Industry awaits FDA’s reaction to ephedra action

Two major industry associations have urged their members to refrain from selling ephedra until judicial and regulatory processes are resolved, in the wake of a US District Court ruling in April that the Food and Drug Administration erred in its sweeping ban on the herbal supplement ephedra.

?In response to the uncertainty surrounding this issue, the American Herbal Products Association Executive Committee has decided to advise AHPA members to refrain from offering for sale any ephedrine-containing dietary supplements,? explained president Michael McGuffin. ?We fully expect the FDA will appeal this decision. Nearly every attorney we have talked to has told us that the FDA does not take a defeat without an appeal. Whether they will succeed, we don?t know.?

The other group, the Utah Natural Products Alliance (UNPA), issued a similar statement to its members.

Meanwhile, a rash of editorials in American newspapers have come out blasting the court?s decision, some using the issue as a springboard to attack the efficacy of the Dietary Supplement Health Education Act.

?I estimate about 98 per cent of the papers that have picked up on this issue have taken the position that DSHEA isn?t working,? said Loren Israelsen, executive director of the UNPA. The Orlando Sentinel has taken a particularly aggressive stance.?

The more influential New York Times called the court decision ?disappointing? and concluded that the FDA?s ?lack of authority to issue a blanket ban on ephedra ? is a clarion call to the Bush administration and Congress to change the 1994 law.?

It is this kind of language that worries Israelsen. ?I am concerned that some feel ephedra symbolizes what is wrong with the dietary supplements industry and what is wrong with DSHEA. In the past 10 years, there have been a number of bills attempting to change or gut the law, and those congressional critics will use this court ruling as further ammunition.

?I believe as an industry, we are best served by focusing our efforts on the full and proper implementation of DSHEA ? with respect to GMPs, developing analytical methods, new and old dietary ingredients policies, qualified health claims and reimbursement of supplements for personal health savings accounts. All those issues tend to be diminished because inevitably, the conversation seems to turn back to ephedra.?

In the Utah court?s ruling, the judge concluded that the FDA failed to meet its burden of proof that dosages of 10mg or less per day of the ephedrine alkaloids found in ephedra present an unreasonable risk of illness or injury. The court also concluded that the FDA?s use of a risk-benefit analysis in determining an unreasonable risk of ephedrine-containing dietary supplements was ?improper.?

While this ruling effectively opens the door to sales of ephedra under 10mg, former major ephedra suppliers do not appear to be rushing back to market.

?We have no plans to reintroduce ephedra at this point,? said a spokeswoman at Metabolife. ?I haven?t heard of any such plans.?

The company that filed the lawsuit, Utah-based Nutraceutical Corporation, also does not intend to resume sales.

Such inactivity in the wake of the court?s ruling may be due in part to the fact it is widely known ephedra dosages as low as 10mg do not have any effect on weight loss — which was its major target market in the US. In fact, AHPA has issued a statement to its members reminding them of that fact. Prior to the ban, the FDA received 18,000 reports of adverse events, including 164 deaths. To his knowledge, however, virtually all of these were for high-dose ephedra extracts that were sold in supplements that also contained caffeine, Israelsen said.

Ephedra, also known as ma huang, grows mainly in Mongolia and the bordering regions of China. Because its ephedrine alkaloids act as a mild stimulant, it has been used for about 5,000 years as a natural remedy for symptoms of asthma, allergies and sinus problems.

In China, the production and distribution of ephedra preparations is tightly controlled by a permit system; only a few companies are permitted to produce such preparations, which are then handled by a designated distributor in each major region of the country. While found in traditional Chinese medicine preparations, ephedra is not sold as a dietary supplement.

Though there is no pan-European ban, most EU member states have imposed strict restrictions on ephedra?s use, and in many countries, including the UK, only an herbalist is allowed to dispense it.