a

GAO

United States Government Accountability Office

Report to the Chair, Subcommittee on 

Agriculture, Rural Development, Food 

and Drug Administration, and Related 

Agencies, Committee on Appropriations, 

House of Representatives

September 2008 FOOD LABELING

FDA Needs to Better 

Leverage Resources, 

Improve Oversight, 

and Effectively Use 

Available Data to Help 

Consumers Select 

Healthy Foods

GAO-08-597
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 2008

FOOD LABELING

FDA Needs to Better Leverage Resources, Improve 

Oversight, and Effectively Use Available Data to Help 

Highlights of GAO-08-597, a report to the Consumers Select Healthy Foods

Chair, Subcommittee on Agriculture, Rural 

Development, Food and Drug 

Administration, and Related Agencies, 

Committee on Appropriations, House of 

Representatives 

Two thirds of U.S. adults are 

overweight, and childhood obesity 

and diabetes are on the rise. To 

reverse these health problems, 

experts are urging Americans to eat 

healthier. Food labels contain

information to help consumers who

want to make healthy food choices. 

The Food and Drug Administration 

(FDA) oversees federal labeling

rules for 80 percent of foods. GAO 

was asked to examine (1) FDA’s 

efforts to ensure that domestic and 

imported foods comply with

labeling rules, (2) the challenges

FDA faces in these efforts, and 

(3) the views of key stakeholders

on FDA actions needed to mitigate

misleading labeling. GAO analyzed

FDA data, reports, and

requirements on food labeling 

oversight and compliance and 

interviewed agency and key

stakeholder group officials.

What GAO Recommends

GAO is recommending actions for 

FDA to ensure that labeling office

managers have the information 

they need to oversee compliance

with labeling laws; ensure the 

public has timely access to 

information on labeling violations 

on FDA’s public Web site; and 

better leverage resources to 

achieve its mission. In commenting 

on a draft of this report, FDA stated 

that the report raised important

issues, and agreed, with

qualifications, with some of GAO’s 

recommendations, but did not 

comment on others. 

FDA’s oversight and enforcement efforts have not kept pace with the growing 

number of food firms. As a result, FDA has little assurance that companies 

comply with food labeling laws and regulations for, among other things, 

preventing false or misleading labeling. Specifically: 

• FDA does not have reliable data on the number of labels reviewed; the 

number of inspections, which include label reviews, has declined. For 

example, of the tens of thousands of foreign food firms in over 150 

countries, just 96 were inspected by FDA in 11 countries in fiscal year 

2007—down from 211 inspections in 26 countries in 2001. 

• FDA’s testing for the accuracy of nutrition information on labels in 2000

through 2006 was limited. FDA could not provide data for 2007. 

• Although the number of food firms in FDA’s jurisdiction has increased, the 

number of warning letters FDA issued to firms that cited food labeling 

violations has held fairly steady. 

• FDA does not track the complete and timely correction of labeling 

violations or analyze these and other labeling oversight data in routine 

reports to inform managers’ decisions, or ensure the complete and timely

posting of information on its Web site to inform the public. 

• In addition to its official recalls database, FDA’s Center for Food Safety 

and Applied Nutrition has continued to waste resources on a second recall

database that FDA had agreed to eliminate in 2004, as GAO had 

recommended. 

FDA has reported that limited resources and authorities challenge its efforts

to carry out its food safety responsibilities—these challenges also impact 

efforts to oversee food labeling laws. FDA’s Food Protection Plan cites the

need for authority to, among other things, collect a reinspection user fee,

accredit third-party inspectors, and require recalls when voluntary recalls are 

not effective. 

Stakeholders from health, medical, and consumer groups identified actions

they believe will mitigate misleading labeling and help consumers identify

healthy food. Several stakeholders support a simplified, uniform front-ofpackage symbol system to convey nutritional quality to consumers. The 

United Kingdom, Sweden, and the Netherlands have developed voluntary 

nutrition symbols, while the European Commission has proposed requiring

front-of-package labeling of key nutrients. 

To view the full product, including the scope 

and methodology, click on GAO-08-597. 

For more information, contact Lisa Shames at 

(202) 512-3841 or shamesl@gao.gov. 
Page i GAO-08-597 FDA Food Labeling Oversight

Contents

Letter 1

Results in Brief 5

Background 9

FDA Has Limited Assurance That Companies Are Complying with 

Food Labeling Requirements 13

FDA Reports That Resource Constraints and Limited Authority 

Challenge Efforts to Carry Out Food-Related Responsibilities, 

Including Food Labeling 28

Key Stakeholders Suggested Actions to Help Mitigate Misleading 

Labeling and Assist Consumers’ Efforts to Identify 

Healthy Food 33

Conclusions 42

Recommendations for Executive Action 44

Agency Comments and Our Evaluation 45

Appendixes

Appendix I: Objectives, Scope, and Methodology 48

Appendix II: FDA-Regulated and -Inspected Domestic and Foreign Food 

Firms, Fiscal Years 2001 through 2007 51

Appendix III: FDA Inspections of Food Firms in Foreign Countries, Fiscal 

Years 2001 through 2007 53

Appendix IV: Funding and Staffing Information by FDA Mission, Fiscal 

Years 1998 through 2007 56

Appendix V: FDA’s Administration of Health Claims in Response to the 

Pearson v. Shalala Ruling 60

Appendix VI: Comments from the Food and Drug Administration 65

GAO Comments 72

Appendix VII: GAO Contact and Staff Acknowledgments 75

Tables Table 1: The Number of Countries in Which FDA Conducted 

Inspections and the Number of Foreign Food Firms 

Inspected, Fiscal Years 2001 through 2007 15

Table 2: Accuracy of Nutrition Labeling Information for Food 

Samples Tested, Fiscal Years 2000 through 2006 16
Contents

Page ii GAO-08-597 FDA Food Labeling Oversight

Table 3: The Number of Food Products Tested and Violations 

Found in Nutrition Facts Panels, Fiscal Years 2000 through 

2006, for the Top Nine Countries in Value of Agricultural, 

Fish, and Seafood Imports 17

Table 4: Number of Violations of the Misbranding Provision of the 

Federal Food, Drug, and Cosmetic Act Cited in 326 FDA 

Food-Labeling-Related Warning Letters, Fiscal Years 2002 

through 2007 20

Table 5: Number of Imported Food Product Entry Lines Examined 

for Labeling Compliance, Refused Import, and Released 

with Comment, Fiscal Years 2002 through 2007 23

Table 6: Violations Cited in Food-Labeling-Related Import Refusals, 

Fiscal Years 2002 through 2007 24

Table 7: Imported Food Products Examined for Labeling 

Compliance, Products Refused Import, and Products 

Released With Comment for Fiscal Years 2002 through 

2007, for the Top Nine Countries in Value of Agricultural, 

Fish, and Seafood Imports 25

Table 8: Estimated Staffing and Funding for the Office of Nutrition, 

Labeling, and Dietary Supplements for Fiscal Years 1999 

through 2007 and Estimated Staffing and Funding for Food 

Labeling Related and Other Activities for Fiscal Years 2005 

through 2007 30

Table 9: Domestic Food Firms and Total Domestic Firms under 

FDA's Jurisdiction, by Fiscal Year 51

Table 10: Firms Inspected by FDA and States under Contract with 

FDA, Fiscal Years 2001 through 2007 52

Figures Figure 1: FDA Example of a Nutrition Facts Panel 11

Figure 2: Domestic Food Firms under FDA’s Jurisdiction and the 

Number of Firms Inspected by Both FDA and States 

under Contract with FDA, Fiscal Years 2001 through 

2007 14

Figure 3: FDA Food-Labeling-Related Warning Letters and All 

Other FDA Warning Letters Issued, Fiscal Years 2002 

through 2007 19

Figure 4: Selected Front-of-Package Symbols Used in Other 

Countries 36
Contents

Page iii GAO-08-597 FDA Food Labeling Oversight

Abbreviations

AMA American Medical Association

CFSAN Center for Food Safety and Applied Nutrition

FACTS Field Accomplishments and Compliance Tracking System

FDA Food and Drug Administration

FSIS Food Safety and Inspection Service

FTC Federal Trade Commission

FTE full-time-equivalent

HHS Department of Health and Human Services

mg milligram

NLEA Nutrition Labeling and Education Act

OASIS Operational and Administrative System for Import Support

ORA Office of Regulatory Affairs

RES Recall Enterprise System

USDA U.S. Department of Agriculture

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Page 1 GAO-08-597 FDA Food Labeling Oversight

United States Government Accountability Office

Washington, D.C. 20548

A

September 9, 2008 Letr

The Honorable Rosa DeLauro

Chair

Subcommittee on Agriculture, Rural Development, 

Food and Drug Administration, and Related Agencies

Committee on Appropriations

House of Representatives

Dear Madam Chair:

Two thirds of U.S. adults are overweight, and the incidence of childhood 

obesity and diabetes has been rising. In an effort to reverse these growing 

public health problems, medical professionals are encouraging Americans 

to eat healthier, more nutritious foods. In 2005, the Department of Health 

and Human Services (HHS) and the U.S. Department of Agriculture (USDA) 

issued Dietary Guidelines for Americans. These guidelines and the food 

guide pyramid,1

 developed by USDA to visually convey the guidelines and 

other nutrition information, help policy makers design and implement 

nutrition-related programs. Federal agencies must promote this guidance 

in carrying out federal food, nutrition, or health programs; meals served 

under the school lunch program must be consistent with the guidance. This 

guidance provides science-based dietary direction for consumers to limit 

their sugar, fat, and salt; eat more whole grains, fruits, and vegetables; and 

monitor portion size. According to the guidance, a healthy diet reduces the 

risk for chronic diseases, such as heart disease, certain cancers, diabetes, 

and stroke—all major causes of death and disability in the United States. 

Food labels contain information to help consumers who want to follow the 

dietary guidance and to make healthy food choices that best fit their dietary 

needs. Within HHS, the Food and Drug Administration (FDA) is responsible 

for administering federal food labeling requirements, in accordance with 

the Federal Food, Drug, and Cosmetic Act, as amended.2

 This act prohibits 

labeling that, among other things, is false or misleading or fails to list the 

amounts of certain nutrients. When industry, consumer groups, or others 

believe that certain types of food labeling information is false or 

1

Go to http://www.MyPyramid.gov to view USDA’s 2005 revised food guide pyramid—

entitled MyPyramid—and access hyperlinks to other nutrition information sponsored by 

the federal government. 

2

21 U.S.C. §§ 301-399.
Page 2 GAO-08-597 FDA Food Labeling Oversight

misleading, or that changes to requirements are needed for public health, 

or for other reasons, they may request or formally petition FDA to issue 

regulations or guidance to address the problem. 

FDA oversees industry compliance with the food labeling requirements as 

part of its food oversight mission. FDA’s Center for Food Safety and 

Applied Nutrition (CFSAN)—one of its six mission centers—is responsible 

for food, cosmetics, and related products. Within CFSAN, the Office of 

Nutrition, Labeling, and Dietary Supplements publishes regulations and 

guidance on food labeling and provides policy interpretations for 

overseeing compliance with statutes and regulations that, among others 

things, prohibit false or misleading labeling. FDA’s Office of Regulatory 

Affairs (ORA) undertakes inspections and enforcement activities for all 

FDA centers. 

FDA’s guidance for inspecting domestic or foreign food firms—such as 

manufacturers, processors, and other food-handling businesses—directs 

investigators to focus primarily on food safety issues and to review the 

labels on at least three products during every food safety inspection. To 

augment its inspection capacity, FDA contracts with states to carry out 

food safety inspections, following FDA guidance. When FDA inspects food 

shipments entering the United States from a foreign country, it may also 

review food labels. To test for the accuracy of labeling information, 

investigators may send samples of domestic or imported food to FDA 

laboratories for analysis. FDA also may follow up on complaints from 

consumers, consumer groups, individual firms, industry groups, or others 

who believe they have identified food that violates FDA’s labeling 

regulations. 

FDA has a number of tools for responding when food labeling violations 

are identified. It may ask companies to voluntarily recall any food that has 

already entered the distribution chain. FDA may also send a warning letter 

to a firm, which is a notice that enforcement actions may be forthcoming if 

corrections are not made; according to FDA guidance, warning letters are 

used for serious violations. For less serious violations, FDA may send an 

untitled letter, which is an informal communication that corrective actions 

are needed. At any point, FDA may hold a regulatory meeting with the firm 

to resolve a labeling violation or work with a firm to obtain voluntary 

compliance. When violations are not corrected, FDA may initiate actions to 

seize and remove the food from the marketplace (a seizure) or enjoin a firm 

from continuing a practice that violates food labeling statutes and 

regulations (an injunction). For food imported from a foreign country, FDA 
Page 3 GAO-08-597 FDA Food Labeling Oversight

may issue an import refusal to prevent a shipment with a serious labeling 

violation from entering the United States. FDA may also release a shipment 

“with comment”—that is, allow the shipment with a labeling violation to 

enter the United States with notice to the importer that subsequent 

shipments might be refused entry if the violation is not corrected. In 

addition, FDA maintains an “import alert” list to detain entries of foreign 

foods that appear to have significant recurring or unusual violations. 

In January 2007, we added federal oversight of food safety to our 

High-Risk Series, which is intended to raise the priority and visibility of 

government programs that are in need of broad-based transformation to 

achieve greater economy, efficiency, effectiveness, accountability, and 

sustainability.3

 In particular, we have noted that federal expenditures by 

FDA and USDA for food oversight have not been commensurate with the 

volume of foods regulated by the agencies or consumed by the public. In 

November 2007, a report for FDA’s Science Board—FDA Science and 

Mission at Risk—pointed out the erosion in FDA’s science base and the 

inadequacy of FDA’s information technology infrastructure.4

 The report 

cited numerous management challenges that have contributed to FDA’s 

inability to fulfill its mission and that cannot be addressed with available 

resources. Also in November 2007, FDA issued its Food Protection Plan: 

An Integrated Strategy for Protecting the Nation's Food Supply (Food 

Protection Plan),5

 which recognized the need for several changes to ensure 

the safety of the nation’s food supply and identified new authorities needed 

to implement the new strategy, such as the authority to charge user fees for 

certain reinspections. In a May 2008 letter (the May 2008 resource needs 

assessment), FDA’s Commissioner identified the resources needed in broad 

categories to, among other things, begin implementing the Food Protection 

Plan to protect against new and emerging threats to food safety.6

 We have 

testified that FDA’s plan is a good first step, but pointed out that it does not 

provide a clear description of resources and strategies that Congress will 

3

GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007).

4

HHS, FDA, FDA Science and Mission at Risk (Washington, D.C.: November 2007).

5

HHS, FDA, Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food 

Supply (Washington, D.C.: November 2007).

6

FDA’s Commissioner provided the assessment of immediate resource needs in a 

May 3, 2008, letter in response to a request from the Ranking Member, Subcommittee on 

Labor, Health and Human Services, Education, and Related Agencies, Senate Committee on 

Appropriations. 
Page 4 GAO-08-597 FDA Food Labeling Oversight

need to assess the likelihood of the plan’s success.7 Also, with respect to 

making the most of resources, in May 2008 we issued a special publication 

entitled Federal User Fees: A Design Guide, which presented various ways 

to design user fees to encourage greater efficiency, equity, and revenue 

adequacy and to reduce the administrative burden on the agency and 

payers of the fees.8

You asked us to examine (1) FDA’s efforts to ensure that domestic and 

imported foods comply with food labeling requirements, including those 

prohibiting false or misleading labeling; (2) the challenges FDA faces in its 

efforts to administer and enforce food labeling requirements; and (3) the 

actions stakeholders from health, medical, and consumer organizations 

believe are needed to mitigate the effects of food labeling practices they 

consider misleading and to help consumers identify healthy food. 

For this report, our definition of “food” includes conventional food, dietary 

supplements, infant formula, and medical food; we excluded animal feed, 

which the Federal Food, Drug, and Cosmetic Act includes in its definition 

of food. We did not independently determine whether particular food labels 

were false or misleading; the examples we cite are food labels that FDA or 

a health, medical, industry, or consumer group characterized as false or 

misleading. We also did not evaluate how efficiently FDA used its resources 

or the impact of changing priorities; nor did we compare FDA resource 

trends with other federal agencies. To examine FDA’s efforts to ensure that 

domestic and imported foods comply with food labeling statutes and 

regulations, we analyzed FDA’s and CFSAN’s plans and reports; guidance 

and regulations; and data on labeling-related oversight, enforcement, 

recalls, warning letters, and complaints. Regarding data for labeling-related 

oversight, we analyzed the food establishments or facilities (which we call 

firms) inspected for 7 fiscal years (2001 through 2007); nutrition labeling 

samples for 7 fiscal years (2000 through 2006); warning letters and 

enforcement actions related to imports for 6 fiscal years (2002 through 

2007); and seizures and injunctions for 10 fiscal years (1998 through 

2007)—the periods for which reliable and comparable FDA data were 

7

GAO, Federal Oversight of Food Safety: FDA Has Provided Few Details on the Resources 

and Strategies Needed to Implement its Food Protection Plan, GAO-08-909T (Washington, 

D.C.: June 12, 2008); and Federal Oversight of Food Safety: FDA’s Food Protection Plan 

Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical, GAO-08-435T

(Washington, D.C.: Jan. 29, 2008).

