December 6, 2018
“Ensuring the safety and effectiveness of over-the-counter antiseptic hand wash and rub products is a critical part of our consumer protection mission. Food handlers rely on these products to keep food safe. And consumers rely on the FDA to make sure that they’re effective. The FDA has been undertaking a comprehensive review of the active ingredients used in a variety of OTC antiseptic washes and rubs. Not all products are the same or used in similar settings. We’ve already taken steps to make sure products used in consumer and health care settings are safe and effective. And today we’re taking important new steps to address the safety and effectiveness of similar products used by food handlers,” said FDA Commissioner Scott Gottlieb, M.D. “Antiseptic hand washes and rubs can be an important part of strategies for preventing foodborne diseases. But if they don’t work as expected, or aren’t used as intended, they can also contribute to antimicrobial resistance. The products used by food handlers are intended to reduce harmful bacteria on the skin and prevent disease caused by transfer of the harmful bacteria when food is being handled. So, these products must be able to prevent the spread of bacteria and viruses. Through the process we’re announcing today, we’ll gain new information from industry, stakeholders and the public to inform our ongoing review of these OTC antiseptic drug products and help ensure the reliability of the tools available to curb the spread of foodborne illness.”
Today the FDA issued a Request for Information (RFI) and established a docket to obtain data, information and comments that will assist the agency in assessing the safety and effectiveness of OTC food handler antiseptic drug products, (i.e., antiseptic hand washes or rubs intended for use in food handling settings). The FDA has tentatively concluded that food handler antiseptics may differ from antiseptic products addressed in other rulemakings.
This tentative determination is based on the current categorization of other antiseptic products and considers factors that may include specific microorganisms of concern in food handling environments, as well as the safety of repeated-exposure use patterns. It also considers issues raised by the public health consequences of foodborne illness, differences in frequency and type of use and contamination of the hands by dirt, grease and other oils. There has been support from industry and interested parties for an OTC food handler antiseptic category. Some information and data have already been submitted to the FDA in support of establishing such a category. The FDA believes more information is needed to assist the agency in evaluating the safety and effectiveness criteria appropriate for food handler antiseptics.
Through this RFI, the agency is asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service or consumption of food occurs. The FDA is also seeking comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics, safety and effectiveness criteria, as well as test methods to demonstrate the safety and effectiveness of food handler antiseptics. This information and data will inform the agency’s ongoing review of OTC antiseptic drug products.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.