Congress directed the U.S. Government Accountability Office (GAO) to study FDA’s implementation of qualified health claims for food.
By statute, health claims on food labels must have significant scientific agreement, but in 2002, in response to a court decision, the U.S. Food and Drug Administration (FDA) decided to allow qualified health claims with less scientific support. Congress directed the U.S. Government Accountability Office (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—those claims referring to a food’s effect on body structure or function. The GAO reviewed FDA documents and consumer studies and interviewed stakeholders from health, medical, industry, and consumer groups.
Research has 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. The 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. However, 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.
The GAO concluded that even if the FDA were to provide such guidance, structure/function claims pose a serious oversight dilemma for the agency. That is because the 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. The 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.
GAO recommends the 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 report (pdf)