FDA HUMAN DRUG REVIEW AND APPROVAL BASICS MODULE

Although FDA regulates dietary supplements, these products are not regulated as drugs by CDER. Dietary supplements are compounds that do not make health claims regarding the treatment of a specific disease or condition and are therefore regulated by FDA as foods. FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and prescription and OTC drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed.