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United States Government Accountability Office:
GAO:
Report to Congressional Committees:
January 2011:
Food Labeling:
FDA Needs to Reassess Its Approach to Protecting Consumers from False
or Misleading Claims:
FDA Health Claims for Food:
GAO-11-102:
GAO Highlights:
Highlights of GAO-11-102, a report to congressional committees.
Why GAO Did This Study:
The Food and Drug Administration (FDA) oversees federal requirements
to prohibit false or misleading food labels; the Federal Trade
Commission enforces the prohibition against false or misleading
advertising. By statute, health claims on food labels must have
significant scientific agreement, but in 2002, in response to a court
decision, FDA decided to allow qualified health claims with less
scientific support. Structure/function claims refer to a food’s effect
on body structure or function and are also used on food. Congress
directed GAO to study FDA’s implementation of qualified health claims
for food. GAO examined (1) the results of FDA’s efforts to allow the
use of qualified health claims and oversight of these claims and (2)
consumers’ understanding of the claims. GAO also examined FDA’s
oversight of structure/function claims. GAO reviewed FDA documents and
consumer studies and interviewed stakeholders from health, medical,
industry, and consumer groups.
What GAO Found:
FDA’s efforts to protect consumers from false or misleading claims are
conducted in a complex and challenging legal and regulatory
environment. From 2002, when FDA announced its decision to allow
qualified health claims on food labels-—following a court decision
involving its authority to regulate dietary supplements-—through
September 2010, FDA received 16 petitions from companies proposing 60
claims on food labels. After reviewing the scientific evidence
presented in the petitions, FDA determined that there was enough
credible scientific evidence for the agency to allow the use of 12
qualified health claims, by modifying language to qualify the claims
and characterize in detail the strengths and limitations of the
scientific support for those claims. In overseeing qualified health
claims for food labels, FDA has issued two warning letters to food
companies—-both in 2010—-for citing health benefits that were not in
the allowed qualified health claims or supported by scientific
evidence.
Research showed, and stakeholders indicated, that consumers find it
difficult to understand the differences between health claims with
significant scientific agreement and the lower level of scientific
support for qualified health claims. Research also showed that
consumers find it difficult to distinguish among the many different
types of claims on food labels, including health claims, qualified
health claims, and structure/function claims.
FDA data indicate that companies now minimally use qualified health
claims on foods but more widely use structure/function claims to
convey their foods’ health benefits. Companies’ use of
structure/function claims is subject to the general statutory
requirement that labeling not be false or misleading. However, FDA has
not given companies guidance on the scientific support needed to
prevent false or misleading information for a structure/function claim
for food or given its inspectors instructions for identifying
potentially false or misleading information in such claims when
examining food labels as part of food facility compliance inspections.
Even if FDA were to provide such guidance, structure/function claims
pose a serious oversight dilemma for the agency. That is because FDA—
unlike the Federal Trade Commission (FTC), which can require companies
to submit any relevant evidence as part of an investigation of whether
claims are substantiated—does not have the ability to compel companies
to turn over their substantiation documents. GAO’s work indicates that
FDA’s efforts to meet that burden are hampered by the lack of access
to the evidence that a company relies on to make such a claim. In
particular, while FDA may ask a company to provide its scientific
support for a claim, FDA does not have express legal authority to
compel the company to provide such information. FTC, on the other
hand, which is responsible for protecting consumers from false
advertising generally, has the authority to compel companies to
provide the support. FTC officials said that the Commission would have
difficulty taking enforcement actions against companies for alleged
false structure/function claims on food labels and in advertisements
without access to companies’ proprietary market and scientific
research.
What GAO Recommends:
GAO recommends FDA identify and request from Congress authorities to
access companies’ evidence for potentially false or misleading
structure/function claims on food to establish scientific support,
provide guidance to industry on the evidence it needs to support such
claims, and provide direction to FDA inspectors to help identify
claims for further review. FDA generally agreed with the first two
recommendations but found the third to be impractical; GAO clarified
that recommendation.
View [hyperlink, http://www.gao.gov/products/GAO-11-102] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
FDA Has Allowed the Use of 12 Qualified Health Claims on Food Labels
and Provided Limited Oversight for These Claims:
Consumers Have Difficulty Understanding the Level of Scientific
Support for Qualified Health Claims and How These Claims Differ from
Other Claims:
Industry More Widely Uses Structure/Function Claims on Food with
Minimal FDA Oversight, but FTC Has Taken Some Action When These Claims
Were Deceptive:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Response:
Appendix I: FDA's Administration of Health Claims in Response to
Pearson v. Shalala:
Appendix II: Objectives, Scope, and Methodology:
Appendix III: Types of Claims FDA Recognizes, and Industry May Use, on
Food:
Appendix IV: Health Claims That May Be Used On Food Labels:
Appendix V: Warning Letters Issued for Claim Violations on Food Labels
and Web Sites, December 2009 through February 2010:
Appendix VI: Comments from the Department of Health and Human Services:
Appendix VII: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Twelve Qualified Health Claims Allowed for Use on Food,
through September 2010:
Table 2: Petitions and Proposed Qualified Health Claims for Food
Labeling Submitted Annually, Calendar Year 2002 through September 30,
2010:
Table 3: Types of Claims FDA Found on Food Labels in Its Survey of
Grocery Stores:
Table 4: Two FDA Warning Letters Issued in February 2010 Regarding
Qualified Health Claims:
Table 5: Twelve Health Claims Based on Significant Scientific
Agreement That May Be Used on Food Labels:
Table 6: Five Health Claims Based on Authoritative Statements That May
Be Used on Food Labels:
Table 7: Other Warning Letters and the Untitled Letter FDA Issued for
Labeling Claim Violations, December 2009 through February. 2010:
Abbreviations:
CFSAN: Center for Food Safety and Applied Nutrition:
EU: European Union:
FDA: Food and Drug Administration:
FLAPS: Food Label and Package Survey:
FTC: Federal Trade Commission:
FTE: full-time equivalent:
g: gram:
HHS: Department of Health and Human Services:
IOM: Institute of Medicine:
LDL: low-density lipoprotein:
mg: milligram:
NLEA: Nutrition Labeling and Education Act:
RACC: referenced amount customarily consumed:
[End of section]
United States Government Accountability Office:
Washintgon, DC 20548:
January 14, 2011:
The Honorable Daniel K. Inouye:
The Honorable Thad Cochran:
United States Senate:
The Honorable Harold Rogers:
Chairman:
The Honorable Norman D. Dicks:
Ranking Member:
Committee on Appropriations:
House of Representatives:
Consumers increasingly seek information on food labels to help them
make healthy food choices, and they rely on federal agencies to ensure
that such information is truthful. Food companies may use health-
and/or nutrient-related claims on food labels to appeal to consumers,
distinguish their products from their competitors', and otherwise
increase their sales. However, when those claims are false or
misleading, consumers' efforts to select healthy food may be
undermined. Under federal statutes and regulations, health claims on
food must either (1) be authorized by FDA upon a determination that
"significant scientific agreement" exists among qualified experts that
the totality of publicly available scientific evidence supports the
claims or (2) be based on an authoritative statement of a scientific
body of the federal government or the National Academy of Sciences.
Through separate statutes, the Food and Drug Administration (FDA) and
the Federal Trade Commission (FTC) share jurisdiction over health-and
nutrient-related claims made by food manufacturers. FDA oversees
federal food labeling requirements that prohibit, among other things,
food labeling that is false or misleading; FTC oversees federal
consumer protection requirements that prohibit, among other things,
deceptive acts or practices in advertising, including food
advertising. Under a memorandum of understanding, the two agencies
agreed that FDA has primary responsibility for food labeling and FTC
has primary responsibility for food advertising. FTC has recently
emphasized that health claims on food must be adequately substantiated
and presented in a manner that is truthful and not deceptive. FDA
regulations allow companies to use an authorized health claim on a
label or petition FDA for authorization of a new health claim. To
ensure health claims have the proper support, FDA analyzes and reviews
research on nutrition and the role of food in maintaining health.
FDA categorizes health-and nutrient-related claims on food labels as
follows:
* Health claims characterize the relationship of any substance to a
disease or health-related condition (e.g., diets low in sodium may
reduce the risk of high blood pressure, a disease associated with many
factors).
* Structure/function claims describe the role of, or characterize the
mechanism by which, a nutrient affects a body structure or function
(e.g., calcium helps build strong bones).
* Nutrient content claims characterize the level of a nutrient in a
food (e.g., good source of vitamin C).
Qualified health claims are health claims that characterize the
relationship of a food component to a disease or health-related
condition, as modified with a disclaimer or otherwise qualified by FDA
to characterize the strengths and limitations of the scientific
support to address the claim's potentially misleading nature. For
example, the following is a qualified health claim allowed by FDA
characterizing the relationship between the consumption of tomatoes
and the risk of gastric cancer:[Footnote 1] "Four studies did not show
that tomato intake reduces the risk of gastric cancer, but three
studies suggest that tomato intake may reduce this risk. Based on
these studies, FDA concludes that it is unlikely that tomatoes reduce
the risk of gastric cancer." Qualified health claims for food are not
provided for in statute. Instead, they came about as a consequence of
FDA's decisions following a 1999 federal appeals court ruling (Pearson
v. Shalala). The court held that the First Amendment does not permit
FDA to prohibit a potentially misleading health claim on a dietary
supplement label unless FDA considers whether qualifying language on
the label could negate the potentially misleading nature of the claim.
(Dietary supplements are products that contain certain dietary
ingredients such as vitamins, minerals, or herbs, intended to
supplement the diet, and are labeled as dietary supplements.)
After the court ruling, in 2000, FDA announced an interim enforcement
strategy to allow companies to petition the agency for qualified
health claims on dietary supplements and established criteria for the
agency to consider in exercising its enforcement discretion to not
take actions. In 2002, FDA announced its decision to expand this
approach to include qualified health claims on conventional food as
well. The next year, FDA issued guidance to industry on procedures for
petitioning the agency for qualified health claims for food. Once FDA
announces, on the basis of its review of scientific evidence, that it
intends to consider exercising its enforcement discretion for the use
of a qualified health claim, any food company that meets the same
criteria with the same food may use the claim.
In 2008, we reported that stakeholders from health, consumer, and
medical groups advocated eliminating qualified health claims on food
labels because they confused and misled consumers and might encourage
consumption of foods with few or no health benefits.[Footnote 2]
The Subcommittees on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies, Senate and House Committees on
Appropriations, directed that we study issues regarding FDA's
implementation of qualified health claims on food.[Footnote 3]
Specifically, this report examines (1) the results of FDA's efforts to
allow the use of qualified health claims on food, and its oversight of
these claims and (2) what is known about consumers' understanding of
qualified health claims on food. In addition, the report examines
industry's use of structure/function claims on food and FDA's
oversight of these claims. Appendix I provides updates to information
we reported in 2008 on FDA's implementation and administration of
health claims, including qualified health claims, in response to
Pearson v. Shalala.
The term "food" is used throughout this report to mean "conventional
food," not to include dietary supplements or animal feed. To determine
the results of FDA's efforts to allow the use of qualified health
claims on food, we assessed FDA data and documentation, including
industry petitions and FDA guidance; reviewed research on companies'
use of health-and nutrient-related claims on foods; and obtained the
views of industry, FDA, and others on the advantages and disadvantages
of using qualified health claims. To determine FDA's oversight of
qualified health claims, we analyzed FDA guidance and related
documents on the enforcement of food labeling claims, analyzed warning
letters and other FDA actions, and compared and contrasted FDA's and
FTC's responsibilities and authorities with respect to food labeling
and advertising claims. To determine what is known about consumers'
understanding of qualified health claims on conventional food labels,
we reviewed research by FDA and others on consumers' understanding of
such claims and interviewed stakeholders--researchers and industry and
consumer, medical, and health groups we identified with input from the
National Academies' Institute of Medicine, and FDA officials--for
their views on what the research demonstrates about consumer
perception. To examine industry's use of structure/function claims on
food labels and FDA's oversight of these claims, we assessed FDA data,
documentation, and studies on industry's use of these claims, and
efforts to oversee their use. We also discussed the use of
structure/function claims with Canadian and European Union officials.
We also examined FTC's actions to correct structure/function claims it
found to be deceptive in food advertising. We assessed the quality of
the studies, including how the data they contained were initially
developed and analyzed, and found those data to be of sufficient
quality and reliability for the purposes used.
We conducted this performance audit from January 2010 through December
2010 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
II contains more detailed information on our objectives, scope, and
methodology.
Background:
The following sections discuss (1) the statutes, regulations, and
guidance that underpin FDA's framework for overseeing claims on food
labels and (2) FDA's organization for overseeing food labels.
FDA's Framework for Overseeing Claims on Food Labels:
FDA's framework for overseeing food labeling is based on statutes and
FDA regulations and guidance. Specifically, the Federal Food, Drug,
and Cosmetic Act prohibits the misbranding of food, which includes,
among other things, food labeling that is false or misleading. The
Nutrition Labeling and Education Act of 1990 (NLEA), amended the
Federal Food, Drug, and Cosmetic Act to require that health claims for
food labels be authorized by FDA following a determination by FDA that
"significant scientific agreement" exists among qualified experts that
the totality of publicly available scientific evidence supports the
claims. According to FDA documents, the primary goals of NLEA were to
(1) make nutrition information available to assist consumers in
selecting foods that could lead to healthier diets; (2) eliminate
consumer confusion by establishing definitions for nutrient content
claims that are consistent and that consumers could rely on; (3) help
consumers maintain healthy dietary practices and protect them from
unfounded health claims, so a health claim used on a product would be
one that consumers could rely on to give them truthful and not
misleading information; and (4) encourage product innovation by
developing and marketing nutritionally improved food.
