authorities around the world have concluded
that Red Bull Energy Drink is safe for consumption. An 8.4 fl. oz. can
of Red Bull Energy Drink contains 80 mg of caffeine--about the same
amount of caffeine as a cup of home-brewed coffee, and about half as
much caffeine as many coffee house coffees. Caffeine has been safely
consumed for hundreds of years and is one of the most researched and
widely consumed food ingredients in the world. It is a naturally
occurring alkaloid that is present in the leaves, seeds, and fruits of
more than 60 plants. Caffeine also can be synthetically manufactured.
There is no chemical difference between synthetic caffeine and
naturally sourced caffeine.
For its part, Health Canada scientists conducted an extensive
review of the scientific literature on caffeine. Based on this review,
in March 2010, Health Canada advised that healthy adults are not at
risk for potential adverse effects from caffeine at daily consumption
levels of up to 400 mg caffeine (approximately 5 mg/kg bodyweight). The
FDA referred to Health Canada's conclusions in its August 10, 2012 and
November 21, 2012 letters to Senator Durbin. Health Canada just
published an updated risk assessment of energy drinks and reaffirmed
its earlier views.
For adolescents 13 and older, Health Canada has not developed
definitive advice, but concluded that daily caffeine intake of up to
2.5 mg/kg body weight would not cause adverse health effects. This dose
would suggest that teenagers (with an estimated range of body weights
between 40-70 kg, or 90-155 lbs) could consume 100 to 175 mg of
caffeine daily, depending on the individual body weight of the
teenager. Health Canada described this as a conservative approach
because older and heavier adolescents may be able to consume adult
doses of caffeine, recognizing the importance of body weight to an
individual's metabolism of caffeine.
As you consider the safety of energy drink consumption by
teenagers, it is important to note that the FDA has considered teen
exposure to caffeine from all sources, including energy drinks, and
found that the contribution of energy drinks is minor when compared to
caffeine consumption from coffee, soft drinks, and tea. In its November
21, 2012 letter to Senator Durbin, the FDA explained:
In an effort to better understand consumption patterns for
potentially susceptible subgroups, FDA contracted for the
performance of an in-depth analysis of caffeine consumption by
the U.S. population, which was completed in September 2009 and
revised in August 2010 (Somogyi 2010). . . .
This report indicates that the mean amount of caffeine consumed
by the U.S. population is consistent with past FDA estimates,
remaining relatively stable at approximately 300 milligrams per
person per day (mg/p/day), despite the entry of ``energy
drinks'' into the marketplace. . . . Significantly, this report
also indicates that teens and young adults (14-21 years of age)
consume, at the mean, approximately one-third (or about 100 mg/
p/d) the amount of caffeine as adults, and that their caffeine
consumption is mainly from coffee, soft drinks, and tea.
According to the report, ``energy drinks'' contribute a small
portion of the caffeine consumed, even for teens. . . .
An even more recent caffeine consumption survey in the United
States shows that within each age group (including children and
teenagers), 90 percent or more do not consume energy drinks at all, and
more than 93 percent of the caffeine consumption within each age group
comes from sources other than energy drinks. As in the FDA study, among
all children and teenagers, the primary source of caffeine was found to
be coffee, tea, and soft drinks. Perhaps these results are not
surprising because energy drinks represent only 2 percent of the total
soft drink market. Thus, given the very limited consumption of energy
drinks (and corresponding intake of caffeine from energy drinks), we
believe that any comprehensive discussion regarding the consumption of
caffeine also must include caffeinated soft drinks (which are widely
consumed by children and teenagers), coffee, and tea.
Because people have different tolerance levels of caffeine, the
daily consumption of Red Bull products should conform to a person's
intake of caffeine from any source. Of course, as a general
proposition, children should consume less caffeine than adults due to
their lower body weight, which is why we do not market our product to
children and do not recommend our products for consumption by children.
In fact, Red Bull product labels specifically state that the product
is not intended for consumption by children. Further, to help enable
all consumers to make informed consumption decisions, our product
labels will declare caffeine content.
As you may know, the FDA is in the process of considering current
safety data on caffeine, including data on caffeine-containing energy
drinks, and we fully expect the agency to agree with the conclusions of
other health authorities regarding the safe use of caffeine in Red
Bull products. We are supporting the FDA's evaluation by providing Red
Bull product safety information to the agency.
Taurine, another ingredient in Red Bull products, is an amino acid
and a natural constituent of the human body that performs a number of
useful functions. It is found in foods such as poultry, fish, and
shellfish. It also is found in human breast milk, which is why it is
frequently found as an additive in infant formulas. The safety of
taurine consumption through energy drinks is supported by health
authorities around the world. By way of example, in February 2009, the
EFSA published its scientific opinion on ingredients of energy drinks
and concluded that taurine does not raise any safety concerns at the
levels present in Red Bull Energy Drink. EFSA further considered the
possibility of synergistic effects among the key ingredients in Red
Bull Energy Drink and concluded that the scientific data do not
support the possibility of interactions between the ingredients.
The other ingredients used in Red Bull products, which are FDA-
approved food/color additives or generally recognized as safe (GRAS)
substances such as sugars, inositol and B-vitamins, also satisfy the
FDA's ingredient safety and regulatory standards. In fact, one 8.4 fl.
oz. (250 mL) can of Red Bull Energy Drink contains 27 grams of sugars
and 110 calories. Non-diet soft drinks contain about the same amount of
sugar and calories as energy drinks, but are consumed more frequently
and in larger volumes.
Red Bull is an Aspirational, Adult Brand and a Premium Product
Positioned for and Marketed to Adults
Since its inception in 1987 and launch in the U.S. in 1997, Red
Bull always has been and remains an aspirational, adult brand and a
premium product positioned for and marketed to adults. This is
reflected through our can design, pricing, and core marketing messages,
as well as the content, timing, and placement of our advertising and
communications. Over time, RBNA's marketing strategy evolved and our
investments became more focused. For example, in 2011, RBNA made a
strategic decision to refine our marketing activities to focus further
on adults 18-34 years of age, which always has been our primary target
demographic. This allowed us to leverage our positioning--our premium
package design, package sizes, and pricing--and play to our strengths
via differentiation from our competition within the energy drink
category. Since 2012, RBNA has continued to sharpen our marketing
communications and investments to reach this target demographic,
recognizing, however, that no company can ensure that its marketing
materials will only reach a particular audience, as people of all ages
and demographics may be attracted to them.
To be clear, RBNA has never targeted our marketing to children and
we will not do so in the future. Regarding teenagers, RBNA believes
that the underlying science and historical product use support the
conclusion that Red Bull products may be safely consumed by teenagers
in the same way as coffee, tea, or caffeinated soft drinks. However,
because teenagers younger than 18 do not represent our target
demographic, we do not focus our marketing activities on them.
To further promote balanced nutrition and consumer awareness, we
remain open to discussing changes for the entire beverage industry.
