Final answer:
The FDA regulates dietary supplements by ensuring quality and monitoring labeling claims, while manufacturers are responsible for the safety of their products and compliance with Good Manufacturing Standards. Dietary supplements are treated like food, not drugs, and manufacturers can make certain health claims with a disclaimer. Post-1994 DSHEA, the FDA's role is more reactive, removing unsafe products rather than approving them pre-market.
Step-by-step explanation:
FDA Role vs. Manufacturer Responsibility in Dietary Supplement Regulation
The U.S. Food and Drug Administration (FDA) plays a key role in regulating dietary supplements in the United States. Under the Federal Food, Drug, and Cosmetic Act, the FDA is responsible for ensuring the quality of food products, including dietary supplements, and monitoring the claims made on product labels regarding their composition and health benefits. Unlike pharmaceuticals, dietary supplements are treated more like food, which means they must adhere to Good Manufacturing Standards but are not subject to the same stringent testing and approval process that drugs undergo. Manufacturers have the responsibility to ensure the safety of supplements prior to marketing them, and they can make certain health claims about their products; however, these claims must be accompanied by a disclaimer stating that the FDA has not evaluated the claims and the products are not intended to "diagnose, treat, cure, or prevent any disease".
Since the enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the onus of ensuring the safety of dietary supplements has shifted largely to the manufacturers. They are no longer required to obtain FDA approval before marketing their products, unless a new dietary ingredient is introduced. Post-marketing, the FDA can take action to remove products from the market if they are found to be hazardous. This regulatory approach contrasts with the regulation of medicines, where the FDA is heavily involved in the pre-market testing and approval process to ensure drug safety and efficacy.