WASHINGTON, D.C., April 14, 2005 – The Council for Responsible Nutrition (CRN), one of the dietary supplement industry’s leading trade associations, issued the following statement in response to yesterday’s ruling by the U.S. District Court, District of Utah, Central Division issued in Nutraceutical Corporation v. Crawford, a lawsuit brought by Nutraceutical Corp. and Solaray, Inc. (Plaintiffs) challenging FDA’s ban on ephedra.
Statement by Steven M. Mister, Esq., President and CEO:
Yesterday’s decision was the next step in a legal process that serves to protect consumers. Both companies and individuals have a right to challenge laws and regulations and it is reasonable to expect regulations to conform to statutory standards in order to withstand legal challenges.
This ruling applies only to a very specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban, nor should anyone leap to inappropriate conclusions about what this means for DSHEA. The standard of DSHEA that companies may not market dietary supplements that pose a significant or unreasonable risk of illness or injury is not questioned by yesterday’s decision.
The court’s ruling—which leaves in place a ban on all but those dietary supplements with 10 mg or less of ephedrine alkaloids per daily dose—demonstrates that DSHEA works, and that FDA will be held to the statutory standards of proof in the law. It further underscores that dietary supplements are not to be treated as drugs or medical devices and that FDA must acknowledge those distinctions in its administrative and enforcement measures.
Even while applauding FDA’s December 2003 decision to ban ephedra, CRN warned that FDA’s analysis and rationale for the restriction would need to be able to withstand judicial and scientific scrutiny. It appears, at least in this case, the court has questioned FDA’s basis for evaluating what is an "unreasonable risk" and the adequacy of FDA’s record for banning low dosage ephedra-containing supplements.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. For more information on CRN, visit http://www.crnusa.org