05.01.03
Following on the heels of AHPA’s Citizen Petition, Senator Richard Durbin introduced bill S.722 titled the “Dietary Supplement Safety Act of 2003.” This legislation is intended to “protect consumers from dangerous dietary supplements such as ephedra and other stimulants by requiring manufacturers to submit proof that their product is safe prior to bringing it to market.” Senator Durbin did admit that dietary supplements can be beneficial for consumers, however, he also said that not ALL dietary supplements are safe, particularly, stimulants and steroids. There were three major points set forth in Senator Durbin’s bill that are of interest. First, the legislation would require manufacturers of the most dangerous types of dietary supplements—stimulants—to submit proof that their product is safe prior to bringing that product to market. The bill also expands FDA’s authority to require proof of safety from any dietary supplement maker if the agency has received information suggesting that the product is causing death or other serious adverse health effects. If manufacturers fail to show that their product is safe, then the bill said FDA could take the product off the market. Secondly, the bill would require manufacturers to report serious adverse health events, such as heart attack, seizure, stroke or death, to FDA no later than 15 calendar days after they receive them. Finally, the Durbin bill intends to close a loophole in current law that, according to a press release from Senator Durbin, “has been exploited by many dietary supplement manufacturers, allowing anabolic steroids to be sold widely as dietary supplements.” This bill would eliminate that loophole by clarifying that anabolic steroids are not dietary supplements and are subject to regulation that restricts their availability under the Controlled Substances Act.