HHS Proposes Stronger Ephedra Regs, Ban Still Possible

WASHINGTON--The Department of Health and Human Services (HHS) released a bevy of information today regarding the future of dietary supplements containing ephedra and ephedrine alkaloids. HHS' press conference took place only a couple of weeks after a major league baseball player's death was linked in the media to an ephedrine-containing product. "We want to caution all Americans--particularly athletes and those who engage in strenuous activities--about using dietary supplements that contain ephedra," said HHS Secretary Tommy Thompson. "There continue to be serious questions about the risks surrounding this particular dietary supplement."

FDA Commissioner Mark McClellan, M.D., Ph.D., was also on hand to drive home the point of combining hardcore workouts with a product containing ephedra, caffeine and other stimulants.

While most of the actions announced Feb. 28 regard the weight-loss side of this controversial herb, FDA sent 24 warning letters to manufacturers of sports supplements containing ephedra or ephedrine alkaloids and that do not provide substantiated claims for sports performance. The companies have 15 days to respond with substantiation for their claims. Among the companies on the receiving end of these letters are major sports supplement players such as Twinlabs, AST Sports Science, Natural Balance and Universal Nutrition.

Michael McGuffin, president of the American Herbal Products Association (AHPA), stated that FDA has the authority under the Dietary Supplement Health and Education Act (DSHEA) to go after companies that do not substantiate claims. "I agree with FDA for removing products from the marketplace without substantiated claims."

John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition (CRN), reported that there has been a number of studies supporting enhanced athletic performance with ephedra consumption, including a recent one involving the Canadian military. "But we are pleased HHS is taking these actions, such as posting these labeling requirements, to limit harm to consumers," he said, adding CRN will comment on the proposed rule.

HHS also announced the results of the RAND Corp. study, commissioned in June 2002 by the National Institutes of Health regarding the benefits and risks of ephedra and ephedrine alkaloids. Of the 20 studies that met the company's criteria for quality research, there was limited evidence supporting the use of ephedra for short-term weight loss, although it appeared that both the combination of ephedra and caffeine and ephedrine alkaloids and caffeine had similar weight-loss benefits. "The RAND report . finds only limited evidence of health benefits resulting from ephedra use," HHS stated. "[T]here are reasons for heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury."

The authors of the RAND study concluded ephedra was associated with higher risks of mild to moderate side effects that included heart palpitations, psychiatric and upper gastrointestinal effects, and autonomic hyperactivity such as tremor and insomnia, especially when taken with other stimulants. In its review of 16,000 adverse event reports (AERs), the authors stated there were two deaths, four heart attacks, nine strokes, one seizure and five psychiatric cases linked to ephedra use in which records appeared through and no other contributing factors were identified. However, the authors noted the cases show no causality, and that such events may have happened anyway given the number of ephedra users.

In matters of ephedra product marketing, HHS stated a comment period is currently open for a Feb. 28 Federal Register proposed rule covering product labeling. The labeling would begin with "WARNING: Contains ephedrine alkaloids. Heart attack, stroke, seizure and death have been reported after consumption of ephedrine alkaloids."

According to David Seckman, executive director of the National Nutritional Foods Association (NNFA), the industry submitted a similar warning label for government approval years ago, albeit without "death" as a possible side effect. Is this FDA's way of making consumers stay away from products containing ephedra and ephedrine alkaloids without banning them? "FDA has the authority to ban them, but it doesn't have the scientific evidence--that's an awfully high burden of proof it has to meet," Seckman said.

The notice also questions the extent of FDA's regulatory reach when overseeing these types of supplements. In the HHS press release, McClellan alluded to FDA's uncertainty over how to effectively oversee products containing ephedra and ephedrine alkaloids. "The standard for regulating the safety of dietary supplements is largely untested, but we are committed to finding the right public health solution," he said.

Seckman postulated, "FDA is looking to see if they should be given more authority--or a different kind of authority--to regulate ephedra supplements." NNFA will be commenting on the proposed rule under which FDA asks for direction regarding its authority.

Interestingly, HHS reported that synthetic ephedrine products, which are regulated as drugs and carry mandatory warning labels, "have not been associated with the same kind of severed adverse events as have occurred with dietary supplements containing ephedra. This long experience with synthetic ephedrine suggests that significant restrictions on labeling, marketing and access to ephedrine might effectively address unreasonable risks associated with certain forms of ephedra."

"Although the overall evidence suggests that serious adverse events from ephedra appear to be infrequent," McClellan stated, "we know that such events can be very serious and possibly fatal. . We also believe that FDA's system for regulating synthetic versions of the chemicals in ephedra appear to have a much better track record of safety. To give us the strongest possible basis for further regulatory action, we are asking for quick comments on whether these dietary supplements present an unreasonable risk of harm, and whether it makes sense for FDA to seek new authority in the area."

According to McGuffin, he finds McClellan's view on the safety profile of synthetic ephedrine hard to believe. "AERs for ephedra were available to the public for years, while AERs for synthetic ephedrine have never been made public," McGuffin said. AHPA will also be submitting comment.

The notice can be found at www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-npr0003.pdf. Comments regarding the notice must be received by April 7 via www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm.

In additional ephedra news, on March 17 the National Advisory Council for the National Center for Complementary and Alternative Medicine (NCCAM), part of NIH, will assess the evidence on ephedra's safety and efficacy to develop a research agenda regarding the herb.

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