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Critics say FDA lacks power to effectively regulate supplements

July 29th, 2009

Critics of the Food and Drug Administration’s regulation of dietary supplements say that the agency needs to be given more power in order to protect consumers from the potential health risks associated with these products. Concerns about the FDA’s regulation of supplements arose this week after the agency warned consumers about reports of acute liver injury and kidney failure among consumers taking over-the-counter body-building products.

While the FDA has the power to review and monitor the safety of prescription drug products, these powers are much weaker when it comes to dietary supplements. While drugmakers must demonstrate that their products are safe before the FDA allows them on the market, supplement manufacturers do not have to subject their products to FDA pre-approval. The manufacturers are supposed to inform the FDA of safety problems which arise with these supplements and to voluntarily recall them in the event of serious safety concerns.

The FDA can only recall supplements when it receives reports of serious problems with a supplement and can prove substantial health risks. Because of this, many consumers may be injured by unsafe supplements before they are recalled. In 2004, the FDA issued a recall of herbal Fen Phen products that contained ephedra, but only after the agency had received more than 16,000 side effects reports involving ephedra products.

Travis Tygart, the head of the United States Anti-Doping Agency, which controls the drug testing of American Olympic athletes, says that the FDA’s “ineffective regulatory scheme” keeps it from having enough power to protect consumers from the health risks of dangerous supplements. “Consumers who don’t hear or read about the warning will continue to use them because it’s so hard to recall them,” Tygart says.

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