FDA took several actions in response to the Pearson v. Shalala ruling,
such as issuing guidance on how companies should submit petitions to
FDA and how FDA would review the scientific evidence and exercise its
enforcement discretion. (See app. I for information on FDA's
implementation and administration of health claims in response to
Pearson v. Shalala.) In 2003, FDA issued interim guidance to industry
for submitting petitions for qualified health claims on food labels
and for reviewing the scientific evidence for those claims, and
explained its intention to consider exercising its enforcement
discretion to not take enforcement actions against companies that use
qualified health claims as FDA specified. In 2006 FDA issued
additional guidance to industry that described how the agency would
review the scientific evidence industry submitted in support of the
proposed qualified health claims. FDA specified that a petition for
qualified health claims should, among other things, (1) identify the
relationship between the substance and the disease in the United
States and demonstrate that the substance is a food, a food
ingredient, or food component that has been shown to be safe and
lawful at levels necessary to justify a claim; (2) propose a claim--a
statement that describes the benefit of the food substance--and (3)
present scientific evidence that supports the claim, including copies
of computer literature searches on studies and all research articles
supporting the claim. Petitions may be submitted by individuals, food
manufacturing companies, food distributors, trade or professional
associations, or a combination of these. For this report, we generally
refer to petitioners as companies.
As specified in its 2003 and 2006 guidance, FDA conveys its
determinations to allow qualified health claims and its intention to
exercise enforcement discretion with respect to certain requirements
of the Federal Food, Drug, and Cosmetic Act to petitioners. In letters
to the companies announcing its intention to exercise enforcement
discretion, FDA stipulates the wording of the qualified health claims
and any conditions on their use. FDA also alerts petitioners that the
claims must meet the general requirements for FDA's labeling
regulations for health claims, except for the requirement that the
evidence for the claim meet the significant scientific agreement
standard and that the claim be made in accordance with an authorizing
regulation. The qualified health claims and all conditions regarding
their use are posted on FDA's Web site to alert all food companies
that the claims are available for use without further FDA review or
approval. When FDA decides to deny a proposed claim, it describes its
review of the scientific evidence and the rationale for its decision
in correspondence to the petitioners and posts the letters conveying
those denials on its Web site. In addition, in 2009 FDA issued final
guidance for industry describing its process for the scientific review
of health claims, including qualified health claims, in which it
stated that it would reevaluate health claims and qualified health
claims as new scientific evidence emerged.
As with health claims, companies also use structure/function claims to
convey the health benefits of their foods or dietary supplements. The
Dietary Supplement Health and Education Act of 1994 established
special requirements for structure/function claims on dietary
supplement labels. Specifically, under the act, if a dietary
supplement label includes a structure/function claim, it must have a
disclaimer stating, "This statement has not been evaluated by the Food
and Drug Administration. This product is not intended to diagnose,
treat, cure or prevent any disease." Products intended for use in the
diagnosis, mitigation, treatment, cure, or prevention of a disease are
considered drugs under the Federal Food, Drug, and Cosmetic Act. In
addition, a structure/function claim on a dietary supplement label
must have substantiation and either (1) claim a benefit related to a
classical nutrient deficiency disease and disclose the prevalence of
such disease in the United States, (2) describe the role of a nutrient
or dietary ingredient intended to affect the structure or function in
humans, (3) characterize the documented mechanism by which a nutrient
or dietary ingredient acts to maintain such structure or function, or
(4) describe general well-being from consumption of a nutrient or
dietary ingredient[Footnote 4]. These requirements do not apply to
structure/function claims on food labels. However, the use of such
claims for food is subject to the Federal Food, Drug, and Cosmetic
Act's requirement that labeling not be false or misleading, and FDA
has not issued guidance to companies regarding the proper use of
structure/function claims on food labels.
Appendix III provides information on the different types of health-and
nutrient-related claims that may be found on food labels. Appendix IV
presents the 12 health claims for food that have significant
scientific agreement and 5 health claims for food that are based on
authoritative statements.
FDA's Organization for Overseeing Food Labels:
Within FDA, food labeling is under the jurisdiction of the Office of
Foods' Center for Food Safety and Applied Nutrition (CFSAN). Within
CFSAN, the Office of Nutrition, Labeling and Dietary Supplements is
responsible for reviewing qualified health claim petitions, and the
Office of Regulation, Policy, and Social Sciences conducts consumer
research on health claims and qualified health claims. In addition,
for more than 30 years, FDA has conducted surveys and studies of
labels on processed, packaged food. In 2010 FDA reported the results
of its most recent Food Label and Package Survey (FLAPS) of claims
used on food packages in grocery stores nationwide. The most recent
FLAPS, conducted during 2006 and 2007, was the 13th in a series of
labeling studies and the first to include qualified health claims.
FDA's Office of Regulatory Affairs carries out food safety and
labeling compliance inspections and enforcement activities. When the
office identifies a labeling violation, FDA may send a warning letter--
a notice that an enforcement action may be forthcoming if corrections
are not made--or, for a less serious violation, an untitled letter
communicating that corrective action is needed. At any point during
the oversight process, FDA may hold a regulatory meeting with the
company to resolve the labeling violation. For a serious labeling
violation, FDA may ask a company to voluntarily recall food that has
already entered the distribution chain.[Footnote 5] When a violation
is not corrected, FDA may initiate actions to seize and remove the
food from the marketplace (seizure) or enjoin a company from
continuing the 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 a notice to the
importer that subsequent shipments might be refused entry if the
violation is not corrected. In addition, FDA maintains "import alerts"
that flag entries of imported foods that appear to be violative and
may be detained, based on, for example, significant recurring or
unusual violations.
Since January 2007, federal oversight of food safety has been on GAO's
high-risk list of government programs that need broad-based
transformation to achieve greater economy, efficiency, effectiveness,
accountability, and sustainability.[Footnote 6] Our September 2008
report on food labeling discusses in detail FDA's oversight of food
labeling laws and regulations.[Footnote 7] As we reported, FDA had
little assurance that companies complied with food labeling laws and
regulations for preventing false or misleading labeling, among other
things. We found weaknesses in FDA's oversight and use of data and
resources. For example, although FDA's inspection guidance directs
inspectors to examine three product labels during a food facility
inspection, FDA did not have reliable data on the number of labels
examined or which inspections included label examinations. In
following up on our recommendations in that report, we found that FDA
has taken action on four of the report's seven recommendations and
plans to continue addressing our remaining recommendations for better
leveraging its resources and staff as resources become available.
FDA Has Allowed the Use of 12 Qualified Health Claims on Food Labels
and Provided Limited Oversight for These Claims:
Since 2002, when it announced its decision to allow companies to
petition the agency for qualified health claims on food, FDA has
determined that it would allow the use of 12 qualified health claims
for food, and spent at least an estimated $12.8 million since 2000 on
health claim and qualified health claim activities. FDA data indicate
that companies' interest in qualified health claims has slowed. In
addition, FDA has exercised limited oversight of industry's use of
these claims.
FDA Has Allowed the Use of 12 Qualified Health Claims for Food:
From 2002 through September 2010, FDA received 16 petitions proposing
60 claims, which it considered for qualified health claims on food
labels.[Footnote 8] After reviewing the scientific evidence presented
in the petitions, FDA determined that there was enough credible
scientific evidence for the agency to modify 12 health claims with
qualifying language to characterize in detail the strength and
limitations of the scientific support for those claims. In letters to
petitioners, FDA stated that it intended to consider exercising its
enforcement discretion to not enforce certain requirements of the
Federal Food, Drug, and Cosmetic Act and its implementing regulations
for these qualified health claims. The claims had to meet the other
requirements for health claims and any claim-specific conditions
stipulated by FDA. FDA posted the 12 qualified health claims and
conditions for their use on its Web site. Table 1 lists the 12
qualified health claims that are available for use on food labels.
Table 1: Twelve Qualified Health Claims Allowed for Use on Food,
through September 2010:
Food/disease risk: Tomatoes/reduced risk for prostate cancer;
Qualified health claim: Very limited and preliminary scientific
research suggests that eating one-half to one cup of tomatoes and/or
tomato sauce a week may reduce the risk of prostate cancer. FDA
concludes that there is little scientific evidence supporting this
claim.
Food/disease risk: Tomatoes/reduced risk for ovarian cancer;
Qualified health claim: One study suggests that consumption of tomato
sauce two times per week may reduce the risk of ovarian cancer, while
this same study shows that consumption of tomatoes or tomato juice had
no effect on ovarian cancer risk. FDA concludes that it is highly
uncertain that tomato sauce reduces the risk of ovarian cancer.
Food/disease risk: Tomatoes/reduced risk for gastric cancer;
Qualified health claim: Four studies did not show that tomato intake
reduces the risk of gastric cancer, but three studies suggest that
tomato intake may reduce this risk. Based on these studies, FDA
concludes that it is unlikely that tomatoes reduce the risk of gastric
cancer.
Food/disease risk: Tomatoes/reduced risk for pancreatic cancer;
Qualified health claim: One study suggests that consuming tomatoes
does not reduce the risk of pancreatic cancer, but one weaker, more
limited study suggests that consuming tomatoes may reduce this risk.
Based on these studies, FDA concludes that it is highly unlikely that
tomatoes reduce the risk of pancreatic cancer.
Food/disease risk: Green tea/reduced risk for breast cancer;
Qualified health claim: Two studies do not show that drinking green
tea reduces the risk of breast cancer in women, but one weaker, more
limited study suggests that drinking green tea may reduce this risk.
Based on these studies, FDA concludes that it is highly unlikely that
green tea reduces the risk of breast cancer.
Food/disease risk: Green tea/reduced risk for prostate cancer;
Qualified health claim: One weak and limited study does not show that
drinking green tea reduces the risk of prostate cancer, but another
weak and limited study suggests that drinking green tea may reduce
this risk. Based on these studies, FDA concludes that it is highly
unlikely that green tea reduces the risk of prostate cancer.
Food/disease risk: Nuts/reduced risk for heart disease;
Qualified health claim: Scientific evidence suggests but does not
prove that eating 1.5 ounces per day of most nuts [such as name of
specific nut] as part of a diet low in saturated fat and cholesterol
may reduce the risk of heart disease. [See nutrition information for
fat content.].
Food/disease risk: Walnuts/reduced risk for coronary heart disease;
Qualified health claim: Supportive but not conclusive research shows
that eating 1.5 ounces per day of walnuts, as part of a low saturated
fat and low cholesterol diet and not resulting in increased caloric
intake may reduce the risk of coronary heart disease. See nutrition
information for fat [and calorie] content.
Food/disease risk: Omega-3 fatty acids/reduced risk for coronary heart
disease;
Qualified health claim: Supportive but not conclusive research shows
that consumption of EPA and DHA omega-3 fatty acids may reduce the
risk of coronary heart disease. One serving of [Name of the food]
provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition
information for total fat, saturated fat, and cholesterol content.][A].
Food/disease risk: Monounsaturated fatty acids from olive oil/reduced
risk for coronary heart disease;
Qualified health claim: Limited and not conclusive scientific evidence
suggests that eating about 2 tablespoons (23 grams) of olive oil daily
may reduce the risk of coronary heart disease due to the
monounsaturated fat in olive oil. To achieve this possible benefit,
olive oil is to replace a similar amount of saturated fat and not
increase the total number of calories you eat in a day. One serving of
this product contains [x] grams of olive oil.
Food/disease risk: Unsaturated fatty acids from canola oil/reduced
risk for coronary heart disease;
Qualified health claim: Limited and not conclusive scientific evidence
suggests that eating about 1½ tablespoons (19 grams) of canola oil
daily may reduce the risk of coronary heart disease due to the
unsaturated fat content in canola oil. To achieve this possible
benefit, canola oil is to replace a similar amount of saturated fat
and not increase the total number of calories you eat in a day. One
serving of this product contains [x] grams of canola oil.
Food/disease risk: Corn oil/reduced risk for heart disease;
Qualified health claim: Very limited and preliminary scientific
evidence suggests that eating about 1 tablespoon (16 grams) of corn
oil daily may reduce the risk of heart disease due to the unsaturated
fat content in corn oil. FDA concludes that there is little scientific
evidence supporting this claim. To achieve this possible benefit, corn
oil is to replace a similar amount of saturated fat and not increase
the total number of calories you eat in a day. One serving of this
product contains [x] grams of corn oil.
Source: FDA.
Note: The 12 claims are based on 15 proposed claims.
[A] The omega-3 fatty acids, EPA (eicosapentaenoic acid) and DHA
(docosahexaenoic acid), are components of some fatty fish (primarily
cold-water fish), fish oils, other foods (e.g., seaweed), and food
ingredients (e.g., algal oils).
[End of table]
In addition, FDA denied 42 of the 60 proposed claims. In letters to
the petitioners conveying these decisions, FDA discussed its
consideration of the specific scientific evidence submitted to support
the claims it denied and how it reached a final determination that
"neither a disclaimer nor qualifying language would suffice to prevent
consumer deception" if the claims were used. FDA attributed each of
the denials to the lack of credible scientific evidence to support the
claim. In addition to the 42 claims that were denied and the 15 used
to develop the 12 allowed qualified health claims, 1 proposed claim is
pending, and 2 were withdrawn.
