FDA Releases Allergen, Food Safety, and Plant-Based Alternative Labeling Guidances

Constituent Update

January 6, 2025

Today the U.S. Food and Drug Administration (FDA) released four guidance documents to help industry and other interest holders understand and comply with FDA regulations concerning food allergens, low-moisture ready-to-eat human foods, and labeling of plant-based alternatives to animal-derived foods. The guidance documents are listed below with links to related webpages.

• Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5). This final guidance will replace both the draft and final guidance documents on food allergen labeling that were issued in November 2022. The new guidance has been updated based on comments submitted to the draft guidance and consists of questions and answers about food allergen labeling requirements, including the labeling of tree nuts, sesame, milk, eggs, incidental additives, highly refined oils, dietary supplement products, and certain specific packing and labeling situations, such as individual units within a multiunit package.   
• Final Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. The final guidance outlines the approach the FDA generally intends to take when evaluating the public health importance of food allergens that are not one of the nine major food allergens identified by law in the U.S. The major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.  
• Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event. The draft guidance is intended to help manufacturers and processors of Low Moisture Ready-to-Eat (LMRTE) human foods, including powdered infant formula, comply with requirements for current good manufacturing practices, hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply.
• Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods. The draft guidance is intended to provide industry with best practices for naming and labeling plant-based alternatives to eggs, seafood, poultry, meat, and dairy, excluding plant-based milk alternatives. The guidance, if finalized, will help industry develop labels that help consumers understand the nature of plant-based alternative foods, including differences among these products, so they can make informed decisions.  

Although you can comment on any guidance at any time, to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the comment close date. Submit comments electronically on http://www.regulations.gov.