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The Dietary Supplement Health and Education Act of 1994 mandated that the FDA regulate dietary supplements as foods, rather than as drugs. Consequently, dietary supplements are defined as a kind of food under the statute, [ 39 ] with the caveat that this does not exempt them from being treated as drugs in the way that other foods are exempted ...
The FDA can only ban a supplement if the FDA finds proof that the supplement is dangerous. This means that unsafe or ineffective supplements can be sold freely, while the FDA has only a limited capacity to monitor adverse reactions from supplements. [19] [20] David Kessler, commissioner of the FDA when DSHEA was approved, has stated that
The Center for Food Safety and Applied Nutrition (CFSAN (/ ˈ s ɪ f ˌ s æ n / SIF-san)) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics, as opposed to drugs, biologics, medical devices, and radiological products, which also fall under the purview of the FDA.
Dietary supplements sold in the U.S. aren’t approved by the FDA nor are they reviewed by the agency for their safety and effectiveness. The FDA's "tools are extremely limited," Cohen said.
Northwell Health partnered with Stacker to explain how the FDA regulates drugs and dietary supplements differently, and how to find safe and effective supplements.
FDA-approved drugs cannot be ingredients in dietary supplements. Supplement products are or contain vitamins, nutritionally essential minerals, amino acids, essential fatty acids and non-nutrient substances extracted from plants or animals or fungi or bacteria, or in the instance of probiotics, are live bacteria.