FDA considers ephedra ban

| 7/25/2003

The federal Food and Drug Administration is considering a nationwide ban on ephedra, The Associated Press reported July 24.

The possible action was revealed by FDA Commissioner Mark McClellan as he spoke before two House panels.

The agency had not acted up till now against the herbal supplement because of legal restrictions. Under the Dietary Supplement Health and Education Act, to ban a supplement, the FDA said it must “show that the supplement presents a ‘significant or unreasonable risk of illness or injury’ under the conditions recommended or suggested in labeling.”

However, The AP reported Health and Human Services Secretary Tommy Thompson said July 23 that companies producing supplements such as ephedra should report possible side effects to the agency, and that Congress should update the 1994 law to allow that to occur.

Ephedra is an herbal supplement frequently sold at convenience stores, and is often marketed as an “energy booster” and weight-loss aid. However, while the product is available over-the-counter, that does not mean it’s a good idea to use it.

According to HealthScout, a health information Web site, the supplement is linked to almost 100 deaths, including high school, college and professional athletes who have collapsed during games or practice. For some, the danger is especially acute.

More and more governments have been looking at regulating or banning the drug in recent years.

In early 2002, Health Canada requested a recall of certain products containing ephedra/ephedrine from the market after a risk assessment team concluded that these products pose a serious risk to health.

In May of this year, Gov. Rod Blagojevich signed into law a measure that bans the sale of pills containing ephedra in Illinois. Under the new law, all over-the-counter sales of ephedra would be banned except in products that receive approval from the Secretary of Health and Human Services, and then only when deemed “safe and effective for its intended use” or under a label approved by the federal Food and Drug Administration.

And while the drug is legal in most states, it still represents a risk for truckers who take it. Donna Ryun of OOIDA’s member services said truckers who are about to take a drug test “should advise attending physician of any non-prescription drugs (even herbal) that you are taking.” Ephedra can initially cause a false positive on drug tests, making it look as if the trucker has taken a forbidden substance.