FSMA 204 · Regulatory reference
The fresh-cut definition, before and after
FDA’s 2026 final guidance adopted a new definition of fresh-cut produce — the same wording it had proposed for the Food Traceability List.
There were never two competing definitions — the traceability side simply had none.
FDA released its final fresh-cut produce guidance on 11 August 2026, announced in the Federal Register the following day. It carries a revised definition that first appeared publicly in the February 2026 draft traceability guidance, where FDA noted the wording was similar but not identical to the 2018 version and said it planned to adopt it when finalising the fresh-cut guidance. It did.
Worth stating plainly: neither rule defines the term. “Fresh-cut produce” does not appear in the definitions at 21 CFR 117.3, and it is not defined at 21 CFR 1.1310. Both versions live in guidance, which describes FDA’s current thinking and is not legally enforceable — and the traceability one is still a draft.
What the alignment changes in practice is that one classification now answers two questions: whether a product is ready-to-eat fresh-cut produce for purposes of the preventive controls guidance, and whether it sits on the Food Traceability List under FSMA 204. The exercise is to pull your product list and check each SKU against the exclusions. Some operations will find fewer covered products than they assumed. Others will find more.
Three definitions, in order
The wording below is verbatim. Language that is new or changed in the 2026 final version is marked.
2008 final guidance superseded
“This guidance covers fresh-cut fruits and vegetables that have been minimally processed (e.g., no lethal kill step), and altered in form, by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment.”
The gap: it stopped at the consumer or a retail establishment. Product sold onward to another processing facility sat outside the stated scope.
2018 draft guidance never final
“Any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking).”
The gap: only two exclusions — blanching or cooking. Freezing, canning and packing in syrup were left ambiguous.
2026 final guidance in effect
“Any fresh fruit or vegetable (or combination thereof) that has been physically altered to no longer be in its whole state (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching, freezing, cooking, canning, or packing in a juice, syrup, or dressing), with or without a wash or other treatment before being distributed in fresh form (e.g., to a consumer, a retail food establishment, or a manufacturing/processing facility).”
What closed: the exclusion list grew from two items to five. The destination gap closed — product moving to another manufacturing or processing facility is now explicitly in scope. And the reference to harvesting dropped away, since field operations are addressed under other rules.
What the Food Traceability List actually says
This is the part that surprises people. The traceability rule does not define fresh-cut produce. The FTL carries three short entries and assumes you already know what the term means:
- Fruits (fresh-cut) — includes all types of fresh-cut fruits. Fruits listed in § 112.2(a)(1) are exempt under § 1.1305(e).
- Vegetables other than leafy greens (fresh-cut) — includes all types of fresh-cut vegetables other than leafy greens. Same exemption applies.
- Leafy greens (fresh-cut) — includes all types of fresh-cut leafy greens, single and mixed.
That is the whole of it. From the rule’s publication in November 2022, industry worked with an undefined term. Note also that fresh-cut appears in three separate entries, not one — fresh-cut leafy greens sit with leafy greens, not with vegetables.
One strawberry, three states
The fastest way to test the definition is to follow a single commodity as it is processed.
| Product state | Part 117 RTE fresh-cut | Food Traceability List |
|---|---|---|
| Whole strawberriesUnprocessed, fresh | Not covered | Not on the list |
| Sliced strawberries, freshPhysically altered, distributed fresh | Covered | On the list |
| Sliced strawberries, frozenFreezing is an excluded process | Not covered | Not on the list |
The third row carries a recordkeeping consequence worth knowing. Under the draft traceability guidance, records need not be kept for an FTL food produced at an intermediate step that is no longer an FTL food by the end of the event. A facility that slices whole strawberries and then freezes them at the same location does not maintain traceability records for that product — even though an FTL food existed in the middle.
Falling outside is not the same as being finished
FDA addresses that third row directly. Manufacturers of ready-to-eat foods that are not fresh-cut produce as defined — frozen cut fruit is the agency’s own example — but whose process includes cutting raw agricultural commodities or washing cut produce may still find the guidance useful, particularly its control measures for washing. The cutting and the wash step carry the same hazards whether or not the finished product lands inside the definition.
The case that catches people: citrus
Citrus is explicitly excluded from the FTL. Orange, clementine, tangerine, mandarin, lemon, lime, citron, grapefruit, kumquat and pomelo are all named as outside the tropical tree fruit entry. But the fresh-cut fruits entry says all types of fresh-cut fruits, without carving citrus out.
| Whole oranges | Not on the list |
| Fresh orange segments | On the list |
Cutting it brings it in. The same inversion runs the other way with cabbage: whole head cabbages are named as outside the leafy greens entry, but shredded cabbage for slaw is a fresh-cut vegetable.
Four things to keep straight
- The term is not defined in either rule. Both versions live in guidance, which is not legally enforceable. The FTL entries are part of the traceability rule; the meaning of fresh-cut is not.
- The traceability guidance is still a draft. The fresh-cut guidance is final. The accurate statement is that FDA aligned its thinking on both sides — not that the law changed.
- The scope limits differ. The fresh-cut guidance applies only to ready-to-eat product with a water activity above 0.85, and is directed at facilities and farm mixed-type facilities — not at farms. The FTL carries no water activity limit.
- The list can change. The FTL may be revised through the process at 21 CFR 1.1465. Check the current version before relying on it.
Sources
- Federal Register notice announcing the final guidance — Docket FDA-2018-D-3583
- Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce — FDA final guidance, August 2026
- Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables — FDA final guidance, February 2008. Docket FDA-2008-D-0108. Superseded by the 2026 guidance and no longer published on FDA’s site.
- Food Traceability List — where the three fresh-cut entries appear, revisable under 21 CFR 1.1465
FSPCA Food Traceability Rule course
3–4 December 2026 · Ventura, California. Two days on the official FSPCA curriculum, with an AFDO certificate of successful completion. Seating is limited to 16.
See course detailsEducational summary of publicly available FDA guidance. Not legal or regulatory advice. Guidance represents FDA’s current thinking and is not legally enforceable — verify current requirements against FDA’s published documents before making compliance decisions.