FDA Final Rule Blocks Sale of Some OTC Antibacterial Soaps

Much of medicine is highly concerned with aseptic practices to reduce bacterial transmission and infection in patients. Practitioners in nuclear medicine like technologists and pharmacists strive towards cleaner clinical areas, better techniques, and, thus, safer intravenous radioactive medication administration to patients. Medical professionals like us may even use this mentality when purchasing products for use at home. In the hand soap or body wash aisle, we may prefer products claiming to be “antibacterial” or “antimicrobial” in attempt to protect ourselves and our family the same way we protect our patients at work. Recently, however, the US Food and Drug Administration (FDA) has issued a final rule blocking the sale of certain over-the-counter (OTC) antibacterial soaps for consumers. 

This action was taken as part of the FDA's OTC Drug Review, the ongoing process to review the safety and efficacy of longstanding medicines that were marketed to consumers without a prescription since before May 1972. Prompted by new information on potential risks, the FDA gave manufacturers three years to provide more information about each ingredient's safety and efficacy.  Potential safety risks include effects of systemic (whole-body) absorption and long-term exposure as well as development of bacterial resistance. To show efficacy, the FDA sought studies demonstrating antiseptic washes provided a direct clinical benefit to consumers like fewer infections when compared to washing with non-antibacterial soap and water.

Insufficient safety and efficacy data were provided to the FDA so triclosan, triclocarban, and 17 other active ingredients in OTC consumer antiseptic washes intended for use with water are now deemed “not generally recognized as safe and effective”.  All hand and body washes with these ingredients are considered “misbranded” and must be removed from the market or reformulated within a year. Many manufacturers have already removed these now-banned ingredients or replaced them with three others: benzalkonium chloride, benzethonium chloride and chloroxylenol. The FDA has deferred decisions on the safety and efficacy of these three active ingredients to allow another year for manufacturers to provide sufficient information. In the future, the FDA will also make separate decisions about antiseptic active ingredients for products used in healthcare, in the food industry, in first-aid antiseptic rubs or in hand sanitizer rubs.

Protecting ourselves and our families at home still means washing our hands regularly with soap and water. But with so little information on the risks of long-term daily use and no proven clinical benefit over plain soap and water, certain antiseptic chemicals are no longer allowed in our hand and body washes. Thanks for your diligent work to keep consumers safe FDA! We all look forward to your future guidance on similar products used in the healthcare setting.