Limits on ephedra advance

Date: 28-03-2003 Posted by: Anabolic Info TeamUnited States

A new bill in the U.S. Senate would require manufacturers of dietary supplements containing ephedra and other stimulants to prove their products are safe before marketing them.
The bill that U.S. Sen. Dick Durbin, D-Ill., introduced Wednesday drew praise from Kevin Riggins, a Lincoln man whose son died after taking ephedra last fall. Riggins, meanwhile, is monitoring new ephedra regulations in Lincoln and lobbying for pending state legislation that would ban ephedra.

"We see at least a modicum of safety with this law," Riggins said of Durbin's bill. "Not regulating things we put in our bodies makes no sense to me."

Drug manufacturers must prove to the U.S. Food and Drug Administration that their products are safe and effective, but herbal dietary supplements are exempt from such safety reviews. That means the FDA must prove such an herbal supplement is unsafe before the FDA can remove it from the market.

Durbin's bill would require manufacturers of herbal stimulants to prove their products are safe and to turn over reports of adverse side effects within 15 days. The bill also would reclassify anabolic steroids, which now are marketed as dietary supplements, as drugs.

Recent studies have linked ephedra to 117 deaths and more than 17,000 other health problems, but manufacturers submitted only 10 such reports in 2001, Durbin said in a prepared statement.

The dietary supplement industry maintains its products are safe and effective. Industry estimates show more than 3 billion serving of ephedra were sold in 1999 alone, and the vast majority of users reported no ill effects.

The Lincoln City Council banned selling ephedra products to minors last week and ordered merchants to move the products behind their counters. Today is the deadline for complying with the ordinance, Riggins said, but his surveys showed virtually every Lincoln retailer has already complied.

On the state level,measures banning the sale of ephedra have passed both houses of the General Assembly. Now the Senate bill is pending in the House and vice versa.

Riggins has been campaigned heavily against what he called aggressive lobbying by the ephedra industry.

"It is impossible for anyone to calculate exactly how many people have had their lives ended or their health ruined by ephedra ... but whether it was 500 or five, it was too many," Durbin said.

The FDA is considering requiring warning labels on ephedra products and studying other regulations.