Ephedra: The FDA Decision
Chester J. Zelasko, Ph.D. | January 13, 2004

Ephedra, also known as ma huang, has been a popular weight loss supplement for several years. It has gained notoriety because 137 deaths have been linked to its use for weight loss and athletic performance, including several well-known athletes.

In a ruling given on December 30, 2003, the U.S. Food and Drug Administration concluded that dietary supplements containing ephedrine alkaloids (such as ephedra) present an unreasonable risk to the public health and are adulterated and unacceptable under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act. After 60 days, manufacturers will no longer be able to sell the product (1). The delay is to allow Congress to examine the rule banning products containing ephedra. For all intents and purposes, the product will be banned around March 1, 2004.

The reason for the ban is the adverse effects. You probably know someone (or are someone) who used ephedra for weight loss--it's obviously not fatal to everyone. There are two issues that can give us some insight.

1. Is there enough research to determine the effectiveness of ephedra for weight loss?
Ephedra has been used in a number of clinical trials. From a MedLine search, the latest six-month clinical trial compared ephedra users to a placebo group. The ephedra group lost 2 pounds per month while the placebo group lost an average of 1 pound per month--not overwhelming results for the consistent use of the product for six months.

In a meta-analysis on the safety and efficacy of ephedra reported in the Journal of the American Medical Association, ephedra users seem to lose about one kilogram (about 2 pounds) more than those using a placebo in short-term trials (3).

This raises an even more basic question: regardless of safety, was it cost effective to use the product? It doesn't appear so based on the research. I can give you dozens of ways to lose another pound every month that will improve your health, not put it at risk, and most of them are free.

2. The subjects in clinical trials were under the supervision of a healthcare professional for most of the studies.
That's a very important point--it means the participants could report any unusual symptoms immediately. In later trials, they were also tested regularly for abnormal cardiac responses.

The important message is that ephedra, when used as directed by a healthcare professional and with regular check-ups to report any adverse events, was safe. But how many people see their doctors regularly when losing weight? Another problem is the typical American philosophy "If a little is good, more has to be better"--misuse of the product probably resulted in the serious adverse effects, including death. While abuse is always possible with any type of supplement or over-the-counter medication, the search for something to ease the effort of losing weight will always run the risk for abuse. The ban of ephedra is appropriate for that reason.

Weight loss is simple but not easy. As we always say at Better Life Unlimited, lifestyle changes--eating less, eating better, and exercising more--are the solution to weight loss. Nothing else will give you the permanent results you desire.

Reference:

  1. FDA Website: www.cfsan.fda.gov/~dms/ds-ephed.html
  2. Boozer CN, et al. Herbal ephedra/caffeine for weight loss: a 6-month randomized safety and efficacy trial. Int J Obes Relat Metab Disord. 2002. 26(5):593-604.
  3. Shekelle PG, et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA. 2003. 26;289(12):1537-45.
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