Nutrition Labeling: FDA and USDA Need a Coordinated Assessment of Food
Label Accuracy (Letter Report, 12/29/94, GAO/RCED-95-19).
The Nutrition Labeling and Education Act of 1990 seeks to provide
consumers with uniform and accurate nutrition information on food
labels. To help guarantee the accuracy of this information, the Food
Safety and Inspection Service (FSIS) and the Food and Drug
Administration (FDA) will do laboratory analyses of food products and
visual reviews of food labels. However, relatively few labels will be
verified by laboratory analyses, and the visual reviews will not verify
the accuracy of the nutrient values. Because of these limitations and
the flexibility given food companies in developing the nutrient values
on labels, the accuracy of the information provided on about 50,000
labels will depend largely on the food industry. Because the new
nutrition labeling requirements have applied to food companies only
since August 1994, it is too soon to evaluate the federal agencies'
policies and procedures to ensure the accuracy of nutrition information
on labels. Although FSIS will use information from its enforcement
program to evaluate the effectiveness of its policies and procedures,
unlike FDA, it does not plan to statistically assess the overall
accuracy of the nutrition information on labels for meat and poultry.
Without such an assessment, the federal government may be unable to
evaluate the effectiveness of its nutrition labeling program for all
products in the marketplace.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: RCED-95-19
TITLE: Nutrition Labeling: FDA and USDA Need a Coordinated
Assessment of Food Label Accuracy
DATE: 12/29/94
SUBJECT: Food and drug law
Consumer protection
Labeling law
Food industry
Federal regulations
Product safety
Food inspection
Consumer education
Safety regulation
Information disclosure
IDENTIFIER: FSIS Nutrition Labeling Compliance Pilot Program
FDA Food Label and Package Survey
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Cover
================================================================ COVER
Report to the Chairman, Subcommittee on Nutrition and Investigations,
Committee on Agriculture, Nutrition, and Forestry, U.S. Senate
December 1994
NUTRITION LABELING - FDA AND USDA
NEED A COORDINATED ASSESSMENT OF
FOOD LABEL ACCURACY
GAO/RCED-95-19
Nutrition Labeling
Abbreviations
=============================================================== ABBREV
FDA - Food and Drug Administration
FSIS - Food Safety and Inspection Service
GAO - General Accounting Office
USDA - United States Department of Agriculture
Letter
=============================================================== LETTER
B-258079
December 29, 1994
The Honorable Tom Harkin
Chairman, Subcommittee on Nutrition
and Investigations
Committee on Agriculture, Nutrition,
and Forestry
United States Senate
Dear Mr. Chairman:
Scientific evidence demonstrating a direct relationship between
nutrition and health increasingly has focused consumers' attention on
the nutritional content of the foods they purchase. Responding to
this interest, the food industry provided more nutrition information
about its products. However, this information was at times
inconsistent and misleading. To address public concerns and problems
with food labels, the Congress enacted the Nutrition Labeling and
Education Act of 1990 to provide consumers with accurate nutrition
information on food labels.
The Food Safety and Inspection Service (FSIS) of the U.S. Department
of Agriculture (USDA) is responsible for nutrition labels on meat and
poultry products, and the Food and Drug Administration (FDA) in the
Department of Health and Human Services is responsible for labels on
all other food products. The agencies' regulations became effective
on May 8, 1994. The Congress enacted a 3-month extension for certain
products until August 8, 1994. The regulations require food
companies to follow specific requirements relating to the labels'
format, nutrient values, nutrient content claims, and health claims.
Nutrient values are the amounts or quantities of specific nutrients,
such as fat, protein, and sodium, contained in a serving--defined in
the regulations as the amount customarily consumed. Nutrient content
claims cover terms such as "light" and "low fat," and health claims
characterize the relationship of a specific nutrient to a disease or
health-related condition, such as sodium and high blood pressure.
You asked us to describe (1) what the new nutrition labeling
regulations require food companies to do to develop accurate nutrient
values for labels, (2) what enforcement steps FDA and FSIS are taking
to help ensure the accuracy of nutrition information on food labels,
and (3) what plans the agencies have for evaluating the overall
effectiveness of their nutrition labeling policies and procedures.