Caffeine consumption surveys commissioned by both the FDA and the food
industry demonstrate that the primary dietary contributors of caffeine
in all age groups (including teens and youth) are coffee, tea and soft
drinks. Caffeine from energy drinks represents a very small
contribution to the overall daily intake. Indeed, some major soft drink
companies are marketing products such as juices and waters with
caffeine in them as well. The broader solution to excessive consumption
of calories and caffeine must go beyond energy drinks, which are a
niche product representing only 2 percent of the total soft drink
market.
Conclusion
We are committed to empowering consumers to make informed choices
about the amount of caffeine they consume and to differentiating
ourselves from our competitors by positioning Red Bull as the premium,
adult energy drink brand. Red Bull products are safe for teenagers and
adults to consume, but we agree that children should consume little or
no caffeine, including from caffeinated sodas, coffees, teas, or energy
drinks. We are therefore interested in being a leader in a broad,
industry-wide solution to the public health concerns surrounding sugar-
and caffeine-containing beverages.
Thank you again for inviting RBNA to testify. We look forward to
partnering with you on these issues going forward.
Senator Blumenthal. Thank you very much.
Ms. Weiner?
STATEMENT OF JANET WEINER, CHIEF OPERATIONS OFFICER AND CHIEF
FINANCIAL OFFICER, ROCKSTAR, INC.
Ms. Weiner. Good afternoon, Senator Blumenthal, Senator
Markey, and----
Senator Blumenthal. You might want to turn on your----
Ms. Weiner. Oh, I am sorry.
Senator Blumenthal. Push the button.
Ms. Weiner. Aha, thank you. OK.
Good afternoon, Senator Blumenthal, Senator Markey, and
Ranking Member Thune, and members of the Committee. My name is
Janet Weiner. I am the Chief Operations Officer and Chief
Financial Officer for Rockstar, Inc., the manufacturer of
Rockstar energy drink products. I am also co-owner of the
company.
I thank the Committee for inviting Rockstar to speak at
today's hearing, and I welcome this opportunity to discuss
Rockstar's commitment to the safety of our products and the
responsibility of our brand marketing practices.
I believe Rockstar represents a model of entrepreneurial
enterprise that has grown from an ambitious idea into an
American success story. Energy drinks like ours are an
extremely popular and growing product category, having sold
more than 34 billion units in the United States since 2000. I
would like to speak about Rockstar's commitment to consumer
safety.
Rockstar's commitment to consumer safety is the company's
number one priority. The use and levels of caffeine within our
energy drink formulations have been determined, based upon the
consensus of an independent, highly qualified expert panel led
by Dr. John Doull of the University of Kansas Medical Center,
to be generally recognized as safe--the acronym is GRAS--under
FDA standards.
In addition to caffeine, Rockstar contains other
ingredients that have been determined to be GRAS, consistent
with FDA guidance, and safe for consumption. The expert panel
commissioned by our company has concluded that there is no
expected safety concern associated with these ingredients alone
or in combination from consumption of Rockstar energy drink
products.
At either 160 milligrams per 16 ounces or 240 milligrams
per 16 ounces, depending on the product, Rockstar contains far
less caffeine than a 16-ounce cup of Starbuck's Pike Place
roast, their house blend, which contains 330 milligrams,
according to the Starbuck's website.
The difference in caffeine levels are important to keep in
mind insofar as coffee and tea, rather than energy drinks, are
the most significant sources of caffeine for Americans,
including teens and children. The FDA-commissioned Somogyi
report on caffeine consumption among the U.S. population
indicated that teens and young adults aged 14 to 21 years
consume on average approximately one third the amount of
caffeine as people over 21, a level of consumption that has
remained constant even as energy drinks gain in popularity.
Further, the report found that energy drinks contributed
only a small portion of caffeine consumed by teenagers and that
the most significant source of caffeine for both children aged
2 to 13, as well as teens aged 14 to 17, was coffee, tea, and
soft drinks. Researchers at Penn State and the Diet Assessment
Center likewise found that energy drinks were minor
contributors to overall caffeine intakes in all age groups.
As outlined in greater detail in my prepared statement,
recent analyses have called into question two of the most cited
sources alleging energy drink risks. For example, a July 25,
2013, report commissioned by the American Beverage Association,
Pinney Associates noticed that the Drug Abuse Warning Network,
SAMHSA DAWN--referred to as the DAWN report, this is the
emergency room report--findings rely upon extrapolated sample
data, which can skew the reported national statistics regarding
emergency room visits associated with energy drinks.
Additionally, as the ABA has recently noted, the authors of
the Arria letter paint an inaccurate picture of caffeine use
and safety, ignoring the vast body of robust and reliable
scientific evidence that has for decades established the safety
of caffeine at the levels present in energy drinks, including
for younger consumers. A copy of both the Pinney Associates'
analysis of the DAWN report and the ABA's response to the Arria
letter have been submitted with my prepared statement to the
Committee.
I would like to speak about Rockstar's labeling and
marketing practices. Rockstar takes pride in the fact that its
product labeling is as transparent and clearly defined as
possible. On its product labels, Rockstar has for many years
included the following information--ingredients in our
products, including caffeine, vitamins, sugars, and amino
acids; the amount of total caffeine per serving, as well as the
total caffeine from all sources per container.
A consumer advisory statement that reads ``Not recommended
for children, pregnant or nursing women, or those sensitive to
caffeine.'' An example of Rockstar energy drink's label is
attached to my prepared statement to the Committee.
Like other foods and beverages, Rockstar energy drink
products comply with FDA regulations relating to consumable
products, and as part of its commitment to consumer safety,
Rockstar has voluntarily committed to provide serious adverse
events to the FDA reported to us by consumers that are alleged
to be associated with consumption of Rockstar products.
Rockstar has long committed to refrain from marketing its
products to children under 12. In addition to our clearly
labeled consumer advisory that Rockstar energy drinks are not
recommended for children, we also do not promote our products
to children via our company website, nor does Rockstar
currently market or sell its products in K to 12 schools,
including high schools.
Rockstar's target demographic is persons 18 to 35 years of
age. Rockstar engages in marketing activities including event
and athlete sponsorship and promotion in action sports, motor
sports, and live music events that target the 18 to 35 age
group.
In conclusion, I wish to thank the Chair and the members of
the Committee for providing Rockstar with this opportunity to
discuss our commitment to product safety and responsible
marketing practices, and I look forward to answering any
questions you may have.
[The prepared statement of Ms. Weiner follows:]
Prepared Statement of Janet Weiner, Chief Operations Officer and Chief
Financial Officer, Rockstar, Inc.
Chairman Rockefeller, Ranking Member Thune, and members of the
Committee, my name is Janet Weiner, I am the Chief Operations Officer
and Chief Financial Officer for Rockstar, Inc., the manufacturer of
Rockstar Energy Drink products. I am also co-owner of the company.
