Ephedra Exceptions

Last week Nutraceutical Corp. filed a federal lawsuit challenging the Food and Drug Administration's ban on ephedra products. Among other things, the complaint notes that the FDA continues to allow the sale of ephedra tea, which is treated as a food. In a press release, the company's attorney, Jonathan Emord, says:

Nutraceutical and Solaray [its subsidiary] have marketed whole-herb ephedra as a dietary supplement since at least 1988. This is the same ingredient found in ephedra tea that remains on the market, even today. Nutraceutical and Solaray's product contains 10 mg or less of naturally occurring ephedrine alkaloids per daily serving, while ephedra tea can have as much as 30 mg of ephedrine alkaloids per cup. We think the disparate treatment of dietary supplements and food is clearly arbitrary and capricious.

In his book Why Is America So Fat?, health food store owner Ben Kennedy highlights another inconsistency: Several over-the-counter remedies, including Primatene Tablets, Bronkaid, and Quelidrine Syrup, contain ephedrine, while many others contain pseudoephedrine, a similar stimulant also found in ephedra. He argues that the FDA's decision to focus on nutritional supplements marketed for weight loss reflects the political clout of the big pharmaceutical companies. It also reflects the FDA's judgment that weight loss is not an important enough application to justify the (admittedly small) risk posed by ephedra--a judgment that Emord argues the agency does not have legal authority to impose on consumers. And it presents an opportunity, should the ban be overturned in court, to demand more regulatory authority over nutritional supplements.

Comments

[Allen Glosson]

The regulation is coming anyway. See this article from the Life Extension Foundation about an effort in Europe to severely restrict all dietary supplements.

In fact, the LEF, either directly, or by proxy, has been fighting the FDA for years regarding claims for dietary supplements. The FDA continues to lose these cases and, as is the wont of most government agencies, refuses to comply with federal court orders.

[Dave S.]

It seems pretty odd that they would ban it when used as a dietary supplement for weight loss, but keep it legal when used as a brochodilator. But hey, if you are feeling sleepy, at least you can still get a cheap speed buzz at the 7-11.