Proposed ruling by FDA could take antibacterial soaps off shelves

16 June 2014 22:37 Source:ICIS News

HOUSTON (ICIS)--Proposed rules by the Food and Drug Administration (FDA) could ban antibacterial soaps and body washes from US store shelves and endanger the public, the American Cleaning Institute (ACI) said on Monday.

Banning the antibacterial cleaning items from store shelves could end American consumers’ access to the benefits of the antibacterial products, potentially leading to 7.5m new cases of food-borne illness and more than $38bn in annual health care costs, the ACI said. 

The FDA proposals had genesis is the agency’s loss in a lawsuit filed by the Natural Resources Defense Council, which sued the FDA to make a regulatory ruling about the antibacterial agent triclosan.

A consent decree enforced by the court shows the timeline for the rulemaking on consumer antibacterial soaps and washes.

The rulemaking timeline on the consumer antiseptic hand wash products monograph shows that publication of the tentative final monograph was done by 16 December 2013, with a comment period for tentative final monograph due by Monday, 16 June 2014.

A rebuttal comment period for the tentative final monograph is set to take place by 17 February 2015, with FDA review of comment, drafting of final monograph and final review and approval by FDA, the Department of Health and Human Services and the Office of Management and Budget due by 31 August 2016.

Publication of the final monograph is scheduled by 15 September 2016.

In comments to the FDA, the ACI and the Personal Care Products Council also asked the agency to support safety evaluation approaches that avoid or minimise animal testing and, among several other recommendations, to review available and extensive data that shows there is no correlation between antibacterial soap use and antibiotic resistance.

The detailed comments can be found online at

Additionally, the ACI said that the FDA appears to have not considered that the consumer category includes the use of antibacterial soaps in public areas such as schools, airports, daycares and other facilities.

The ACI represents formulators of soaps, detergents and general cleaning products used in household, commercial, industrial and institutional settings as well as the companies that supply the ingredients and finished packaging for these products.

The ACI members also include oleochemical producers, making such chemicals as fatty alcohols, fatty acids and glycerine.

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By Judith Taylor