Court Backs FDAs Ephedra Ban, Risk-Benefit Ruling

DENVERA three-judge panel of the 10th U.S. Circuit Court of Appeals here issued a ruling Aug. 17 that the Food and Drug Administration (FDA) adhered to Congressional mandate in conducting a risk-benefit analysis to determine if ephedra presents an unreasonable risk of illness or injury. This ruling in support of the FDA ban on ephedra at any dose reverses the April 2005 ruling by Salt Lake City federal judge Tena Campbell, who ruled not only did FDA err in using risk analysis to support its ban of ephedra, but her judicial review also found no evidence to support FDAs conclusion that 10 mg per day of ephedra presented a significant or unreasonable risk.

The worry is that the FDA can say to anyone, We dont like you, youre out of here, said attorney Jonathan Emord, whose firm Emord & Associates represents Nutraceutical Corp., one of the original companies to challenge the FDA ban last year. He noted the Park City, Utah-based company will seek a hearing in front of the entire 10th Circuit. The petition calls for all 19 judges of the circuit to review the decision of the three-judge panel, he reported. If the petition is denied, Nutraceutical Corp. will appeal the matter to the U.S. Supreme Court.

While some debate the implications the ruling has on the public perception of the safety or efficacy of ephedra and other herbal products, there is more concern about FDAs use of the risk-analysis paradigm and how the courts interpretation of the Dietary Supplement Health and Education Act (DSHEA) could affect the industry going forward.

Few reputable companies rushed out to put ephedra products back on the shelves following the Campbell decision. In fact, trade groups such as the American Herbal Products Association (AHPA) advised members to avoid a hasty return to marketing ephedra. In a sense, the industry largely knew this FDA rulemaking was something we were going to have to live by, and this recent court ruling just clarified it, said Michael McGuffin, president of AHPA. This came as no big surprise. He said while the issue of ephedra is important, the other issue with the ruling is the precedent it sets for FDA assessment method as well as how the industry is going to regroup and figure out how to operate under this type of rulemaking.

The challenge in this new FDA risk-benefit assessment precedent is the agency can tip the scales against a product by considering a products benefit as nonsignificant. With the benefit at zero, FDA then needs only to find any level of risk to reach an unreasonable risk of illness or harm, said McGuffin. For instance, ephedra helps people lose weight, which FDA did not consider a significant benefit, noting the loss is a mere pound per month. He noted the second benefit associated with ephedra is based in Traditional Chinese Medicine and relates to bronchial congestion. But using this benefit for ephedra would put it in the area of drug use, so that does not apply to dietary supplements, he said. Thus [FDA] assigns the benefit of ephedra to zero, and any of the reported risks would tip the scales. ... This is the precedent the ruling establishes.

Marc Ullman, a partner at the firm Ullman Shapiro & Ullman, added many herbs are noted for benefits that FDA can easily deem convenience benefits or not major health-wise. However, he noted the significance of this and other related rulings is the apparent narrow view the courts are taking on the de novo clause of DSHEA.

Normally when an administrative agency takes action, unless Congress has expressly said otherwise, the courts are supposed to give great deference to the agencyas long as its decision was made according to the agencys area of expertise, he explained. So the courts arent supposed to question agency fact finding, unless Congress tells them to go back to square one. De novo is a Latin term used in law to mean starting over or anew. Under a broader view, the de novo clause in DSHEA would mean FDAs rulemakingin this case a risk-benefit assessmentwould be reopened and scrutinized. However, Ullman pointed out in recent rulings on ephedra, the courts have construed that de novo clause in DSHEA very narrowly. The courts have basically said Congress wasnt clear, so we are not going to apply that fresh look analysis to administrative rulemaking decisions; thats their area of expertise and Congress hasnt told us to go back to square one. So they will only take that de novo approach when FDA takes specific enforcement action against somebody, he noted.

A copy of the 10th Circuit and U.S District Court rulings are available from Emord by calling (202) 466-6937.