The Centers for Disease Control and Prevention (CDC) estimates each year 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases. And for many consumers, food recalls related to the mislabeling of required allergens poses another serious health threat. It's the responsibility of the United States (U.S.) Food and Drug Administration (FDA) to assure foods sold in the U.S. are safe and properly labeled by establishing food labeling requirements.
This article covers food safety labeling regulations, prepping for the FDA’s FSMA Section 204, the importance of label accuracy for recall prevention
Significant acts & initiatives to educate yourself
To keep consumers safe, the food industry is highly regulated. With that comes multiple acts and initiatives food producers must follow to stay compliant.
Food Allergen Labeling and Consumer Protection Act (FALCPA)
As a part of its routine regulatory functions, the FDA inspects a variety of packaged foods to ensure they are properly labeled.
FALCPA identifies nine foods or food groups as major food allergens, which account for over 90% of all documented food allergies in the U.S. and represent the foods most likely to result in severe reactions:
- Milk
- Eggs
- Fish (e.g., bass, flounder, cod)
- Crustacean shellfish (e.g., crab, lobster, shrimp)
- Tree nuts (e.g., almonds, walnuts, pecans)
- Peanuts
- Wheat
- Soybeans
- Sesame
Incorrect packages or labels that fail to identify allergens are the leading cause of food recalls by the FDA and the U.S. Department of Agriculture (USDA). Food manufacturers must prevent mislabeling products as well as avoid cross-contamination with allergens from other products.
Produce Traceability Initiative (PTI)
This voluntary, industry-wide effort is designed to help the fresh food industry maximize the effectiveness of track and trace procedures, develop a standardized industry approach to enhance the speed and efficiency of traceability systems, and achieve supply chain-wide adoption of electronic traceability of every case of produce.
The fresh food industry handles about six billion cases of produce in the U.S. each year. The use of standards in the supply chain will help narrow the impact of recalls, protecting both consumers and industry members.
Whether you are a small community farming operation or a major produce supplier, it is essential to have PTI-compliant labels. A PTI-compliant label must contain these elements:
- Voice Pick Code
- Global Trade Item Number (GTIN)
- Batch/Lot Number
- Pack/Harvest Date
- GS1-128 barcode in human- and machine-readable
- Supplier ID # and Tracking #
Food Safety Modernization Act (FSMA)
The FDA’s FSMA was signed into law in 2011 and enacted in response to changes in the global food system and understanding of foodborne illness. The FSMA shifts the focus from how commercial farms, packing operations, and food processing facilities respond to foodborne illness to how they prevent it.
How? The FSMA:
- Moves 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.
- Requires food and beverage companies to establish or enhance operations, plans, and procedures for preventing food safety issues, including product recalls.
- Forces food and beverage companies to adopt more emerging products and technologies that help keep food safe.
What is FSMA Section 204?
The implementation of Section 204 of FSMA, the Food Traceability Proposed Rule, would impose a much broader standard, identifying specific items that now need to be tracked and traced by everyone that touches them.
FSMA Section 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.
How to start preparing for FSMA Section 204
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.
Four things you can do now to prepare for FSMA Section 204:
Identify any ingredients that go into your products and are on the FTL.
Know the data you are required to track and store based on your role in the supply chain.
Leverage labels that align with PTI standards with human- and machine-readable GS1-128 barcodes.
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 the food industry’s biggest ally in recall prevention
Food manufacturers must ensure accurate labeling to avoid costly recalls, protect brand reputation, and safeguard consumers. Mislabeling allergens, expiration dates, or using the wrong label can have serious consequences.
To prevent labeling-related recalls, businesses can enable role-based access within their labeling software and utilize network licensing to streamline multi-user environments. Implementing a secure label approval process and leveraging centralized label management are also critical steps.
When selecting a barcode labeling system, prioritize features such as data validation to prevent errors, electronic label approval workflows to ensure only accurate labels are used, and robust security, traceability, and version control to maintain compliance with FDA and industry standards.
