WASHINGTON, DC—Ephedra’s days are numbered as an herbal weight loss aid.
Late last year, the Food and Drug Administration stated that it intends to ban ephedra as a dietary supplement for weight loss later this year. Similar botanicals promoted for weight control, including Bitter Orange, may be next. Though the final ruling has not yet been issued, supplement makers are already pulling back from marketing products containing the embattled herb.
Ephedra has been under FDA scrutiny since 1994, when a cluster of 200 adverse events associated with an ephedra product was reported in Texas.
For the better part of the 1990’s, the American Herbal Products Association “25/100” guideline was deemed acceptable by FDA. The guideline suggests that a single serving dose of 25 mg ephedra, and a maximum daily intake of 100 mg, would safeguard against adverse effects, which can include increased heart rate, elevated blood pressure, and nausea. In 1997, FDA added a limit of no more than 7 consecutive days of use to its safety recommendation.
Sale of ephedra products soared in the late ’90s, reaching 3 billion “servings” per year in the US for weight loss and enhancement of athletic performance.
The herb has always had its critics, but there was no strong imperative to ban it until the sudden death last March of Steve Bechler, the Baltimore Orioles rising star pitcher, who was taking the herb to enhance his field performance. His death, at age 23, was partially attributed to ephedra, and it followed several other ephedra-associated deaths among high profile professional and college athletes. Consumer advocacy groups including Public Citizen called loudly for a ban.
To date, there have been roughly 1,500 ephedra-related adverse events reported to the FDA. Supplement makers have logged more than 18,000 complaints associated with ephedra products, but only 300 frank adverse events.
Most reports are poorly documented, acknowledged Johanna Dwyer, Dsc, RD, senior scientist at the National Institutes of Health’s Office of Dietary Supplements. Speaking at a conference on obesity sponsored by the Food and Drug Law Institute, Dr. Dwyer noted that there are just over 150 well-documented adverse events in the medical literature.
In 2000, an Arthur Anderson survey commissioned by herbal trade associations showed that adverse events rates were declining despite rising ephedra sales.
Nonetheless, FDA opted to err on the side of caution, prompted in part by two very recent studies in the Journal of the American Medical Association. The first, a metanalysis of 52 controlled trials and 65 case reports, showed that at dose levels of 60–80 mg per day, products containing ephedra or ephedrine alone or in combination with caffeine produced a 2–3 fold greater risk of nausea, vomiting, psychiatric symptoms, and autonomic hyperactivity compared with placebo (Shekelle PG, et al., JAMA 2003; 289(12): 1537–1545).
The second study showed, among other things, that a botanical combination called Metabolife 365 containing 20 mg ephedra, produced measurable changes in heart rate, blood pressure and QT intervals at 1, 3 and 5 hours after ingestion. The authors concluded that these changes do suggest potential for heart problems, although they did not document any in their cohort (McBride BF, et al., JAMA 2004; 291(2): 216–221).
Ephedra is a sympathomimetic amine with norepinephrine-like effects on hypothalamic satiety centers, explained Dr. Dwyer. It is thermogenic, and also lypolytic, owing to its ability to stimulate beta-receptors in brown fat.
Several studies show ephedra does, indeed, produce measurable weight loss. Shekelle and colleagues showed that a dose of 60–80 mg per day, the herb burns 2 pounds per month. Another trial showed that ephedra alone burns roughly 1 pound per month more than placebo. When combined with caffeine, this increases to 2.5 pounds. Contrary to all the advertising hype, there is no evidence that ephedra improves athletic performance.
Supplement companies are promoting other herbs as substitutes for ephedra. The leading candidate is Bitter Orange (Citrus aurantium), which contains several sympathomimetic alkaloids, including synephrine. At doses of 10–40 mg, synephrine in Bitter Orange can induce weight loss by stimulating lipolysis and increasing basal metabolic rate. FDA is not convinced that Bitter Orange is any safer than ephedra. Scrutiny of this herb is likely to be intense.
Many herbal medicine experts and industry representatives believe FDA’s ephedra ban is misguided, and that a useful herb is being maligned not because of its inherent risk but owing to gross misuse. Ephedra has a long history of safe use in traditional Chinese medicine (TCM). It is widely used in combination with other plants to treat respiratory conditions. The potential cardiovascular changes are well documented in classic Chinese medical texts, which detail how to attenuate these effects with other botanicals.
FDA has stated that use of ephedra in TCM will be sheltered from the ban on weight loss products. In practice, however, the stigma associated with ephedra could make the herb difficult to obtain in the near future.
Mark Blumenthal, founder of the American Botanical Council, a non-profit herbal education organization, said the one positive effect of the FDA’s ephedra ban is that it puts to rest the often-heard complaint from supplement critics that under existing federal policies, the FDA is rendered powerless to ensure public safety.
“Clearly, FDA is fully empowered to take action and pull products off the market without any changes to existing federal regulations,” Mr. Blumenthal told Holistic Primary Care.
