FDA COMPLIANCE · FOOD SAFETY
Quick answer
FSMA 204 is FDA’s Food Traceability Rule (21 CFR part 1, subpart S). It requires anyone who manufactures, processes, packs or holds a food on FDA’s Food Traceability List to keep Key Data Elements for each Critical Tracking Event, keep a written traceability plan, and give FDA records within 24 hours of a request. The original compliance date was January 20, 2026. FDA proposed moving it 30 months to July 20, 2028, and Congress then directed FDA not to enforce the rule before that date. FDA says it intends to comply, so July 20, 2028 is the date to plan for. The rule covers foreign firms that produce listed foods for U.S. consumers too.
What FSMA 204 is not
- It is not a rule for every food. It applies to foods on the Food Traceability List and to foods that contain a listed food as an ingredient in the same form, such as fresh.
- It is not a registration or a certificate. There is nothing to file with FDA; you keep records and produce them on request.
- It is not cancelled. The requirements stand; only the date FDA will enforce them moved.
Updated November 2026. Food brands that sell nut butters, fresh-cut fruit, soft cheeses, smoked fish or deli salads through retailers, marketplaces and their own sites keep hearing “FSMA 204” from buyers and warehouses. Some think the rule took effect in January 2026, others think it was dropped. This guide explains what the rule requires, which foods and businesses it covers, the exemptions, and the current compliance date, using FDA’s own pages. It is general information, not legal advice.
Table of Contents
What is FSMA 204?
Section 204 of the FDA Food Safety Modernization Act (FSMA) told FDA to designate foods that need additional recordkeeping and to set those requirements. FDA published the final rule, “Requirements for Additional Traceability Records for Certain Foods,” on November 21, 2022 (87 FR 70910). It sits in 21 CFR part 1, subpart S, and is usually called the Food Traceability Rule.
FDA’s stated goal is faster identification and removal of potentially contaminated food during an outbreak or recall. The rule adds to the general source and recipient records many food businesses already keep under 21 CFR part 1, subpart J.
What is the FSMA 204 compliance date now?
FDA’s Food Traceability Rule page (content current as of November 4, 2026) sets out the history:
- The original compliance date for everyone subject to the rule was January 20, 2026.
- FDA proposed extending the compliance date by 30 months to July 20, 2028 (proposed rule published August 7, 2025).
- The Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 then directed FDA not to enforce the Food Traceability Rule before July 20, 2028. FDA says it intends to comply with that directive.
So, as of November 2026, FDA will not enforce the rule before July 20, 2028. FDA keeps a single compliance date for everyone because traceability only works if each business in the supply chain passes the same information along. Some older materials, including a line still on FDA’s own rule page, show January 20, 2026; that was the original date. FDA also has a draft enforcement discretion policy for certain smaller retail food establishments and restaurants, which would apply only if finalized, and held a public meeting on lot-level tracking on November 6, 2026.
Which foods are on the Food Traceability List?
The Food Traceability List (FTL) includes:
- Cheeses, other than hard cheeses: fresh soft or soft unripened, soft ripened or semi-soft, and cheeses made from unpasteurized milk.
- Shell eggs from domesticated chickens.
- Nut butters, including shelf-stable, refrigerated and frozen tree nut and peanut butters (not soy or seed butters).
- Fresh produce: cucumbers, herbs, leafy greens, melons, peppers, sprouts, tomatoes and tropical tree fruits, plus fresh-cut fruits, fresh-cut vegetables and fresh-cut leafy greens.
- Seafood: finfish (fresh, frozen and previously frozen), smoked finfish, crustaceans and molluscan shellfish (bivalves).
- Ready-to-eat deli salads (refrigerated), such as egg, potato, pasta and seafood salad, but not meat salads.
The rule also covers foods that contain a listed food as an ingredient, as long as that ingredient stays in the form on the list. Check FDA’s full list for the exact descriptions and exclusions. For example, whole head cabbage is not a listed leafy green, and foods for animals are not on the list.
What records does the rule require?
At its core, the rule ties Key Data Elements (KDEs) to Critical Tracking Events (CTEs), linked by a traceability lot code.
| Requirement | What FDA asks for |
|---|---|
| Critical Tracking Events | Harvesting, cooling before initial packing, initial packing of a raw agricultural commodity, first land-based receiving of food from a fishing vessel, shipping, receiving and transformation. The KDEs differ by event. |
| Traceability lot code | Assigned when you initially pack a raw agricultural commodity, perform first land-based receiving from a fishing vessel, or transform a food. You do not create a new code when you only ship. The code must appear in the records for every later event. |
| Traceability plan | Written procedures for how you keep the records, how you identify FTL foods you handle and how you assign lot codes, plus a point of contact. Farms that grow or raise FTL foods also need a farm map. |
| Record format | Original paper or electronic records, or true copies, kept legible and protected from loss. Records are kept for 2 years. |
| FDA requests | Records must be made available within 24 hours of a request, or a reasonable time FDA agrees to. During an outbreak, recall or other public health threat, an electronic sortable spreadsheet may be required within 24 hours, unless you are exempt from that part. |
Two definitions matter for ecommerce brands. Shipping means arranging transport of a food from one location to another, including between your own sites at different addresses, but it does not include selling or shipping directly to a consumer. Transformation includes manufacturing, commingling, repacking or relabeling when the output is an FTL food.