FDA Officials Estimated Spending at Least $12.8 Million to Implement
and Administer Health Claims and Qualified Health Claims since 2000:
Since FDA decided to allow companies to petition the agency for
qualified health claims, it has carried out a number of activities to
implement the framework for qualifying claims and making scientific
determinations on proposed claims. These activities included, among
others, developing guidance for industry and FDA staff; carrying out
research; and analyzing studies, surveys, and other scientific
evidence submitted in support of the proposed claims. FDA officials
estimated that, for the 11 fiscal years 2000 through 2010, CFSAN has
spent at least $12.8 million, including expenses for nearly 88.7 full-
time equivalent (FTE) staff, to implement and administer health claims
and qualified health claims. FDA officials provided estimates because
they said that the agency does not maintain data on expenditures and
staff charges for the different responsibilities performed by CFSAN's
Office of Nutrition, Labeling, and Dietary Supplements staff. However,
for offices outside the Office of Nutrition, Labeling, and Dietary
Supplements that worked on qualified health claim activities for food
labeling, such as the Office of the Chief Counsel, FDA officials could
not provide estimates with any degree of confidence on expenditures
and staff years spent on activities related to health or qualified
health claims since 2000. It is also unclear what portion of the
estimated $12.8 million was used solely for qualified health claim
activities and what portion was used for regulatory activities on the
12 health claims for food. However, in FDA's technical comments on a
draft of this report, the agency pointed out that many of the health
claims assessed under the significant scientific agreement standard
were completed prior to 2000.[Footnote 9]
Companies Minimally Use Qualified Health Claims:
FDA data and other research indicate that companies' interest in
qualified health claims has slowed. FDA's and industry's initial
expectation of a flood of petitions for qualified health claims on
food was never realized, according to agency officials. As shown in
table 2, three-quarters (45 of 60) of the proposed claims for food
labels were submitted in five petitions in 2004, and only one petition
with one proposed claim was submitted after 2006.
Table 2: Petitions and Proposed Qualified Health Claims for Food
Labeling Submitted Annually, Calendar Year 2002 through September 30,
2010:
Calendar year: 2002;
Number of petitions submitted: 2;
Number of proposed claims submitted: 3.
Calendar year: 2003;
Number of petitions submitted: 4;
Number of proposed claims submitted: 4.
Calendar year: 2004;
Number of petitions submitted: 5;
Number of proposed claims submitted: 45.
Calendar year: 2005;
Number of petitions submitted: 2;
Number of proposed claims submitted: 2.
Calendar year: 2006;
Number of petitions submitted: 2;
Number of proposed claims submitted: 5.
Calendar year: 2007;
Number of petitions submitted: 0;
Number of proposed claims submitted: 0.
Calendar year: 2008;
Number of petitions submitted: 0;
Number of proposed claims submitted: 0.
Calendar year: 2009;
Number of petitions submitted: 1;
Number of proposed claims submitted: 1.
Calendar year: 2010;
Number of petitions submitted: 0;
Number of proposed claims submitted: 0.
Calendar year: Total;
Number of petitions submitted: 16;
Number of proposed claims submitted: 60.
Source: GAO analysis of FDA data.
[End of table]
In addition, research by FDA and others shows that companies are
making minimal use of qualified health claims. In 2010, FDA reported
its latest FLAPS results of claims on food labels in grocery
stores.[Footnote 10] As shown in table 3, few food labels--only 0.4
percent--had qualified health claims.
Table 3: Types of Claims FDA Found on Food Labels in Its Survey of
Grocery Stores:
Claim type: Qualified health claim;
Percentage of labels with claim type: 0.4.
Claim type: Health claim (based on significant scientific agreement or
an authoritative source);
Percentage of labels with claim type: 4.3.
Claim type: Structure/function claim;
Percentage of labels with claim type: 5.5.
Claim type: Other implied nutrient content claim[A];
Percentage of labels with claim type: 5.6.
Claim type: "Healthy" claim (an implied nutrient content claim)[A];
Percentage of labels with claim type: 7.6.
Claim type: Significant source claim[A];
Percentage of labels with claim type: 20.5.
Claim type: Nutrient content claim;
Percentage of labels with claim type: 53.2.
Source: FDA survey conducted in 2006-2007.
Note: A sampled label may have had multiple claims. The claim types
are those used by FDA in the survey.
[A] A type of nutrient content claim.
[End of table]
Moreover, according to a 2009 study by West Virginia University
researchers, companies that could have used qualified health claims
more often did not.[Footnote 11] This study focused on labels of foods
eligible to use qualified health claims. Specifically, it found that
only 4.6 percent of food packages eligible for a qualified health
claim actually used one. Instead, companies chose to use a different
type of claim to convey the health or nutritional benefits of their
food.
FDA Oversight of Qualified Health Claims Is Limited:
FDA continues to use its enforcement discretion for qualified health
claims and has not taken enforcement actions against companies for
violations involving these claims. However, as part of an oversight
initiative targeting food labeling compliance, FDA issued 17 warning
letters to food companies, from December 2009 to February 2010,
including 2 for violations related to their use of qualified health
claims. FDA officials stated that to the best of their knowledge these
were the first warning letters the agency had issued regarding
qualified health claims on food.
The two warning letters for qualified health claims were issued to
Fleminger, Inc., for claims about green tea, and Diamond Food, Inc.,
for claims about walnuts. As shown in table 4, according to FDA's
warning letters, the companies (1) failed to use the specific
qualified health claims statements allowed by FDA and (2) added
language that was not supported by scientific evidence. Specifically,
according to FDA's letter to Fleminger, Inc., the company's Web site
had stated that high consumption of green tea is associated with
reduced risks for cancer of the esophagus, stomach, colon, rectum,
pancreas, urinary bladder, lung, liver and ovary--claims regarding
diseases that FDA did not find support for, and did not include in the
qualified health claims. Noting that the statements on the Web site
altered the meaning of the qualified health claim language and
misrepresented FDA's conclusions, FDA found that the statements caused
the products to be misbranded in violation of the Federal Food, Drug,
and Cosmetic Act. In its warning letter to Diamond Food, Inc., FDA
said, among other things, that the product label contained health
claims that were not authorized by FDA, in violation of the Federal
Food, Drug, and Cosmetic Act. The label had the phrase "OMEGA-3 2.5 g
per serving" and heart symbols adjacent to information about the
amount of omega-3 in the product--implying that omega-3 reduces the
risk of coronary heart disease and that the relationship between
walnuts and coronary heart disease is related to the omega-3 fatty
acid content of walnuts. However, as FDA's letter points out, there is
not sufficient evidence to identify omega-3 fatty acid as the
substance in walnuts that reduces the risk of coronary heart disease.
Table 4: Two FDA Warning Letters Issued in February 2010 Regarding
Qualified Health Claims:
Company, date of warning letter, and product cited for violation:
Fleminger, Inc.; (Feb. 22, 2010); TeaForHealth™ green tea products;
Dr. Lee's TeaForHealth® 710EGCG™ inabottle™ Green Tea and
TeaForHealth® 710EGCG™ Ready-To-Drink Natural Brewed Green Tea;
Qualified health claims allowed for product:
1. "Two studies do not show that drinking green tea reduces the risk
of breast cancer in women, but one weaker, more limited study suggests
that drinking green tea may reduce this risk. Based on these studies,
FDA concludes that it is highly unlikely that green tea reduces the
risk of breast cancer";
2. "One weak and limited study does not show that drinking green tea
reduces the risk of prostate cancer, but another weak and limited
study suggests that drinking green tea may reduce this risk. Based on
these studies, FDA concludes that it is highly unlikely that green tea
reduces the risk of prostate cancer";
Excerpts from the warning letter: The letter states that the following
claims, presented on the company's Web sites, were unauthorized and
not consistent with either of the qualified health claims FDA allows
for green tea:
Examples of health claim on www.teaforhealth.com include the
following: "Green tea may reduce the risk of breast and prostate
cancers. FDA has concluded that there is credible evidence supporting
this claim although the evidence is limited";
Examples of health claim on www.greenteahaus.com in the form of
headings categorized as "educational materials" include the following:
"Epidemiological and clinical studies on the relationship between
cancer risk and the consumption of green tea...";
Examples of health claims in "The Truth in Tea" include the following:
* "High consumption of green tea [is] associated with reduced cancer
rates of the breast, esophagus, stomach, colon, rectum, pancreas,
urinary bladder, prostate, lung, liver and ovary...";
* "Recent medical research has provided evidence that drinking green
tea may reduce the risk of fatal heart attack, stroke, Alzheimer's
disease, Parkinson's disease, help reduce body fat and help fight
viral infection."
Company, date of warning letter, and product cited for violation:
Diamond Food, Inc. (Feb. 22, 2010); Diamond of California Shelled
Walnuts;
Qualified health claims allowed for product: "Supportive but not
conclusive research shows that eating 1.5 oz of walnuts per day, as
part of a low saturated fat and low cholesterol diet, and not
resulting in increased caloric intake, may reduce the risk of coronary
heart disease. Please refer to nutrition information for fat content
and other details about the nutritional profile of walnuts";
Excerpts from the warning letter: The letter states that the following
statement on the product label is an unauthorized health claim:
"The omega-3 in walnuts can help you get the proper balance of fatty
acids your body needs for promoting and maintaining heart health. In
fact, according to FDA, supportive but not conclusive research shows
that eating 1.5 oz of walnuts per day, as part of a low saturated fat
and low cholesterol diet, and not resulting in increased caloric
intake, may reduce the risk of coronary heart disease." The letter
further states that the statement suggests that the evidence
supporting a relationship between walnuts and coronary heart disease
is related to the omega-3 fatty acid content of walnuts. There is not
sufficient evidence to identify a biologically active substance in
walnuts that reduces the risk of coronary heart disease.
Source: FDA documents.
Note: FDA's warning letters to both companies also cited violations
other than those for qualified health claims; these violations are not
shown in the table.
[End of table]
In a March 2010 open letter to industry, the FDA Commissioner noted
that the warning letters did not attempt to cover all products with
labeling violations, but that they did cover a range of concerns about
how false or misleading labels can undermine the "intention of
Congress to provide consumers with labeling information that enables
consumers to make informed and healthy food choices." The warning
letters gave companies 15 working days from the receipt of the letters
to respond with the steps that they are or will be taking to correct
their label violations. According to FDA officials, all the companies
responded to the warning letters. When FDA has verified that the
violations have been addressed, it will issue, and post to its Web
site, closeout letters indicating that corrective actions were taken,
according to the officials. As of December 23, 2010, FDA had not
issued closeout letters for any of the 17 companies that received
these warning letters for labeling violations. (Appendix V summarizes
the other 15 warning letters and an untitled letter that FDA issued
regarding claims found on food labels during the December 2009 through
February 2010 oversight initiative.)
Consumers Have Difficulty Understanding the Level of Scientific
Support for Qualified Health Claims and How These Claims Differ from
Other Claims:
Research has shown, and stakeholders have indicated, that consumers
find it difficult to understand the differences between qualified
health claims and health claims with significant scientific agreement.
Consumers have similar difficulties understanding the differences
among health, structure/function, and other health-and nutrient-
related claims. European Union (EU) and Canadian food labeling
officials, noting the potential for qualified health claims to confuse
or mislead consumers about the benefits of a food, stated that their
governments do not allow the use of qualified health claims on food
labels.
Consumers Have Difficulty Understanding the Level of Scientific
Support for Qualified Health Claims, According to Research and
Stakeholders:
Research conducted over the past decade by FDA, FTC, and the
International Food Information Council on consumers' understanding of
qualified health claims consistently shows that consumers find it
difficult to understand the degree of scientific support for qualified
health claims on food labels.[Footnote 12] In particular, according to
our analysis of this research, consumers cannot consistently
distinguish between health claims, which have significant scientific
agreement, and qualified health claims, which have lower levels of
scientific evidence (i.e., good/moderate and low levels of scientific
support). For example,
* According to a 2009 FDA study, which was based on a Web-based survey
of over 7,000 adults, the respondents could not distinguish between
the strength of scientific evidence for claims with significant
scientific agreement and for claims with good/moderate levels of
support.[Footnote 13] Specifically, respondents' ratings of scientific
support for two health claims with substantial scientific support
(i.e., the benefits of soluble fiber and of stanol esters from
vegetable oil in reducing the risk of heart disease) were not
consistently different than ratings for the qualified health claims
for omega-3 fatty acids and heart disease, which have good/moderate
scientific support.[Footnote 14]
* FDA's 2009 study also found that respondents could not consistently
distinguish between the level of support for qualified claims related
to (1) omega-3 fatty acids for reducing the risk of heart disease,
which has good/moderate scientific support, and (2) monosaturated fat
from olive oil for reducing the risk of heart disease, which has a low
level of scientific support.
* The International Food Information Council's 2008 research on
consumers' understanding of qualified health claims, based on a Web-
based survey of 5,642 adults, showed that words such as "inconclusive"
meant different things to different consumers.[Footnote 15] According
to the council, some consumers believed that "inconclusive" implied
"honesty" and "believability," while others believed that it implied
extreme negativity. However, the phrase "not conclusive" is used in
four qualified health claims, including the walnut claim: "Supportive
but not conclusive research shows that eating 1.5 ounces per day of
walnuts, as part of a low saturated fat and low cholesterol diet and
not resulting in increased caloric intake, may reduce the risk of
coronary heart disease."
* The council's research also showed that consumers had trouble
distinguishing the four distinct levels of scientific support behind
claims--that is, distinguishing among the (1) significant scientific
agreement for health claims and, for qualified health claims, the (2)
moderate scientific evidence, (3) limited or low scientific evidence,
and (4) little or extremely low scientific evidence. Regardless of the
different language options used, 78 percent of consumers ranked the
four levels incorrectly.