I thank the Committee for inviting Rockstar to speak at today's
hearing, and I welcome this opportunity to discuss with this esteemed
panel Rockstar's commitment to the safety of our products and the
responsibility of our brand marketing practices.
Rockstar represents a model of entrepreneurial enterprise that has
grown from an ambitious idea into an American success story, from a
small drink manufacturer to a major force in the beverage industry.
Founded in 2001 with a single product, the Rockstar Energy Drink
portfolio now consists of over 20 flavors and is currently sold in more
than 30 geographies around the world including the United States,
Canada, Europe, Asia, Australia, and the Middle East. Rockstar's
current market share in the United States is roughly 15 percent of the
overall energy drink market.
Energy drinks are an extremely popular and growing product
category, having sold more than 34 billion units in the United States
since 2000. As such, energy drinks are very much a mainstream product
with broad participation from a range of companies within the beverage
industry. Following on the next page is chart showing a sample of
energy drinks marketed by some of the largest beverage manufacturers in
the U.S., which are all in addition to the products manufactured by the
companies present here today.
The energy drink market is made more competitive by concentrated
``energy shots,'' such as 5-Hour Energy and similar products. These
products account for approximately 11 percent of the energy market.\1\
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\1\ See Food and Drug Administration, Laszlo P. Somogyi, Caffeine
Intake by the U.S. Population 2 (updated Dec. 2012) (hereinafter
``Somogyi Report'').
Rockstar's commitment to consumer safety is the company's number
one priority, and I will outline for the Committee the steps we have
taken to insure this objective.
Before I do that, I would like to make the following assertions,
which are based upon a recent Rockstar submission to the U.S. Food and
Drug Administration (``FDA''),\2\ and which address certain inaccurate
or questionable claims regarding the safety of the use of caffeine in
our energy drinks products and, specifically, such claims regarding the
health of children and teenagers.
---------------------------------------------------------------------------
\2\ Letter from Kathleen M. Sanzo, on behalf of Rockstar, Inc. to
Michael M. Landa, Director, Center for Food Safety and Applied
Nutrition, U.S. Food and Drug Administration (June 18, 2013)
(hereinafter ``Landa Letter'').
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First, the use of caffeine within our energy drink formulations has
been determined, based upon the consensus of a highly qualified expert
panel (hereinafter ``GRAS panel''),\3\ to be Generally Recognized as
Safe (``GRAS'') under FDA standards. As part of this determination, the
panel specifically considered the effect of caffeine on children.
---------------------------------------------------------------------------
\3\ Rockstar's GRAS panel was comprised of the following
individuals: Dr. John Doull Ph.D., M.D. (University of Kansas Medical
Center); Dr. Stanley M. Tarka Ph.D. (Consultant); Dr. John A. Thomas
Ph.D. (University of Indiana School of Medicine).
---------------------------------------------------------------------------
As we stated in our recent letter to the FDA:
Various sub-populations were considered during the GRAS
determination including evaluation of age or sex specific
effects of caffeine. The effect of caffeine on children was
considered, and it was determined, based on limited studies,
that there is no evidence to support the conclusion that
children display increased sensitivities to dietary caffeine.
For example, as reported by Tema Nord, the Nordic Council of
Ministers Working Group on Food Toxicology and Risk Evaluation,
``Studies on caffeine dependency and withdrawal symptoms in
children and adolescents, although few, draw the same picture
of the physical and psychological findings as in adults''
(Meltzer et al., 2008). Dietary exposure to caffeine in
children and the corresponding potential to affect
neurodevelopment in children was considered. Studies conducted
under placebo controlled settings using large populations of
healthy children with asthma or attention deficit disorder
demonstrate that consumption of large dietary quantities of
caffeine on a daily basis (i.e., 5 to 10 mg/kg body weight per
day) for extended durations is without adverse effects on
various developmental measures (e.g., motor function,
cognition, behavior, general health, deafness, blindness)
(Lindgren et al., 1992; Stein et al., 1996; Schmidt et al.,
2006, 2007, 2012). Although the current published information
provides no evidence that children display increased
sensitivities, Rockstar notes that caffeinated Rockstar energy
drinks are not intended for use by children . . ., nor are
Rockstar products directly marketed to this population group.
Caffeinated energy drinks manufactured by Rockstar are clearly
labeled not recommended for children. . . . It was therefore
concluded that the intended use of caffeine within Rockstar
energy drinks does not represent a risk to children under the
age of 12 as this population group is not an intended user of
Rockstar energy drink products.\4\
---------------------------------------------------------------------------
\4\ Landa Letter at 7.
Second, case reports purporting to link energy drink consumption
with severe adverse effects do not demonstrate a causal relationship
between caffeine and the effects that were reported. As explained in
---------------------------------------------------------------------------
our June 18, 2013 letter to the FDA:
During the GRAS determination, Rockstar, and the Expert Panel,
recognized the increasing concerns expressed by the media and
scientific community pertaining to the safety of caffeinated
energy drinks. It was determined that these concerns were
exclusively driven by various case reports in which the
consumption of an energy drink was associated with severe
adverse reactions and alleged death in some individuals. A
critical review of published case-reports documenting
incidences of severe adverse effects in association with energy
drink consumption was conducted during the GRAS determination.
It was concluded that case-reports do not represent cause-
effect relationships as such information is subject to many
other significant confounding events/information (e.g., lack of
information on exposures, the presence of pre-existing or
undiagnosed conditions, or improper and falsely documented use
patterns of the drink and/or other substances such as drugs and
alcohol). This view was supported by the U.S. FDA as reflected
within the statement on the Agency CAERs database (for which
reports of energy drink associated adverse effects have been
documented) that ``the adverse effect report itself about a
particular product only reflects information AS REPORTED [FDA's
emphasis] and does not represent any conclusion by FDA
regarding a causal relationship or association with the product
or ingredient.'' The potential for confounding that is implicit
within these types of case report studies is significant, and
this limitation has in many instances not received proper
consideration.\5\
---------------------------------------------------------------------------
\5\ Id. at 5-6.
Additionally, as I will discuss at greater length below, a report
released on July 25, 2013, by Pinney Associates further calls into
question the reliability of certain data that has been cited to suggest
a causal link between energy drinks and emergency room visits.\6\
---------------------------------------------------------------------------
\6\ Pinney Associates, Emergency Department Visits Involving Energy
Drinks and Limitations of the Drug Abuse Warning Network (DAWN) (July
25, 2013) (hereinafter ``Pinney Report'').
---------------------------------------------------------------------------
I. Rockstar's Commitment to Consumer Safety
Rockstar Energy Drink products contain levels of caffeine that are
GRAS under FDA standards. In August 2012, the FDA stated that for
healthy adults, caffeine intake up to 400 milligrams per day is not
associated with general toxicity, cardiovascular effects, effects on
bone status and calcium balance, changes in adult behavior, incidence
of cancer, or effects on male fertility.
In addition to caffeine, Rockstar contains other ingredients that
are consistent with FDA GRAS guidance and are safe for consumption.
