FDA to hand sanitizers: Show us you work.

hand sanitizers

The government is planning to put hand sanitizers under the microscope.

The Food and Drug Administration wants the manufacturers of over-the-counter antiseptic rubs – products like like Purell Foaming Hand Sanitizer, 3M Hand Gel and many, many others – to prove that some of their ingredients are effective and safe. The FDA isn’t actually claiming that hand sanitizers are ineffective or unsafe, but it wants to know more about what it calls “gaps in scientific data on certain active ingredients;” specifically alcohol (ethanol or ethyl alcohol), isopropyl alcohol and benzalkonium chloride.

Millions of Americans use antiseptic rubs daily to help reduce bacteria on their hands, sometimes many times each day. “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….” says Dr. Janet Woodcock, who directs the FDA’s Center for Drug Evaluation and Research.

Long-term impact

The FDA says many things have changed since it began reviewing topical antiseptics in the 1970s.  These changes include how frequently some of these products are used, scientific knowledge about the impact of their frequent use and the FDA’s own safety standards.  So, the agency wants take a new look at the long-term safety of using hand sanitizers daily and their use by certain groups, such as pregnant women and children, for whom absorption of the active ingredients may have a greater impact on their health.

So, the FDA is proposing a rule that will give companies a year to submit new data about the ingredients.  The FDA will then evaluate the data and the comments it receives and then publish a final rule about over-the-counter antiseptic rubs.Says Dr. Woodcock “…it’s our responsibility to determine whether these products are safe and effective….To do that, we must fill the gaps in scientific data on certain active ingredients.”


About the Author

Ed Tobias
Ed Tobias brings more than four decades of reporting and news management experience to his work at Rx411. Tobias managed news coverage for Associated Press Radio for over twenty years. This included coverage of the 9/11 attacks, the Iraq War, Hurricane Katrina, the death of Princess Diana, the Challenger and Columbia shuttle disasters and national election primaries, conventions and campaigns. He was part of the team that built AP’s on-line video operation. Prior to joining AP, Tobias was News Director at all-news WTOP in Washington, D.C.