* FTC's 2005 study presented the findings of research on consumers'
perceptions of print advertisements containing qualified health
claims, obtained from interviews of 480 adults, in eight
geographically dispersed shopping mall facilities.[Footnote 16]
According to FTC officials, although it might be possible to
communicate the proper order of various levels of qualification using
strongly worded language or graphical displays, it would nonetheless
be difficult to develop qualifying language in advertising to
communicate a low level of scientific certainty. The survey results
indicated that none of the tested language, whether appearing in real
or fictitious product advertisements, communicated serious limitations
in scientific evidence. In addition, consumers interpreted all of the
tested advertisements in a disparate fashion. For example, in an
advertisement for a fictitious antioxidant vitamin supplement, about
two-thirds of the consumers responding either overestimated or
underestimated the certainty of the science.
Furthermore, on the basis of its own research as well as FDA's, FTC
has continued to express concern about the potential for qualified
health claims to mislead consumers. In 2009, the Director of FTC's
Bureau of Consumer Protection announced that one of the bureau's
primary goals was to prevent claims made in food advertising that were
not supported by the weight of the scientific evidence, noting that
one outlier study should not be the sole basis of a claim,
particularly for a health benefit.[Footnote 17] According to FTC's
Enforcement Policy Statement of Food Advertising, the commission
believes that qualified claims based on evidence that is inconsistent
with the larger body of evidence have the potential to mislead
consumers and therefore are likely to violate the Federal Trade
Commission Act. Further noting that "objective claims carry with them
the implication that they are supported by valid evidence," in its
policy statement, FTC recognized that qualified health claims may be
permitted in certain limited instances--if they expressly convey
"clearly and fully" the extent of scientific support. However, as
noted in the statement, if such claims are not consistent with the
majority of evidence, they could potentially mislead consumers and,
under its legal framework, FTC would find them deceptive.
If consumers cannot properly distinguish among the claims, they may be
unable to make informed decisions about the likelihood that a food
will have the claimed health benefit. Some consumer and health
association stakeholders told us that qualified health claims should
be eliminated because of consumers' confusion, although a few
suggested that the claims with moderate scientific support should
remain. In addition, in a January 2007 letter to FDA, the American
Medical Association stated that it continues to vigorously oppose the
use of qualified health claims on foods; that FDA has no basis for
allowing them because, according to the association, Pearson v.
Shalala does not apply to foods; and that recent research has shown
that qualifying language cannot remedy the possible deceptiveness of
qualified health claims. On the other hand, the Grocery Manufacturers
Association supports the continued use of qualified health claims, and
according to the association representatives, some members find them
to be a useful advertising tool.
In part because of the results of FDA's research on consumers'
understanding of qualified health claims, the European Union does not
allow these claims on food labels, according to EU labeling officials.
These officials said that these claims may confuse or mislead
consumers. Similarly, Canada does not allow these claims because of
their potential to confuse or mislead consumers, according to a
Canadian food labeling official.
Research and Stakeholders Find Consumers Have Difficulty
Distinguishing among Health, Qualified Health, Structure/Function, and
Nutrient Content Claims:
According to research conducted by FDA, the International Food
Information Council, and academia, consumers have difficulty
distinguishing among the many different types of claims on food
labels, including health claims, qualified health claims,
structure/function claims, and nutrient content claims. For example,
* According to a 2008 article on how 1,077 participants in a 2006 FDA
study interpreted health messages on food labels, when respondents
were well acquainted with the nutrient or diet-disease relationship--
such as the link between calcium and osteoporosis--there was no
difference in how strongly respondents believed in the stated health
benefit, regardless of whether the claim was a health,
structure/function, or nutrient content claim.[Footnote 18]
* According to the International Food Information Council's 2008
study, consumers rate the level of scientific evidence and other
attributes associated with a product containing a structure/function
claim as similar to the evidence and other attributes of health claims
with significant scientific agreement on a product. Specifically, the
council found that consumers are just as likely to purchase a product
with a structure/function claim, which FDA does not review, as they
are to purchase a product with a health claim supported by significant
scientific agreement, which FDA does review. Furthermore, structure/
function claims were perhaps the most popular of all the claims the
council tested: Most consumers liked their brevity and general health
messages more than health claims, which they saw as too wordy and too
disease specific. For example, several consumers mentioned that they
did not like to see the word "cancer" on the labels for their food
products, even if the label asserted the food would help prevent
cancer.
* Academic researchers also noted that consumers tend to interpret the
lack of disclaimers (statements that FDA has evaluated the claims on
certain dietary supplements) as meaning that the claim had received
FDA's review and approval.[Footnote 19]
FDA reviews some health-and nutrient-related claims on food, but many
are not reviewed (e.g., structure/function claims), and as a result,
public health may not be adequately protected, according to a 2010
report by the National Academies' Institute of Medicine (IOM).
According to this IOM report, consumers have difficulty assessing the
scientific merits of these claims. Similarly, some health and consumer
stakeholders we interviewed said that FDA should particularly review
structure/function claims because consumers do not understand the
difference between them and health claims that do receive FDA's
review. They also said that like health claims, structure/function
claims should have scientific standards to ensure they are not false
or misleading and that these claims should not be allowed on foods
that are high in sugar, saturated fat, or sodium.
In addition, according to FDA officials, the agency would be better
able to take enforcement action against companies that make false or
misleading structure/function claims if it had express authority to
access company research. Furthermore, a contributing author of the IOM
report explained that while FDA can conduct its own studies as
resources permit, it needs authority to require food companies to
provide studies focused on specific claims and products. Some
stakeholders, such as representatives from the American Society for
Nutrition and the Center for Science in the Public Interest, said that
FDA should have authority to require consumer and scientific studies
from industry so that industry, rather than FDA, bears the burden of
proof that a claim is truthful and not misleading. However, a
representative from the American Dietetic Association expressed
concern that giving FDA access to companies' research could hinder
industries' willingness to conduct research, while a representative
from the Grocery Manufacturers Association opposed any suggestions
that FDA be given additional authority to require proprietary studies
from its members.
Industry More Widely Uses Structure/Function Claims on Food with
Minimal FDA Oversight, but FTC Has Taken Some Action When These Claims
Were Deceptive:
While FDA data indicate that industry's interest in qualified health
claims on food labels has slowed to one petition for such a claim
since 2006, data also indicate that industry more widely uses
structure/function claims to communicate health benefits to consumers,
with minimal FDA oversight. However, FTC has taken action to cause a
major food company to withdraw deceptive structure/function claims on
its labels and advertising.
Industry More Often Uses Structure/Function Claims on Food with
Minimal FDA Oversight:
As noted earlier and in table 3, FDA's FLAPS results found only about
0.4 percent of food labels in grocery stores had qualified health
claims. In contrast, about 4.3 percent had health claims, and 5.5
percent had structure/function claims. The most common claims found in
the FLAPS study were nutrient content claims or variations of these
claims. Consumers can usually check the nutrition facts panels or
ingredients lists, which are required on food labels, for
corroborating information for nutrient content claims. Although
consumers are able to verify information from nutrient facts panels,
they do not have such information readily available on labels for
health claims, qualified health claims, or structure/function claims.
Also, the 2009 study by West Virginia University researchers showed
that companies that could have used qualified health claims chose more
than twice as often to use structure/function claims.[Footnote 20]
This study focused on labels of foods eligible to use qualified health
claims. Specifically, it found that only 4.6 percent of food packages
eligible for a qualified health claim actually used one, while 9.4
percent of these eligible packages used structure/function claims
instead. The study identified possible reasons for choosing structure/
function claims more often than qualified health claims; for example,
(1) structure/function claims, unlike qualified health claims, do not
mention diseases; (2) companies do not want consumers to relate
unpleasant or unfavorable associations (such as cancer or colon
polyps) with their products; and (3) the qualifying language FDA used
in the qualified health claims is more limiting than companies had
hoped. In addition, research funded by the food industry has shown
that consumers prefer to see shorter, simpler claims on food labels.
Also, companies are not required to submit scientific support or
obtain FDA's premarket review and approval before using a
structure/function claim on a food label.
As we said earlier, FDA is responsible for ensuring the proper
labeling of food, and the use of structure/function claims is subject
to the general statutory requirement that labeling not be false or
misleading. However, FDA has not given companies guidance on the
scientific support needed to prevent false or misleading information
in a structure/function claim for food. FDA has guidance for the
dietary supplements industry on the scientific support needed to
prevent false or misleading information for a structure/function claim
for dietary supplements.[Footnote 21] In technical comments, FTC staff
stated that "FDA could issue a statement that the same principles
apply to foods."
One way for FDA to identify potentially false or misleading structure/
function claims would be by including an examination of these claims
in food facility compliance inspections. Following the Compliance
Program Guidance Manual, inspectors are instructed to examine any
three food labels from a facility. Inspectors are to focus their label
reviews on violations, such as failure to declare allergens and
failure to provide nutrition information. For nutrient content claims
on food labels, inspectors can check the facts panels and ingredients
lists to help corroborate the claims. Their inspection guidance manual
identifies the statutes and regulations for health claims and nutrient
content claims but does not provide instructions for identifying
potentially false or misleading structure/function claims for food.
If FDA determines that a structure/function claim is false or
misleading, it may send a warning letter to the company. Although FDA
officials could not identify any warning letters or enforcement
actions for such violations on food labels, they provided two warning
letters issued in 2001 for nutrient content claim violations, in which
FDA also expressed concerns with structure/function claims made by the
companies on their food labels.[Footnote 22] Specifically, those
warning letters mentioned the following structure/function claim
concerns:
* One warning letter, for New Morning Organic Ginseng Crunch and
Organic GinkgOs, noted the label claims "for mental concentration,
physical vitality and energy and its ... anti-oxidant qualities" and
"to sustain memory." According to FDA's warning letter, the foods were
represented as cereals. The letter noted that the claimed effect must
be achieved through the nutritive value of a food, and that otherwise
the product would be considered a drug under the Federal Food, Drug,
and Cosmetic Act, and therefore subject to FDA's drug regulations.
* The second warning letter, for Hansen's Healthy Start Immune Juice,
had a label claim stating that "Echinacea ... may help stimulate the
body's production of interferon." FDA again stated that the claimed
effect had to be achieved through the nutritive value of the food and
that otherwise the product would be considered a drug under the
Federal Food, Drug, and Cosmetic Act, and therefore subject to FDA's
drug regulations.
FDA officials told us that these warning letters were issued about 16
months after an FDA-sponsored stakeholder meeting in 2000, which was
convened to seek input for what FDA viewed at the time as a need for
immediate attention to the growing use of structure/function claims
and the serious oversight dilemma they posed for FDA. At the meeting,
the stakeholders--from FDA, industry, consumer groups, and academia--
identified an urgent need for regulating and overseeing structure/
function claims and noted that FDA could not wait for legislative
changes. The stakeholders stated, among other things, that:
* consumers cannot be confident that the claims are truthful and not
misleading because their scientific support is unclear,
* some consumers lack the tools or understanding needed to evaluate
claim messages and understand what they mean, and:
* consumers cannot clearly distinguish among health claims, structure/
function claims, and other claims.
In a January 2001 "Letter to Manufacturers," FDA reminded food
companies that, among other things, "the claimed structure/function
effects for foods must be achieved through nutritive value. If [they
are] not, the product is subject to regulation as a drug."
Subsequently, in a 2006 Federal Register notice, FDA requested
comments on a series of questions on, among other things, whether it
should require companies to notify FDA within 30 days before marketing
a food with a structure/function claim, and whether FDA should require
a disclaimer stating that FDA had not reviewed or approved the claim.
As we noted earlier, federal law requires such notification and a
disclaimer on dietary supplements for all structure/function claims
that reads, "This statement has not been evaluated by the Food and
Drug Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease." In commenting on these issues, two
consumer groups supported requiring companies to submit
structure/function claims for foods with novel ingredients (e.g.,
ingredients that are added to and not normally found in the food) to
FDA for premarket approval. One of the consumer groups noted that
disclaimers for dietary supplements have been shown to be ineffective,
and thus the group was not suggesting they be used on food. A few
industry groups commented that they believed FDA lacked authority to
require a disclaimer or premarket approval. FDA has not adopted a
disclaimer or notification requirement for structure/function claims
on food labels.
Unlike FTC, which may require companies to provide the evidence to
support their advertising claims, FDA bears the burden of proving that
a structure/function claim is false or misleading without having the
authority to compel companies at the investigation stage to produce
the evidence that the companies assert as support for their
advertising claims. According to senior attorneys in FDA's Office of
the Chief Counsel, FDA's efforts to meet that burden are hampered by
the lack of access to the evidence that a company relies on to make
such a claim. In particular, while FDA may ask a company to provide
its evidence, FDA does not have express legal authority to compel the
company to provide information. To support an action, FDA may need to
review the scientific literature to determine whether the literature
supports a claim--an effort that may be time consuming and labor
intensive. FDA may also need to establish through research how
consumers perceive the claim. If the structure/function claim, or any
claim for that matter, is one for which there is little publicly
available information, it can be difficult for FDA to develop the
evidence needed to support an enforcement action. It also can be
difficult to evaluate the support for a structure/function claim when
the functions, such as "immunity" or "attention," do not have
generally established measures for the claimed benefit. For example,
it is not necessarily clear what outcome measures would be a valid
means of assessing whether a food "improves vitality."
Furthermore, in contrast to the United States, the EU follows a
different course: EU Commission officials told us the responsible EU
food agency must preapprove the type of food claims that FDA calls
structure/function claims before they can be used. EU Commission
officials also stated that their scientific review agency rejected 85
percent of structure/function claims companies have submitted because
of the lack of scientific support. Canada is also reviewing structure/
function claims food companies have submitted by developing a list of
approved claims; it too has rejected most claims, including some found
on labels in the United States, according to a Canadian official. To
protect the public from false or misleading claims, the Canadian food
labeling agency is working with the Canadian agency that regulates
advertising to develop a framework for regulating structure/function
claims.
