FSMA 204 regulation in the United States: what changes for exporters, producers and food distributors

In recent days, the Food and Drug Administration (FDA) has issued an important update on the Food Traceability Rule, the section of the Food Safety Modernization Act (FSMA) focused on food traceability under Section 204, with more time now available for compliance. Below is an overview of the requirements, timeline and practical tools that matter for producers, brands and distributors across the supply chain.

What FSMA 204 is and why it matters

FSMA 204 is a U.S. federal rule that introduces enhanced traceability requirements for specific categories of high-risk foods included in the Food Traceability List (FTL). Its purpose is to speed up the identification and removal of contaminated or potentially unsafe products from the food supply chain, helping reduce the impact of foodborne illness outbreaks.

To understand which food products fall within the scope of FSMA 204, you can refer to the table at the end of this article, which summarizes the main categories on the Food Traceability List (FTL) and their typical impact on data and labeling across the U.S. supply chain.

See FSMA 204 food table

The rule applies not only to companies based in the U.S., but also to anyone who manufactures, imports, processes, packs or holds foods included on the list, including European producers and distributors exporting to the United States.

Main traceability requirements

According to updated FDA guidance, businesses covered by FSMA 204 must:

Record and maintain traceability data for critical events (CTEs, Critical Tracking Events) such as harvesting, packing, shipping and receiving; the required information must include key elements (KDEs, Key Data Elements) such as lot, date, location, and details on who supplied and received the product.
Provide data to the FDA quickly: typically within 24 hours of a request from the authority.
Retain documentation for at least two years and make sure it is easily accessible in the event of an audit or investigation.

Extended compliance timeline

Food traceability in the USA One of the most important points in the update concerns timing: the FDA has moved the full application date for FSMA 204 to July 20, 2028. This extension reflects the complexity of aligning traceability systems across the full supply chain - especially for exporters-importers, logistics partners and distributors - while leaving the rule's technical requirements unchanged.

The new date does not change the underlying obligations. Companies still need to prepare for the current requirements and work with their partners to support an effective transition to digital traceability systems.

Operational implications across the supply chain

For businesses exporting to the U.S. market - as well as for distributors and logistics operators involved in the supply chain - the update has practical consequences:

Coordination with U.S. partners: producers and distributors need to align their data systems with U.S. customers and suppliers so there is a shared understanding of KDEs and CTEs.
Adoption of digital systems: electronic data management is becoming essential, especially for meeting response-time requirements and ensuring data accuracy.
The role of distributors and storage facilities: even operators involved only in logistics or distribution may fall within scope if they handle products on the FTL. It therefore becomes critical to map and share traceability data across the entire chain.
Packaging and labels: traceability lot codes (TLCs) linked to products must match the traceability documentation. This may require updates to packaging workflows and labeling software.

Why it is important to act now

Although the 2028 deadline gives companies more time to organize compliance, supply chain cooperation still requires coordinated action involving suppliers, customers and logistics partners. Waiting too long can lead to operational disruption during audits or FDA investigations, inefficiencies in traceability systems that create additional costs, and compliance risks if health emergencies arise or official requests are not met on time.

FSMA 204 represents a major shift in how high-risk foods must be traced across the U.S. supply chain. For food companies, exporters and distributors, the latest FDA update offers greater clarity on both timing and the tools needed to comply.

Starting now with preparation and traceability system upgrades not only supports regulatory compliance, but also strengthens food safety and builds trust with U.S. business partners.

Food Traceability List (FTL) categories subject to FSMA 204

Below is a table summarizing the food categories included in the FDA Food Traceability List (FTL) for FSMA 204, together with their typical impact on data and labeling.

