The role of labeling in food safety and product recalls

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. For many consumers, food recalls related to the mislabeling of required allergens pose another serious health threat. It's the responsibility of the United States (US) Food and Drug Administration (FDA) to ensure that foods sold in the US are safe and properly labeled by establishing food labeling requirements.

Below are some significant acts and initiatives to educate yourself on this month. 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)

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 nine foods or food groups as major food allergens, which account for over 90% of all documented food allergies in the US 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 US 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. By developing a standardized industry approach, PTI seeks to enhance the speed and efficiency of traceability systems and achieve supply chain-wide adoption of electronic traceability for every case of produce.
Barcode serialization plays a critical role in this process, it's used to track perishable goods, comply with food safety regulations, and manage product recalls. With barcode serialization, companies can trace the origin of ingredients, manage expiration dates, and enhance overall food safety. In food recalls, serialization allows affected products to be quickly and accurately identified, minimizing the impact on consumers by helping prevent foodborne illnesses. Additionally, efficient product isolation helps companies avoid bad press, preserving their brand reputation.

The fresh food industry handles about six billion cases of produce in the US 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.

With the FSMA Section 204 final ruling being published in November 2022, let us dive deeper into it.

What is FSMA Section 204?

Current law requires only those 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 who 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:

• 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.

Food Date Labeling Act

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 US 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.

Labeling accuracy is one of the food industry’s biggest allies in recall prevention.

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.

Processes to help prevent labeling related recalls:

• Enable role-based access to your food labeling software
• Leverage network licensing for multi-user labeling environments
• Enforce a secure label approval process
• Leverage centralized label management
• Automate printing from your business system

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:

• Data validation capabilities to prevent labeling errors from happening.
• Electronic label approval workflows to ensure only accurate labels are entering production.
• Security, traceability, and version history control to ensure your labels and label printing process complies with the FDA and other industry standards.

By implementing 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.