FDA continues to investigate safety of active ingredients in hand sanitizers

FDA issued a final rule on April 11 that would ban certain harmful active ingredients in OTC hand sanitizers. The regulation finalized a previous determination from FDA that 28 active ingredients, including triclosan and benzethonium chloride, are not allowed in these products.

The agency said it also needs more information on three other active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—to help verify that products with these ingredients are safe and effective for regular use by consumers. FDA said it does not intend to take action at this time to remove from the market hand sanitizers that contain these three active ingredients. Ethyl alcohol is the most common ingredient in hand sanitizers.

“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement.

Handwashing with plain soap and running water is the best way to avoid getting sick and preventing the spread of germs, according to CDC. If soap and water are not available, individuals should follow CDC’s recommendation to use an alcohol-based hand sanitizer that contains at least 60% alcohol.

The final rule is part of an ongoing effort from FDA to minimize the health risks from sanitizers as well as reduce the threat of antibiotic resistance. In 2016, FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer hand sanitizers.

Going forward, products that contain any ineligible active ingredients will require FDA approval under a new drug application or abbreviated new drug application prior to marketing.