What You Need to Know About FSMA 204 Compliance

Ensuring food safety and traceability is more critical than ever, and FSMA 204 sets the standard for compliance. With enforcement beginning in 2025, businesses in the food supply chain must act now to meet new traceability requirements. This guide breaks down everything you need to know about FSMA 204, from key compliance elements to enforcement deadlines—helping you stay ahead of regulations and protect your business.

What Is FSMA 204?

FSMA (Food Safety Modernization Act) Section 204 refers to the Food Traceability requirements, which are aimed at enhancing the traceability of certain foods in the U.S. food supply chain. These regulations focus on improving the ability to trace foods throughout the entire supply chain, particularly when it comes to outbreaks of foodborne illnesses.

FSMA 204 Final Rule on Requirements for Food Traceability

The latest updates on FSMA 204 are related to the FDA’s implementation and the final rule surrounding food traceability. Here are some key points:

1. Traceability Records:

FSMA 204 requires certain entities in the food supply chain to maintain records that can trace the movement of foods, particularly those that are higher risk, like fresh produce, seafood, and other perishable products. This is meant to make it easier for the FDA to track products back through the supply chain in the event of contamination.

2. Covered Foods:

The rule applies to certain foods listed by the FDA, which generally include high-risk foods like leafy greens, tomatoes, seafoods, packaged goods and others that are typically involved in foodborne illness outbreaks. The rule also establishes criteria for which foods fall under this traceability system.

3. Key Data Elements:

Companies will need to collect and store key data elements (KDEs) related to the traceability of foods, such as:

1. Lot number
2. Product description
3. Quantity
4. Supplier information
5. Shipping dates and destinations

4. One Up, One Down:

Under FSMA 204, businesses must be able to trace products “one step forward and one step back” in the supply chain. This means if you receive a product from a supplier, you need to be able to identify where the product went afterward, and vice versa.

5. Compliance Deadlines:

While the FSMA 204 rule was finalized, the FDA provided time for industry sectors to comply. Businesses have already been given specific timelines based on their size, with smaller businesses having additional time to implement the full system.

6. Impact on Technology:

There has been a push towards using modern technology, such as blockchain and other digital systems, to comply with traceability requirements. Many companies are adopting traceability software solutions to keep track of the required data elements and streamline reporting.

7. FDA Guidance:

The FDA has been working on issuing additional guidance to help industry players understand the specifics of what is required under FSMA 204. There may be additional clarifications or updates to the rule as they refine the implementation process.

FSMA 204 Food Traceability List

The Food Traceability List (FTL) outlines high-risk foods that require additional recordkeeping under FSMA 204. The FDA developed this list to enhance food safety by enabling faster identification and removal of potentially contaminated foods, reducing the risk of foodborne illness outbreaks. Businesses handling these foods—or products containing them in their raw form—must comply with FSMA 204’s traceability requirements.

Foods Covered Under the Food Traceability List

The FTL includes various food categories, including fresh produce, dairy, seafood, and ready-to-eat items. Key examples include:

• Dairy Products – Soft cheeses (brie, feta, mozzarella) and cheeses made from unpasteurized milk.
• Eggs & Nut Butters – Shell eggs and all types of nut butters, including almond, peanut, and hazelnut.
• Fresh Produce – Tomatoes, cucumbers, peppers, leafy greens (romaine, spinach, kale), and fresh herbs (cilantro, parsley, basil).
• Fruits – Fresh-cut fruit, fresh melons (cantaloupe, honeydew, watermelon), and tropical tree fruits (mango, papaya, jackfruit).
• Seafood – Fresh, frozen, and smoked finfish (tuna, salmon, cod), crustaceans (shrimp, crab, lobster), and bivalve mollusks (clams, oysters, mussels).
• Sprouts & Deli Salads – All fresh sprouts (alfalfa, radish, bean sprouts) and refrigerated ready-to-eat deli salads (egg salad, potato salad, seafood salad).

FSMA 204 Compliance Dates & Timeline

2025: FSMA 204 Deadline – Enforcement Begins (h3)

The FDA’s final rule specifies that January 2025 is when the traceability requirements start to be enforced. This means businesses need to ensure that they have fully implemented the necessary systems to comply with FSMA 204 by this date. At this point, traceability records will need to be maintained for covered foods as specified by the FDA. While there will be no penalty until 2026, now is the time to act to make sure all systems are “go” before it’s too late.

2026: FDA Penalties for FSMA 204 – Non-Compliance Imposed

Starting January 1, 2026, the FDA can begin imposing penalties for non-compliance. This includes penalties for failing to maintain traceability records or not being able to produce required documentation upon request by the FDA. Penalties could include fines or other enforcement actions if companies do not meet the required traceability standards.

FSMA 204 Compliance Requirements

The key components that businesses need to focus on for compliance are:

• Key Data Elements (KDEs): Companies must maintain and provide key data about covered foods, such as lot numbers, shipping information, and other critical data points.
• Traceability Documentation: Entities must have traceability records in place that can track the movement of food products one step forward and one step back in the supply chain. This includes supplier and recipient information, as well as dates of shipment.
• Technology and Data Systems: Businesses will likely need to implement or update their traceability systems, utilizing technologies like blockchain, cloud-based systems, or other digital solutions to ensure accurate, real-time tracking of products.

FDA Penalties for FSMA 204 Non-Compliance

While penalties are not the focus right now, the FDA has made it clear that businesses that fail to comply with the traceability requirements will face enforcement actions beginning Tuesday, January 20, 2026. These penalties could be:

• Fines for businesses failing to maintain the appropriate traceability records.
• Product recalls or market withdrawals if the FDA finds traceability issues tied to contamination or outbreaks.
• Suspension of operations or other sanctions for non-compliant companies.

The FDA’s Push for Readiness

In addition to enforcing penalties, the FDA and industry groups have been pushing for businesses to get ahead of this rule, as the FDA intends to use the traceability records to help with quicker responses in the event of a foodborne illness outbreak or contamination, ensuring that food can be traced and removed from the supply chain quickly.

What Does the FSMA 204 Final Rule Mean for Food Businesses?

• Immediate Action: Companies should start implementing systems now to meet the January 20^th, 2026 deadline. This includes assessing their current traceability systems, upgrading technologies, and training personnel.
• Tech Investments: This may also lead businesses to invest in technologies like digital traceability platforms that can more easily handle the required KDEs and provide real-time access to traceability data.
• Documentation Systems: Whether using paper or digital systems, businesses must ensure that they can track food products efficiently through the supply chain and meet the regulatory requirements for detailed documentation.

Meet FSMA 204 Compliance Standards with CAI Software

CAI Software offers solutions purpose-built for food and beverage manufacturers and distributors. Whether you need to start from ground zero or give your existing systems a boost, we have the right tools to help you meet compliance standards and exceed your customers’ expectations. To learn more, check out our FSMA Whitepaper and book time with one of our food and beverage experts.