EPHEDRA LABELING SUPPORTED BY SCIENCE-A BAN IS NOT, INDUSTRY TELLS FDA

Statement Cites Expert Medical and Scientific Opinions on Safety, Benefits, and No Need for Ban of Ephedra

WASHINGTON (April 8, 2003) - A national standard on a warning label for Ephedra products is supported by the current science on Ephedra, but a ban based on an arbitrary and undefined standard of "significant or unreasonable risk" is not, the Ephedra Education Council (EEC) told the Food and Drug Administration (FDA) in a statement released today.

The statement was submitted to the FDA on April 7, 2003, in response to the reopening of the comment period on pending Ephedra regulations. Citing the opinions of leading medical and scientific experts, the industry reaffirmed that Ephedra dietary supplements are safe and have significant health benefits for consumers. The EEC also concluded that under current law-the 1994 Dietary Supplement Health and Education Act (DSHEA)-FDA has sufficient authority to regulate Ephedra and other dietary supplements.

In the statement submitted on behalf of the industry, EEC's general counsel, Wes Siegner, said, "A strong, comprehensive warning is needed, but the required warning should provide consumers with accurate information to facilitate informed choices, rather than blatantly mislead them-as does the currently proposed warning."

Addressing the inexact measure of "significant or unreasonable risk," the statement declared that under the FDA's current definition, "there is no question that Ephedra supplements that meet current industry standards are safe and provide significant public health benefits for consumers who need to lose weight."

The statement continued, "The two most recent and comprehensive scientific reviews of Ephedra, the RAND Report and the Cantox Report, establish (that) Ephedra supplements provide a significant weight loss benefit...a risk assessment of Ephedra and caffeine based on human clinical data (shows) that Ephedra products are safe when properly labeled and formulated, and adverse event reports are not useful for assessing safety, and do not establish that Ephedra has caused serious adverse events."

On the issue of FDA authority, the EEC said, "There is absolutely no basis for concluding that FDA has need for additional legislative authority...At least one FDA commissioner since the passage of DSHEA has consistently stated, and has testified before Congress, that DSHEA provides ample authority to regulate dietary supplements."