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Response to the Alaska Case Involving Ephedra Products

Statement from The Ephedra Education Council


Washington, DC (February 8, 2001) ---
"In response to the Alaska case, the Ephedra Education Council released the following statement today:

Responsible industry stands behind its policy of not manufacturing or distributing dietary supplements that contain synthetic ephedrine. In fact, trade associations that represent the vast majority of ephedra manufactures and distributors have continually asked FDA to prohibit the use of synthetic ephedrine in herbal ephedra products. It has been the policy of industry, and has, at the urging of industry, been adopted as law in several states.

As recently as October 2000, these same trade associations filed a citizen petition with FDA urging the agency to adopt this prohibition as well as serving limits, restriction on sale to minors, prohibition on marketing for illicit purposes and a strong warning label. This case, which involved a product that had synthetic ephedrine, further demonstrates that it is time for FDA to act upon Industry�s request.

It is also important to note that a article press report states that synthetic ephedrine and herbal Ephedra are the same substance upon entering the bloodstream. However, this statement fails to acknowledge that herbal Ephedra contains less potent ingredients, in a smaller quantity, than pure synthetic ephedrine.

Additionally, in the same press report, the plaintiff�s attorney was referenced as saying that the case was strengthened by the recent publication of the Haller and Benowitz study in the New England Journal of Medicine. This study reviewed adverse events reported by the FDA. However, as has been demonstrated in the past, the findings represent old information that has already been contradicted by experts. Specifically, in the past year a seven-member panel of scientific and medical experts has reviewed and discredited the same adverse events, many of which were deemed irrelevant by FDA. Finally, the recently released Cantox Study analyzed in detail all the available scientific data on Ephedra, including the adverse event reports. This exhaustive study, using standards set by the National Academy of Sciences, revealed no serious concerns dealing with toxicity, or other potentially harmful effects, from the use of responsibly manufactured and marketed herbal ephedra productsAdditionally, in the same article the plaintiff attorney was referenced as saying that the case was strengthened by the recent publication of the Haller and Benowitz study in the New England Journal of Medicine. This study reviewed adverse events reported by the FDA. However, as stated in the past, the findings represent old information that has already been contradicted by experts. Specifically, in the past year a seven-member panel of scientific and medical experts has reviewed and discredited the same adverse events, many of which were deemed irrelevant by FDA. And finally, the recently released Cantox Study analyzed in detail all the available scientific data on Ephedra, including the adverse event reports. The exhaustive study revealed no serious concerns dealing with toxicity or other potentially harmful effects.

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The Ephedra Education Council is supported primarily by members of the Ephedra Committee of the American Herbal Products Association, a recognized leader in promoting the safe and responsible marketing of dietary supplements. The Council provides factual information to the media and public about dietary supplements containing Ephedra. For more information, logon to www.EphedraFacts.com.

 

 

 

 

 


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