Metabolife Challenges FDA Ephedra Ban

Metabolife respectfully disagrees with the decision of the Food and Drug Administration to ban ephedra based dietary supplements. Metabolife strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed. Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss.

Metabolife has long supported reasonable, science-based regulations for all dietary supplements. We have supported bans on sales to minors and on marketing for athletic performance enhancement.

Under the Dietary Supplement Health and Education Act (DSHEA), the FDA lacks data and information that would enable it to meet the burden of proving that ephedra products -- when taken in accordance with their label directions for use -- present a significant or unreasonable risk of illness or injury. To the contrary: the data currently before the agency, including the extensive history of use of ephedra as a dietary supplement, establish that ephedra dietary supplements can reasonably be expected to be safe when used under their intended conditions of use. To the extent the FDA has safety concerns with the use of ephedra, it should address those concerns by imposing strict science-based labeling requirements rather than banning the product outright.

Following the publication of the final rule by the FDA, Metabolife will carefully consider its options. In the meantime, Metabolife continues to meet the demands of its customers with products that do not contain ephedra.

Metabolife press release, Dec. 30, 2003