The Dietary Supplements Health and Education Act (DSHEA) of 1994 was a major milestone for the supplement industry. It modified the Federal Food, Drug, and Cosmetic Act (FDCA) and became the basis for the regulation of dietary supplements. The DSHEA established special procedures for statements of structure and function of dietary supplements, as well as pre-marketing safety notifications for products containing new dietary ingredients (NDIs).The FDA can take action against a manufacturer or distributor if a supplement is found to be unsafe once it is on the market. Products that contain substances similar to those found in prescription drugs are marketed to children as dietary supplements.
The DSHEA also prohibits the FDA from limiting the potency of ingredients in vitamin and mineral products that are not “inherently dangerous” and prevents the agency from removing “useless” ingredients from dietary supplements. Good manufacturing practices (GMPs) are essential for ensuring the safety of dietary supplements. These regulations help ensure the safety of the food supply by banning misleading claims, standardizing supplement concentrations, and regulating doses greater than one and a half times the recommended dietary amounts (RDA) as “over-the-counter drugs”. Companies that manufacture and supply only dietary ingredients are exempt from 21 CFR Part 111. Glycosaminoglycans are naturally produced by the human body, but can also be supplemented by diet. The FDA does not require that supplement labels be accurate, so it is important to do your research before taking any supplement.
The Proxmire Amendment prohibits the FDA from limiting the potency of ingredients in vitamin and mineral products that are not “inherently dangerous”.The supplement industry has organized to ensure that consumers are aware of “medicinal uses” that are not on product labels. To ensure the safety and effectiveness of dietary supplements, it is important to persuade Congress to change the law. The DSHEA of 1994 was a major step forward in regulating dietary supplements. It established special procedures for statements of structure and function, pre-marketing safety notifications for NDIs, and GMPs for ensuring safety. It also prohibited the FDA from limiting potency of certain ingredients and prevented them from removing “useless” ingredients from dietary supplements.
Consumers should be aware of potential medicinal uses that may not be on product labels, and should always do their research before taking any supplement.