America is a nation of germaphobes, if the ubiquity of alcohol-based disinfectants like Purell is any indication. But the FDA is now wondering if your favorite pathogen-busting product is actually safe and effective.
The agency on Wednesday proposed a new regulatory rule that would require antiseptic rub manufacturers to provide more data proving the safety and efficacy of certain active ingredients in their over-the-counter products. The ingredients in question are ethanol or ethyl alcohol, isopropyl alcohol, and benzalkonium chloride, which are used in more than 90% of antiseptic rubs.
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“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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
“To do that, we must fill the gaps in scientific data on certain active ingredients,” she added.
The FDA’s proposed rule is part of a broader review of antiseptic products, including wipes and washes, and was spurred by concerns in the medical community that rising daily use of such sanitizers hadn’t been proven irrevocably to be safe and effective. In its statement, the agency pointed to some recent evidence that heavy use could increase the presence of sanitizing chemicals in the bloodstream, which may be harmful for children, pregnant women, and other consumers.
No products would have to be pulled from the market under the new guidance. But if the rule is finalized, companies like the privately-held Gojo Industries (maker of Purell) would have to conduct more research into the possible consequences of extended use of their products.