You also asked that we provide suggestions for improvement on the
basis of the observations we made.
RESULTS IN BRIEF
------------------------------------------------------------ Letter :1
FDA's and FSIS' regulations clearly specify the level of accuracy
necessary for the nutrient values provided on the new labels, but the
agencies give companies a great deal of flexibility in how they
develop the values.
To help ensure the accuracy of the nutrition information on food
labels, the agencies will (1) perform laboratory analyses to
independently verify the accuracy of the nutrition information on
labels; (2) conduct visual reviews of labels to determine compliance
with the requirements for format, nutrient content claims, and health
claims; (3) work with companies to correct any inaccurate labels
identified; and (4) where appropriate, pursue legal action against
manufacturers of products with violative labels. However, the sheer
number of nutrition labels--about 500,000--and the limited resources
the agencies have at their disposal could limit the effectiveness of
the enforcement steps the agencies are taking.
Plans by FDA to evaluate the effectiveness of its policies and
procedures for nutrition labels include an assessment of industry's
compliance obtained through a periodic statistical survey of food
products and the nutrition information on their labels. FSIS does
not plan to conduct such a statistical assessment because of resource
constraints. Without a statistical approach for meat and poultry
products, the federal government may not be able to evaluate the
effectiveness of its nutrition labeling program for all nutrition
labels in the marketplace.
BACKGROUND
------------------------------------------------------------ Letter :2
The 1990 act required FDA to issue new nutrition labeling regulations
for all foods except meat and poultry products. Under FDA's
regulations, food companies must provide more nutrition information
in a uniform format on more food products than ever before. About
250,000 food product labels are under FDA's jurisdiction. Although
the 1990 act did not apply to meat and poultry products, the
Secretary of Agriculture decided to issue new nutrition labeling
regulations for these products that are very similar to FDA's. About
247,000 labels come under FSIS' jurisdiction.
The new regulations require food companies to provide information for
certain nutrients and to follow specific criteria when making a
nutrient content claim or health claim on a food product's label.
For example, for most foods, the regulations require companies to
provide information on the amount of 14 nutrients in a serving in a
label's "Nutrition Facts" panel. (See app. I for an example of the
new food label.) These "nutrient values" must appear in a uniform
format for ease of comparison among food products. The nutrient
values serve as the basis for a variety of nutrient content and
health claims. (See app. II for examples of labels' nutrient
content and health claims.) The regulations specify the general
requirements for the use of these content and health claims.
The two agencies are also responsible for (1) reviewing food labels
to determine industry's compliance with their nutrition labeling
regulations and (2) monitoring overall program operations to identify
problems and take corrective action.
FOOD COMPANIES HAVE A GREAT
DEAL OF FLEXIBILITY IN
DEVELOPING NUTRIENT VALUES FOR
LABELS
------------------------------------------------------------ Letter :3
FDA's and FSIS' regulations give food companies a great deal of
flexibility in choosing the procedures they use to develop the
nutrient values reported on food labels. The agencies' regulations
clearly specify the acceptable range for accuracy of the nutrient
information provided on the new labels. The regulations also lay out
the procedures and analytical methods the agencies will use to verify
label information to determine compliance with the accuracy
provisions of the regulations. However, the agencies' regulations do
not require companies to use specific procedures to develop the
nutrient values.
For FDA, the flexibility afforded food companies is a continuation of
past practices. FDA officials told us that FDA never required food
companies to use specified procedures to determine the nutrient
values for labels under its prior nutrition labeling regulations.
For FSIS, however, not requiring food companies to use particular
procedures is a change from past requirements. Before FSIS issued
its nutrition labeling regulations in January 1993, it had required
companies seeking approval for nutrition labels to conduct laboratory
analyses of their products using FSIS-specified analytical methods
and to submit analytical data that substantiated the nutrient values
listed on the labels. In addition, to ensure that this nutritional
information continued to be accurate over time, companies had to
periodically submit the results of new laboratory analyses to FSIS.
