• The U.S. Food and Drug Administration (FDA) recently updated its Frequently Asked Questions accompanying the agency’s fifth edition Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act guidance, originally finalized in January 2025. The October 29, 2026 updates provide additional clarification regarding major food allergen labeling, manufacturing controls, allergen-free claims, and the agency’s revised interpretations of certain allergen categories.
  • Consistent with the January 2025 guidance, FDA reiterated that milk from ruminants other than cows (such as goats and sheep) and eggs from birds other than chickens (such as ducks, geese, and quail) are considered major food allergens. FDA also confirmed that ingredient declarations and “Contains” statements should identify the specific animal source, such as “goat milk” or “duck eggs.”
  • FDA also provided additional clarification regarding tree nuts. The agency confirmed that coconut and several other tree nuts, including chestnut, pili nut, shea nut, ginkgo nut, and kola nut, are no longer considered major food allergens for labeling purposes. As a result, these ingredients should no longer be declared in a “Contains” statement, although they must still appear in the ingredient list by their common or usual names when used as ingredients.
  • Several new FAQs focus on allergen labeling statements and FDA’s expectations regarding potentially inconsistent claims. FDA stated that it is generally not appropriate to use a “wheat-free” claim together with a “may contain wheat” advisory statement, or to pair a “Contains peanuts” statement with a “may contain peanuts” statement. According to FDA, such combinations may provide inconsistent allergen information and raise concerns under the prohibition against false or misleading labeling.
  • Keller and Heckman will continue to monitor FDA guidance and policy developments relating to food allergen labeling and food safety compliance and will provide updates on significant developments.