The agency announced that it is formally seeking 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,” as reported in Happi.
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 Executive Vice President, Technical & 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.