8

GAO, Federal User Fees: A Design Guide, GAO-08-386SP (Washington, D.C.: May 29, 2008).
Page 5 GAO-08-597 FDA Food Labeling Oversight

available. To identify challenges, we reviewed FDA reports and testimonies 

and analyzed funding and staffing data for FDA, CFSAN, and ORA for 

10 fiscal years (1998 through 2007) and the Office of Nutrition, Labeling, 

and Dietary Supplements, which began maintaining comparable data in 

1999, for 9 fiscal years (1999 through 2007). We also reviewed FDA 

oversight and enforcement authorities and court rulings regarding FDA 

labeling. For comparison, we examined similar information for USDA’s 

Food Safety and Inspection Service (FSIS) and the Federal Trade 

Commission (FTC), which also oversee and enforce requirements related 

to food labeling. For stakeholder positions, we analyzed the views of 

health, medical, consumer, and industry groups obtained from interviews 

and documents, such as reports and petitions. We assessed the reliability of 

the data used in this report and found it to be sufficiently reliable for the 

purposes used. We conducted this performance audit from January 2007 

through September 2008 in accordance with generally accepted 

government auditing standards. Those standards require that we plan and 

perform the audit to obtain sufficient, appropriate evidence to provide a 

reasonable basis for our findings and conclusions based on our audit 

objectives. We believe that the evidence obtained provides a reasonable 

basis for our findings and conclusions based on our audit objectives. 

Appendix I contains more detailed information on our objectives, scope, 

and methodology. 

Results in Brief FDA has limited assurance that domestic and imported foods comply with 

food labeling requirements, such as those prohibiting false or misleading 

labeling. This is because, while the number of food firms has increased 

annually, the number of inspections, warning letters, and most enforcement 

actions to address violations, has decreased or remained steady. 

Specifically, we found the following: 

• Label reviews: Although FDA guidance directs investigators to review 

labels on at least three food products when inspecting domestic and 

foreign firms, FDA has no reliable data on the number of labels that 

were actually reviewed. Moreover, the number of inspections of food 

firms has not kept pace with the growth in firms from 2001 through 

2007. The number of domestic firms under FDA’s jurisdiction increased 

from about 51,000 to more than 65,000, while the number of firms 

inspected declined slightly, from 14,721 to 14,566. FDA has inspected 

few foreign firms, while the number of imported food lines has 

increased. For example, during 2007, the United States imported food 

from tens of thousands of foreign food firms in more than 150 countries, 
Page 6 GAO-08-597 FDA Food Labeling Oversight

yet FDA inspected only 96 firms in 11 countries. In addition, FDA’s 

limited sampling of inspected food to test for the accuracy of nutrient 

information on labels found high error rates for certain nutrients. 

• Communications: The number of warning letters FDA issued to firms 

that included food labeling violations has held relatively steady since 

2002, while the total number of letters decreased by nearly half—from 

806 in 2002 to 434 in 2007. However, official data on warning letters may 

also be incomplete. In addition, FDA does not track the number of 

regulatory meetings initiated by its field offices for labeling violations, 

and it does not know whether the field offices are using the same 

criteria for these meetings. 

• Enforcement actions: FDA has initiated actions resulting in 21 seizures 

and 2 injunctions for food labeling violations, since 1998. FDA also has 

refused entry to an average of about 2,500 food product lines, annually, 

that had food labeling violations, since 2002. In addition, as of 

January 2008, FDA had 64 active import alerts for labeling violations. 

Moreover, FDA does not provide its managers with routine reports on, for 

example, (1) the status of labeling violations to help them ensure that 

corrections are made quickly and properly and (2) trends in labeling 

violations by types of products, companies, and countries to help inform 

their decisions for setting priorities and allocating resources. In addition, 

FDA does not ensure that the information it posts on its public Web site—

such as warning letters that identify labeling violations—is complete and 

posted promptly to inform consumers’ food purchase decisions. 

Furthermore, CFSAN continues to maintain a duplicate database of firms’ 

food recalls that FDA had agreed to eliminate in response to our 2004 

recommendation.9

FDA has reported that limited resources and authorities significantly 

challenge its efforts to carry out food safety responsibilities—challenges 

that also impact efforts to administer and enforce labeling requirements. 

Specifically, we found the following:

• Resources: From 1999 through 2007, funding and staffing for CFSAN’s 

Office of Nutrition, Labeling, and Dietary Supplements rose and fell 

9

GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of 

Potentially Unsafe Food, GAO-05-51 (Washington, D.C.: Oct. 6, 2004).
Page 7 GAO-08-597 FDA Food Labeling Oversight

several times. Funding fluctuated from $6.8 million to $10.0 million and 

staffing from 65 to 88 full-time-equivalent (FTE) staff. In 2007, funding of 

$8.2 million was its lowest since 2001, and staffing of 65 FTEs was a 

9-year low. However, the portion of that office’s funding and staffing 

dedicated to food labeling activities has held fairly constant since 

2005—with funding rising from $1.1 million to $1.3 million and staffing 

from 9.0 to 10.5 FTEs. In addition, officials told us FDA does not have 

the resources to conduct the substantial additional research on 

consumer perceptions necessary to demonstrate that a food label is 

misleading.

• Authority: FDA’s Food Protection Plan notes that certain authorities are 

not available to most food programs that could allow FDA to maximize 

resources—authorities that could also facilitate labeling oversight. The 

plan seeks, among other things, authority to charge user fees for 

reinspecting firms that had violated important requirements; accredit 

qualified third parties to conduct certain types of reviews and 

inspections; and mandate food recalls if necessary, which it may do for 

infant formula and certain medical products. Such authorities currently 

help other regulatory agencies and are maintained by other FDA mission 

centers. As FDA pursues new statutory authority for user fees, it could 

benefit from information in GAO’s Federal User Fees: A Design Guide

to, among other things, ensure optimal efficiency and minimal burden.10

Regarding accrediting third parties, FDA could benefit from lessons 

learned in other FDA programs that use third parties to leverage 

inspection resources. 

Stakeholders we interviewed—including key health, medical, and 

consumer organizations—identified several actions that they believe will 

mitigate misleading labeling and help consumers identify healthy food. For 

example, according to many, consumers find the range of information on 

labels confusing and misleading. To help consumers more easily and 

quickly identify healthy food, many stakeholders in the United States and 

overseas support the addition of a uniform system of symbols on the frontof-package labels to indicate nutritional quality. The National Academies’ 

Institute of Medicine recommended in 2006 that industry, government, 

scientists, and consumer groups jointly develop such a system. Other 

countries, such as the United Kingdom and Sweden have developed 

voluntary nutrition symbol systems, and Canada is consulting with 

10GAO-08-386SP.
Page 8 GAO-08-597 FDA Food Labeling Oversight

stakeholders and proposing research on front-of-package nutrition 

symbols. The European Commission has proposed a system for mandatory 

front-of-package nutrition labeling. FDA held a public hearing in 2007 to 

solicit comments on front-of-package nutrition symbols and has begun 

researching this approach. 

We are recommending seven actions that FDA should take to (1) ensure 

that labeling office managers have the information they need to oversee 

compliance with food labeling laws and regulations; (2) ensure that the 

public has timely access to information on food labeling violations that may 

have serious health consequences on FDA’s public Web site; and (3) better 

leverage resources to carry out food-related mission responsibilities, 

including developing detailed information on how the new authorities it 

seeks would help it achieve its mission, and evaluating options for 

conveying nutritional quality that will mitigate consumer confusion and 

misleading labeling. 

In commenting on a draft of our report, FDA stated that the report raised 

some important issues regarding its regulation of food labeling and it did 

not dispute the report’s data, analyses, or findings. It commented, however, 

that the report inappropriately references food labeling as part of its food 

safety mission, although it acknowledges that there may be some aspects 

of food labeling that can affect the safe use of food. That notwithstanding, 

FDA requires investigators to review at least three labels during food safety 

inspections. FDA also stated that within its overall public health mission, it 

has a multitude of competing priorities. We acknowledged FDA’s 

competing priorities in the report’s conclusions and framed the 

recommendations so as to help manage these competing priorities by 

better leveraging resources and using available tools and data for riskbased decisions. 

With respect to our recommendations, FDA generally agreed with some, 

but with qualifications. Regarding our recommendations that FDA ensure 

managers have information they need for effective food labeling oversight 

by maintaining and analyzing data they need on violations in routine 

reports, FDA agreed that being able to track any and all information that 

would allow investigators to better do their jobs would be useful to the 

agency. However, FDA stated that data collection requires time and effort 

and it is important to make sure that data entry does not become so 

burdensome that it takes away from other investigative work. FDA did not 

commit to taking any actions in response to these recommendations. We 

maintain that FDA cannot make risk-based decisions, including resource 
Page 9 GAO-08-597 FDA Food Labeling Oversight

allocation decisions, effectively without analyzing the detailed food 

labeling data that the agency has collected for many years. Regarding our 

recommendation that FDA provide timely and complete data for 

consumers on its public Web site, FDA said that it already does post and 

maintain much of the information. However, as our report points out, FDA 

did not post warning letters promptly and had no assurance that the posted 

data on food labeling violations were accessible. In addition, consumers 

should receive complete and timely information and statistics to inform 

their food purchase decisions. Regarding our recommendation on 

collaboration with federal agencies and other stakeholders to evaluate 

labeling options, FDA provided information on the focus of its current 

research and identified many aspects of symbols that it intends to 

research. However, a broad research agenda will likely require extensive 

resources over several years. We considered FDA’s competing resource 

demands when we developed our last recommendation—to better leverage 

those resources by collaborating with other federal agencies and 

stakeholders who may be able to contribute resources in the form of staff 

or funding. Finally, FDA did not comment on our recommendations related 

to tracking regulatory meetings, providing Congress with information on 

the new authorities requested in the Food Protection Plan, and posting 

updates of the status of implementation of this plan on FDA’s public Web 

site. 

Background The Federal Food, Drug, and Cosmetic Act, as amended, prohibits the 

“misbranding” of food, which includes, among other things, labeling that is 

false or misleading. In 1990, Congress amended the act to mandate that 

certain nutrition information be provided on packaged foods in a specified, 

standardized format—only recently have other countries, such as Canada, 

initiated mandatory nutrition labeling. The act, and FDA regulations 

implementing it, require food labels to include nutrient, ingredient, and 

other important content information that consumers can use to make 

healthy dietary choices, and to avoid allergens (such as peanuts) and other 

ingredients (such as sulfites) that can cause life-threatening reactions in 
Page 10 GAO-08-597 FDA Food Labeling Oversight

people who are sensitive to them. For example, the act and FDA’s 

regulations, with some exceptions,11 require that food labels include the 

following:

• a Nutrition Facts panel that identifies the serving size; the number of 

servings per container; the number of calories per serving; and the 

amount of certain nutrients, such as fiber, vitamins, fat, and sodium;12

• an ingredients list that identifies the product’s ingredients by their 

common or usual names, in order of predominance by weight; 

• the required information in English;

13 and

• a declaration of the source (e.g., tree nuts) of major allergens.

Figure 1 depicts an example of a Nutrition Facts panel from FDA’s 

regulations illustrating nutrition information and visual display.

11Certain small businesses are exempt from certain labeling requirements and other 

exceptions exist—for example, packaged fresh fruits or vegetables, in which nutrients vary 

depending on growing conditions, are not generally required to include a Nutrition Facts 

panel. 

12Dietary supplements have different labeling requirements. 

13On labels for products distributed solely in Puerto Rico or in a U.S. Territory where the 

predominant language is not English, the predominant language may be substituted for 

English.
Page 11 GAO-08-597 FDA Food Labeling Oversight

Figure 1: FDA Example of a Nutrition Facts Panel 

The act and FDA regulations also require that health claims—that is, claims 

characterizing the relationship of certain nutrients to a disease or a healthrelated condition—on food labels be authorized by FDA. For example, a 

main dish that contains 140 milligrams (mg) or less of sodium per 100 

grams may be labeled with the claim that “diets low in sodium may reduce 

the risk of high blood pressure, a disease associated with many factors,” 

provided there are no nutrients in the food at levels that would disqualify it 

from making this claim. In regulations, FDA has authorized the use of 

claims for 12 relationships between a nutrient and a disease or healthrelated condition. 

For purposes of compliance, with certain exceptions, a food is subject to 

enforcement action under FDA regulations if the number of calories or the 

Source: FDA.
Page 12 GAO-08-597 FDA Food Labeling Oversight

amount of certain nutrients, such as fat and sugar, is more than 20 percent 

over the amount declared in the Nutrition Facts panel. The Institute of 

Medicine established the reference nutrient values that FDA used (along 

with the Dietary Guidelines for Americans) to establish the daily values for 

nutrients on the Nutrition Facts panel. In addition, for compliance and 

enforcement purposes, the amount of certain nutrients naturally occurring 

in the food must be at least equal to 80 percent of the value declared on the 

label; the amount of added nutrients in fortified or fabricated foods must be 

at least equal to the amount shown on the panel. According to FDA, these 

variations are allowed because, for naturally occurring nutrients, values 

cannot be precisely controlled and depend on weather and soil conditions, 

among other variables; in addition, values will vary because different 

laboratories use different methods and testing devices. 

FDA’s procedures for handling a product complaint require staff to obtain 

sufficient information from the complainant to evaluate the complaint and 

determine if it requires follow-up. Also, the complaint is to be documented 

in the Field Accomplishments and Compliance Tracking System (FACTS). 

For a food-labeling-related complaint, the information documented in 

FACTS should include, among other things, any injury, illness, or adverse 

event that was reported as having occurred as a result of incorrect labeling, 

and any follow-up actions. Complaints of significant illness or injury must 

receive immediate and thorough follow-up, while follow-up on those 

complaints that do not involve injury or illness may be deferred until the 

next scheduled inspection of the responsible firm, which may be in a few 

weeks, months, or several years.

Similarly, FTC authorities prohibit unfair or deceptive acts or practices in 

or affecting commerce, including false or misleading advertising of food 

products. In some cases, FDA and FTC have certain overlapping 

jurisdiction for regulating food advertising, labeling, and promotion. In a 

1971 memorandum of understanding, the agencies agreed that FTC would 

exercise primary responsibility for ensuring that food advertising is truthful 

and not misleading, and that FDA would have primary responsibility for 

ensuring that food labeling is truthful and not misleading.
Page 13 GAO-08-597 FDA Food Labeling Oversight

FDA Has Limited 

Assurance That 

Companies Are 

Complying with Food 

Labeling Requirements

FDA’s use of oversight and enforcement tools has not kept pace with the 

growing number of food firms. As a result, FDA has limited assurance that 

companies in the food industry are in compliance with food labeling 

requirements, such as those prohibiting false or misleading labeling. FDA’s 

testing of nutrition information has been limited and has found varying 

degrees of compliance. Actions in response to labeling violations, such as 

issuing warning letters, have generally decreased or remained steady. In 

addition, FDA has not analyzed data on labeling violations and follow-up 

activities to inform its managers or the public. Furthermore, CFSAN has 

continued to maintain a duplicate food recall system that FDA had agreed 

to eliminate in response to a recommendation we made in a 2004 report.14

Food Labeling Oversight 

Has Not Kept Pace with the 

Growing Number of Firms 

While the number of domestic food firms has increased, FDA has not 

increased the number of its inspections in response to this increase (see 

fig. 2). Also, FDA does not have reliable data on the total number of labels 

reviewed because investigators do not have to enter this information into 

the FACTS database, which documents other inspection details. In the 

absence of reliable data on the number of labels reviewed, and assuming 

that investigators were reviewing three labels each time, as FDA officials 

told us was the common practice, the number of labels reviewed would 

have declined with the decline in the number of inspections. 

14GAO-05-51.
Page 14 GAO-08-597 FDA Food Labeling Oversight

Figure 2: Domestic Food Firms under FDA’s Jurisdiction and the Number of Firms 

Inspected by Both FDA and States under Contract with FDA, Fiscal Years 2001 

through 2007

FDA has conducted few inspections in foreign food firms and that number 

has declined significantly—from 211 in 26 countries in 2001 to 95 in 11 

countries in 2007—even as the United States has received hundreds of 

thousands of different imported food product entry lines15 from tens of 

thousands of foreign food firms in more than 150 countries. (See app. II for 

information on the number of domestic and foreign food firms inspected 

under FDA’s jurisdiction during fiscal years 2001 through 2007.) Table 1 

shows the number of countries and foreign food firms inspected over this 

period. 

15A food product entry line is each portion of a shipment that is a separate type of product. 

0

10

20

30

40

50

60

70

2001 2002 2003 2004 2005 2006 2007

Number of food firms (in thousands)

Source: GAO analysis of FDA FACTS data.

Fiscal year

Food firms inspected

Total food firms

14.7 14.7

17.5

59.3 58.3

16.7

14.6

62.9

51.0

58.6

65.5

61.9

18.0

15.2
Page 15 GAO-08-597 FDA Food Labeling Oversight

Table 1: The Number of Countries in Which FDA Conducted Inspections and the 

Number of Foreign Food Firms Inspected, Fiscal Years 2001 through 2007

Source: GAO analysis of FDA data.

a

The total number of countries was adjusted to count each country only once. FDA had conducted 

inspections in some countries more than once over the 7-year period.

