Bitter pill for FDA: law on herbal supplements

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Sen. Orrin Hatch, R-Utah, the author of a 1994 bill that protects dietary supplement makers while putting consumers at unnecessary risk, said recently that he is willing to consider making herbal supplement manufacturers report adverse side effects of their wares. In return, Sen. Richard Durbin, D-Ill., has dropped an amendment to a defense bill that would require companies that sell supplements on military bases to report side effects.

Our troops are hardly the only ones who are put at risk by unscientific and unregulated supplements, though, as the recent ephedra controversy showed.

The Food and Drug Administration's recent announcement of its intention to ban weight-loss or "athletic performance enhancing" products containing ephedra was good news. However, it took more than 100 deaths, including that of a major-league baseball player, more than 10,000 recorded complaints, and countless scientific studies for the FDA to ban this dangerous supplement.

Because of the 1994 Dietary Supplement Health and Education Act, which Hatch co-authored and which limited FDA's authority to regulate dietary supplements, the FDA still can't be sure that it has met the regulatory burden to enact the ban; manufacturers are likely to sue.

Ephedra should have been banned a long time ago. If it had been considered a pharmaceutical product and thus subject to the same scientific standards, ephedra would not have made it to market in the first place.

However, as a supplement regulated under the Dietary Supplement Health and Education Act, ephedra was marketed without any proof of efficacy -- or studies showing that the supplement is safe. In fact, under DSHEA, the government, not the manufacturer, shoulders the burden of proving a product is dangerous (rather than the manufacturer proving it is safe, as is the case with pharmaceuticals).

There is in place a double standard for dealing (harshly) with pharmaceuticals and food additives vs. dealing (leniently) with supplements, and this is intolerable. The Dietary Supplement Health and Education Act is handcuffing the FDA's efforts to protect public health -- and the only ones benefiting from the law are manufacturers who cannot present scientific data about the safety of their "natural" products.

Why the disparity in treatment between synthetic pharmaceuticals and "natural" supplements? Dietary supplements (products you might expect to find in a "health food" store, not a pharmacy) are assumed to be safe unless chemically altered or adulterated in some form. The misconception lies in the notion that anything present in nature must be healthy and anything synthetic must be dangerous. But as the country has found with ephedra, this is not necessarily the case.

Even when the FDA attempts to act within its powers, little may be done. In 1997 when the FDA first attempted to regulate ephedra by requiring warning labels and dosage restrictions, the move to protect public health was blocked. Why? Because the FDA had not met the excessive burden of proving there was "significant or unreasonable risk of injury" associated with the use of ephedra. Is it possible that the death of the Baltimore Orioles pitcher Steve Belcher in 2003 and the pain of many other ephedra users could have been avoided? That is a question DSHEA's congressional authors will surely struggle with.

The regulations the FDA is attempting to enact will only affect the sale of ephedra, not the regulatory system itself or the problems that allowed ephedra to remain on the market for so long. If the ban on ephedra is enacted, it may serve as a good precedent for proceedings against other supplements, but it will not grant the FDA the broader power necessary to protect the public health from dangerous supplements.

As the nation becomes increasingly health-conscious but also vulnerable to "quick fixes," Americans are turning more and more to so-called "natural" remedies, including some dangerous supplements. Sixty percent of Americans take some sort of dietary supplement every year, and consumers need realistic and accurate information about the supplements they take. It is time that Congress rewrote the law to allow the FDA to better do its job and protect consumers from dangerous supplements.

Stier is associate director at the American Council on Science and Health in New York.