Texas ephedrine proposal
This article was originally published in The Tan Sheet
Executive Summary
State Board of Health Regulatory Committee tables discussion of the proposal to require the FDA MedWatch toll-free number on all ephedrine-containing dietary supplements until its January meeting. The committee plans to hold a stakeholder meeting to discuss alternate language in December. The proposed rule was scheduled to be presented to the committee Nov. 18 (1"The Tan Sheet" Nov. 15, p. 3). House Government Reform Committee Chair Dan Burton (R-Ind.) voices "grave concerns" with the MedWatch system in a Nov. 16 letter to the Texas Department of Health. "I continue to be concerned that the FDA has not developed an effective system to monitor the adverse events of dietary supplements," Burton says. "One of my concerns is that the development of this proposal will send Texans in to a reporting system that will not be responsive to their needs." Burton also asks if the requirement would be extended to OTCs, Rx drugs and special nutritional products including infant formula
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