GMA/FDA CLASH OVER SUPPLEMENTS.
If the ruling holds, a product cannot claim, for example, that it "lowers cholesterol," because high blood cholesterol is associated with coronary disease. GMA has asked the federal agency to reconsider this portion of the ruling. "Indirect implied disease claims--that relate to risk factors for a disease, but that do not involve a direct manifestation of the disease itself--are proper structure/function claims for dietary supplements and also for conventional foods," says Stacey Zawel, GMA's vice president, scientific and regulatory policy. "Thus, 'lowers cholesterol' is an appropriate structure/function claim because elevated serum cholesterol is neither a disease nor a direct manifestation of a disease. A person with elevated cholesterol will not necessarily have heart disease. It is precisely in this area--dietary management of risk factors--that dietary supplements and conventional foods can make a major contribution to public health."
GMA believes that FDA is exceeding its legal authority in excluding nearly all implied disease claims and placing them on the same level as explicit disease claims (e.g., prevents or treats a disease). "FDA does not have the authority to expand its own jurisdiction," says Zawel, referring to limits placed on FDA by Congress in the Dietary Supplement Health and Education Act of 1994 (DSHEA). "DSHEA was intended to limit FDA authority to restrict dietary supplement manufacturers from disseminating truthful and non-misleading speech about the health benefits of their products. Congress expressly recognized that structure/function claims can indirectly imply a use in the prevention of disease and intended to permit dietary supplement manufacturers to make claims relating to disease prevention, so long as manufacturers did not directly claim or imply disease prevention or treatment. FDA should regulate structure/function claims by differentiating between two subcategories of implied disease claims--claims that di rectly imply a disease and claims that only indirectly imply the treatment or prevention of disease."
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|Date:||May 1, 2000|
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