FDA Concerned About Ephedra Alternatives

OXFORD, Miss.--In a Jan. 20 address at the University of Mississippi, Mark McClellan, M.D., Ph.D., commissioner of the Food and Drug Administration (FDA), discussed his continuing concerns with dietary supplements. He also reported how Ole Miss will be helping the agency allay these concerns via research being conducted at the school's Cochran Center.

One issue McClellan touched on was how there are currently supplements in the marketplace with chemically distinct and less well understood components than ephedra that may have similar adverse pharmacologic effects or pose health risks for other reasons. We are particularly concerned about the possible health impacts of the growing number of ephedra alternatives now on the market, he said. Some of these contain ephedrine alkaloids that will be covered under the new rule, and we will be taking those off the market soon--though again, I think any responsible manufacturer or distributor would do that now.

Particular dietary ingredients McClellan singled out included bitter orange (Citrus aurantium), aristolochic acid and usnic acid, which is derived from lichens. FDA issued consumer advisories about aristolochic acid and usnic acid in 2001.

McClellan also went into detail about how FDA and Health and Human Services (HHS) plan to approach verifying the safety of supplements. We will work actively to identify the highest priority areas to develop such evidence and work with partners in the public and private sector to improve the evidence base, he said. With good manufacturing regulations, it will be easier to compare and evaluate products based on accurate information on their active ingredients. I know the Cochran Center is working on many ideas that can help along this effort to improve the safety and effectiveness of dietary supplements used by Americans.

McClellan said FDA will be doing more work in the coming months to more closely evaluate the potential safety risk of these products. McClellan added FDA may take further action to remove unsafe dietary supplements from the market if they pose an unreasonable risk to the public health.