FDA Rules on Safe Ingredients for Hand Sanitizers

Hand sanitizers save the day for many people who work and play in messy or germ-filled environments – from schools to outdoor work sites. A simple squirt of an OTC hand sanitizer can kill germs and clean your hands without water. But are the ingredients used to make them effective and, most importantly, safe?

The U.S. Food and Drug Administration issued a final rule designed to ensure hand sanitizers on the market today are safe, effective, and that the active ingredients are consistent, up-to-date, and reflect current scientific knowledge. Consumer antiseptic rub products, as they are formally known, are in widespread and frequent use, with millions of Americans using these products daily, often multiple times a day, to reduce bacteria on their hands.

“In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.  “We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers.”

At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.

Drug products containing any ineligible active ingredients will require approval under a new drug application or abbreviated new drug application prior to marketing.

Less than 3% of the marketplace will be affected by the issuance of this final rule.  

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