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General Assembly to review additional steroids

30 September 2009 2,026 views No Comment

WASHINGTON — The Food and Drug Administration told Congress Tuesday that it has limited abilities to keep dietary supplements with steroids from hitting market shelves.

“FDA generally cannot identify violative products before they enter the marketplace,” said Michael Levy, director of the FDA’s division of new drugs and labeling compliance, at a hearing of the Senate Judiciary crime and drugs subcommittee. “After products enter the market, we must undertake a painstaking investigative and analytical process” to show the products violate the law.

Levy said that dietary supplement makers need not prove a product is safe unless it contains a new ingredient not previously part of the food supply. That allows unscrupulous companies to market products that can pose health risks, he said.

“Marketing a steroid product as a ‘dietary supplement’ conveys to the consumer a false sense of safety and legitimacy for these potentially harmful products,” Levy said.

Daniel Fabricant, interim executive director and CEO of the Natural Products Association, which represents retailers, manufacturers, suppliers and distributors of health foods and dietary supplements, said his industry is being “victimized by a guerilla-style criminal drug-peddling operation.” He said the solution is enforcement of current laws.

The subcommittee chairman, Sen. Arlen Specter, a Pennsylvania Democrat and Philadelphia Phillies fan, said before the hearing that his interest was piqued in part by the case of Phillies pitcher J.C. Romero, who was suspended for 50 games this season after testing positive for androstenedione, a substance that slugger Mark McGwire used in the 1990s that was later banned by baseball.

Romero sued the manufacturer of an over-the-counter supplement earlier this year, arguing that it should bear the blame for his suspension because it misrepresented its products and ingredients.

“We’re looking at whether there’s adequate protection for consumers from getting these supplements which have steroids or steroid-like substances,” Specter told The Associated Press in an interview. “These tainted products can cause life-threatening injuries, such as kidney failure and liver injury.”

Congress rewrote the dietary supplements regulations in 1994. Some critics say the regulations are not strong enough.

Now, the Major League Baseball Players Association is pressing Congress to establish stricter reporting requirements for supplement manufacturers and tougher penalties for repeat offenders. The union is also lobbying Congress to require that supplements be analyzed by a federally certified lab that would determine the ingredients to be listed on the label.

Don Fehr, head of the baseball players union, said the lack of government regulation is especially problematic for amateur and professional athletes who might use over-the-counter supplements because a positive test for a banned substance can lead to suspension.

“Players, like everyone else, have no idea what they’re taking,” Fehr said in an interview. “I’m sure there are some good supplement products in the market that are safe, effective and accurately identified. I hope these products can be protected. But as of now, there is no way a player or anyone else can know with certainty that what they are taking is accurately described on the label.”

Last week, Food and Drug Administration investigators executed a search warrant of BodyBuilding.com, seeking evidence that it deals in designer steroids and andro. The FDA conducted a similar probe of American Cellular Labs in July.

Steve Mister, president and CEO of the Council for Responsible Nutrition, which represents the dietary supplement industry, said there is a “small fringe” of manufacturers that offer products which include steroids and other banned substances. He said sports nutrition supplements account for about 10 percent of the $25 billion supplement industry, and “those muscle enlargement products that seem to be a concern are just a small fraction of that.”

Copyright © 2009 The Associated Press. All rights reserved.


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