FSMA 204

The FDA Food Traceability Rule

What is FSMA Rule 204?

FSMA Rule 204 is a regulation that was finalized by the Food and Drug Administration (FDA) in November 2022. It requires food producers, handlers, packers, processors, and distributors to maintain records of certain information about food that is considered to be high-risk. This information includes the identity of the food, the lot or batch number, the date of production or packaging, and the name and address of the manufacturer, processor, packer, or holder of the food.

The rule applies to all foods that are on the Food Traceability List (FTL), which includes 20 different categories of food. These foods are considered to be high-risk because they are more likely to be associated with foodborne illness outbreaks.

The purpose of FSMA Rule 204 is to help the FDA quickly identify and trace the source of any foodborne illness outbreaks that may occur. By having access to this information, the FDA can more quickly remove contaminated food from the market and prevent further illnesses.

What are the requirements of FSMA Rule 204?

The requirements of FSMA Rule 204 vary depending on the type of food and the stage of the supply chain. However, all covered businesses must maintain records of the following information:

  • The identity of the food
  • The lot or batch number
  • The date of production or packaging
  • The name and address of the manufacturer, processor, packer, or holder of the food
  • The name and address of the first US importer of the food

In addition to these basic requirements, covered businesses may also be required to maintain records of other information, such as the following:

  • The location where the food was produced or handled
  • The ingredients used in the food
  • The processing steps that the food underwent
  • The temperature and humidity conditions at which the food was stored
  • The distribution channels through which the food was sold

What are the penalties for non-compliance with FSMA Rule 204?

The penalties for non-compliance with FSMA Rule 204 can be significant. The FDA can issue civil penalties of up to $10,000 per violation per day. In some cases, the FDA may also bring criminal charges against violators.

How can businesses comply with FSMA Rule 204?

There are a number of steps that businesses can take to comply with FSMA Rule 204. These steps include:

  • Understanding the requirements of the rule. The FDA has published a number of resources to help businesses understand the FSMA Rule 204, including a guidance document and a list of frequently asked questions.
  • Developing a traceability system. Businesses will need to develop a traceability system that allows them to track the movement of their food products from the point of production to the point of sale. There are a number of software solutions available that can help businesses implement a traceability system.
  • Maintaining records. Businesses will need to maintain records of the information specified in the rule for a period of at least five years. These records should be stored in a secure location and accessible to FDA inspectors upon request.
  • Communicating with the FDA. Businesses should communicate with the FDA early in the process to ensure that they are in compliance with the rule. The FDA has established a number of resources to help businesses communicate with the agency, including a help desk and a website.

By taking these steps, businesses can ensure that they are complying with the FSMA Rule 204 and helping to protect public health.


FSMA Rule 204 is a significant new requirement for food businesses in the US. However, the new traceability requirements are designed to help protect public health and ensure that the food supply in the US is safe. By understanding the requirements of the rule and taking steps to comply, businesses can help to ensure that their products are safe for consumers.

About dFarm

The US FDA issued the Food Safety Modernization Act (FSMA) Rule 204 in January 2023 mandating recordkeeping and reporting for certain food producers and supply chain intermediaries, with regulatory compliance required by January 2026.  

dFarm advanced capabilities such as deep whole chain data collection and continuous real-time access deliver unparalleled transparency and visibility into supply chain dynamics.  This enhanced visibility enables food producers and intermediate services to surpass current FSMA 204 requirements and achieve food traceability at speeds and precision previously impossible, enabling consumers to realize superior food safety.

What is FSMA 204?

The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).