Dietary supplements are regulated by the FDA as foods, not as drugs. Drugs must be approved by the FDA before they can be sold or marketed, while supplements do not require this approval. Supplement companies are responsible for having proof that their products are safe and that the claims on the label are truthful and not misleading. As long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), the company does not have to provide safety tests to the FDA before the product is marketed.
The Food Safety and Inspection Service (FSIS), a USDA agency, issues policy guidelines, nutrition labels and memos on food products (USDA, food labeling). The FDA regulates more than 80% of the U. S. food supply, including dairy products, seafood, processed and packaged foods, and even bottled water.
The USDA is also responsible for the agencies responsible for the United States dietary guidelines and for the benefits of the Supplemental Nutrition Assistance Program (SNAP). The Department of Agriculture (USDA) recently declared that vitamins and minerals can still be added to organic products while they clarify what additional nutrients can be added to organic products. The FDA is the federal agency that oversees both supplements and drugs, but their regulations for dietary supplements are different from those for prescription or over-the-counter drugs. This interim measure allows vitamins and minerals, including vitamins A and D, folic acid or calcium, to organic foods after October 21. Manufacturers and distributors of dietary supplements and dietary ingredients are responsible for evaluating the safety and labeling of their products before they are marketed to ensure that they meet all regulatory requirements.
The FDA regulates dietary supplements under a different set of regulations than those that cover conventional foods and medications.