FTC Has Taken Some Enforcement Action on Deceptive Structure/Function
Claims on Food:
Although FTC, operating under its memorandum of understanding with
FDA, has not historically focused on claims on food labels, it has
recently emphasized that health claims on food must be adequately
substantiated and presented in a manner that is truthful and not
deceptive, according to FTC officials. To clarify how its authority
related to FDA's labeling regulatory scheme under NLEA, FTC issued an
Enforcement Policy Statement on Food Advertising in May 1994 that
provided the legal framework for its related enforcement actions.
Under that framework, FTC would find an advertisement deceptive and
therefore unlawful, if:
* the advertisement contained a representation or omission of a
material fact that is likely to mislead consumers acting reasonably
under the circumstances, or:
* the advertiser did not possess and rely on reasonable substantiating
evidence of the claim's truth.
FTC has filed complaints on claims made in food advertising that it
alleged to violate the Federal Trade Commission Act, and taken
enforcement actions for alleged false structure/function claims on
food labels and in advertisements.[Footnote 23] Specifically, in 2009,
FTC reached a settlement with Kellogg on a complaint alleging that the
company made unsubstantiated claims that Frosted Mini-Wheats was
"clinically shown to improve kids' attentiveness by nearly 20
percent." The company agreed to refrain from making comparable claims.
In 2010, FTC reopened the complaint based on claims made by Kellogg
that Rice Krispies cereal "now helps support your child's immunity."
To resolve the investigation into the new claims, Kellogg agreed to
new advertising restrictions and a revised settlement order.
FTC officials told us the commission could not have taken the actions
that it did without authorities, such as access to companies'
proprietary market and scientific research. They said FTC needed
research and documentation from Kellogg to determine whether the
information supported an enforcement action. FTC has authority to
compel companies to provide evidentiary documents, among other things,
and therefore it can get such documents on a voluntary basis. FTC
obtained Kellogg's documents showing that the attentiveness claim was
allegedly false. According to the FTC complaint, Kellogg's research
showed that the cereal increased children's attentiveness by only
about 11 percent.
FTC officials told us that they had informed FDA about their actions
concerning Kellogg. However, because Kellogg cooperated, the two
agencies did not have to coordinate further. Since September 2009,
through monthly working group meetings, FDA and FTC have been
coordinating to, among other things, prevent duplication of effort and
share information on cases of mutual interest.
Conclusions:
Initially in 2002, FDA thought it would receive a flood of petitions
for qualified health claims from food companies. However, this demand
never materialized, and in fact, FDA has received only 16 petitions
with 60 proposed claims and only 1 petition since 2006. Furthermore,
the 12 qualified health claims that FDA has allowed are being
minimally used by food companies. Structure/function claims are
another matter, making up more than 5 percent of all food labels. FDA
recognized a decade ago the growing use of such claims and the serious
oversight dilemma they pose. Unlike FTC, which can require companies
to provide the evidence to support their food advertising claims, FDA
bears the burden of proving that a structure/function or other type of
claim is false or misleading. Our work indicates that FDA's efforts to
meet that burden are hampered by the lack of access to the scientific
support that a company relies on to make such a claim. In particular,
while FDA may ask a company to provide its support, FDA does not have
express legal authority to compel the company to provide it. FTC, on
the other hand, has authority to compel companies to provide
evidentiary documents.
Furthermore, FDA has not given companies guidance on the level of
scientific evidence needed to prevent false or misleading information
in a structure/function claim for food; by not providing such
guidance, FDA may not be doing all it can to help ensure that food
labels are free from false or misleading claims. Moreover, FDA has not
given its inspectors instructions in the Compliance Program Guidance
Manual for identifying potentially false or misleading information in
structure/function claims when examining food labels as part of food
facility compliance inspections; without such instructions, inspectors
may be missing one way for FDA to identify potentially false or
misleading structure/function claims.
Recommendations for Executive Action:
To ensure that the health-related claims on food labels are not false
or misleading to consumers, we recommend that the Secretary of Health
and Human Services direct the Commissioner of FDA to take the
following three actions:
* identify and request from Congress the authorities needed to access
evidence from food companies regarding potentially false or misleading
structure/function or other claims on food that would allow the agency
to establish whether there is scientific support for the claims;
* provide guidance to industry on the type and strength of scientific
evidence needed to prevent false or misleading information in a
structure/function claim; and:
* amend the Compliance Program Guidance Manual instructions to FDA
inspectors for reviewing food labels during inspections of food
facilities, to include steps for identifying potentially false or
misleading structure/function claims for further review.
Agency Comments and Our Response:
We provided a draft of this report to the Secretary of Health and
Human Services and FTC's General Counsel for their review and comment.
In written comments, the Department of Health and Human Services'
(HHS) Assistant Secretary for Legislation stated that FDA welcomed the
report for calling attention to the extremely complex and challenging
legal and regulatory environment under which FDA works to protect
consumers from false and misleading label claims on foods,
particularly qualified health claims and structure/function claims.
HHS stated that FDA also welcomed the report for calling attention to
the differences in the legal authorities between FDA and FTC that
allow FTC to compel companies to provide evidence supporting their
advertising claims. FTC staff provided technical comments that we
incorporated in the report, as appropriate.
With regard to our recommendations, HHS indicated that FDA generally
agreed with our first two recommendations but believes that our third
recommendation is impractical. Specifically, regarding our first
recommendation--to identify and request from Congress the authorities
needed to access evidence from food companies regarding potentially
false or misleading structure/function or other claims on food that
would allow the agency to establish whether there is scientific
support for the claims--HHS commented that FDA would work to determine
better approaches to enhancing its oversight of structure/function
claims, including whether additional statutory authorities are needed.
Regarding our second recommendation--to provide guidance to industry
on the type and strength of scientific evidence needed to prevent
false or misleading information in a structure/function claim--HHS
noted FDA's support for providing guidance to industry on the type of
evidence needed. FDA agreed to consider developing such guidance as
agency priorities and resources permit. FDA has guidance for the
dietary supplements industry on the scientific support needed to
prevent false or misleading information for a structure/function claim
for dietary supplements. As we noted earlier, in technical comments,
FTC staff stated that "FDA could issue a statement that the same
principles apply to foods."
Regarding our third recommendation--to amend the Compliance Program
Guidance Manual instructions to FDA inspectors for reviewing food
labels to include steps for identifying potentially false or
misleading structure/function claims during inspections of food
facilities--FDA agreed that field investigators, to whom the
Compliance Program Guidance Manual is targeted, have significant
exposure to food labels that may contain any one of a myriad of
structure/function claims during their routine inspections of food
producers. However, the agency sees significant challenges to
providing specific steps to investigators to identify potentially
false or misleading structure/function claims during inspections. FDA
found the recommendation impractical, noting that judging whether a
structure/function claim is false or misleading requires knowledge of
the science that would support or dispute the claim. FDA believes it
would be impossible to provide inspectors with the knowledge necessary
to make such an assessment in the field. FDA further states that,
while structure/function claims are not highlighted as an area of
emphasis, the Compliance Program Guidance Manual includes instructions
for inspectors to collect information to determine the extent to which
food products are in compliance with all labeling requirements and
provides additional references regarding the types of claims permitted
on food labels. We agree that the guidance manual includes several
instructions to help inspectors review food labeling. It contains, for
example, the requirements for the nutrition facts panel and identifies
allergens that must be declared. The guidance manual also identifies
the statute and regulations for health claims and nutrient content
claims, as well as the statute and regulations prohibiting food
labeling that is false or misleading. However, the Compliance Program
Guidance Manual does not provide instructions to help inspectors
identify potentially false or misleading structure/function claims on
food. While we agree it may be impractical for field inspectors to
judge whether a claim is false or misleading, we believe that FDA can
amend the instructions for inspectors with steps to help them identify
potentially false or misleading structure/function claims that may
warrant further FDA review--leaving the determinations of whether the
claims are indeed potentially false or misleading to FDA staff with
the necessary science backgrounds. We clarified our recommendation.
HHS's written comments appear in appendix VI.
FDA also provided technical comments that we incorporated in the
report, as appropriate.
We are sending copies of this report to the appropriate congressional
committees, the Secretary of Health and Human Services, the
Commissioner of FDA, the Federal Trade Commission, and other
interested parties. In addition, the report will be available at no
charge on GAO's Web site at [hyperlink, http://www.gao.gov.
If you or 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. Key contributors to this report are
listed in appendix VII.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: FDA's Administration of Health Claims in Response to
Pearson v. Shalala:
In 2008 we reported on the Food and Drug Administration's (FDA)
efforts to help consumers choose healthy foods through the information
provided on food labels.[Footnote 24] In that report we presented
information on FDA's administration of health claims, and specifically
its treatment of qualified health claims, after the Pearson v. Shalala
ruling. That information is repeated here with some modifications.
As we reported, the Nutrition Labeling and Education Act of 1990
(NLEA)[Footnote 25] amended the Federal Food, Drug, and Cosmetic Act
to include provisions that govern the use of health claims on food
labeling.[Footnote 26] 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 27] 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 health claims for
dietary supplements to be subject to the same statutory procedures and
standards as health claims for conventional food. Instead, health
claims for dietary supplements 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 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 28] However, before the rule could be finalized, Congress
passed legislation that generally prohibited FDA from implementing the
NLEA for dietary supplements until December 15, 1993.[Footnote 29]
Therefore, in January 1993, when FDA adopted the final rules for
health claims for conventional foods, it did not finalize rules for
health claims on dietary supplements.[Footnote 30] However, 1 year
later, after the prohibition of implementation of NLEA for dietary
supplements had expired, FDA adopted a rule that subjected health
claims for dietary supplements to the same general requirements that
applied to conventional foods.[Footnote 31] Under those rules, any
person wanting to include a health claim on the label for a
conventional food or dietary supplement 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 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, 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.[Footnote 32] 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 33]
Following the decision in Pearson v. Shalala, FDA announced its plan
to respond, stating that it would deny, without prejudice, all
petitions for the use of health claims on dietary supplements that did
not meet the significant scientific agreement standard while the
agency conducted and completed a rulemaking to consider the procedures
and standards governing such claims. 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 34] FDA stated that it would continue to approve health
claims for dietary supplements that met the significant scientific
agreement standard, but it would exercise its enforcement discretion
and not take action against health claims for dietary supplements that
failed to meet the standard under certain circumstances. Specifically,
upon the submission of a valid petition for preapproval of a health
claim for a dietary supplement, 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.
In 2002, the agency announced the availability of guidance, updating
its approach to implementing the decision in Pearson v. Shalala.
[Footnote 35] In large part, the procedures remained the same;
however, FDA included health claims for conventional foods under the
procedures, even though Pearson v. Shalala 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. 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 36] 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 37] 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 38] 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 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 39] In that
announcement, FDA presented several regulatory alternatives it might
take, stating that it could (1) incorporate the interim procedures and
evidence-based ranking system the agency described in its 2000
guidance into regulation; (2) subject health claims to notice-and-
comment rulemaking, as before Pearson v. Shalala, 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 did not work
on this proposed rulemaking in 2010.
FDA issued final guidance describing the evidence-based review system
it intends to use to evaluate publicly available scientific evidence
for health claims and qualified health claims in January
2009.[Footnote 40] This guidance replaced the 2003 guidance document
describing the evidence-based ranking system.[Footnote 41] The 2009
guidance document set out an approach that FDA intends to use to
evaluate the results of studies from which scientific conclusions can
be drawn and rate the strength of the total body of publicly available
evidence.
In a 2010 case before the U.S. District Court for the District of
Columbia, a dietary supplement manufacturer challenged FDA's decisions
regarding specific health claims.[Footnote 42] At issue in this case
were five proposed health claims describing a purported relationship
between selenium and the risk of cancer. FDA had denied four of the
claims outright, and it stated that it would exercise enforcement
discretion regarding a modified version of the remaining claim. The
manufacturer challenged the denial of the four claims and the modified
claim, describing the modified claim as an imposition of an onerous,
value-laden set of qualifications and as unreasonably long and
burdensome for industry to include.[Footnote 43] The court examined
FDA's review of the scientific evidence, referencing procedures laid
out in the agency's 2009 guidance document. The court questioned a
number of FDA's conclusions and remanded the denied claims to the
agency to reevaluate.[Footnote 44] In addition, the court found FDA's
modified disclaimer at odds with the First Amendment. The court stated
that "FDA is obligated to at least consider the possibility of
approving [the manufacturer's] proposed language with the addition of
[a] 'short, succinct, and accurate disclaimer[].'"[Footnote 45]
[End of section]
Appendix II: Objectives, Scope, and Methodology:
We examined (1) the results of FDA's efforts to allow the use of
qualified health claims on food, and its oversight of these claims and
(2) what is known about consumers' understanding of qualified health
claims on food. In addition, we examined industry's use of structure/
function claims on food and FDA's oversight of these claims.
To examine the results of FDA's efforts to allow food companies to use
qualified health claims on food, we assessed FDA data and
documentation, including health claim guidance and petitions from
industry. We reviewed petitions for qualified health claims and FDA's
letters to petitioners stating that if a company used the submitted
claim as modified by FDA, the agency would exercise its enforcement
discretion and not take action against the claim. We also requested
data on FDA resources devoted to qualified health claims and
petitions. Although FDA does not maintain data on expenditures and
staff charges that would allow it to provide the actual amount it
expended on qualified health claims since 2000, FDA estimated that its
Center for Food Safety and Applied Nutrition (CFSAN) expended at least
$12.8 million since 2000, including the expenses associated with about
88.7 full-time equivalent staff, to administer health and qualified
health claim activities for food labeling. This estimate does not
represent FDA's total expenditures on activities related to health
claims and qualified health claims for the period because FDA
officials could not provide estimates or actual data on expenditures
and staff years for other than CFSAN with any degree of confidence.
