Dietary supplement safety should be of primary concern to consumers. Because they are assumed to be safe unless proven otherwise, dietary supplements present special safety challenges. In 2000 the FDA received 500 dietary supplement adverse event reports; that number rose to 553 in 2001 and to 1214 in 2002. Adverse events caused by dietary supplements [...]
Supplements are now being performed by the Office of Nutritional Products, Labeling, and Dietary Supplements’ Division of Dietary Supplement Programs, which comprises a regulations and review team, a compliance and enforcement team, and a clinical review team. Led by Dr. Susan Walker, the division creates policies, regulations, and guidance documents to ensure the safe manufacture [...]
The DSHEA gave the FDA the authority to establish special good manufacturing practices for dietary supplements. In March 2003 the FDA released its “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices,” which addresses important components of dietary supplement manufacture, including design and construction of manufacturing facilities, quality-control procedures, testing of the final product(s) or [...]
Manufacturers of dietary supplements often seek to promote their product by providing supporting material such as a scientific study or the statement of a medical or nutrition professional. Under certain conditions, this additional material is not considered to be “labeling,” per se, and is therefore not regulated in the same fashion. If the manufacturer uses [...]
The use of health claims on food products is regulated by the Nutrition Labeling Education Act of 1990. Health claims describe the relationship between a specific nutrient and a disease or condition. In order to appear on the food or dietary supplement label, health claims must be evaluated and preapproved by the FDA based on [...]
Labels must include the word supplement and identify the product as a dietary supplement. The required information on dietary supplement labels includes the name and quantity of each nutrient and dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (except inert ingredients) in the blend. Since 1997 all supplements must bear [...]
