Javelin Worldwide

Short answer: No. Nor are One-A-Day vitamins or most any other nutritional supplement sold over the counter, through Direct Selling or in health food stores or GNC (or anywhere else for that matter).

Below is the statement from the FDA's website (which you may want to review for your own research and education regarding dietary supplements. Go to: http://vm.cfsan.fda.gov/~dms/supplmnt.html%20.

"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."