According to FSIS, it did not retain these requirements because the
move from voluntary to mandatory nutrition labeling placed an
additional burden on companies in terms of the number of products
requiring nutrition information as well as the amount of nutrient
information required on individual labels. Because of this increased
burden, the agency wanted to enable companies to develop nutrition
information for labels in the most cost-effective manner possible.
In addition, the agency believed that food companies should be
responsible for the accuracy of the information on the labels.
FDA AND FSIS ARE TAKING STEPS
TO ENSURE ACCURATE NUTRITION
INFORMATION ON LABELS, BUT
LIMITATIONS EXIST
------------------------------------------------------------ Letter :4
FDA and FSIS are taking some steps--laboratory analysis of food
products, visual reviews of product labels, and cooperation with food
companies to get inaccurate labels corrected--aimed at ensuring that
consumers get accurate nutrition information on food labels.
However, the sheer number of nutrition labels--about 500,000--and the
limited resources the agencies have at their disposal, coupled with
FDA's lack of explicit authority to demand company records on how the
nutrient values on labels were established could limit the
effectiveness of the enforcement steps the agencies are taking.
RELATIVELY FEW LABELS WILL
BE VERIFIED BY LABORATORY
ANALYSES
---------------------------------------------------------- Letter :4.1
FDA and FSIS perform independent laboratory analyses of food products
to verify the accuracy of nutrient values and related nutrient
content or health claims on labels. However, because of limited
resources, the agencies will only verify annually about 500 out of
the 500,000 food labels for which they are responsible. FDA and FSIS
officials indicated that while the number of products selected for
laboratory verification is relatively small, these efforts play an
important part in their enforcement strategy by demonstrating an
agency presence to the industry.
In selecting foods for laboratory analysis, FDA will generally target
food items that FDA inspectors believe, based on past experience,
have labeling problems. This practice has the benefit of enabling
FDA to efficiently use its limited laboratory resources to correct
specific problem areas.
According to FDA officials, the agency plans to analyze up to 415
food samples annually for compliance with the nutrition labeling
requirements. However, FDA may not achieve this number.
Historically, the number of samples actually analyzed has fallen
short of agency goals because of competing demands for laboratory
resources for higher- priority programs such as medical foods\1 and
infant formula. In addition, laboratory officials told us that
existing laboratory resources could be strained because the types of
analyses required to verify some of the information contained on the
new labels were more complex and time-consuming than previous
analyses.
Initially, FDA plans to analyze only food products that have health
claims or nutrient content claims that FDA inspectors believe are
inaccurate. For these food products, FDA will analyze only the
nutrients that are the basis for the questionable claims on labels.
The agency will phase in more complete laboratory analyses for
surveillance purposes.
FSIS has begun to select a limited number of food items for
laboratory analysis. Unlike FDA, FSIS did not verify nutrient values
through laboratory analyses before the new regulations were enacted.
To conduct such analyses, FSIS launched its Nutrition Labeling
Compliance Pilot Program in February 1994. Under this pilot program,
FSIS selected about 40 food products for analysis by September 1994
in order to test and refine systems to collect, handle, and analyze
samples and to report laboratory results. During fiscal year 1995,
FSIS plans to verify nutrient values through laboratory analysis on
about 100 food products. FSIS is limiting its analyses to 100
samples, according to agency officials, because of limited resources.
Like FDA, FSIS intends to target its verification efforts at products
with potential problems. FSIS plans to adjust its laboratory
verification procedures in response to its first year's experience.
--------------------
\1 A medical food is a specially formulated food that is used under
medical supervision for dietary management of a medical disorder.
VISUAL LABEL REVIEWS WILL
PROVIDE SOME ACCURACY CHECKS
---------------------------------------------------------- Letter :4.2
While the accuracy of nutrient values reported on labels can be
verified only through laboratory analysis, FDA and FSIS will make
some limited accuracy checks on other information on labels as part
of their reviews of labels. These reviews, which involve a visual
check of all nutrition elements on labels, are intended to determine
compliance with the rules for format, nutrient content claims, and
health claims. However, the accuracy checks will be limited to
certain types of errors, such as inconsistencies between nutrient
values and related nutrient content claims made on the label. The
reviews will not verify the accuracy of the nutrient values on the
labels.
