FDA Proposes to Create Separate Regulatory Category for Antiseptic Products Used in Food Handling


The Food and Drug Administration (FDA) announced its proposal to create a separate regulatory category for antiseptic products used in food handler settings.

The FDA has established a docket to obtain data, information, and comments that will assist the agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter (OTC) human use. 

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 use by food handlers in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs. it is also inviting 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 effectiveness of food handler antiseptics. 

In general, the FDA is seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics. This information and data will inform FDA's ongoing review of OTC antiseptic drug products and will specifically inform our review of food handler antiseptic products.

The American Cleaning Institute (ACI) says it welcomes the proposal from the FDA. ACI, along with the Personal Care Products Council, submitted a citizen petition in 2014 requesting that FDA create the food handler category as “a threshold step to address the safety and efficacy of active ingredients for use in this category of products.”

“The use of antiseptic hand hygiene products, like antibacterial soaps and hand sanitizers, is critical to infection control and disease prevention in food handler settings,” said Richard Sedlak, ACI's executive vice president of technical and international affairs. “The transfer of bacteria to food at food handling operations can potentially affect large numbers of people through their exposure to or consumption of contaminated food.”

ACI is leading a multi-year research effort to demonstrate the safety and efficacy of the antiseptic ingredients used in hand hygiene products in consumer and healthcare settings. The ongoing research is meant to comply with complex safety data requests from the FDA. 

“The American Cleaning Institute looks forward to providing FDA the necessary data on food handler antiseptic products that ensure their safety and effectiveness in helping to reduce the risk of food-borne disease transmission,” added Sedlak.

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