May 2005

Trade associations unite on ephedra

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 three groups are the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA).

The groups are urging their members from selling any supplements containing ephedrine until FDA clarifies the court decision.

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 FDA clarifies what it intends to do about this U.S. District Court decision.

The letter is posted on AHPA’s Web site: www.ahpa.org/05_0517_Crawford.pdf.

Source: American Herbal Products Association, www.ahpa.org

Industry News from:
Chiropractic News from: