Ephedra and FDA

I wish to comment on the article in the February 6 issue headed “Did Delay of Ephedra Ban Cause Unnecessary Deaths?”

I appreciate the reporting done by Psychiatric News on such an important issue in medicine, but there are a few points that merit balance.

As quoted in the article, Sidney Wolfe, director of Public Citizen’s Health Research Group, accused the FDA of “wait(ing) more than two years after Public Citizen first petitioned” the FDA in 2001 to take action against this dietary supplement. This is incorrect.

The FDA began several actions against ephedra products years earlier than this article suggests. The history behind this combustible mix of science and politics has been recently elucidated in a review I wrote titled “Safety Concerns Regarding Ephedrine-Type Alkaloid-Containing Dietary Supplements” for the February issue of Military Medicine.

In fact, the FDA’s attempts to address this issue were curtailed by the Government Accounting Office (GAO). The GAO declared that the science behind the FDA’s stance was lacking but merited more study. Since then, a RAND study was completed providing the needed science-based data to support the FDA’s moving forward again. The language involved in the FDA’s document trail on this issue (see, for example, Federal Register1997; 62:30677-30724) supports that not only was the FDA quite concerned about this particular dietary supplement and its risks to the public health, but that it was also attempting to take action on the issue.

I would offer instead that any finger pointing is more accurately directed at the powerful dietary-supplement industry and lobby, which originally strongly fought the FDA’s regulating efforts but now has advertised itself as taking the lead on removing ephedra products, now that the FDA has finally been successful in its regulating efforts.

More broadly, attention should be paid to re-evaluating the wisdom of the 1994 Dietary Supplement Health and Education Act. By simply labeling dietary supplements as “not to be used to diagnose, cure, mitigate, treat, or prevent disease,” manufacturers can avoid their products being termed “drugs” and thus escape FDA regulation. The law does not require premarketing approval of supplement ingredients or products, or labeling regarding dosing or warnings. Yet dietary supplements have at times not been able to deliver the benefits advertised or to deliver risks not disclosed or discovered as yet, or both. The increasingly potent, highly concentrated substances found in dietary supplements are minimally regulated for safety, let alone effectiveness.

Moreover, while the article noted a few psychiatric complications, the abuse liability of ephedra products has not been well publicized. This has been reviewed in the Military Medicine article noted above and outlined more completely in an extensive case report and review I co-wrote with Christina Waite in the November-December issue of the journal Psychosomatics; the article is posted online at http://psy.psychiatryonline.org/cgi/content/full/44/6/508?.

Ephedra products have been marketed as sexual enhancers and as legal alternatives to illegal stimulants. In fact, some ephedra products have tested positive for controlled substances of abuse, supporting the well-researched quality-control problems inherent in many of these products.