Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released updated guidance to help food makers label allergens clearly and follow the latest rules from the Food Allergen Labeling and Consumer Protection Act and the FASTER Act. This update affects food companies who need to keep their labels safe and accurate for people with allergies. The new guidance is available now, and the FDA welcomes comments anytime, making it easier to stay on top of allergen safety.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
Expanded 'milk' and 'eggs' definitions
The final guidance states that for the definition of a "major food allergen," FDA considers "milk" to include milk from domesticated cows, goats, sheep, or other ruminants and "eggs" to include eggs from domesticated chickens, ducks, geese, quail, and other fowl (announced January 7, 2025). If you have milk or egg allergies, this clarifies which animal sources FDA treats as allergens for labeling.
Revised list of tree nut allergens
The final guidance revises the list of tree nuts that the FDA considers to be major food allergens (published January 7, 2025). If you have a tree nut allergy, this guidance clarifies which tree nuts FDA treats as major allergens for labeling purposes.
Labeling Q&A on sesame, oils, supplements
The guidance includes questions and answers about labeling sesame, incidental additives, highly refined oils, dietary supplement products, fish and crustacean shellfish, and specific packing situations such as individual units within a multiunit package. These clarifications were published as part of Edition 5 on January 7, 2025 and are meant to help make allergen information on packaged foods clearer.
FDA issues updated allergen guidance
The FDA published a revised final guidance (Edition 5) on food allergen labeling on January 7, 2025. The guidance consolidates prior draft and final documents and answers questions about how to label allergens so labels are clearer for people buying food.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-11438 — Combined Notice of Filings #2
The Federal Energy Regulatory Commission got updates from several power companies about their electric rates, with changes set to start on October 25, 2023, and November 1, 2024. These updates could affect how much customers pay for electricity and give the public a chance to comment by June 24, 2026. If you’re connected to these companies, keep an eye on these dates and possible rate changes!
2026-11421 — Presidential Declaration of a Major Disaster for the Crow Tribe of Montana
The President declared a major disaster for the Crow Tribe of Montana after a severe winter storm hit in December 2025. This means people and businesses there can now apply for low-interest disaster loans to help fix damage or recover lost income. Physical damage loan applications are due by August 1, 2026, and economic injury loan applications by March 1, 2027.
2026-11446 — MQR Storage, LLC; Notice of Surrender of Preliminary Permit
MQR Storage, LLC has decided to give up its early permit for a pumped storage project near Tracy, California. This means the permit will officially end by July 3, 2026, freeing up the site for new applicants after that date. No money changes hands now, but this move opens the door for fresh energy ideas in the area.
2026-11467 — Privacy Act of 1974; System of Records
The USPS is updating how it handles driver info and mail tracking for its Highway Contract Route drivers. They’re moving from paper to a digital system and launching a new mobile app to make mail delivery smoother and safer. These changes start April 10, 2026, with no extra costs or delays, and they affect all USPS contractors using these routes.
2026-11428 — Proposed Information Collection Activity; ACF-700 Tribal Annual Report
Tribal child care programs that get federal money will fill out a shorter, easier annual report called the ACF-700. This update cuts down on repetitive questions and removes old COVID-related data, saving tribes time and effort. Comments on these changes are open until August 7, 2026, so tribes can share their thoughts before it’s finalized.
2026-11374 — Finished Carbon Steel Flanges From India: Final Results of Countervailing Duty Administrative Review; 2023
The U.S. Department of Commerce found that Indian producers of finished carbon steel flanges got unfair government help during 2023. Because of this, extra duties (taxes) will apply to these imports starting June 8, 2026, making sure U.S. businesses compete on a level playing field. If you import or sell these steel flanges, get ready for some changes that could affect prices and timing.
Previous / Next Documents
Previous: 2024-31532 — Heritable Intentional Genomic Alterations in Animals: The Approval Process; Guidance for Industry; Availability
The FDA just released clear rules for companies making genetic changes in animals that can be passed to their babies. This new guidance explains how to get FDA approval and what to expect during the process, helping developers move faster and smarter. Starting January 7, 2025, anyone working with these animal gene edits should follow these steps to avoid delays and extra costs.
Next: 2024-31534 — Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability
The FDA just released new guidance to limit lead in processed foods made for babies and kids under 2 years old. This helps keep little ones safer by reducing lead exposure in their food. Food makers should follow these action levels starting now to protect kids’ health without big costs or delays.