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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services To ensure that the health-related claims on food labels are not false or misleading to consumers, the Secretary of Health and Human Services should direct the Commissioner of FDA 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.
Closed - Not Implemented
In 2013, FDA officials responded that because of competing priorities and reduced resources, FDA has no plans to seek additional authorities from Congress to access evidence from food companies regarding scientific data to support structure/function claims. FDA's foods program is focused on implementing the new authorities and requirements of the Food Safety Modernization Act of 2011. In 2014, FDA stated again that it will not implement this recommendation.
Department of Health and Human Services To ensure that the health-related claims on food labels are not false or misleading to consumers, the Secretary of Health and Human Services should direct the Commissioner of FDA 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.
Closed - Not Implemented
In 2014, FDA officials stated that, as resources and priorities permit, FDA will explore development of guidance for structure-function claims on food. In July 2015, FDA responded that the agency continues to work through important issues in developing guidance to industry on the type and strength of scientific evidence needed to substantiate structure/function claims on infant formulas. FDA remains committed to publishing this guidance. As resources and priorities permit, FDA will explore development of additional guidance for structure/function claims on other conventional foods.
Department of Health and Human Services To ensure that the health-related claims on food labels are not false or misleading to consumers, the Secretary of Health and Human Services should direct the Commissioner of FDA to 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.
Closed - Not Implemented
FDA officials stated in 2013 that they will not implement this recommendation because they believe it would be impossible to provide investigators with the knowledge they need to assess whether or not structure/function claims are false or misleading. However, GAO did not recommend that inspectors make these assessments, but that instructions be updated so that inspectors could identify potentially false or misleading claims that need further review by others. As of May 27, 2014, FDA maintains that they will not implement this recommendation.

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