FDA Issues Guidance for Control of Listeria in Ready-to-Eat Foods | Practical Law

FDA Issues Guidance for Control of Listeria in Ready-to-Eat Foods | Practical Law

The Food and Drug Administration (FDA) has released revised draft guidance for preventing contamination of ready-to-eat (RTE) foods with the Listeria bacteria. The guidance is intended to help companies comply with the FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations (CGMPs).

FDA Issues Guidance for Control of Listeria in Ready-to-Eat Foods

Practical Law Legal Update w-005-4258 (Approx. 3 pages)

FDA Issues Guidance for Control of Listeria in Ready-to-Eat Foods

by Practical Law Commercial Transactions
Law stated as of 17 Jan 2017 • USA (National/Federal)
The Food and Drug Administration (FDA) has released revised draft guidance for preventing contamination of ready-to-eat (RTE) foods with the Listeria bacteria. The guidance is intended to help companies comply with the FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations (CGMPs).
On January 17, 2017, the Food and Drug Administration (FDA) announced that it had released revised draft guidance for preventing contamination of ready-to-eat (RTE) foods with the Listeria bacteria. Cooking and pasteurization both kill Listeria, but RTE foods like deli meats, sprouts, and smoked seafood are susceptible to contamination.
The guidance on Listeria contamination in RTE food is intended to help companies comply with the FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations (CGMPs) (21 C.F.R. § 110.3-110.110), which serve as one of the bases for FDA inspections.
The revisions bring the FDA's guidance into compliance with recent changes in the CGMPs' requirements for:
  • Production of RTE food that is both:
    • exposed to the environment prior to packaging; and
    • does not receive a treatment or control measure (such as pasteurization) that would minimize the risk of contamination.
  • Human food preventative controls regarding environmental pathogens in RTE foods.
The FDA will be soliciting comments on the revised draft guidance until July 26, 2017.
For more on how to comply with the CGMPs, see Practice Note, FSMA Regulation on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Checklist.