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Triclosan Concern In Congress Spurs Call For Final Antimicrobial Monograph

This article was originally published in The Tan Sheet

Executive Summary

Concern about the safety of triclosan prompts a lawmaker to pressure FDA to finalize the OTC Topical Antimicrobial Drug monograph, first proposed in 1972

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Consent Decree Orders FDA Action On Triclosan OTC Monographs

A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under one deadline of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand wash products by Dec. 16, with a final monograph due by Sept. 15, 2016.

Consent Decree Orders FDA Action On Triclosan OTC Monographs

A Nov. 21 consent decree sets multiple deadlines over a five-year period to make FDA finalize its OTC topical antimicrobial drug products monograph with respect to triclosan. Under one deadline of note to triclosan product makers, the agency must publish a tentative final monograph for consumer antiseptic hand wash products by Dec. 16, with a final monograph due by Sept. 15, 2016.

Researchers Suggest Reducing Triclosan Use Following NIH-Funded Study

The study exploring the impact of triclosan on cardiac and skeletal muscle function in animals prompts researchers to call for a “dramatic reduction” of the ingredient in consumer products. Industry says the study used “unrealistically large” doses of the antibacterial ingredient that do not represent real-world conditions.

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