The Food and Drug Administration (FDA) proposed a rule requesting more scientific data to support the safety and efficacy of certain active ingredients found in topical consumer antiseptic rubs that are sold over-the-counter (OTC). The Agency’s proposed rule is to ensure that regular use of these products does not pose unknown safety and efficacy concerns.
Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, stated, “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
Currently, the Centers for Disease Control and Prevention (CDC) recommends using an alcohol-based hand sanitizer containing ≥60% alcohol if soap and water are not available. In order to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognized as safe and effective to reduce bacteria on the skin, the FDA is requesting manufacturers to provide data for alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride. Some data has suggested that systemic exposure for some antiseptic active ingredients is higher than once thought. The FDA is focused on compiling additional data on the long-term safety of daily, repeated exposure to these ingredients by users, and on its use by specific populations such as pregnant women and children, where topical absorption of active ingredients may be important.
Manufacturers who wish to continue marketing these products under the OTC Drug Review are required to provide additional data on the active ingredients’ safety and efficacy, as well as data to assess absorption. The proposed rule is part of the Agency’s larger review of OTC antiseptic active ingredients and will be available for public comment for 180 days.
For more information call (888) 463-6332 or visit FederalRegister.gov.