Over-the-counter antiseptic wash products, containing certain active ingredients, can no longer be marketed by companies, according to a final rule released by the FDA. The final rule applies to products containing one or more of 19 specified active ingredients, including triclosan and triclocarban, commonly used ingredients. Manufactures lacked evidence that the ingredients are both safe for long-term daily use as well as more effective than plain soap and water in preventing illnesses and spreading certain infections.1 The final rule does not affect consumer hand sanitizers, wipes, or antibacterial products used by health care professionals.
The FDA proposed a rule in 2013 after data suggested that long-term exposure to these active ingredients, such as triclosan and triclocarban, could pose health risks, including bacterial resistance or hormonal effects. Manufacturers were required under the proposed rule to provide the FDA with additional safety and effectiveness data if they were to continue marketing the consumer products.
In response to comments submitted to the FDA, rulemaking has been deferred for 1 year on 3 additional ingredients used in antibacterial wash products to allow for new safety and effectiveness data. The 3 additional ingredients include benzalkonium chloride, benzethonium chloride and chloroxylenol.
Manufacturers have 1 year to comply with the FDA’s final rule by removing products from the market, or by reformulating its products.
Reference
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The Food and Drug Administration. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-21337.pdf. September 2, 2016.
