A legal challenge to the Food and Drug Administration's proposed ban on ephedra is most likely on the way, according to regulatory expert Marc Ullman, a partner in the New York law firm Ullman, Shapiro & Ullman. "Companies concerned about product liability with suits in the pipeline would have a great motivation to challenge this," Ullman said. "Other companies that base their business on ephedra may make a determination to challenge this."
On Dec. 30, 2003, U.S. Department of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan, M.D., held a press conference to announce the impending final rule on dietary supplements containing ephedra. The rule, which will effectively ban the sale of ephedrine alkaloid-containing supplements, states: "Dietary supplements containing ephedra present an unreasonable risk of illness or injury." At press time, the final rule was scheduled to be published in the Federal Register by the end of January and go into effect 60 days after publication.
The FDA also issued a consumer alert and sent letters to 62 manufacturers telling them that as soon as the rule takes effect, they must stop selling ephedra products. Illinois, California and New York had already banned ephedra sales. According to the FDA's Web site, "The rule does not pertain to traditional Chinese herbal remedies. It generally doesn't apply to products like herbal teas that are regulated as conventional foods."
Major industry groups such as the Council for Responsible Nutrition and the American Herbal Products Association stated that they will most likely not object to FDA's ban as outlined at the press conference, but they'll make a final review when the rule is published.
The February 2003 death of Baltimore Orioles pitcher Steve Bechler became a lightning rod for the controversy surrounding the ephedra issue and, by extension, the Dietary Supplement Health and Education Act of 1994. Thompson referred to DSHEA at the press conference as "a very controversial law" and commented that he had "already indicated that I would like to see the law changed."
Mark Blumenthal, founder and executive director of the American Botanical Council, said "The main point of the ban is that it shows that the FDA does have the power and the authority to remove what it deems to be unsafe supplements from the market."
Blumenthal and Ullman agree that the current steps on ephedra may be FDA's political ploy for major revisions to DSHEA. "If challenged, the way it's going to be played in the media and in Congress is that this is a problem with DSHEA, and we need to either fix DSHEA, amend DSHEA or repeal DSHEA," Blumenthal said.
Both men fear if a legal challenge overturns the FDA's rule on ephedra, it could further solidify opposition to DSHEA.
Industry consultant Loren Israelsen, president of LDI Group Inc., believes that FDA did not have political underhandedness in mind when banning ephedra. But he also believes that change is on the way nonetheless. "I view it as being the Siva principle at work—we are in the process of creative destruction. We will see profound change in how we are regulated one way or another. That can be a very positive change if done in an enlightened way," Israelsen says. "If we're too selfish, we risk losing it all. If we're too flabby and soft on it, we risk getting run over. This is going to be Mr. Toad's Wild Ride. Is it good or bad? You know what? It's both. And the outcome still is in our hands."
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