Regulators: It's hard to keep tabs on dietary supplements

WASHINGTON -- The market for dietary supplements is so vast that federal regulators have trouble determining which ones are laced with steroids and should be off limits to consumers, they told a Senate panel Tuesday.

"We have a difficult time figuring out exactly what products are on the market," said Michael Levy, director of new drug and labeling compliance at the Food and Drug Administration's Center for Drug Evaluation and Research. "Once those products are on the market, it's not easy to figure out exactly what's in those products. The only way to truly do that is to test them in a lab, which is a cost- and resource-intensive type of activity."

The hearing, held by the crime and drugs subcommittee of the Senate Judiciary Committee, came a week after a federal raid on the warehouse and headquarters of, a Boise, Idaho, company. Investigators said in court documents that they suspect of illegally marketing and distributing anabolic steroids.

Tuesday's hearing was called by Sen. Arlen Specter, D-Pa., a Philadelphia Phillies fan whose interest in the subject was heightened this baseball season when pitcher J.C. Romero tested positive for a banned substance and was suspended for 50 games.

Specter's aim was to look at whether consumers have adequate protections from misleading or potentially life-threatening products. It's not clear, though, that the hearing answered that question. At one point, Specter told regulators with the FDA and the Drug Enforcement Administration that they needed to be more proactive about asking Congress for assistance when they need it.

"Come to us — don't make us come to you," he said.

After the hearing, Levy said that the FDA wasn't there to request any new legislative authority from Congress.

"The agency was here merely to point out the challenges of enforcing the law in this area and in dealing with dietary supplements that are tainted with steroids and steroid-like ingredients," he said.

However, industry representatives, who attended the hearing in force, said they think there are plenty of laws on the books to address the problem. Legitimate businesses are being victimized by the proliferation of what Daniel Fabricant of the Natural Products Association called a "guerrilla-style criminal drug-peddling operation." Federal regulators just need to act, Fabricant said.

"We believe that tougher enforcement and prosecution to the full (extent) of the law are the best ways to stop the criminals," Fabricant said. "The barriers to enforcement are simple: money, manpower and will."

Sen. Orrin Hatch, R-Utah, whose state is home to a number of dietary supplement businesses, said that he agreed, but that he thought Congress should shift more resources toward the FDA's and the DEA's enforcement efforts.

"I think FDA is overburdened as it is," said Hatch, who other than Specter was the only other senator at the hearing. "I blame Congress for a lot of these things. We don't give it enough support."

Advocates for athletes, however, called for better regulations. It's all too easy for young athletes — even those as young as middle school — to buy products online, said Travis Tygart, the chief executive of the U.S. Anti-Doping Agency.

He was accompanied to the hearing by Jareem Gunter, a former football player at Lincoln University in Missouri, whose liver failed when he bought a product off the Internet that he thought was free of harmful substances, including those banned by his team.

"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 established mineral supplements has been hijacked by unscrupulous profiteers," Tygart said.

In recent months, the FDA has sent out more warning letters and more recalls — as well as more consumer outreach, Levy said. That includes consumer advisories about potentially dangerous weight loss products tainted with active pharmaceutical ingredients.

"This is a part of a re-emphasis on drug safety and on taking swift, aggressive enforcement action against companies who are in violation of drug approval and quality requirements," Levy said. received five warning letters from 2002 to 2006, according to court documents. Levy wouldn't say whether the raid is a part of the re-emphasis, but he did say there are a number of enforcement options regulators have to halt the sales of steroid-tainted products: injunctions, seizing the products and criminal sanctions.

Mostly, though, they're being responsive to a cluster of incidents where people got sick or injured from supplements laces with steroids, Levy said, pointing to a raid on American Cellular Labs in Pacifica, Calif.


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