Ephedra is illegal again—even at 10 milligrams and even in Utah. But that might only be temporary. And no matter what transpires, all supplements may be affected.
The legal saga of ephedra, which began almost before the Dietary Supplement Health and Education Act of 1994 gave supplements a legal home, hit its newest milestone in a ruling by a three-judge panel of the 10th U.S. Circuit Court of Appeals in Denver. The Aug. 17 ruling overturned an April 2005 ruling by Utah Judge Tena Campbell essentially allowing low-dose ephedra to be legal in that state—which was a reversal of the U.S. Food and Drug Administration's 2004 ruling to pull all ephedra from the market.
Jonathan Emord, attorney for the plaintiffs, Park City, Utah-based Nutraceutical Corp., said his clients will appeal the ruling to the full 10th Circuit Court of Appeals.
According to Susan Brienza, an attorney in the Denver office of Patton Boggs LLP, "The plaintiffs argued that the FDA did not have strong enough evidence to ban low-dose, 10-milligram ephedra. And No. 2, the FDA was wrong in applying a risk/benefit analysis." Brienza noted that risk/benefit analysis is typically used to judge drug safety. The 10th Circuit ruled for the FDA on both issues.
Mark Blumenthal, executive director of the American Botanical Council, said while there are political and public relations issues involved in the ephedra situation, which "a whole section of the supplement industry wants to go away," the main concern is one of science. "The real issue here from a science point of view is to what extent [FDA's judgment of] zero tolerance for ephedrine alkaloids is scientifically sustainable. The way I understand the decision, there's no tolerance for any level of ephedrine alkaloids in any dietary supplement."
In fact, the issue of science and FDA's authority to evaluate the safety of supplements may, from a legal standpoint, be greater than seen at first glance. "The court has decided for the future what the standard is by which the FDA is permitted to judge the safety of any supplement," Brienza said. "The appellate opinion gave deference to the FDA on both the evaluation of the scientific evidence and on the safety standard." She added that she agreed with American Herbal Products Association President Michael McGuffin that the case will set a precedent for the determination of safety for all supplements.
"FDA refused, in its rulemaking process, to acknowledge any benefits for ephedra, even for traditional uses. If the benefit side is judged as 'zero,' the outcome of any risk/benefit analysis will necessarily be skewed," McGuffin said in a release. "But this court has now specifically stated that FDA's risk/benefit mechanism 'correctly followed the Congressional directive,' and industry will need to evaluate the implications of this as precedent."
Blumenthal added that with herbal dietary supplements the difficulty of a risk/benefit analysis is magnified because there "are no officially recognized benefits, which means the risk will always seen to be greater."
And while traditional uses of the herb, such as traditional Chinese medicine, have been protected in all of the ephedra rulings, Blumenthal said that in practice the issue is more complex. "The crackdown does affect the ability of legitimate [health care professionals] from being able to get ephedra herbal formulations. … It does affect your freedom of choice as a health consumer and the scope of practice for some licensed health care professionals."
Natural Foods Merchandiser volume XXVII/number 10/p. 17