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Congress, Concerned About Steroids, Reviews Law on Dietary Supplements

The Food and Drug Administration, meanwhile, has warned consumers not to use products marketed for bodybuilding that contain steroids or steroidlike substances, or that claim to increase testosterone. The agency says users risk liver failure, kidney damage and other serious health problems.

Now Congress is investigating whether laws, health agency resources and manufacturing guidelines are adequate to protect the public from products that illegally contain steroids but masquerade as dietary supplements.

Under the law, dietary supplements are generally defined as products that contain or are derived from natural foodstuffs like minerals or herbs and do not claim to prevent, mitigate or cure specific illnesses.

But when products marketed as supplements are found to contain pharmaceutical ingredients like steroids, the federal government considers them misbranded — and unapproved illegal drugs.

Testifying on Tuesday at a Senate hearing on bodybuilding products, Travis T. Tygart, chief executive of the United States Anti-Doping Agency, estimated that hundreds of illegal products containing steroids were now available in the United States. As evidence of the problem, Mr. Tygart introduced Jareem Gunter, a former college baseball player who said he suffered acute liver failure after taking a bodybuilding product called Superdrol.

“Jareem had no way of knowing that a regulatory scheme designed over 15 years ago for a few companies selling a limited number of simple vitamins and mineral supplements has been hijacked by unscrupulous profiteers,” Mr. Tygart told members of the Senate Judiciary Committee Subcommittee on Crime and Drugs at the hearing on bodybuilding products.

“These companies are exploiting the lack of premarket regulation to sell magic powders and pills in a bottle while using the reputation of the health food and vitamin industry to cloak themselves with the appearance of safety and respectability,” he said.

The hearing, convened by Senator Arlen Specter, Democrat of Pennsylvania, comes during an investigation into products that illegally contain steroids by the Food and Drug Administration. While the human body naturally produces anabolic or tissue-building androgenic steroids, like the hormone testosterone, federal regulators said products that contained hidden synthetic forms of the steroids might pose a health hazard. That is because they are not subject to the kinds of safety and effectiveness testing required of prescription drugs and are often made without quality control standards.

The federal government considers anabolic steroids to be controlled substances. That means some anabolic steroids can be used legally, if a doctor writes a prescription for a patient to treat a legitimate medical condition, while other steroids are illegal for any use in the United States.

Unlike pharmaceutical companies, which must provide the agency with proof of a drug’s safety and efficacy before it is approved for sale, natural products companies do not have to submit dietary supplements for clearance before they go on the market. The crackdown on steroid products sold as supplements raises the question of whether regulations governing dietary supplements are adequate to protect consumers from companies that flout the law.

During the hearing, federal authorities described how some companies that illegally marketed steroids as dietary supplements had exploited weaknesses in regulations. Representatives of the natural products industry, meanwhile, recommended tougher enforcement of existing laws and full prosecution of suspected violators.

The F.D.A. generally does not receive information about over-the-counter products containing steroids before marketing and the agency generally cannot identify such products that violate the law before they go on sale, according to Senate testimony by Michael Levy, the director of the F.D.A.’s division of new drugs and labeling compliance. Once these products do go on sale, the agency has to undertake painstaking investigation and analysis to prove they are illegal, he said.

“We are really urging consumers not to use products marketed as containing steroids or steroidlike ingredients,” Mr. Levy said in a phone interview Tuesday. “We want parents to pay attention to the types of supplements their kids are taking and, if they are taking these products, urge them to stop.”

Mr. Tygart, of the Anti-Doping Agency, recommended legislative changes that would give the agency greater power over dietary supplements both before and after they go on sale.

But Richard Kingham, a lawyer who specializes in food and drug law, testified that there was no need to amend existing law because the F.D.A. already had many enforcement tools at its disposal. Many products containing anabolic steroids, promoted in stores or the Internet as dietary supplements, violate provisions in the law on label claims or new ingredients, he said. To take action against products before they go on sale, the F.D.A. would not have to prove they were unsafe, but merely show that a company had violated premarket procedures, he said.

Bodybuilding supplements represent roughly 10 percent of the estimated $25 billion dietary supplement industry. Products containing anabolic steroids represent only a subset of the bodybuilding category, Mr. Kingham said. It would be a mistake to alter the law, he said, simply to deal with a small number of outlier products.
Category: World | Views: 886 | Added by: magictr | Tags: Dietary Supplements, Steroids | Rating: 0.0/0
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