FDA Calls for More Data on Safety and Efficacy of OTC Hand Sanitizers

The FDA is asking for more scientific data to support the safety and effectiveness of certain active ingredients in OTC topical antiseptic rubs, including hand sanitizers.

The FDA is asking for more scientific data to support the safety and effectiveness of certain active ingredients in OTC topical antiseptic rubs, including hand sanitizers.

The proposed rule does not mean the FDA thinks these products are unsafe or ineffective.

“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, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press 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 CDC recommends washing hands with plain soap and water. However, if these resources aren’t available, individuals should use an alcohol-based hand sanitizer that contains at least 60% alcohol.

The FDA would like to see more data on 3 active ingredients in these types of products: alcohol, isopropyl alcohol, and benzalkonium chloride.

In addition, the FDA is interested in data on the long-term use of the products, especially in certain populations like pregnant women and children.

The proposed rule will be open to public comment for 180 days. Companies will have 1 year to submit new data and information.