The U.S. Food and Drug Administration (FDA) is releasing an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods. L. mono, a pathogen that can grow even in cold, refrigerated environments, is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.
The emphasis on prevention in this draft guidance is consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the FDA’s current good manufacturing practice (CGMP) requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.