FDA to Exted Food Tracibility Rule Compliance Deadline Post Shutd

The federal government is back in business, and those who may be scrambling to comply with the January 20, 2026, deadline for the Food and Drug Administration’s (“FDA” or the “Agency”)  Food Traceability Rule (“FTR” or “Final Rule”) will be pleased with the likely possibility of a generous extension from the agency—to July 20, 2028.

The FTR, which applies to domestic and foreign entities producing food for U.S. consumption, was issued back in November 2022 as part of the implementation of the FDA Food Safety Modernization Act (“FSMA”). The FSMA directed FDA to establish additional traceability recordkeeping requirements for foods likely to cause adverse health consequences should they become contaminated in the supply chain.

Accordingly, the Final Rule establishes traceability requirements beyond those already required in the federal Food, Drug, and Cosmetic Act (“FDCA”) for persons who manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (“FTL”), developed using a risk-ranking model previously published by FDA. The FTL identifies foods such as fruits and vegetables, fish, shellfish, eggs, some cheeses, and nut butters intended for human consumption for which the additional traceability records are required. The Final Rule also covers multi-ingredient products that contain specifically listed FTL foods as ingredients if they remain in the same form that is included in the FTL (e.g., “fresh” herbs that remain in their fresh form when included in a multi-ingredient product).

FDA states that the requirements in the Final Rule “will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.”

The original deadline for compliance was set to January 2026—three years after the Final Rule’s effective date of January 20, 2023. However, on August 6, 2025, FDA proposed a compliance delay of thirty (30) months which, if finalized, brings the new date for compliance to July 20, 2028.

“The Final Rule requires a higher degree of coordination between members of the food industry than has been required in the past, including the sharing of accurate data with supply chain partners,” the FDA proposal states, noting that the proposed extension allows industry additional time, across all regulated sectors, to fully implement the requirements. “[T]o achieve full public health benefits of the final rule, all covered entities must comply.”

The proposed extension to July 2028, however, does not change the FTR or its requirements, which we unpack below.

The FTR at a Glance

Who’s covered

The FTR applies to those who manufacture, process, pack, or hold foods on the FTL, unless an exemption applies.

What’s required

Compliance requirements depend on the particular food category and the role of a business within the supply chain. The 179-page Final Rule is detailed and the requirements are broken down in a helpful chart prepared by FDA, located here, that lists the key data elements (“KDEs”) required for certain critical tracking events (“CTEs”) in the food’s supply chain, such as harvesting, cooling, initial packing, shipping, receiving, and transformation. Indeed, “[t]he information that firms must keep and send forward…varies depending on the type of supply chain activities they perform with respect to an FTL food…” Therefore, familiarity with this chart will be helpful toward achieving compliance.

The FTR requires covered entities to:

• maintain records containing KDEs associated with CTEs in the food’s supply chain.
  • KDEs: For each CTE, KDEs may include, for example,
    • location descriptions for the immediate subsequent recipient (other than a transporter) of the food;
    • commodity and variety of food, if applicable;
    • quantity and unit of measure of the food;
    • location (specific requirements for produce, aquacultured food);
    • date;
    • reference document type and document number;
  • share information with other entities in their supply chain (for example, provide the Initial Packer with a business name and phone number, along with the various KDEs above, except for the reference document type and number).
  • provide information to FDA within 24 hours, or within some reasonable time to which FDA has agreed;
  • create a traceability plan, which includes:
    • a description of procedures used to maintain records (including format and location of records);
    • a description of procedures used to identify foods on the FTL that the covered entity manufactures, processes, packs, or holds;
    • a description of how traceability lot codes are assigned to foods on the FTL, if applicable;
    • a statement identifying a point of contact regarding the traceability plan and records;
    • a farm map (including aquaculture) if food on the FTL (other than eggs) is grown or raised, with specific details;
    • updates as needed to ensure that the information reflects current practices and to ensure compliance with the Final Rule; and
    • retaining previous plans for two years after update.
  • provide records to FDA within 24 hours of a request for official review (or within some reasonable time to which FDA has agreed), as well as any information needed to understand the records, 87 Fed. Reg. 71087 (Nov. 21, 2022). With exceptions, the information is required to be in an electronic sortable spreadsheet.

