September is National Food Safety Education Month and Section 204 of the Food Safety Modernization Act (FSMA) will go into effect in January 2026, so it is a perfect time to talk about labeling for food safety.
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 blog goes over food safety labeling regulations, prepping for the FDA’s FSMA Section 204, the importance of label accuracy for recall prevention, and if a recall is unavoidable, how labeling solutions help identify the products to remove from the supply chain.
To keep consumers safe, the food industry is highly regulated. With that comes multiple acts and initiatives food producers must follow to stay compliant.
This act was passed in 2004 to make it easier for food allergic consumers or their caregivers to identify (and avoid) foods that contain major allergens. As a part of its routine regulatory functions, the FDA inspects a variety of packaged foods to ensure they are properly labeled.
FALCPA identifies eight* 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:
* In 2021, sesame was added as the 9th major food allergen in the U.S. Labeling requirements for sesame will be effective January 1, 2023.
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.
Learn more about allergen labeling software or download an allergen label sample for CODESOFT label design software. CODESOFT Enterprise includes the Tagged Text Management feature to automatically highlight allergens when listed in ingredients.
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:
CODESOFT includes a built-in formula that makes creating Voice Pick Codes quick and easy.
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:
With the FSMA Section 204 final ruling being published in November 2022, let us dive deeper into it.
Current law requires only that entities in the food industry be able to declare from where they directly bought something, and to whom they directly sold it. 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. So far, the FTL includes:
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.
The Food Date Labeling Act, reintroduced in Congress in May 2023, would require standardized date labeling with separate phrases indicating whether the date is just a suggestion of peak quality (“BEST if used by”) or a different phrase (“USE by”) if there is an increased risk of food-born illness past a certain date.
Nearly 10% of all wasted food in the U.S. is due to confusion over how to interpret food date labels—often mistakenly thought of as “expiration dates.” The numerous types of date labels confuse consumers who believe their food will make them sick when more often the manufacturer intends to relay a guarantee of peak quality.
By establishing an easily understood food date labeling system, the Food Date Labeling Act offers a practical solution to improving consumer understanding, reducing food waste, and supporting sustainable practices. The Food Date Labeling Act also allows food to be sold or donated after its labeled quality date, helping more food reach those who need it.
Leverage database connections to easily pull “BEST if used by” or “USE by” dates onto food labels.
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:
Standards already exist to help farmers, growers, shipping/receiving, packers, manufacturers, processors, etc., achieve the degree of supply chain visibility required by FSMA Section 204. The Global Location Number (GLN) system established by GS1 US provides a unique 13-digit number for identifying all parties and locations in a supply chain.
A GS1 US-compliant barcode can identify everything from the specific farm, product type, and harvest date to ship date – information that becomes instantly available to every entity that handles the item along the supply chain.
Download a free 30-day trial of CODESOFT.
Food manufacturers must produce quality products as well as ensure the labeling of their products is accurate – the wrong representation of allergens, the wrong expiration dates, or even the wrong label altogether can result in excessive costs, negatively impact brand reputation, and put consumers at risk.
Beyond product recall prevention efforts, labeling accuracy also plays a key role once a product recall is initiated – it allows companies to quickly identify, locate, and remove affected products.
When choosing the appropriate barcode labeling system that helps your company with FSMA compliance, food industry initiatives, and protecting public health, look for one that supports:
By implementing LABEL ARCHIVE label security and traceability software, you can establish permissions to control access to all your label files, implement a multi-stage electronic approval process, and keep record of changes, comments, revisions, and print history for every label. LABEL ARCHIVE also integrates with CODESOFT, so you can easily create and print compliant food labels and leverage robust database connections to increase labeling accuracy by minimizing human error throughout the labeling process.
Jenna Wagner, Global Marketing Director, is a successful strategic marketing executive with over 20 years of marketing experience in software technology and consulting services. She is a creative, dynamic, results-driven leader who possesses a passion for developing her teams. She leverages her deep understanding of the solutions and industries she serves to deliver impactful customer value throughout the global supply chain to help organizations barcode better.
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