Food Labeling
FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods
Gao ID: GAO-08-597 September 9, 2008
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.
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: (1) 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. (2) FDA's testing for the accuracy of nutrition information on labels in 2000 through 2006 was limited. FDA could not provide data for 2007. (3) 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. (4) 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. (5) 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-of-package 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.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
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GAO-08-597, Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods
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Improve Oversight, and Effectively Use Available Data to Help Consumers
Select Healthy Foods' which was released on October 9, 2008.
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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:
GAO Highlights:
Highlights of GAO-08-597, a report to the Chair, Subcommittee on
Agriculture, Rural Development, Food and Drug Administration, and
Related Agencies, Committee on Appropriations, House of
Representatives.
Why GAO Did This Study:
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 Found:
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-of-package 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.
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.
To view the full product, including the scope and methodology, click on
[[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-597]. For more
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
FDA Has Limited Assurance That Companies Are Complying with Food
Labeling Requirements:
FDA Reports That Resource Constraints and Limited Authority Challenge
Efforts to Carry Out Food-Related Responsibilities, Including Food
Labeling:
Key Stakeholders Suggested Actions to Help Mitigate Misleading Labeling
and Assist Consumers' Efforts to Identify Healthy Food:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendixes:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: FDA-Regulated and -Inspected Domestic and Foreign Food
Firms, Fiscal Years 2001 through 2007:
Appendix III: FDA Inspections of Food Firms in Foreign Countries,
Fiscal Years 2001 through 2007:
Appendix IV: Funding and Staffing Information by FDA Mission, Fiscal
Years 1998 through 2007:
Appendix V: FDA's Administration of Health Claims in Response to the
Pearson v. Shalala Ruling:
Appendix VI: Comments from the Food and Drug Administration:
GAO Comments:
Appendix VII: GAO Contact and Staff Acknowledgments:
Tables 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:
Table 2: Accuracy of Nutrition Labeling Information for Food Samples
Tested, Fiscal Years 2000 through 2006:
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:
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:
Table 5: Number of Imported Food Product Entry Lines Examined for
Labeling Compliance, Refused Import, and Released with Comment, Fiscal
Years 2002 through 2007:
Table 6: Violations Cited in Food-Labeling-Related Import Refusals,
Fiscal Years 2002 through 2007:
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:
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:
Table 9: Domestic Food Firms and Total Domestic Firms under FDA's
Jurisdiction, by Fiscal Year:
Table 10: Firms Inspected by FDA and States under Contract with FDA,
Fiscal Years 2001 through 2007:
Figures:
Figure 1: FDA Example of a Nutrition Facts Panel:
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:
Figure 3: FDA Food-Labeling-Related Warning Letters and All Other FDA
Warning Letters Issued, Fiscal Years 2002 through 2007:
Figure 4: Selected Front-of-Package Symbols Used in Other Countries:
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:
Letter September 9, 2008:
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,[Footnote 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.[Footnote 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 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 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.[Footnote 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.[Footnote 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),[Footnote 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.[Footnote 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 need to assess the likelihood of the plan's success.[Footnote 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.[Footnote 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
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, 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.[Footnote 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
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.[Footnote 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 front-of-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 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 risk-based 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 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 people who are sensitive
to them. For example, the act and FDA's regulations, with some
exceptions,[Footnote 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;[Footnote 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;[Footnote 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.
Figure 1: FDA Example of a Nutrition Facts Panel:
This figure an example of a nutrition facts panel.
[See PDF for image]
Source: FDA.
[End of figure]
The act and FDA regulations also require that health claims--that is,
claims characterizing the relationship of certain nutrients to a
disease or a health-related 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 health-related 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 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.
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.[Footnote 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.
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:
This figure is a combination bar graph showing 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. The
X axis represents fiscal year, and the Y axis represents the number of
food firms (in thousands).
Fiscal year: "2001";
Food firms impacted: 14.7;
Total food firms: 51.0.
Fiscal year: "2002";
Food firms impacted: 14.7;
Total food firms: 58.6.
Fiscal year: "2003";
Food firms impacted: 17.6;
Total food firms: 58.3.
Fiscal year: "2004";
Food firms impacted: 18.0;
Total food firms: 59.3.
Fiscal year: "2005";
Food firms impacted: 16.7;
Total food firms: 61.9.
Fiscal year: "2006";
Food firms impacted: 15.2;
Total food firms: 62.9.
Fiscal year: "2007";
Food firms impacted: 14.6;
Total food firms: 65.5.
[See PDF for image]
Source: GAO analysis of FDA FACTS data.
[End of figure]
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 lines[Footnote
15] 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.
Table 1: The Number of Countries in Which FDA Conducted Inspections and
the Number of Foreign Food Firms Inspected, Fiscal Years 2001 through
2007:
Foreign inspection: Number of countries;
Fiscal year: 2001: 26;
Fiscal year: 2002: 22;
Fiscal year: 2003: 22;
Fiscal year: 2004: 20;
Fiscal year: 2005: 16;
Fiscal year: 2006: 15;
Fiscal year: 2007: 11;
Fiscal year: Total: 54[A].
Foreign inspection: Number of food firms;
Fiscal year: 2001: 211;
Fiscal year: 2002: 169;
Fiscal year: 2003: 148;
Fiscal year: 2004: 153;
Fiscal year: 2005: 132;
Fiscal year: 2006: 125;
Fiscal year: 2007: 95;
Fiscal year: Total: 1,034.
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.
[End of table]
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.
Table 2: Accuracy of Nutrition Labeling Information for Food Samples
Tested, Fiscal Years 2000 through 2006:
Fiscal year: 2000;
Domestic samples: Number tested: 106;
Domestic samples: Number in violation: 15;
Domestic samples: Percentage in violation: 14%;
Imported samples: Number tested: 150;
Imported samples: Number in violation: 36;
Imported samples: Percentage in violation: 24%;
Total domestic and imported samples: Number tested: 256;
Total domestic and imported samples: Number in violation: 51;
Total domestic and imported samples: Percentage in violation: 20%.
Fiscal year: 2001;
Domestic samples: Number tested: 93;
Domestic samples: Number in violation: 24;
Domestic samples: Percentage in violation: 26;
Imported samples: Number tested: 53;
Imported samples: Number in violation: 20;
Imported samples: Percentage in violation: 38; Total domestic and
imported samples: Number tested: 146; Total domestic and imported
samples: Number in violation: 44; Total domestic and imported samples:
Percentage in violation: 30.
Fiscal year: 2002;
Domestic samples: Number tested: 85;
Domestic samples: Number in violation: 12;
Domestic samples: Percentage in violation: 14;
Imported samples: Number tested: 88;
Imported samples: Number in violation: 23;
Imported samples: Percentage in violation: 26;
Total domestic and imported samples: Number tested: 173;
Total domestic and imported samples: Number in violation: 35;
Total domestic and imported samples: Percentage in violation: 20.
