GAO Suggests that FDA Shift Gears Regarding Health Claims in Food Labeling

Jan 28, 2011   

The GAO, an independent agency that investigates the efficacy of federal programs for Congress, recently issued a report recommending that the FDA reform the way it handles claims made in food labeling. This report comes as a result of a performance audit that the GAO conducted throughout 2010 where the FDAs oversight of qualified health claims and structure/function claims was evaluated.

While health claims are those that characterize the relationship between a food or food component and a health-related condition, “qualified health claims” have an added limitation. In a qualified health claim, the relationship between the consumption of a food and a health-related condition is limited by providing a statement in labeling that qualifies the amount of scientific support backing the claim. In contrast, structure/function claims are those that describe the relationship between a food or food component and its effect on a structure or function of the body.

The key issue that the FDA must consider regarding both of these types of claims is whether food manufacturers possess a level of scientific support to make these claims. The FDA is tasked with overseeing and enforcing federal food labeling requirements, which prohibits the use of false or misleading claims in food labeling. However, in the area of health-related claims, the FDA is not the only agency tasked with enforcing federal requirements. The Federal Trade Commission (FTC) is responsible for enforcing federal laws that prohibit deceptive acts and practices. The FTC shares jurisdiction with the FDA in the area of health-related claims, and where the FDA focuses mainly on food labeling, the FTCs focus is on food advertising.

Although the FDA also targets food manufacturers for making improper claims in advertising, a key distinction between the FDA and FTC is that the latter possesses subpoena power. While the FTC can require companies to turn over relevant evidence concerning the scientific support substantiating its claims, the FDA has no such power. This distinction is highlighted in the GAOs report and according to the GAO, may be a critical factor limiting the efficacy of the FDAs oversight of health-related claims in food labeling. Because of this limited ability to force companies to turn over documents in support of their claims, the GAO concluded its study with a recommendation that the FDA to seek guidance from Congress regarding what authority could be used to require companies to provide scientific evidence of health-related claims.

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