June 2, 1997
Contact:
Mary Burnette
202-872-1488
Long-Awaited FDA Proposal Allows Continued Marketing of Ephedra, But With Strict Restraints
The dietary supplement industry and the Food and Drug Administration (FDA) have been working together for a number of years to address the safety issues associated with ephedra-containing products. Manufacturers are already voluntarily implementing both warning labels and dosage limitations.
In 1996, The Council for Responsible Nutrition (CRN) adopted a policy supporting dosage limits of 10 mg per unit, and a recommendation against product combinations of ephedra with other stimulant ingredients such as caffeine. These recommendations are consistent with the FDA proposal, although FDA's dosage limit is somewhat lower (less than 8 mg per unit).
Some aspects of the proposal go beyond CRN's policy and will have to be evaluated by the CRN membership. These include restricting usage to seven days and disallowing claims relating to weight loss or body building. "While these provisions may be controversial, the industry recognizes that the safety issues surrounding ephedra need to be effectively addressed, and will continue to work with the agency to assure that products are labeled appropriately and used safely," said Annette Dickinson, Ph.D., CRN Director of Scientific and Regulatory Affairs.
At times during this long process of dealing with safety issues posed by ephedra, FDA has claimed that the Dietary Supplement Health and Education Act (DSHEA) of 1994 prevents the agency from effectively dealing with safety issues. This proposal shows that FDA has full authority to assure safety within the provisions of DSHEA.
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