FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

December 9, 2022By Sophia R. Gaulkin

Last week, the U.S. Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements.

The draft guidance, “Questions and Answers Regarding Food Allergen Labeling (Edition 5),” replaces the 16-year-old Edition 4 of the final guidance with new and revised questions and answers related to:

  • The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which, inter alia, amended the Federal Food, Drug, and Cosmetic Act (FDC Act) to define “major food allergen”;
  • The Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), which amended the definition of “major food allergen” to include sesame, effective Jan. 1, 2023;
  • The applicability of food allergen labeling requirements to specific products (e.g., labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and
  • Other technical labeling matters.

Under Section 201(qq) of the FDC Act, “major food allergens” include milk, eggs, peanuts, wheat, soybeans, fish, shellfish, tree nuts, and effective Jan. 1, 2023, sesame.  In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq):

  • Jawless fish (e.g., lampreys);
  • Bony fish (e.g., trout); and
  • Cartilaginous fish (e.g., shark, rays, and skates).

Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements:

  • Bulk containers (e.g., reusable totes of bulk food shipped for further processing, labeling, or repacking);
  • Spice mixes and seasoning mixes with incidental additives that might contain a major food allergen;
  • Ingredients from major food allergens produced through genetic engineering when they contain proteins derived from a major food allergen or through using the major food allergen’s DNA sequence;
  • Dietary supplement ingredients, including dietary ingredients, source ingredients, and other ingredients containing a major food allergen;
  • Unit containers in a multiunit retail food package that contain a major food allergen; and
  • All packaged foods served or sold on transportation carriers (e.g., airlines).

On the other hand, these products are not subject to food allergen labeling requirements:

  • Pet foods, animal feeds, cosmetics, drugs, or household cleaning products;
  • An ingredient derived from a major food allergen that does not contain protein (e.g., ingredients processed using technology that reliably produces a protein-free ingredient and for which the manufacturer can ensure that the ingredient does not contain protein);
  • Foods in which a major food allergen has been unintentionally incorporated due to cross-contact; and
  • Roots, leaves, stems, bark, or other parts distinct from the tree nut or allergenic portion of a tree nut bearing plant.

The final guidance, which accompanies and shares the same title as the draft guidance, preserves the questions and answers from Edition 4, with minor editorial and organizational changes.

Comments on the draft guidance must be submitted by Jan. 29, 2023.  After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate.  Going forward, FDA intends to continue to revise and add questions and answers, and issue subsequent editions of the guidance document.  With that in mind, we expect that the next edition will come sooner than 16 years from now.