Fiscal year: 2003;
Domestic samples: Number tested: 147;
Domestic samples: Number in violation: 34;
Domestic samples: Percentage in violation: 23;
Imported samples: Number tested: 188;
Imported samples: Number in violation: 60;
Imported samples: Percentage in violation: 32;
Total domestic and imported samples: Number tested: 335;
Total domestic and imported samples: Number in violation: 94;
Total domestic and imported samples: Percentage in violation: 28.
Fiscal year: 2004;
Domestic samples: Number tested: 181;
Domestic samples: Number in violation: 43;
Domestic samples: Percentage in violation: 24;
Imported samples: Number tested: 131;
Imported samples: Number in violation: 38;
Imported samples: Percentage in violation: 29;
Total domestic and imported samples: Number tested: 312;
Total domestic and imported samples: Number in violation: 81;
Total domestic and imported samples: Percentage in violation: 26.
Fiscal year: 2005;
Domestic samples: Number tested: 141;
Domestic samples: Number in violation: 27;
Domestic samples: Percentage in violation: 19;
Imported samples: Number tested: 77;
Imported samples: Number in violation: 19;
Imported samples: Percentage in violation: 25;
Total domestic and imported samples: Number tested: 218;
Total domestic and imported samples: Number in violation: 46;
Total domestic and imported samples: Percentage in violation: 21.
Fiscal year: 2006;
Domestic samples: Number tested: 115;
Domestic samples: Number in violation: 23;
Domestic samples: Percentage in violation: 20;
Imported samples: Number tested: 96;
Imported samples: Number in violation: 27;
Imported samples: Percentage in violation: 28;
Total domestic and imported samples: Number tested: 211;
Total domestic and imported samples: Number in violation: 50;
Total domestic and imported samples: Percentage in violation: 24.
Fiscal year: Total;
Domestic samples: Number tested: 868;
Domestic samples: Number in violation: 178;
Domestic samples: Percentage in violation: 21%;
Imported samples: Number tested: 783;
Imported samples: Number in violation: 223;
Imported samples: Percentage in violation: 28%;
Total domestic and imported samples: Number tested: 1,651;
Total domestic and imported samples: Number in violation: 401;
Total domestic and imported samples: Percentage in violation: 24%.
Source: GAO analysis of FDA FACTS data.
Note: FDA was unable to provide these data for fiscal year 2007.
[End of table]
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.
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:
U.S. dollars in billions.
Canada ($15.6);
Food samples tested, fiscal years 2000-2006: Number tested: 93;
Food samples tested, fiscal years 2000-2006: Number in violation: 13;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
14%.
Mexico ($9.8);
Food samples tested, fiscal years 2000-2006: Number tested: 200;
Food samples tested, fiscal years 2000-2006: Number in violation: 87;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
44.
China[A] ($4.2);
Food samples tested, fiscal years 2000-2006: Number tested: 26;
Food samples tested, fiscal years 2000-2006: Number in violation: 7;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
27.
Thailand ($3.1);
Food samples tested, fiscal years 2000-2006: Number tested: 18;
Food samples tested, fiscal years 2000-2006: Number in violation: 8;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
44.
Italy ($2.8);
Food samples tested, fiscal years 2000-2006: Number tested: 31;
Food samples tested, fiscal years 2000-2006: Number in violation: 8;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
26.
Indonesia ($2.8);
Food samples tested, fiscal years 2000-2006: Number tested: 2;
Food samples tested, fiscal years 2000-2006: Number in violation: 0;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
0.
Chile ($2.7);
Food samples tested, fiscal years 2000-2006: Number tested: 8;
Food samples tested, fiscal years 2000-2006: Number in violation: 2;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
25.
Australia ($2.6);
Food samples tested, fiscal years 2000-2006: Number tested: 10;
Food samples tested, fiscal years 2000-2006: Number in violation: 1;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
10.
Brazil ($2.4);
Food samples tested, fiscal years 2000-2006: Number tested: 7;
Food samples tested, fiscal years 2000-2006: Number in violation: 4;
Food samples tested, fiscal years 2000-2006: Percentage in violation:
57.
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.
[End of table]
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 percent of the samples were
not within the allowable range for iron.[Footnote 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.
Figure 3: FDA Food-Labeling-Related Warning Letters and All Other FDA
Warning Letters Issued, Fiscal Years 2002 through 2007:
This figure is a bar graph showing FDA food-labeling-related warning
letters and all other FDA warning letters issued, fiscal years 2002
through 2007. The X axis represents fiscal year, and the Y axis
represents the number of warning letters. The darker shading represents
food-labeling-related warning letters, and the lighter shading
represents all other FDA warning letters. The X axis represents fiscal
year, and the Y axis represents the number of warning letters.
Fiscal year: 2002;
Food-labeling-related warning letters: 67;
All other FDA warning letters: 739.
Fiscal year: 2003;
Food-labeling-related warning letters: 107;
All other FDA warning letters: 654.
Fiscal year: 2004;
Food-labeling-related warning letters: 75;
All other FDA warning letters: 655.
Fiscal year: 2005;
Food-labeling-related warning letters: 68;
All other FDA warning letters: 451.
Fiscal year: 2006;
Food-labeling-related warning letters: 85;
All other FDA warning letters: 441.
Fiscal year: 2007;
Food-labeling-related warning letters: 373;
All other FDA warning letters: 61.
[See PDF for image]
Source: GAO analysis of FDA's online databases of warning letters.
[End of figure]
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.
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:
Food-labeling-related violation: Meets the generic finding that the
"label is false or misleading in any particular";
Number of violations in the 326 letters: 163;
Percentage of total violations: 24.1%.
Food-labeling-related violation: Fails to meet the requirements to bear
health and/or nutrient content claims;
Number of violations in the 326 letters: 129;
Percentage of total violations: 19.1.
Food-labeling-related violation: Fails to declare all of the
ingredients by their common or usual name;
Number of violations in the 326 letters: 107;
Percentage of total violations: 15.8.
Food-labeling-related violation: Does not comply with the format and
content requirements for nutrition information;
Number of violations in the 326 letters: 84;
Percentage of total violations: 12.4.
Food-labeling-related violation: Lacks common or usual name of the
food;
Number of violations in the 326 letters: 46;
Percentage of total violations: 6.8.
Food-labeling-related violation: Lacks name and location of the
manufacturer, packer, or distributor;
Number of violations in the 326 letters: 30;
Percentage of total violations: 4.4.
Food-labeling-related violation: Contains undeclared flavoring,
coloring, or chemical preservatives;
Number of violations in the 326 letters: 27;
Percentage of total violations: 4.0.
Food-labeling-related violation: Bears a drug claim not allowed on a
dietary supplement label;
Number of violations in the 326 letters: 25;
Percentage of total violations: 3.7.
Food-labeling-related violation: Fails to declare accurate weight,
quantity, or numerical count;
Number of violations in the 326 letters: 22;
Percentage of total violations: 3.2.
