FDA Requests Data from Manufacturers to Analyze Safety of Hand Sanitizers
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FDA Requests Data from Manufacturers to Analyze Safety of Hand Sanitizers

Millions of Americans use antiseptic rubs daily to help reduce bacteria on their hands

June 29, 2016

Is your hand sanitizer safe? The Food and Drug Administration (FDA) would like to find out for sure.

The FDA has 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).

Antiseptic rubs are products that are intended to be used by consumers when soap and water are not available, and are left on and not rinsed off with water. Millions of Americans use antiseptic rubs daily, sometimes multiple times a day, to help reduce bacteria on their hands.

"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 Janet Woodcock, in a written statement. Woodcock is the director of the 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."

To properly assess the safety of ingredients, 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.

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 FDA is particularly 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 is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients.

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.