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.
voluntary dietary supplement 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 register their facility with the
FDA. For more information, see
Registration of Food Facilities.