Food-labeling-related violation: Fails to declare sources of all major
food allergens;
Number of violations in the 326 letters: 16;
Percentage of total violations: 2.4.
Food-labeling-related violation: Does not meet the standard identity
indicated on the label;
Number of violations in the 326 letters: 10;
Percentage of total violations: 1.5.
Food-labeling-related violation: Does not meet standard that
information required be prominently placed on the label;
Number of violations in the 326 letters: 9;
Percentage of total violations: 1.3.
Food-labeling-related violation: Claims, inaccurately, to contain
ginseng;
Number of violations in the 326 letters: 5;
Percentage of total violations: 0.7.
Food-labeling-related violation: Offered for sale under the name of
another food;
Number of violations in the 326 letters: 2;
Percentage of total violations: 0.3.
Food-labeling-related violation: Fails to declare the food is an
imitation;
Number of violations in the 326 letters: 2;
Percentage of total violations: 0.3.
Food-labeling-related violation: Total;
Number of violations in the 326 letters: 677;
Percentage of total violations: 100%.
Source: GAO analysis of FDA warning letters.
[End of table]
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.
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.[Footnote 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.[Footnote 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 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
labeling-related 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
food-labeling-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.[Footnote 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.
Import refusals: FDA refused entry to 15,226 imported food product
entry lines that had labeling violations from fiscal years 2002 through
2007.[Footnote 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.[Footnote 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:
Fiscal year: 2002;
Product lines examined for labeling compliance: Number: 16,275;
Product lines refused import that had labeling violations: Number:
2,357;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 14.5%;
Product lines released with comments that had labeling violations:
Number: 1,518;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 9.3%.
Fiscal year: 2003;
Product lines examined for labeling compliance: Number: 29,383;
Product lines refused import that had labeling violations: Number:
2,919;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 9.9;
Product lines released with comments that had labeling violations:
Number: 3,104;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 10.6.
Fiscal year: 2004;
Product lines examined for labeling compliance: Number: 30,598;
Product lines refused import that had labeling violations: Number:
2,671;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 8.7;
Product lines released with comments that had labeling violations:
Number: 2,657;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 8.7.
Fiscal year: 2005;
Product lines examined for labeling compliance: Number: 38,782;
Product lines refused import that had labeling violations: Number:
2,498;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 6.4;
Product lines released with comments that had labeling violations:
Number: 2,304;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 5.9.
Fiscal year: 2006;
Product lines examined for labeling compliance: Number: 34,753;
Product lines refused import that had labeling violations: Number:
2,497;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 7.2;
Product lines released with comments that had labeling violations:
Number: 2,885;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 8.3.
Fiscal year: 2007;
Product lines examined for labeling compliance: Number: 34,215;
Product lines refused import that had labeling violations: Number:
2,284;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 6.7;
Product lines released with comments that had labeling violations:
Number: 2,383;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 7.0.
Fiscal year: Total;
Product lines examined for labeling compliance: Number: 184,006;
Product lines refused import that had labeling violations: Number:
15,226;
Product lines refused import that had labeling violations: Percentage
of total product lines examined: 8.3%;
Product lines released with comments that had labeling violations:
Number: 14,851;
Product lines released with comments that had labeling violations:
Percentage of total product lines examined: 8.1%.
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.
[End of table]
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:
Food-labeling-related violation: Lacks required nutrition information;
Number of violations: 6,909;
Percentage of total violations: 25%.
Food-labeling-related violation: Lacks the common or usual ingredient
name;
Number of violations: 4,840;
Percentage of total violations: 18.
Food-labeling-related violation: Fails to declare accurate weight,
quantity, or numerical count;
Number of violations: 3,519;
Percentage of total violations: 13.
Food-labeling-related violation: Lacks information in English;
Number of violations: 3,348;
Percentage of total violations: 12.
Food-labeling-related violation: Lacks name and location of the
manufacturer, packer, or distributor;
Number of violations: 1,906;
Percentage of total violations: 7.
Food-labeling-related violation: Lacks common or usual name of the
food;
Number of violations: 1,576;
Percentage of total violations: 6.
Food-labeling-related violation: Fails to indicate apparent added
coloring;
Number of violations: 1,022;
Percentage of total violations: 4.
Food-labeling-related violation: Bears a label that is inconspicuous
and unlikely to be read;
Number of violations: 842;
Percentage of total violations: 3.
Food-labeling-related violation: Bears false and misleading
information;
Number of violations: 673;
Percentage of total violations: 2.
Food-labeling-related violation: Bears a label with 1 of 13 "other"
categories with less than 1 percent of the violations cited[A];
Number of violations: 628;
Percentage of total violations: 2.
Food-labeling-related violation: Fails to declare apparent color
additive Yellow No. 5;
Number of violations: 552;
Percentage of total violations: 2.
Food-labeling-related violation: Does not meet FDA's standard of
identity;
Number of violations: 397;
Percentage of total violations: 1.
Food-labeling-related violation: Fails to declare a chemical
preservative;
Number of violations: 356;
Percentage of total violations: 1.
Food-labeling-related violation: Fails to declare the trans fat
content;
Number of violations: 222;
Percentage of total violations: 1.
Food-labeling-related violation: Lacks prominent statement of the
percentage of vegetable or fruit juice;
Number of violations: 217;
Percentage of total violations: 1.
Food-labeling-related violation: Fails to declare sulfites;
Number of violations: 174;
Percentage of total violations: 1.
Food-labeling-related violation: Bears an unauthorized nutrient/health
claim;
Number of violations: 158;
Percentage of total violations: 1.
Food-labeling-related violation: Total;
Number of violations: 27,339;
Percentage of total violations: 100%.
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."
