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CHPA on ephedrine

This article was originally published in The Tan Sheet

Executive Summary

Texas' implementation of possible new labeling requirements for ephedrine-containing dietary supplements would be "premature, given that the existing rule...only became fully effective in November," the trade association advises the Texas Board of Health. State regulators are considering requiring FDA's toll-free MedWatch number to appear on product labeling, along with a statement that it is illegal to sell the products to people under 18 (1"The Tan Sheet" Nov. 15, p. 3). CHPA's Nov. 30 comments request the state first evaluate the effects of its current regs, which require labeling warning against use by those with certain health conditions as well as saying the products are not "intended" for use by minors. CHPA additionally says MedWatch has "deficiencies" and manufacturers distributing products across state lines would face severe economic difficulties complying with unique labeling regs in one state

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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 18 AERs Too Few To Support MedWatch Proposal - AHPA

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Texas Ephedrine 18 AERs Too Few To Support MedWatch Proposal - AHPA

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