Labeling laws enacted in California and the recent death of an Illinois high school football player combined to turn up the regulatory heat on ephedra, the herbal sports-performance and weight-loss supplement.
In late September, California Gov. Gray Davis signed into law two bills requiring strong warning labels on products that contain ephedrine, saying the federal government has not been aggressive enough in labeling the supplement.
Days after Davis signed his bills, U.S. Health and Human Services Secretary Tommy G. Thompson asked the Food and Drug Administration to recommend mandatory warning labels for ephedra products, and said the regulatory agency is developing good manufacturing practices for dietary supplements. The GMPs, allowed under the Dietary Supplement Health Education Act, are similar to the standards over-the-counter drug manufacturers follow to ensure the products purchased by consumers contain what the label indicates.
"We will move as aggressively as the law and the science allow us to protect the public from the potential dangers of ephedra and other products, including taking actions to stop unlawfully marketed drug products," Thompson said.
Consumer watchdog group Public Citizen also weighed in, asking the FDA to ban the sale of ephedra, which is sometimes blamed for medical complications, such as heart attacks and high blood pressure. The herb also has been linked to deaths, including that of a 16-year-old athlete who suffered a fatal heart attack after taking the ephedra and kola bean extract combination sold as Yellow Jackets. Yellow Jackets are made by a Dutch company, NV Pharmaceuticals.
The California labeling laws also require strong warnings on products containing steroid hormone precursors.
Natural Foods Merchandiser volume XXIII/number 11/p. 5