Silver Spring, MD (May 17, 2005) -- Three dietary supplement trade associations have sent a unified message to the Food and Drug Administration (FDA) about the recent Utah District Court ruling on low-dose ephedra products. The American Herbal Products Association (AHPA) full board and executive committee discussed the issue before approaching the Council for Responsible Nutrition and the National Nutritional Foods Association. The joint letter — urging FDA to address issues raised by that ruling promptly — was sent today to Lester Crawford, Acting Commissioner of the Food and Drug Administration, with a copy to Michael Leavitt, Secretary of Health and Human Services.
The United States District Court for the District of Utah ruled on April 13, 2005, that the 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.”
On April 25, in response to the uncertainty surrounding this issue, the AHPA Executive Committee 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.
The letter is posted on AHPA’s website: http://www.ahpa.org/05_0517_Crawford.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