GAO Says FDA Needs New Authority to Protect Consumers from Misleading Food Claims
The Government Accountability Office determined in a report to Congress that the Food and Drug Administration needs to reassess its approach and obtain new authority to better protect consumers from false or misleading claims on food labels.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
“Qualified” Health Claims Have Been Minimally Used
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.
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 Being Used Instead, These Can’t be False or Misleading
FDA data indicate that instead, companies are now more widely using structure/function claims to convey their foods’ health benefits. These claims refer to a food’s effect on body structure or function, and are subject to the general statutory requirement that such labeling not be false or misleading.
FDA Has Not Issued Guidance on the Scientific Support Needed for S/F Claims
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. In addition, FDA has not 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.
FDA Also Lacks Authority to Compel Firms to Submit Evidence on S/F Claims
The GAO states that even if FDA were to provide such guidance, structure/function claims pose a serious oversight dilemma for the agency. This is because the FDA has no express legal authority to require companies to submit relevant evidence as part of an investigation of whether their claims are substantiated. Instead, the burden falls on FDA to prove that a structure/function or other type of claim is false or misleading.
GAO Recommends FDA Request Needed Authority, Give Guidance to Inspectors
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 Says It Will Work to Enhance Oversight of S/F Claims, Consider if More Authority Needed
According to GAO, FDA generally agreed with its recommendations and said it would work to determine better approaches to enhancing its oversight of structure/function claims, including whether additional statutory authorities are needed.
(GAO-11-102, dated January 2011)