[End of table]
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 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:
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Canada ($15.6);
Products: Examined for labeling compliance: Number: 45,377;
Products: Refused import that had labeling violations: Number: 1,174;
Products: Refused import that had labeling violations: Percentage of
products examined: 2.6%;
Products: Released with comments that had labeling violations: Number:
1,538;
Products: Released with comments that had labeling violations:
Percentage of products examined: 3.4%.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Mexico ($9.8);
Products: Examined for labeling compliance: Number: 25,622;
Products: Refused import that had labeling violations: Number: 1,964;
Products: Refused import that had labeling violations: Percentage of
products examined: 7.7;
Products: Released with comments that had labeling violations: Number:
830;
Products: Released with comments that had labeling violations:
Percentage of products examined: 3.2.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): China[A] ($4.2);
Products: Examined for labeling compliance: Number: 8,595;
Products: Refused import that had labeling violations: Number: 655;
Products: Refused import that had labeling violations: Percentage of
products examined: 7.6;
Products: Released with comments that had labeling violations: Number:
991;
Products: Released with comments that had labeling violations:
Percentage of products examined: 11.5.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Thailand ($3.1);
Products: Examined for labeling compliance: Number: 5,362;
Products: Refused import that had labeling violations: Number: 253;
Products: Refused import that had labeling violations: Percentage of
products examined: 4.7;
Products:
Products: Released with comments that had labeling violations: Number:
489;
Products: Released with comments that had labeling violations:
Percentage of products examined: 9.1.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Italy ($2.8);
Products: Examined for labeling compliance: Number: 4,891;
Products: Refused import that had labeling violations: Number: 429;
Products: Refused import that had labeling violations: Percentage of
products examined: 8.8;
Products: Released with comments that had labeling violations: Number:
563;
Products: Released with comments that had labeling violations:
Percentage of products examined: 11.5.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Indonesia ($2.8);
Products: Examined for labeling compliance: Number: 1,726;
Products: Refused import that had labeling violations: Number: 156;
Products: Refused import that had labeling violations: Percentage of
products examined: 9.0;
Products: Released with comments that had labeling violations: Number:
173;
Products: Released with comments that had labeling violations:
Percentage of products examined: 10.0.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Chile ($2.7);
Products: Examined for labeling compliance: Number: 1,136;
Products: Refused import that had labeling violations: Number: 34;
Products: Refused import that had labeling violations: Percentage of
products examined: 3.0;
Products: Released with comments that had labeling violations: Number:
133;
Products: Released with comments that had labeling violations:
Percentage of products examined: 11.7.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Australia ($2.6);
Products: Examined for labeling compliance: Number: 697;
Products: Refused import that had labeling violations: Number: 100;
Products: Refused import that had labeling violations: Percentage of
products examined: 14.3;
Products: Released with comments that had labeling violations: Number:
67;
Products: Released with comments that had labeling violations:
Percentage of products examined: 9.6.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Brazil ($2.4);
Products: Examined for labeling compliance: Number: 2,321;
Products: Refused import that had labeling violations: Number: 220;
Products: Refused import that had labeling violations: Percentage of
products examined: 9.5;
Products: Released with comments that had labeling violations: Number:
338;
Products: Released with comments that had labeling violations:
Percentage of products examined: 14.6.
Country (value of agricultural, fish, and seafood imports in 2006, in
billions): Total;
Products: Examined for labeling compliance: Number: 95,727;
Products: Refused import that had labeling violations: Number: 4,985;
Products: Refused import that had labeling violations: Percentage of
products examined: 5.2%;
Products: Released with comments that had labeling violations: Number:
5,122;
Products: Released with comments that had labeling violations:
Percentage of products examined: 5.4%.
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.
[End of table]
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, 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, 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.[Footnote 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. 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 food-labeling- 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 Food-Related 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.
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.[Footnote 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 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:
Dollars in millions.
Fiscal year: 1999;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 83;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: $7.5.
Fiscal year: 2000;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 80;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: 6.9.
Fiscal year: 2001;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 73;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: 6.8.
Fiscal year: 2002;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 88;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: 9.7.
Fiscal year: 2003;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 86;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: 8.6.
Fiscal year: 2004;
Staffing level (FTEs): Food-labeling-related: [A];
Staffing level (FTEs): Other: [A];
Staffing level (FTEs): Total: 83;
Budget authority: Food-labeling-related: [A];
Budget authority: Other: [A];
Budget authority: Total: 10.0.
Fiscal year: 2005;
Staffing level (FTEs): Food-labeling-related: 10.0;
Staffing level (FTEs): Other: 73.0;
Staffing level (FTEs): Total: 83;
Budget authority: Food-labeling-related: $1.2;
Budget authority: Other: $8.8;
Budget authority: Total: 10.0.
Fiscal year: 2006;
Staffing level (FTEs): Food-labeling-related: 9.0;
Staffing level (FTEs): Other: 65.0;
Staffing level (FTEs): Total: 74;
Budget authority: Food-labeling-related: 1.1;
Budget authority: Other: 7.7;
Budget authority: Total: 8.8.
Fiscal year: 2007;
Staffing level (FTEs): Food-labeling-related: 10.5;
Staffing level (FTEs): Other: 54.5;
Staffing level (FTEs): Total: 65;
Budget authority: Food-labeling-related: 1.3;
Budget authority: Other: 6.9;
Budget authority: Total: 8.2.
Source: FDA CFSAN finance and other officials.
[A] For 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.
[End of table]
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.
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.[Footnote 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.[Footnote
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.)
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.[Footnote 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.[Footnote 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 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.[Footnote 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 front-
of-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.
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.[Footnote 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.[Footnote 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-of-
package 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 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.
Figure 4: Selected Front-of-Package Symbols Used in Other Countries:
This figure is a picture of selected front-of-package symbols used in
other countries.
[See PDF for image]
Source: Government officials from the United Kingdom, the Netherlands,
and Sweden.
[End of figure]
Consumers and health organizations in many countries have a heightened
interest in the benefits of choosing healthy foods, including several
that 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
less-healthy 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 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.[Footnote 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 heart-check 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,
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.
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.[Footnote 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 considered "whole grain."[Footnote 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.[Footnote 34] Industry-
sponsored 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 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. 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.[Footnote 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.
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 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 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.
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 [hyperlink,
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,
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
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,[Footnote 36] 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. 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 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.
[End of section]
Appendix II: FDA-Regulated and -Inspected Domestic and Foreign Food
Firms, Fiscal Years 2001 through 2007:
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:
Fiscal year: 2001;
Domestic food firms: 51,020;
Total domestic firms: 114,696;
Percentage of total domestic firms: 44.5%.
Fiscal year: 2002;
Domestic food firms: 58,593;
Total domestic firms: 120,403;
Percentage of total domestic firms: 48.7.
Fiscal year: 2003;
Domestic food firms: 58,268;
Total domestic firms: 120,403;
Percentage of total domestic firms: 48.4.
Fiscal year: 2004;
Domestic food firms: 59,305;
Total domestic firms: 123,892;
Percentage of total domestic firms: 47.9.
Fiscal year: 2005;
Domestic food firms: 61,930;
Total domestic firms: 127,887;
Percentage of total domestic firms: 48.4.
Fiscal year: 2006;
Domestic food firms: 62,929;
Total domestic firms: 136,129;
Percentage of total domestic firms: 46.2.
Fiscal year: 2007;
Domestic food firms: 65,520;
Total domestic firms: 139,176;
Percentage of total domestic firms: 47.1.
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.
[End of table]
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 FDA-regulated firms inspected, for fiscal years 2001 through
2007, by FDA and states under contract with FDA.
Table 10: Firms Inspected by FDA and States under Contract with FDA,
Fiscal Years 2001 through 2007:
Fiscal year: 2001;
Foreign firms inspected by FDA: Food firms: 211;
Foreign firms inspected by FDA: Total firms: 892;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 23.7%;
Domestic firms inspected by FDA: Food: firms: 8,922;
Domestic firms inspected by FDA: Total firms: 16,006;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 55.7%;
Domestic firms inspected under contracts with states: Food firms:
6,688;
Domestic firms inspected under contracts with states: Total firms:
16,875;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 39.6%;
Total firms inspected[A]: Food: firms: 14,932;
Total firms inspected[A]: Total firms: 32,733;
Total firms inspected[A]: Food firms as a percentage of total firms:
45.6%.