We reviewed the literature to identify the extent to which different
health-and nutrient-related claims are used on food labels in grocery
stores and interviewed industry associations and others regarding the
marketing advantages and disadvantages of using qualified health and
structure/function claims. We obtained data from articles by FDA and
West Virginia University researchers to determine the use of qualified
health and structure/function claims on food labels. We assessed the
quality of the studies on which the articles were based and found them
to be of sufficient quality for the purposes of this review.
To examine FDA's oversight of qualified health claims, we reviewed FDA
guidance and related documents on inspection and enforcement of food
labeling claims. We also reviewed those warning letters and
enforcement actions that FDA officials were able to identify having
taken in response to violations, since 2001, as well as the results of
its January 2010 initiative to target oversight of labeling
compliance. We assessed the reliability of FDA's data on petitions and
health claims by (1) reviewing available information about the data
and the system that produced them, (2) interviewing agency officials
knowledgeable about the data, and (3) comparing the results with other
sources of data for reasonableness. When we found inconsistencies in
the data, we discussed them with agency officials and worked with them
to correct the inconsistencies. We determined the data were
sufficiently reliable for the purposes of this review.
To examine what is known about consumers' understanding of qualified
health claims on conventional food labels, we conducted a literature
search of various databases, such as PubMed, MEDLINE, and ProQuest, to
identify relevant research studies; we also asked stakeholders we
interviewed to recommend studies. Our selection criteria were that the
studies be based on original research on consumers' understanding of
qualified health claims and be less than 10 years old. We identified
six research studies, conducted by FDA, the Federal Trade Commission
(FTC), the International Food Information Council, and academia, that
met these criteria. In addition, FDA and the International Food
Information Council identified research studies they had conducted
that also addressed consumers' understanding of other types of claims
on food labels, including structure/function claims. These were the
aforementioned International Food Information Council study and an
additional FDA study. Two GAO social science analysts reviewed,
assessed, and agreed on the quality of each of the studies we used and
found that, while all the studies had some limitations, the
limitations were not so great as to preclude the studies' use.
We identified stakeholders from health, consumer, and industry groups,
as well as researchers, to represent the views of different sectors
with regard to consumer perceptions and policy options related to
qualified health claims and structure/function claims. We asked FDA
and the National Academies' Institute of Medicine to comment on the
list of stakeholders we developed to ensure fairness and balance. The
final list included the following:
* health associations: the American Heart Association, American
Dietetic Association, American Medical Association, and the American
Society for Nutrition;
* consumer groups: the Consumer Federation of America and the Center
for Science in the Public Interest;
* an industry association: the Grocery Manufacturers Association; and:
* researchers: the International Food Information Council; FTC; FDA;
and Neal Hooker, Chair of Food Marketing, St. Joseph's University,
Philadelphia, Pennsylvania.
We also interviewed food labeling officials at agencies from the two
largest exporters of agricultural products to the United States--
Canada and the European Union--to determine how these trading partners
regulated qualified health and structure/function claims.
To examine industry's use of structure/function claims and FDA's
oversight of these claims, we reviewed studies by FDA and researchers
at West Virginia University and discussed the results with FDA
compliance officials. We also obtained copies of FDA's warning letters
and discussed those and FDA oversight activities. We met with FTC
officials and compared and contrasted FDA's and FTC's responsibilities
and authorities with respect to food labeling and advertising claims,
and examined actions taken by FTC against a company for deceptive
structure/function claims. We also met with FTC officials to discuss
the commission's interactions with FDA on overseeing the proper use of
claims on food labeling and advertising.
We conducted this performance audit from January 2010 through December
2010 in accordance with generally accepted government auditing
standards. Those standards required 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 III: Types of Claims FDA Recognizes, and Industry May Use, on
Food:
FDA recognizes several types claims that are used on food labels,
including the following.
Health Claims:
* Health claims may be authorized by FDA when it determines that there
is significant scientific agreement among qualified experts that a
totality of publicly available scientific evidence supports the claim,
as provided under the Nutrition Labeling and Education Act of 1990.
For example, "Diets low in sodium may reduce the risk of high blood
pressure, a disease associated with many factors" is one such health
claim.
* Health claims may also be based on an authoritative statement of a
scientific body of the U.S. government or the National Academy of
Sciences, as provided under the Food and Drug Administration
Modernization Act of 1997;[Footnote 46] such claims may be used 120
days after notification to FDA. One such claim states: "Diets rich in
whole grain foods and other plant foods and low in total fat,
saturated fat, and cholesterol may reduce the risk of heart disease
and some cancers."
* Qualified health claims are health claims to which FDA has added
qualifying language to characterize the strength and limitations of
the scientific evidence in support of the claim's potentially
misleading nature, as described in FDA's 2003 Consumer Health
Information for Better Nutrition Initiative guidance. One such claim
states: "Very limited and preliminary scientific research suggests
that eating one-half to one cup of tomatoes and/or tomato sauce a week
may reduce the risk of prostate cancer. FDA concludes that there is
little scientific evidence supporting this claim."
Structure/Function Claims:
Structure/function claims describe the role of a nutrient to affect a
bodily structure (e.g., bones) or bodily function (e.g., digestion),
or characterize the mechanism by which a nutrient acts to maintain
such structure or function. For example, "Calcium helps build strong
bones." FDA is not required by statute to and does not review or
approve these claims.
Nutrient Content Claims:
* Nutrient content claims characterize the level of a nutrient in a
food using terms such as "free," "high," and "low" (e.g., "high in
vitamin C"), or compare the level of a nutrient in a food with that of
another food, using terms such as "more," "reduced," and "lite,"
(e.g., "contains 10 percent more of the Daily Value for fiber than
white bread," "reduced fat--50 percent less fat than our regular
brownies," or "lite cheese cake, 1/3 fewer calories and 50 percent
less fat than our regular cheesecake"), as provided under the
Nutrition Labeling and Education Act of 1990.
* Nutrient content claims may be based on an authoritative statement
of a scientific body of the U.S. government or the National Academy of
Sciences, as provided under the Food and Drug Administration
Modernization Act of 1997. One such claim is "good source of choline,"
which must reference the amount or percentage of the daily value of
choline in each serving. (Choline is an essential nutrient usually
grouped within the B-complex vitamins.)
Implied Nutrient Content Claims:
* Claims about a food or ingredient that suggest that the nutrient is
absent or present in a certain amount or claims about a food that
suggest a food may be useful in maintaining healthy dietary practices
and that are made with an explicit claim (e.g., "healthy, contains 3
grams of fat") are implied claims.
* Claims that a food contains or is made with an ingredient that is
known to contain a particular nutrient may be made if the product is
"low" in or a "good source" of the nutrient associated with the claim
(e.g., "good source of oat bran").
* Equivalence claims--"contains as much [nutrient] as a [food]"--may
be made if both reference food and labeled food are a "good source" of
a nutrient on a per serving basis (e.g., "contains as much vitamin C
as an 8 ounce glass of orange juice").
The following label statements are generally not considered implied
claims unless they are made in a nutrition context: (1) avoidance
claims for religious, food intolerance, or other non-nutrition-related
reasons (e.g., "100% milk free"); (2) statements about non-nutritive
substances (e.g., "no artificial colors"); (3) added value statements
(e.g. "made with real butter"); (4) statements of identity (e.g.,
"corn oil" or "corn oil margarine"); and (5) special dietary
statements made in compliance with a specific provision of Part 105 of
Title 21 of the Code of Federal Regulations.
[End of section]
Appendix IV: Health Claims That May Be Used On Food Labels:
Table 5 provides information, including sample claim language, on the
12 health claims authorized for foods that meet certain requirements
that are based on FDA's determination that there is significant
scientific agreement among qualified experts that all publicly
available scientific evidence supports the claims. Table 6 provides
information, including the required wording, on the 5 health claims
for food that are based on an authoritative statement of scientific
body of the U.S. government or the National Academy of Sciences.
Table 5: Twelve Health Claims Based on Significant Scientific
Agreement That May Be Used on Food Labels:
Food/disease risk: Calcium/osteoporosis;
Claim requirements: The claim must:
* "make clear that adequate calcium or calcium and vitamin D intake
throughout life in a healthful diet are essential to reducing
osteoporosis risk";
* "not imply that adequate calcium or adequate calcium and vitamin D
intake is the only recognized risk factor for the development of
osteoporosis";
* "not attribute any reduction in risk of osteoporosis to maintaining
an adequate dietary calcium or dietary calcium and vitamin D intake
throughout life";
Model claim:
Calcium and osteoporosis health claim:
* "Adequate calcium throughout life, as part of a well-balanced diet,
may reduce the risk of osteoporosis" or "Adequate calcium as part of a
healthful diet, along with physical activity, may reduce the risk of
osteoporosis in later life";
Calcium, vitamin D, and osteoporosis:
* "Adequate calcium and vitamin D throughout life, as part of a well-
balanced diet, may reduce the risk of osteoporosis" or "Adequate
calcium and vitamin D throughout life, along with physical activity,
may reduce the risk of osteoporosis in later life."
Food/disease risk: Sodium/hypertension;
Claim requirements: Required terms::
* "Sodium," "high blood pressure";
Includes physician statement (Individuals with high blood pressure
should consult their physicians) if claim defines high or normal blood
pressure;
Model claim: Diets low in sodium may reduce the risk of high blood
pressure, a disease associated with many factors.
Food/disease risk: Dietary lipids/cancer;
Claim requirements: Required terms:
* "Total fat" or "fat";
* "Some types of cancers" or "some cancers";
Does not specify types of fats or fatty acids that may be related to
risk of cancer;
Model claim: Development of cancer depends on many factors. A diet low
in total fat may reduce the risk of some cancers.
Food/disease risk: Dietary saturated fat and cholesterol/coronary
heart disease;
Claim requirements: Required terms:
* "Coronary heart disease" or "heart disease";
Includes physician statement (individuals with elevated blood total--
or LDL--cholesterol should consult their physicians) if claim defines
high or normal blood total--and LDL--cholesterol;
Model claim: While many factors affect heart disease, diets low in
saturated fat and cholesterol may reduce the risk of this disease.
Food/disease risk: Fiber-containing grain products, fruits, and
vegetables/cancer;
Claim requirements: Required terms:
* "Fiber," "dietary fiber," or "total dietary fiber";
* "Some types of cancer" or "some cancers";
Does not specify types of dietary fiber that may be related to risk of
cancer;
Model claim: Low-fat diets rich in fiber-containing grain products,
fruits, and vegetables may reduce the risk of some types of cancer, a
disease associated with many factors.
Food/disease risk: Fruits, vegetables and grain products that contain
fiber, particularly soluble fiber/coronary heart disease;
Claim requirements: Required terms:
* "Fiber," "dietary fiber," "some types of dietary fiber," "some
dietary fibers," or "some fibers";
* "Saturated fat" and "cholesterol";
* "Heart disease" or "coronary heart disease";
Includes physician statement ("Individuals with elevated blood total--
or LDL--cholesterol should consult their physicians") if claim defines
high or normal blood total--and LDL--cholesterol;
Model claim: Diets low in saturated fat and cholesterol and rich in
fruits, vegetables, and grain products that contain some types of
dietary fiber, particularly soluble fiber, may reduce the risk of
heart disease, a disease associated with many factors.
Food/disease risk: Fruits and vegetables/cancer;
Claim requirements: Required terms:
* "Fiber," "dietary fiber," or "total dietary fiber";
* "Total fat" or "fat";
* "Some types of cancer" or "some cancers";
Characterizes fruits and vegetables as "Foods that are low in fat and
may contain vitamin A, vitamin C, and dietary fiber";
Characterizes specific food as a "good source" of one or more of the
following: dietary fiber, vitamin A, or vitamin C;
Does not specify types of fats or fatty acids or types of dietary
fiber that may be related to risk of cancer;
Model claim: Low-fat diets rich in fruits and vegetables (foods that
are low in fat and may contain dietary fiber, vitamin A, or vitamin C)
may reduce the risk of some types of cancer, a disease associated with
many factors. Broccoli is high in vitamins A and C, and it is a good
source of dietary fiber.
Food/disease risk: Folate/neural tube defects;
Claim requirements: Required terms:
Terms that specify the relationship (e.g., women who are capable of
becoming pregnant and who consume adequate amounts of folate)
"folate," "folic acid," "folacin," "folate, a B vitamin," "folic acid,
a B vitamin," "folacin, a B vitamin," "neural tube defects," "birth
defects, spinal bifida, or anencephaly," "birth defects of the brain
or spinal cord--anencephaly or spinal bifida," "spinal bifida or
anencephaly, birth defects of the brain or spinal cord";
Must also include information on the multifactorial nature of neural
tube defects, and the safe upper limit of daily intake;
Model claim: Healthful diets with adequate folate may reduce a woman's
risk of having a child with a brain or spinal cord defect.
Food/disease risk: Dietary noncariogenic carbohydrate sweeteners/
dental caries;
Claim requirements: Required terms:
* "Does not promote," "may reduce the risk of," "useful [or is useful]
in not promoting," or "expressly [or is expressly] for not promoting"
dental caries;
* "Dental caries," or "tooth decay";
* "Sugar alcohol" or "sugar alcohols" or the name or names of the
sugar alcohols;
or D-tagatose, or sucralose;
Note: D-tagatose may be identified as "tagatose";
When the substance that is the subject of the claim is a noncariogenic
sugar (i.e., D-tagatose) the claim shall identify the substance as a
sugar that, unlike other sugars, does not promote the development of
dental caries;
Includes statement that frequent between-meal consumption of foods
high in sugars and starches can promote tooth decay;
Packages with less than 15 square inches of surface area available for
labeling may use a shortened claim;
Model claim: Full claim: Frequent between-meal consumption of foods
high in sugars and starches promotes tooth decay. The sugar alcohols
in [name of food] do not promote tooth decay. Shortened claim (on
small packages only): Does not promote tooth decay.
