ACI Approves FDA Proposal for Food Handler Antiseptics

The American Cleaning Institute (ACI) welcomed a proposal by the Food and Drug Administration (FDA) to create a separate regulatory category for antiseptic products used in food handler settings. 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.”

ACI, along with the Personal Care Products Council (PCPC), 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.”

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.

More info: www.cleaninginstitute.org; www.personalcarecouncil.org