FDA Issues Ruling on Hand Sanitizers

April 12, 2019

The most common active ingredient in consumer antiseptic hand rubs, ethyl alcohol, is still under investigation by the U. S. Food and Drug Administration (FDA), according to a final FDA rule on the safety and effectiveness of hand sanitizers issued last week.

The final rule verified a previous determination from the FDA that 28 active ingredients are not suitable for hand sanitizers, including triclosan and benzethonium chloride. Triclosan has since been removed from hand sanitizers and very few containing benzethonium chloride are available in retailers and pharmacies.

However, the FDA has not issued a definitive rule on three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol. At this time, the FDA does not intend to remove hand sanitizers containing these three active ingredients from the market.

As less than 3% of hand sanitizers use an active ingredient other than ethyl alcohol, the final ruling removing other ingredients will not affect many manufacturers.

The American Cleaning Institute (ACI) issued a statement in response to the ruling pledging to assist the FDA in its continuing investigations.

“Hand sanitizers are a critical part of healthy hand hygiene routines for millions of people every single day,” the statement read. “On behalf of our members who produce hand sanitizers and their ingredients, the American Cleaning Institute looks forward to providing additional data to ensure the FDA has complete and up-to-date information on ethanol and benzalkonium chloride used in these beneficial products. ACI welcomes the agency’s decision to allow adequate time to complete the new studies to generate the data the agency is requesting.”