FDA seeks more data on safety, effectiveness of antiseptic rubs
The FDA is asking manufacturers for more scientific data on the safety and effectiveness of topical antiseptic rubs — including hand sanitizers — that are marketed over-the-counter to consumers.
The agency said it is particularly interested in data about the long-term safety of daily, repeated exposure to these rubs and their use among populations such as children and pregnant women. It has made similar rule proposals in the past seeking additional data on antibacterial soaps and antiseptics.
According an FDA news release, emerging science suggests that systemic exposure to some of the ingredients in topical antiseptic rubs is higher than previously thought, highlighting the need for more data on the effects of such exposure on humans.
“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “These products provide a convenient alternative when hand washing with plain soap and water is unavailable, but it’s our responsibility to determine whether these products are safe and effective so that consumers can be confident when using them on themselves and their families multiple times a day. To do that, we must fill the gaps in scientific data on certain active ingredients.”
The FDA said its request for more data does not mean the rubs are ineffective or unsafe. As of now, none of the products currently being marketed to consumers is being removed from the market, the agency said.
It is asking manufacturers for data on three active ingredients: ethanol or ethyl alcohol, isopropyl alcohol and benzalkonium chloride.
The FDA will not finalize a rule until after companies have been able to submit new data and the public has had a chance to comment, a process that will take more than 1 year. – by Gerard Gallagher
Disclosure: Woodcock reports no relevant financial disclosures.