August 17, 2006
(August 18, 2006, Silver Spring, MD) -- A three-judge panel of the 10th Circuit U.S. Court of Appeals ruled yesterday in favor of the U.S. Food and Drug Administration (FDA) in a case that had challenged the agency's 2004 prohibition of any level of ephedrine in dietary supplements.
FDA established, in a regulation that became effective on April 12, 2004, that "dietary supplements containing ephedrine alkaloids are adulterated under section 402 (f)(1)(A) of the Federal Food, Drug, and Cosmetic Act" (21 CFR 119.1). FDA's decision in this matter was based on its conclusion that ephedrine presents an "unreasonable risk of illness or injury," which conclusion was drawn by "a risk/benefit analysis to ascertain whether the risks of the product outweigh its benefits" (68 FR 6798). Prior to this ruling, extracts of ephedra (Ephedra spp.) were broadly sold as ingredients in weight-loss products, and Asian herbal formulas including ephedra herb were marketed for traditional uses.
A legal challenge to FDA's final rule on ephedrine in dietary supplements was brought by Nutraceutical Corporation and its brand, Solaray, in May 2004. Nutraceutical challenged both FDA's use of a risk/benefit analysis in making an "unreasonable risk" determination, and the regulation's ban on even low-dose ephedrine products. Solaray had sold an ephedra dietary supplement that was formulated and labeled to deliver less than 10 mg per day of ephedrine alkaloids. The U.S. District Court for the District of Utah found in April 2005 in Nutraceutical's favor on both of these causes of action, findings that have now been reversed by the Court of Appeals.
"The American Herbal Products Association has long had concerns about FDA's ruling on ephedrine and the outcome of this case," noted Michael McGuffin, the association's president. "FDA refused, in its rulemaking process, to acknowledge any benefits for ephedra, even for traditional uses. If the benefit side is judged as 'zero,' the outcome of any risk/benefit analysis will necessarily be skewed," he added. "But this Court has now specifically stated that FDA’s risk/benefit mechanism 'correctly followed the congressional directive,' and industry will need to evaluate the implications of this as precedent."
Of particular interest in yesterday's ruling:
The plain language of the statute [the Dietary Supplement Health and Education Act, or DSHEA] directs the FDA to restrict distribution of dietary supplements which pose any risk that is unreasonable in light of its potential benefits.
The [Food, Drug and Cosmetic Act] should not be read too restrictively but in manner consistent with the statute's overriding purpose to protect public health …. Accordingly, DSHEA should receive a liberal construction where the FDA has taken remedial steps in response to a perceived public health problem.
The burden remains on the agency to show that risks associated with a dietary supplement outweigh benefits and are, therefore, unreasonable. Thus, a risk-benefit analysis does not undermine congressional intent by improperly shifting the burden of proof onto manufacturers of dietary supplements.
… an "unreasonable risk" is relative to the circumstances; the potential risk is more "unreasonable" if the potential benefit is smaller… In contrast to "significant risk," "unreasonable risk" accounts for whether the benefits justify the risks. The use of "unreasonable" to qualify risk in addition to "significant" makes it clear that Congress intended to integrate a risk-benefit analysis in the former.
The evidence in the administrative record was sufficiently probative to demonstrate by a preponderance of the evidence that EDS [ephedrine dietary supplements] at any dose level pose an unreasonable risk. The greater weight of the evidence supports the FDA’s ban on EDS, thus satisfying the agency's burden.
The FDA's extensive research identified the dose level at which ephedrine alkaloids present unreasonable risk of illness or injury to be so minuscule that no amount of EDS is reasonably safe. The FDA reasonably concluded that there is no recommended dose of EDS that does not present an unreasonable risk.
The FDA was not arbitrary or capricious in its Final Rule; the FDA met its statutory burden of justifying a total ban of EDS by a preponderance of the evidence.
We find that the FDA correctly followed the congressional directive to analyze the risks and benefits of EDS in determining that there is no dosage level of EDS acceptable for the market.
Jonathan Emord, as counsel to Nutraceutical Corp., has indicated that the company will appeal this decision to the full 10th Circuit Court of Appeals.
Yesterday's ruling can be found at http://www.ck10.uscourts.gov/opinions/05/05-4151.pdf.
The American Herbal Products Association (AHPA) represents the core of the botanical trade -- comprised of the finest growers, processors, manufacturers and marketers of herbal products -- AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbs are manufactured, labeled, and sold. Website: www.ahpa.org.
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