Exemptions

Companies may be exempt from the requirements of the FTR if an exemption applies. Even for those manufacturing, processing, packing, or holding foods that appear on the FTL, exemptions exist for:

• Farms. Produce farms or mixed-type facilities performing farm activities that are not covered farms under 21 CFR part 112.4(a) are not subject to the Final Rule. With exceptions, covered farms under the latter are those with an average annual monetary value of produce sold during the previous 3-year period of more than $25,000 (adjusted for inflation using 2011 as the baseline year).
• Comingled raw agricultural commodities (RACs). RACs may be eligible for an exemption if certain conditions are met.
• Fishing vessels or those manufacturing, processing, packing, or holding food obtained from a fishing vessel. May have limited requirements.
• Molluscan shellfish. Those manufacturing, processing, packing, or holding raw bivalve molluscan shellfish may be eligible for an exemption.
• Retail food establishments (RFEs) and restaurants. Those with an average annual monetary value of food sold or provided during the previous three years of not more than $250,000, adjusted for inflation, or those purchasing food directly from a farm, may be eligible for an exemption.
• Certain types of processing. Produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, meeting the conditions of 21 CFR 112.2(b), may be eligible for an exemption.
• Personal consumption/holding food for specific consumers. May be eligible for an exemption.
• Rarely consumed raw (RCR). Produce listed as RCR under the Produce Safety Rule of 21 CFR 112.2 (a)(1) is exempt from the FTR.
• Farm-to-School or Farm-to-Institution Programs. Entities conducting a farm-to-school or farm-to-institution program are exempt where the food produced and packaged on the farm is sold or donated to the school or institution, though the school or institution must maintain a record of the farm as the source of the food for 180 days.
• S. Department of Agriculture (USDA) Jurisdiction. Entities which manufacture, process, pack, or hold food during or after the time when it is within the exclusive jurisdiction of the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, are exempt with respect to such foods.
• Dietary Supplements. Most dietary supplements are not subject to the FTR, provided they do not include an FTL ingredient, such as a fresh herb.
• Animal Food. Food intended for consumption by non-human animals is exempt.

Waivers

FDA may decide to waive the requirements of the FTR for a particular company if it determines that the company meets each of the following criteria:

• application of the FTR requirements would result in economic hardship;
• a waiver would not significantly impair FDA’s ability to rapidly and effectively identify recipients to prevent or mitigate a foodborne illness outbreak or address credible threats of serious adverse health consequences or death to humans or animals; and
• a waiver will not otherwise be contrary to the public interest.

Petitions for Modification/Exemptions

FDA will consider modifications or exemptions on its own initiative or in response to a citizen petition.

The Proposed Extension

Comments on the Proposed Rule of August 5, 2025, extending the compliance deadline from January 20, 2026, to July 20, 2028, were due September 8, 2025; thus the comment period has closed. However, EBG is monitoring should any opportunity for additional comments be reopened. Especially in light of the month-long government shutdown in October 2025, and the potential beneficial impact to industry, we expect that the proposed extension will likely become final.

What Companies Can Do Now to Prepare for Compliance with the FTR

FDA’s proposed generous extension of thirty (30) months to reach compliance is an opportunity for covered entities to review their policies and processes, identify gaps in compliance, and implement systems to ensure that the full requirements of the FTR can be met come July 20, 2028. FDA advises that covered entities should use this time “to ensure coordination between their supply chain partners to full implement the final rule requirements.”

Since the FTR applies to domestic and foreign entities producing food for U.S. consumption, noncompliance with the FTR recordkeeping requirements could lead to costly regulatory enforcement actions for both foreign and domestic industry stakeholders. For instance, noncompliant food articles offered for import are subject to refusal of admission under section 801(a)(4) of the FDCA (21 U.S.C. § 381). These penalties could risk impacting both reputation and profitability.

Entities potentially impacted by the Final Rule—and especially those that may have faced challenges to meeting the original January 20, 2026 deadline, should take advantage of the extension, if granted, by noting the resources available on FDA’s Food Traceability webpage; supply chain examples for various foods; the Small Entity Compliance Guide, and Frequently Asked Questions on the Food Traceability Rule. These, in addition to seeking guidance from counsel and other advisors, will assist in determining:

• Whether the company is subject to the FTR through manufacturing, processing, packing, or holding specific foods on the FTL;
• If the company is subject to the FTR, whether it qualifies for an exemption (or waiver);
• If no exemption applies, detail on the company’s recordkeeping requirements with respect to KDEs associated with CTEs in the food’s supply chain;
• What information must be shared by the company with other entities in the supply chain, and with the FDA; and
• Whether the company’s traceability plan complies with the requirements of the Final Rule.

The 30-month reprieve notwithstanding, the requirements and exemptions are specific and detailed, so working towards compliance now will help to eliminate challenges as the deadline approaches. If you have questions, please reach out to any of the authors of this post.