FDA requests additional information to address data gaps for consumer hand sanitizers
Sherry Ward, AltTox
The US Food and Drug Administration issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in consumer antiseptic rubs (hand sanitizers) marketed over-the-counter (OTC). 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. 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.
There are many non-animal approaches available for developing the nonclinical portion of data being requested for these types of products, including dermal penetration, skin irritation, and skin sensitization test methods.
The Federal Register notice:
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; A Proposed Rule by the Food and Drug Administration on 06/30/2016