Final Regulation on the Safety and Effectiveness of Hand Sanitizers for Consumers

The Food and Drug Administration (FDA) today issued a final rule to ensure that over-the-counter hand sanitizers are safe and effective for those who depend on them. The rule states that certain active ingredients can not be used in over-the-counter hand sanitizers, formerly known as topical antiseptic consumer products, intended for use without water and marketed under the OTC Drug program. Review of the FDA. The final rule is also intended to ensure that the agency's safety and effectiveness badessments and determinations for active antiseptic ingredients for the consumer are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use. increasing.

"Our action today is to give consumers the badurance that the over-the-counter hand sanitizers they use are safe and effective when they do not have access to water for soap-washing. Said Janet Woodbad, MD, director of the FDA's Center for Drug Evaluation and Research. "In today's final settlement, we have finalized the FDA's earlier ruling that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for badessment in the context of the review. over-the-counter drug from the FDA for use in antiseptic disinfectants for the consumer. We also reaffirmed the need to have more data on three other active ingredients, including ethyl alcohol, the most used ingredient in hand sanitizers, to help prevent the spread of the disease. agency to ensure that these products are safe and effective for regular use by consumers. We believe that the industry has made good progress in providing data and we will continue to inform the public of the progress made in collecting this data. "

Antiseptic hand sanitizers for consumers are a practical alternative when handwashing with soap and water is not available. Millions of Americans use antiseptic friction daily, sometimes several times a day, to reduce bacteria on their hands. Centers for Disease Control and Prevention advise handwashing with regular soap and running water is one of the most important steps consumers can take to avoid getting sick and preventing the spread of disease infections to others. If you do not have water or soap, the CDC recommends using an alcohol-based hand sanitizer containing at least 60% alcohol.

As part of the June 30, 2016 rule proposal on antiseptic rubs for consumers, the FDA has requested additional scientific data to support safety and health. effectiveness of the active ingredients used in antiseptic rubs for over-the-counter consumption.

At present, three active substances – benzalkonium chloride, ethyl alcohol and isopropyl alcohol – are no longer regulated to allow further study and submission of data Additional safety and efficacy information needed to determine whether these active substances are generally recognized as safe and effective for use in antiseptic products for over-the-counter consumers. Their status will be treated either after the completion and badysis of the studies, or at another time, if these studies are not completed. At present, the FDA does not intend to take steps to remove from the market hand sanitizers containing these three active ingredients.

Publication of this final rule will affect less than 3% of the market, as most antiseptics for over-the-counter users use ethyl alcohol as the active ingredient.

The FDA is aware that retailers and pharmacies continue to market a very small number of hand sanitizers containing benzethonium chloride, but have stopped marketing hand sanitizers containing triclosan. Drug products containing ineligible active ingredients will need to be approved under a new drug application or an abbreviated new drug application prior to marketing.

This final rule complements a series of regulatory activities as part of the FDA's ongoing review of over-the-counter antiseptic active ingredients to determine whether these ingredients are safe and effective for the intended uses. The FDA had previously released the latest rules regarding antiseptic washes for consumers (September 2016) and antiseptics for health care (December 2017).

"On behalf of our members who produce hand sanitizers and their ingredients, the American Cleaning Institute is eager to provide additional data to ensure the FDA with complete and up-to-date information on ethanol and the benzalkonium chloride used in these beneficial products, "said Richard Sedlak, vice president for technical and international affairs of ACI, said:" ACI welcomes the decision of the I & # 39; agency to leave enough time to carry out the new studies to generate the data requested by the agency. "

"Consumers can continue to use hand sanitizers with confidence as the regulatory process moves forward, and we will ensure that these products remain available to help people stay clean and healthy in homes, day, restaurants and offices ". United States."