Appendix III lists the countries and the number of inspections FDA 

conducted in each country, from fiscal years 2001 through 2007. 

In addition, FDA reported inspecting about 1 percent of the different food 

product entry lines that came into the United States annually during fiscal 

years 2002 through 2007. However, unlike investigators who perform 

inspections at manufacturing firms, the investigators who review labels on 

imported foods are not able to see the manufacturing process, the 

ingredients stored on shelves, the product formulation, and other 

documents that provide key information that helps to identify labeling 

violations. 

Testing to Determine the 

Accuracy of Nutrient 

Information Is Limited and 

Outdated, and Shows 

Varying Degrees of 

Compliance

While FDA has tested some targeted nonrandom samples of food products 

to determine the accuracy of nutrition information on their labels, it has 

tested relatively few food products from some major exporting countries. 

In addition, FDA has done no random sampling since the 1990s, when some 

compliance rates varied considerably from the amount identified on the 

Nutrition Facts panel. From fiscal years 2000 through 2006, FDA collected 

targeted samples of 868 domestic products and 783 imported products for 

tests of compliance with nutrition labeling regulations. FDA was unable to 

provide information on samples taken and test results for fiscal year 2007 

because, according to an agency official, the person who analyzed those 

data had retired from FDA. 

According to FDA officials, investigators often selected samples because 

they noticed obvious labeling violations, such as a candy bar with a 

Nutrition Facts panel that did not identify any fat or sugar. As table 2 

shows, about 21 percent and 28 percent, respectively, of the domestic and 

imported foods tested were in violation.

. 

Fiscal year 

Foreign inspection 2001 2002 2003 2004 2005 2006 2007 Total

Number of countries 26 22 22 20 16 15 11 54a

Number of food firms 211 169 148 153 132 125 95 1,034
Page 16 GAO-08-597 FDA Food Labeling Oversight

Table 2: Accuracy of Nutrition Labeling Information for Food Samples Tested, Fiscal Years 2000 through 2006

Source: GAO analysis of FDA FACTS data. 

Note: FDA was unable to provide these data for fiscal year 2007.

The number of samples of imported food FDA has tested for accuracy of 

nutrition labeling does not relate to the volume of imports or the rate of 

violations in products from a given country, as table 3 shows. One type of 

food with a high percentage of violations was infant formula—4 of the 10 

formula products sampled were in violation—because they lacked the 

vitamins, minerals, or other nutrients required by law. 

 Domestic samples Imported samples Total domestic and imported samples

Fiscal 

year

Number 

tested

Number in 

violation

 Percentage 

in violation 

Number 

tested

Number in 

violation

Percentage 

in violation 

Number 

tested

Number in 

violation

Percentage 

in violation 

2000 106 15 14% 150 36 24% 256 51 20%

2001 93 24 26 53 20 38 146 44 30

2002 85 12 14 88 23 26 173 35 20

2003 147 34 23 188 60 32 335 94 28

2004 181 43 24 131 38 29 312 81 26

2005 141 27 19 77 19 25 218 46 21

2006 115 23 20 96 27 28 211 50 24

Total 868 178 21% 783 223 28% 1,651 401 24%
Page 17 GAO-08-597 FDA Food Labeling Oversight

Table 3: The Number of Food Products Tested and Violations Found in Nutrition 

Facts Panels, Fiscal Years 2000 through 2006, for the Top Nine Countries in Value of 

Agricultural, Fish, and Seafood Imports 

Source: GAO analysis of value of imports data for 2006 from USDA’s Foreign Agricultural Service and testing data from FDA’s FACTS. 

Notes: 

The country from which a food product was imported may not be the country of origin of the food 

product. For example, food imported from Canada may have originated in another country. 

FDA was unable to provide FACTS sample testing data for fiscal year 2007.

a

The data for China do not include Hong Kong and Macau.

While FDA has conducted targeted, nonrandom sampling of labels on 

imported and domestic food products suspected of having inaccurate 

information (beyond the allowable ranges) for nutrients listed on their 

labels, FDA has not conducted random sampling on nutrition labeling since 

the 1990s. In 1994 and again in 1996, FDA tested 300 randomly selected 

products to determine the extent to which nutrient information on the 

Nutrition Facts panel was within the allowable range. According to FDA’s 

analysis of these products, 87 percent (in 1994) and 91 percent (in 1996) of 

the nutrients were within the allowable range. However, compliance rates 

varied significantly for a few nutrients. For example, in 1994 and 1996, 

respectively, 48 percent and 47 percent of the samples were not within the 

allowable range for vitamin A; 48 percent and 12 percent of the samples 

were not within the allowable range for vitamin C; and 32 percent and 31 

U.S. dollars in billions

Food samples tested, fiscal years 2000-2006

Country (value of agricultural 

imports for 2006)

Number 

tested 

Number in 

violation

Percentage in 

violation

Canada ($15.6) 93 13 14%

Mexico ($9.8) 200 87 44

Chinaa ($4.2) 26 7 27

Thailand ($3.1) 18 8 44

Italy ($2.8) 31 8 26

Indonesia ($2.8) 2 0 0

Chile ($2.7) 8 2 25

Australia ($2.6) 10 1 10

Brazil ($2.4) 7 4 57
Page 18 GAO-08-597 FDA Food Labeling Oversight

percent of the samples were not within the allowable range for iron.16

These variances are important because consuming too much or too little of 

certain vitamins and iron may have adverse health consequences. FDA 

officials cited resource constraints and other priorities as reasons for not 

updating these studies and told us that FDA has no plans for future studies. 

Actions in Response to 

Labeling Violations Have 

Generally Decreased or 

Remained Steady 

FDA has available several tools to ensure that food labeling complies with 

requirements: (1) issuing warning and untitled letters and holding 

regulatory meetings and (2) taking enforcement actions—seizures, 

injunctions, import refusals, and import alerts. However, we found that 

FDA’s efforts have generally declined or held steady. 

FDA Warning Letters for Food 

Labeling Violations Have 

Remained Steady

From fiscal years 2002 through 2007, FDA issued 463 warning letters to 

firms with serious violations that included food labeling violations—often 

with other food-safety-related violations—notifying them that enforcement 

actions might be forthcoming if corrections were not made. The number of 

warning letters issued annually that included food-labeling-related 

violations held relatively steady during the period. On the other hand, the 

number of letters issued for all FDA-regulated products (e.g., food, drugs, 

and medical devices) decreased by nearly half—from 806 letters in fiscal 

year 2002 to 434 in fiscal year 2007. However, as we conducted our study, 

FDA continued to find additional warning letters that had been issued for 

fiscal years 2002 through 2007. In addition, according to FDA, its Fiscal 

Year 2007 Enforcement Story reported 471 warning letters for 2007. Thus, 

the number of food-labeling-related warning letters, as well as total FDA 

warning letters, may be higher than we report. Figure 3 shows the number 

of warning letters issued annually for fiscal years 2002 through 2007.

16Life Sciences Research Office, Federation of American Societies for Experimental Biology. 

“Analytical Data and Label Review of 300 Food Products” (Bethesda, MD: October 1994). 
Page 19 GAO-08-597 FDA Food Labeling Oversight

Figure 3: FDA Food-Labeling-Related Warning Letters and All Other FDA Warning 

Letters Issued, Fiscal Years 2002 through 2007 

The labeling-related warning letters addressed violations for different 

product types—including candy, baked goods, seafood, and juice drinks—

that were identified through inspections or testing product samples. About 

52 percent (241 of 463) of the letters were for dietary supplements. Of the 

463 food-labeling-related warning letters, 326 cited specific violations of 

the misbranding provision of the Federal Food, Drug, and Cosmetic Act; 

the other 137 letters cited other statutory provisions and regulations. As 

shown in table 4, the 326 letters that cited the misbranding provision 

included references to 677 violations in 15 different categories. 

0

100

200

300

400

500

600

700

800

900

2002 2003 2004 2005 2006 2007

Number of warning letters

Fiscal year

67 107 75 68 85 61

739

654

655

451 441

373

All other FDA warning letters

Food-labeling-related warning letters

Source: GAO analysis of FDA’s online database of warning letters.
Page 20 GAO-08-597 FDA Food Labeling Oversight

Table 4: Number of Violations of the Misbranding Provision of the Federal Food, 

Drug, and Cosmetic Act Cited in 326 FDA Food-Labeling-Related Warning Letters, 

Fiscal Years 2002 through 2007

Source: GAO analysis of FDA warning letters.

FDA officials explained that they try to focus their oversight efforts on the 

labeling violations of public health significance and on the types of 

products with widespread or persistent violations. For example, on 

October 17, 2005, FDA issued 29 warning letters to manufacturers of cherry 

juice and other fruit products for unapproved claims related to diseases, 

and 25 letters on October 12, 2006, to makers of dietary supplement 

products that had drug claims or unauthorized health claims.

Food-labeling-related violation

Number of 

violations in the 326 

letters

Percentage 

of total 

violations

Meets the generic finding that the “label is false or 

misleading in any particular” 163 24.1%

Fails to meet the requirements to bear health 

and/or nutrient content claims 129 19.1

Fails to declare all of the ingredients by their 

common or usual name 107 15.8

Does not comply with the format and content 

requirements for nutrition information 84 12.4

Lacks common or usual name of the food 46 6.8

Lacks name and location of the manufacturer, 

packer, or distributor 30 4.4

Contains undeclared flavoring, coloring, or 

chemical preservatives 27 4.0

Bears a drug claim not allowed on a dietary 

supplement label 25 3.7

Fails to declare accurate weight, quantity, or 

numerical count 22 3.2

Fails to declare sources of all major food allergens 16 2.4

Does not meet the standard identity indicated on 

the label 10 1.5

Does not meet standard that information required 

be prominently placed on the label 9 1.3

Claims, inaccurately, to contain ginseng 5 0.7

Offered for sale under the name of another food 2 0.3

Fails to declare the food is an imitation 2 0.3

Total 677 100%
Page 21 GAO-08-597 FDA Food Labeling Oversight

FDA officials told us that warning letters are an important and very public 

tool for ensuring compliance with FDA regulations and alerting other 

companies of practices that are not acceptable. Furthermore, FDA, in 

accordance with Freedom of Information Act requirements, makes these 

letters available on its public Web site.17 However, we found several 

problems with FDA’s public dissemination of warning letters that call into 

question the accuracy of its numbers. For example, we tested the reliability 

of this database and found that it was missing over 220 warning letters. 

When we brought the missing letters to their attention, FDA officials told 

us they posted them. Although FDA officials assured us that the database 

was complete and accurate, in February 2008 and later, we found duplicate 

letters in the database as well as additional letters that had been issued 

during fiscal years 2006 and 2007. Therefore, the number of warning letters 

posted on FDA’s Web site for fiscal years 2002 through 2007 may be 

different from the number shown in figure 3. In April 2008, FDA officials 

told us they were continuing to work on the database and to discuss 

potential process improvements to help ensure that all letters are posted.

In fiscal year 2001, FDA had issued nearly twice as many warning letters for 

all violations than in 2002. FDA officials attributed the decrease in warning 

letters, in part, to new policies that transferred the approval of warning 

letters from FDA centers and districts to the Office of Chief Counsel. FDA 

officials told us that the target turnaround time for issuing a warning 

letter—the elapsed time between the day officials identify the violation, 

either through an inspection, laboratory test, or illness outbreak 

investigation, and the day FDA issues a warning letter—is about 4 months. 

This is a nearly fourfold increase over the 30-workday target time we 

reported in February 2005.18 A longer lag time to issue a warning letter 

increases the number of days for which consumers may consume the 

misbranded food before FDA posts these serious problems on its Web site. 

In addition, FDA estimated that it has sent one third as many untitled 

letters—correspondence citing violations that FDA deems as not 

warranting a warning letter—as warning letters. We did not assess untitled 

letters because FDA did not centrally track the letters in a database, nor did 

17To access warning letter data on FDA’s public Web site, go to 

http://www.fda.gov/foi/warning.htm. 

18GAO, Mad Cow Disease: FDA’s Management of the Feed Ban Has Improved, but 

Oversight Weaknesses Continue to Limit Program Effectiveness, GAO-05-101 (Washington, 

D.C.: Feb. 25, 2005).
Page 22 GAO-08-597 FDA Food Labeling Oversight

it maintain copies centrally until fiscal year 2008. Regarding regulatory 

meetings, FDA could not tell us how many were held because these 

meetings are handled exclusively by the district offices and are not 

centrally tracked. FDA does not receive any information on the extent to 

which districts are using these meetings and whether the different field 

offices are using the same criteria for these meetings. 

More Serious Enforcement 

Actions on Labeling Are 

Generally Limited

FDA has taken few enforcement actions—seizures, injunctions, and import 

refusals—for food labeling violations and issued a number of labelingrelated import alerts. FDA was able to provide us with data on seizures and 

injunctions for 10 years and on import refusals and import alerts for 6 

years.

Seizures: In fiscal years 1998 through 2007, FDA had initiated actions that 

resulted in court seizures of 21 products in domestic commerce for foodlabeling-related violations. Of the 21 seizures, most were of imported 

products. Olive oil, dietary supplements, and mushrooms were the most 

frequently seized products. 

Injunctions: According to FDA documents, the courts enjoined two 

companies in response to possible labeling violations for fiscal years 1998 

through 2007.19 On February 3, 2006, FDA obtained a consent decree of 

permanent injunction against Natural Ovens Bakery, Inc., for allegedly 

introducing misbranded foods, including dietary supplements, and 

misbranded and unapproved drugs into interstate commerce and for 

causing foods to become misbranded. According to FDA documents, the 

injunction was obtained after a 20-year history of noncompliance with FDA 

regulations, and 3 years after an April 8, 2003, warning letter that FDA's 

Minneapolis District Office had issued in response to inspections 

conducted in December 2002, February 2002, and September 2001. The 

other was a consent decree of permanent injunction, entered in September 

2003 against a dietary supplement manufacturer—Hi-Tech 

Pharmaceuticals, Inc.—for allegedly labeling dietary supplements with 

drug claims, which violated food labeling requirements and caused FDA to 

have to regulate the supplements as drugs and, specifically, as unapproved 

new drugs. FDA considered this injunction to be food-labeling-related. 

19After fiscal year 2007 ended, FDA obtained another consent decree of permanent 

injunction prohibiting Brownwood Acres Foods, Inc., from promoting its fruit products and 

dietary supplements with unauthorized health claims and unapproved drug claims.
Page 23 GAO-08-597 FDA Food Labeling Oversight

Import refusals: FDA refused entry to 15,226 imported food product entry 

lines that had labeling violations from fiscal years 2002 through 2007.20 In 

fiscal year 2002, while FDA examined the fewest labels, it refused entry to 

the highest percentage of foods; conversely, in fiscal year 2005, FDA 

examined the greatest number of labels, and refused entry to the lowest 

percentage of foods over the 6-year period. In addition, over this period, 

14,851 products that had labeling violations were released “with 

comments”—meaning that FDA allowed the shipment with a labeling 

violation to enter the United States with notice to the importer that 

subsequent shipments could be refused entry if the violation was not 

corrected.21 Releases with comment are intended to cover deficiencies FDA 

regards as minor, nonhealth-significant. If FDA finds additional imports of 

one of these products with the same violation 60 or more days after the 

earlier shipment is released with comments, FDA may consider detention, 

according to FDA officials. (See table 5.) 

Table 5: Number of Imported Food Product Entry Lines Examined for Labeling Compliance, Refused Import, and Released with 

Comment, Fiscal Years 2002 through 2007

Source: GAO analysis of FDA Operational and Administrative System Import Support data.

Note: While food labeling was listed as a reason in each import refusal and release with comment, it 

was not necessarily the only reason, nor was it necessarily the most serious violation.

20FDA currently uses the term “import refusals” for its detention authority under section 

801(a) of the Federal Food, Drug, and Cosmetic Act. 

21According to FDA officials, there may also be shipments that were detained for labeling 

violations, reconditioned by the owner, and then released. 

Product lines 

examined for labeling 

compliance

Product lines refused import that had 

labeling violations

Product lines released with comments that 

had labeling violations

Fiscal 

year Number Number

Percentage of total 

product lines examined Number

Percentage of total product 

lines examined 

2002 16,275 2,357 14.5% 1,518 9.3%

2003 29,383 2,919 9.9 3,104 10.6

2004 30,598 2,671 8.7 2,657 8.7

2005 38,782 2,498 6.4 2,304 5.9

2006 34,753 2,497 7.2 2,885 8.3

2007 34,215 2,284 6.7 2,383 7.0

Total 184,006 15,226 8.3% 14,851 8.1%
Page 24 GAO-08-597 FDA Food Labeling Oversight

For import refusals, the most frequent labeling violations cited were the 

lack of required nutrition information (25 percent); the failure to list the 

common or usual name of each ingredient (18 percent); the failure to 

accurately state the product’s weight, measure, or numerical count (13 

percent); and the failure to provide the label in English (12 percent). (See 

table 6.) 

Table 6: Violations Cited in Food-Labeling-Related Import Refusals, Fiscal Years 

2002 through 2007

Source: GAO analysis of FDA data.

a

The “other” category includes 13 types of violations, such as “inaccurately represents fish as catfish” 

and “fails to declare all major food allergens.”

