Two days of emotionally charged congressional hearings in July brought lawmakers closer to banning or severely restricting the sale of ephedra dietary supplements, or so it seemed to those in the industry. Some believe such a ruling could have a ripple effect throughout the herbal supplement industry, undermining the Dietary Supplement Health and Education Act.
The hearings, held by the House Committee on Energy and Commerce, examined the manufacturing, distribution and regulation of ephedra supplements. On the first day of hearings, several expert witnesses in the medical sciences gave testimony, as did executives from ephedrine-based product manufacturers. Also testifying were the parents of young men who died after using ephedra, including former Baltimore Orioles pitcher Steve Bechler. The second day of testimony focused on the regulation of ephedra products in professional sports.
Most of the testimony from the scientific community highlighted the potentially negative effects of ephedra, but not without objections. Attorneys and executives from pharmaceutical companies pointed out scientific error and ethics questions in the studies presented.
Robert Hermann, vice president of operations at Metabolife International Inc., said his company supports regulation, as long as it's scientifically warranted.
"We ask only that it is grounded on the rigors of clinical evidence, rather than the hearsay of anecdotal reports," he said. "Clinical trials, not call records from consumers, are the only sound method to evaluate the safety and efficacy of dietary supplements containing ephedra. To my knowledge there is not a single well-controlled clinical study which demonstrates that ephedra supplements are unsafe when taken as directed."
Mark Blumenthal, executive director of the American Botanical Council, said the hearings seemed to have been one-sided, with the scientific panel consisting almost completely of witnesses who support more regulation. "The Food and Drug Administration has been waiting for signs of progress to get backup for more regulation," he said.
Blumenthal wasn't alone in that perception. During the hearing, Cynthia Culmo, R.Ph., a former official with the Texas Department of Health, said, "The situation isn't a scientific issue any longer. It's a political issue, won by a political agenda."
Marc Ullman, of the New York law firm Ullman, Shapiro & Ullman, representing NVE Pharmaceuticals, said lawmakers came out of the hearings with more momentum to create new legislation regulating ephedra and other supplements, but without the evidence necessary to do so. "Politically, the hearings were disastrous for ephedra marketers and the supplements industry in general," Ullman said.
Retailers and marketers in the herb and supplement industries have already felt the shadow cast by ephedra's bad press. "The problem is, this is spilling over into other herbs," Blumenthal said, noting Sen. Dick Durbin's effort to have the federal government closely scrutinize the herb and supplement industry. In March, Durbin, D-Ill., proposed an amendment to the Federal Food, Drug and Cosmetic Act that is widely perceived to have the ability to undo DSHEA. "Ephedra is not representative of the majority of herbal supplements," said Blumenthal.
Diana Roach, certified clinical herbalist and owner of Evergreen Herbal Market in Rio Rancho, N.M., said an all-out ban on ephedra would be nothing short of political backlash that would adversely affect the herbal supplements industry in general. "It's an opportunistic thing to get DSHEA out," she said. "[The FDA] already has plenty of regulatory powers."
Instead of using the stronger Chinese version, Roach uses an American form of ephedra in her allergy formula to open up nasal passages. She said she is not sure what she will do if ephedra is banned, since her allergy formula is probably one of the most popular items in her store.
"When people come into our store asking about ephedra products for weight loss, we make sure to ask about heart conditions and health, and usually try to recommend other products," Roach said. "We also do counseling about how to change diet and exercise."
Blumenthal said ephedra's days are numbered anyway, at least as a weight-loss aid and athletic-performance enhancer. "There has already been a rush toward non-ephedra or ephedra-free weight-loss products," he said. Many conventional retailers, including 7-Eleven, GNC, CVS and Eckerd, have already pulled ephedra-based weight-loss products from their shelves.
Insurance issues have also put a strain on ephedra producers. And, aside from any possible federal restrictions, local jurisdictions are taking regulation into their own hands. Illinois has banned the sale of ephedra, while similar legislation is pending in California, New York and Massachusetts.
Natural Foods Merchandiser volume XXIV/number 9/p. 11