What are allergens and dietary flags and which allergens should I include on labels to be FDA-compliant?

Galley includes the FDA recognized allergens in your account that can be used to tag ingredients and vendor items which will then appear in recipes that they are used in. Additional custom dietary flags can also be created (ex. sulphites). All allergens will be included on nutritional labels and custom dietary flags can be optionally included on nutrition labels. 

allergens

To comply with the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetics Act, the following major food allergens must be included on labels of prepared and packaged foods sold at retail food stores and food service establishments (packaged for sale on their premises). 

Top 9 Major Food Allergens:

  • Milk
  • Eggs
  • Fish*
  • Crustacean Shellfish*
  • Tree Nuts*
  • Peanuts
  • Wheat
  • Soybeans
  • Sesame

Note: The common name must be identified for fish & crustacean shellfish ingredients . The type of tree nut must be listed (e.g. walnut) in the ingredient list or contains statement to comply with the labeling requirements. Visit this article here for more information. 

 

❗On January 6, 2025, the FDA released the 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) which clarifies additional requirements for major food allergen labeling. 

Due to current research, the FDA only recognizes the following tree nuts as a tree nut allergen:

Common Name
Almond
Black Walnut
Brazil Nut
California Walnut
Cashew
Filbert/Hazelnut
Heartnut/Japanese Walnut
Macadamia nut/Bush Nut
Pecan
Pine nut/Pinon nut
Pistachio
Walnut (English, Persian)

This means listing coconut, beech nuts, chestnuts, or any other nuts that are not listed in the above table would deem the nutrition label out of compliance due to the final guidance: 

Only the tree nuts listed in Table 1 are considered major food allergens, and, therefore, must meet the food allergen labeling requirements of section 403(w) of the FD&C Act. Because other tree nuts that are not listed in Table 1 do not have a robust body of evidence to support inclusion as a major food allergen, they should not be included in the “Contains” statement even if they are used as ingredients because the “Contains” statement is reserved for major food allergens. Tree nuts used as ingredients, but not listed in Table 1, would still be required to be listed by common or usual name in the ingredient list (21 CFR 101.4).

The allergen contains statement is strictly reserved for the presence of any of the top 9 major food allergens. This is to make it easier for consumers to determine if a food contains a major food allergen or not. 

For more information visit, How do I account for types or species in my allergen dietary flags?