A new bill would require manufacturers of dietary supplements containing stimulants such as ephedra to undergo premarket safety approval.

The Dietary Supplement Safety Act of 2003, introduced in late March by Sen. Richard Durbin, D-Ill., would also mandate manufacturers to report serious adverse events, such as heart attack or death, to the U.S. Food and Drug Administration within 15 days and would require an annual report of all adverse events. One serious AER would trigger a review of the product's safety and could result in the FDA pulling the product from the shelves.

The bill would also prevent steroid precursors that promote muscle growth from being marketed as dietary supplements.

Ephedra continues to be among the most scrutinized supplements on the market. Most recently, a bill introduced by Sen. Jackie Speier, D-Daly City, that would ban the sale of ephedra in California, began to make its way through committees in the state Legislature.

Under the Dietary Supplement Health and Education Act, manufacturers are already required to submit information on the safety of all new supplements. DSHEA also gives FDA the authority to stop the sale of a supplement if it poses an imminent health hazard.

David Seckman, executive director of the National Nutritional Foods Association, said the bill would provide no more consumer protection than DSHEA. "The bill unnecessarily expands the authority of the FDA and strikes at the heart of DSHEA," he said.

"We recognize that Sen. Durbin has raised some issues of long-standing concern. However, we believe that those issues can, and should, be dealt with by the Food and Drug Administration under the existing law," said Judy Blatman, a spokeswoman for the Council for Responsible Nutrition. Although the FDA has not yet fully enforced DSHEA, Blatman said there appears to be a renewed commitment to do so under new FDA chief Mark McClellan, M.D.

"The industry also needs to take some steps to work with FDA to show that the law can work," Blatman said. "For example, the AER system is something that would benefit from further discussion. But mandatory AERs are not the approach that we think will be most valuable. Currently, AERs do not provide enough specific, qualified information to come to conclusions about the cause of an adverse event."

CRN is considering a new reporting system that would qualify the information received and would focus on quality, not quantity, Blatman said.

To voice your opinion on this pending legislation, go to the NNFA's Advocacy Action Center on www.nnfa.org.

Natural Foods Merchandiser volume XXIV/number 5/p.