These Supplements Are Sold Nearly Everywhere, but Are They Safe?

By TIMOTHY EGAN

arlier this year, Dr. Bernard Greisemer, a sports medicine physician from St. Louis, was asked at a Senate hearing about the difference between anabolic steroids, which it is a felony to sell or possess without a prescription, and steroid precursors like androstenedione, which are sold legally at nearly every mall in the United States.

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Dr. Greisemer said pediatricians treat both of them the same way — and say both could have devastating side effects on the growing number of young people who are taking them to build up their bodies.

The dangers of large doses of anabolic steroids to young people are poorly studied. But the dangers of the substances known as precursors are even less understood.

Makers of precursors say they metabolize as steroids and mimic male hormones. They are marketed under names like Ripped Fuel and Teen Advantage. But the manufacturers' claims have not been proved, medical experts say, and if the precursors do act like steroids, they may confer some of the same risks — acne and shrinkage of the testicles, which is reversed when the drugs are stopped, and growth of breast tissue, which may not go away even when a man stops taking the drugs. They may also cause an adolescent's bones to stop growing prematurely, leading to shortened stature.

"The fact that people would take products like this, that are freely available on the market, without thinking about their safety or efficacy is frightening," said Dr. Paul Coates of the Office of Dietary Supplements at the National Institutes of Health.

Yet, despite the warnings, there has been little federal regulation of precursors, which are sold as dietary supplements. A landmark 1994 law, the Dietary Supplement Health and Regulation Act, leaves it up to companies that make such products to ensure they are safe before selling them.

The law was intended to make it easier to sell vitamins and so-called natural health products, supporters say, and was never meant to open the floodgates to what is now the fastest-growing segment of the $18 billion dietary supplement industry.

Companies say their products are legal as long as they do not make a specific claim to curing an illness. And under current Food and Drug Administration guidelines, manufacturers of steroid precursors and other supplements do not need to register with the agency or get approval from the regulators before selling them. They are sold on shelves next to vitamins and herbal remedies.

But even the trade association that promotes dietary supplements, the Council for Responsible Nutrition, says steroid precursors should carry tougher warning labels and not be sold to people under 18.

Some members of Congress have proposed taking steroid precursors off the over-the-counter market and having them classified as a controlled substance. But the two chief Congressional sponsors of the bill that deregulated dietary supplements in 1994 — Senator Orrin G. Hatch, Republican of Utah, and Senator Tom Harkin, Democrat of Iowa — say the F.D.A. already has the power to regulate precursors and other powerful supplements, and should be taking more forceful action.

Twice in the last year, the two senators wrote to the agency, asking it to clarify the legal status of marketing efforts by companies that make steroid precursors.

"We are extremely concerned about the potential harmful effects of androstenedione and its use, particularly by young people," Mr. Hatch and Mr. Harkin wrote. They said that even with the passage of the dietary supplement law, the F.D.A. has the authority to take action if there is sufficient evidence that the compounds are found to be unsafe.

But to date, the agency has not issued any warnings or taken any measures to regulate steroid precursors. William K. Hubbard, an associate commissioner, said in a letter that it was evaluating the "legal and scientific" issues. The F.D.A. said it had no further comment on the issue.

Critics say the 1994 law has allowed companies to sell and market a broad range of potentially dangerous products without fear of government interference.

"These supplement companies do not fear the F.D.A., because they have yet to remove a single dietary supplement," said David Schardt, a nutritionist at the Center for Science in the Public Interest, a nutrition advocacy group.

Dr. John Cardellina, a vice president at the dietary supplement trade association, said most sports supplements need no further guidance than is on the label. But he said steroid precursors should not be taken by anyone under 18.