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Texas ephedrine proposal

This article was originally published in The Tan Sheet

Executive Summary

State Board of Health approves on Jan. 14 issuing proposed regulations requiring that the FDA MedWatch toll-free number and a warning prohibiting sales to persons 17 or younger appear on the labeling of all ephedrine-containing dietary supplements. If made final, the MedWatch requirement will go into effect Sept. 1, 2001, giving FDA time to make planned changes to the MedWatch adverse event reporting system; the warning banning sale to minors would become effective Jan. 1, 2001. The proposed rule will be published in the Feb. 4 Texas Register for a 60-day comment period. The amendment to Texas' existing rules for ephedrine products was proposed last fall (1"The Tan Sheet" Nov. 15, 1999, p. 3). CFSAN Director Joseph Levitt, speaking at a CHPA regulatory forum on dietary supplements in Washington, D.C. Jan. 13, noted, "We advertise the MedWatch number every way we can. And if the state of Texas thinks that that's a good idea in this case...I'm not terribly bothered by that"

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