Court strikes ephedra ban; enjoins FDA from blocking ephedra sale

Townsend Letter for Doctors and Patients,  Oct, 2005  

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On April 13, 2005, the US District Court, District of Utah, Central Division (Judge Tena Campbell presiding) ruled in Nutraceutical Corporation v. Crawford that FDA's February 2004 Final Rule banning all ephedrine-alkaloid dietary supplements violated the dietary supplement adulteration provision of the Food Drug and Cosmetic Act (21 USC 342(f)). The Court enjoined FDA from taking any enforcement action to block the plaintiffs from selling supplements containing 10 mg or less of ephedrine alkaloids per daily dose. The Court ordered FDA to reopen the ephedra rulemaking and adopt a dose-dependent toxicity analysis, consistent with the intent of Congress.

The Court granted the Plaintiffs the declaratory and injunctive relief they sought, agreeing with them that FDA had exceeded its statutory authority by failing to interpret the dietary supplement adulteration provision in a dose-dependent manner as Congress had intended. In its Final Rule FDA required dietary supplement companies to prove their products create a significant benefit to avoid being declared adulterated if the FDA found any evidence of risk. The Court rejected FDA's rule, holding the Food Drug and Cosmetic Act to impose no requirement whatsoever that a dietary supplement (or a food) prove a benefit to be lawfully saleable (the Court noted that potato chips would be illegal under that standard). The Court agreed with Plaintiffs that FDA had to determine the precise dose at which ephedrine alkaloids produced toxicity and impose a ban only at that level and above. Instead, FDA overreached, banning all ephedrine alkaloid supplements, regardless of dose, on a record lacking evidence of harm at ephedrine alkaloid daily dose levels of 10 mgs or lower.

The decision declares FDA's ephedra ban unlawful, requires FDA to reopen its ephedra rulemaking to perform a dose-dependent toxicity analysis, and enjoins FDA from taking any enforcement action to block the Plaintiffs from selling their dietary supplements containing 10 mgs or less ephedrine alkaloids per daily dose.

Emord & Associates represented the plaintiffs. A copy of the decision is available from the firm (contact Cynthia Lewis or DuWayne Hamilton at 202-466-6937).

Emord & Associates, PC

1050 Seventeenth Street, NW, Suite 600

Washington, DC 20036 USA

202-466-6937 / Fax 202-466-6938

www.emord.com

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