The FDA is inviting public comment on the safety and effectiveness of “consumer antiseptic products intended for use with water,” referred to as consumer antiseptic washes. This proposed rule seeks to update a 1994 rule (1994 TFM) that was published in the Federal Register on June 17, 1994 (59 FR 31402) that classified “certain antiseptic active ingredients” as safe.
The FDA now has two objectives. First, it seeks to gather additional information to support the safe nature of the active ingredients in antiseptics. Second, it will require manufacturers to prove that their consumer antiseptic washes are more clinically beneficial than nonantibacterial soap and water.
This proposed rule distinguishes between health care antiseptics and consumer antiseptic handwashes. The FDA planned to apply the same effectiveness criteria to both consumer antiseptic and health care personnel handwashes, but agrees with public comment that these two categories should be handled separately because they serve different purposes. Thus, the current proposed rule covers only consumer antiseptics, which include “antibacterial soaps, handwashes, and antibacterial body washes,” but do not include hand sanitizers.
Because of new developments in technology and new information about the amount and risks of systemic exposure to these active ingredients, the active ingredients in antiseptic washes that had been classified as safe should be reevaluated to comply with current safety standards. Triclosan, a primary ingredient, was found in a recent study to have a negative effect on muscle function in mice and fish. Therefore, the FDA invites “comment on what these findings tell us about triclosan’s potential impact on human health and the submission of additional data on this subject.” The FDA is also concerned about widespread antiseptic use impacting the development of bacterial resistance.
Furthermore, a demonstration that consumer antiseptic washes are more clinically beneficial than nonantibacterial soap and water is necessary to balance the perceived risk of using these washes. After the end of the 180-day commenting period, manufacturers will have one year to submit their research. If they cannot prove that consumer antiseptic washes are safe for human use and more beneficial as regular soap and water, then the FDA will require them to change the advertising of these products or to stop selling them.
Interested parties are invited to submit comments about any aspect of this proposed rule by June 16, 2014, by any of the following methods:
- Regulations.gov: http://www.regulations.gov;
- Mail: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
All comments must include the Agency name, Docket No. FDA-1975-N-0012, and Regulatory Information Number (RIN) 0910-AF69.
This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.