Given today's federal judge's ruling striking down the FDA's ban of the dangerous natural weight-loss supplement, ephedra, we would like to remind you what we said about the matter when the FDA first made the decision. This commentary is only more relevant today...
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FDA vs. Congress on Ephedra Ban
Jeff Stier, Esq.
published on January 9, 2004
The Food and Drug Administration's announcement of its intention to ban weight loss or "athletic performance enhancing" products containing ephedra is good news. However, it took over 100 deaths, including that of a major league baseball player, over 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 (DSHEA), 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 DSHEA, 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 DSHEA 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 (let alone efficacy) 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 that 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 and misfortune 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.
Jeff Stier, Esq. is an associate director and Kimberly Bowman a research intern at the American Council and Health.
