FSMA 204 refresher: everything you need to know with one year to go

With the January 20, 2026 deadline just one year away, we review why the bill was formed, how businesses are feeling about it, and where they should be in their preparation process. 

Traceability - it’s one of the big talking points in the industry right now. One of the reasons for this is FSMA 204, the FDA’s collection of new rules on traceability record-keeping, which will come into effect from January 20, 2026.  

With just a year to go, the clock is ticking for businesses that need to put any new processes in place to get compliant. With that in mind, let’s review the bill itself and what you need to be doing now, in the next six months and a year from today.  

First, the basics... 

What is FSMA 204? 

The Food Safety Modernization Act (FSMA) 204 is a pivotal regulation established by the Food & Drug Administration (FDA) in the US, consisting of new rules on traceability record-keeping. 

 Who does FSMA 204 affect? 

Anyone who manages foods listed on the Food Traceability List (FTL) in the US. The list is comprehensive and encompasses various categories, including: 

- non-pasteurised cheeses 

- nut butters 

- an extensive range of fresh produce (such as fruits, vegetables, and seafood) 

- and pre-packaged ready-to-eat salads.  

These regulations are designed to ensure “the safety and quality of the food supply chain by enhancing data-driven transparency and accountability” according to the FDA. 

The compliance date for all persons subject to the record-keeping requirements is Tuesday, January 20, 2026. 

How is the industry feeling about it? 

When we asked US food industry professionals last year, 68% said they felt ready for the deadline. But when we dug deeper, only 50% had digital systems in place to manage the changes. 

Of course, as our experts have explained, it is feasible and possible to be ready and not be fully digitised, because the rule doesn't require a digital platform. But it does requires a searchable, sortable spreadsheet within 24 hours of a FSMA 204 request.  

To achieve this the data has to be easily accessible. Using a digitised system, like the Foods Connected platform, enables businesses to access that information quickly, accurately and confidently  due to the fact it is all stored in one central location, creating one source of truth across the supply chain. 

What are the key requirements of FSMA 204? 

FSMA 204 specifies the need for a series of Critical Tracking Events (CTEs) that reflect crucial junctures for safety in the supply chain. By tracking the events, it is possible to identify the source of any contamination, food safety or quality issues that may arise during: 

• The harvesting and cooling of ingredients and produce 
  

• The initial packing to make food products suitable for transportation 
  

• The shipping and receiving of products by retailers and manufacturers 
  

• The stage at which food products are transformed into consumer-ready goods 

The tracking of CTEs requires the maintenance of records containing what are described as Key Data Elements (KDEs) such as the product’s name, lot code and date of manufacture.  

Lot codes are particularly vital for tracing food products in the event of a safety risk or recall. Data needs to be collected by the food business at each CTE, shared with supply chain partners and retained for two years following the sale or distribution of the food item. 

Finally, those designated as responsible for FSMA 204 compliance must maintain proper record-keeping through the creation of a traceability plan. This plan should be accessible to the FDA within 24 hours of being requested, along with an electronic spreadsheet containing traceability information to address any risks to wider public health. 

With one year to go what should businesses be doing to be FSMA 204 compliant? 

Companies can take concrete steps so that their traceability record-keeping adheres to FSMA 204 guidelines by the compliance date. These include capturing KDEs as part of wider standardisation and digitisation efforts. This can be facilitated by implementing robust data management systems and utilising technologies like cryptographic ledger technology for enhanced data integrity and transparency. 

By identifying and addressing gaps in capturing and preserving data across the supply chain, companies can establish a comprehensive and reliable traceability system. Furthermore, promoting compliance across their network of vendors, suppliers, and customers through training programmes and regular audits can further strengthen traceability practices and mitigate potential risks. By prioritising traceability, companies can enhance food safety, improve risk management, and build trust with consumers and regulatory authorities.  

5 actions to take to get FSMA 204 ready 

1. Make sure you have successfully mapped your entire supply chain 

Digitising your business can help with this. 45% of the businesses we spoke to said this was their main business priority in 2025. Supply chain mapping solutions like ours at Foods Connected, can help businesses digitise, map and create a connected supply chain no matter what stage of the traceability journey they are at. 

2. Put a roadmap in place

A food traceability plan is essential to this. It will make sure expectations are met and the appropriate investments are made.

3. Assess where changes need to be made

Key areas include: 

– updating your labelling requirements 

– improving the master data management in your ERP 

– addressing interoperability between supply chain partners 

4. Back up your target compliance readiness completion deadline

Make sure it's at least six months before the actual compliance date — and then run simulations to pressure test your system and process. This will reveal if your plan is working properly and ensure you are not missing any of the rule’s core requirements. 

5. Be ready well in advance

Use third-party experts when it makes sense, do rigorous pressure tests and be ready to explain and defend why your system is going to achieve compliance for you, your organisation and meets the requirements of the FDA. 

Need help getting FSMA 204 compliant? 

The Foods Connected award-winning suite of software solutions specialises in traceability and supply chain management. Our platform includes digital record-keeping solutions that can be easily used to fulfil FSMA 204 requirements regarding KDEs and CTEs.  

By digitising your vital data, we can ensure your company fulfils one of the main requirements of a compliant food traceability system. End-to-end traceability insights that can be shared across the supply chain in real-time - giving companies confidence that they are ‘data ready’ for the FSMA 204 deadline. 

A unique differentiator of the Foods Connected platform is that we are data agnostic. We are able to take data that has been collected across the various stages of the supply chain and transform it into a standardised format - allowing for clear farm-to-fork traceability. Companies can therefore connect a variety of data points into a standardised, end-to-end traceability solution. 

The deadline for FSMA 204 regulation compliance is 20 January 2026. If you’d like to speak to our traceability and FSMA 204 specialists about the approaching legislation and how it affects your business click below to schedule a meeting.