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FDA announces plans to implement ephedrine safety measures.


On June 2, the FDA proposed to reduce risks associated with ephedrine-containing dietary supplements by limiting the amount of ephedrine that can be contained in supplements and implementing a number of labeling and marketing changes intended to protect consumers. Citing hundreds of adverse reactions believed related to ephedrine, the FDA plans to prohibit the marketing of products that contain more than 8 mg of ephedrine alkaloids per serving and to forbid labeling that recommends consuming more than 24 mg in a 24-hour period. Other changes include limiting use to seven days, prohibiting claims that promote long-term intake, and requiring that labels of certain products bear a warning that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death." The FDA proposal would also prohibit supplement manufacturers to combine ephedrine with other botanical stimulants, such as caffeine.

Ephedrine alkaloids, contained in plants in the genus Ephedra and in botanicals such as Sida cordifolia, are amphetamine-like compounds with strong stimulant effects on the heart and nervous system. "We urge people to talk to their doctors before using dietary supplements containing ephedrine alkaloids, and to always use them with caution," said interim FDA Commissioner Dr. Michael Friedman.

  US Department of Health and Human Services, press release, June 2, 1997.  
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