What does the statement mean: “These statements have not been evaluated by the FDA?” What is FDA approval and are True Source products required to be FDA approved?
The 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), dietary supplement manufacturers are responsible for ensuring that a dietary supplement is safe before it is marketed. The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, dietary supplement manufacturers are not required to register their products with the FDA or 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 d
