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FDA Takes Steps To Promote The Safety And Effectiveness Of Over-The-Counter Antiseptic Hand Washes Intended In Food Handling

Last updated on Tuesday, December 11, 2018

(UNDATED) - Ensuring the safety and effectiveness of over-the-counter antiseptic hand wash and rub products is a critical part of the Food and Drug Administration.

"Food handlers rely on these products to keep food safe. And consumers rely on the FDA to make sure that they're effective," says FDA Commissioner Scott Gottlieb, M.D. "The FDA has been undertaking a comprehensive review of the active ingredients used in a variety of over the counter antiseptic washes and rubs. Not all products are the same or used in similar settings."

The FDA has taken steps to make sure products used in consumer and health care settings are safe and effective.

"Antiseptic hand washes and rubs can be an important part of strategies for preventing foodborne diseases," said Gottlieb. "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 a transfer of the harmful bacteria when food is being handled. So, these products must be able to prevent the spread of bacteria and viruses."

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 over the counter 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.

Officials say 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 the 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 over the counter antiseptic drug products.

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