top of page

Start Preparing For FSMA 204 Requirements, Today!

As we prepare for the new FDA FSMA 204 requirements on November 7th, many companies who handle foods included on the Food Traceability List (FTL) are wondering “Where should I start and what are my next steps?”. While the proposed requirements currently apply only to foods on the FTL, it's important for companies to understand that the sooner they start adopting best practices across their organization to enable end-to-end traceability, the better. This is mainly because of two reasons a)The FSMA 204 requirements are designed to eventually cover all FDA-regulated food products industry-wide b)Executing comprehensive traceability across your supply chains will take a while, typically months and sometimes even years.


To kick off your FSMA 204 initiative, you can follow the following steps:

  1. First, identify products on the Food Traceability List that your company deals with.

  2. Next, review what supply chain role you will play with each of those products.

  3. Familiarize yourself with the Critical Tracking Events and Key Data Elements you may be required to track based on your role.

  4. Then, identify items for which entity has to generate a Traceability Lot Code and items for which Traceability Lot Codes should be carried forward.

  5. Address any internal process changes to ensure that you are properly aligned with the FDA-defined receiving, transformation, creation and shipping Critical Tracking Events (or growing in the case of the farmer).

  6. Drive any internal data readiness progress to ensure these Key Data Elements are captured and stored in the proper way and are easily accessible.

  7. Talk to your supply chain partners about what they are doing to prepare for FSMA Rule 204.

  8. Once you have covered all items on the FTL, repeat the process for other food items which you feel may fall under future FDA purview and ensure readiness. You can do this parallel to step 9 or after.

  9. Finally, start vetting different traceability solutions - traceability projects take time and you should start NOW.


While the FDA still allows paper records to be sufficient for FSMA 204 compliance, it’s no secret that data digitization will be key for any company to address the FSMA 204 requirements. This is why the TagOne team is uniquely positioned to help you navigate those tricky FSMA 204 waters.

With over 17 years of experience, our blockchain-enabled traceability management system has been custom-built for the Food & Natural Products industry. We offer two main FSMA 204 compliance packages so you can get started right away wherever you're comfortable.

Our FSMA 204 Basic Compliance Pack is your low-cost option to successfully address the FSMA 204 ruling as it stands today. This package covers the following:

  • Self-setup of your company account on the TagOne FSMA204 compliance cloud

  • Self-setup of relevant master data - Products, Suppliers, Other

  • Capture, Digitization and storage of your specific CTEs and KDEs via pre-built excel sheets or the TagOne mobile app

  • One-click FDA reporting in a matter of seconds

With our FSMA 204 Compliance + Package, you receive all of the functionality of our Basic Compliance pack PLUS a bunch of key functionality such as:

  • Master Data Management

  • Document Management

  • Traceability Reports

  • Recalls and Returns

  • Inventory Management

  • Audit Logs

  • Ability to add comprehensive supporting information (Documents/Photos/Data) to each transaction beyond the FSMA 204 focused KDEs

Need compliance consulting? We do that too! TagOne fully understands that the path to transparency is unique for every company, and we want to support you every step of the way.

For more information on FSMA 204 requirements, Critical Tracking Events, Key Data Elements, Traceability Lot Codes and more, head over to our FSMA 204 webpage.


bottom of page