[ascct] Query regarding FDA proposed rule on consumer antiseptics

  • From: Jessica Sandler <JessicaS@xxxxxxxx>
  • To: "'ascct@xxxxxxxxxxxxx'" <'ascct@xxxxxxxxxxxxx'>
  • Date: Tue, 25 Feb 2014 16:27:58 +0000

Dear ASCCT members,

We are interested in learning about how representatives of personal care 
companies are dealing with FDA's recently proposed rule on the safety and 
effectiveness of consumer antiseptic washes (Federal Register 78:76444).  FDA 
identified numerous safety data gaps for seven ingredients to be filled by 
animal tests.  The ingredients are:


*                     Hexylresorcinol

*                     Iodophors (i.e., all iodine-containing ingredients)

*                     Triclocarban

*                     Benzalkonium chloride

*                     Benzethonium chloride

*                     Chloroxylenol

*                     Triclosan


We will be submitting comments on the proposed rule but are interested to know 
whether companies plan to initiate animal testing of these ingredients during 
the six-month comment period for the proposed rule.  Since FDA has raised 
doubts over the efficacy of these ingredients, we are hoping that companies 
would establish the efficacy of each ingredient (if they haven't already) and 
consider the reformulation and relabeling of products containing them prior to 
initiating any required testing.

Any thoughts or input on this process would be greatly appreciated.

Jessica Sandler
Director, Regulatory Testing Division
People for the Ethical Treatment of Animals
JessicaS@xxxxxxxx<mailto:JessicaS@xxxxxxxx>
757-622-7382, ext. 8001



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