For example, FDA's regulations state that in order to make a
"fat-free" claim, a product must contain less than 0.5 grams of fat
per "reference amount customarily consumed." If a label shows that a
product contains more than 0.5 grams--say 1 gram--of fat per
reference amount customarily consumed and also makes a fat-free
claim, a review of the label could indicate a problem with the
label's accuracy. The reviewer would need to obtain additional
information from the company or have the food analyzed to determine
whether the fat-free claim, the amount of fat, or both were in error.
FDA and FSIS differ in how they will conduct their reviews and in
their authority to demand company records, such as data from
laboratory analyses to support the nutrient values on labels. Since
food companies subject to FDA's regulations are permitted to use food
labels without obtaining FDA's prior approval, FDA's reviews of
labels will occur after food products have already entered the
marketplace. In performing their label reviews, FDA inspectors can
request, but not require, companies to provide supporting
documentation for nutrient values. According to an FDA official,
food companies frequently refuse requests for supporting
documentation because no provision of the Food, Drug, and Cosmetic
Act explicitly grants FDA access to food production records, other
than those records concerning infant formula. In recent years,
legislation has been proposed to give FDA additional inspection
authority, including the authority to inspect company records for
enforcement purposes. However, none of the proposals have been
enacted.
In August 1994, FDA initiated a major effort to identify food
products that should have contained the new nutrition facts panel on
their labels but did not. (See app. I.) In the effort, FDA
employees visited retail grocery stores throughout the United States
to identify companies that did not have the required nutrition facts
panel on the labels of their food products. Then, FDA inspectors
visited the plants of each of those companies to check whether the
labels being placed on their food products had the required nutrition
facts panel.
In contrast, FSIS requires meat and poultry companies to obtain
approval of their labels before using them. FSIS headquarters staff
review nutrition information as part of the agency's preapproval
process for labels. These reviews are intended to determine
compliance with requirements for format and nutrient content claims,
not to determine whether the nutrient values are accurate. In
performing these visual reviews, FSIS' staff rely on the unverified
nutrient values that appear on the label. The staff do not have
company data supporting the nutrient values nor the results of agency
laboratory analyses available for use in reviewing the labels. While
FSIS requires companies to have documentation supporting the nutrient
values on labels at their processing plants, this information is not
forwarded to headquarters staff for use in verifying the information
on the labels. To aid in label reviews, FSIS has developed an
automated system that compares nutrient content claims with the
nutrient values appearing on a label. This system enables staff to
determine if the nutrient content claims are consistent with the
regulations.
During fiscal year 1995, FDA plans to have its field inspectors
review about 10,000 domestic food product labels and about 10,000
imported food product labels. FSIS expects to review about 100,000
meat and poultry product labels with nutrition information under its
preapproval process.
AGENCIES WILL WORK WITH
COMPANIES TO CORRECT
INACCURACIES
---------------------------------------------------------- Letter :4.3
Once label violations are detected, the agencies have indicated that,
in general, they plan to work with food companies to correct
inaccurate labels rather than impose sanctions in all cases.
For example, FDA does not intend to take compliance action against
any product for which it determines the company made a "good faith"
effort to appropriately provide nutrition labeling. Rather, FDA will
work with companies cooperatively to effect the necessary changes.
In FDA's experience, such cooperation usually brings about the
desired result--that is, accurately labeled food products at lower
resource expenditures.
FSIS has said that it is not its intent to proceed in a punitive
manner against companies when problems surface during compliance
monitoring. FSIS expects the company to locate the source of any
discrepancy and rectify the problem, such as changing the values on
the label and correcting the cause of the problem.
Both agencies have the authority to exercise a variety of sanctions
for label violations. For example, FDA can (1) issue written
warnings to violators, (2) seize products that violate the
regulations, (3) seek a court injunction prohibiting a company from
introducing an improperly labeled product into interstate commerce,
and (4) seek criminal prosecutions and penalties. FSIS sanctions
include (1) withholding permission to use the label, which in effect
precludes further production of the product; (2) detaining the
product in commerce; and (3) prosecuting the violator if the company
intentionally misbranded the product.
