Federal regulators want makers of popular hand sanitizers and rubs such as Purell to prove their products actually work.
The Food and Drug Administration asked for more scientific data to determine whether antiseptic sanitizers and rubs are safe and effective. The agency issued a proposed rule on Wednesday that calls for more information, but doesn’t pull any products off the market.
The popular antiseptic sanitizers are a liquid, gel or foam that enables people to clean their hands without the need for water. Purell boasts that it kills “99.99 percent of illness-causing germs.”
“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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
To do that, the FDA said it needs to fill gaps in scientific data on active ingredients in the rubs, including alcohol and ethanol.
The rule requires manufacturers that want to market such products to provide additional data on the safety and effectiveness of active ingredients in the sanitizer or rub.
The rule follows earlier regulations from the agency on soaps. In 2013, the FDA required manufacturers of hand soaps and body washes to prove their products are safe for long-term daily use and are more effective than regular soap and water in preventing infections.
