ACI to FDA: Antibacterial Ingredients Play Beneficial Role in Hygiene and Health for Millions


  • ACI Submits Data Substantiating the Safety and Effectiveness of Antibacterial Ingredients Triclosan and Chloroxylenol 
  • Proposed Agency Rules Overlook Existing Data That Supports Their Continued Use in Antibacterial Soaps

Washington, D.C. | June 19, 2014 –Antibacterial handwash products containing the ingredients triclosan and chloroxylenol play “beneficial roles in the daily hygiene routines of millions of people throughout the U.S. and the world,” which should be thoroughly recognized by the Food and Drug Administration.

American Cleaning Institute (www.cleaninginstitute.org), the trade association for the U.S. cleaning products industry, submitted separate sets of comments to the FDA in support of the respective ingredients. Restrictive new rules proposed by the FDA governing antibacterial soaps and washes – and their ingredients – could effectively end consumer access to the popular category of products.

ACI expressed concern FDA has not assessed a substantial amount of existing safety data that are available on both ingredients prior to proposing that additional safety data are necessary to support the safety of their use in antibacterial soaps.

ACI said the agency “neglected a substantial amount of relevant information” beyond what is reported in FDA’s proposed regulation.

“The available toxicological information provides no evidence for data gaps or gives cause for concern under typical use conditions of triclosan in consumer antiseptic wash products,” writes Richard Sedlak, ACI Executive Vice President, Technical & International Affairs.

“After a transparent and scientific evaluation of existing data in accordance with established principles, we expect FDA will find that the triclosan database, in association with more recently published information, is sufficient for demonstrating the safety and efficacy of triclosan.”

Similarly, in regard to chloroxylenol, Sedlak writes that the “available toxicological information provides no evidence for data gaps or gives cause for concern under typical use conditions for chloroxylenol in consumer antiseptic wash products.”

“Efficacy against pathogenic bacteria has been demonstrated. We believe that existing data on chloroxylenol is sufficient for demonstrating its safety and efficacy. Evaluation of the data in accordance with established principles, utilizing a weight of evidence approach, should lead FDA to conclude chloroxylenol deserves the official status of generally recognized as safe and effective.”

Both sets of comments make clear that existing evidence clearly shows that triclosan and chloroxylenol are not causing hormonal effects in humans, are not contributing to antibiotic resistance related to daily use of antibacterial soaps, and that both ingredients are effective at killing germs that can make people sick.

The complete sets of comments can be found at www.fightgermsnow.com.



The American Cleaning Institute® (ACI) is the Home of the U.S. Cleaning Products Industry® and represents the $30 billion U.S. cleaning products market. ACI members include the formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical producers. ACI (www.cleaninginstitute.org) and its members are dedicated to improving health and the quality of life through sustainable cleaning products and practices.