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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
Following the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a "special category under the general umbrella of 'foods,'" according to the FDA.
In the same year, the European Food Safety Authority also approved a dietary supplement health claim for calcium and vitamin D and the reduction of the risk of osteoporotic fractures by reducing bone loss. [17] The U.S. FDA also approved Qualified Health Claims (QHCs) for various health conditions for calcium, selenium and chromium picolinate. [18]
Supplements aren’t regulated by the U.S. Food and Drug Administration the way medications are; they’re considered a subcategory of food, not drugs, so anything the manufacturer feels is safe ...
"Treating vitamin D deficiency may result in improvement of RLS symptoms, but more research is needed," she said. ... (Mirapex) are approved by the FDA for the treatment of moderate to severe RLS ...