Category (FTL - FDA)	Indicative examples	Typical notes / exclusions (to be assessed case by case)	Typical impact on data and labels (U.S. supply chain)
Cheese (made from pasteurized milk), fresh soft or soft unripened	ricotta, mascarpone, cream cheese, robiola, queso fresco	Often excluded if frozen or previously frozen, shelf-stable, or aseptically processed and packaged - FDA definitions should be checked carefully.	Requires stronger lot control and a clear link between lots and shipments; a clearly readable lot code on the label (text or 2D code), combined with digital CTE records for receiving and shipping, can be useful.
Cheese (made from pasteurized milk), soft ripened or semi-soft	brie, camembert, feta, mozzarella, taleggio, blue cheese	Often excluded if frozen or previously frozen, shelf-stable, or aseptically processed and packaged - verification is needed at product level.	Lot codes on packs and cartons must match supporting documents; mixed lots on pallets require particular attention because traceability may need to be managed by logistics unit.
Cheese (made from unpasteurized milk), other than hard cheese	raw milk cheeses that do not qualify as hard cheese	Often excluded if frozen or previously frozen, shelf-stable, or aseptically processed and packaged - case-by-case review is advisable.	Requires disciplined lot traceability through processing and distribution; U.S. importers and distributors should receive complete KDEs, including supplier, location, dates and lots.
Shell eggs	domesticated chicken shell eggs	Specific FDA category: "shell eggs".	Traceability relies on lots, locations and movement records; receiving and shipping records become even more important for wholesalers and distributors.
Nut butters	peanut butter, almond butter, pistachio butter, hazelnut butter, walnut butter	Includes shelf-stable, refrigerated, frozen and previously frozen products; soy butters and seed butters are generally excluded, but definitions should be checked.	Businesses need to connect ingredient lots with finished-product lots; in U.S. retail and foodservice, this may increase demand for structured KDE data shared with importers.
Cucumbers (fresh)	fresh cucumbers of all varieties	Under FDA terminology, "fresh" normally excludes previously frozen product.	Lots or batches may need to be identified from origin and maintained on secondary packaging; logistics labels with lot code and unit identifier can be helpful.
Herbs (fresh)	basil, parsley, cilantro and other fresh herbs	Some herbs may fall under specific exceptions, so FDA definitions should be reviewed.	Because recalls can be especially sensitive in this category, rapid lot management and documented cold-chain control are important; U.S. distributors need to trace suppliers and batches quickly.
Leafy greens (fresh)	lettuces, Romaine lettuce, spinach, kale, arugula, pak choi	Some forms or conditions may be excluded, for example specific whole-head products or regulatory exceptions, so verification is recommended.	This category often requires more granular traceability at batch or lot level, along with accurate CTE records; carton labels and transport documents may need to be adjusted accordingly.
Leafy greens (fresh-cut)	ready salad mixes, washed and cut leaves	Under FDA terminology, "fresh-cut" does not include previously frozen product.	This affects processing-lot management for mixes and how businesses document the relationship between input lots and output lots; 2D or QR codes can support internal traceability, together with carton coding.
Melons (fresh)	cantaloupe, honeydew, watermelon and other melons	FDA category designated as "fresh".	Batch identification should remain consistent across cases and pallets; for U.S. distributors, the link between receiving, lot and destination is particularly important.
Peppers (fresh)	fresh peppers of all varieties	FDA category designated as "fresh".	Logistics labels and warehouse CTE tracking may need to be updated; repacking activities require special attention and supporting records.
Sprouts (fresh)	alfalfa sprouts, broccoli sprouts, radish sprouts, mixed sprouts	Includes fresh sprouts, subject to the FDA definition.	This category often requires very rapid traceability in the event of recalls; standardizing KDE data formats with U.S. distributors and wholesalers - for example through structured files, EDI or portals - can be very useful.
Tomatoes (fresh)	fresh tomatoes of all varieties	FDA category designated as "fresh".	Case and pallet coding must keep the lot visible and consistent with shipping documents; if sorting or repacking takes place in the U.S., lot integrity becomes especially important.
Tropical tree fruits (fresh)	mango, papaya, guava, lychee and other tropical fruits	Certain species are excluded under FDA definitions, so the official list and applicable exceptions should be checked carefully.	For importers and distributors, it is important to maintain the link between customs records and lots; pallet labels with unique identifiers and lot codes are often useful.
Fruits (fresh-cut)	ready fruit mixes, portioned fruit	Some fruit types may be subject to specific exceptions, so case-by-case verification is advisable.	This affects the recording of ingredients versus production lots; in retail and foodservice, greater attention may be required for processing lots and digital audit trails.
Vegetables other than leafy greens (fresh-cut)	julienne vegetables, diced vegetables, mixed vegetables excluding leafy greens	Some vegetables may fall under specific exceptions, so definitions should be checked.	Businesses need traceability for in-process lots and related CTEs; it is useful to define data-exchange standards with U.S. logistics operators and distributors so each shipment is supported by complete KDEs.
Finfish, histamine-producing species	tuna, mackerel, swordfish, mahi mahi	This is a subcategory within "Finfish (fresh, frozen, and previously frozen)".	Lot traceability must remain consistent with logistics conditions and supporting records; for foodservice distributors, it is important to trace the product through to the delivery point and retrieve data quickly in case of an alert.
Finfish, species potentially contaminated with ciguatoxin	grouper, barracuda, snapper	This is a subcategory within "Finfish (fresh, frozen, and previously frozen)".	Accurate origin and batch data, together with shipment traceability, become even more important; standard pallet or case identifiers and strong receiving and shipping records are advisable.
Finfish, species not associated with histamine or ciguatoxin	cod, salmon, trout, tilapia	Certain species or segments may be governed by specific rules, so FDA definitions and any USDA-related distinctions should be checked.	The main issue here is the rapid availability of KDEs and CTEs; businesses should consider structured data flows with importers and distributors to respond quickly to regulatory requests.
Smoked finfish (refrigerated, frozen, and previously frozen)	smoked salmon, smoked mackerel and similar products	Includes smoked or smoke-flavored fishery products under the FDA definition.	Lot traceability and cold-chain documentation are critical; labels on both consumer packs and outer cases should align with date, lot and shipping/receiving location records.
Crustaceans (fresh, frozen, and previously frozen)	shrimp, crab, lobster, crayfish	Includes all crustacean species in the forms listed.	For U.S. retail and foodservice, lot-level traceability through to the customer is particularly important; pallet labels linked to shipping records can make this easier to manage.
Molluscan shellfish, bivalves (fresh, frozen, and previously frozen)	oysters, clams, mussels	Specific exemptions or dedicated regulatory regimes may apply, so these cases should be checked carefully.	Traceability data are often highly structured in this category; businesses need consistency across lots and identifiers, as well as fast access to KDEs. Shared standard formats with importers and distributors may be required.
Ready-to-eat deli salads (refrigerated)	potato salad, egg salad, pasta salad, seafood salad	This is a refrigerated RTE category; specific exclusions may apply, for example for certain meat salads.	Traceability must cover the full chain from ingredients to production to distribution; distributors need to be able to isolate affected lots quickly and reconstruct destinations across retail and foodservice channels.

Operational note: the rule can also apply to foods that contain FTL ingredients if the ingredient remains in the same form in which it appears on the list - for example "fresh" or "fresh-cut" - according to FDA definitions. For specific products, it is always advisable to check the corresponding item directly on the official FDA page.

For the official and continuously updated list, see: FDA - Food Traceability List.