Texas ephedrine rules
This article was originally published in The Tan Sheet
Executive Summary
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
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California ephedrine
Assembly bill No. 2294, introduced Feb. 24 by Susan Davis (D), would prohibit the sale or distribution of dietary supplements containing ephedrine unless labeling warns about potential adverse reactions and contraindications and states people under 18 should not take the product. The bill also would require labeling bear a toll-free number consumers could call to report adverse effects to the State Department of Health Services. The bill's introduction follows a February "informational" hearing chaired by Davis, whose district is in San Diego, where Metabolife International, manufacturer of the ephedra supplement Metabolife 356, is located. Similar measures are being considered by Texas and New York City; comments on the Texas proposed regs are due by April 4 (1"The Tan Sheet" Feb. 28, In Brief)
California ephedrine
Assembly bill No. 2294, introduced Feb. 24 by Susan Davis (D), would prohibit the sale or distribution of dietary supplements containing ephedrine unless labeling warns about potential adverse reactions and contraindications and states people under 18 should not take the product. The bill also would require labeling bear a toll-free number consumers could call to report adverse effects to the State Department of Health Services. The bill's introduction follows a February "informational" hearing chaired by Davis, whose district is in San Diego, where Metabolife International, manufacturer of the ephedra supplement Metabolife 356, is located. Similar measures are being considered by Texas and New York City; comments on the Texas proposed regs are due by April 4 (1"The Tan Sheet" Feb. 28, In Brief)
California ephedrine
Assembly bill No. 2294, introduced Feb. 24 by Susan Davis (D), would prohibit the sale or distribution of dietary supplements containing ephedrine unless labeling warns about potential adverse reactions and contraindications and states people under 18 should not take the product. The bill also would require labeling bear a toll-free number consumers could call to report adverse effects to the State Department of Health Services. The bill's introduction follows a February "informational" hearing chaired by Davis, whose district is in San Diego, where Metabolife International, manufacturer of the ephedra supplement Metabolife 356, is located. Similar measures are being considered by Texas and New York City; comments on the Texas proposed regs are due by April 4 (1"The Tan Sheet" Feb. 28, In Brief)