The move is part of the FDA’s larger review of active ingredients in over-the-counter (OTC) antiseptic products. The Agency has previously proposed this sort of rulemaking in April of last year, regarding health care antiseptics, and in December of 2013, regarding consumer antiseptic washes, according to a press release about the new proposal.
Companies have one year to submit their new data to the Agency and 60 days beyond that to submit comments or related information. For the first 180 days, the rule is also open for public comment. Once all the data and comments are in, the FDA will begin its evaluation.
Use case
The FDA has initiated the investigation in large part because hand sanitizers are abundant and in common use now. “The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations…for which topical absorption of the active ingredients may be important,” according to the release.
The FDA also notes that full body exposure (meaning absorbed antiseptic ingredients are present in consumers’ blood or urine) is likely higher than anticipated. So again, knowing the full effects of repeated product exposure is crucial.
Active and effective
But it’s not only frequent consumer use that has the FDA looking in to hand sanitizer: “Based on new scientific information and input of outside scientific and medical experts on an independent advisory committee, the agency is requesting additional scientific data to demonstrate that the active ingredients used in consumer antiseptic rubs are generally recognized as safe and effective to reduce bacteria on skin,” states the press release.
The key active in most (90%, according to the FDA) OTC hand sanitizer rubs is either ethanol or ethyl alcohol. But that’s not the only ingredient being looked at here. “The agency is requesting manufacturers provide data for three active ingredients -- alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride,” explains the press release.
Going beyond safety, the FDA will also be evaluating the efficacy of actives in reducing bacteria on the skin.