These other ingredients include B-Vitamins, Ginseng, Milk Thistle, L-
Carnitine, Inositol, and Taurine. The caffeine contribution to the
finished drinks from the inclusion of Guarana is less than 1 milligram
per serving. Taurine is an amino acid that is naturally present in
human flesh, and is in meat, mother's breast milk, and popular baby
formulas. As explained in an April 25, 2013 scientific white paper
signed by John Doull, Ph.D., M.D., a Professor in the Department of
Pharmacology at the University of Kansas Medical Center, addressing the
safety of Rockstar's products--a copy of which is attached to this
statement as Attachment 1--the expert panel commissioned by our company
has concluded that under the conditions of intended use in Rockstar
Energy Drink products, the combination of ingredients as used in
Rockstar is safe for consumption and GRAS based on scientific
procedures.\7\
---------------------------------------------------------------------------
\7\ Intertek Cantox, Scientific White Paper: Summary of Data
Supporting the Safety of Rockstar Energy Drinks 3, 21-23 (April 25,
2013) [hereinafter Scientific White Paper].
---------------------------------------------------------------------------
The caffeine content in Rockstar Energy Drink products is well
below this threshold and considerably lower than that contained in a
sixteen ounce cup of premium brand coffee.
For example, a sixteen ounce can of Rockstar Energy Drink will
contain either 160 milligrams of caffeine or 240 milligrams of
caffeine, depending on the product. By contrast, the same sixteen
ounces of Starbuck's Pike Place coffee is identified on the company's
website as containing 330 milligrams of caffeine.\8\
---------------------------------------------------------------------------
\8\ Starbucks Corp., Pike Place Roast Nutritional Information,
http://www.starbucks.com/menu/drinks/brewed-coffee/pike-place-roast
(last visited July 28, 2013).
Coffee and tea, rather than energy drinks, are the most significant
sources of caffeine for Americans, including teens and children. A FDA-
commissioned report authored by Laszlo P. Somogyi on caffeine
consumption among the U.S. population in 2009, and then updated in 2010
and again in 2012, indicated that teens and young adults ages 14 to 21
years consume, on average, approximately one-third the amount of
caffeine as people over 21--about 100 milligrams per day. Importantly,
the 2012 report also showed that the average amount of caffeine
consumed has remained constant. Further, the report found that ``
`energy drinks' contributed only a small portion of caffeine consumed
by teenagers.'' and that the most significant source of caffeine for
both children aged 2 to 13 and teens aged 14 to 17 was coffee, tea, and
soft drinks.\9\
---------------------------------------------------------------------------
\9\ Somogyi Report at Dec. 2012 update.
---------------------------------------------------------------------------
Based on data gathered from 2009 through 2010, the U.S. National
Center for Health Statistics' National Health and Nutrition Examination
Surveys (``NHANES'') reported very low energy drink consumption among
adolescents, including just 1.1 percent consumption of energy drinks
among adolescent girls and 4.5 percent among adolescent boys. A similar
conclusion was reached by researchers at Pennsylvania State University
and the Diet Assessment Center, who found that the percentage of energy
drink users reported in the Kantar Worldpanel Beverage Consumption
Survey was low, and that energy drinks ``were minor contributors to
overall caffeine intakes in all age groups.'' \10\
---------------------------------------------------------------------------
\10\ Diane C. Mitchell, et al., Beverage Caffeine Intakes in the
U.S. abstract (April 2012).
---------------------------------------------------------------------------
According to the National Coffee Association, ``[t]he teenage years
are the key entry point into the coffee market.'' \11\ Of Americans who
drink coffee, 52 percent reported that they began consuming coffee one
time per week or more between the ages of 13 and 19, with another 8
percent that began to consume coffee regularly before they turned
13.\12\
---------------------------------------------------------------------------
\11\ National Coffee Assoc., 2012 National Coffee Drinking Trends
52 (2012).
\12\ Id. at 52-53 (2012).
Source: National Coffee Assoc., 2012 National Coffee Drinking
---------------------------------------------------------------------------
Trends at 52.
Looking at the years in greater detail, the National Coffee
Association found that the ages of ``16-18 emerge as the most
important--34 percent of coffee consumers began drinking coffee weekly
or more often in those years.'' \13\ Factoring in all ages, the mean
age at which consumers started drinking coffee is 19 years old.
---------------------------------------------------------------------------
\13\ Id. at 52.
Source: National Coffee Assoc., 2012 National Coffee Drinking
---------------------------------------------------------------------------
Trends at 53.
Rockstar has been extremely distressed by the proliferation and
amount of inaccurate information that has appeared in the media based
upon erroneous reports and manipulated data. We hope that this hearing
will help to debunk the misinformation that has been unfortunately
perpetuated by the media, by questionable methodology in reports
prepared by the Drug Abuse Warning Network (``DAWN''), and by the
distorted information presented in the ``Arria Letter.'' Although the
DAWN report has attracted significant attention, careful analysis of
the report and the public data relied on by the authors, does not
appear to be consistent with a signal of substantial medical harm.
As identified in a recent analysis by Pinney Associates,
commissioned by the American Beverage Association (``ABA''), reports of
energy drink-related Emergency Department (``ED'') visits need to be
viewed in a broader context, as an analysis of DAWN public use data
indicates that drug-related ED visits have also increased (both by a
similar proportion and absolute magnitude as compared to energy drinks)
for a number of other products, including infant formula, vitamins, and
laxatives. In 2011, energy drink-related visits were estimated to
comprise only 0.41 percent of all drug-related ED visits.\14\
---------------------------------------------------------------------------
\14\ Pinney Report at 4 (citing Substance Abuse and Mental Health
Services Administration (``SAMHSA'') extrapolated estimates that energy
drink related visits totaled 20,783 in 2011 whereas all drug related
visits totaled 5.1 million for the same year).
---------------------------------------------------------------------------
Further, Pinney Associates noted the DAWN report's findings rely on
extrapolated sample data which can distort the estimate and skew the
reported national statistics regarding emergency room visits associated
with energy drinks.\15\
---------------------------------------------------------------------------
\15\ PinneyAssociates specifically found that:
DAWN projects to a national estimate of cases based on combining
results from two sources: approximately 183 hospitals in 13 major
metropolitan areas, and approximately 50 supplementary hospitals in
2011. Although the metropolitan hospitals actually report more cases,
the supplementary hospitals actually exert greater influence on the
projected national estimate. On average, one case in the supplementary
sample represents 135 weighted cases, whereas one case in any of the 13
main metropolitan areas represents, on average, fewer than 5 weighted
cases. Therefore, a single case from a supplementary hospital can count
27 times more than a case from one of the metropolitan hospitals that
report data to DAWN. This can distort the estimate. For example, a
small `outbreak' at a community hospital could potentially skew the
national statistics; a single case of energy drink use presenting to a
hospital in the supplementary sample could be counted as though it were
863 cases (the maximum weight for a single case in 2011), possibly
seriously skewing the national statistics and resulting in misleading
trend data.
