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FDA Bans Antibacterial Consumer Washes with Any of 19 Active Ingredients

Wednesday, September 07, 2016
Sandler, Travis & Rosenberg Trade Report

Companies will no longer be able to market over-the-counter consumer antiseptic products intended for use with water (i.e., hand washes and body washes) that contain one or more of 19 specific active ingredients, including triclosan and triclocarban, under a new final rule from the Food and Drug Administration. Manufacturers will have until Sept. 6, 2017, to comply with this rule by removing such products from the market or reformulating them (i.e., removing the identified ingredients). This rule does not cover health care antiseptics, consumer antiseptic rubs (e.g., hand sanitizers and wipes), antiseptics identified as “first aid antiseptics,” or antiseptics used by the food industry.

The FDA is taking this action because manufacturers did not demonstrate that the 19 identified ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. “In fact,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, “some data suggests that antibacterial ingredients may do more harm than good over the long term.”

The FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxylenol  – to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these ingredients may be marketed during this time while data are being collected.

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