FDA Needs Authority To See Evidence on Structure/Function Claims, Says GAO

January 14, 2011

WASHINGTON—A report today from the Government Accountability Office says the FDA needs more authority from Congress to help police potentially misleading claims on food labels. Specifically, GAO says FDA should be able to see food companies’ evidence for so-called structure/function claims—the increasingly familiar claims that a given product affects the structure or function of the body. Those claims typically take the form that a food with calcium, say, “builds strong bones.” But according to the Center for Science in the Public Interest, structure/function claims are often unsubstantiated, or worse, illegally imply the food will prevent or treat a disease.

“If a company wants to claim a food will ‘maintain healthy joints’ or ‘support healthy eyes,’ the FDA should at least be able to see the company’s evidence for that, and if there is weak evidence the claim should not be allowed,” said CSPI senior regulatory counsel Ilene Ringel Heller. “Claims that a sugary drink, a yogurt, or a cereal provides ‘immunity’ to some unspecified disease would not and should not survive that kind of scrutiny.”

The GAO also called on the FDA to issue guidance to industry spelling out the type and strength of the scientific evidence needed to prevent false or misleading structure/function claims. CSPI says that for conventional foods, Congress should also give the FDA authority to disallow structure/function claims that are not backed by significant scientific agreement.


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