Triclosan Concern In Congress Spurs Call For Final Antimicrobial Monograph
This article was originally published in The Rose Sheet
Executive SummaryConcern about the safety of triclosan has Rep. Ed Markey pressuring FDA to finalize the OTC Topical Antimicrobial Drug monograph, first proposed in 1972
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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 a pair of deadlines 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 Sept. 15, 2016.
Triclosan use in consumer hand-wash products could be addressed by FDA in a proposed rule targeted for February release. Sunscreen also is identified as a priority in the agency’s semi-annual regulatory agenda.
Industry has come out against a study exploring the impact of triclosan on cardiac and skeletal muscle function in animals, which they say is a “publicity campaign” and used “unrealistically large” doses of the anti-bacterial ingredient that do not represent real-world conditions. The NIH-funded study prompted investigators to call for a “dramatic reduction” in the ingredient’s use in consumer products.