The U.S. Food and Drug Administration (FDA) regulates that drugs are on the market and enforces recalls when enough substandard performance, undeclared ingredient, or adverse side effect reports are received. According to the FDA, “recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.” There are three types of FDA recalls—Class I, II, and III. A Class I recall is the most severe, and issued when a product or device is likely to have severe adverse health effects.
In late December, a previously healthy 28-year-old man from North Carolina experienced liver failure that required a transplant after several weeks of using a dietary supplement called Mass Destruction. According to their website, the “U.S. Food and Drug Administration is advising consumers to immediately stop using” this product, “marketed as a dietary supplement for muscle growth.” The supplement, which contains at least one synthetic anabolic steroid, has been linked to the liver failure of the North Carolina man.
Two US Senators recently introduced the Dietary Supplement Labeling Act of 2013. Sen. Richard Blumenthal (D-Conn.) and Sen. Dick Durbin (D-Ill.) say the law is needed to help oversee the ever growing list of dangerous dietary supplements and herbal medications that can cause adverse reactions in people who take these products, but are on the market totally unregulated by the federal Food and Drug Administration (FDA).