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# FDA Asks for More Data on Hand Sanitizers
- URL: https://www.fdaweb.com/fda-asks-for-more-data-on-hand-sanitizers/
- Published: 2016-06-29T12:00:00.000Z
- Updated: 2026-09-14T21:12:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136088

Hand sanitizers sure make your hands smell fresh and clean, but do they actually work to kill/reduce bacteria on the hands? A new FDA proposed rule is requesting that manufacturers provide additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). “The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe,” the agency says. It requires manufacturers who want to continue marketing these products under the OTC Drug Review to provide the additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption.

“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,” CDER director **Janet Woodcock** explains in a [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm509097.htm?ref=fdaweb.com). “To do that, we must fill the gaps in scientific data on certain active ingredients.”

[The CDC advises](http://www.cdc.gov/handwashing/?ref=fdaweb.com) that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the it recommends using an alcohol-based hand sanitizer that contains at least 60% alcohol, FDA notes. Based on new scientific information and recommendations from an independent [advisory committee](http://www.fda.gov/AdvisoryCommittees/Calendar/ucm407136.htm?ref=fdaweb.com), the agency is requesting manufacturers provide data for three active ingredients — alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride. “Since 2009, 90% of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient,” it says.

“The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients by consumers, and on the use of these products by certain populations, including pregnant women and children, for which topical absorption of the active ingredients may be important,” the agency release says. “Emerging science also suggests that for some antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and that more information is needed about the effects of repeated daily human exposure to some antiseptic active ingredients.”