11.01.02
FDA Tackles Ephedra
Tommy Thompson, secretary, U.S. Department of Health and Human Services (HHS), Bethesda, MD, has requested that FDA evaluate the best scientific evidence available and recommend the strongest possible mandatory warning label possible for ephedra products. According to Mr. Thompson, “Based on the scientific data available, we will take appropriate steps to protect the public health. 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.” These actions, however, do not preclude further measures that may be taken in response to findings of a review of ephedra that is currently being conducted by the Rand Corporation. In other developments, FDA has established a new program to proactively analyze all herbal ephedra products to ensure that they contain natural ingredients and not synthetic ingredients as required by law. The agency also noted that it is illegal for companies to market non-herbal synthetic ephedrine alkaloid products as dietary supplements. FDA will analyze ephedra products to determine if natural ingredients are being used. Lastly, FDA is continuing its efforts to prevent marketers from advertising ephedra products as alternatives to street drugs. FDA recently sent a letter to Xoch Linnebank, who operates a website based in the Netherlands. The website was advertising the ephedra product Yellow Jacket as “herbal XTC.” The website stated, “The Yellow Jacket has an extremely stimulating rush, with sensations one would attribute to E or amphetamines.”
Tommy Thompson, secretary, U.S. Department of Health and Human Services (HHS), Bethesda, MD, has requested that FDA evaluate the best scientific evidence available and recommend the strongest possible mandatory warning label possible for ephedra products. According to Mr. Thompson, “Based on the scientific data available, we will take appropriate steps to protect the public health. 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.” These actions, however, do not preclude further measures that may be taken in response to findings of a review of ephedra that is currently being conducted by the Rand Corporation. In other developments, FDA has established a new program to proactively analyze all herbal ephedra products to ensure that they contain natural ingredients and not synthetic ingredients as required by law. The agency also noted that it is illegal for companies to market non-herbal synthetic ephedrine alkaloid products as dietary supplements. FDA will analyze ephedra products to determine if natural ingredients are being used. Lastly, FDA is continuing its efforts to prevent marketers from advertising ephedra products as alternatives to street drugs. FDA recently sent a letter to Xoch Linnebank, who operates a website based in the Netherlands. The website was advertising the ephedra product Yellow Jacket as “herbal XTC.” The website stated, “The Yellow Jacket has an extremely stimulating rush, with sensations one would attribute to E or amphetamines.”