As a result of its study of the FDA's implementation of qualified health claims for food , the U.S. Government Accountability Office (GAO) is calling for more authority for the FDA from Congress to help police potentially misleading claims on food labels. The study, which was directed by Congress, examines the results of FDA's efforts to allow the use of qualified health claims and oversight of these claims; consumers' understanding of the claims; and the FDA's oversight of structure/function claims. As part of the study, the Congressional Watchdog also reviewed FDA documents and consumer studies and interviewed stakeholders from health, medical, industry, and consumer groups.
The GAO’s research shows 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. The study also found 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.
The study notes that FDA data indicates 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, the Congressional Watchdog notes that the 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, and even if FDA were to provide such guidance, structure/function claims pose a serious oversight dilemma for the agency.
The report states the FDA’s efforts are hampered by lack of access to the evidence that a company relies on to make such a claim. This 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. FTC officials told the GAO 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.
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.
The three recommendations for executive action are:
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.
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.
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.
The full report can be downloaded from the Congressional Watchdog’s website.
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