Pinney Report at 9.
---------------------------------------------------------------------------
Additionally, as the ABA has recently noted, the Authors of the
Arria Letter paint a distorted and highly inaccurate picture of
caffeine use and safety, ignoring the vast body of robust and reliable
scientific evidence that has, for decades, established the safety of
caffeine at the levels presented in energy drinks, including for
younger consumers.
A copy of both the ABA-commissioned Pinney Report analysis of the
DAWN report and the ABA's response to the Arria letter have been
submitted with these statements for the Committee's hearing record as
Attachments 2 and 3, respectively.
The opportunity to discuss the ABA and Pinney Report's recent
findings regarding the DAWN report and the Arria Letter would not only
be welcomed, but is imperative, as these two documents call into
question the majority of recent reports in the media that claim there
is a discernible pattern of adverse effects related to energy drink
consumption and caffeine consumption patterns by adolescents.
In considering such claims, it is important to note again that an
ordinary cup of coffeehouse coffee, such as Starbucks' Pike Place
blend, contains more caffeine than our products. Moreover, setting
quantity aside, the caffeine contained in our products is the same in
terms of benefits and effects as the caffeine contained in ordinary
coffee. It is important to recognize that caffeine is a well-studied,
widely-used, and safely consumed ingredient.
II. Rockstar's Labeling and Marketing Practices
Rockstar Energy Drink product labels clearly state the ingredients
in our products, including caffeine, vitamins, sugars, and amino acids.
In addition to clearly listing ingredients, Rockstar Energy Drink
products also list the amount of total caffeine per serving and the
total caffeine from all sources per container. We take pride in the
fact that Rockstar product labeling is as transparent and clearly
defined as possible.
Further, Rockstar Energy Drink product labels contain the consumer
advisory statement ``Not recommended for children, pregnant or nursing
women, or those sensitive to caffeine.''
Below is an example of a label from a Rockstar Energy Drink, which
demonstrates the full range of information that is stated clearly on
each container of our product:
Like other foods and beverages, Rockstar Energy Drink products are
regulated by the FDA. Rockstar complies with applicable laws and
regulations related to the manufacture, labeling, sale, and
distribution of consumable products. Additionally, as part of its
commitment to consumer safety, Rockstar has voluntarily committed to
report to the FDA any serious adverse events reported to us by
consumers that are alleged to be associated with consumption of
Rockstar products Rockstar conforms to the adverse reporting system and
will continue to do so.
As a member of the ABA, Rockstar has also committed to refrain from
marketing its products to children under 12. In addition to our
clearly-labeled consumer advisory that Rockstar Energy Drinks are not
intended for children, we also do not promote our products to children
via our company website. Simply put, Rockstar does not market products
to children under 12 years of age. Similarly, as a member of the ABA,
Rockstar has committed not to market or sell its products in K-12
schools, including high schools.
Rockstar's target demographic is persons 18 to 35 years of age.
Rockstar engages in marketing activities, including event and athlete
sponsorship and promotion in action sports, motor sports, and live
music events that target the 18 to 35 age group.
III. Conclusion
In conclusion, I reiterate that Rockstar Energy Drink products are
safe for consumers and fully compliant with FDA regulations. According
to a review conducted by Professor John Doull of the University of
Kansas Medical Center, the combination of ingredients contained in
Rockstar is safe for consumption. Moreover, contrary to certain
inaccurate allegations, our products contain less caffeine than
Starbucks ordinary house blend, on a per ounce basis, and our products
clearly display the caffeine content from all sources per container.
Finally, the target audience for Rockstar's marketing initiatives is
persons 18 to 35 years of age.
I thank the Chair and members of the Committee for providing
Rockstar the opportunity to discuss our commitment to product safety
and responsible marketing practices, and I look forward to answering
any questions you may have.
______
Attachment 1
April 25, 2013
Scientific White Paper: Summary of Data Supporting the Safety of
ROCKSTAR Energy Drinks
Prepared for: Rockstar, Inc.; Prepared by: Intertek Cantox
Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks
Table of Contents
Executive Summary
1.0 Introduction
2.0 Comparison of Caffeine Content of Different Foods
3.0 Caffeine Safety Assessment
4.0 Summary of CAERS Reports
4.1 Incidence of Adverse Reports Versus Volumes Sold
5.0 Consideration of Caffeine Consumption by Adolescents
6.0 Other Ingredients
7.0 Conclusions
8.0 References
List of Tables
Table 1 Caffeine Content of Select Energy Drinks Available in the U.S.
Marketplace
Table 2 Caffeine Content of Select Energy Shots Available in the U.S.
Marketplace
Table 3 Caffeine Content of Select Food and Beverage Products Available
in the U.S. Marketplace
Table 4 Summary of Most Relevant Dietary Intake Assessments Conducted
Using 2009-2010 NHANES Data
______
Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks
Executive Summary
Energy drinks have been targeted in the U.S. media recently in
response to reported adverse events--which have been inaccurately
reported by the media--and the fact that two U.S. Senators have
requested that the U.S. Food and Drug Administration (FDA) investigate
the energy drink category. In response to these concerns, Rockstar,
Inc. (manufacturer of Rockstar energy drink products) would like to
report that an independent Expert Panel has reviewed key ingredients
and use levels in Rockstar energy drink products and concluded that the
intended use of the key ingredients in all Rockstar products is
``Generally Recognized As Safe'' (GRAS) based on scientific procedures.
The Expert Panel evaluation was provided under the guidance of Dr. John
Doull Ph.D., M.D., also the signatory of this White Paper, while the
GRAS process was conducted by Dr. Ashley Roberts (Ph.D.) of Intertek
Cantox. Intertek Cantox is a global leader in providing regulatory,
scientific, and toxicology consulting services specific to the areas of
food safety and nutrition. For over 25 years, Intertek Cantox experts
have successfully resolved complex scientific issues, developed
effective regulatory compliance plans, and facilitated global
regulatory approvals for new products.
The safety of Rockstar energy drink products is further supported
on the basis that:
1. Rockstar energy drink products contain either 160 mg or 240 mg
of caffeine per 16 ounce can, depending on product, which is
less than that of the following Starbucks coffee:
Starbucks ``Pike Place Roast'' (standard house blend) 16 ounce
Grande coffee contains 330 mgs of caffeine. (source: Starbucks
website--web link here)
2. Rockstar fulfills all requirements stipulated by the FDA to sell
products labelled as either Conventional Foods or as Dietary
Supplements.
3. Rockstar energy drink products indicate the total amount of
caffeine from all sources on all product labels.
4. Rockstar energy drink products include the following statement
on all product labels: ``Not recommended for children, pregnant
or nursing women, or those sensitive to caffeine.''
