Texas ephedrine proposal
This article was originally published in The Tan Sheet
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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