Nutraceutical Corp Again Challenges Ephedra Products Ban

Nutraceutical Corporation is not giving up its fight to save ephedra products. The ban reversal predictably prompted complaints from activists and politicians who have always opposed DSHEA.

Ephedra might be more dangerous than a multivitamin, its risks, which stem mainly from stimulating the cardiovascular system, are well within the range considered acceptable for OTC drugs. Mark McClellan, FDA administrator when the ephedra ban was imposed, himself conceded "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 insist on a complete ban, as opposed to warning labels and dosage recommendations?

In 2004, the Food and Drug Administration (FDA) banned dietary supplements containing the herbal stimulant ephedra. In a decision recently overturned by a federal judge in Utah, the FDA concluded 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 (OTC) medicines, such as Sudafed, Primatene and Bronkaid, that contain ephedrine, the most potent stimulant in ephedra diet products, 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.

The FDA and Ephedra Diet Products

The FDA decided dietary supplements containing ephedra -- used mainly as energy boosters and weight loss aids or diet products -- were unacceptably dangerous because it judged their benefits are outweighed by their risks. FDA then asserted its authority to impose that determination on consumers who, once informed of the risks, might have come to a different conclusion.

On April 14, in response to a lawsuit brought by Nutraceutical Corp. and its Solaray subsidiary, 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' intent."

Judge Campbell also found FDA should have presented more evidence 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. She enjoined the FDA from blocking plaintiffs' sale of supplements having a daily dose of 10 milligrams or less of ephedra alkaloids and instructed FDA to rewrite its rule.