Fiscal year: 2002;
Foreign firms inspected by FDA: Food firms: 169;
Foreign firms inspected by FDA: Total firms: 791;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 21.4;
Domestic firms inspected by FDA: Food: firms: 8,175;
Domestic firms inspected by FDA: Total firms: 16,428;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 49.8;
Domestic firms inspected under contracts with states: Food firms:
6,979;
Domestic firms inspected under contracts with states: Total firms:
19,885;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 35.1;
Total firms inspected[A]: Food: firms: 14,877;
Total firms inspected[A]: Total firms: 36,216;
Total firms inspected[A]: Food firms as a percentage of total firms:
41.1.
Fiscal year: 2003;
Foreign firms inspected by FDA: Food firms: 148;
Foreign firms inspected by FDA: Total firms: 757;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 19.6;
Domestic firms inspected by FDA: Food: firms: 10,507;
Domestic firms inspected by FDA: Total firms: 20,027;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 52.5;
Domestic firms inspected under contracts with states: Food firms:
7,674;
Domestic firms inspected under contracts with states: Total firms:
19,710;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 38.9;
Total firms inspected[A]: Food: firms: 17,658;
Total firms inspected[A]: Total firms: 39,429;
Total firms inspected[A]: Food firms as a percentage of total firms:
44.8.
Fiscal year: 2004;
Foreign firms inspected by FDA: Food firms: 153;
Foreign firms inspected by FDA: Total firms: 932;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 16.4;
Domestic firms inspected by FDA: Food: firms: 10,370;
Domestic firms inspected by FDA: Total firms: 19,264;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 53.8;
Domestic firms inspected under contracts with states: Food firms:
8,173;
Domestic firms inspected under contracts with states: Total firms:
20,916;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 39.1;
Total firms inspected[A]: Food: firms: 18,172;
Total firms inspected[A]: Total firms: 40,173;
Total firms inspected[A]: Food firms as a percentage of total firms:
45.2.
Fiscal year: 2005;
Foreign firms inspected by FDA: Food firms: 132;
Foreign firms inspected by FDA: Total firms: 844;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 15.6;
Domestic firms inspected by FDA: Food: firms: 8,258;
Domestic firms inspected by FDA: Total firms: 17,489;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 47.2;
Domestic firms inspected under contracts with states: Food firms:
8,849;
Domestic firms inspected under contracts with states: Total firms:
21,493;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 41.2;
Total firms inspected[A]: Food: firms: 16,809;
Total firms inspected[A]: Total firms: 38,924;
Total firms inspected[A]: Food firms as a percentage of total firms:
43.2.
Fiscal year: 2006;
Foreign firms inspected by FDA: Food firms: 125;
Foreign firms inspected by FDA: Total firms: 788;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 15.9;
Domestic firms inspected by FDA: Food: firms: 7,071;
Domestic firms inspected by FDA: Total firms: 15,485;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 45.7;
Domestic firms inspected under contracts with states: Food firms:
8,447;
Domestic firms inspected under contracts with states: Total firms:
23,054;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 36.6;
Total firms inspected[A]: Food: firms: 15,332;
Total firms inspected[A]: Total firms: 38,558;
Total firms inspected[A]: Food firms as a percentage of total firms:
39.8.
Fiscal year: 2007;
Foreign firms inspected by FDA: Food firms: 96;
Foreign firms inspected by FDA: Total firms: 327;
Foreign firms inspected by FDA: Food firms as a percentage of total
firms: 29.1;
Domestic firms inspected by FDA: Food: firms: 6,106;
Domestic firms inspected by FDA: Total firms: 13,395;
Domestic firms inspected by FDA: Food firms as a percentage of total
firms: 45.6;
Domestic firms inspected under contracts with states: Food firms:
8,692;
Domestic firms inspected under contracts with states: Total firms:
22,967;
Domestic firms inspected under contracts with states: Food firms as a
percentage of total firms: 37.8;
Total firms inspected[A]: Food: firms: 14,661;
Total firms inspected[A]: Total firms: 36,199;
Total firms inspected[A]: Food firms as a percentage of total firms:
40.5.
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.
[End of table]
[End of section]
Appendix III: FDA Inspections of Food Firms in Foreign Countries,
Fiscal Years 2001 through 2007:
Country: Mexico;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
17;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
15;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
15;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
16;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
26;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
104.
Country: Ecuador;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
11;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
24;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
11;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
10;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
64.
Country: Chile;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
15;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
11;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
52.
Country: Peru;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
18;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
9;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
50.
Country: Brazil;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
12;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
21;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
46.
Country: Thailand;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
22;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
46.
Country: Canada;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
4;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
38.
Country: China;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
16;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
33.
Country: Taiwan;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
32.
Country: Argentina;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
19;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
31.
Country: India;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
30.
Country: South Korea;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
14;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
6;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
28.
Country: Australia;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
12;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
27.
Country: Costa Rica;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
11;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
27.
Country: Vietnam;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
27.
Country: Honduras;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
24.
Country: Fiji;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
13;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
21.
Country: Singapore;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
18.
Country: Estonia;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
16.
Country: Guatemala;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
16.
Country: South Africa;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
11;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
16.
Country: Germany;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
1;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
15.
Country: Nicaragua;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
15.
Country: El Salvador;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
14.
Country: Jamaica;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
3;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
3;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
14.
Country: Latvia;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
14.
Country: Uruguay;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
14;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
14.
Country: Venezuela;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
14.
Country: Italy;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
1;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
13.
Country: Morocco;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
13.
Country: New Zealand;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
6;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
13.
Country: Poland;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
13;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
13.
Country: Norway;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
6;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
11.
Country: France;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
10.
Country: Romania;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
10.
Country: Surinam;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
10;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
10.
Country: Iceland;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
9.
Country: Malaysia;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
9;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
9.
Country: Bulgaria;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
8.
Country: Colombia;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
8.
Country: Hong Kong;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
8;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
8.
Country: Cyprus;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
7.
Country: Panama;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
7.
Country: Trinidad and Tobago;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
7;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
7.
Country: The United Kingdom;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
1;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
6.
Country: Turkey;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
5;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
5.
Country: Spain;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
4;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
4.
Country: Belgium;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
3.
Country: Greece;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
3;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
3.
Country: Hungary;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
3;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
3.
Country: Finland;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
2.
Country: Haiti;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
1;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
2.
Country: Japan;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
2.
Country: The Netherlands;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
2;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
[Empty];
Number of FDA inspections of foreign food firms, by fiscal year: Total:
2.
