Food safety modernization safety act (FSMA) labeling

About FSMA

The Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food requires food and beverage companies to establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls.

The FSMA is a major step in shifting focus from how food and beverage manufacturers, suppliers, and retailers respond to food contamination to how they prevent food contamination in the first place. How?

• The FSMA shifts more power over food safety controls from companies to the FDA because the FDA will have mandatory recall authority and the ability to keep suspect food from being shipped
• The FSMA requires food and beverage companies to establish or enhance operations, plans, and procedures for preventing food safety issues, including product recalls
• The FSMA requires food and beverage companies to rely more on emerging products and technologies that help keep food safe

The FDA compliance date for all persons subject to the recordkeeping requirements is January 20, 2026, but the time to prepare for FSMA Rule 204 is now.

What is FSMA Rule 204?

The implementation of Section 204 of FSMA, the Food Traceability Proposed Rule, imposes a broad standard, identifying specific items that now need to be tracked and traced by all companies in the supply chain.

FSMA Rule 204 calls for the FDA to create a list of foods – the Food Traceability List (FTL) – that need additional recordkeeping and establish those recordkeeping requirements. So far, the FTL includes:

• Leafy greens, melons, sprouts, cucumbers, tomatoes, peppers, fresh herbs, tropical tree fruits, and all fresh-cut items
• Soft ripened and semi-soft cheeses
• Shell eggs
• Nut butter
• Some categories of seafood
• Ready-to-eat deli salads

If you grow, ship, pack, process, manufacture, or sell any of the foods on the FTL, you are required to keep additional records on these items. For example, a retailer or foodservice operator may be responsible for storing data related to several steps along the supply chain, especially if the brand owns the warehouses or distribution centers that service store locations. Learn what key data elements you might be required to keep.

Four things you can do now to prepare for FSMA Rule 204:

1. Identify any ingredients that go into your products and are on the FTL.
2. Know the data you are required to track and store based on your role in the supply chain.
3. Leverage labels that align with PTI standards with human- and machine-readable GS1-128 barcodes.
4. For large retailers, processors, manufacturers, distributors, or foodservice operators – find traceability solutions to ensure compliance across your supplier network and standardize your labels across all suppliers with a unified supplier labeling system.

Labeling accuracy is one of the food and beverage industry’s biggest allies in recall prevention. TEKLYNX provides food and beverage companies with barcode label software solutions that help increase labeling accuracy, because the software itself significantly reduces the room for human error throughout the labeling process.