FDA Releases new food labeling regulations on allergens and plant-based alternatives to animal foods
Labeling and recordkeeping throughout the supply chain from producers to consumers is one of the cornerstones of food traceability in the U.S. that ensures safety, quality control and rapid response to potential contamination or recalls.
“Food traceability is the ability to follow the movement of a food product and its ingredients through all steps in the supply chain, both backward and forward,” explains the U.S. Food and Drug Administration (FDA).“Traceability involves documenting and linking the production, processing, and distribution chain of food products and ingredients.”
The FDA is responsible for assuming that foods sold in the United States are safe, wholesome, and properly labeled. This applies to foods produced domestically, as well as food from foreign countries.
“The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA's jurisdiction,” says the FDA.
FDA Issues New Guidance to Help Meet Food Labeling Rules
Food Safety magazine reported in early January 2025 that the FDA has released new guidance documents to help the industry comply with food labeling regulations concerning allergens and plant-based alternatives to animal foods.
The FDA’s two new food labeling guidelines:
- Allergens Labeling: The FDA released the fifth edition of a question-and-answer document regarding food allergen labeling requirements of the FD&C Act. The guidance replaces the draft and final guidance documents on food allergen labeling issued in November 2022.
Says the FDA: “This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”
Under the guidance, “a major food allergen” is one of the following foods or food groups, or an ingredient that contains protein derived from one of the following:
o Foods: Milk, eggs, peanuts, wheat, soybeans, and sesame.
o Food Groups: Fish (such as bass, flounder, cod), crustacean shellfish (such as crab, lobster, shrimp), and tree nuts (such as almonds, walnuts, pecans).
The Q&A addresses the fact that there is a penalty for failure to comply with the food allergen labeling requirements with misbranded products subject to enforcement actions such as recalls, import refusal, and seizure by the FDA.
Food Safety magazine also says that The FDA also released a final guidance for FDA staff and interested stakeholders on the evaluation of the public health importance of food allergens other than the nine major allergens defined in the U.S. law (see Foods listed above).
- Labeling Plant-Based Alternatives to Animal Foods: Food Safety magazine says the FDA published a draft industry guidance on the labeling of plant-based alternatives to animal foods.
Says the FDA: “These recommendations for manufacturers are intended to help ensure that consumers understand the nature or source of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions.
This draft guidance may also help manufacturers of plant-based alternatives to animal-derived foods ensure that the labeling for, and names of, their products are truthful and non-misleading and accurately describe the food.
The scope of this guidance includes plant-based alternatives to eggs, seafood, poultry, meat, and dairy products (excluding plant-based milk alternatives ) that fall under FDA jurisdiction. This draft guidance does not address the naming and labeling of plant-based milk alternatives; that topic is being addressed elsewhere.”
FDA Issues Food Safety Regulations for RTE, Low-Moisture Foods
Food Safety magazine also reported that the FDA has released a draft guidance for industry regarding low-moisture ready-to-eat (RTE) foods. The FDA cites examples of RTE, low-moisture foods include:
- Powdered infant formula.
- Peanut butter.
- Nut butters.
- Powdered drink mixes.
- Chocolate.
- Medical foods in powdered and paste forms.
- Processed tree nuts.
- Milk powders.
- Powdered spices.
- Snack foods such as chips and crackers.
- Granola bars.
- Dry cereal.
“The recommendations in this guidance can help manufacturers/processors of LMRTE foods comply with the requirements for current good manufacturing practices (CGMPs), hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply for these foods,” the FDA said.
Specifically, the guidance discusses:
- Establishing and implementing a sanitation program and routine environmental monitoring program.
- Conducting adequate root cause investigations (RCIs) following a pathogen contamination event.
- Applying a sanitizing treatment when remediating a pathogen contamination event;
- taking steps to identify affected food.
- The limitations of relying solely on a product testing program as verification that pathogen contamination has been eliminated.
Understanding Labeling in the Food Traceability Process
Understanding labeling in the food traceability process involves traceability lot codes (TLC), key data elements (KDEs), the food traceability list (FTL):
- Traceability Lot Code (TLC): The cornerstone of food traceability labeling is the TLC. This unique alphanumeric identifier is assigned to specific batches or lots of food products. The TLC must be assigned in the following situations:
o When initially packing a raw agricultural commodity (RAC).
o During the first land-based receiving of food obtained from a fishing vessel.
o When transforming a food product
The TLC serves as a crucial link throughout the supply chain, allowing for precise tracking of food items.
- Key Data Elements (KDEs): Labels and associated records must include KDEs linked to the TLC. These KDEs provide essential information about the food product at various Critical Tracking Events (CTEs) throughout the supply chain. KDEs typically include:
o Food description.
o Quantity and unit of measure.
o Location information for suppliers and recipients.
o Date of receipt or shipping.
o Reference to relevant traceability records.
- Food Traceability List (FTL): The FDA has established a FTL that identifies high-risk foods requiring additional recordkeeping. Foods on this list, such as certain cheeses, seafood products, and fresh produce, are subject to more stringent labeling and traceability requirements.
A Look at Labeling Requirements Along the Supply Chain
Another way to examine food traceability is to look at labeling requirements along the supply chain:
- Farm Level: At the farm level, producers must assign TLCs to their products and maintain records of the growing location, harvest date, and initial packing information.
- Processing and Manufacturing: Food processors and manufacturers must label products with TLCs and maintain records of ingredients used, processing dates, and any transformations made to the food.
- Distribution and Warehousing: Distributors and warehouses must maintain labels and records that allow for both forward and backward tracing of products, including receipt and shipping information.
- Retail and Food Service: Retail establishments and restaurants must keep records of the products they receive, including the TLCs and associated KDEs
The food industry is increasingly adopting digital technologies, such as FreshByte Software, to enhance traceability:
- Barcodes and QR codes on labels allow for quick scanning and access to traceability information.
- Radio-frequency identification (RFID) tags can provide real-time tracking of food products throughout the supply chain.
- Blockchain technology is being explored to create immutable records of food traceability data.
FreshByte’s software has been proven to fully utilize the technologies that handle new barcodes and RFIDs on leafy greens, pears, apples, and other fresh produce.
Contact FreshByte Software today to learn more about how our solutions meet and exceed government regulations for easy tracing and inventory tracking.
