The American Cleaning Institute (ACI) submitted in-depth data and information to the Food and Drug Administration (FDA) to update the agency’s review of germ-killing antiseptic hand cleaning products that are widely used in commercial food handling settings.
ACI recommended that the agency align the scope of its review with the Food Safety Modernization Act (FSMA) in its comments, which were submitted to the FDA July 22.
“FSMA regulations require food safety evaluation and intervention throughout the supply chain, including the growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, and consumption of food,” says ACI in its comments. “Food safety interventions include proper employee health and hygiene, of which hand washing and sanitization is a critical component.”
ACI expressed concern that “FDA may be taking an unduly restrictive approach to assessing the monograph eligibility of active ingredients intended for food handler antiseptic drug products.”
While the agency had previously stated it expected that many antiseptic active ingredients used in these products may not have been on the market prior to 1972 – when the Over-the-Counter Drug Review was first established – ACI claims otherwise.
“In January 1972, before the inception of the OTC drug review, FDA announced that it was convening an advisory panel on ‘all antibacterial ingredients used in OTC drugs for repeated daily consumer use as prophylaxis against minor skin infections or transmission of disease.’”
ACI continues in its comments, “In this notice, FDA specifically identified ‘food handlers’ as among those who ‘may benefit from the antibacterial action of these products.’ This language is consistent with the recognition that antiseptics, with broad claims to prevent transmission of disease, were already in use and of benefit to food handlers. Therefore, the potential eligibility of antiseptics for food handler use has been clear from the beginning of the OTC drug review.
Therefore, it would be unreasonable for FDA to require, as a condition of monograph eligibility, the submission of labeling specific to food handler use when it is well known that such products, with more general antiseptic claims, were historically used by food handlers.”
The ACI says it should be sufficient enough to show that ingredients were intended for antiseptic use covering food handling and that food handle specific labeling is not necessary.
The active ingredients currently used by ACI members in food handler antiseptics include benzalkonium chloride (BAC), benzethonium chloride (BZT), chloroxylenol (PCMX), ethanol (EtOH) and povidone-iodine (PVP-I). ACI says that new data being generated to the support the safe use of these antiseptic ingredients – including those to address human exposure – “will be sufficient to meet the safety data needs of food handler products.”
Research is underway to fill in data gaps on how frequently food handler antiseptics are used by employees in those settings, says ACI.