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ACI Statement: FDA Final Rule on Healthcare Antiseptic Ingredients

  • Agency Defers Rulemaking, ACI Continues to Provide Safety, Efficacy Data on Five Key Antibacterial Ingredients

Washington, D.C. – December 19, 2017 – The American Cleaning Institute (ACI) issued the following statement in response to the Food and Drug Administration’s (FDA) final rule governing the use of antibacterial ingredients in healthcare antiseptic products, including soaps, hand washes and rubs:

"The American Cleaning Institute (ACI) welcomes the decision by the Food and Drug Administration to defer rulemaking on critically important ingredients used in healthcare antiseptic products," said Richard Sedlak, Executive Vice President, Technical & International Affairs.

"Manufacturers need sufficient time to provide FDA with additional safety and efficacy data to support the continued use of these products in healthcare facilities.

"ACI has already been sharing detailed information with FDA on five active ingredients we are supporting on behalf of our members: benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, and povidone-iodine.

"The active ingredients used in healthcare antiseptic drug products have very favorable benefit/risk ratios demonstrated over many years of extensive use. These products clearly save lives by reducing bacterial transmission that can cause infections in healthcare settings."

"By reducing Healthcare-Associated Infections, these products also reduce health care costs. There is no evidence of adverse health effects in humans as a result of the use of health care topical antiseptic products. In addition, a robust body of research supports the safety of active ingredients used in healthcare topical antiseptic products."


Contact: Brian Sansoni, American Cleaning Institute, 202.662.2517 or bsansoni@cleaninginstitute.org