Food/disease risk: Soluble fiber from certain foods/coronary heart
disease;
Claim requirements: Required terms:
* "Heart disease" or "coronary heart disease";
* "Saturated fat" and "cholesterol";
In specifying the substance the claim uses the term "soluble fiber"
qualified by the name of the eligible source of the soluble fiber,
which is either whole oat or barley or psyllium seed husk;
Claim specifies the daily dietary intake of the soluble fiber source
necessary to reduce the risk of coronary heart disease;
Claim specifies the amount of soluble fiber in one serving of the
product;
Additional required label statement:
Foods bearing a psyllium seed husk health claim must also bear a label
statement concerning the need to consume them with adequate amounts of
fluids;
e.g., "Notice: This food should be eaten with at least a full glass of
liquid. Eating this product without enough liquid may cause choking.
Do not eat this product if you have difficulty in swallowing";
Model claim: Soluble fiber from foods such as [name of soluble fiber
source, and, if desired, name of food product], as part of a diet low
in saturated fat and cholesterol, may reduce the risk of heart
disease. A serving of [name of food product] supplies __ grams of the
[necessary daily dietary intake for the benefit] soluble fiber from
[name of soluble fiber source] necessary per day to have this effect.
Food/disease risk: Soy protein/coronary heart disease;
Claim requirements: Required terms:
* "Heart disease" or "coronary heart disease";
* "Soy protein";
* "Saturated fat" and "cholesterol";
Claim specifies daily dietary intake levels of soy protein associated
with reduced risk; Claim specifies amount of soy protein in a serving
of food;
Model claim: (1) Twenty-five grams of soy protein a day, as part of a
[diet] low in saturated fat and cholesterol, may reduce the risk of
heart disease. A serving of [name of food] supplies __ grams of soy
protein; (2) Diets low in saturated fat and cholesterol that include
25 grams of soy protein a day may reduce the risk of heart disease.
One serving of [name of food] provides __ grams of soy protein.
Food/disease risk: Plant sterol/stanol esters/coronary heart disease;
Claim requirements: Required terms:
* "May" or "might" reduce the risk of coronary heart disease;
* "Heart disease" or "coronary heart disease";
* "Plant sterol esters" or "plant stanol esters"; except "vegetable
oil" may replace the term "plant" if vegetable oil is the sole source
of the sterol/stanol ester;
Claim specifies plant sterol/stanol esters are part of a diet low in
saturated fat and cholesterol; Claim does not attribute any degree of
coronary heart disease risk reduction; Claim specifies the daily
dietary intake of plant sterol or stanol esters necessary to reduce
coronary heart disease risk, and the amount provided per serving;
Claim specifies that plant sterol or stanol esters should be consumed
with two different meals each a day;
Model claim: (1) Foods containing at least 0.65 grams per [serving] of
vegetable oil sterol esters, eaten twice a day with meals for a daily
total intake of least 1.3 grams, as part of a diet low in saturated
fat and cholesterol, may reduce the risk of heart disease. A serving
of [name of food] supplies __ grams of vegetable oil sterol esters;
(2) Diets low in saturated fat and cholesterol that include two
servings of foods that provide a daily total of at least 3.4 grams of
plant stanol esters in two meals may reduce the risk of heart disease.
A serving of [name of food] supplies __ grams of plant stanol esters.
Source: FDA.
[End of table]
Table 6: Five Health Claims Based on Authoritative Statements That May
Be Used on Food Labels:
Food/disease risk: Whole grain foods/reduced risk of heart disease and
certain cancers;
Food requirements: Contains 51 percent or more whole grain ingredients
by weight per referenced amount customarily consumed (RACC), and;
Dietary fiber content at least:
3.0 grams (g) per RACC of 55 g; 2.8 g per RACC of 50 g; 2.5 g per RACC
of 45 g; 1.7 g per RACC of 35 g; Low fat;
Required wording of health claim: Diets rich in whole grain foods and
other plant foods and low in total fat, saturated fat, and cholesterol
may reduce the risk of heart disease and some cancers.
Food/disease risk: Potassium/reduced risk of high blood pressure and
stroke;
Food requirements: Good source of potassium; Low sodium; Low total fat;
Low saturated fat; Low cholesterol;
Required wording of health claim: Diets containing foods that are a
good source of potassium and that are low in sodium may reduce the
risk of high blood pressure and stroke.
Food/disease risk: Fluoridated water/reduced risk of dental caries;
Food requirements: Bottled water meeting the standards of identity and
quality set forth in 21 CFR 165.110;
Meet all general requirements for health claims in 21 CFR 101.14) with
the exception of the minimum nutrient contribution (21 CFR
101.14(e)(6));
Total fluoride >0.6 to 1.0 mg/L;
Excluding bottled water products specifically marketed for use by
infants;
Required wording of health claim: Drinking fluoridated water may
reduce the risk of [dental caries, or tooth decay].
Food/disease risk: Saturated fat, cholesterol, and trans fat/reduced
risk of heart disease;
Food requirements: Low saturated fat; Low cholesterol; Bear
quantitative trans fat labeling; Contain less than 0.5 g trans fat per
RACC; Contain less than 6.5 g total fat;
Required wording of health claim: Diets low in saturated fat and
cholesterol, and as low as possible in trans fat, may reduce the risk
of heart disease.
Food/disease risk: Substitution of saturated fat with unsaturated
fatty acids/reduced risk of heart disease;
Food requirements: Vegetable oils, spreads, and shortenings that have
a total unsaturated fat content of 80 percent or more of total fat.;
Required wording of health claim: Replacing saturated fat with similar
amounts of unsaturated fats may reduce the risk of heart disease. To
achieve this benefit, total daily calories should not increase.
Source: FDA.
[End of section]
[End of table]
Appendix V: Warning Letters Issued for Claim Violations on Food Labels
and Web Sites, December 2009 through February 2010:
FDA launched an initiative to address claim violations in food
labeling in late 2009 and early 2010 in which it issued 17 warning
letters and an untitled letter informing companies that the claims on
their product labels and/or Web sites violated FDA's food labeling
statutes and regulations. Two of the 17 warning letters were for
qualified health claims violations and are summarized in table 4 of
this report. The remaining 15 warning letters and the untitled letter
are summarized in table 7.
Table 7: Other Warning Letters and the Untitled Letter FDA Issued for
Labeling Claim Violations, December 2009 through February. 2010:
Action: Warning letters:
Company (date of letter): Nestle USA (Dec. 4, 2009);
Product and/or product line: Juicy Juice Brain Development Fruit Juice
Beverage (Apple);
Violation(s): The product makes claims such as "no sugar added," which
are not allowed on products intended for children under 2 years of age
because appropriate dietary levels have not been established for
children in this age range.
Company (date of letter): Nestle USA (Dec. 4, 2009);
Product and/or product line: Juicy Juice All-Natural 100% Juice Orange
Tangerine; Juicy Juice All-Natural 100% Juice Grape;
Violation(s): The product labels imply that the products are 100
percent juice when they are actually juice blends with added flavors.
Company (date of letter): Nestle Nutrition (Feb. 22, 2010);
Product and/or product line: Gerber's 2nd Foods Carrots;
Violation(s): The product makes claims such as "healthy," "excellent
source of ... vitamin A," and "no added sugar," which are not allowed
on products intended for children under 2 years of age because
appropriate dietary levels have not been established for children in
this age range.
Company (date of letter): Nestle Nutrition (Feb. 22, 2010);
Product and/or product line: Gerber Graduates Fruit Puffs line;
Violation(s): The product makes claims such as "good source of iron,
zinc, and vitamin E," which are not allowed on products intended for
children under 2 years of age because appropriate dietary levels have
not been established for children in this age range.
Company (date of letter): Beech-nut Nutrition Corporation (Feb. 22,
2010);
Product and/or product line: Beechnut DHA Plus line of products;
Violation(s): The product makes claims on its Web site such as "no
added refined sugar" and "plus vitamins and minerals," which are not
allowed on products intended for children under 2 years of age because
appropriate dietary levels have not been established for children in
this age range.
Company (date of letter): Beech-nut Nutrition Corporation (Feb. 22,
2010);
Product and/or product line: Beechnut Whole Grain Oatmeal with mixed
fruit;
Violation(s): The product makes claims such as "low sodium," "plus
fiber," and "plus vitamins & minerals," which are not allowed on
products intended for children under 2 years of age because
appropriate dietary levels have not been established for children in
this age range.
Company (date of letter): Dreyers Grand Ice Cream, Inc. (Feb. 22,
2010);
Product and/or product line: Nestle Drumstick Classic Vanilla Fudge;
Violation(s): The front panel shows that the product has no trans fat,
but it does not have a disclosure statement to alert consumers that
the product has significant levels of saturated fat and total fat.
Company (date of letter): Dreyers Grand Ice Cream, Inc. (Feb. 22,
2010);
Product and/or product line: Dreyers Dibs Bite Sized Ice Cream Snacks
Vanilla Ice Cream with Nestle Crunch Coating;
Violation(s): The front panel shows that the product has no trans fat,
but it doesn't have a disclosure statement to alert consumers that the
product has significant levels of saturated fat and total fat.
Company (date of letter): First Juice, Inc. (Feb. 22, 2010);
Product and/or product line: Organic Fruit and Veggie Juice Beverage
products;
Violation(s): The product make claims such as "plus calcium," and "50%
less sugar," which are not allowed on products intended for children
under 2 years of age because appropriate dietary levels have not been
established for children in this age range.
Company (date of letter): First Juice, Inc. (Feb. 22, 2010);
Product and/or product line: Purple carrot products;
Violation(s): The products make claims that the products will "reduce
the risk of cancer and stroke," This claim has not been authorized by
FDA for use on food products.
Company (date of letter): Gorton's, Inc. (Feb. 22, 2010);
Product and/or product line: Gorton's Beer Battered Crispy Battered
Fish Fillets;
Violation(s): The front panel shows that the product has no trans fat,
but it does not have a disclosure statement to alert consumers that
the product has significant levels of sodium, saturated fat, and total
fat.
Company (date of letter): Guangzhou Yong Want Foods Ltd. (Feb. 22,
2010);
Product and/or product line: Baby Mum-Mum Original Selected Superior
Rice Rusks;
Violation(s): The product makes claims such as "low in fat," and "no
added fats for oils," which are not allowed on products intended for
children under 2 years of age because appropriate dietary levels have
not been established for children in this age range.
Company (date of letter): Ken's Foods, Inc. (Feb. 22, 2010);
Product and/or product line: Ken's Healthy Options™ Dressings Parmesan
& Peppercorn; Sweet Vidalia® Onion Vinaigrette; Raspberry Walnut;
Violation(s): The product makes claims such as "Healthy Options," but
has more fat than is allowed in products labeled as "healthy."
Company (date of letter): PBM Products, LLC (Feb. 22, 2010);
Product and/or product line: Parent's Choice Little Puffs Plus Calcium
Blueberry Naturally Flavored product; Parent's Choice Little Puffs
Made With Whole Grains Peach-Mango Naturally Flavored product;
Violation(s): The product makes claims such as "plus calcium," which
are not allowed on products intended for children under 2 yrs of age
because appropriate dietary levels have not been established for
children in this age range.
Company (date of letter): Pompeian, Inc. (Feb. 22, 2010);
Product and/or product line: Pompeian Imported Extra Light Olive Oil;
Violation(s): The product makes nutrient content claims such as “light,”
and "high in good monounsaturated fat," but does not meet the
requirement to make these claims.
Company (date of letter): Redco Foods, Inc. (Feb. 22, 2010);
Product and/or product line: Salada Naturally Decaffeinated Green Tea;
Violation(s): The product makes claims that it will treat, prevent, or
cure diseases such as Alzheimer's disease, rheumatism, and cancer.
These types of claims are not allowed on food products.
Company (date of letter): Redco Foods, Inc. (Feb. 22, 2010);
Product and/or product line: Salada Naturally Decaffeinated Green Tea;
Violation(s): The product makes claims on the product Web site that it
is effective in the prevention of cardiovascular disease, but this
claim has been not authorized for this product.
Company (date of letter): Redco Foods, Inc. (Feb. 22, 2010);
Product and/or product line: Salada Naturally Decaffeinated Green Tea;
Violation(s): The product makes claims such as “fortified with
antioxidants,” but the claim does not meet the requirements of the
antioxidant regulation.
Company (date of letter): Schwan’s Consumer Brands (Feb. 22, 2010)
Product and/or product line: Mrs. Smith's Classic Coconut Custard Pie;
Violation(s): The front panel shows that the product has no trans fat,
but it does not have a disclosure statement to alert consumers that
the product has significant levels of saturated fat and total fat.
Company (date of letter): Spectrum Organic Products, Inc.; (Feb. 22,
2010);
Product and/or product line: Organic All Vegetable Shortening;
Violation(s): The front panel shows that the product has no trans fat,
but it does not have a disclosure statement to alert consumers that
the product has significant levels of saturated fat and total fat. The
product makes nutrient content claims such as "cholesterol free,"
"less saturated fat than butter," and "good source of ...
monounsaturated fat" but does not meet the legal requirements to make
these claims.
Company (date of letter): Sunsweet Growers, Inc. (Feb. 22, 2010);
Product and/or product line: Antioxidant Blend Dried Fruit Mix;
Violation(s): The product makes claims such as "full of nutritious
antioxidants," but the claim does not meet the requirements of the
antioxidant regulation.
