(571) 447-5500
January 2025
Docket Number: FDA-2022-D-0099
Issued by: Human Foods Program
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 The new guidance has been updated based on comments submitted to the draft guidance and consists of questions and answers about food allergen labeling requirements, including the labeling of tree nuts, sesame, milk, eggs, incidental additives,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. It is important to note that several tree nuts, to include coconut, have been removed from the list of allergenic tree nuts (below).

Table 1. Tree Nuts FDA Considers as Major Food Allergens with Their Common or Usual Names and Scientific Names.

FD&C Act ed5 Allergen List Nuts

Posted in FDA and USDA Regulatory Update, Foods.