FDA Asks For Safety And Effectiveness Of Active Ingredients In Hand Sanitizers

Amid increased use of over-the-counter (OTC) antiseptic hand sanitizers, the US Food and Drug Administration (FDA) is requesting more scientific data from manufacturers on the products’ safety and effectiveness. According to the agency, it does not believe that the products are ineffective or pose a safety risk, but it would like to be made aware of any presently unknown safety and efficacy concerns.

Antiseptic rubs are intended to be used in the absence of soap and water, however millions of Americans use hand sanitizers multiple times a day to control bacteria levels on their hands. The Centers For Disease Control and Prevention (CDC) recommend that consumers use an alcohol-based sanitizer containing a minimum of 60 percent alcohol.

“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, 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.”

The FDA’s decision to request additional information on active ingredients in antiseptic rubs, was motivated by the release of new scientific evidence and on the advice of a medical advisory committee. Manufacturers of these products are being asked to provide data on the three most commonly used active ingredients in hand sanitizers: alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride.

According to the FDA, 90 percent of all consumer hand sanitizers use ethanol or ethyl alcohol to kill bacteria present on the skin. Of particular interest to the FDA is the absorption data for these active ingredients.

Recent studies have suggested that systemic exposure for some antiseptics – where the ingredient can be detected in the blood or urine – is more common than previously thought. Because of this, the FDA is seeking out information related to the safety of repeated, long-term exposure to these products.

While the FDA has yet to finalize this rule, companies marketing their antiseptic products under the OTC Drug Review will be required to provide the FDA with additional safety data for their hand sanitizers. For now, the agency is not requiring the removal of any antiseptic products from the market.