5. A Panel of independent experts qualified by training and
experience to assess the safety of food and food ingredients
(the Expert Panel) has critically evaluated the intended
conditions of use including use levels and estimated dietary
intakes of caffeine in Rockstar energy drink beverages. The
Expert Panel applied the requisite safety standard, i.e., there
must be a reasonable certainty of no harm under the conditions
of intended use of the substance. The Expert Panel unanimously
concluded that such use of caffeine is safe and GRAS based on
scientific procedures.
6. The Expert Panel also evaluated the intended conditions of use
including use levels and estimated daily intakes of taurine, L-
carnitine and inositol in Rockstar energy drink products. The
Expert Panel unanimously concluded that such uses are safe and
GRAS based on scientific procedures.
7. Upon evaluating the intended use included use levels and
estimated daily intakes of guarana extract, milk thistle
extract and ginseng extract, the Expert Panel unanimously
concluded that the use of these extracts in Rockstar energy
drink products is safe, and GRAS based on scientific
procedures.
8. In evaluating these ingredients, the Expert Panel considered the
potential for synergistic effects of the ingredients as well as
any known adverse health effects.
9. Claims that the American Academy of Pediatrics recommends no
more than 100 mg caffeine per day for adolescents are
inaccurate. Neither Rockstar nor the U.S. FDA (FDA letter dated
November 21, 2012) has been able to verify this purported
recommendation.
10. Adverse event reports do not establish a cause and effect
relationship, and the number of such reports for Rockstar is
very low in comparison to retail sales of approximately 3
billion cans of Rockstar energy drink products in the USA since
Rockstar brand inception in 2001.
The above points are addressed more fully in the following sections
of this report.
``Energy drinks'' are popular drinks available for purchase at most
supermarkets, box stores, grocery stores, convenience stores and gas
stations, with current annual unit sales in USA for all brands
estimated to be 4.4 billion units (Rockstar personal communication).
There are numerous brands of energy drinks currently on the market
containing caffeine. Caffeine is the constituent of teas, coffees and
colas that is responsible for the increased alertness following
consumption. Since inception in 2001, Rockstar has produced over 3
billion cans of Rockstar energy drink products for the U.S. market.
Rockstar energy drink products in the 2013 portfolio contain either 160
mg or 240 mg of total caffeine from all sources per 16 oz. ounce can
(with one 16 oz. can containing two 8 oz. servings), depending on
product.
The FDA posted a summary of adverse effect reports (AER) obtained
via the Center for Food Safety and Applied Nutrition Adverse Event
Reporting System (CAERS) through October 2012, that related to products
marketed as energy drinks or energy shots, which included the brands
Red Bull, 5 Hour Energy, Monster, and also Rockstar (U.S. FDA, 2012a).
The reports were received under this post-surveillance system between
January 1, 2004 and October 23, 2012. It is important to note that
these reports cannot determine cause and effect, as stated by the FDA
in the summary: ``the adverse effect report itself about a particular
product only reflects information AS REPORTED [FDA's emphasis] and does
not represent any conclusion by FDA regarding a causal relationship or
association with the product or ingredient.''
The summary of CAERS reports (through October 2012) released by the
FDA included only 13 reports for Rockstar--including zero deaths--over
the 7 year time frame of 2006 to 2012. The lethal dose of caffeine in
an average person weighing 150 pounds (68 kg) is approximately 10,000
mg of caffeine, which is equivalent to the consumption of 41 cans of 16
oz. Rockstar or 656 ounces of liquid--putting it in perspective this
amount of liquid weighs 41 pounds. This volume is 10 times greater than
the total amount of fluid that is typically consumed in a day and it is
therefore physically impossible to consume this many drinks.
Compared to the over 2 billion cans of Rockstar products sold in
the U.S. since 2006 (with over 3 billion sold since brand inception in
2001), the 13 CAERS reports attributed to Rockstar energy drink
products between 2006 and October 2012 (and it should be noted that
these are only recorded in the AER system, and represent no defined
relationship or proof of association with the product or ingredient)
represent a very small fraction (0.00000065 percent) of the overall
number of units produced since 2006. It is also important to note that
of the 13 CAERS reports received regarding Rockstar energy drink
products over the 7 year time frame, 6 of those 13 CAERS reports
received allegedly claimed either product spoilage or object in can.
The SAMHSA Drug Abuse Warning Network issued a report (SAMHSA,
2011) on hospital visits involving energy drinks (along with alcohol
and/or illegal or legal drug abuse or intake) but the report did not
specify how many of the visits cited involved Rockstar products.
Greater than 50 percent of patients in the SAMHSA report aged 18 to 25
admitted to combining drug or alcohol use along with the energy drinks.
The SAMHSA study did not present any estimate as to the quantity of
energy drinks or amount of caffeine consumed, and it cannot be
determined if the other half of subjects, particularly younger
subjects, willingly disclosed all other drug or alcohol use. Thus, drug
and alcohol use in addition to the energy drinks is likely to have been
much higher than the admitted 50 percent identified in the report.
Numerous multi-ingredient foods and beverages contain caffeine
including coffee, tea, chocolate, soft-drinks and ice cream, which have
a long history of safe consumption in the U.S. and global diet, and are
targeted towards all age groups. Regulating food products on the basis
of caffeine content would therefore impact many different product
categories. Following a comprehensive evaluation of the literature for
caffeine, a panel of independent scientists, qualified by scientific
training and relevant national and international experience to evaluate
the safety of food ingredients, was convened to evaluate the conditions
of use of caffeine in Rockstar energy drink products. The Expert Panel
unanimously concluded that the intended use of caffeine, produced in
accordance with current good manufacturing practice and meeting
applicable Food Chemical Codex specification, in Rockstar energy drink
products at levels up to 120 mg per 8 oz. serving (a centration of 15
mgs of caffeine per ounce) is safe. One 16 oz. can of Rockstar energy
drink contains 2 servings, with total caffeine from all sources at 160
mg or 240 mg depending on the specific Rockstar product. The Expert
Panel unanimously found further that use intended use of caffeine in
Rockstar energy drink beverages is GRAS based on scientific procedures.
The Expert Panel also noted that, in their unanimous opinion, other
qualified experts would concur with these conclusions.
The caffeine level in energy drinks currently manufactured by
Rockstar, at 80 mg or 120 mg per 8 oz. serving, is considerably less
than in that of an 8 oz. serving of Starbucks or Einstein Bros.
coffees, which would provide more caffeine at 160 mg and 150 mg
respectively, while the 20 oz. Starbucks Pike Place Roast coffee
contains 415 mg of caffeine. Ben and Jerry's Coffee Heath Bar Crunch
also contains 84 mg of caffeine per 8 oz. serving.
Some media reports and health group websites have stated that the
American Academy of Pediatrics (AAP) recommends that adolescents
(persons ages 12 to 19) should not consume more than 100 mg of caffeine
per day. However, following a thorough search of the literature a
detailed reference for this statement could not be found in these
reports.
In the FDA letter dated November 21, 2012 (U.S. FDA, 2012c), it is
stated that the FDA contacted the AAP and reviewed their website but
was not able to get verification that the AAP has a policy statement
supporting an upper limit of 100 mg caffeine per day for adolescents.
