The FDA Has Some Concerns About Your Hand Sanitizer

In your car, in your purse, at the gym and gas station—hand sanitizers or antiseptic rubs are everywhere we look, but to our dismay, it may not be the best idea to slather it on every chance we get. Yesterday, the U.S. Food and Drug Administration (FDA) requested additional scientific data to back up the safety and effectiveness claims of three active ingredients—alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride—almost always found in these over-the-counter sanitizers. According to the FDA, 90 percent of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient since 2009.

“These products provide a convenient alternative when hand washing with plain soap and water is unavailable, “says Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, “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.”

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However, the new proposed rule from the FDA doesn’t require any recalls or any consumer hand sanitizer products to be taken off shelves. Instead, it requires brands that want to continue marketing these products under the Over-the-Counter Drug Review to provide the FDA with additional data on the safety and efficacy of the active ingredients, including data to evaluate absorption.

In the meantime, the Center for Disease Control (CDC) recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol when plain soap and running water are unavailable, which they describe as being one of the most crucial steps we can take to avoid sickness and the spread of infection.