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.” Read more…