FDA Finalizes Food Safety Guidance for Ready-to-Eat Fresh-Cut Produce Operations

The U.S. Food and Drug Administration (FDA) has released final guidance to help manufacturers and processors of ready-to-eat fresh-cut produce comply with requirements under the FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) rule.

The final guidance, released August 11, 2026, provides recommendations and examples for protecting fresh-cut ready-to-eat produce from contamination with biological hazards.

Why Fresh-Cut Produce Requires Additional Attention

FDA notes that fresh-cut produce can be particularly susceptible to contamination throughout the supply chain.

Contamination may be introduced during growing, transportation, manufacturing, commingling with other products, or at retail. The opportunity for contamination can also increase as products move through these different stages.

An important consideration is that fresh-cut produce generally does not receive a kill step that would eliminate pathogens introduced during production or handling, and most fresh-cut products are sold ready-to-eat.

What Is Considered Fresh-Cut Produce?

FDA defines fresh-cut produce as fruits or vegetables that have been physically altered from their whole state without undergoing additional processing such as freezing or cooking and that are distributed in fresh form.

Examples provided by FDA include:

• Chopped lettuce
• Cut cantaloupe
• Diced onions
• Shredded carrots

Physical alterations can include chopping, dicing, peeling, shredding, and similar activities.

Guidance for Implementing Preventive Controls

The final guidance provides recommendations and examples illustrating how requirements under the Preventive Controls for Human Food rule can be implemented to protect ready-to-eat fresh-cut produce from biological hazards.

The guidance is intended to help manufacturers and processors understand FDA’s current thinking regarding contamination prevention for these operations.

Final Guidance Replaces 2008 FDA Guidance

The new final guidance reflects public comments FDA received following publication of its draft guidance in October 2018.

It also replaces FDA’s previous fresh-cut produce guidance issued in 2008.

FDA encourages industry to continue advancing food safety practices, including developing and implementing best practice documents tailored to specific commodities and production processes.

What Fresh-Cut Produce Operations Should Consider

Manufacturers and processors of ready-to-eat fresh-cut produce should review the final guidance and compare FDA’s recommendations with their existing food safety programs and preventive control procedures.

Operations may wish to evaluate how their current practices address biological hazards associated with the production and handling of fresh-cut produce and determine whether changes are appropriate based on FDA’s updated recommendations.

EAS Perspective

The final guidance provides fresh-cut produce operations with updated recommendations for applying the Preventive Controls for Human Food requirements to products that present unique contamination challenges.

Because these products are commonly consumed ready-to-eat and typically do not undergo a kill step, effective preventive controls and contamination prevention practices remain particularly important.

Fresh-cut produce manufacturers and processors should review the new guidance and determine whether existing food safety plans and operational practices align with FDA’s current recommendations.