In November 2022, the Food and Drug Administration (FDA)’s Center for Food Safety and Applied Nutrition (CFSAN) released Draft Guidance on food allergen labeling entitled, “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food,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.” This update of the previous Edition 4 adds new question and answer topics to the guidance.


With some exceptions, the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the label of a food fabricated from two or more ingredients to declare each ingredient by its common or usual name. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires the labels of foods regulated under the FD&C Act to declare the presence of each major food allergen on the product label using the name of the food source from which each allergen is derived. “Major food allergen” was defined as milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. The Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) amended the definition of major food allergen to include sesame, effective January 1, 2023. Allergens may be declared in the ingredient list or in a separate “Contains” statement following the ingredient list.

Key Takeaways From the Draft Guidance

In the Draft Guidance, FDA clarifies several new topics, including:

  • Whether packaged for retail sale or in bulk, food ingredients and finished foods that contain a major food allergen must comply with the labeling requirements.
  • The following kinds of fish are considered allergenic: Jawless fish (hagfish, lampreys, etc), Bony fish (trout, flounder, bass, salmon, tilapia, cod, mackerel, tuna, grouper, etc), and Cartilaginous fish (shark, rays, skates, etc.)
  • Pet foods and animal feeds are not subject to the allergen labeling requirements.
  • FDA considers proteins from major food allergens produced through the use of genetic engineering to be derived from major food allergens and require allergen labeling (e.g., milk-derived protein).
  • To clarify the meaning of “tree nuts” requiring allergen labeling, FDA has provided the following non-exhaustive list of tree nuts: Tree Nuts List
  • The unit containers in a multiunit or multicomponent retail food package are not exempt from allergen labeling requirements, even if they are exempt from other labeling requirements. However, no labeling is needed if the individual unit is an unlabeled inner sleeve intended solely for protection of the product (ex: sleeves of crackers) and does not contain any written, printed, or graphic matter.
  • If the food contains a major food allergen in an incidental additive that is exempt from ingredient labeling, manufacturers need to declare the food source of the major food allergen in a “Contains” statement. For example, if you use wheat flour while processing rice crackers, and do not declare “wheat” in the ingredient list, you must list “wheat” in a “Contains” statement after the ingredient list.
  • Manufacturers may not include in the “Contains” statement information about food allergens other than the defined major food allergens or other substances to which consumers may have sensitivities. However, manufacturers may provide such information in a voluntary statement separate from the “Contains” statement to alert consumers (e.g., “Other Allergen Information: mustard” or “Other Information: Includes gluten”).
  • For dietary supplements, if a dietary ingredient contains a major food allergen, but the name of the dietary ingredient does not identify the allergen, manufacturers may include the allergen disclosure parenthetically in the Supplement Facts Panel, in the ingredients list, or in a separate “Contains” statement (e.g., “bovine colostrum (milk),” “ingredients: bovine colostrum (milk),” or “Contains milk.”).

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