The FSMA 204 traceability rule requires extra records for certain foods so FDA can trace them faster during an outbreak. It does not apply to every food, and it is not a labeling rule. Shehadeh Giannamore, PLLC advises food companies on FDA requirements, including the records that attach to a specific food and a specific role in the supply chain.
The original compliance date was January 20, 2026. FDA later proposed moving that date 30 months, to July 20, 2028. Congress then directed FDA not to enforce the Food Traceability Rule before July 20, 2028, in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA’s traceability page says the agency intends to follow that directive. Some FDA pages still print January 20, 2026, including a line on the same final-rule page and a constituent update current as of July 24, 2026. Read July 20, 2028 as the date FDA says it will not enforce before. Do not treat the older printed date as the one the agency is using.
What the food traceability rule is
Section 204 of the FDA Food Safety Modernization Act told FDA to name foods that need more traceability records, and to set those records by regulation. The final rule is the Requirements for Additional Traceability Records for Certain Foods. People shorten that to FSMA 204 or the Food Traceability Rule.
The point is speed in an outbreak. FDA wants to follow a food from the place it was grown, packed, or made to the place it was held or sold, using a shared lot code rather than a stack of paper that each company keeps in its own format. The rule sits on top of older record rules. It does not replace facility registration, preventive controls, or the prior notice you file before an imported food arrives.
Covered companies keep a traceability plan. They record key data elements at critical tracking events. Those events are the steps FDA treats as the points that have to be visible, such as harvesting, cooling, packing, shipping, receiving, and transforming a food into something else. The data elements are the facts that have to travel with that step, including the traceability lot code and where that code came from. You pass the required information to the next person in the chain. FDA’s page describes that sharing as the reason everyone on the list has to be ready on the same date.
Who must comply
The rule applies to persons who manufacture, process, pack, or hold a food on the Food Traceability List. “Hold” includes storing it. A farm, a packer, a manufacturer, a distributor, and a retail food establishment can each be covered if they handle a listed food. The duty follows the food, not the job title on a business card.
A food that contains a listed food as an ingredient can also be covered, unless an exemption applies. Putting listed leafy greens into a bagged salad does not drop the greens off the list. Cooking or another kill step can change the analysis. Do not guess that step. Match the finished food to FDA’s list and to the exemption for that process.
Importers are not outside the rule because the food was packed abroad. If you hold or sell a listed food in the United States, the U.S. records still have to exist. Prior notice of imported food is a different filing. It tells FDA a shipment is coming. It does not create the lot-level history this rule asks for.
Which foods are on the list
FDA’s Food Traceability List is a closed list of higher-risk foods, not a list of all FDA-regulated food. Check the current list before you build a program. The groups on it include the following.
Fresh leafy greens, fresh-cut leafy greens, fresh herbs, fresh cucumbers, fresh melons, fresh tropical tree fruits, fresh-cut fruits, and fresh-cut vegetables other than leafy greens. Whole head cabbages such as green, red, and savoy cabbage are not in the leafy-green line. Some produce that is already outside the produce-safety rule, such as collards and dill, is also outside this rule under 21 CFR 1.1305(e).
Cheeses other than hard cheeses, including certain fresh soft cheeses made from pasteurized milk and cheeses made from unpasteurized milk. Hard cheeses such as cheddar, romano, and parmesan are defined by FDA’s cheese standards and are not the target. Cheeses that are frozen, shelf stable, or aseptically packaged are excluded from those lines. Grade A cottage cheese on the Interstate Milk Shippers list is exempt.
Shell eggs of the domesticated chicken, and foods that contain raw unpasteurized eggs. Nut butters, including peanut butter and tree-nut butters, in shelf-stable, refrigerated, and frozen forms. Finfish, smoked finfish, crustaceans, and molluscan shellfish, fresh, frozen, or previously frozen, as the list specifies each group. Ready-to-eat deli salads such as egg salad, potato salad, pasta salad, and seafood salad. Meat salads are not in that line.
That is the shape of the list, not every footnote. Sprouts are on it. A tomato that is canned may be treated differently from a tomato that is fresh-cut. If your SKU is close to a line on the list, read that line. A nearby food is not covered just because it is fresh.
Who is not automatically covered
The final rule puts full and partial exemptions in 21 CFR 1.1305. Some turn on what the food is. Produce already exempt from the produce-safety rule can be exempt here. A kill step, such as a treatment that adequately reduces pathogens, can change what the next person has to keep. Pasteurized eggs are addressed in those exemption paragraphs.
