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Metabolife Begins $1.5 Mil. Preemptive Campaign Against "20/20" Angle

This article was originally published in The Tan Sheet

Executive Summary

Metabolife International has launched a $1.5 mil. radio, print and Internet campaign to preemptively combat what the company expects to be a negative report by ABC-TV's "20/20" on the firm's ephedra-containing supplement Metabolife 356.

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FDA's scientific justification for its proposed rule restricting the use of ephedrine alkaloids in dietary supplements is "open to question," GAO says in a report on the ephedrine proposed rule issued Aug. 4.

Ephedrine supplements lack "significant" abuse, should not be controlled -- coalition.

EPHEDRINE-CONTAINING SUPPLEMENT ABUSE REJECTED BY INDUSTRY COALITION as a reason to assign controlled substance status to the OTC drug and dietary supplement ingredient. In April 17 comments to FDA on the World Health Organization's potential rescheduling of ephedrine, the Dietary Supplement Safety and Science Coalition (DSSSC) stresses the history of use and safety of the ingredient, stating "ephedrine is not a controlled substance in the U.S. today, nor should it be internationally."

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EPHEDRINE ALKALOID PER-SERVING LIMIT OF 8 MG SUGGESTED BY FDA in a proposed rule published in the June 4 Federal Register. The rule is directed at dietary supplement products containing ephedrine alkaloids derived from raw botanicals -- products usually labeled as containing "ephedra," "Chinese ephedra" or "ma huang" that are sold for weight loss, increased energy and body building. The proposal does not apply to OTC drugs.

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