Dietary Supplements

Dietary Supplements

FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

FDA’s post-marketing responsibilities include monitoring safety, e.g. dietary supplement serious adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to follow the cGMP rule of 111 of the CFR.

 

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