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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 1˝ 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. Choiničre 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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