In an announcement that caps years of warnings regarding the herbal supplement ephedra, Health and Human Services Secretary Tommy Thompson advocated the "strongest possible mandatory warning label" for all ephedra products on October 8. Ephedra, which goes by the names of ma huang, ephedrine, sida cordifolia, and epitonin, has been used in China for thousands of years. This chemical elevates blood pressure, stimulates the sympathetic nervous system and the heart, increases perspiration, and suppresses appetite, among other effects. In the United States, these characteristics have turned ephedra into a popular component of numerous weight loss, energy enhancing, and sports performance supplements. Common name brands include Metabolife 356, Stacker 2, and Natural Trim.
Extracted from several plant varieties, ephedra’s status as an herbal supplement rather than a prescription drug has allowed distributors to elude the strict standards of the Food and Drug Administration (FDA) in the past. However, two high-profile studies published by the Mayo Clinic Proceedings and the New England Journal of Medicine have helped bolster the case against ephedra. The reports found that ephedra use was correlated with stroke, myocardial infection, hypertension, seizures, and other cardiovascular and central nervous system afflictions.
Additionally, an August Senate hearing chaired by Dick Durbin (D-IL) emphasized FDA data linking ephedra to 81 deaths and 1400 other complications over a seven-year period. These complications included heart attack, stroke and high blood pressure. The American Medical Association (AMA) has been urging the FDA to remove ephedra products from the US market since January. The Canadian counterpart of the FDA has already done so.
In June, Thompson authorized a study conducted by the RAND Corporation that hopes to clarify questions surrounding dosage, uses, and harmful effects of the herb. In the meantime, Thompson has begun cracking down on manufacturers of synthetic ephedra, which is an illegal drug. Furthermore Metabolife, the largest US manufacturer of ephedra, is currently under investigation by the Justice Department.
Although the results of the RAND study have been delayed from their fall release date, Thompson has already urged the FDA to endorse “the strongest possible mandatory warning label” for ephedra products. The FDA has also announced its intent to verify that all currently marketed ephedra is natural, rather than the synthetic and illegal version. The RAND Corporation findings will determine whether further measures will be taken against the controversial supplement.
Sources
http://www.fda.gov/bbs/topics/NEWS/2002/NEW00844.html
http://www.cnn.com/2002/HEALTH/06/14/hhs.epedra/index.html
http://www.kcweb.com/herb/ephedra.htm
http://durbin.senate.gov/~durbin/new2001/press/2002/08/2002904B58.html
Mayo Clin Proc. 2002 Jan;77(1):12-6
N Engl J Med 2000 Dec 21;343(25):1833-8
