When it comes to dietary supplements, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the agency's oversight. These products are regulated by the FDA as foods, not as drugs. However, many dietary supplements contain ingredients that can interact with medications or medical conditions, and some are falsely marketed as dietary supplements, putting consumers at risk. For this reason, it's important to consult with a health professional before using any dietary supplement.
In 1973, the FDA appointed an expert advisory panel to explore over-the-counter vitamins as part of the agency's comprehensive review of over-the-counter drugs. Thanks to the efforts of manufacturers, the 1973 regulations were annulled and re-proposed in 1975.Senator William Proxmire (Democrat from Wisconsin) became a champion of the supplement industry during this time. Today, many supplements are marketed without being proven to work as claimed, leading the FDA or FTC to update them after they have been distributed. Consumers are often misled into believing that supplements and medications are equally effective alternatives, since supplements are cheaper and more natural with fewer side effects.
Scientific validation should only be kept archived for statements about structure and function, which state that a supplement maintains, supports, stimulates, regulates, or promotes the proper functioning of the body. Despite extensive research on dietary supplements, public health has paid little attention to the challenges posed by their regulation. The FDA recognized the medical dangers of these claims but could only act against manufacturers and sellers on a case-by-case basis under outdated and incomplete regulations from 1941. The FDA still oversees some of the manufacturing processes and tries to control misleading claims, but it doesn't have enough reach to ensure that all manufacturers comply with regulations. Before 1994, dietary supplements were subject to the same regulatory requirements as FDA foods.
Pharmaceutical products must go through rigorous testing and allocate a large part of their budget to obtain FDA approval and go to market; producing a supplement involves a much smaller investment.