Country: Total;
Number of FDA inspections of foreign food firms, by fiscal year: 2001:
211;
Number of FDA inspections of foreign food firms, by fiscal year: 2002:
169;
Number of FDA inspections of foreign food firms, by fiscal year: 2003:
148;
Number of FDA inspections of foreign food firms, by fiscal year: 2004:
153;
Number of FDA inspections of foreign food firms, by fiscal year: 2005:
132;
Number of FDA inspections of foreign food firms, by fiscal year: 2006:
125;
Number of FDA inspections of foreign food firms, by fiscal year: 2007:
96;
Number of FDA inspections of foreign food firms, by fiscal year: Total:
1,034.
Source: GAO analysis of FDA data.
[End of table]
[End of section]
Appendix IV: Funding and Staffing Information by FDA Mission, Fiscal
Years 1998 through 2007:
Dollars in millions.
[See PDF for image]
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.
[End of table]
[End of section]
Appendix V: FDA's Administration of Health Claims in Response to the
Pearson v. Shalala Ruling:
The Nutrition Labeling and Education Act of 1990 (NLEA)[Footnote 37]
amended the Federal Food, Drug, and Cosmetic Act[Footnote 38] 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.[Footnote 39] 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.[Footnote 40] 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.[Footnote 41] 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.[Footnote
42] However, 1 year later, after the prohibition of implementation of
NLEA for dietary supplements had expired, FDA adopted a rule that
subjected dietary supplement health claims to the same general
requirements that applied to conventional foods.[Footnote 43] 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,[Footnote 44] 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.[Footnote 45]
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 rulemaking to reconsider the procedures and standards
governing such claims.[Footnote 46] 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.[Footnote 47] 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.[Footnote
48] 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 inappropriate.[Footnote 49] 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.[Footnote 50] 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).[Footnote 51] 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.[Footnote 52] 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 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-by-case
basis."[Footnote 53]
[End of section]
Appendix VI: Comments from the Food and Drug Administration:
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
Department Of Health & Human Services:
Office Of The Secretary:
August 19, 2008:
Lisa R. Shames:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street NW:
Washington, DC 20548:
Dear Ms. Shames:
Enclosed are the Department's comments on U.S. Government
Accountability Office's (GAO) draft report entitled: "Food Labeling:
FDA Needs to Better Leverage Resources, Improve Oversight, and
Effectively Use Available Data to Help Consumers Select Healthy Foods"
(GAO 08-597).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
Vincent J. Ventimiglia, Jr.:
Secretary for Legislation:
Attachment:
General Comments For The Department Of Health And Human Services (HHS)
On The U.S. Government Accountability Office's (GAO) Draft Report
Entitled: "Food Labeling ” FDA Needs To Better Leverage Resources,
Improve Oversight, And Effectively Use Available Data To Help Consumers
Select Healthy Foods" (GAO-08-597):
The Food and Drug Administration (FDA) appreciates the opportunity to
review and comment on the Government Accountability Office's (GAO)
draft report. While GAO has raised some important issues regarding the
regulation of food labeling, FDA does not believe that the report
places food labeling in the appropriate context given the agency's
overall public health mission, and the multitude of competing
priorities it faces. Specifically, the FDA endeavors to "better
leverage resources, improve oversight, and effectively use available
data to help consumers select healthy foods." Further, GAO's findings
fail to account for all the varied initiatives that FDA and the
Department of Health and Human Services (HHS) have undertaken to fight
obesity and ensure that foods are labeled in a manner that fosters
consumer education and healthy choices.
See comment 1.
Food Safety and the Food Protection Plan:
Throughout the GAO report, reference is made to food labeling being a
part of FDA's food safety mission. Food labeling informs the consumer
about the basic nature, characteristics, and other attributes, such as
nutritional content, of a food. Although there may be some aspects of
food labeling that can affect the safe use of the food, e.g., alerting
allergic consumers to ingredients they need to avoid or providing
information on how to safely handle, cook, or store a food, food
labeling does not describe the food's safety, nor can it be used to
determine the safety of a food product. In light of the different
issues involved, including different statutory authority, FDA generally
treats and staffs food safety and food labeling as separate areas of
responsibility.
See comment 2.
The report refers to the Food Protection Plan (FPP) several times. The
references imply that the provisions of the FPP are specifically
focused on and/or directed to deal with issues related to false or
misleading labeling. The FPP was designed to address food safety and
defense concerns. Some of the actions may have some bearing on food
labeling issues, but food labeling concerns were not the focus or
impetus for developing the plan or for the plan's requested new
authorities for FDA. The multiple references to the FPP throughout the
report present a false impression that the FPP is either principally or
substantially about food labeling.
See comment 3.
Resources, Priorities, and Information Technology:
The report states that GAO did not assess how efficiently FDA used its
resources or the impact of competing priorities when evaluating FDA's
approach to the problem of misleading food labeling. However, these
issues are central to all FDA regulatory decisions, including those
regarding food labeling. With the exception of food labeling violations
that concern the presence of major food allergens, most misleading food
labeling violations do not present a high risk to public health.
Nevertheless, our field force frequently conducts labeling examinations
during their inspection and investigative activities. For example,
continuous efforts are made to ensure that required labeling is in
English, and that it conforms to other specifications that help
consumers in their purchasing decisions.
See comment 4.
See comment 5.
Another tool we rely upon is targeted sampling. FDA believes that
targeted sample collection is the best use of agency resources for
identifying misleading food labeling violations. Risk-based targeted
sampling is the most valuable approach in all regulatory areas,
including such examples as testing leafy greens and seafood for
bacteria that cause foodborne illness. Random sampling is not, however,
an efficient use of agency resources, except in limited circumstances
where the agency believes it is important to establish baseline data.
Regarding GAO's concerns about FDA's information technology (IT)
systems, we have several initiatives underway to improve those systems,
and to ensure that they support our business processes. IT systems
support our research, risk assessments, inspection, surveillance and
other activities, and are designed to serve those needs. FDA has
developed strategic plans to respond to high-profile challenges in
priority areas. FDA is committed to our mission and committed to
effecting beneficial changes necessary to protect America's public
health. FDA does not believe that tracking and analyzing data and
providing routine reports on food labeling violations is the best use
of agency resources, given the vast array of competing priorities
confronting the agency.
See comment 6.
Finally, when FDA learned of the discrepancy between the warning
letters issued and the warning letters posted on the website, FDA
engaged in an intense and thorough reconciliation process, and
continues to proactively work to put measures into place to prevent
such discrepancies from occurring in the future. The Division of
Freedom and Information (DFOI) and the Office of Regulatory Affairs
(ORA) continue to conduct audits of the agency's warning letter
database.
FDA Comments on GAO Recommendations:
Recommendation: 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 type of violation, information about corrective
actions taken or, if no action was taken, the reason why;
* Analyzing violation data in routine management reports; and:
* Tracking untitled letters and regulatory meetings related to food
labeling violations and analyze whether these are an effective use of
resources.
