WASHINGTON — After reviewing the safety and effectiveness of hand sanitizers, the US Food and Drug Administration has ruled that dozens of active ingredients can’t be used in the antiseptic rubs, but the agency still wants answers about the most common active ingredient.
The rule, issued Thursday, “reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these products are safe and effective for regular use by consumers,” Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said in an announcement.
“We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data.”
The final rule regarding dozens of other ingredients will affect less than 3% of the marketplace because most common hand sanitizers use ethyl alcohol, according to the FDA.
“We finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs,” Woodcock said.
Yet “our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe and effective when they don’t have access to water to wash with soap.”
The agency noted that retailers and pharmacies market a very low number of consumer hand sanitizers containing benzethonium chloride but have stopped marketing hand sanitizers containing the antibacterial agent triclosan.
The American Cleaning Institute, which represents the cleaning products industry, released a statement in response to the rule on Thursday.
“On behalf of our members who produce hand sanitizers and their ingredients, the American Cleaning Institute looks forward to providing additional data to ensure the FDA has complete and up-to-date information on ethanol and benzalkonium chloride used in these beneficial products. ACI welcomes the agency’s decision to allow adequate time to complete the new studies to generate the data the agency is requesting. Consumers can continue to use hand sanitizer products with confidence as this regulatory process moves forward,” the statement says.
The rule comes after an FDA investigation that started in 2016 into whether long-term exposure to certain ingredients sanitizers might be harmful to pregnant women and children. The rule will be effective one year after it is published in the Federal Register on Friday, according to the FDA.
Used by millions of Americans daily and often repeatedly, over-the-counter sanitizers are meant to reduce bacteria when handwashing is either inconvenient or impossible.
The US Centers for Disease Control and Prevention advises that washing your hands with soap and water is key for preventing the spread of germs. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer that contains at least 60% alcohol.
In the investigation, the FDA wanted to know more about three ingredients in these products: ethanol (or ethyl alcohol), isopropyl alcohol and benzalkonium chloride.
Ethyl alcohol is a primary alcohol and isopropyl a secondary alcohol; though related, they have different chemical properties and absorbency.
“At this time, three active ingredients — benzalkonium chloride, ethyl alcohol, and isopropyl alcohol — are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use,” the FDA announcement said.
The status of those ingredients will be addressed either after completion of the studies or at another time, according to the agency.
