The FDA announced it wants more information about active ingredients in certain topical antiseptic rubs, including common hand sanitizers.
The agency hopes more data will demonstrate the effectiveness of sanitizers and guarantee no unknown risks can arise from regular use of the products.
“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,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “To do that, we must fill the gaps in scientific data on certain active ingredients.”
The rule would require manufacturers to provide data for three active ingredients: alcohol, isopropyl alcohol and benzalkonium chloride. The majority of antiseptic rubs use alcohol as their active ingredient.
The FDA said it is particularly interested in how pregnant women and children are affected.
Jim Arbogast is the vice president of hygiene sciences and public health advancements for GOJO, the company that owns the hand sanitizer brand Purell.
In a statement, Arbogast said, “GOJO is dedicated to developing the safest, most effective hygiene products and is working with the FDA to advance and share the latest science on these active ingredients.”
The statement referenced a study published by researchers at the University of Cincinnati that found the use of alcohol-based hand sanitizers even as often as 30 times an hour results in miniscule absorption into the skin.
The FDA's plan to study sanitizers is will be open to public comment for 180 days.