OVERALL EVALUATION OF NEW LABEL
POLICIES IS NOT PLANNED
------------------------------------------------------------ Letter :5
Both agencies plan to use information obtained from their enforcement
activities--including laboratory verifications and label reviews--to
monitor the industry's response to the new regulations. Such
information, however, cannot be used to evaluate the overall
effectiveness of the new label policies because it cannot provide an
assessment of the level of industry compliance with the new
regulations.
Recognizing this, FDA plans to evaluate the overall effectiveness of
its label requirements by assessing information obtained from both
its (1) enforcement activities and (2) periodic survey of a
statistical sample of food products, known as the Food Label and
Package Survey.\2 In the 1995 cycle of this biennial survey, FDA
plans to resume laboratory verifications of the nutrient values on
labels for a statistically valid sample of products.\3 The sample of
products collected and analyzed for this survey is separate and in
addition to those targeted for the laboratory verification described
earlier. According to FDA officials, any product sampled as part of
the biennial survey that has an inaccurate label would be targeted
for verification under the compliance sampling program. Only food
products that are FDA's responsibility will be included in the
survey.
In contrast, according to FSIS officials, resource constraints will
prevent the agency from periodically assessing the overall accuracy
of nutrition information on labels by analyzing a statistical sample
of meat and poultry products. Without such statistical assessments,
FSIS will not be able to evaluate the overall effectiveness of its
policies and procedures.
--------------------
\2 FDA conducts the Food Label and Package Survey to monitor the
labeling practices of U.S. food manufacturers.
\3 FDA contracted for laboratory verification of nutrient values of a
sample of 300 products in May 1994. However, because of
methodological limitations in that analysis, FDA believes that the
1995 survey will provide the first assessment of industry compliance
with the new regulations.
CONCLUSIONS
------------------------------------------------------------ Letter :6
The Nutrition Labeling and Education Act of 1990 is intended to
provide consumers with uniform and accurate nutrition information
about the foods they eat. The new nutrition labeling regulations
provide the framework for more uniform and informative food labels.
To help ensure the accuracy of the nutrition information on labels,
the agencies will perform laboratory analyses of food products and
visual reviews of food labels. However, relatively few labels will
be verified by laboratory analyses, and the visual reviews will not
verify the accuracy of the nutrient values. Because of these
limitations and the flexibility afforded food companies in developing
the nutrient values on labels, the accuracy of the nutrition
information provided on about 500,000 labels will depend largely on
the food industry.
Because food companies have been obligated to label their products in
accordance with the new nutrition labeling requirements only since
August 8, 1994, it is too early to evaluate the agencies' policies
and procedures to ensure the accuracy of the nutrition information on
labels. Although FSIS will use information obtained from its
enforcement program to evaluate the effectiveness of its policies and
programs, unlike FDA, it does not plan to statistically assess the
overall accuracy of the nutrition information on labels for meat and
poultry products. Without such a statistical assessment of meat and
poultry products, which account for about half of all labels, the
federal government may not be able to evaluate the effectiveness of
its nutrition labeling program for all products in the marketplace.
RECOMMENDATION
------------------------------------------------------------ Letter :7
We recommend that the Secretary of Agriculture and the Secretary of
Health and Human Services develop a coordinated evaluation strategy
that will provide for an overall assessment of the accuracy of the
nutrition information provided on all food labels.
AGENCY COMMENTS AND OUR
EVALUATION
------------------------------------------------------------ Letter :8
USDA and FDA provided written comments on a draft of this report;
these comments are presented in appendixes III and IV, respectively.
The agencies generally agreed with the report's findings,
conclusions, and recommendation.
USDA said that it supports our recommendation and looks forward to
working with FDA in developing an assessment strategy that will
ensure the credibility of the nutrition information on all food
labels.
FDA commented that it would coordinate with FSIS to the extent
possible but added that given the resource constraints FDA and FSIS
are experiencing, a coordinated effort may be difficult to achieve
without undue delays to FDA's regulatory activities. We believe that
a coordinated evaluation strategy will be more cost-effective to the
federal government as a whole and may possibly save FDA resources if
it can share certain evaluation costs with FSIS. FDA also made a
number of specific technical comments on the draft. We made changes
to the report to
SCOPE AND METHODOLOGY
------------------------------------------------------------ Letter :9
To identify FDA's and FSIS' policies and procedures for ensuring that
the nutrition information presented on the new food labels is
accurate, we reviewed and analyzed the agencies' regulations,
interviewed food labeling officials at the two agencies, and reviewed
documentation provided by agency officials. We also visited FDA's
Atlanta Center for Nutrient Analysis to observe and discuss the
procedures the Center used to perform independent laboratory analysis
of food products to verify the information on the labels.
