Keep the cold chain and the coverage intact.

The FDA traceability rule, lot by lot

FDA's Food Traceability Rule (21 CFR Part 1, Subpart S) implements Section 204(d) of the FDA Food Safety Modernization Act. It covers persons who manufacture, process, pack, or hold foods on FDA's Food Traceability List, and foods that contain a listed food as an ingredient when that ingredient stays in the form shown on the list. Start by checking your product list against the Food Traceability List.

The rule ties records to Critical Tracking Events. Of the seven it names, shipping and receiving are the core of a distributor's records:

• Receiving. For each traceability lot you receive, keep the traceability lot code, quantity and unit of measure, product description, the immediate previous source (other than a transporter), where you received it, the date, the lot code source, and the reference document type and number (21 CFR 1.1345).
• Shipping. For each lot you ship, keep the matching records for the immediate subsequent recipient (other than a transporter) and your ship-from location, and give the first seven items to that recipient in electronic, paper, or other written form (21 CFR 1.1340). FDA counts a move between two of your own locations at different street addresses as shipping and receiving.
• Traceability plan. A written plan describing how you maintain the records (format and location), how you identify listed foods, and how you assign lot codes if applicable, with a point of contact.

Under 21 CFR 1.1455, records go to FDA within 24 hours of a request (or a reasonable time FDA agrees to). When the request is to help during an outbreak, recall, or other threat to public health, you provide an electronic sortable spreadsheet unless a size-based exemption applies. Records are kept for 2 years. Another entity can keep them, but producing them on time stays your job.

On timing, FDA's page says the original compliance date was January 20, 2026, that FDA proposed extending it by 30 months to July 20, 2028, and that Congress directed FDA not to enforce the rule before that same date. FDA says it intends to comply with that directive.

When a supplier recalls, you're a consignee

FDA's recall provisions in 21 CFR Part 7 sit in a subpart titled "Guidance on Policy, Procedures, and Industry Responsibilities" and say what firms should do. Part 7 defines a consignee as anyone who received, purchased, or used the product being recalled, so a distributor that bought a recalled lot is one. Section 7.49 says consignees that receive a recall communication should immediately carry out the recalling firm's instructions and, where necessary, extend the recall to their own consignees.

FDA assigns each recall a class to show the relative degree of health hazard:

• Class I: a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death.
• Class II: the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
• Class III: the product is not likely to cause adverse health consequences.

A market withdrawal is different. It involves a minor violation FDA would not take legal action on, or no violation at all, such as normal stock rotation.

When you pass a recall down the line, section 7.49 says the communication should be brief and to the point, identify the product, size, lot numbers, codes, or serial numbers, explain the reason and any hazard, give specific instructions, and give recipients a ready way to report back. Underwriters ask about recall history, so a written recall procedure and a log of past recalls belong in your product liability submission.

California registration for holding food

California adds its own requirement. Health and Safety Code 110460 says no person shall engage in the manufacture, packing, or holding of any processed food in the state unless the person has a valid registration from the department. The registration is valid for one calendar year from the date of issue unless revoked, and the statute says it is not transferable.

The statute's exceptions are specific:

• Persons engaged exclusively in storing, handling, or processing dried beans.
• Cottage food operations registered or permitted under Section 114365.
• Microenterprise home kitchens as defined in Section 113825.

None of those exceptions is written for a general food warehouse. If you hold processed food in California, confirm your registration status with the state before assuming you're exempt. Outside California, requirements vary by state.

When I quote a California distributor, I ask for the state registration along with your FDA food facility registration.

Official sources

• FDA: FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods
• 21 CFR 1.1340 (shipping KDEs), Cornell LII
• 21 CFR 1.1345 (receiving KDEs), Cornell LII
• 21 CFR 1.1455 (records, 24-hour request, retention), Cornell LII
• 21 U.S.C. 350f, Reportable Food Registry, Cornell LII
• 21 CFR 7.3, recall definitions, Cornell LII
• 21 CFR 7.49, recall communications, Cornell LII
• 21 CFR 1.500, FSVP definitions, Cornell LII
• 21 CFR 1.502, FSVP requirement, Cornell LII
• California Health and Safety Code 110460, california.public.law