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Triclosan is not GRAS/GRAE in OTC Antiseptic Products, Says FDA

September 13, 2016

The U.S. Food and Drug Administration (FDA) issued a final rule establishing that triclosan and 18 other active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not Generally Recognized as Safe and Effective (GRAS/GRAE) and are misbranded. The final rule is part of the ongoing review of OTC drug products that FDA is conducting, and amends the 1994 tentative final monograph for antiseptic drug products.

This final rule, which became effective on September 6, 2016, involves over 700 consumer antiseptic wash drug products that are formulated with one or more of the 19 active ingredients. An announcement on the final rule can be found on FDA’s website.

The final rule does not impact the use of triclosan in food-contact applications.