While the Food and Drug Administration does have some authority regarding dietary supplements, the agency's purview is limited to post-market action. The Dietary Supplement Health and Education Act of 1994 says that the manufacturer is responsible for ensuring that the product is safe and the product label is truthful and not misleading. Manufacturers do not need to register their products with FDA nor get FDA approval, unlike over-the-counter and prescription drugs. FDA monitors voluntary adverse event reporting, labeling and claims, and can take action against any unsafe dietary supplement after it reaches the market. (The FTC deals with supplement advertising.)
Illinois Democratic Senator Dick Durbin said in a release today that there are 29,000 varieties of dietary supplements on the market today, with 1,000 new products introduced each year. "Many of these products are safe; I take my vitamins every day. The problem is that some supplements contain concetrated extracts of herbs and botanicals mixed with other ingredients that can be harmful."
FDA banned gamma hydroxybutyric acid (GHB, also known as the "date rape" drug) in 1990, but manufacturers found a way to circumvent the ban by using chemically similar cousins gamma butyrolactone and 1,4-butanediol. And remember ephedrine? The traditional Chinese herbal remedy was used for number of ailments and as a weight loss supplement. After high rates of serious adverse events, including death, were reported, there was a failed effort (defeated in large part thanks to lobbying by the dietary supplement industry) to regulate and evaluate ephedrine. FDA finally banned ephedrine-containing supplements in April 2004.
So what can FDA do about it? The GAO report suggests that FDA issue guidance to clarify the difference between dietary supplements and foods with dietary ingredients added to prevent manufacturers from reclassifying their products as dietary supplements (and avoiding FDA regulation of the product as a food) and improve education and outreach efforts to the consumer. Congress should grant FDA additional authority to require manufacturers to provide information on their products' additives and ingredients and report adverse events.
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