February 28, 2003 (Austin, TX) The Department of Health and Human Services and the Food and Drug Administration this afternoon released the long-awaited report from the RAND Corporation on the safety and efficacy of ephedra dietary supplements. The report, titled, "Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects" was produced by an independent scientific and medical committee under the auspices of the RAND Corp. and is available at www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.
FDA also issued a press release "HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra" in which the agency explained that it was proposing regulations on the warnings of the labeling of ephedra supplements with a 30-day comment public period (www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html).
FDA's proposed regulations are on Docket No. 95N-0304, OC 200362: "Dietary Supplements Containing Ephedrine Alkaloids; Reopening of the Comment Period." The public comment period closes on April 7, 2003 (available at www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-npr0003.pdf).
FDA's proposed rules include so-called "black box" warnings, in which specific warnings are posted in bold in a black box on the primary label of the product with additional black box warnings to be included in other labeling literature.
According to FDA's release, "To protect Americans from the potentially serious risks of these dietary supplements, HHS and FDA are going to:
- Seek rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record as quickly as possible to support new restrictions on ephedra-containing products.
- Seek rapid public comment on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra.
- Seek rapid comment on a strong new warning label on any ephedra products that continue to be marketed.
- Immediately execute a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement.
During a press conference with herb industry associations, FDA's Christine Lewis Taylor said that the agency had sent warning letters earlier today to 26 companies who were selling ephedra products for sports and athletic performance enhancement, a claim the agency does not consider appropriate or warranted.
In addition HHS Secretary Tommy Thompson and FDA Commissioner Mark McClellan MD, PhD, issued strong warnings to the American public on the potential risks associated with using ephedra in strenuous sports-related activities, in diet programs that stress the cardiovascular system, when used for extended periods of time, or when used with caffeine and other stimulants.
"We want to caution all Americans - particularly athletes and those who engage in strenuous activities - about using dietary supplements that contain ephedra," said Secretary of Health and Human Services Tommy G. Thompson. "There continue to be serious questions about the risks surrounding this particular dietary supplement."
"FDA will do all we can to protect Americans from potentially dangerous dietary supplements," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. "We are particularly concerned about the risks of using products containing ephedra during heavy workouts, with caffeine and other stimulants, in a diet program that stresses the cardiovascular system, or by people under the age of 18. We are also concerned about potential stresses to the body caused by the long-term use of ephedra. The standard for regulating the safety of dietary supplements is largely untested, but we are committed to finding the right public health solution."
The FDA release attempts to summarize the RAND report:
"The RAND study has concluded that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants. Moreover, its review of some 16,000 adverse event reports revealed two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases involving ephedra in which the records appeared thorough and no other contributing factors were identified. RAND called such cases 'sentinel events,' because they may indicate a safety problem but do not prove that ephedra caused the adverse event. The study recognized that such case studies are a weak form of scientific evidence. Other unmeasured factors may have contributed, and such serious adverse events are likely to happen (albeit at very low rates) among the millions of users of ephedra anyway. The study also identified other such events potentially associated with ephedra, in which other factors may have contributed to the adverse events or in which records were inadequate."
A sentinel event is an "early warning to suggest that certain populations may be susceptible to specific adverse effects," according to Richard Kingston, PharmD, of Prosar International Poison Center in Minneapolis, a leading expert in product safety and post-market surveillance. "Hopefully, this will allow closer scrutiny of these types of events to search for any cause-effect relationships," he added.
Of particular additional interest to ABC members is that FDA's Dr. Taylor said that Agency believes it can take appropriate measures to deal with ephedra under the provisions of DSHEA. However, she noted that if people think that DSHEA is inadequate, they can submit comments as to whether legislative initiatives should be taken to amend DSHEA to deal with ephedra safety. This appears to be an invitation to various members of the public to call for Congressional action to modify DSHEA and produce more stringent legislation to regulate ephedra, and possibly by extension, other herbal supplements as well.
Additional information on ephedra, including safety issues and recent regulatory history, is available in ABC's Ephedra monograph from its new book The ABC Clinical Guide to Herbs, available on the ABC website (to be posted at www.herbalgram.org on March 1).
Founder & Executive Director
American Botanical Council
P.O. Box 144345, Austin, TX 78714-4345
tel: 512-926-4900 fax: 512-926-2345
Contact: Cheryl Dipper
American Botanical Council
P.O. Box 144345
Austin, Texas 78714-4345
Phone: 512/926-4900, ext. 121