A year ago, the Food and Drug Administration (FDA) banned dietary supplements containing the herbal stimulant ephedra. In a decision that was recently overturned by a federal judge in Utah, the FDA concluded that all such products are "adulterated" because they pose an "unreasonable risk of illness or injury."
Yet, the FDA took no action against over-the-counter medicines, such as Primatene and Bronkaid, that contain ephedrine, the most potent stimulant in ephedra, or the many cold and allergy remedies that contain pseudoephedrine, another alkaloid found in the plant. These products are considered safe and effective drugs, rather than unreasonably risky dietary supplements.
To make things even more confusing, the FDA also continued to allow the use of ephedra in traditional Asian medicine because its practitioners "typically do not use products marketed as dietary supplements." Hence, loose, dried ephedra prescribed by herbalists remained legal, while exactly the same substance was prohibited when chopped up, placed inside a capsule, and sold in a health food store.
This strange situation is largely a result of a 1994 law aimed at limiting the FDA's authority over dietary supplements. The law and the FDA's interpretation of it are part of a continuing struggle over how much freedom Americans should have to control their own health.
The FDA decided that dietary supplements containing ephedra, used mainly as energy boosters and weight loss aids, were unacceptably dangerous because, in its judgment, their risks outweighed their benefits. The agency thereby asserted its authority to impose that determination on consumers who, once informed of the risks, might have arrived at a different conclusion.
On April 14, in response to a lawsuit brought by Nutraceutical Corp. and its Solaray susidiary, U.S. District Judge Tena Campbell ruled that the ephedra ban violated the Dietary Supplement Health and Education Act (DSHEA). "The FDA's imposition of a risk-benefit analysis places a burden on the producers of [ephedra products] to demonstrate a benefit as a precondition of sale," she said, "and that is contrary to Congress's intent."
Campbell also found that the FDA should have presented more evidence to show that even relatively low doses of ephedra alkaloids, such as the 10 milligrams a day recommended by Nutraceutical, present a "significant or unreasonable risk," DSHEA's standard for deeming a product adulterated. "The plain language of the statute requires a dose-specific analysis," she wrote. Campbell enjoined the FDA from blocking the plaintiffs' sale of supplements containing 10 milligrams or less of ephedra alkaloids in a daily dose and instructed it to rewrite its rule.
The decision predictably prompted complaints from activists and politicians who have always opposed DSHEA's transfer of power from regulators to consumers. "If FDA can't take a supplement as dangerous as ephedra off the market," said Sen. Edward M. Kennedy (D-Mass.), "then Congress needs to change the law to allow it to do so."
While ephedra might be more dangerous than, say, a multivitamin, its risks, which stem mainly from its stimulation of the cardiovascular system, are well within the range considered acceptable for over-the-counter drugs. Mark McClellan, FDA administrator when the ephedra ban was imposed, himself conceded that "serious adverse events from ephedra appear to be infrequent."
Although the FDA pretended to weigh ephedra's risks against its benefits, the agency's de facto position seems to be that any risk is unacceptable. Otherwise, why would it insist on a complete ban, as opposed to warning labels and dosage recommendations?
The comments of ephedra's detractors in the medical community reflect a similar absolutist stance. The AMA's American Medical News reports that "physicians said dosage levels are irrelevant when talking about the return to market of a supplement that has been linked to stroke, heart attack and death in extreme cases and has generated more than 18,000 consumer complaints."
Dosage levels are irrelevant? I hope these physicians do not practice medicine according to that principle
The FDA, the medical establishment, and the pharmaceutical industry all want to prevent the emergence of an alternative drug market in which consumers can obtain cheap, effective, and reasonably (though not completely) safe products without permission from the government's gatekeepers. Just as ephedra competed with prescription diet drugs, St. John's wort competes with antidepressants and red rice yeast competes with cholesterol-lowering drugs such as Mevacor.
You don't have to believe that natural remedies are necessarily superior to recognize the subversive potential of the "dietary supplement" loophole. Or to welcome it, as millions of Americans already do.