Ephedra ban takes effect

| 4/14/2004

A nationwide ban on the sale of ephedra was scheduled to take effect Monday, April 12, according to documents from the federal Food and Drug Administration.

The final rule banning ephedra was published Feb. 6. Typically, such actions take effect 60 days after the publication of a final rule.

"This FDA rule reflects what the scientific evidence shows - that ephedra poses an unreasonable risk to those who use it," Health and Human Services Secretary Tommy G. Thompson said in a statement. "The regulations prohibit the sale of dietary supplements containing ephedra, and we intend to take swift action against anyone who puts consumers at risk by continuing to sell such products after the prohibition takes effect."

Ephedra is a naturally occurring substance derived from plants, the FDA said. It is often referred to by its Chinese name, Ma huang. The dietary supplement contains ephedrine, which is regulated as a drug when it is produced artificially.

Ephedra is often marketed as a weight loss aid, and many athletes use it in an attempt to enhance sports performance.

Thompson announced in December that the FDA planned to ban the supplement. In addition, the FDA issued a consumer alert at that time regarding the safety of dietary supplements containing ephedra and notified manufacturers of its intent to publish a final rule that will say dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury.

"In December, we advised consumers to stop using ephedra products, and we asked responsible companies to stop selling them," FDA Commissioner Mark B. McClellan said.

The FDA, in statements regarding the ban, pointed to a number of studies, including one by Rand Corp., noting safety risks associated with products containing the chemical.

“Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes,” the FDA said in a statement.

In addition, the agency and a number of states that have already banned the substance pointed to the deaths of a number of prominent athletes who used the drug, including Baltimore Orioles pitching prospect Steve Bechler.

Despite months of government buildup to the ban, it was nearly held up after one manufacturer of the herbal supplement made an 11th-hour attempt to block the ban. Late Monday, a judge rejected the request.

NVE Pharmaceuticals Inc. of Newton, NJ, which makes the ephedra product Stacker 2, had asked U.S. District Judge Joel Pisano to block the FDA’s action, The Associated Press reported. Pisano refused to grant a temporary restraining order after a hearing April 12, the date the ban was to take effect.

As FDA and other officials waited for Judge Pisano’s decision and for the ban to take effect, they issued a warning to consumers.

“Until the final rule prohibiting the sale of ephedra-containing dietary supplements takes effect, FDA reiterates its warning to consumers: ‘Do not take these products. They are simply too risky,’” McClellan said.

--by Mark H. Reddig, associate editor

Mark Reddig can be reached at mark_reddig@landlinemag.com.