Are dietary supplements regulated by the FDA?
Dietary supplements differ from pharmaceuticals in the fact that dietary supplements are governed by the Dietary Supplement Safety and Education Act (DSHEA) of 1994. The DSHEA defines dietary supplements as “a product taken by mouth that contains a dietary ingredient intended to supplement the diet”. Basically, the DSHEA is a legislative act which makes the manufacturer of a dietary supplement responsible for making certain that the supplement is safe before they begin marketing the supplement. The FDA (Food and Drug Administration) does not become involved with the dietary supplement product until the product is being marketed and sold at which point the FDA is responsible for regulating the product only if the supplement is deemed to be unsafe to the public. Dietary supplements versus pharmaceuticals Unlike dietary supplements, pharmaceuticals are required to undergo extensive testing pertaining not only to the safety of the pharmaceutical but also to the efficacy of the product. In
Dietary supplements are regulated, although not in the way prescription or over-the-counter drugs are. Because dietary supplements are foods, and not drugs, the Food and Drug Administration (FDA) has the power to ensure that products on the market are both safe and accurately labeled. Substantiation of label claims should be on file at the marketer’s offices. Dietary Supplements should not claim to cure, treat or prevent illness.
Dietary supplements are regulated, although not in the way prescription or over-the-counter drugs are. Because dietary supplements are foods, and not drugs, the Food and Drug Administration (FDA) has the power to ensure that products on the market are both safe and accurately labeled. Before a product can be sold, a manufacturer must first notify the FDA of all intended label claims and ensure that they can be substantiated.
