A federal judge in Utah has ruled that the Food and Drug Administration's 2004 ban on dietary supplements containing ephedra goes beyond the agency's statutory authority. In a case brought by supplement makers Nutraceutical Corp. and Solaray, U.S. District Judge Tena Campbell concluded that the FDA erred in determining that any amount of ephedrine renders a product "adulterated."
Under the Dietary Supplement Health and Education Act, supplements are considered adulterated if they pose "a significant or unreasonable risk of illness or injury." The FDA interpreted "unreasonable" to mean that the product's risks outweigh its benefits. "The FDA's imposition of a risk-benefit analysis places a burden on the producers of [ephedrine-containing products] to demonstrate a benefit as a precondition of sale, and that is contrary to Congress' intent," Campbell concluded.
She also found that the FDA should have presented more evidence to show that even relatively low doses of ephedrine (such as the 10 milligrams a day recommended by the plaintiffs) present a significant or unreasonable risk. "The plain language of the statute requires a dose-specific analysis," she wrote. Campbell enjoined the FDA from blocking the sale of supplements containing 10 milligrams or less of ephedrine in a daily dose and instructed it to rewrite its rule.
Over the short term, the ruling will increase consumer choice (in Utah, at least), but over the long term it will encourage the FDA and other critics of the dietary supplement law to seek more power for the agency to order the removal of products it doesn't like. Let's hope they fail. Although the legal treatment of so-called dietary supplements that are actually drugs in raw form is hard to justify in the context of the federal government's broader regulatory system, it gives people a little more leeway than they would otherwise have to ingest what they choose.