Of the nine countries with the greatest value of agricultural, fish, and 

seafood imports to the United States in fiscal year 2006, Canada was the 

largest—with a total value of $15.6 billion; Mexico was second with $9.8 

Food-labeling-related violation 

Number of 

violations

Percentage 

of total 

violations

Lacks required nutrition information 6,909 25%

Lacks the common or usual ingredient name 4,840 18

Fails to declare accurate weight, quantity, or numerical count 3,519 13

Lacks information in English 3,348 12

Lacks name and location of the manufacturer, packer, or 

distributor 1,906 7

Lacks common or usual name of the food 1,576 6

Fails to indicate apparent added coloring 1,022 4

Bears a label that is inconspicuous and unlikely to be read 842 3

Bears false and misleading information 673 2

Bears a label with 1 of 13 “other” categories with less than 1 

percent of the violations citeda 628 2

Fails to declare apparent color additive Yellow No. 5 552 2

Does not meet FDA’s standard of identity 397 1

Fails to declare a chemical preservative 356 1

Fails to declare the trans fat content 222 1

Lacks prominent statement of the percentage of vegetable 

or fruit juice 217 1

Fails to declare sulfites 174 1

Bears an unauthorized nutrient/health claim 158 1

Total 27,339 100%
Page 25 GAO-08-597 FDA Food Labeling Oversight

billion, followed by China with $4.2 billion. As shown in table 7, during 

fiscal years 2002 through 2007, Canada also had the most food labels 

reviewed (45,377) and lowest rate of import refusals (2.6 percent) where a 

labeling violation was cited, while Australia had the fewest label reviews 

(697) and the highest rate of import refusals (14.3 percent) where a labeling 

violation was cited.

Table 7: Imported Food Products Examined for Labeling Compliance, Products Refused Import, and Products Released With 

Comment for Fiscal Years 2002 through 2007, for the Top Nine Countries in Value of Agricultural, Fish, and Seafood Imports

Source: GAO analysis of FDA OASIS data and value of imports data for 2006 from USDA’s Foreign Agricultural Service.

Note: The country from which a food product was imported is not necessarily the country of origin of 

the food product. For example, food imported from Canada may have originated in the United 

Kingdom. In addition, while food labeling was a reason in each of the import refusals and imports 

released with comment, it was not necessarily the only reason, nor was it necessarily the most serious 

violation.

a The data for China do not include Hong Kong and Macau.

Import alerts: As of January 28, 2008, FDA gave us information on active 

import alerts for 64 food products that officials characterized as labeling 

violations. For example, FDA issued import alerts for several different 

types of biscuits imported from India that did not use the common or usual 

name for ingredients. Once a product is on the import alert list, FDA does 

not remove it until the firm appears to have corrected the violation, 

Products

Examined for 

labeling 

compliance

Refused import that had labeling 

violations

Released with comments that 

had labeling violations

Country (value of 

agricultural, fish, and 

seafood imports in 2006, in 

billions) Number Number

Percentage of 

products examined Number

Percentage of 

products 

examined

Canada ($15.6) 45,377 1,174 2.6% 1,538 3.4%

Mexico ($9.8) 25,622 1,964 7.7 830 3.2

Chinaa ($4.2) 8,595 655 7.6 991 11.5

Thailand ($3.1) 5,362 253 4.7 489 9.1

Italy ($2.8) 4,891 429 8.8 563 11.5

Indonesia ($2.8) 1,726 156 9.0 173 10.0

Chile ($2.7) 1,136 34 3.0 133 11.7

Australia ($2.6) 697 100 14.3 67 9.6

Brazil ($2.4) 2,321 220 9.5 338 14.6

Total 95,727 4,985 5.2% 5,122 5.4%
Page 26 GAO-08-597 FDA Food Labeling Oversight

according to FDA officials. Twenty of the 64 products on import alert were 

added during fiscal year 2007, and 1 of the remaining 44 had been in effect 

since April 2000. In technical comments on a draft of this report, FDA 

indicated that 64 alerts seemed too low and that it may not have provided 

us with all import alerts for labeling violations. However, FDA did not 

provide additional information or documentation on those alerts.

FDA Has Collected but Not 

Analyzed Data on Labeling 

Violations and Follow-up 

Actions 

 FDA does not centrally track or analyze data on potentially serious 

labeling violations or firms’ actions to correct those violations. We 

repeatedly requested any routine reports on labeling compliance that FDA 

managers used to help them carry out their program oversight 

responsibilities. However, according to officials, they do not generate such 

routine reports due, in part, to resource limitations and to limitations in 

FDA information systems. For example, over the past decade, FDA has 

never analyzed the results of the laboratory tests on the accuracy of 

labeling information (e.g., the Nutrition Facts panel and declared allergens) 

on domestic and imported foods. An official said they had always wanted 

to develop computer programs that would identify trends, but did not have 

the staff to do so. Also, FDA does not routinely analyze and report on 

trends in labeling violations. As a result, FDA managers do not have 

important information to inform their decision making on setting priorities 

for overseeing compliance with labeling requirements and allocating 

resources for labeling program activities. 

Furthermore, FDA does not provide consumers and others with important 

information on its public Web site to help inform their food purchasing 

decisions. As we have previously noted, FDA’s Web site’s posting of 

warning letters has not been kept current and complete. In addition, 

although FDA maintains import refusals and warning letters, its Web site 

does not provide the public with summary information on, and trends in, 

serious labeling violations by, for example, product type, company, and 

country.

In addition, from fiscal years 2001 through 2007, FDA documented 

approximately 2,600 complaints from consumers on food labeling issues in 

FACTS—its compliance tracking system. These data included complaints 

that ingredients—such as allergens—in the food were not listed on the 

label and may harm consumers’ health. However, the data concerning 

complaints were not entered into FACTS in a way that would facilitate 

analysis. Specifically, standard terminology was not used and information 

on complaint resolutions was captured in different data fields. As a result, 
Page 27 GAO-08-597 FDA Food Labeling Oversight

FDA program managers cannot readily use these FACTS data to track the 

timely and appropriate resolution of consumer labeling complaints. 

CFSAN Continues to 

Maintain Duplicate Recall 

Database

According to our analysis of FDA’s Recall Enterprise System (RES) 

database, 409 of the 1,295 food product recalls that firms carried out during 

fiscal years 2003 through 2007 listed food labeling violations, such as failing 

to list added chemical preservatives on labels, as a factor. While food 

labeling was listed as a reason in each of the 409 recalls, it was not 

necessarily the only reason nor was it necessarily the most serious 

violation. In addition, almost 57 percent of the labeling-related recalls were 

for violations that FDA classifies as high risk—that is, posing a reasonable 

probability of causing serious adverse health consequences or death—such 

as labels that fail to identify certain allergens in the food, such as tree nuts, 

that are potentially deadly to individuals who are sensitive to them. 

However, CFSAN maintains an unofficial database of food recalls and 

reported that it was able to identify more labeling-related recalls than we 

did in using the official RES. In the course of our work, we learned that 

CFSAN has continued to maintain this unofficial database for food recalls 

apart from the official RES. In October 2004, we first reported CFSAN’s use 

of this duplicative recall database and the discrepancies between the 

unofficial data and the official data.22 At the time, CFSAN program staff told 

us they used the unofficial database to generate reports for Congress 

because it contained the most accurate data. We pointed out that keeping 

the second database raised significant questions about the validity and 

reliability of the official system. We also pointed out FDA’s substantial 

investment in the RES and the duplication of resources spent maintaining 

two separate data systems. Although FDA agreed with our 

recommendation to eliminate the duplicative recall database, it has 

continued using resources to maintain the second system—resources that 

could be used on other CFSAN work. 

When FDA provided the RES data electronically for our independent 

analysis, officials told us it was the official source for CFSAN recalls, 

including the food-labeling-related recalls. We developed criteria for 

selecting labeling-related recalls on the basis of various labeling terms and 

sections on food labeling in the Federal Food, Drug, and Cosmetic Act. 

22GAO-05-51.
Page 28 GAO-08-597 FDA Food Labeling Oversight

FDA agreed that our criteria for identifying labeling-related recalls were 

valid. In December 2007, FDA provided final fiscal year 2007 data to 

complete our analysis. Subsequently, in April 2008, as part of our quality 

assurance procedures, we provided FDA with our list of labeling-related 

recalls to review for completeness. CFSAN officials informed us in May 

2008 that by using their unofficial database, they identified about 250 foodlabeling-related recalls that were not in our list. Of the 250, 171 were in the 

official system data but were not captured by the criteria we used. 

Regarding the remaining 79 recalls, we were unable to locate them in the 

RES data provided to us. In technical comments on a draft of this report, 

FDA noted that the 79 recalls had coding differences. However, FDA did 

not provide us with the codes that corresponded to the RES data. We had 

originally thought that these 79 recalls were missing from the official 

database and, therefore, were not posted on the FDA public Web site—

thus, we drafted a recommendation that FDA post all recalls in a timely 

manner. However, after FDA commented that the differences could be due 

to coding, we deleted this recommendation. It appears that the 409 

labeling-related recalls we identified may be a minimum number and, thus, 

may understate the number of recalls with labeling violations. Because we 

did not receive the unofficial database, we did not independently analyze it 

or assess its validity and reliability.

FDA Reports That 

Resource Constraints 

and Limited Authority 

Challenge Efforts to 

Carry Out FoodRelated 

Responsibilities, 

Including Food 

Labeling 

FDA’s Science Board Advisory Committee report, the Commissioner’s May 

2008 resource needs assessment, and the Food Protection Plan cite 

challenges to FDA’s efforts to carry out food safety and other food-related 

responsibilities, in part, because its resources have not kept pace with its 

increasing responsibilities—challenges that directly impact its oversight of 

labeling requirements. In addition, FDA does not have certain authorities 

that it reports would allow it to better leverage resources and carry out its 

food-related missions. These authorities could help FDA administer and 

enforce the food labeling requirements. 
Page 29 GAO-08-597 FDA Food Labeling Oversight

FDA Asserts That 

Resources Have Not Kept 

Pace with Growing 

Responsibilities 

According to the Science Board report, the demands on FDA have soared, 

but resources have not increased in proportion to demand. In the May 2008 

resource needs assessment, FDA’s Commissioner identified the immediate 

need for additional resources—for improvements in FDA’s science, 

information technology, and program capabilities—to ensure the safety of 

FDA-regulated imports and protect the food supply. Likewise, the Food 

Protection Plan asserts FDA’s ever-expanding responsibilities—such as 

safeguarding the evolving food demands of consumers; overseeing the 

increasing volume, variety, and sources of imported food; and staying 

ahead of the emerging threats to food safety and security—and all of the 

skills, technologies, and initiatives that it is planning to meet these new 

challenges. However, as we have testified, it is unclear what the total costs 

will be to fully implement the plan; thus, we continue to have concerns 

about FDA’s lack of specificity on the resource needs.23

Although FDA received increased funding for new bioterrorism-related 

responsibilities following September 11, 2001, staffing levels for CFSAN 

have declined since then and funding (in constant dollars) has stagnated. 

Between fiscal years 2003 and 2007, the number of FTE employees in 

CFSAN headquarters dropped about 20 percent, from 950 to 763, and 

inspection and enforcement staff decreased by about 19 percent, from 

2,217 to 1,806 (see app. IV). While funding in nominal dollars increased 

from $406.8 million in 2003 to $457.1 million in 2007, when adjusted for 

inflation, funding in the 2 years is nearly the same—$465.7 million and 

$465.8 million, respectively—in constant 2008 dollars. At the same time, as 

we have previously noted, the number of FDA-regulated domestic food 

firms increased more than 10 percent—from about 58,270 in 2003 to about 

65,520 in 2007. Also, the number of different imported food product entry 

lines has tripled in the past 10 years, and imports account for 15 percent of 

the food supply. Appendix IV provides detailed information on FDA 

funding and FTEs for each center. 

For fiscal years 1999 through 2007, the FTE staff years for the Office of 

Nutrition, Labeling, and Dietary Supplements reached its highest level in 

2002 (88) and its lowest in 2007 (65), according to data provided by FDA 

finance and other officials. Within the office, funding and staffing for food 

labeling activities, as estimated by an FDA finance official, have remained 

fairly steady since fiscal year 2005, the first year for which FDA staff were 

23GAO-08-909T.
Page 30 GAO-08-597 FDA Food Labeling Oversight

able to separate resources for labeling-related activities from other Office 

of Nutrition, Labeling, and Dietary Supplements work (see table 8). 

Table 8: Estimated Staffing and Funding for the Office of Nutrition, Labeling, and 

Dietary Supplements for Fiscal Years 1999 through 2007 and Estimated Staffing and 

Funding for Food Labeling Related and Other Activities for Fiscal Years 2005 

through 2007

Source: FDA CFSAN finance and other officials.

 aFor fiscal years 1999 through 2004, FDA did not separately track the amount of resources used for 

food-labeling-related activities, according to an FDA finance official. 

FDA’s Science Board reported on the growing disparity between FDA 

resources and responsibilities. Noting that the demands on FDA have 

soared, while resources have not increased proportionately, the committee 

concluded that the disparity has made it increasingly “impossible” for FDA 

to maintain its historic public health mission. In the May 2008 resource 

needs assessment, the FDA Commissioner identified the immediate need 

for additional staff to enable the agency to affect its food-safety-related 

goals. This would benefit administering and enforcing food labeling 

requirements. In addition, according to FDA officials, the agency generally 

does not address misleading food labeling because it lacks the resources to 

conduct the substantive, empirical research on consumer perceptions that 

it believes it would need to legally demonstrate that a label is misleading, as 

the agency believes is required by court rulings, such as Pearson v. Shalala, 

which is discussed in appendix V.

Dollars in millions

Staffing level (FTEs) Budget authority 

Fiscal 

year

Food-labelingrelated Other TotalFood-labelingrelated Other Total

1999 a a 83 a a $7.5

2000 a a 80 a a 6.9

2001 a a 73 a a 6.8

2002 a a 88 a a 9.7

2003 a a 86 a a 8.6

2004 a a 83 a a 10.0

2005 10.0 73.0 83 $1.2 $8.8 10.0

2006 9.0 65.0 74 1.1 7.7 8.8

2007 10.5 54.5 65 1.3 6.9 8.2
Page 31 GAO-08-597 FDA Food Labeling Oversight

FDA Has Reported That 

Certain Authorities It Lacks 

for Food Programs, 

Including Labeling, Would 

Help It Leverage Resources 

and Carry Out Regulatory 

Responsibilities

The Food Protection Plan identified a number of legislative changes—new 

authorities FDA recognized were needed, including, among others, the 

authority to charge user fees for certain reinspections, accredit third-party 

inspectors for certain reviews, and mandate recalls when voluntary recalls 

are not effective. FDA has these authorities for certain other products it 

regulates but not for food labeling activities or most food oversight efforts. 

In addition, FDA has never used its detention authority under the 

Bioterrorism Act of 2002 to detain potentially dangerous food because, 

according to the agency, its other authorities and regulatory tools have 

been adequate to date to protect public health.

Several FDA centers have the authority to collect user fees for particular 

activities. For example, FDA’s Center for Devices and Radiological Health 

has the authority to collect and retain user fees from firms for reviewing 

and approving premarket applications for medical devices. The center uses 

the fees to offset the costs of reviewing and approving these applications 

and to increase staffing levels. In its Fiscal Year 2009 Justification of 

Estimates for Appropriations Committees for FDA, HHS proposed a 

reinspection user fee on food industry firms that fail to meet important 

manufacturing and food safety requirements. This fee would cover the full 

cost of reinspections and the associated follow-up work.24 We have 

presented various ways to design user fees to encourage greater efficiency, 

equity, and revenue adequacy and to reduce the administrative burden on 

the agency and payers of the fees.25 For example, the extent to which a 

program is funded by user fees should generally be guided by who 

primarily benefits from the program. If a program primarily benefits the 

general public (e.g., national defense), it should be supported by general 

revenue, not user fees; if it primarily benefits identifiable users, such as 

customers of the U.S. Postal Service, it should be funded by fees; and if a 

program benefits both the general public and users, it should be funded in 

part by fees and in part by general revenues. The guide may provide useful 

direction to FDA as it proceeds with its proposed reinspection user fee. 

(Funding data presented in app. IV also show user fees collected by some 

FDA centers.) 

24The department’s 2009 justification also proposed user fees for issuing food and animal 

feed export certificates—a proposal recommended in the Food Protection Plan. 

25GAO-08-386SP. 
Page 32 GAO-08-597 FDA Food Labeling Oversight

Regarding the authority to accredit qualified third-party inspectors, which 

the Food Protection Plan states will allow FDA to allocate inspection 

resources more effectively, FDA plans to use these highly qualified parties 

to, among other things, carry out certain voluntary reviews in foreign food 

facilities, where few inspections and label reviews are currently done. As 

we testified in May 2008, FDA’s Center for Devices and Radiological Health 

has accredited third-party organizations to conduct voluntary inspections 

of foreign firms that manufacture medical devices, and these third parties 

completed six inspections in 4 years.26 We noted that an incentive for firms 

to participate included the opportunity to reduce the number of inspections 

conducted to meet FDA’s and other countries’ requirements. Disincentives 

include bearing the cost of the inspections and the potential consequences 

that could include regulatory action. We further noted that the small 

number of inspections raised questions about the practicality and 

effectiveness of using accredited third-party inspectors to quickly help FDA 

increase the number of foreign firms inspected.

