CU urges FDA to address a Utah District Court opinion on Ephedra



April 21, 2005
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
VIA FACSIMILE: (301) 443-3100
Dear Dr. Crawford:
Consumers Union, Publisher of Consumer Reports magazine, is deeply concerned about an opinion issued by a Utah District Court last week allowing low doses of ephedra back on the market, and potentially impacting the ability of the Agency to ban as adulterated even higher doses of ephedra or other dangerous dietary supplement products.
Unfortunately, the Court decided that the Agency: (1) was wrong to weigh the supplements risks against its minimal benefits; and (2) presented insufficient evidence to ban low-dose ephedra products. The decision will allow the plaintiff manufacturers to market their dietary supplements containing a 10 mg or less daily dose of ephedrine alkaloids. We urge the FDA to vigorously defend its ability to take action against dangerous supplements and appeal the District Court’s decision. We also strongly urge the Agency to ask Congress for the clear authority to ban dangerous products such as ephedra, and to mandate that dietary supplement manufacturers tell the FDA when they become aware of serious injuries associated with the use of their products.
In addition, we would like to alert the Agency to the current sale of products that appear to violate the Agency’s ephedra ban, and an advertisement assuring consumers that the ephedra ban is no longer in effect. The site states:

    Ephedra Ban Lifted! A Federal Judge has invalidated the Ephedra Ban! Get your Ephedra based Fat Burners here today! Check out our entire line of Ephedra Based Fat Burner Products here Click here to view
Our review of the ingredients of the products advertised on the above website reveals products that contain Ma Huang or ephedra in doses of up to 2000 mg. We urge the Agency to increase its monitoring to discourage ephedra makers from attempting to take advantage of the Court’s decision, and to take immediate enforcement action to halt sales of ephedra-containing dietary supplements in violation of the Agency’s ban.
Thank you in advance for your attention to this important public safety concern.
Sincerely,
Janell Mayo Duncan
Legislative and Regulatory Counsel
Washington Office