FDA Response: FDA agrees 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. However, it is important to remember
that data collection requires time and effort. It is important to make
sure that data-entry does not become so burdensome that it takes away
from other investigative work.
See comment 7.
Recommendation: Ensure that the public has timely access to information
on food labeling violations that may have serious health consequences
by requiring all the centers and offices to post on FDA 's public
website, within a specified time frame, key information such as
* All warning letters;
* All recalls;
* Statistics on serious enforcement actions (e.g. import refusals) by
country, type of food, and the problem found (e.g. undeclared
allergen); and:
* Information on violations that FDA classifies as serious (e.g.
product identification, exposure symptoms);
FDA Response: FDA already posts and maintains much of this information
on its website. FDA will keep the information as up to date as possible
given resource and time limitations.
See comment 8.
FDA's Detention Authority for Foods:
In several places throughout the draft GAO report, it is suggested that
the only context in which FDA detains food is under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
(Bioterrorism Act). While the Bioterrorism Act gives FDA authority to
administratively detain an article of food if certain conditions are
met, the report should clearly note that FDA has another type of
detention authority under section 801 of the Federal Food, Drug, and
Cosmetic Act (FFDCA). This second type of detention authority applies
to imported articles, including food, which appears to violate the
FFDCA. The two types of authority are outlined below.
See comment 9.
FFDCA 801(a) ” When FDA initiates refusal of admission under section
801(a) because it has made an initial determination that a food offered
for import appears to violate the FFDCA, the food is said to be
"detained" pending a final decision as to its admissibility. While the
food is under detention, the importer has an opportunity to introduce
testimony and, in some circumstances, can request authorization to
bring the product into compliance. After this process, the product will
ultimately be admitted into domestic commerce or refused admission. In
this context, detention thus refers to withholding release of a product
pending a decision regarding admission or refusal.
FFDCA 304(h) ” Section 304(h) covers any article of food that presents
a threat of serious adverse health consequences or death to humans or
animals. Although section 304(h) was added to the FFDCA by the
Bioterrorism Act, an act or threat of terrorism is not required to use
the authority. Credible evidence or information indicating that the
article presents a threat of serious health consequences or death is
the evidentiary standard for using this authority. See 21 CFR Part 1,
subpart K, and FFDCA section 304(h). FDA has not yet used its detention
authority under the Bioterrorism Act because, to date, FDA has been
able to use other authorities and regulatory tools to adequately
protect the public health. Although the section 304(h) authority
applies to both domestic and imported food, FDA expects to use this
authority principally for domestic food. If imported food is subject to
administrative detention under section 304(h), it is very likely also
subject to detention and refusal of admission under section 801(a), as
described above.
Nutrition Labeling, Nutrition Symbols, and Consumer Research:
Concerning the report's recommendation that FDA develop a simplified
system for conveying the overall nutritional quality of a food to
consumers, here is some background on how FDA's current nutrition
labeling requirements came into existence and on the agency's consumer
research in this area. In 1990 Congress amended the FFDCA by enacting
the Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101-
535, 104 Stat. 2353). NLEA established mandatory nutrition labeling for
packaged foods to enable consumers to make more informed and healthier
food product choices in the context of their daily diets. The United
States was likely the first government to institute mandatory nutrition
labeling for packaged foods. In 1993, FDA issued regulations
implementing the NLEA. Prior to issuing these regulations, FDA
conducted consumer research to determine how best to meet the
objectives of the new law. Based on this research, FDA established a
standardized format in a tabular form for the nutrition label so that
consumers could readily recognize and become familiar with the
nutrition information provided in labeling. It included nutrients to
limit in the diet (e.g. saturated fat, sodium), as well as nutrients
that consumers need in their diet (e.g. vitamin A, fiber). This section
of the label is referred to as Nutrition Facts and is well recognized
by consumers. The research also resulted in the decision to include a
benchmark, the percent Daily Value (%DV), for consumers in the
Nutrition Facts so that they could readily compare products and could
judge how a product fits into their overall diet. The %DV has
facilitated the development of education programs on the use of the
Nutrition Facts for planning healthful diets and is integrated into the
Dietary Guidelines for Americans.
Among the regulations to implement NLEA, the agency set forth general
principles for nutrient content claims (21 CFR 101.13), which are
claims that characterize the level of a nutrient in a food (e.g., "low
fat," "good source of fiber"), and for health claims (21 CFR 101.14),
which are claims that characterize the relationship of a food substance
to a disease or health-related condition (e.g., "calcium may reduce the
risk of osteoporosis"). Once such claims have been authorized by FDA,
manufacturers may use them in food labeling, when products are
eligible. The agency has been aware that in recent years there has been
a trend in food labeling to use symbols and icons on the label to
indicate the nutritional attributes and quality of the food product;
however, the agency lacked adequate information about how various
symbols are understood and used by consumers, and how symbols may
affect food choices available in the marketplace.
FDA received a petition from a consumer organization requesting that
the agency explore the use of front- of-package symbols to convey the
healthfulness of foods (Docket No. 2006P-0498). After receiving the
petition, the agency held a public hearing to afford industry,
consumers, and other interested parties the opportunity to provide
research and comments on the use of symbols to communicate nutrition
information on food labels. The public hearing notice outlined three
main issues and posed questions for each of these issues. The first
issue was concerned with the types of foods that bear nutrition symbols
and the nutrient requirements for those symbols. The second issue was
concerned with consumer understanding and use of nutrition symbols. The
third issue was concerned with the economic impacts of nutrition
symbols on food labels. The agency is currently evaluating the
information received and the necessary next steps.
CFSAN is also taking steps to better understand how consumers interpret
and use front-of-package nutrition symbols and how these symbols affect
food choices. Its Office of Regulations, Policy, and Social Sciences
(ORPSS) received funding to conduct two studies for FY07 and FY08. The
first FY07 study (Consumer Perceptions of Nutrition Quality Indicators)
is complete, and included four focus groups (two in Calverton, MD and
two in Albany, NY) with adult respondents. The purpose of these groups
was to evaluate consumers' reactions to a variety of front-of-package
symbol schemes that are currently found in the marketplace, and to
other front-of-package symbols that can potentially be used to
communicate the nutritional characteristics of packaged foods. The
findings from these groups will inform the experimental variables (i.e.
conditions) selected for an upcoming Internet panel experiment
(Evaluation of Nutrition Symbols on Food Packages) that will provide
empirical information about accurate and erroneous judgments and
inferences that consumers make in response to front-of-package symbols.
