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.