GAO Recommends that FDA Tighten its Grip on Structure/Function Claims in Food Labeling

January 23, 2011

By Ricardo Carvajal

The Government Accountability Office ("GAO") issued a report recommending in part that FDA “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.”  As acknowledged by FDA, the agency currently lacks “express legal authority to compel” a company to provide such evidence.  In its response to the report, FDA indicated that it will consider “whether additional statutory authorities are needed."

In recommending that FDA seek additional authority, GAO noted that the Federal Trade Commission ("FTC") already has authority to compel production of evidentiary documents during its investigations, and that FTC could not have taken its recent actions on certain claims in food advertising without that authority.  GAO also noted that the European Union has adopted premarket review of similar claims, and that 85% of such claims have been rejected due to a lack of scientific support.  Similarly, Canada has initiated review of structure/function claims, most of which have been rejected – including some claims used in labels of food marketed in the U.S.

In preparing and issuing its report, GAO was responding to a Congressional directive to study FDA’s implementation of qualified health claims.  The report provides no recommendations with respect to FDA’s oversight of those claims.