The Food Protection Plan does not describe how FDA expects to design 

and implement the proposed accredited third-party inspection program to 

inspect foreign food firms or how this proposal will help it leverage 

resources. In contrast, USDA uses third-party Agricultural Commodity 

Meat Graders—contracted for their expertise—to carry out certain reviews 

in its livestock and meat grading and certification programs. 

FDA’s Food Protection Plan also asserts that the agency needs mandatory 

recall authority for food. It has this authority for infant formula and 

medical devices that present a health hazard. Other agencies, such as the 

National Highway Traffic Safety Administration and the Consumer Product 

Safety Commission, use their recall authority to help protect consumers 

from products that can cause serious injuries, such as unsafe infant car 

seats. We have previously proposed that Congress consider giving FDA 

mandatory food recall authority.27

The Bioterrorism Act of 2002 gave FDA the authority to administratively 

detain any article of food found during an examination, inspection, or 

investigation, if it has credible evidence or information indicating that the 

26GAO, Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign 

Manufacturing Establishments, GAO-08-780T (Washington, D.C.: May 14, 2008). 

27GAO-05-51.
Page 33 GAO-08-597 FDA Food Labeling Oversight

article of food presents a threat of serious adverse health consequences or 

death, for labeling and other violations. However, FDA has never used this 

authority. 

According to the agency, its other authorities and regulatory tools, such as 

its authority to refuse entry of imports under section 801 of the act, have 

been adequate to date to protect public health. In contrast, USDA has 

detention authority for meat and poultry products in interstate commerce 

that its FSIS uses to prevent shipments under its jurisdiction from entering 

U.S. commerce, if the agency has reason to believe that the food is 

adulterated or misbranded. USDA reported that, from July through 

September 2006, its import investigators detained 15 shipments—about 

9,500 pounds—of imported meat products.

FDA officials acknowledged that implementing the Food Protection Plan

will require additional resources, and that FDA will need to partner with 

Congress to obtain the additional statutory authorities to transform the 

safety of the nation’s food supply. However, as we testified in May 2008, 

FDA’s congressional outreach strategy is general.28 When we asked FDA 

officials if they had a congressional outreach strategy, officials said that 

they had met with various committees to discuss the Food Protection Plan. 

When we asked if they had provided draft language to congressional 

committees on the various authorities, FDA officials explained that they 

had only provided technical assistance, such as commenting on draft bills, 

to congressional staff when asked. 

Key Stakeholders 

Suggested Actions to 

Help Mitigate 

Misleading Labeling 

and Assist Consumers’ 

Efforts to Identify 

Healthy Food 

Key stakeholders—officials from health, medical, and consumer 

organizations in the United States and Europe—advocate a uniform frontof-package symbol to help consumers select healthy food and avoid 

misleading or confusing labeling. Some U.S. trading partners have 

implemented voluntary front-of-package nutrition symbols and several U.S. 

manufacturers and groceries are using front-of-package symbols. In 

addition, many stakeholders identified or petitioned FDA for other actions 

that they believe FDA should pursue to avoid misleading labeling and help 

consumers identify nutritious foods. Some stakeholders noted that taking 

such actions may require FDA to redirect resources. 

28GAO-08-435T and GAO-08-909T.
Page 34 GAO-08-597 FDA Food Labeling Oversight

Other Countries and Several 

Key Stakeholders Favor 

Uniform Front-of-Package 

Nutrition Symbols

Consumers have reported understanding certain labeling terms, such as 

“sugar” and “vitamins,” and finding benchmarks (such as daily reference 

values) helpful in comparing products, but they generally found nutrition 

labeling confusing, especially certain technical and numerical information, 

according to a recent synthesis of nutrition studies.29 For example, 

consumers had difficulty in understanding the role that nutrients played in 

their diet, and the relationship between sugar and carbohydrates as well as 

the terms “cholesterol” and “fatty acids.” While a few studies suggest that 

many consumers look at Nutrition Facts panels when they buy food for the 

first time, some studies suggest that consumers may simply look at the 

information but not process it further. The National Academies’ Institute of 

Medicine, which is often called on to advise federal agencies on health 

issues, reported in 2006 that there is little evidence that the information on 

food labels has a significant impact overall on eating or food purchasing.30

The institute had previously recommended that FDA and others increase 

research on the nutrition label and pointed out that manufacturers’ use of 

nutrition symbols underscores the need to improve strategies for using the 

food label as an educational tool. In addition, in a November 2007 letter to 

FDA, the American Medical Association (AMA) stated that there is 

evidence that consumers have difficulty in making appropriate judgments 

about which foods are the healthiest. 

Several major health and consumer organizations in the United States, as 

well as in Canada and Europe, advocate mandatory, uniform front-ofpackage nutrition rating systems to help consumers select healthy foods. In 

the United States, the AMA and the American Heart Association advocate 

such a system, and the Institute of Medicine’s 2006 report recommended 

that food and beverage companies work with government, scientific, public 

health, and consumer groups to develop and implement an industrywide 

system. Furthermore, to help consumers choose more nutritious foods, the 

scientists with expertise in nutrition and public health who developed the 

29Gill Cowburn and Lynn Stockley, Consumer Understanding and Use of Nutrition 

Labeling: a Systematic Review, Public Health Nutrition (University of Oxford: August 

2004). This comprehensive synthesis reported on 103 studies. Using a set protocol and 

standard published criteria, the authors judged 9 percent of the studies to be of high or 

medium-high quality. This study also included studies from other countries that have less 

nutrition labeling than the United States. We determined this synthesis was sufficiently 

reliable for our purposes. 

30National Academies, Institute of Medicine, Food Marketing to Children and Youth: Threat 

or Opportunity?, National Academies Press (Washington, D.C.: 2006).
Page 35 GAO-08-597 FDA Food Labeling Oversight

2005 Dietary Guidelines for Americans expressed concern that 

consumers did not have a scientifically valid system to show nutrient 

density on food labels, and recommended that HHS and USDA develop this 

system. In addition, the Center for Science in the Public Interest petitioned 

FDA in 2006 to develop a simple, uniform, science-based rating system that 

could be graphically represented on the front of food packages to give 

consumers consistent, reliable nutrition information. 

Although the European Union does not require nutrition labeling for all 

foods, it does require it on foods that have health or nutrition claims or that 

have voluntarily added vitamins or minerals, according to a European 

Union official. In addition, several countries, including the United 

Kingdom, the Netherlands, and Sweden, have implemented voluntary, 

front-of-package nutrition labeling systems, while Canada is proposing 

research on how such systems influence food purchases, among other 

things, and consulting stakeholders. The European Commission has 

proposed a mandatory, front-of-package labeling system. 

Figure 4 shows the front-of-package nutrition symbols for systems in the 

United Kingdom, the Netherlands, and Sweden, which help consumers in 

those countries identify healthy foods.
Page 36 GAO-08-597 FDA Food Labeling Oversight

Figure 4: Selected Front-of-Package Symbols Used in Other Countries

Consumers and health organizations in many countries have a heightened 

interest in the benefits of choosing healthy foods, including several that 

These two symbols are used on foods that are healthier than other foods in the same category.

Healthiest

Less healthy

Least healthy

(Key added by GAO)

Sources: Government officials from the United Kingdom, the Netherlands, and Sweden.

An example of a United Kingdom traffic light

The Netherland’s healthy choice Sweden’s keyhole
Page 37 GAO-08-597 FDA Food Labeling Oversight

have implemented (see fig. 4) or are considering front-of-package nutrition 

labeling systems. For example:

• The United Kingdom: The Food Standards Agency implemented a 

voluntary front-of-package traffic light symbol to help consumers 

distinguish between the healthiest choices (green light), less-healthy 

choices (amber light), and least healthy choices (red light) with respect 

to fat, saturated fat, salt, sugars, and usually calories, as well. Officials 

report that preliminary sales data suggest that this system is influencing 

consumers’ purchases toward healthier products. In addition, 

manufacturers are developing new products and reformulating lesshealthy products so that their foods may move into the amber or green 

light category, according to U.K. officials. The United Kingdom’s 

National Heart Forum (an alliance of 50 heart health organizations) has 

endorsed the traffic light system. 

• The Netherlands: The Netherlands uses a voluntary front-of-package 

“healthy choice” symbol, which was developed by the food industry and 

endorsed by the Ministry of Health. According to a Ministry official, 

standards for applying the symbol vary by food category, taking into 

account the characteristics of each category—for example, fiber is 

included in the criteria for bread products. A foundation was 

established—the Choices International Foundation—to introduce the 

symbol to other countries. The qualifying criteria for using the symbol 

will be reevaluated every 2 years by an independent scientific 

committee, according to the official. 

• Sweden: The National Food Administration uses a voluntary front-of-

`package keyhole logo to identify the healthiest foods within particular 

food categories. Products that carry the symbol are lower in fats, sugars, 

and sodium and contain more fiber than other foods within the same 

category. According to agency officials, the introduction of the keyhole 

logo resulted in the development of healthier products and the 

continuous reformulation of existing products.

• Canada: The House of Commons’ Committee on Health’s 2007 report, 

Healthy Weights For Healthy Kids, recommended that the country’s 

health agency—Health Canada—phase in a mandatory, standard, 

simple, front-of-package labeling requirement for prepackaged food, 

starting with foods advertised primarily to children. In addition, the 

Chronic Disease Prevention Alliance of Canada supports this 

recommendation. As of April 2008, Health Canada commented that it is 
Page 38 GAO-08-597 FDA Food Labeling Oversight

taking several steps, including consulting with stakeholders and 

proposing consumer research on, among other things, front-of-package 

symbols. 

• European Union: The European Commission has proposed legislation 

that would require prepackaged food to display information on calories, 

fat, saturated fat, carbohydrates, sugars, and salt on package fronts, 

according to documents released by the commission.31 A commission 

official told us that member states would still be able to promote 

additional national front-of-package labeling systems if they comply 

with requirements of the proposed legislation. The European Union’s 

Commissioner for Health stated that food labels can have a huge 

influence on consumers’ purchasing decisions, and confusing, 

overloaded, or misleading labels can be a hindrance to consumers. The 

European Heart Network (an alliance of 30 heart health organizations in 

26 countries) and the European Consumers’ Organization also support 

mandatory front-of-package labeling. 

In the United States, health and consumer associations have developed 

nutrition symbols to help consumers. For example, the American Heart 

Association developed the heart-check logo to help consumers identify 

heart-healthy foods. Currently, over 800 products from over 100 companies 

use the logo, and one major line of foods was developed with the heartcheck criteria as a key driver, according to the association. While most 

companies reformulate products before applying for the logo certification, 

the association also works with companies on 20 to 40 products a year to 

help them meet its criteria. In addition, the Whole Grains Council, a 

nonprofit consumer group working to increase consumption of whole 

grains, developed the Whole Grain Stamp to identify products with at least 

a half serving of whole grains, with the grams of whole grain specified. A 

“100%” banner can be placed on the stamps when all of the grain is whole 

grain. The stamps have been used on over 1,700 products from 180 

companies in the United States, Canada, and the United Kingdom. 

In addition, manufacturers have developed numerous symbols to market 

their foods to health-conscious consumers, and supermarkets have used 

symbols to help consumers identify healthier foods. At a September 2007 

FDA public hearing on front-of-package and other nutrition symbols, 

31For information on this proposal, go to the following Web site: 

http://www.europarl.europa.eu/oeil/FindByDocnum.do?lang=en&docnum=COM/2008/40.
Page 39 GAO-08-597 FDA Food Labeling Oversight

several manufacturers and supermarket chains reported increased sales 

and reformulations associated with their use of nutrition symbols. For 

example, Kraft has reported that the more than 500 products carrying its 

Sensible Solution symbol accounted for a sizable portion of its overall 

revenue growth. Hannaford, a northeastern supermarket chain, reported 

that it improved the nutrient quality of its store brand products before 

introducing its symbol for nutrition quality that it calls Guiding Stars, which 

is based on mathematical formulas giving a weighted value to many 

nutrients. Hannaford also reported increased sales for products with stars.

According to the Institute of Medicine, however, the consistency, accuracy, 

and effectiveness of the proprietary graphics currently in use have not been 

evaluated or empirically validated, and they may fall short of their potential 

as guides to more nutritious choices. Many stakeholders also share a 

concern about the proliferation of such graphics. FDA officials told us that 

the agency assigned an individual part time to focus on research on 

nutrition symbols. In comments, FDA told us it has completed one study. In 

addition, FDA plans to issue a summary of the 2007 public hearing and to 

identify gaps in the information that stakeholders provided during or after 

the hearing, at the request of FDA.

The Grocery Manufacturers/Food Products Association opposes 

mandatory front-of-package nutrition symbols and maintains that nutrition 

symbols should continue to be voluntary because the industry’s use of 

symbols to communicate nutrition information is truthful, not misleading, 

and consistent with FDA’s clear regulations for making representations 

about nutrition. According to the association, in recent years, many food 

companies have reformulated thousands of food products to improve their 

nutrient profiles, and many manufacturers are using symbols and related 

graphic designs on labels to supplement the Nutrition Facts panel. In 

addition, the Keystone Center, an industry-funded nonprofit organization, 

has held discussions to determine whether it should develop a voluntary 

front-of-package system. In 2007, the center convened a group of experts 

from industry, government, consumer, and academic organizations to study 

the various systems used in the United States. As of July 2008, this group 

had not released information on the status of its effort. According to FDA 

officials, FDA acts as an observer in this group. However, FDA has not yet 

collaborated with the relevant federal agencies and stakeholders with 

nutrition expertise to evaluate labeling approaches and options. 
Page 40 GAO-08-597 FDA Food Labeling Oversight

Stakeholders Suggested 

Other Actions That FDA 

Should Take to Help 

Consumers Identify Healthy 

Foods

Several medical, health, and consumer association stakeholders suggested 

FDA actions that they believe would mitigate misleading and confusing 

labeling. While some stakeholders noted that these actions may require 

FDA to redirect resources, they also believe such actions would help 

consumers identify healthy foods. 

• Eliminate qualified health claims: Stakeholders, such as the AMA, 

have suggested that FDA eliminate the use of qualified health claims on 

food labels because consumers cannot distinguish among the four levels 

of scientific support that FDA uses—significant scientific agreement, 

scientific evidence that is not conclusive, limited scientific evidence that 

is not conclusive, and very little scientific and preliminary evidence. 

According to the stakeholders, these claims confuse or mislead 

consumers and may encourage the consumption of foods with little or 

no health benefits. This view was supported by findings from 2005 and 

2007 FDA studies.32 In commenting on a draft of this report, FDA 

questioned whether it had the authority to eliminate the use of such 

claims. See appendix V for more information on FDA’s administration of 

health claims.

• Establish criteria for characterizing the amount of whole grains in 

food: The use of the term “whole grain” increased in popularity after the 

2005 Dietary Guidelines underscored the importance of these foods in 

the American diet. Some studies suggest that consumers, as well as 

dieticians and other nutrition experts, cannot accurately identify which 

foods are primarily whole grain. In 2004, General Mills, Inc., petitioned 

FDA to establish criteria for the phrases “excellent source of whole 

grains,” “good source of whole grains,” and “made with whole grains” to 

help prevent false or misleading labeling of grain products. FDA denied 

the petition, but it acknowledged the need for action and stated that 

claims such as “good source” have been used only with regard to 

nutrients—not foods—and that FDA needs to consider how to classify 

different kinds of statements and whether public comments are needed. 

In 2006, FDA developed draft guidance that identified what foods it

32FDA, Experimental Study of Qualified Health Claims: Consumer Inferences about 

Monounsaturated Fatty Acids from Olive Oil, EPA and DHA Omega-3 Fatty Acids, and 

Green Tea (2007). FDA, Brenda Derby and Alan Levy, Effects of Strength of Science 

Disclaimers on the Communication Impacts of Health Claims (September 2005). 
Page 41 GAO-08-597 FDA Food Labeling Oversight

considered “whole grain.” 33 FDA officials stated that they expect to 

continue work on this issue when they can hire additional staff. 

• Prohibit foods that contain substantial amounts of saturated fat from 

being labeled as “trans fat free”: FDA has not objected to products 

being labeled as “trans fat free” that have less than 0.5 grams of trans fat 

per serving, and does not restrict the amount of saturated fat in “trans 

fat free” foods. However, as stakeholders pointed out, saturated fat, like 

trans fat, raises low density lipoprotein (LDL or “bad cholesterol”) levels 

in the blood, increasing the risk of heart disease. Initially, FDA proposed 

limiting “trans fat free” labeling to foods with less than 0.5 grams of 

saturated fat, but FDA later stated that insufficient scientific 

information existed to support whether 0.5 was the appropriate level. 

FDA is evaluating available research to determine how to best address 

the issue.

