United States: FDA Bans Sale Of OTC Antiseptic Wash Products Containing Certain Active Ingredients

On September 2, 2016, FDA issued a final rule prohibiting the sale of antiseptic wash products (including liquid, foam, gel hand soap, bar soaps, and body washes) that contain one or more of 19 specific active ingredients, including two of the most common used ingredients—triclosan and triclocarban. When issuing the proposed rule in 2013, FDA requested safety and efficacy data regarding use of certain active ingredients in antibacterial products. Those ingredients are added to consumer products with the intent of reducing or preventing bacterial infection. FDA concluded that "antibacterial hand and body wash manufacturers did not demonstrate that the 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 infection." In fact, Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, said that "... some data suggests that antibacterial ingredients may do more harm than good over the long-term." Some of the potential health risks that are under study include bacterial resistance or hormonal effects. FDA issued a proposed rule in June 29, 2016, requesting information to address data gaps on safety and efficacy of consumer hand "sanitizers"or wipes (used when no water is available as opposed to antiseptic wash products that are intended for use with water and are rinsed off after use). For now, these products are not affected by the final rule. Likewise, antibacterial products used in health care settings, such as hospitals and nursing homes, have not been prohibited. In addition, FDA will allow the use of three active ingredients—benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX)—in antibacterial products for one more year, pending the collection by the agency of new safety and effectiveness data regarding the use of such ingredients. Industry has one year to comply with the rule, which will become effective on September 6, 2017.

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Colleen Heisey
Jonathan Berman
 
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