FDA aims to issue a proposed rule on OTC antimicrobial hand-wash products in February, according to its latest semi-annual regulatory agenda.

The agency has been under pressure to take action on topical antimicrobial products for consumer use, with concerns surrounding the use of ingredient triclosan, which has been associated with endocrine disruption and other adverse health effects in animal studies.

In January 2010, Rep. Ed Markey, D-Mass., urged FDA to finalize its OTC Topical Antimicrobial Drug monograph, which lists both triclosan and related compound triclocarbon as health-care antiseptic active ingredients. In his letter, the congressman suggested that the chemicals “may be both ineffective and unsafe to human health and the environment” Also see "Triclosan Concern In Congress Spurs Call For Final Antimicrobial Monograph" - HBW Insight, 11 January, 2010..

FDA movement related to antimicrobial products traces back to a 1974 Advance Notice of Proposed Rulemaking. Over the years, FDA has repeatedly delayed rulemaking on the subject, and debate has escalated between industry and NGOs over the health benefits of consumer antimicrobial products versus their potential risks.

Industry came out against an August 2012 study funded by the National Institutes of Health, which called for a “dramatic reduction” in the use of triclosan due to research suggesting a link between exposure and impaired cardiac and skeletal muscle function in mice.

The American Cleaning Institute and the U.K.-based Cosmetic, Toiletry and Perfumery Association lambasted the study, criticizing the “unrealistically large” doses of ingredient used and dismissing it as a “publicity campaign” built on “scare stories” Also see "Researchers Call For Reduced Triclosan Use Following NIH-Funded Study" - HBW Insight, 27 August, 2012..

Consumer and environmental watchdogs also have questioned whether widespread use of triclosan and other antimicrobial agents leads to antibiotic resistance, which the Personal Care Products Council and other industry representatives have sought to refute with scientific evidence Also see "Triclosan Does Not Contribute To Antibacterial Resistance, New Study Says" - HBW Insight, 10 October, 2011..

In light of antibiotic resistance concerns, FDA’s Nonprescription Drugs Advisory Committee has recommended that the agency require proof of benefit from marketers of non-alcohol-based consumer antiseptic products prior to sale as part of the final monograph for antimicrobials.

According to the unified agenda for all Department of Health and Human Services agencies, FDA is targeting July for release of a proposed rule on leave-on antiseptics.

Sunscreen Rules On Horizon?

FDA expects to continue to chip away at the sunscreen products review, planning by July to issue an advanced NPRM on the safety of sunscreen active ingredients.

FDA has pushed back its target for the potential addition of ingredients to the sunscreen monograph through time and extent applications to September, when it hopes to issue a NPRM.

Final action on sunscreens has long been on the agency's priority list. A final monograph for sunscreen products emerged in 1999, but industry pressure has consistently stayed its publication.

In June 2011, FDA released a final rule on sunscreen testing and labeling requirements, as well as a proposed rule to cap SPF values and an advanced NPRM related to certain delivery formats including spray sunscreens, wipes, powders and body washes Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 June, 2011..

FDA has attributed delays in its rulemaking to the extraordinary number of public comments and the amount of data it has received from stakeholders awaiting sunscreen regulation.

FDA Regulatory Agenda Targets Antimicrobial Hand Washes, Sunscreen

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