Other exemptions turn on who you are and how small the operation is. FDA publishes an exemptions tool because the thresholds are not one number for every farm, retailer, and restaurant. This article does not restate those dollar lines. Using a figure from a 2014 proposed rule, or from a blog, is how companies exempt themselves by mistake.
An exemption is also not a reason to keep no records at all. Preventive controls, the produce safety rule, seafood HACCP, and buyer requirements can still demand a lot code and a supplier file. FSMA 204 adds a specific set of data elements for listed foods. It does not erase the file you already keep.
How this rule differs from other FSMA duties
FSMA is a statute with many sections. Section 204 is the traceability section. The posts below are about other sections, and the dates in them are the dates of those actions.
In 2012 FDA used FSMA to suspend a food facility’s registration after a peanut-butter outbreak. That was a registration power, not a lot-code rule. FDA actions highlight new authority under FSMA describes that suspension. It does not describe the Food Traceability List.
In 2014 FDA reopened proposed rules on produce safety, preventive controls for human food, animal food, and the foreign supplier verification program. FDA releases proposed FSMA rules is about those proposals. They are not the 204 recordkeeping rule, and the comment dates in that post are long closed.
Prior notice is the filing for a food before it is offered for import. FDA issues final rule on prior notice for imported food covers the 2013 requirement to name a country that previously refused the food. A complete prior notice does not satisfy a traceability plan.
What FSMA 204 compliance looks like in the file
Write down whether each food you make, pack, or hold is on the list. Do that by the finished food and by the ingredients. A cracker that contains peanut butter is a different question from a plain cracker.
Assign the traceability lot code at the step the rule treats as the start for that food, and keep the source of that code when you receive it from someone else. If you transform the food, the new lot has to point back to the lots that went in. A shipping record that names the product but not the lot will not answer an outbreak question.
Describe the procedures in a traceability plan you can show. Name how you assign lot codes, how you link incoming lots to outgoing lots, and who keeps the records. Then test one lot with the people who ship to you and the people you ship to. FDA’s getting-started notes tell covered companies to talk with supply chain partners before the enforcement date, because the data has to move between systems.
Food consultant services on this site cover ingredient status and labels. Use them for whether the formula and the package are lawful. Use this page for whether the lot records exist. The two reviews answer different questions.
Questions about FSMA 204 compliance
What is the FSMA 204 traceability rule?
It is FDA’s final rule on additional traceability records for foods on the Food Traceability List. It comes from section 204 of the FDA Food Safety Modernization Act. Covered companies keep a traceability plan and key data elements at critical tracking events, and they pass that information along the supply chain.
Who must comply?
Persons who manufacture, process, pack, or hold a food on the Food Traceability List, unless an exemption in 21 CFR 1.1305 applies. Foods that contain a listed food as an ingredient can also be covered. Farms, manufacturers, distributors, and retail food establishments can each have duties.
When is the compliance date?
The original date was January 20, 2026. FDA proposed extending it to July 20, 2028. A 2026 appropriations act directed FDA not to enforce the rule before July 20, 2028, and FDA says it will follow that directive. Some FDA pages still display January 20, 2026. Confirm the sentence you rely on against the current FDA traceability page.
Does the rule apply to every food?
No. It applies to the foods FDA listed, and to foods that contain those foods as ingredients, unless an exemption fits. Most packaged grocery items are not on the list.
Is prior notice the same as FSMA 204?
No. Prior notice is the import filing before a food is offered for admission. FSMA 204 is lot-level recordkeeping for listed foods, including foods made in the United States.
What if my buyer already requires a lot code?
A buyer code helps only if it matches the rule’s lot code, the key data elements, and the plan you can produce. A private portal is not a substitute for checking whether your food is on the list.
Check the list before you build the spreadsheet
FSMA 204 compliance starts with one question. Is this food, or an ingredient in it, on the Food Traceability List, and is this company the one who manufactures, processes, packs, or holds it? If the answer is yes, the traceability plan and the lot-code handoff are the work, and July 20, 2028 is the enforcement date FDA has said it will honor. If you want that question answered for a specific SKU, contact the firm with the product name and where you sit in the chain.
This article is general information, not legal advice. Reading it does not create an attorney-client relationship. FDA pages still disagree with each other on the printed date. Read the current traceability page, and the statute that directs enforcement, before you set a go-live date.