Who is exempt from FSMA 204?
The full and partial exemptions are listed in 21 CFR 1.1305. Among them:
- Small producers: produce farms that are not covered farms under the Produce Safety Rule, produce farms and other raw agricultural commodity producers averaging no more than $25,000 a year in sales over the previous 3 years (adjusted for inflation from 2020), and shell egg producers with fewer than 3,000 laying hens at a farm.
- Small retail food establishments and restaurants averaging no more than $250,000 a year in food sold or provided over the previous 3 years (adjusted for inflation from 2020).
- Farms selling directly to consumers, for food produced on that farm.
- Foods that receive a kill step or are changed so they are no longer on the list, with conditions, including receiving records and, in some cases, written agreements renewed at least every 3 years.
- Produce rarely consumed raw as listed in 21 CFR 112.2(a)(1), and certain raw bivalve shellfish under the National Shellfish Sanitation Program.
- Transporters of food, nonprofit food establishments, food held for personal consumption, and foods while under USDA’s exclusive jurisdiction.
Several exemptions are partial and still require some records. FDA offers an online exemptions tool that walks through yes or no questions.
What FSMA 204 means for food brands selling online
- Check your catalog against the list. A shelf-stable almond butter is covered; a sunflower seed butter is not. Foods that contain a listed food are covered only if the ingredient stays in its listed form, such as fresh.
- Map who physically handles the food. The rule applies to the persons who manufacture, process, pack or hold FTL foods. Agree in writing which records your co-packer, warehouse or fulfillment partner keeps, and which lot codes travel with each shipment.
- Keep lot codes visible from production to shipment. Shipping and receiving records depend on the lot code assigned at transformation or initial packing.
- Use the extra time. Because the rule depends on each business passing information to the next, retail and distribution partners may ask for your traceability plan and lot-level data as they prepare. Having them ready makes those conversations easier.
- If you import, the rule covers foreign firms producing FTL foods for U.S. consumption. It sits alongside FSVP, Prior Notice and facility registration; see our FSVP importer guide and Prior Notice guide.
How Eva Commerce helps food brands
Eva Commerce does not build traceability systems or write traceability plans. Eva handles the FDA filings food brands need to sell in the U.S.: food facility registration ($240, renewed every two years), U.S. Agent service for foreign facilities ($250 a year), DUNS support, Prior Notice for imported shipments ($30 per shipment) and food label review. Published prices are on our FDA compliance services page.
Eva also runs Amazon, Walmart, TikTok Shop and Shopify growth for food brands, so product data, labels and listings stay consistent across channels. Book a call or call 858-315-2020.
Frequently asked questions
Is FSMA 204 delayed?
Yes. The original compliance date was January 20, 2026. FDA proposed July 20, 2028, and Congress directed FDA not to enforce the rule before that date. FDA says it intends to comply, so plan for July 20, 2028.
What foods does FSMA 204 cover?
Foods on FDA’s Food Traceability List, including soft cheeses, shell eggs, nut butters, several fresh fruits and vegetables and fresh-cut produce, finfish, smoked finfish, crustaceans, bivalve shellfish and refrigerated ready-to-eat deli salads, plus foods containing them in the listed form.
Who is exempt from FSMA 204?
Exemptions in 21 CFR 1.1305 include certain small farms and producers, retail food establishments and restaurants averaging no more than $250,000 a year in food sales, transporters, foods that receive a kill step, and produce rarely consumed raw. Some exemptions are partial.
Does FSMA 204 apply to shipments directly to consumers?
No. FDA’s definition of shipping excludes the sale or shipment of a food directly to a consumer. Shipments between businesses, and between your own locations at different addresses, are shipping events.
How fast must records be given to FDA?
Within 24 hours of a request, or within a reasonable time FDA agrees to. In an outbreak, recall or other public health threat, FDA can ask for an electronic sortable spreadsheet within 24 hours.
Can Eva Commerce help with FSMA 204?
Eva does not build traceability systems, but handles food facility registration, U.S. Agent service, DUNS, Prior Notice and label review, and runs marketplace growth for food brands. Book a call or call 858-315-2020.
Sources: FDA, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (content current as of November 4, 2026); FDA, Food Traceability List; Federal Register, Food Traceability Rule compliance date extension proposed rule (August 7, 2025); eCFR, 21 CFR part 1, subpart S, including 21 CFR 1.1305; 87 FR 70910 (November 21, 2022). General information, not legal advice.
