FDA Wants More Data on Hand Sanitizers

"Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low," said Dr. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "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."

The U.S. Food and Drug Administration published a proposed rule June 29 that requests additional scientific data to support the safety and effectiveness of some active ingredients used in hand sanitizers and topical consumer antiseptic rubs generally that are marketed over the counter, with the agency stating that its request "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, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low," said Dr. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "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."

FDA cites CDC's advice in this area, which is that washing your hands with ordinary soap and running water is one of the most important steps consumers can take to avoid getting sick and prevent the spread of infections to other people. If soap and water are not available, CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent 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 percent of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient," FDA's announcement states. "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 agency said it is especially interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important. "Emerging science also suggests that for some antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients," according to the announcement, which said this rule is part of FDA's ongoing review of OTC antiseptic active ingredients to ensure they are safe and effective. FDA 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, and companies will have one year to submit new data and information; comments on any new data or information may then be submitted to the docket for an additional 60 days. The agency's final determination will be published as a final rule.

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