We also did an independent search of the AAP website and did not
identify any such policy statement. Thus, it is incorrect to state that
that the maximum safe amount of caffeine for adolescents is 100 mg per
day.
In a letter dated August 10, 2012 concerning caffeine, the FDA
stated that while the Agency is reviewing recently published safety
studies on caffeine, ``the available studies do not indicate any new,
previously unknown risks associated with caffeine consumption'' (U.S.
FDA, 2012b). Furthermore, in another letter dated November 21, 2012
(U.S. FDA, 2012c) the FDA stated that it has ``searched the literature
but did not find any information that calls into question the safety''
of taurine, an amino acid, or guarana, an herb, as currently used in
beverages.
Given the above, there is no expectation that consumption of
Rockstar energy drink products containing 80 mg or 120 mg of caffeine
per 8 oz. serving (160 mg or 240 mg caffeine per 16 ounce can), in
adherence with the product label, should be associated with adverse
health effects. Also, the Expert Panel convened to evaluate the safety
of caffeine also assessed ginseng extract, guarana extract, L-
carnitine, milk thistle extract, inositol and taurine, and concluded
unanimously that the use of these ingredients in Rockstar energy drink
products are safe. The Expert Panel also found such uses to be GRAS
based on scientific procedures. Estimates of dietary intakes of these
non-caffeine ingredients from consumption of Rockstar energy drink
products were determined to be well below estimates of consumption from
other food sources and/or orders of magnitude below no-adverse-effect
levels determined from safety studies. As all ingredients are present
in amounts that are GRAS and/or are found in various foods in
comparable amounts, there is no expected safety concern associated with
these ingredients alone, or in combination, from consumption of
Rockstar energy drink products.
Summary of Data Supporting the Safety of ROCKSTAR Energy Drinks
1.0 Introduction
``Energy Drinks'' are popular drinks with current USA annual sales
for all brands estimated to be 4.4 billion units (Rockstar, personal
communication). There are numerous brands of energy drinks currently on
the market, with the predominant ingredient being caffeine. Caffeine is
the constituent of teas, coffees and colas that is responsible for the
increased alertness following consumption. The amounts of caffeine in
the individual brands of energy drinks are highly variable as are the
serving sizes. Since inception in 2001, Rockstar, Inc. (Rockstar) has
produced over 3 billion cans of Rockstar energy drink products for the
North American market (Rockstar personal communication).
The U.S. Food and Drug and Drug Administration (FDA) posted a
summary of adverse effect reports (AER) obtained via the Center for
Food Safety and Applied Nutrition Adverse Event Reporting System,
(CAERS) through October 2012 that related to products marketed as
energy drinks and energy shots, which included the brands Red Bull, 5
Hour Energy, Monster, and also Rockstar (U.S. FDA, 2012a). The reports
were received under this post-surveillance system between January 1,
2004 and October 23, 2012. It is important to note that these reports
cannot determine cause and effect as stated by the FDA in the summary:
``the adverse effect report itself about a particular product only
reflects information AS REPORTED [FDA's emphasis] and does not
represent any conclusion by FDA regarding a causal relationship or
association with the product or ingredient.''
The purpose of this report is to review the CAERS received through
October 2012, and to summarize the data supporting the safety of
Rockstar energy drinks.
In considering the safety of Rockstar energy drinks, it is
important to clarify that these products are not intended for certain
populations known to be sensitive to caffeine. Therefore the label
includes a statement that Rockstar products are ``not recommended for
children, pregnant or nursing women, or those sensitive to caffeine.''
Rockstar considers ``children'' to encompass individuals under age 12.
2.0 Comparison of Caffeine Content of Different Foods
The amount of caffeine in Rockstar energy drink products is
comparable to or less than that of standard coffee, which is widely
consumed and purchased in specialty coffee shops.
Numerous foods and beverages contain caffeine including coffee,
tea, chocolate, soft-drinks and ice cream that have a long history of
safe consumption in the U.S. and global diet and are targeted towards
all age groups. Regulating food products on the basis of caffeine
content would therefore impact many different products. Energy drinks
manufactured by Rockstar contain 80 mg or 120 mg of caffeine per 8 oz.
serving. On a per can basis, caffeine levels of 160 mg to 240 mg are
present in a 16 oz. can of Rockstar energy drink products. These
amounts of caffeine are comparable to brand name coffees that are
readily available in the U.S. Concentrations of caffeine present in 16
oz. servings of coffee obtained from common U.S. retailers were found
to vary from 206 mg (Dunkin Donuts), 300 mg (Einstein Bros.), to 320 mg
(Starbucks). Thus, 8 oz. servings of Starbucks or Einstein Bros.
coffees would provide more caffeine (160 mg and 150 mg, respectively)
than would be provided in an 8 oz. serving of Rockstar (80 mg or 120
mg, depending on product).
The amounts of caffeine in various energy drinks sold in the U.S.
marketplace in serving sizes of 8 oz. or greater are summarized in
Table 1. The amount of caffeine in Rockstar energy drink products is
comparable to most other energy drink brands but is less than one sixth
the caffeine concentration of 5-Hour Energy (a concentrated energy
shot).
Table 1.--Caffeine Content of Select Energy Drinks Available in the U.S. Marketplace
----------------------------------------------------------------------------------------------------------------
Energy Drinks Package Size (oz.) Caffeine (mg) Concentration (mg/oz.)
----------------------------------------------------------------------------------------------------------------
NOS 16.0 260 16.3
----------------------------------------------------------------------------------------------------------------
Rockstar Energy Drink 16.0 160 10.0
----------------------------------------------------------------------------------------------------------------
Rockstar Sugar Free 16.0 160 10.0
----------------------------------------------------------------------------------------------------------------
Rockstar Zero Carb 16.0 240 15.0
----------------------------------------------------------------------------------------------------------------
Monster Energy 16.0 160 (est.) 10.0 (est.)
----------------------------------------------------------------------------------------------------------------
Monster Lo-Carb 16.0 160 (est.) 10.0 (est.)
----------------------------------------------------------------------------------------------------------------
Full Throttle 16.0 200 12.5
----------------------------------------------------------------------------------------------------------------
RedBull 16.0 154 9.6
----------------------------------------------------------------------------------------------------------------
RedBull Sugar Free 16.0 154 9.6
----------------------------------------------------------------------------------------------------------------
The amount of caffeine in energy shots, which are a different type
of product than energy drinks, is indicated in Table 2.
Table 2.--Caffeine Content of Select Energy Shots Available in the U.S. Marketplace
----------------------------------------------------------------------------------------------------------------
Energy Shot Package Size (oz.) Caffeine (mg) Concentration (mg/oz.)
----------------------------------------------------------------------------------------------------------------
5-Hour ENERY 2.0 200 (est.) 100.0 (est.)