• Require the labels of foods commonly consumed in one sitting to show 

total calories, fat, and other nutrition information: Several health and 

consumer stakeholders believe consumers may be misled by Nutrition 

Facts panels for foods, such as large sodas, candy bars, muffins, and 

other foods, that are normally consumed in one sitting, but are labeled 

as two or more servings. In 2005, the Institute of Medicine 

recommended that FDA revise requirements so that foods typically 

consumed in one sitting prominently display the total calorie content of 

the product as well as the standard per-serving format.34 Industrysponsored research found that the participants in four focus groups 

generally favored the listing of nutrients for the whole container, 

although some want nutrients listed for both the full container and per 

serving. In April 2005, FDA published an advance notice of proposed 

rulemaking requesting comments on this issue. In 2008, FDA noted that 

it needed to review the comments submitted in response to the 2005 

notice, and to coordinate this area with its plans to revise the daily 

intake reference values (used to establish the daily values for the 

Nutrition Facts panel) described in a 2007 advance notice of proposed 

rulemaking. The Grocery Manufacturers/Food Products Association 

opposes requiring nutrition information for the entire contents of the 

33FDA, “Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements” 

(Feb. 17, 2006). 

34National Academies, Institute of Medicine, Preventing Childhood Obesity: Health in the 

Balance, National Academies Press (Washington, D.C.: 2005).
Page 42 GAO-08-597 FDA Food Labeling Oversight

package on the food label, noting that nutrition information for the 

entire package would give consumers “permission” or “encouragement” 

to eat the entire package. 

• Clarify the definition of “natural” as it applies to food: The Sugar 

Association has petitioned, with the support of the Center for Science in 

the Public Interest and others, that FDA define the term “natural” on the 

basis of USDA’s definition, as articulated in its Foods Standards and 

Labeling Policy Book. USDA policy defines “natural” to permit only 

minimal processing, including roasting, drying, and fermenting, to 

preserve or make food edible. Under this USDA policy, foods that go 

through certain processes, such as chemical bleaching, that 

fundamentally alter the raw product, are not considered “natural.” Both 

groups assert that FDA allows manufacturers to label products as “100% 

natural” even if they contain highly processed ingredients, citing 

partially hydrogenated oils and high fructose corn syrup. However, the 

Corn Refiners Association believes that USDA and FDA should have 

different definitions of “natural” because, among other things, the two 

agencies regulate fundamentally different products—USDA-regulated 

meat and poultry products are understood to be less processed than 

FDA-regulated foods. FDA acknowledged in 1993 that clarifying the 

definition of “natural” would abate some of the complaints that the 

term’s use is misleading. More recently, FDA noted that it lacks 

resources to undertake a rulemaking to revisit the definition. 

Conclusions With its current approach to oversight and enforcement, FDA cannot be 

assured that food firms are complying with labeling requirements. In light 

of the resource constraints and many responsibilities that FDA has 

reported, it is especially important that FDA start by making better use of 

the tools and data it has available. However, FDA’s use of warning letters 

and enforcement actions have at best held steady, despite increased 

responsibilities. FDA is not using the information that it has to inform 

managers’ decisions on setting priorities and allocating resources. FDA 

does not maintain in an accessible format, or analyze in routine reports, 

information it has on such areas as labeling violations discovered during 

inspections, the results of tests on the accuracy of labels, warning letters, 

recalls, and import refusals. Moreover, although information on whether 

and how labeling violations are addressed is critical for effectively 

overseeing the labeling program. FDA does not (1) centrally maintain 

information on regulatory meetings and (2) know whether field offices are 

applying the same criteria for meetings and whether meetings are effective. 
Page 43 GAO-08-597 FDA Food Labeling Oversight

While FDA posts information for the public on its Web site—such as 

warning letters, import refusals, and import alerts—it does not ensure that 

the information is complete and posted promptly. As a result, the public 

may not have the information needed about products in violation of the law 

to inform their purchase decisions. Furthermore, CFSAN has continued to 

expend resources maintaining a duplicative data system for food-related 

recalls, which it agreed to eliminate in 2004. We reiterate our prior 

recommendation that FDA should eliminate this system. 

Going forward, to better administer and enforce labeling requirements, 

FDA has begun to pursue several authorities that are available to other 

centers within FDA and other regulatory agencies. In particular, CFSAN 

does not have the authority to charge user fees, accredit third-party 

inspectors, or require recalls for most food. As a result, CFSAN is not as 

well positioned as other programs that have these authorities to carry out 

its responsibilities. FDA’s Food Protection Plan recognized the need for 

additional resources and new authorities, to ensure the safety of the 

Nation’s food supply. However, as FDA proceeds in seeking new authorities 

it will need to ensure that any it chooses to pursue are designed and 

implemented efficiently and appropriately and, in particular, that any user 

fees it develops are well-designed and based on best practices and sound 

criteria, such as that specified in GAO’s Federal User Fees: A Design 

Guide.35 In addition, any FDA program for accrediting third parties would 

likely benefit from lessons learned in another FDA-accredited third-party 

program. Moreover, as we have previously testified, while FDA’s plan is a 

good first step, it does not contain a clear description of resources and 

strategies. Congress will need those details to assess the likelihood of the 

plan’s success. 

Finally, the many issues stakeholders raised about label information that 

they believe confuse consumers compete for FDA’s attention and 

resources. Nonetheless, FDA has information on the approaches that U.S. 

industry and other countries are taking to give consumers simplified 

nutrition information at a glance with front-of-package symbols. However, 

given FDA’s competing priorities and its minimal progress in addressing 

misleading labeling thus far, collaboration with other federal entities and 

stakeholders could afford an opportunity for FDA to better leverage 

resources to pursue front-of-package labeling or other initiatives for 

minimizing consumer confusion. 

35GAO-08-386SP.
Page 44 GAO-08-597 FDA Food Labeling Oversight

Recommendations for 

Executive Action

We recommend that the Commissioner, FDA, take the following seven 

actions:

Ensure that labeling office managers have the information they need to 

oversee compliance with food labeling statutes and regulations by

• maintaining, in a searchable format, data on food labeling violations, 

including the type of violation and information about corrective actions 

taken or, if no action was taken, the reason why; 

• analyzing violation data in routine management reports; and

• tracking regulatory meetings related to food labeling violations and 

analyzing whether regulatory meetings are an effective use of resources.

Ensure that the public has timely access to information on food labeling 

violations that may have serious health consequences by requiring all of the 

centers and offices to post on FDA’s public Web site, within a specified time 

frame, key information, such as all warning letters; statistics on serious 

enforcement actions (e.g., import refusals) by country, type of food, and the 

problem found (e.g., undeclared allergen); and information (e.g., product 

identification and exposure symptoms) on violations that FDA classifies as 

serious.

Better leverage resources to carry out food safety and other regulatory 

responsibilities, including administering and enforcing labeling 

requirements, by

• providing Congress with specific, detailed information on the new 

statutory authorities identified in the Food Protection Plan, such as the 

authority to charge user fees, accredit third-party inspectors, and 

mandate food recalls, with specific information on how these 

authorities would help achieve its mission;

• posting on FDA’s public Web site periodic updates of the status of 

implementation of the Food Protection Plan, including goals achieved 

and time frames for completing the remaining work; and

• collaborating with other federal agencies and stakeholders experienced 

in nutrition and health issues, to evaluate labeling approaches and 

options for developing a simplified, empirically valid system that 
Page 45 GAO-08-597 FDA Food Labeling Oversight

conveys overall nutritional quality to mitigate labels that are misleading 

to consumers.

Agency Comments and 

Our Evaluation

We provided a draft of this report to HHS for review and comment. In 

written comments, FDA stated that the report raised some important issues 

regarding its regulation of food labeling. FDA did not dispute the report’s 

data, analyses, or specific findings. It commented, however, that the report 

inappropriately references food labeling as part of its food safety mission, 

although it acknowledges that there may be some aspects of food labeling 

that can affect the safe use of food. That notwithstanding, FDA directs 

investigators to review at least three labels during food safety inspections. 

Moreover, food labeling responsibilities are part of FDA’s statutory mission, 

and the Federal Food, Drug, and Cosmetics Act and FDA’s regulations set 

out FDA’s labeling responsibilities. FDA also stated that within its overall 

public health mission, it has a multitude of competing priorities. We 

acknowledged FDA’s competing priorities in the report’s conclusions and 

framed the recommendations so as to help manage these competing 

priorities by better leveraging resources and using available tools and data 

for risk-based decisions.

Regarding our first three recommendations for ensuring that managers 

have the information they need to oversee compliance with food labeling 

statutes and regulations—by (1) maintaining data on labeling violations 

and the corrective actions taken, in a searchable format, (2) analyzing that 

data in routine management reports, and (3) tracking regulatory meetings 

on labeling violations to assess whether they are an effective use of 

resources—FDA agreed that being able to track any and all information 

that would allow investigators to better do their jobs would be useful to the 

agency. However, FDA stated that data collection requires time and effort 

and it is important to make sure that data entry does not become so 

burdensome that it takes away from other investigative work. FDA did not 

commit to taking any actions in response to these recommendations. We 

maintain that FDA cannot make risk-based decisions, such as allocating 

resources efficiently and effectively, without careful analysis of this type of 

data on its regulatory programs—FDA’s systems already maintain 

substantial data on food labeling and related violations. Analyzing these 

data for routine reports could help inform labeling managers’ decisions and 

help them target labeling resources. We stand by these recommendations.

With respect to our recommendation for ensuring the public has timely 

access to information on labeling violations that may have serious health 
Page 46 GAO-08-597 FDA Food Labeling Oversight

consequences—that FDA require centers and offices to post key 

information (e.g., warning letters or import refusals) on FDA’s public Web 

site and specify time frames for doing so—FDA commented that it already 

posts and maintains much of this information, and that it would keep the 

information as up to date as possible, given resource and time limitations. 

However, as we discuss in this report, FDA’s target time for issuing warning 

letters and posting them is 4 months after violations are found. Providing 

information that is complete and timely can help the public avoid 

potentially dangerous food and make healthy food purchase decisions. The 

draft we sent to FDA for comment recommended that FDA post all recalls 

to its public Web site in a timely manner. We eliminated recalls from this 

recommendation because, in technical comments, FDA told us that the 

recalls in CFSAN’s unofficial database that we thought were missing from 

RES were the result of coding differences. We stand by this 

recommendation as amended. 

Our final three recommendations are aimed at better leveraging resources. 

Two are aimed at helping FDA keep the Food Protection Plan on track by 

(1) providing specific, detailed information to Congress on how the new 

authorities in the Food Protection Plan will help FDA achieve its mission 

and (2) posting periodic updates on the status and time frames for 

implementing the plan on FDA’s public Web site. FDA stated that the plan 

was designed to address food safety and defense concerns, although some 

of the actions presented in it may have some bearing on food labeling 

issues. It was not our intent to suggest that the plan’s primary focus was on 

food labeling; we have clarified this in the report. Nonetheless, in this 

report and in recent testimonies, we have expressed our concerns that FDA 

has not given Congress sufficient, detailed information on how it will 

implement the plan and use the new authorities—information Congress 

needs to support the initiatives. Furthermore, updates can reassure the 

public of FDA’s progress. FDA did not explicitly address what action, if any, 

it would take in response to these two recommendations. With respect to 

our last recommendation—that FDA collaborate with other federal 

agencies and stakeholders on evaluating options for developing a 

simplified, empirically valid system for conveying overall nutritional quality 

to help consumers—FDA agreed with the need to evaluate the 

communication effects of nutrition symbols and presented a research 

agenda. Because the agenda appears to be ambitious given FDA’s limited 

resources, our recommendation will continue to encourage FDA to 

collaborate with other federal agencies and stakeholders who may be able 

to contribute resources, as it evaluates options to develop a simple, valid 

system to communicate nutritional quality.
Page 47 GAO-08-597 FDA Food Labeling Oversight

FDA’s written comments and our detailed evaluation appear in appendix VI. 

FDA also provided technical comments, which we incorporated 

throughout the report, as appropriate.

As agreed with your office, unless you publicly announce the contents of 

the report earlier, we plan no further distribution of it until 30 days from the 

date of this report. At that time, we will send copies of the report to the 

appropriate congressional committees, the Secretary of Health and Human 

Services, the Commissioner of the Food and Drug Administration, and 

other interested parties. We will also make copies available to others upon 

request. In addition, the report will be available at no charge on the GAO 

Web site at http://www.gao.gov.

If you or members of your staff have any questions about this report, please 

contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on the 

last page of this report. GAO staff who made key contributions to this 

report are listed in appendix VII.

Sincerely yours,

Lisa Shames

Director, Natural Resources and Environment
Page 48 GAO-08-597 FDA Food Labeling Oversight

Appendix I

Objectives, Scope, and Methodology AAppenednxidexiIs

This report examines (1) the Food and Drug Administration’s (FDA) efforts 

to ensure that domestic and imported foods comply with food labeling 

requirements, including those prohibiting false or misleading labeling; 

(2) the challenges FDA faces in its efforts to administer and enforce food 

labeling requirements; and (3) the actions that stakeholders from health, 

medical, and consumer organizations believe are needed to mitigate the 

effects of food labeling practices they consider misleading and to help 

consumers identify healthy food. 

For the purposes of this report, our definition of “food” includes 

conventional food, dietary supplements, infant formula, and medical food,1

but not animal feed, which the Federal Food, Drug, and Cosmetic Act 

includes in its definition of food. We did not determine whether any 

particular food labeling was false or misleading. We also did not evaluate 

how efficiently FDA used its resources or the impact of changing priorities; 

nor did we compare FDA resource trends with other federal agencies’ 

resource trends. Regarding data for labeling-related oversight, we analyzed 

the food firms inspected for 7 fiscal years (2001 through 2007); nutrient 

labeling samples for 7 fiscal years (2000 through 2006); warning letters and 

enforcement actions related to imports for 6 fiscal years (2002 through 

2007); and seizures and injunctions for 10 fiscal years (1998 through 

2007)—the periods for which reliable and comparable FDA data were 

available. Funding and staffing data for FDA, the Center for Food Safety 

and Applied Nutrition (CFSAN), and the Office of Regulatory Affairs (ORA) 

were available for 10 fiscal years (1998 through 2007). For the Office of 

Nutrition, Labeling, and Dietary Supplements, which began maintaining 

comparable data in 1999, we report funding and staffing for 9 fiscal years 

(1999 through 2007). Unless otherwise stated, data are presented by federal 

fiscal year.

To determine FDA’s efforts to ensure that domestic and imported foods 

comply with food labeling statutes and regulations, including those related 

to false or misleading labeling, we analyzed FDA’s and CFSAN’s plans and 

reports, guidance and regulations related to food labeling, and policies and 

actions taken in response to petitions and complaints over the last 6 years. 

1

A “medical food” is a food that is formulated to be consumed or administered internally 

under the supervision of a physician, and that is intended for the specific dietary 

management of a disease or condition for which distinctive nutritional requirements, based 

on recognized scientific principles, are established by medical evaluation. An example of a 

medical food is an infant formula that is free of certain amino acids and is designed for 

infants with a rare genetic condition.
Appendix I

Objectives, Scope, and Methodology

Page 49 GAO-08-597 FDA Food Labeling Oversight

We also analyzed data from the Field Accomplishments and Compliance 

Tracking System (FACTS) and Operational and Administrative System for 

Import Support (OASIS) on domestic, foreign, and import inspections 

conducted by FDA, along with domestic inspections conducted by states 

under contract with FDA. To determine the number of warning letters 

issued by FDA, we worked with FDA's Freedom of Information Office and 

ORA to address several problems we found during the course of our review 

regarding the online database of warning letters. After addressing those 

problems, we then searched that database for warning letters that were 

related to food labeling and characterized each letter according to the 

product and the violations cited. We also searched FDA's Recall Enterprise 

System (RES) for recalls identified with food labeling violations as one of 

the reasons for the recall. Regarding violations of Nutrition Facts panel 

regulations, we analyzed data from FACTS for domestic and imported food, 

and also analyzed studies conducted on the accuracy of nutrient labeling. 

We analyzed data from this system on consumer complaints to determine 

the extent to which they were tracked. Finally, we also analyzed data from 

OASIS on food labeling violations for imported food and collected 

information on seizures and injunctions focused on food labeling 

violations. 

To identify challenges, we analyzed funding and staffing data for FDA, 

CFSAN, ORA, and the Office of Nutrition Labeling and Dietary 

Supplements and reviewed FDA oversight and enforcement authorities, 

and court rulings regarding FDA labeling. For comparison, we examined 

some of the same information for the U.S. Department of Agriculture’s 

Food Safety and Inspection Service and the Federal Trade Commission, 

which also oversee and enforce requirements related to food labeling, such 

as those prohibiting false or misleading information about food. 

We assessed the reliability of the data from FACTS and OASIS that we used 

in this report and found them to be sufficiently reliable for these purposes. 

To assess the reliability of these data, we (1) performed electronic testing 

for obvious errors in accuracy and completeness, (2) reviewed related 

documentation, and (3) worked closely with agency officials to identify any 

data problems. 

In addition, we assessed the reliability of the data from the RES. FDA 

recently informed us that CFSAN has continued to use an unofficial 

database that it agreed to eliminate in 2004, which contains additional 

information on recalls that would potentially fit our criteria for analysis.

Despite any limitations of the RES, we believe these data to be sufficiently 
Appendix I

Objectives, Scope, and Methodology

Page 50 GAO-08-597 FDA Food Labeling Oversight

reliable to indicate a minimum number of recalls for the time period we 

reported. 

