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.
