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Like other food substances, dietary supplements are not subject to the safety and efficacy testing requirements imposed on drugs, and unlike drugs they do not require prior approval by the FDA; [40] however, they are subject to the FDA regulations regarding adulteration and misbranding. The FDA can take action against dietary supplements only ...
The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace.
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.
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 don’t require approval from the Food and Drug Administration before being sold to customers, though the agency mandates that companies that manufacture, package, label or ...
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.
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