FSMA 204 lot-level tracking: the ideas FDA is weighing after Nov 6

On November 6, 2026, FDA held a virtual public meeting on “lot-level tracking and potential flexibilities for compliance” under the Food Traceability Rule. FDA has not announced any change to the rule as a result, and none of the ideas below are final. This guide explains what FDA is considering, what has been decided, and what a small food business can do now.

What was the November 6 meeting about?

FDA’s meeting page lists it as a virtual meeting from 12:00 to 3:00 p.m. ET (the Federal Register notice says 3:30 p.m.). It gave the public a chance to share information on implementing the rule, with a focus on lot-level tracking and possible compliance flexibilities. Speakers had to register by October 26, and same-day registration was not allowed. FDA also welcomed written comments in Docket No. FDA-2014-N-0053.

When we checked on November 8, FDA’s meeting page did not say whether a recording or transcript would be posted, so we cannot tell you what speakers said. Check that page for materials.

Why is FDA talking about flexibilities?

Congress asked for it. FDA proposed moving the compliance date to July 20, 2028. In Section 780 of the 2026 continuing appropriations law, Congress directed FDA not to enforce the rule before that date. The same section told FDA to meet quarterly with industry about additional flexibilities for the lot-level tracking requirement. Our compliance date guide covers the dates in detail.

FDA’s discussion paper says it had not decided the scope of any flexibilities. It also says the paper is not draft or final guidance, and that its list is not exhaustive.

1. June 15, 2026First FDA public meeting
2. July 15, 2026Feedback on the discussion paper due
3. November 6, 2026Second FDA public meeting
4. July 20, 2028Date before which Congress directed FDA not to enforce

Dates are from FDA's discussion paper. The paper also lists a March 6, 2026 industry listening session.

Source fda.gov

What ideas are on the table?

The discussion paper lists topics where FDA says it has the most questions. It phrases them as questions, not decisions. They include:

• A reasonable range of lot codes. Some distribution centers say they would have to scan every case to track lot codes through mixed pallets and pick slots. Industry has suggested they record a range of lot codes that could reasonably have been in a shipment, with the method described in their traceability plan.
• Inferred lot codes. A warehouse system might infer which lot codes shipped, based on receiving dates, pick slots and picking order. The paper’s example sends the inferred codes plus a statement of other codes that might also have been included.
• “Eaches.” Items shipped singly after a case is broken are unlikely to carry the lot code.
• Returns and reclamations.
• Food waste recovery.
• Intracompany shipments.
• Shipments for retailers that transform food and send it to other retailers.
• Data standardization for sharing key data elements.

The paper also asks how a range of lot codes could be sent to a retailer, for example in an advance shipping notice, and what guardrails would keep public health benefits intact.

Is any of this final?

No. The paper is for discussion only and is not guidance; FDA says it has not decided which flexibilities to offer. Planning around a flexibility that FDA has not adopted is a gamble.

The one policy FDA has put out in draft form is different and narrower. On October 9, 2026, FDA published a notice of draft guidance saying it intends to use enforcement discretion for all requirements of the rule for retail food establishments and restaurants whose average annual food sales over the previous three years were more than $250,000 but no more than $1,000,000 (rolling, adjusted for inflation using 2020 as the baseline). A draft is not final. See our guide for restaurants and retailers.

What does this mean for a small producer, packer or distributor?

If you pack or make food: the lot code you assign is the base of the system. Nothing FDA is discussing removes the need for a traceability lot code on your product. The paper describes the rule as requiring each lot to carry a code, which can change only when the food is transformed.

If you distribute: the range and inference ideas are aimed at you. Until FDA acts, your records need the lot codes you can actually support. Mixed pallets are the hard case, so see how your system tracks them. Our distributors guide goes through shipping and receiving records.

If you sell to retailers: buyers set their own timelines, whatever FDA does. See why retailers want your data early.

How can I comment?

There are two open paths, both through regulations.gov:

1. Lot-level flexibilities: Docket No. FDA-2014-N-0053. The meeting’s Federal Register notice says comments must be submitted by December 6, 2026.
2. The restaurant and retailer draft guidance: Docket No. FDA-2025-D-6952. The notice asks for comments 45 days after its October 9 publication, which the published notice puts at November 23, 2026. FDA also says you can comment on any guidance at any time.

Comments are posted publicly, so leave out confidential business information. Specific numbers help. For a distributor, that might be how many lot codes sit on a typical pallet or in a pick slot, which are questions the paper itself asks.

What should I do now?

1. Write down where your lot codes are created and where they get lost.
2. Check your traceability plan describes how you track lots.
3. Run a mock recall to see how long a trace takes.
4. Ask your suppliers and buyers what they expect.
5. Recheck FDA’s rule page, which was updated on November 4, 2026.

Where Lotcrumb fits

Lotcrumb is being built to pull lot codes and key data elements from the paperwork you already use and keep them ready to export, so that a change in what FDA accepts does not mean starting over. Join the waitlist.

This guide is general information, not legal or regulatory advice. FDA’s positions can change, so confirm the current status on FDA’s website or with a food safety professional.