April 21, 2005
Consumers Union, Publisher of Consumer Reports magazine, is deeply concerned about an opinion issued by a Utah District Court last week allowing sales of products containing low doses of ephedra — a dietary supplement ingredient linked to serious adverse events, including heart attacks, strokes, and death. The decision potentially impacts the ability of the Agency to ban as adulterated even higher doses of ephedra or other dangerous dietary supplement products.
We strongly support the FDA ban on ephedra on the grounds that it presents “an unreasonable risk of illness or injury.” Unfortunately, the Court decided that the Agency: (1) was wrong to weigh the supplement’s risks against its minimal benefits; and (2) presented insufficient evidence to ban low-dose ephedra products. The decision will allow the plaintiff manufacturer to market its dietary supplements containing ephedrine alkaloids of 10 mg or less per daily dose. The Court’s interpretation of the Dietary Supplement Health and Education Act (DSHEA) incorrectly calls into question the agency’s implementation of the Act, including its ability to weigh the benefits against the risks of supplements—a core precept of FDA regulation.
Today, in a letter to FDA Acting Commissioner Dr. Lester Crawford, Consumers Union urged the Agency to vigorously defend its regulatory authority by appealing the Utah Court’s decision. We also strongly urged the Agency to ask Congress to clarify that DSHEA provides it with authority to ban dangerous products such as ephedra, and for new authority to mandate that dietary supplement manufacturers report all adverse events that may be related to the use of their products. The latter will help FDA gather the evidence it needs to demonstrate the risks of dangerous supplements and protect the consuming public.
Finally, we alerted the Agency to new promotions of banned ephedra products emerging in the wake of the Court decision. Many of the products featured appear to violate the Agency’s ephedra ban. At least one web site assured consumers that the ephedra ban is no longer in effect. No doubt this is just one example of new attempts to market dangerous ephedra products following the Court decision. 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 (http://www.easypricematching.com/Categories.asp?idcategory=39&overture=55)
We have urged 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.
Attached is an editorial from today’s New York Times, entitled “Time to Ban Ephedra.” The editorial expresses disappointment in the Federal Court’s decision, and describes it as a “clarion call” to Congress to “enact overdue legal revisions that will significantly strengthen the agency’s power to monitor and police the supplement industry.”
Consumers Union urges Congress to act quickly to reform DSHEA to make clear that the FDA has the authority it needs to ban dangerous products such as ephedra, and to grant FDA the authority to mandate that dietary supplement manufacturers report all adverse events that may be related to the use of their products.
Janell Mayo Duncan
Legislative and Regulatory Counsel