Silver Spring, MD (April 27, 2005) -- The supplement industry is certainly aware by now that a United States District Court ruled on April 13, 2005, that the Food and Drug Administration (FDA) failed to meet its burden of proof that a dosage of 10 milligrams or less per day of ephedrine alkaloids presents an unreasonable risk of illness or injury when the agency banned all ephedrine-containing dietary supplements last year. The Court also concluded that FDA’s use of a risk-benefit analysis in determining an unreasonable risk of ephedrine-containing dietary supplements was “improper.”
In the intervening weeks the American Herbal Products Association (AHPA) has received numerous requests for clarification as to the extent of the impact of this decision. There have been reports that the judge's ruling should be read as completely overturning the ban on ephedra in dietary supplements, and other analyses, including AHPA’s, that the ruling must be read more narrowly.
FDA has not yet clarified its intention, so it can not be stated with certainty whether the Agency will appeal the District Court's decision or begin to implement its orders. Statements attributed to an FDA spokesperson only clarify that the Agency is evaluating the decision, but that it does not believe the ruling has any application to products with more than 10 mg ephedrine alkaloids.
In response to the uncertainty surrounding this issue, the AHPA Executive Committee on April 25 adopted a position to advise AHPA members to refrain from offering for sale any ephedrine-containing dietary supplements until such time as FDA clarifies what it intends to do about this U.S. District Court decision. This action by the Executive Committee was taken subsequent to notice to the entire AHPA Board.
One of the primary uses for which dietary supplements containing ephedrine alkaloids were marketed prior to April 2004 was for weight loss. AHPA is not aware of any information that would substantiate a claim for weight loss for ephedrine alkaloids alone in amounts less than 10 milligrams per day.
It should be noted that FDA’s final rule on ephedrine alkaloids in dietary supplements specifically stated that it “does not affect the use of Ephedra preparations in traditional Asian medicine ...” and that “... botanical sources of ephedrine alkaloids in traditional Asian herbal therapies are not covered by this rule.” AHPA believes, and has communicated to FDA, that the meaning of this language is that traditional Asian herbal products containing ephedrine alkaloids may be legally marketed. The Court's decision should therefore be assumed to also have no direct impact on this class of goods.
The judicial case is Nutraceutical Corporation and Solaray, Inc., Plaintiffs, vs. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Defendants, and can be downloaded at http://www.ahpa.org/05_0413_USDistrictCourt_Nutraceuticals.pdf.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is 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 responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org