The US Food and Drug Administration 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).
According to a prepared statement from the FDA, “the 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.”
The CDC advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60% alcohol.
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. Since 2009, 90% of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient.
The proposed rule does not require any consumer hand sanitizer products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing these products under the OTC Drug Review to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption.
The request 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 washes1 and health care antiseptics.
The proposed rule will be available for public comment for 180 days.
1. FDA. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Federal Register. 2013