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[Definitie:] "An ergogenic aid is any substance or phenomenon that enhances performance."
(Wilmore and Costill) 
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FDA to better regulate supplements
The Washington Post WASHINGTON - The Food and Drug Administration said Thursday that it is setting up a new system for identifying potentially dangerous and mislabeled dietary supplements, and it promised to aggressively go after companies that sell misleadingly labeled products. Responding to criticism that the government has responded too slowly to the dangers posed by popular supplements such as ephedra and androstenedione - which were both taken off the market in the past year because of health concerns - the FDA outlined a new regulatory scheme for overseeing the fast-growing supplement industry. In addition to upgrading its process for collecting ''signals'' of possible harmful effects in people using supplements, the FDA also set its first standard for determining whether the claims on labels are properly substantiated. From now on, supplement makers will have to show ''competent and reliable scientific evidence'' to back up their health claims, it said. An estimated 1,000 dietary supplement companies sell 29,000 products, but since passage of the 1994 Dietary Supplement Health and Education Act, the industry has been largely free of government oversight. High-profile deaths associated with the diet and bodybuilding supplements ephedra and ''andro'' put pressure on the FDA to use its limited regulatory authority under the law, and Thursday's announcement was an effort to expand its mandate. ''These initiatives refine the direction the agency is taking to regulate dietary supplements,'' FDA acting Commissioner Lester Crawford said. ''We now have a clear road map to share with the dietary supplement industry, while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling,'' he said in a statement. The FDA said it had sent letters to major dietary supplement retailers warning them against selling mislabeled products and threatened enforcement action if they do. Two weeks ago, the agency sent out eight warning letters to distributors that made what it considers to be unsubstantiated weight-loss claims for supplements sold over the Internet, officials said. Under the 1994 act, most dietary supplements do not need FDA review or approval before going on the market, but some new ingredients require a pre-market report on potential safety problems. As another part of its new initiative, the FDA will hold a public meeting on Nov. 15 to discuss what kind of evidence should be required for new these ingredient notifications. |
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