The Federal Food, Drug and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (DSHEA), which defined the “dietary supplement” and established the authority of the FDA with respect to such products. Advertising and other promotional material sent by mail are also subject to regulation by the U. S. Last year, the FDA and the Federal Trade Commission (FTC) sent more than 100 joint warning letters to supplement producers for selling products with fraudulent claims to treat or prevent COVID-19. Since dietary supplements are regulated as foods, they are subject to different regulatory requirements compared to over-the-counter drugs or other medications.
Before DSHEA, the FDA instituted measures in the early 1990s against many popular dietary supplement ingredients, enforcing food additive regulations and claiming they were unapproved food additives. As requested by the FDA, this report focuses on evaluating the inherent safety of an ingredient in a dietary supplement in the absence of contamination. Products intended to treat Alzheimer's disease must obtain FDA approval before being sold to ensure they are safe and effective for their intended medical use. The FDA's role in regulating dietary supplements includes (among other things) inspecting manufacturing facilities, reviewing notifications of new dietary ingredients (NDI) and other regulatory requests on dietary supplements, investigating complaints, monitoring the market, examining supplements and dietary ingredients offered for import to determine if they meet mandatory inclusion requirements, and providing significant benefits by improving market transparency and promoting risk-based regulation.
With DSHEA approval, the burden of proof regarding safety of dietary supplements fell on the FDA by requiring them to determine that an ingredient in a dietary supplement presents a “significant or unreasonable risk of illness or injury” (see Box 1), rather than requiring manufacturers to provide data that supports its safety, as is done with food additives (21) C. Two key issues that need to be addressed are the FDA's inability to know which supplements are on the market and its inability to require recall of supplemental products containing pharmaceutical ingredients. Because dietary supplements, like foods, can be contaminated with foreign toxic substances, the FDA must consider more than just the “inherent safety” of specific ingredients in dietary supplements to properly assess potential public health risks. That's why I recently led the creation of a working group on dietary supplements at the FDA, led from my office and comprised of representatives from various centers and offices across the agency.
The FDA's focus on regulating labeling claims it considered unapproved and indicative of a drug's status was closely followed by an increased use of publications such as self-help books and journal articles that explained these claims and intended uses. The FDA plays an important role in regulating dietary supplements, ensuring that they are safe for consumers and that manufacturers do not make false or misleading claims about their products. The agency is responsible for inspecting manufacturing facilities, reviewing notifications of new dietary ingredients (NDI) and other regulatory requests on dietary supplements, investigating complaints, monitoring the market, examining supplements offered for import to determine if they meet mandatory inclusion requirements, and issuing warnings when necessary. The agency also works with other organizations such as the Federal Trade Commission (FTC) to ensure that consumers are not misled by fraudulent claims about products. The FDA has taken steps to improve its oversight of dietary supplements, including creating a working group on dietary supplements at the agency led from my office. This working group is comprised of representatives from various centers and offices across the agency who are focused on evaluating potential public health risks associated with these products.
The agency is also working with other organizations such as the FTC to ensure that consumers are not misled by fraudulent claims about products. In conclusion, it is clear that the FDA plays an important role in regulating dietary supplements. The agency is responsible for ensuring that these products are safe for consumers and that manufacturers do not make false or misleading claims about their products. The agency is also working with other organizations such as the FTC to ensure that consumers are not misled by fraudulent claims about products.