FDA requests additional information to address data gaps for consumer hand sanitizers

FDA requests additional information to address data gaps for consumer hand sanitizers

The FDA today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC).

Based on new scientific information and input of outside scientific and medical experts on an independent advisory committee, the agency is requesting additional scientific data to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognized as safe and effective to reduce bacteria on skin. The agency is requesting manufacturers provide data for three active ingredients -- alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride.

The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.

Today’s action is part of the FDA’s larger, ongoing review of OTC antiseptic active ingredients to ensure these ingredients are safe and effective. The FDA has previously issued proposed rulemakings on consumer antiseptic washes (December 2013) and health care antiseptics (April 2015).

The proposed rule will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, and comments on any new data or information may then be submitted to the docket for an additional 60 days. The FDA will then evaluate the data and comments received in response to this proposal. The FDA’s final determination will be published as a final rule (final monograph).

Press Release

Federal Register Notice