The US Food and Drug Administration (FDA) on Thursday issued a final rule barring certain active ingredients that have not been demonstrated to be safe and effective from use in over-the-counter (OTC) hand sanitizers.
Specifically, the rule finalizes a proposal in 2016 that bars 28 active ingredients, including triclosan and benzethonium chloride, from eligibility under FDA's OTC drug review for use in consumer OTC hand sanitizers and finalizes a 1994 tentative final monograph (TMF) for those products.
FDA says it did not receive any information since the proposed rule was issued that would support the inclusion of any of the 28 ingredients in its OTC monograph for consumer hand sanitizers.
According to FDA, the final rule will impact less than 3% of the consumer hand sanitizer market, as most currently marketed hand sanitizers use ethyl alcohol as the active ingredient.
Companies wishing to market OTC hand sanitizers containing those ingredients will instead be required to submit a new drug application (NDA) or abbreviated new drug application (ANDA) for review by the agency.
Within the final rule, FDA also details the types of studies that should be conducted to demonstrate that an active ingredient is safe and effective for use in consumer hand sanitizers.
FDA says the final rule "completes a series of actions" over the last six years to more closely regulate the active ingredients in antiseptic soaps to ensure they are safe and work as intended. The actions follow steps FDA took in the 1990s to update the monograph issued in the 1970s for various topical antiseptics.
In 2017, FDA finalized another rule
barring the use of 24 active ingredients in OTC antiseptic washes, rubs and surgical hand scrubs used in health care settings.
"Our action today aims to help provide consumers with confidence that over-the-counter hand sanitizers they're using are safe and effective when they don't have access to water to wash with soap," Center for Drug Evaluation and Research Director Janet Woodcock said.
For the time being, FDA is deferring rulemaking on the use of three other active ingredients, benzalkonium chloride, ethyl alcohol and isopropyl alcohol, to give more time for industry to submit data to support their use.
According to Woodcock, industry has made strides toward providing that data to the agency.
, Final Rule