Ephedrine Labeling MedWatch Reference Proposed In Texas
This article was originally published in The Tan Sheet
Executive Summary
Texas is considering amending its rules pertaining to ephedrine-containing dietary supplements sold in the state to require the toll-free number for FDA's MedWatch adverse event reporting program on product labels. This would be the first time the MedWatch number has been required on a product.
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Texas Ephedrine 18 AERs Too Few To Support MedWatch Proposal - AHPA
The "very small" number of adverse events reported in Texas related to ephedrine alkaloid-containing supplements suggests there is no public health risk, rendering proposed regs requiring the FDA MedWatch toll-free number on product labeling unnecessary, the American Herbal Products Association Ephedra Committee maintains.
Texas ephedrine rules
Written comments on Texas Board of Health proposed regulations for labeling of ephedrine-containing dietary supplements are due April 4. Published in the Texas Register Feb. 4, the proposed rule would require the FDA toll-free MedWatch number and a warning prohibiting sales to persons 17 or younger to appear on labeling (1"The Tan Sheet" Nov. 15, 1999, p. 3). Industry members, including reps from several trade associations, said the regs are unnecessary at a Feb. 23 hearing. The MedWatch number requirement would go into effect Sept. 1, 2001, giving FDA time to modify the adverse event reporting system; the warning regarding minors would become effective Jan. 1, 2001
Texas ephedrine proposal
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"