To determine stakeholders’ views, we analyzed petitions, public responses 

to petitions, and ideas presented during FDA’s November 2007 public 

labeling meetings. We discussed these and other suggestions with health 

and medical associations, including the American Cancer Society, 

American Diabetic Association, American Heart Association, American 

Dietetic Association, American Medical Association, and National 

Academies’ Institute of Medicine; the Center for Science in the Public 

Interest; the Grocery Manufacturers/Food Products Association; the 

Association of Food and Drug Officials; and selected states (California, 

Connecticut, Florida, New York, Texas, and Wisconsin) that the 

Association of Food and Drug Officials and others groups identified as 

being active in food labeling issues. In addition, we contacted officials of 

health or related departments in Canada, the United Kingdom, Sweden, the 

Netherlands, and the European Commission to collect information on their 

use or plans for use of nutrition symbols. We did not independently verify 

the statements of foreign law. We also analyzed consumer studies 

conducted by FDA, industry, and others to identify whether the findings 

supported or failed to support stakeholders’ views. These studies were 

identified by health, consumer, and industry experts and through literature 

searches. For the data we included in our report, we obtained frequency 

counts, survey instruments, and other documents, to review the wording of 

questions, sampling, mode of administration, research strategies, and the 

effects of sponsorship. We used only data that we judged to be reliable and 

valid. 

We conducted this performance audit from January 2007 through 

September 2008 in accordance with generally accepted government 

auditing standards. Those standards require that we plan and perform the 

audit to obtain sufficient, appropriate evidence to provide a reasonable 

basis for our findings and conclusions based on our audit objectives. We 

believe that the evidence obtained provides a reasonable basis for our 

findings and conclusions based on our audit objectives.
Page 51 GAO-08-597 FDA Food Labeling Oversight

Appendix II

FDA-Regulated and -Inspected Domestic and 

Foreign Food Firms, Fiscal Years 2001 

through 2007 ApendxiI

Nearly half of the domestic firms that are subject to FDA regulation are 

food firms—manufacturers, processors, and other food businesses. Table 9 

presents the number and percentage of domestic food firms that are 

subject to FDA’s food regulations and the total number of domestic firms in 

all industries (e.g., pharmaceuticals and medical devices) that are subject 

to FDA regulation, for fiscal years 2001 through 2007. 

Table 9: Domestic Food Firms and Total Domestic Firms under FDA's Jurisdiction, 

by Fiscal Year

Source: GAO analysis of FDA data.

Note: Food firm data were calculated by adding together food, vitamin, and color additive firms. Some 

firms may do business in multiple industries; as a result, there may be double-counting.

Regarding firms inspected under all FDA regulatory programs, food-related 

firms have accounted for between 15 percent and 30 percent of foreign 

firms inspected and between 45 percent and 56 percent of domestic firms 

inspected. Table 10 presents the number and percentage of foreign and 

domestic food-related firms inspected and the total number of FDAregulated firms inspected, for fiscal years 2001 through 2007, by FDA and 

states under contract with FDA.

Fiscal year

Domestic food 

firms

Total domestic

firms

Percentage of total 

domestic firms

2001 51,020 114,696 44.5%

2002 58,593 120,403 48.7

2003 58,268 120,403 48.4

2004 59,305 123,892 47.9

2005 61,930 127,887 48.4

2006 62,929 136,129 46.2

2007 65,520 139,176 47.1
Appendix II

FDA-Regulated and -Inspected Domestic and 

Foreign Food Firms, Fiscal Years 2001 

through 2007

Page 52 GAO-08-597 FDA Food Labeling Oversight

Table 10: Firms Inspected by FDA and States under Contract with FDA, Fiscal Years 2001 through 2007

Source: GAO analysis of FDA data.

a

Since this table reflects the number of firms inspected, not the number of inspections, “total firms 

inspected” tallies the unique firms inspected in a fiscal year. Firms inspected by both FDA and a state 

under contract with FDA are counted in each of those individual totals, but only once in “total firms 

inspected.” Firms were counted in each fiscal year they were inspected.

Foreign firms inspected 

by FDA 

Domestic firms inspected 

by FDA 

Domestic firms inspected 

under contracts with states Total firms inspecteda

Fiscal 

year

Food 

firms

Total 

firms

Food firms 

as a 

percentage 

of total 

firms

Food

 firms

Total 

firms

Food firms 

as a 

percentage 

of total 

firms

Food

 firms

Total

 firms

Food firms 

as a 

percentage 

of total 

firms

Food

 firms

Total 

firms

Food firms 

as a 

percentage 

of total 

firms

2001 211 892 23.7% 8,922 16,006 55.7% 6,688 16,875 39.6% 14,932 32,733 45.6%

2002 169 791 21.4 8,175 16,428 49.8 6,979 19,885 35.1 14,877 36,216 41.1

2003 148 757 19.6 10,507 20,027 52.5 7,674 19,710 38.9 17,658 39,429 44.8

2004 153 932 16.4 10,370 19,264 53.8 8,173 20,916 39.1 18,172 40,173 45.2

2005 132 844 15.6 8,258 17,489 47.2 8,849 21,493 41.2 16,809 38,924 43.2

2006 125 788 15.9 7,071 15,485 45.7 8,447 23,054 36.6 15,332 38,558 39.8

2007 96 327 29.1 6,106 13,395 45.6 8,692 22,967 37.8 14,661 36,199 40.5
Page 53 GAO-08-597 FDA Food Labeling Oversight

Appendix III

FDA Inspections of Food Firms in Foreign 

Countries, Fiscal Years 2001 through 2007 ApendxiI

Number of FDA inspections of foreign food firms, by fiscal year

Country 2001 2002 2003 2004 2005 2006 2007 Total

Mexico 17 15 8 15 7 16 26 104

Ecuador 8 11 24 11 10 64

Chile 13 15 6 7 11 52

Peru 13 18 1 99 50

Brazil 12 6 7 21 46

Thailand 4 10 10 22 46

Canada 13 13 1 74 38

China 9 2 6 16 33

Taiwan 9 7 9 7 32

Argentina 7 5 19 31

India 6 10 7 7 30

South Korea 14 1 7 6 28

Australia 12 6 9 27

Costa Rica 11 4 5 7 27

Vietnam 9 10 8 27

Honduras 9 8 7 24

Fiji 8 13 21

Singapore 10 8 18

Estonia 8 8 16

Guatemala 10 6 16

South Africa 5 11 16

Germany 5 4 4 1 1 15

Nicaragua 8 7 15

El Salvador 8 6 14

Jamaica 2 6 3 3 14

Latvia 7 7 14

Uruguay 14 14

Venezuela 7 7 14

Italy 4 8 1 13

Morocco 13 13

New Zealand 6 7 13

Poland 13 13
Appendix III

FDA Inspections of Food Firms in Foreign 

Countries, Fiscal Years 2001 through 2007

Page 54 GAO-08-597 FDA Food Labeling Oversight

Source: GAO analsysis of FDA data.

Norway 5 6 11

France 1 9 10

Romania 10 10

Surinam 10 10

Iceland 9 9

Malaysia 9 9

Bulgaria 8 8

Colombia 8 8

Hong Kong 8 8

Cyprus 7 7

Panama 7 7

Trinidad and Tobago 7 7

The United Kingdom 1 1 2 1 1 6

Turkey 5 5

Spain 4 4

Belgium 2 1 3

Greece 3 3

Hungary 3 3

Finland 2 2

Haiti 1 1 2

Japan 2 2

The Netherlands 2 2

Total 211 169 148 153 132 125 96 1,034

(Continued From Previous Page)

Number of FDA inspections of foreign food firms, by fiscal year

Country 2001 2002 2003 2004 2005 2006 2007 Total
Appendix III

FDA Inspections of Food Firms in Foreign 

Countries, Fiscal Years 2001 through 2007

Page 55 GAO-08-597 FDA Food Labeling Oversight

(This page is intentionally left blank.)
Page 56 GAO-08-597 FDA Food Labeling Oversight

Appendix IV

Funding and Staffing Information by FDA 

Mission, Fiscal Years 1998 through 2007 ApendxiIV

Dollars in millions

 1998 1999 2000 2001

FTE $ FTE $ FTE $ FTE $

Budget authority, by FDA mission

Foods (mission includes cosmetics) 2,239 $206.2 2,339 $235.2 2,386 $279.7 2,445 $287.5

Center for Food Safety and Nutrition 784 87.8 784 99.9 830 124.6 879 125.9

Office of Regulatory Affairs 1,455 118.5 1,555 135.3 1,556 155.1 1,566 161.6

Human Drugs 1,959 199.6 1,846 200.4 1,838 215.5 1,824 218.5

Center for Drug Evaluation and Research 1,241 142.2 1,130 139.7 1,168 152.2 1,140 151.5

Office of Regulatory Affairs 718 57.4 716 60.7 670 63.3 684 67.0

Biologics 841 95.5 791 95.0 780 106.1 786 108.3

Center for Biologics Evaluation and Research 619 77.7 592 77.8 576 87.5 561 86.2

Office of Regulatory Affairs 222 17.8 199 17.2 204 18.6 225 22.1

Animal Drugs and Feeds 391 41.4 393 43.3 406 49.6 442 64.1

Center for Veterinary Medicine 251 28.6 254 30.7 271 36.5 290 48.4

Office of Regulatory Affairs 140 12.7 139 12.6 135 13.1 152 15.6

Devices and Radiological Products 1,507 144.3 1,432 145.8 1,426 157.7 1,428 165.3

Center for Devices and Radiological Health 1,003 103.8 966 105.6 988 116.0 986 122.0

Office of Regulatory Affairs 504 40.5 466 40.2 438 41.6 442 43.3

National Center for Toxicological Research 218 32.2 223 32.1 217 36.5 206 36.2

Rent and Facilitiesa 0 100.0 0 124.9 0 130.7 0 151.4

Otherb 928 112.7 827 108.6 675 72.3 674 68.0

Subtotal 8,083 $931.9 7,851 $985.3 7,728 $1,048.1 7,805 $1,099.3

User fees, by FDA mission

Foods (mission includes cosmetics) 0 $0 0 $0 0 $0 0 $0

Center for Food Safety and Nutrition 0 0 0 0 0 0 0 0

Office of Regulatory Affairs 0 0 0 0 0 0 0 0

Human Drugs 467 84.6 610 77.9 671 95.7 711 104.0

Center for Drug Evaluation and Research 398 78.7 551 71.8 604 88.2 644 97.0

Office of Regulatory Affairs 69 5.9 59 6.1 67 7.5 67 7.0

Biologics 192 26.6 198 29.3 211 34.6 255 38.9

Center for Biologics Evaluation and Research 187 26.1 195 29.0 204 33.8 248 36.2

Office of Regulatory Affairs 5 0.5 3 0.3 7 0.8 7 2.7

Animal Drugs and Feeds 0 0 0 0 0 0 0 0

Center for Veterinary Medicine 0 0 0 0 0 0 0 0

Office of Regulatory Affairs 0 0 0 0 0 0 0 0

Devices and Radiological Products 51 13.8 48 13.2 46 12.6 45 12.3
Appendix IV

Funding and Staffing Information by FDA 

Mission, Fiscal Years 1998 through 2007

Page 57 GAO-08-597 FDA Food Labeling Oversight

 2002 2003 2004 2005 2006 2007

 FTE $ FTE $ FTE $ FTE $ FTE $ FTE $

2,734 $393.3 3,167 $406.8 3,082 $407.1 2,943 $435.5 2,774 $438.7 2,569 $457.1

924 143.2 950 147.3 910 144.4 884 152.3 812 153.5 763 159.1

1,810 250.1 2,217 259.5 2,172 262.7 2,059 283.3 1,962 285.3 1,806 298.0

1,817 254.7 1,920 274.1 1,943 292.1 1,837 291.5 1,801 297.7 1,772 315.1

1,122 178.0 1,159 188.8 1,218 210.8 1,171 210.5 1,176 217.8 1,185 230.8

695 76.7 761 85.2 725 81.3 666 81.0 625 79.9 587 84.4

894 138.6 947 145.3 792 122.4 768 123.1 730 138.5 763 146.3

657 111.1 701 117.4 559 96.3 553 96.6 533 111.4 557 117.8

237 27.6 246 27.9 233 26.1 215 26.5 197 27.1 206 28.6

570 85.6 596 87.7 592 83.5 571 90.5 538 89.6 537 94.7

323 55.7 341 57.1 346 54.5 330 55.4 321 54.8 318 58.4

247 29.9 255 30.5 246 28.9 241 35.1 217 34.8 219 36.4

1,407 180.0 1,432 193.4 1,376 191.1 1,367 215.0 1,328 220.6 1,358 230.7

965 131.5 968 140.4 935 140.6 970 163.3 929 165.2 952 172.3

442 48.5 464 52.9 441 50.5 397 51.7 399 55.4 406 58.4

221 39.3 226 40.4 207 39.7 187 40.2 190 40.7 183 42.1

0 180.9 0 158.3 0 175.3 0 169.3 0 182.1 0 204.8

668 82.0 652 84.1 575 90.2 508 87.2 532 85.7 523 91.8

8,311 $1,354.4 8,940 $1,390.1 8,567 $1,401.2 8,181 $1,452.3 7,893 $1,493.6 7,705 $1,582.7

0 $0 0 $0 0 $0 0 $0 0 $0 0 $0

0 0 0 0 0 0 0 00 00 0

0 0 0 0 0 0 0 00 00 0

700 109.6 776 129.8 1,006 167.5 1,081 190.7 1,146 211.2 1,143 228.4

658 104.1 742 125.1 972 162.7 1,049 185.6 1,110 205.3 1,103 223.5

42 5.6 34 4.7 34 4.8 32 5.1 36 5.9 40 5.0

242 39.2 282 48.1 246 44.7 273 47.6 249 59.2 282 55.8

237 38.3 274 47.1 238 43.6 265 46.4 239 57.5 270 54.3

5 1.0 8 1.0 8 1.1 8 1.1 10 1.7 12 1.6

00 00 3 1.0 39 8.0 54 8.0 51 11.0

00 00 3 1.0 39 8.0 54 8.0 51 11.0

0 0 0 0 0 0 0 00 00 0

47 13.7 53 23.9 139 30.4 149 29.3 170 34.5 186 36.9
Appendix IV

Funding and Staffing Information by FDA 

Mission, Fiscal Years 1998 through 2007

Page 58 GAO-08-597 FDA Food Labeling Oversight

Dollars in millions

 1998 1999 2000 2001

FTE $ FTE $ FTE $ FTE $

Center for Devices and Radiological Health 32 8.7 32 5.0 30 4.5 30 3.9

Office of Regulatory Affairs 19 5.2 16 8.3 16 8.1 15 8.4

National Center for Toxicological Research 0 0 0 0 0 0 0 0

Rent and Facilitiesa 0 0 0 5.4 0 5.6 0 5.9

Otherc 115 12.7 203 18.9 174 17.3 173 17.8

Subtotal 825 $137.7 1,059 $144.7 1,102 $165.8 1,184 $178.8

Total 8,908 $1,069.6 8,910 $1,130.0 8,830 $1,214.0 8,989 $1,278.1
Appendix IV

Funding and Staffing Information by FDA 

Mission, Fiscal Years 1998 through 2007

Page 59 GAO-08-597 FDA Food Labeling Oversight

Source: GAO analysis of FDA data.

a

Includes GSA rent, other rent, rent-related activities, White Oak Consolidation, and the FDA Buildings 

and Facilities Appropriation. 

b

Includes tobacco program, Office of the Commissioner, Office of Policy, Office of External Affairs, 

Office of Operations/Orphan Grants Administration, Office of Management and Systems, and Central 

Services.

c

Other activities funded in part by user fees, including Office of the Commissioner, Office of Policy, 

Office of External Affairs, Office of Operations/Orphan Grants Administration, Office of Management 

and Systems, Central Services, Export Certification, and Color Certification Fund.

 2002 2003 2004 2005 2006 2007

 FTE $ FTE $ FTE $ FTE $ FTE $ FTE $

32 4.9 35 14.7 126 21.3 134 19.9 156 24.6 172 26.5

15 8.8 18 9.2 13 9.1 15 9.5 14 9.9 14 10.4

0 0 0 0 00 000 0 0 0

0 1.0 0 9.2 0 11.3 0 25.9 0 30.1 0 30.0

168 19.0 206 26.5 180 22.9 187 24.2 186 25.9 202 29.3

1,157 $182.6 1,317 $237.6 1,574 $277.7 1,729 $325.2 1,805 $369.1 1,864 $391.4

9,468 $1,537.0 10,257 $1,627.7 10,141 $1,678.9 9,910 $1,777.5 9,698 $1,862.7 9,569 $1,974.1
Page 60 GAO-08-597 FDA Food Labeling Oversight

Appendix V

FDA’s Administration of Health Claims in 

Response to the Pearson v. Shalala Ruling ApendxiV

The Nutrition Labeling and Education Act of 1990 (NLEA)1 amended the 

Federal Food, Drug, and Cosmetic Act2 to include provisions that govern 

the use of health claims on food labeling. For conventional foods, the NLEA 

requires that any claim that expressly or by implication characterizes the 

relationship of a nutrient to a disease or health-related condition must be 

authorized by the Secretary of Health and Human Services (delegated to 

FDA) through a regulation.3

 Under the NLEA, FDA may authorize a health 

claim for a conventional food if it determines, based on the totality of 

publicly available scientific evidence, that there is “significant scientific 

agreement” among experts—qualified by scientific training and experience 

to evaluate such claims—that the claim is supported by such evidence. 