To obtain industry's perspective on the matters included in our
review, we contacted officials of the American Meat Institute and the
National Food Processors Association.
We performed our work from January through September 1994 in
accordance with generally accepted government auditing standards.
---------------------------------------------------------- Letter :9.1
As arranged with your office, unless you publicly announce its
content earlier, we plan no further distribution of this report until
7 days after the date of this letter. At that time, we will send
copies of this report to the Secretary of Agriculture; the Secretary
of Health and Human Services; the Director, Office of Management and
Budget; and other interested parties. We will also make copies
available to others upon request.
If you or your staff have any questions concerning the report, you
can reach me on (202) 512-5138. Major contributors to this report
are listed in appendix V.
Sincerely yours,
John W. Harman
Director, Food and
Agriculture Issues
EXAMPLE OF THE NEW FOOD LABEL
=========================================================== Appendix I
(See figure in printed
edition.)
Source: Food and Drug Administration.
EXAMPLES OF LABEL NUTRIENT CONTENT
AND HEALTH CLAIMS
========================================================== Appendix II
The new nutrition labeling regulations, in the standard format,
require companies to provide information on the amount of 14
nutrients in a serving in a label's "Nutrition Facts" panel. These
nutrient values serve as the basis for a variety of nutrient content
and health claims. The regulations specify the general requirements
for the use of these content and health claims.
Nutrient content claims (1) expressly or implicitly characterize the
level of a nutrient in a food product or (2) suggest that the food,
because of its nutrient content, may be useful in maintaining healthy
dietary practices. The following are examples of nutrient content
claims:
Free of calories, cholesterol, fat, saturated fat, or sodium.
Very low in sodium.
Lean and extra lean in fat for meat, poultry, or seafood.
High and good source of a beneficial nutrient.
Reduced and less in calories, cholesterol, fat, saturated fat, or
sodium.
Light in calories, fat, or sodium.
Health claims characterize the relationship of a specific nutrient to
a disease or health-related condition. The following are examples of
health claims:
A diet with enough calcium may reduce the risk of osteoporosis later
in life.
A diet low in total fat may reduce the risk of some cancers.
A diet low in saturated fat and cholesterol and high in fruits,
vegetables, and fiber-containing grain products may reduce coronary
heart disease.
A diet low in sodium may reduce the risk of high blood pressure.
(See figure in printed edition.)Appendix III
COMMENTS FROM THE U.S. DEPARTMENT
OF AGRICULTURE
========================================================== Appendix II
(See figure in printed edition.)Appendix IV
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
========================================================== Appendix II
(See figure in printed edition.)
See comment
The following are GAO's comments on the letter from the Food and Drug
Administration's (FDA) Deputy Associate Commissioner for Legislative
Affairs dated December 6, 1994.
GAO'S COMMENTS
FDA agreed with our recommendation and stated that it would
coordinate with FSIS to the extent possible. However, FDA cautioned
that given the resource constraints both agencies are experiencing, a
coordinated effort may be difficult to achieve without undue delays
to the agency's regulatory activities. We believe that a coordinated
evaluation strategy will be more cost-effective to the federal
government as a whole and may possibly save FDA resources if it can
share certain evaluation costs with FSIS.
MAJOR CONTRIBUTORS TO THIS REPORT
=========================================================== Appendix V
RESOURCES, COMMUNITY, AND ECONOMIC
DEVELOPMENT DIVISION, WASHINGTON,
D.C.
Thomas E. Slomba, Assistant Director
Richard B. Shargots, Project Leader
Robert E. Seelinger, Senior Evaluator
Judy K. Pagano, Senior Operations Research Analyst
Carol Herrnstadt Shulman, Communications Analyst