Science Supporting Ephedra Ban Fails FDA’s Own Standard – Nutraceutical
This article was originally published in The Tan Sheet
Executive Summary
Scientific evidence used by FDA to support its outright ban of ephedra would not meet the agency's "own criteria for competent scientific evidence," low-dose ephedra marketer Nutraceutical asserts
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Scientific evidence used by FDA to support its outright ban of ephedra would not meet the agency's "own criteria for competent scientific evidence," low-dose ephedra marketer Nutraceutical asserts. In a brief filed on behalf of the company Oct. 4, Jonathan Emord of Emord & Associates (Reston, Va.) argues that a Utah District Court ruling invalidating the agency's inclusion of low-dose ephedra products in the ban should be upheld. The ultimate outcome of the case will help define the agency's authority to ban supplement products. Nutraceutical sued the agency in May 2004, shortly after the agency's ban of ephedra went into effect. The court ruled in favor of the firm in April 2005 (1 (Also see "Utah Court Overturns Ephedra Ban For Low-Dose Products" - Pink Sheet, 18 Apr, 2005.), p. 5). FDA "failed to follow the statutorily prescribed method for finding a dietary supplement adulterated," the court ruled at the time. The agency neither determined the specific dose at which ephedra becomes toxic nor proved "by a preponderance of the evidence" that the ingredient is toxic in doses of 10 mg or less per day, U.S. District Judge Tena Campbell found. FDA was ordered to bring the rule banning ephedra into compliance with the judgment - an action Emord asserts the agency has not taken - and was enjoined from taking enforcement action against Nutraceutical for selling their low-dose product. FDA appealed this decision in June and filed the opening brief Sept. 2 (2 (Also see "FDA Appeals Utah Ephedra Court Ruling, Defends Use Of Risk/Benefit Analysis" - Pink Sheet, 12 Sep, 2005.), p. 10). Nutraceutical's brief responds to arguments raised by the agency. Specifically at issue is a pharmacokinetic analysis of the ingredient performed by Mario Inchiosa, PhD, New York Medical College. "FDA's reliance on unverified and unpeer-reviewed statements of opinion from one scientist is incompetent under FDA's own review standards for scientific evidence," the firm argues. FDA solicited the statements from Inchiosa because the agency found no studies evaluating the effects of low-dose ephedra in humans, Emord notes in the brief. The mathematical model Inchiosa developed for his pharmacokinetic analysis of ephedra is based on a series of "erroneous" assumptions regarding ephedrine alkaloids, Nutraceutical maintains. Inchiosa's "model extrapolates from continuously intravenously injected epinephrine (a drug much more potent than ephedra)," Nutraceutical says, adding "the model has never been experimentally tested and relies on an approach that violates basic norms of statistics." "FDA routinely rejects as incompetent mere statements of opinion from scientists when they are not peer-reviewed and are not grounded in studies of the ingredients themselves," the firm asserts. According to an FDA draft guidance for the substantiation of supplement claims, this type of modeling "serves, at best, to 'identify relevant reports,' not to constitute relevant reports of science in and of themselves," Emord points out. Moreover, even if Inchiosa's work was "fully creditable, the opinion letters would still not constitute a preponderance of the evidence," the threshold for banning a dietary supplement set by the Federal Food, Drug & Cosmetic Act. Nutraceutical also supports the Utah court's finding that the agency illegally shifted the burden of proving a supplement's safety onto the manufacturer and imposed the requirement that they determine a supplement's benefit before sale. This could bring the appeals court to consider the legislative intent of the Dietary Supplement Health & Education Act. If legislative intent is argued, FDA likely will be found to have overstepped its statutory bounds, especially for using a risk/benefit analysis, Nutraceutical maintains. The "benefit requirement" inherent in the agency's use of a risk/benefit analysis to support the ban of ephedra "destroys [DSHEA's] essential distinguishing principal: while drugs must establish benefit...foods and dietary supplements are presumed safe and have no such pre-market requirement," Emord's brief states. FDA has the right to file a reply to Nutraceutical's brief through Oct. 18. After the court decides if it will hear oral arguments, a decision could be rendered in as little as three to six months, according to Emord. |