Although the NLEA also provided for the use of health claims in dietary 

supplement labeling, Congress did not require dietary supplement health 

claims to be subject to the same statutory procedures and standards as 

conventional food health claims. Instead, dietary supplement health claims 

were to be subject to procedures and standards established in regulations 

issued by the Secretary of Health and Human Services (delegated to FDA). 

In 1991, FDA published a proposed rule in the Federal Register, proposing 

the implementation of the statutory procedures and standards for health 

claims for conventional food, and proposing to adopt those same 

procedures and standards for dietary supplement health claims.4

 However, 

before the rule could be finalized, Congress passed legislation that 

generally prohibited FDA from implementing the NLEA with respect to 

dietary supplements until December 15, 1993.5

 Therefore, in January of 

1993, when FDA adopted the final rules for health claims for conventional 

foods, it did not finalize rules for dietary supplement health claims.6

However, 1 year later, after the prohibition of implementation of NLEA for 

dietary supplements had expired, FDA adopted a rule that subjected 

1

Pub. L. No. 101-535, 104 Stat. 2353.

2

21 U.S.C. §§ 301-397.

3

In addition, a claim may be authorized if a relevant scientific body of the U.S. government 

or the National Academies, or a subdivision thereof, has published an authoritative 

statement, currently in effect, about the relationship between a nutrient and a disease or 

health-related condition to which the claim refers.

4

56 Fed. Reg. 60,537, Nov. 27, 1991.

5

Dietary Supplement Act of 1992, Pub. L. No. 102-571, tit. II § 202, 106 Stat. 4500.

6

58 Fed. Reg. 2478, Jan. 6, 1993.
Appendix V

FDA’s Administration of Health Claims in 

Response to the Pearson v. Shalala Ruling

Page 61 GAO-08-597 FDA Food Labeling Oversight

dietary supplement health claims to the same general requirements that 

applied to conventional foods.7

 Under those rules, any person wanting to 

include a health claim on a conventional food or dietary supplement label 

must petition FDA for authorization before including the claim on the label. 

If FDA determines, based on the totality of publicly available information, 

that there is significant scientific agreement in support of that claim, it will 

authorize its use by issuing it in regulation.

FDA’s health claim regulations for dietary supplements were the subject of 

several lawsuits in the 1990s. In a case known as Pearson v. Shalala,

8

 the 

U.S. Court of Appeals for the District of Columbia Circuit held that the First 

Amendment does not permit FDA to prohibit a potentially misleading 

health claim on the label of a dietary supplement, unless FDA considers 

whether a disclaimer on the product’s label could negate the potentially 

misleading nature of that claim. Specifically, the court stated that although 

inherently or actually misleading information in food labeling or 

advertising may be prohibited, potentially misleading information cannot 

face an absolute prohibition. Instead, potentially misleading information 

may be regulated only if those regulations directly advance a substantial 

government interest, and offer a reasonable fit between the government’s 

goals and the means chosen to accomplish those goals. The court found a 

substantial interest in protecting the public health and preventing 

consumer fraud. However, it found that FDA’s regulation requiring health 

claims to be supported by significant scientific agreement did not directly 

advance the interest in public health, and, even though the regulations 

directly advanced the interest in preventing consumer fraud, the fit 

between the goals of the regulations and the means employed—an outright 

ban without the possibility of a disclaimer—was not reasonable.9

Following the decision in Pearson, FDA announced its plan to respond, 

stating that it would deny, without prejudice, all petitions for the use of 

dietary supplement health claims that did not meet the significant scientific 

agreement standard while the agency conducted and completed a 

7

59 Fed. Reg. 395, Jan. 4, 1994.

8

164 F.3d 650 (1999).

9

In addition, the court found that the Administrative Procedure Act requires that FDA give 

some “definitional content to the phrase ‘significant scientific agreement,’” either in 

regulation or on a case-by-case basis so that the regulated class can “perceive the principles 

which are guiding agency action.” 164 F.3d at 661. FDA subsequently provided guidance 

describing the meaning of the phrase.
Appendix V

FDA’s Administration of Health Claims in 

Response to the Pearson v. Shalala Ruling

Page 62 GAO-08-597 FDA Food Labeling Oversight

rulemaking to reconsider the procedures and standards governing such 

claims.10 Then, according to FDA, once a rule was finalized, the agency 

would revisit the petitions it had denied. However, in 2000, citing concerns 

over additional First Amendment challenges, FDA announced plans to 

modify that policy.11 FDA stated that it would continue to approve dietary 

supplement health claims that met the significant scientific agreement 

standard, but it would exercise its enforcement discretion and not take 

action against dietary supplement health claims that failed to meet the 

standard under certain circumstances. Specifically, upon the submission of 

a valid petition for preapproval of a dietary supplement health claim, if 

FDA did not find significant scientific agreement, but, in evaluating the 

weight of the evidence, did find that the scientific evidence in support of 

the claim outweighed the scientific evidence against it, and consumer 

health and safety were not threatened, the agency would inform the 

petitioner of conditions under which the agency would refrain from taking 

enforcement action against the health claim. If the scientific evidence 

against the health claim outweighed the scientific evidence in support of it, 

FDA would deny any use of the health claim.

Then, in 2002, the agency announced the availability of guidance, updating 

its approach to implementing the Pearson decision.12 In large part, the 

procedures remained the same; however, FDA included health claims for 

conventional foods under the procedures, even though the Pearson case 

directly addressed only dietary supplements. FDA stated that it believed 

that such a move would precipitate greater communication in food labeling 

and thereby enhance public health. In addition, FDA stated that including 

health claims for conventional foods in its enforcement discretion policy 

would help avoid further constitutional challenges. Subsequently, in 2003, 

FDA announced the availability of two new guidance documents describing 

interim procedures that, among other things, addressed a then recent U.S. 

District Court for the District of Columbia decision that found the weight of 

the evidence standard that FDA first articulated in guidance in 2000 was 

1064 Fed. Reg. 67,289, Dec. 1, 1999.

1165 Fed. Reg. 59,855, Oct. 6, 2000.

1267 Fed. Reg. 78,002, Dec. 20, 2002.
Appendix V

FDA’s Administration of Health Claims in 

Response to the Pearson v. Shalala Ruling

Page 63 GAO-08-597 FDA Food Labeling Oversight

inappropriate.13 According to the district court in that case, FDA should 

evaluate qualified health claims based on the presence of “credible 

evidence,” not the weight of the evidence.14 The 2003 guidance documents 

set forth new procedures for qualified health claims for conventional foods 

and dietary supplements. Specifically, qualified health claim petitions 

would be evaluated using an evidence-based ranking system that would 

rate the strength of the publicly available scientific evidence. A claim 

would be denied if there was no credible evidence to support it. Otherwise, 

based on the competent and reliable scientific evidence in support, a claim 

would be assigned to one of four ranked levels—the first level being 

“significant scientific agreement among qualified experts” and the 

remaining three levels being for claims supported by some lower level of 

credible evidence. Each of the three categories not ranked as supported by 

significant scientific agreement would correspond to one of three 

standardized qualifying statements (i.e., disclaimers).15 So long as the 

qualified health claim bore the appropriate language, met other applicable 

health claim regulations, and adhered to criteria established in FDA’s letter 

of enforcement discretion in response to the petition, FDA would exercise 

its enforcement discretion and refrain from acting against the health claim.

In November of 2003, FDA published an Advance Notice of Proposed 

Rulemaking, recognizing the need to establish transparent, long-term 

procedures that have the effect of law.16 In that announcement, FDA 

presented several regulatory alternatives: (1) incorporate the interim 

procedures and evidence-based ranking system we have previously 

discussed into regulation; (2) subject health claims to notice-and-comment 

rulemaking, as before Pearson, but reinterpret the “significant scientific 

agreement” standard to refer to the evidence supporting the claim being 

made, instead of the underlying substance-disease relationship; or (3) treat 

1368 Fed. Reg. 41,387, July 11, 2003.

14Whitaker v. Thompson, 248 F. Supp. 2d 1 (2002). See also Pearson v. Shalala, 130 F. Supp. 

2d 105 (2001).

15Those qualifying statements being (1) “although there is scientific evidence supporting the 

claim, the evidence is not conclusive”; (2) “some scientific evidence suggests ... however, 

FDA has determined that this evidence is limited and not conclusive”; and (3) “very little and 

preliminary scientific research suggests ... FDA concludes that there is little scientific 

evidence supporting this claim.” FDA, Interim Procedures for Qualified Health Claims in 

the Labeling of Conventional Human Foods and Human Dietary Supplements (July 10, 

2003).

1668 Fed. Reg. 66,040, Nov. 25, 2003.
Appendix V

FDA’s Administration of Health Claims in 

Response to the Pearson v. Shalala Ruling

Page 64 GAO-08-597 FDA Food Labeling Oversight

qualified health claims as outside the NLEA and regulate them on a 

postmarket basis (i.e., pursue the product as misbranded if the health claim 

renders the label false or misleading because the claim lacks 

substantiation). FDA does not plan to work on this proposed rulemaking 

this year. In May of 2006, FDA issued guidance concerning FDA’s 

implementation of qualified health claims process. In that guidance, FDA 

reaffirmed the 2003 interim procedures and stated that “FDA is currently 

considering various options regarding the development of proposed 

regulations related to qualified health claims,” and “...[i]n the meantime, 

the agency plans to review qualified health claim petitions on a case-bycase basis.”17

17FDA, Center for Food Safety and Applied Nutrition, FDA’s Implementation of “Qualified 

Health Claims”: Questions and Answers (May 12, 2006). 
Page 65 GAO-08-597 FDA Food Labeling Oversight

Appendix VI

Comments from the Food and Drug 

Administration ApendxiVI

Note: GAO comments 

supplementing those in 

the report text appear 

at the end of this 

appendix.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 66 GAO-08-597 FDA Food Labeling Oversight

See comment 1.

See comment 2.

See comment 3.

See comment 4.

See comment 5.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 67 GAO-08-597 FDA Food Labeling Oversight

See comment 6.

See comment 7.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 68 GAO-08-597 FDA Food Labeling Oversight

See comment 8.

See comment 9.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 69 GAO-08-597 FDA Food Labeling Oversight
Appendix VI

Comments from the Food and Drug 

Administration 

Page 70 GAO-08-597 FDA Food Labeling Oversight

See comment 10.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 71 GAO-08-597 FDA Food Labeling Oversight

See comment 11.

See comment 12.
Appendix VI

Comments from the Food and Drug 

Administration 

Page 72 GAO-08-597 FDA Food Labeling Oversight

The following are GAO’s comments on the Department of Health and 

Human Service’s (HHS) letter dated August 19, 2008.

GAO Comments 1. FDA commented that the report did not place food labeling in the 

appropriate context, given FDA’s overall public health mission and 

competing priorities. We believe the food labeling responsibilities are 

part of that mission. The Federal Food, Drug, and Cosmetic Act 

specifically describes FDA’s mission to include protecting the public 

health by, among other things, ensuring that “foods are safe, 

wholesome, sanitary, and properly labeled.” FDA also commented that 

the report failed to account for all the varied initiatives that FDA and 

HHS have undertaken to fight obesity and ensure that foods are labeled 

in a manner that fosters consumer education and healthy choices. The 

subject of this report is food labeling, not obesity. With respect to 

labeling initiatives to help consumers make healthy food choices, the 

report identifies several areas where stakeholders believe that FDA 

falls short. 

2. Although FDA said that it does not consider food labeling part of its 

food safety mission, it does include reviewing labels as a required step 

in a food safety inspection. Also, overseeing industry compliance with 

labeling requirements is part of FDA’s food oversight responsibilities 

and labeling laws help consumers ensure that the food they buy is safe 

for them eat. That said, since FDA made this distinction, we revised the 

wording in some places in the final report.

3. FDA took issue with the report’s frequent references to the Food 

Protection Plan. FDA stated that the plan was developed to address 

food safety and defense, although it may have some bearing on food 

labeling issues. It was not our intent to suggest that the plan’s primary 

focus was on food labeling, and we have clarified this in the report. The 

report discusses the Plan’s potential to help FDA carry out its food 

regulatory responsibilities and discusses certain provisions that, if 

implemented, may be useful tools in monitoring and enforcing the food 

labeling requirements. 

4. FDA correctly noted that the report does not evaluate how efficiently 

FDA used its resources or the impact of its changing priorities, 

although we did examine resources for food labeling. For example, the 

report provides 10 years of budget data on FDA, with detailed data for 

each center, including (1) total staffing and funding, (2) the portion of 
Appendix VI

Comments from the Food and Drug 

Administration 

Page 73 GAO-08-597 FDA Food Labeling Oversight

Office of Regulatory Affairs’ staffing and funding for inspections and 

other oversight, and (3) staffing and funding supported by user fees. 

However, because FDA was not able to provide risk-based priority 

plans or annual work projections for all labeling activities, we could not 

determine how efficiently labeling resources were used or the impact 

of changing priorities on labeling. 

5. FDA contended that most misleading food labeling violations do not 

present a high risk to public health. However, FDA has not conducted 

the research to identify which food labels are misleading and therefore 

has little or no basis for determining the health impacts of misleading 

labeling violations. 

6. FDA commented that it does not believe that tracking and analyzing 

data and providing routine reports on food labeling violations is the 

best use of its resources, given competing priorities. We maintain that 

risk-based decisions, such as allocating resources effectively, must 

include careful analysis of this type of data on regulatory programs. 

Moreover, FDA already collects most of these data so resource 

investment to generate the reports should be minimal and worth the 

benefits of ensuring that managers’ decisions are well-informed and 

risk-based. As FDA rolls out several initiatives for improving its 

information technology systems, which it states are under way, HHS 

may want to provide FDA managers with training on using the systems 

as management tools.

7. FDA said it agreed that being able to track any and all information that 

would allow its investigators to better do their jobs would be useful to 

the agency, but that data collection requires time and effort. FDA 

continued, it is important to make sure that data entry does not become 

so burdensome that it takes away from other investigative work. 

However, as we previously noted, FDA already collects most of these 

data. With a small resource investment, analyzing these data in reports 

can help managers make more informed decisions. 

8. FDA implied that it may not have the resources to keep data on the 

public Web site up to date. However, providing consumers with 

information that is timely and complete can help them avoid potentially 

dangerous food and make healthy food purchases.

9. FDA commented that the report suggests in several places that the only 

context in which FDA detains food is under the Bioterrorism Act, and 
Appendix VI

Comments from the Food and Drug 

Administration 

Page 74 GAO-08-597 FDA Food Labeling Oversight

that that FDA has another type of detention authority that applies to 

imported articles. However, the report does discuss FDA’s other 

detention authority under section 801(a) of the Federal Food, Drug, and 

Cosmetic Act. The report refers to these actions as “import refusals," 

which is the term that FDA currently uses for these enforcement 

actions. We added a footnote in the text to note this. 

10. FDA's statement—that its survey indicated that 70 percent of adults 

said they look at the Nutrition Facts panel the first time they purchase a 

food—is misleading. In that survey, 44 percent of respondents told 

FDA that they "often" read the panel the first time they purchase a food, 

and 25 percent "sometimes" read the panel at that time; while 31 

percent "rarely" or "never" read the panel.

11. FDA commented that (1) court decisions, beginning with Pearson v. 

Shalala, hold that the First Amendment precludes FDA from 

prohibiting the use of qualified health claims unless FDA can show that 

the claim is inherently misleading, or if the claim is only potentially 

misleading, that the use of a disclaimer would not remedy the claim’s 

potential to mislead, and (2) that absent consumer research or other 

evidence that satisfies the criteria set by the court in Pearson v. 

Shalala, FDA does not have the authority to eliminate qualified health 

claims as a class of claims. We added language to the report to 

acknowledge FDA’s position. 

12. FDA commented that, contrary to our report, FDA’s 2005 and 2007 

qualified health claims experiments did not find that qualified health 

claims might encourage the consumption of foods with little or no 

health benefits. Our report states that, according to the stakeholders 

we consulted, “... these claims confuse or mislead consumers and may 

encourage consumption of foods with little or no health benefits.” It 

then states that “[t]his view was supported by findings from 2005 and 

2007 FDA studies.” This statement is consistent with FDA’s findings. 

According to its public Web site, those studies on qualified health 

claims found that “qualifying statements ... were not understood by 

consumers” and “even when ... understood as intended, qualifying 

statements had unexpected effects on consumers’ judgments about the 

health benefits and overall healthfulness .... ” 
Page 75 GAO-08-597 FDA Food Labeling Oversight

Appendix VII

GAO Contact and Staff Acknowledgments ApendxiVI

GAO Contact Lisa Shames, (202) 512-3841, shamesl@gao.gov

Staff 

Acknowledgments

In addition to the contact named above, Erin Lansburgh, Assistant 

Director; Beverly Peterson, Analyst-in-Charge; Kevin S. Bray; Abby Ershow; 

Bart Fischer; Jennifer Harman; Natalie Herzog; Luann Moy; Allison O’Neill; 

Minette Richardson; Carol Herrnstadt Shulman; and Marcia Whitehead 

made key contributions to this report.

(360780)
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