The experiment will be designed to provide CFSAN's Office of Nutrition,
Labeling and Dietary Supplements (ONLDS) with information about
potential problems stemming from halo effects, information search
truncation, and interactions between front-of-package symbols and other
information on the food label, such as the Nutrition Facts panel (NFP),
nutrient content claims, and health claims. Following the initial
experimental study, we will use FY08 funds to conduct another round of
focus groups (Qualitative Research on Consumer Response to Nutrition
Symbols). The purpose of these groups will be to provide additional
qualitative information about the front-of-package symbol schemes that
were found to be most effective in the Internet panel experiment, and
to discuss ways in which any problems related to misleading labeling
might be addressed and remedied. The findings from these focus groups
will be used to inform the conditions for the second Internet panel
experiment (Consumer Responses to Nutrition Symbols), which will
further evaluate the front-of-package symbol schemes from the first
experiment that were found to most effectively communicate information
to consumers about the nutritional characteristics of packaged foods.
The second study will also evaluate possible remedies (e.g.
disclosures, disclaimers) for any misleading effects that result from
the use of front-of-package symbols.
CFSAN has findings from its nationally representative telephone surveys
that provide important information on consumers' use of the Nutrition
Facts Panel (NFP). Data from the 1996 and 2002 Health and Diet Surveys
indicate that approximately 70% of adults say they look at the NFP the
first time they purchase a food, and that the majority of these adults
use the NFP to compare the nutrition profiles of similar types of
products (e.g. cereals, frozen entrees) and to find the declared
amounts for specific nutrients of concern (e.g. sodium, fats).
Furthermore, findings from the NFP format studies conducted by CFSAN in
the mid-1990's showed that even if consumers cannot define or do not
completely understand a metric found on the NFP (e.g. Percent Daily
Value, or %DV), they can still use that information to compare the
nutrition profiles of two products and accurately determine which
product is more healthful.
See comment 10.
We agree with GAO's recommendation for empirical research to evaluate
the communication effects of nutrition symbols, but believe it is
important to extend our investigation beyond issues related to the
consistency, accuracy, and effectiveness of the symbols. Specifically,
CFSAN believes it is important to determine how consumers will use the
symbols in combination with front-of-package claims and the NFP. We
plan to examine how these different types of label information interact
and influence consumers' decision-making. We also intend to determine
whether the symbols lead to a truncation of consumers' information
search, and whether these symbols result in "halo effects" that create
misperceptions about unrelated product characteristics.
Qualified Health Claims:
The report notes, "Stakeholders, such as the American Heart Association
(AHA), have suggested that FDA eliminate the use of qualified health
claims on food labels" and states that findings from 2005 and 2007 FDA
studies support the view that these claims may encourage consumption of
foods with little or no health benefits. There are two problems with
this discussion of qualified health claims. First, for completeness,
the GAO report should note that court decisions, beginning with Pearson
v. Shalala, hold that the First Amendment precludes FDA from
prohibiting the use of a qualified health claim unless FDA can show
that the claim is inherently misleading or, if the claim is only
potentially misleading, that use of disclaimer would not remedy the
claim's potential to mislead. Thus, absent consumer research or other
evidence that satisfies the Pearson court's criteria, FDA does not have
the authority to eliminate use of qualified health claims as a class of
claims. Secondly, contrary to the statement in the report, FDA's 2005
and 2007 qualified health claim experiments did not find that qualified
health claims might encourage the consumption of foods with little or
no health benefits. This conclusion goes well beyond the data. FDA's
research simply showed that qualified health claims produced halo
effects, that consumers could not use "word only" qualifiers to
determine the level of scientific support for different claims, and
that while consumers could use report card grades to help them
discriminate the level of scientific support between claims, these
grades (i.e. qualifiers) did not remedy the halo effects resulting from
the claims.
See comment 11.
See comment 12.
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 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 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 —. "
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841, s [Hyperlink, shamesl@gao.gov]
hamesl@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.
[End of section]
Footnotes:
[1] Go to [hyperlink, 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.
[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.
[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).
[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).
[10] GAO-08-386SP.
[11] Certain 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.
[12] Dietary supplements have different labeling requirements.
[13] On 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.
[14] GAO-05-51.
[15] A food product entry line is each portion of a shipment that is a
separate type of product.
[16] Life Sciences Research Office, Federation of American Societies
for Experimental Biology. "Analytical Data and Label Review of 300 Food
Products" (Bethesda, MD: October 1994).
[17] To access warning letter data on FDA's public Web site, go to
[hyperlink, http://www.fda.gov/foi/warning.htm].
[18] GAO, 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).
[19] After 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.
[20] FDA currently uses the term "import refusals" for its detention
authority under section 801(a) of the Federal Food, Drug, and Cosmetic
Act.
[21] According to FDA officials, there may also be shipments that were
detained for labeling violations, reconditioned by the owner, and then
released.
[22] GAO-05-51.
[23] GAO-08-909T.
[24] The department's 2009 justification also proposed user fees for
issuing food and animal feed export certificates--a proposal
recommended in the Food Protection Plan.
[25] GAO-08-386SP.
[26] GAO, Medical Devices: FDA Faces Challenges in Conducting
Inspections of Foreign Manufacturing Establishments, GAO-08-780T
(Washington, D.C.: May 14, 2008).
[27] GAO-05-51.
[28] GAO-08-435T and GAO-08-909T.
[29] Gill 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.
[30] National Academies, Institute of Medicine, Food Marketing to
Children and Youth: Threat or Opportunity?, National Academies Press
(Washington, D.C.: 2006).
[31] For information on this proposal, go to the following Web site:
[hyperlink,
http://www.europarl.europa.eu/oeil/FindByDocnum.do?lang=en&docnum=COM/
2008/40].
[32] FDA, 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).
[33] FDA, "Draft Guidance for Industry and FDA Staff: Whole Grain Label
Statements" (Feb. 17, 2006).
[34] National Academies, Institute of Medicine, Preventing Childhood
Obesity: Health in the Balance, National Academies Press (Washington,
D.C.: 2005).
[35] GAO-08-386SP.
[36] 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.
[37] Pub. L. No. 101-535, 104 Stat. 2353.
[38] 21 U.S.C. §§ 301-397.
[39] 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.
[40] 56 Fed. Reg. 60,537, Nov. 27, 1991.
[41] Dietary Supplement Act of 1992, Pub. L. No. 102-571, tit. II §
202, 106 Stat. 4500.
[42] 58 Fed. Reg. 2478, Jan. 6, 1993.
[43] 59 Fed. Reg. 395, Jan. 4, 1994.
[44] 164 F.3d 650 (1999).
[45] 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.
[46] 64 Fed. Reg. 67,289, Dec. 1, 1999.
[47] 65 Fed. Reg. 59,855, Oct. 6, 2000.
[48] 67 Fed. Reg. 78,002, Dec. 20, 2002.
[49] 68 Fed. Reg. 41,387, July 11, 2003.
[50] Whitaker v. Thompson, 248 F. Supp. 2d 1 (2002). See also Pearson
v. Shalala, 130 F. Supp. 2d 105 (2001).
[51] Those 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).
[52] 68 Fed. Reg. 66,040, Nov. 25, 2003.
[53] FDA, Center for Food Safety and Applied Nutrition, FDA's
Implementation of "Qualified Health Claims" Questions and Answers (May
12, 2006).
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