The Government Accountability Office (GAO) issued a report concluding that the Food and Drug Administration needs to reassess its approach to protecting consumers from false or misleading claims, suggesting that the agency seek legal authority to make companies provide scientific support for their health claims and provide guidance to the industry on the necessary evidence to support such claims.
The report was based on a review of FDA documents and consumer studies, as well as interviews of stakeholders from the health, medical, industry, and consumer groups at the request of Congress.
In the eight years since the FDA has allowed qualified health claims on food labels, the agency has received 16 petitions from companies proposing 60 claims on food labels, according to the report, and allowed the use of 12 of those claims. The FDA also issued two warning letters to food companies that it alleged cited health benefits which were not in the allowed qualified health claims or supported by scientific evidence.
The GAO said its research showed that consumers have difficulty distinguishing between different types of claims on food labels – like health claims, qualified health claims, and structure/function claims – and struggle to understand the differences in levels of scientific support. The report also indicated that companies are increasingly relying on structure/function claims to convey health benefits, as such claims are only subject to general statutory requirements that the labels are not false or misleading, and do not require scientific support like health claims.
Regulation of such claims poses a serious dilemma for the FDA, the report said. The FDA has not issued guidance on the scientific support needed to make structure/function claims or provided its inspectors with instructions about how to handle such claims, and it lacks the power to compel companies to turn over substantiation documents.
Calling the FDA’s efforts to protect consumers from false or misleading claims “a complex and challenging legal and regulatory environment,” the report concluded that the FDA should seek express legal authority to establish the power to require companies to provide substantiation.
“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,” according to the report.
To read the GAO’s report, “FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims,” click here.
Why it matters: The GAO’s suggestions would increase the FDA’s power and make it similar to that of the Federal Trade Commission, which can require companies to submit any relevant evidence as part of an investigation of whether claims are substantiated. The GAO report explored the possibility of having the FTC take enforcement actions against companies for alleged false structure/function claims on food labels and advertisements, but concluded that it would be simpler for the FDA to seek greater legal authority and maintain its responsibility for health claims.