Company (date of letter): POM Wonderful (Feb. 23, 2010);
Product and/or product line: POM Wonderful 100% Pomegranate Juice;
Violation(s): The product makes claims that it will treat, prevent, or
cure diseases such as hypertension, diabetes, and cancer. These types
of claims are not allowed on food products.
Action: Untitled letter:
Company (date of letter): Nature's Path Foods, Inc. (Feb. 22, 2010);
Product and/or product line: Organic Flax Plus Multibran Cereal;
Violation(s): The product label includes the nutrient claim,
"excellent source of Omega-3+," which has not been approved for use on
food products.
Source: GAO analysis of FDA information.
[End of table]
[End of section]
Appendix VI: Comments from the Department of Health and Human Services:
Department Of Health And Human Services:
Office of the Assistant Secretary for Legislation
Washington, D.C. 20201:
December 23, 2010:
Lisa Shames:
Director, Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street NW:
Washington, DC 20548:
Dear Ms. Shames:
Attached are comments on the U.S. Government Accountability Office's
draft report entitled, "Food Labeling: FDA Needs to Reassess Its
Approach to Protecting Consumers from False or Misleading Claims" (GAO-
l1-102).
The Department appreciates the opportunity to review and comment on
this draft report prior to publication.
Sincerely,
Signed by:
Jim R. Esquea:
Assistant Secretary for Legislation:
Attachment:
[End of letter]
General Comments of the Department of Health and Human Services to the
Government Accountability Office's (GAO) Draft Report Entitled, "Food
Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers
from False or Misleading Claims" (GAO-11-102):
The Department appreciates the, opportunity to review and comment on
this draft report.
The Food and Drug Administration welcomes this GAO report as a means
of calling attention to the extremely complex and challenging legal
and regulatory environment under which FDA must work to protect
consumers from false and misleading label claims on foods,
particularly qualified health claims and structure/function claims. FDA
also welcomes this GAO report calling attention to the differences in
the legal authorities between FDA and the Federal Trade Commission
(FTC) that allow FTC to compel companies to provide the evidence
supporting their advertising claims.
In the past several years, FDA has:
* Issued two guidance documents addressing the appropriate use of
claims on food labels with one focusing on "sugar free" claims. These
guidances were in response to FDA's Obesity initiative;
* Issued Warning Letters to approximately 29 juice firms that had
unapproved health claims on their websites or product labels;
* Issued a Dear Manufacturer letter on Front of Package Labeling
reminding manufacturers of FDA requirements regarding claims;
* Continued to monitor the marketplace for false/misleading health and
nutrient content claims on food products in addition to monitoring
general false and misleading labeling statements;
* As a result of this monitoring, in March 2010, issued an open letter
to industry from FDA Commissioner Margaret Hamburg urging industry to
correct labeling violations; and;
* In February 2010 as a result of monitoring activities, issued 17
warning letters to companies for a variety of labeling violations,
including failure to incorporate mandatory disclaimer statements when
making nutrient content claims.
In each of the last 10 years, FDA has accomplished its work related to
health c1aims and qualified health claims by supporting an average 8.1
FTEs (at 1700 hours per FTE) per year at a cost of approximately $1
million per year.
GAO Recommendation:
To ensure that the health-related claims on food labels are not false
or misleading to consumers, we recommend that the Secretary of Health
and Human Services direct the Commissioner of FDA to take the
following three actions:
* Identify and request from Congress the authorities needed to access
evidence from food companies regarding potentially false or misleading
structure/function or other claims on food that would allow the agency
to reestablish whether there is scientific support for the claims.
FDA Response:
The agency would like to clarify the scope of its current statutory
authority with respect to health claims; nutrient content claims, and
structure/function claims.
FDA currently reviews the supporting scientific evidence for health
claims and for nutrient content claims. Specifically, for health
claims subject to section 403(r) of the Federal Food, Drug, and
Cosmetic Act (the Act), those who want to use a health claim in food
labeling must submit the evidence used to support the claim through the
Nutrition Labeling and Education Act (NLEA) petition process, or they
may notify the agency of the claim under the Food and Drug
Administration Modernization Act (FDAMA) authoritative statement
notification process. Under the petition process for health claims in
21 CFR 10l.70, a petitioner must submit a summary of scientific data
that provides the basis upon which an authorized health claim can be
justified. FDA also expects a company that wishes to make a qualified
health claim to submit its supportive evidence in a petition, as
described in the agency's 2003 guidance on interim procedures for
qualified health claims (see Appendix I, footnote 34). Similarly, for
nutrient content claims subject to section 403(r) of the Act, the data
and information that must be submitted to FDA in a petition are set
forth in-2l CFR 101.69.
By contrast, companies are currently able to make structure/function
claims in the labeling of food without submitting supporting evidence
to the FDA for review and without being required to provide such
evidence to the agency on request. The agency will work to determine
better approaches to enhancing its oversight of structure/function
claims, including whether additional statutory authorities are
needed.
* Provide guidance to industry on the type and strength of scientific
evidence needed to prevent false or misleading information from a
structure/function claim.
FDA Response:
FDA supports providing guidance to industry on the type and strength
of scientific evidence needed to substantiate a structure/function
claim on the label or in the labeling of conventional foods.
Currently, FDA has issued guidance for industry about substantiating
structure/function claims made on the label or in the labeling of
dietary supplements. As agency priorities and resources permit, FDA
will consider development of guidance for industry to substantiate
structure/function claims for conventional foods.
* Amend the Compliance Program Guidance Manual instructions to FDA
inspectors for reviewing food labels to include steps for identifying
potentially false or misleading structure/function claims during
inspections of food facilities.
FDA Response:
FDA agrees that field investigators, to whom the Compliance Program
Guidance Manual is targeted, have significant exposure to food labels
during their routine inspections of food producers. However, the GAO
recommendation is impractical, as there are significant challenges to
providing specific steps to investigators to identify potentially
false or misleading structure/function claims during inspections.
In particular, to judge whether a structure/function claim is false or
misleading requires in-depth knowledge of the science that would
support or dispute the claim. It would be impossible to provide
investigators with the breadth and level of knowledge necessary to
make an assessment in the field as to whether anyone of the myriad
structure/function claims they might encounter on food labels, with
all the variations in wording that are possible, is false or
misleading. While structure/function claims are not highlighted as an
area of emphasis, the Compliance Program Guidance Manual currently
includes instructions for inspectors to collect information to
determine the extent to which food-products are in compliance with all
labeling requirements and provides additional references regarding the
types of claims permitted on food labels.
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
Lisa Shames, (202) 512-3841 or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the individual named above, Erin Lansburgh, Assistant
Director; Bruce Skud, Analyst-in-Charge; Kevin Bray; Carol Henn; Luann
Moy; Beverly Peterson; and Carol Herrnstadt Shulman made key
contributions to this report.
[End of section]
Footnotes:
[1] In this report we use the word "allow" to describe FDA's assertion
to companies that the agency will consider exercising its discretion
to not take enforcement action against the company for making a
certain health claim so long as that claim is made in accordance with
criteria provided by FDA.
[2] GAO, Food Labeling: FDA Needs to Better Leverage Resources,
Improve Oversight, and Effectively Use Available Data to Help
Consumers Select Healthy Foods, [hyperlink,
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9,
2008).
[3] Consolidated Appropriations Act, 2008, Pub. L. No. 110-161 § 4,
121 Stat. 1844, 1846 (2007) (referencing explanatory statement at 153
Cong. Rec. H15742, H15765).
[4] Manufacturers of dietary supplements making structure/function
claims must notify FDA no later than 30 days after the first marketing
of the dietary supplement with such a claim statement.
[5] The Federal Food, Drug, and Cosmetic Act, as amended by the FDA
Food Safety Modernization Act on January 4, 2011, authorized FDA to
order a mandatory recall if it determines there is a reasonable
probability that an article of food is (1) adulterated or (2)
misbranded with regard to a major food allergen, and the use of or
exposure to the food will cause serious adverse health consequences or
death in humans or animals.
[6] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007).
[7] [hyperlink, http://www.gao.gov/products/GAO-08-597].
[8] Five of the 16 petitions were initially submitted as health claim
petitions under the significant scientific agreement standards but
were converted to qualified health claim petitions at the request of
the petitioners. All 16 petitions proposed claims for use on food
labels, although some were for use on both food and dietary supplement
labels.
[9] FDA noted in its comments that in each of the last 10 years, it
has accomplished its work related to health claims and qualified
health claims by supporting an average 8.1 FTEs (at 1,700 hours per
FTE) per year at a cost of approximately $1 million per year.
[10] According to the FLAPS study, FDA analyzed the 2005 AC Nielsen
Strategic Planner database to identify a sample of 3,000 U.S.
supermarkets with over $2 million in annual revenue, across all
geographic areas. Only products available in at least 2 percent of the
stores in the retail market were considered. The data can be
generalized to 80 to 85 percent (plus or minus 3 percent) of the
retail food sales.
[11] Paula Fitzgerald Bone and Karen Russo France, "Qualified Health
Claims on Package Labels," Journal of Public Policy & Marketing, Vol.
28 (2) Fall 2009, 253-258.
[12] The International Food Information Council is a nonprofit,
nonpartisan communications organization whose mission is to
effectively communicate science-based information about food safety
and nutrition to health professionals, government officials,
consumers, and others.
[13] Conrad J. Choinière and Linda Verrill, 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 (November 2009).
[14] Stanol esters are a group of chemical compounds that reduce low-
density lipoprotein (LDL) cholesterol. They are found naturally
occurring in small quantities in fruits, vegetables, nuts, seeds,
whole grain, legumes, and vegetable oils, and are added to certain
food for their health benefits.
[15] Wendy Reinhardt Kapsak, David Schmidt, Nancy M. Childs, John
Meunier, and Christy White; "Consumer Perceptions of Graded, Graphic
and Text Label Presentations for Qualified Health Claims," Critical
Reviews in Food Science and Nutrition (March 2008) vol. 48, issue 3.
[16] R. Dennis Murphy, FTC, Consumer Perceptions of Qualified Health
Claims in Advertising, Washington, DC (July 2005).
[17] Remarks of David Vladeck, Director, FTC Bureau of Consumer
Protection, before the National Advertising Division Annual
Conference, New York, N.Y., Oct. 5, 2009.
[18] Chung-Tung Jordin Lin, FDA "How Do Consumers Interpret Health
Messages on Food Labels?" Nutrition Today, Vol. 43., No. 6 (November/
December 2008).
[19] Neal Hooker and Ratapol Teratanavat, "Dissecting Qualified Health
Claims: Evidence From Experimental Studies," Critical Reviews in Food
Science and Nutrition, Vol. 48, Iss. 2 (February 2008).
[20] Paula Fitzgerald Bone and Karen Russo France, "Qualified Health
Claims on Package Labels," Journal of Public Policy & Marketing, Vol.
28 (2), Fall 2009, 253-258.
[21] FDA, Center for Food Safety and Applied Nutrition, Guidance for
Industry: Substantiation of Dietary Supplement Claims Made Under
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.
[22] FDA informed us that its data system for tracking warning letters
could not be searched for structure/function claims on food. FDA
officials were able to identify only the two letters discussed herein.
[23] FTC does not use the term "structure/function claim," but FDA
confirmed that the claim met its understanding of a structure/function
claim.
[24] GAO, Food Labeling: FDA Needs to Better Leverage Resources,
Improve Oversight, and Effectively Use Available Data to Help
Consumers Select Healthy Foods, [hyperlink,
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9,
2008).
[25] Pub. L. No. 101-535, 104 Stat. 2353.
[26] 21 U.S.C. §§ 301-399a.
[27] In addition, a claim may be authorized if a relevant scientific
body of the federal 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.
[28] 56 Fed. Reg. 60,537, Nov. 27, 1991.
[29] Dietary Supplement Act of 1992, Pub. L. No. 102-571, tit. II §
202, 106 Stat. 4500.
[30] 58 Fed. Reg. 2478, Jan. 6, 1993.
[31] 59 Fed. Reg. 395, Jan. 4, 1994.
[32] 164 F.3d 650 (D.C. Cir. 1999).
[33] 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.
[34] 65 Fed. Reg. 59,855, Oct. 6, 2000.
[35] 67 Fed. Reg. 78,002, Dec. 20, 2002.
[36] 68 Fed. Reg. 41,387, July 11, 2003.
[37] Whitaker v. Thompson, 248 F. Supp. 2d 1 (D.D.C. 2002). See also
Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001).
[38] 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).
[39] 68 Fed. Reg. 66,040, Nov. 25, 2003.
[40] FDA, Center for Food Safety and Applied Nutrition, Guidance for
Industry: Evidence-Based Review System for the Scientific Evaluation
of Health Claims (January 2009).
[41] FDA, Center for Food Safety and Applied Nutrition, Guidance for
Industry and FDA: Interim Evidence-Based Ranking System for Scientific
Data (July 10, 2003).
[42] Alliance for Natural Health US v. Sebelius, 714 F. Supp. 2d 48
(D.D.C. 2010).
[43] 714 F. Supp. 2d at 58.
[44] The court directed FDA reevaluate one of the claims and draft one
or more disclaimers. For the remaining three denied claims, the court
directed FDA to either draft disclaimers to accompany the
manufacturer's claims, or set forth the empirical evidence that any
disclaimer would fail to correct the claims' purported misleading
effects. 714 F. Supp. 2d at 72.
[45] 714 F. Supp. 2d at 71 (quoting Pearson v. Shalala).
[46] Pub. L.105-115 § 303, 111 Stat. 2296.
[End of section]
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