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New FDA Rulemaking for Food Handler Antiseptic Products

American Cleaning Institute Issued 2014 Request to Create Specific Category for Food Handler Antiseptic Handwash Products

 

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 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, 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 foodborne disease transmission,” added Sedlak.

 

About The American Cleaning Institute®

 

ACI is the Home of the U.S. Cleaning Products Industry® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.

 

Source: The American Cleaning Institute®