FDA Wants Proof That Antibacterial Hand-Sanitizing Products Are Actually Effective

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While you may have a personal choice of antibacterial hand-sanitizing product to wipe, slather, and squirt your way to germ-free mitts, there’s one thing all those products all have in common: they should actually work.

The Food and Drug Administration is proposing a rule that would have manufacturers submitting scientific data on the efficacy of their products, with a focus on gels, rubs, towelettes, and other similar over-the-counter products used to combat bacteria when washing your hands isn’t an option.

The FDA says it doesn’t have any particular concerns over ingredients, but it wants to make sure it stays up on the latest sincere on the topic, especially because these products are so popular.

“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, noting that while the products are a convenient alternative to hand washing, it’s the FDA’s “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,” Woodcock said.

Specifically, the FDA wants more evidence about the safety of long-term, repeated exposure to these products, especially when pregnant women and children are using them.

The industry will have 180 days to comment on the rules proposed Wednesday. In the meantime, manufacturers of the products will have a year to submit evidence that their products are safe when absorbed into the bloodstream, and that they do kill bacteria.

The agency has already proposed such rules for antibacterial soaps used with water, and on hospital sanitizers.

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