Thursday, April 11, 2019
GOJO, in collaboration with other industry leaders, is sharing an abundance of safety and effectiveness data to fulfill the new FDA data requests
As expected, the FDA announced today that it is extending its timeline for rulemaking on three active ingredients commonly used in consumer hand sanitizers - Ethyl Alcohol, Isopropyl Alcohol, and Benzalkonium chloride. The FDA is doing this to allow manufacturers adequate time to complete studies to fulfill new FDA data requests. The FDA stated in its news release, that it “believes industry has made good progress toward providing data.” The FDA also noted that consumer antiseptic hand sanitizers provide a convenient alternative when handwashing with plain soap and water is unavailable and notes that the Centers for Disease Control and Prevention recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.1
In 2016, the FDA established new criteria for assessing the safety and effectiveness of consumer hand sanitizers. Because of this, the FDA asked manufacturers to provide the latest science and studies for these products. It has been more than 20 years since the FDA last collected such data and they have also taken this approach with other product categories as well.
As a science-based industry leader, GOJO scientists continue to work with the FDA to provide safety and effectiveness data on antiseptic products used in consumer settings. GOJO is completing these new studies in collaboration with industry leaders and continues to work with public health thought leaders to advance the science of hand hygiene. There is more safety and effectiveness data for ethyl alcohol than any other antiseptic ingredient, and it is the global gold standard for healthcare.
GOJO is committed to our Purpose: Saving Lives and Making Life Better through Well-Being Solutions.
We applaud the FDA for taking this evidence-based approach to ensure all consumer antiseptic products meet the high standards for safety and effectiveness that our PURELL® products do.