----------------------------------------------------------------------------------------------------------------
Table 3 lists the caffeine content of other foods and beverages.
The amount of caffeine in Rockstar energy drink products on a mg per
oz. basis, while about 3 times greater than soft drinks, is less than
many coffees and some teas. Ben and Jerry's Coffee Heath Bar Crunch
contains as much caffeine as many energy drinks at 84 mg of caffeine
per 8 oz. serving.
Table 3.--Caffeine Content of Select Food and Beverage Products Available in the U.S. Marketplace
----------------------------------------------------------------------------------------------------------------
Concentration (mg/
Product Package Size (oz.) Caffeine (mg) oz.)
----------------------------------------------------------------------------------------------------------------
Starbucks Brewed Coffee (Grande) 16.0 330 20.6
[Pike Place Roast] (Venti) 20.0 415
----------------------------------------------------------------------------------------------------------------
Einstein Bros. Regular Coffee (Medium) a 16.0 300 18.8
----------------------------------------------------------------------------------------------------------------
Dunkin' Donuts Regular Coffee (Medium) 16.0 206 12.9
----------------------------------------------------------------------------------------------------------------
Starbucks Espresso (solo) 1.0 75 75.0
----------------------------------------------------------------------------------------------------------------
Jolt Cola 12.0 72 6.0
----------------------------------------------------------------------------------------------------------------
Coca-Cola 20.0 56 2.8
----------------------------------------------------------------------------------------------------------------
Mt. Dew 20.0 90 4.5
----------------------------------------------------------------------------------------------------------------
Ben & Jerry's Coffee Heath Bar Crunch 8.0 84 10.5
----------------------------------------------------------------------------------------------------------------
Ben & Jerry's Coffee Flavored Ice Cream 8.0 68 8.5
----------------------------------------------------------------------------------------------------------------
Jolt Caffeinated Gum 1 stick 33 33.0 (per stick)
----------------------------------------------------------------------------------------------------------------
Hershey's Special Dark Chocolate Bar 1.45 31 20.7
----------------------------------------------------------------------------------------------------------------
Source: CSPI (2007); source a = Turcotte (2010)
3.0 Caffeine Safety Assessment
Caffeine is present naturally in coffees, teas and herbs and has a
long history of safe use in colas and other foods as an added
ingredient.
Caffeine is considered safe for use in stimulant drug products for
over-the-counter human use to restore mental alertness or wakefulness
during fatigue or drowsiness (21 CFR 340) (U.S. FDA, 2012d). Use of
caffeine in over-the-counter stimulant products to restore mental
alertness or wakefulness during fatigue or drowsiness is acceptable for
adults and for children 12 years of age and older (i.e., adolescents)
and if used at the maximum allowable levels would be over 1000 mg in a
day. This amount of caffeine would equal about 4 Rockstar 16 oz. energy
drinks.
Thus, it is incorrect to state that that the maximum safe amount of
caffeine for adolescents is 100 mg per day.
The conditions of use of caffeine in Rockstar energy drinks has
been evaluated by an Expert Panel in accordance with sections 201(s)
and 409 of the Federal Food, Drug, and Cosmetic Act (U.S. FDA, 2010a,b)
and FDA's implementing regulations in 21 CFR 170.3 and 21 CFR 170.30
(U.S. FDA, 2012d). Those regulations state that the use of a food
substance may be GRAS either through scientific procedures or, for a
substance used in food before 1958, through experience based on common
use in food. The Expert Panel consisted of the following individuals:
John Doull Ph.D., M.D., Stanley M. Tarka, Ph.D. and John A. Thomas,
Ph.D.
Under 21 CFR 170.30(b) (U.S. FDA, 2012d), general recognition of
safety through scientific procedures requires the same quantity and
quality of scientific evidence as is required to obtain approval of the
substance as a food additive and ordinarily is based upon published
studies, which may be corroborated by unpublished studies and other
data and information.
Under 21 CFR 170.30(c) and 170.3(f) (U.S. FDA, 2012d), general
recognition of safety through experience based on common use in foods
requires a substantial history of consumption for food use by a
significant number of consumers.
The Expert Panel unanimously concluded that the intended use of
caffeine, produced in accordance with current good manufacturing
practice and meeting applicable Food Chemical Codex specification, in
Rockstar energy drink products at levels up to 120 mg per 8 oz. serving
is generally recognized as safe (GRAS) based on scientific procedures.
Rockstar energy drink products in the 2013 portfolio contain either 160
mg or 240 mg of caffeine per 16 oz. can depending on product.
The primary data noted by the Expert Panel in their evaluation of
the safety of caffeine were as follows:
The estimated lethal dose for caffeine in adult humans is
10,000 mg (Nawrot et al., 2003). For an adolescent this dose
would be expected to be closer to the adult estimate than for a
child, given their greater body weight and height by age 12,
which is more comparable to adults. Intake of 10,000 mg of
caffeine, from the proposed food uses of caffeine in Rockstar
energy drink products, would require the consumption of forty-
one 16 oz. cans, corresponding to 20 liters of fluid or
approximately 41 pounds of Rockstar energy drink, consumed all
at one time. This volume is far in excess of the amount that
would be consumed by anyone drinking any beverage, including
energy drink consumers.
Recent comprehensive reviews, conducted by qualified
experts, on the reproductive and developmental effects of
caffeine in humans have concluded that no adverse consequences
on reproduction or pregnancy have consistently been linked to
caffeine (SCF, 1999; IOM, 2001; Peck et al., 2010; Brent et
al., 2011). However, the European Commission's Scientific
Committee on Food, the IOM, and Health Canada, recommend a
reduction in caffeine consumption during pregnancy (SCF, 1999;
Nawrot et al., 2003).
The Expert Panel noted that although infants and children
are not intended consumers of energy drinks; consumption by
children and potential effects on the developing nervous system
of growing individuals should be considered. Caffeine has a
long-history of safe use by clinicians for the treatment of
apnea in infants. Caffeine and the structurally similar
methylxanthine, theophyline, also have been widely used for the
treatment of attention deficit disorder (ADHD) and asthma in
young and adolescent children (<12 years of age). Under placebo
controlled settings, the administration of caffeine (5 mg to 10
mg per kg body weight) to infants within the first 10 days of
life for a median duration of 37 days, for treatment of apnea
of prematurity, did not affect motor function, cognition,
behavior, general health or other developmental measures (e.g.,
deafness, blindness) during a 5-year follow-up period (Schmidt
et al., 2006, 2007, 2012). Meta-analyses of controlled studies
evaluating the effects of caffeine on development and behavior
in children and adolescents administered caffeine, or the
structurally similar methylxanthine theophyline, for treatment
of asthma or attention-deficit hyperactivity disorder do not
support an association between methylxanthine use and adverse
effects on cognition or behavior in these individuals (Lindgren
et al., 1992; Stein et al., 1996). The Expert Panel concluded
that available evidence do not suggest that dietary caffeine
would represent a neurodevelopmental risk to humans of any age
group.