GMA/FDA CLASH OVER SUPPLEMENTS.
Recent regulatory actions have put dietary supplements Noun 1. dietary supplement - something added to complete a diet or to make up for a dietary deficiency
diet - a prescribed selection of foods
vitamin pill - a pill containing one or more vitamins; taken as a dietary supplement in the spotlight. The Grocery Manufacturers of America (GMA GMA
glycol methacrylate. ) is asking the Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) to reconsider the latest dietary supplement labeling ruling that prevents the use of implied disease claims. While supportive of the FDA's narrower definition of "disease" as reflected in the final rule on structure/function claims, GMA believes that the effect on its members as a result of the final regulation is tantamount tan·ta·mount
Equivalent in effect or value: a request tantamount to a demand.
[From obsolete tantamount, an equivalent, from Anglo-Norman to a ban on their commercial speech, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. association statements.
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 Dietary Supplement Health and Education Act of 1994 (US legislation) ). "DSHEA was intended to limit FDA authority to restrict dietary supplement manufacturers from disseminating dis·sem·i·nate
v. dis·sem·i·nat·ed, dis·sem·i·nat·ing, dis·sem·i·nates
1. To scatter widely, as in sowing seed.
2. 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 relating to relate prep → concernant
relating to relate prep → bezüglich +gen, mit Bezug auf +acc 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."