FDA Issues Draft Guidance on Food Allergen Labeling Requirements

FDA Issues Draft Guidance on Food Allergen Labeling Requirements

November 30, 2022, Covington Alert

On November 29, 2022, the Food and Drug Administration (FDA) issued a draft guidance which updates the previous edition of the Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act. This fifth edition revises questions and answers to include the ninth major food allergen, sesame, and includes, among many things, questions and answers related to allergen labeling for bulk foods, foods produced through genetic engineering, protein-free ingredients, and dietary supplements.

The fourth edition of the guidance was issued 16 years ago. Since 2006, allergen labeling practices have evolved, novel foods introduced, and sesame became a major food allergen. This draft guidance includes many questions industry raised over the years. At a high level, FDA’s answers include:

• An ingredient derived from a major food allergen that does not contain protein is not subject to the allergen labeling requirements. This is the case for ingredients such as highly refined oils, flavors, and colors that do not contain a protein from the major food allergen, and also for 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.
• The roots, leaves, stems, bark, or other parts that are distinct from the tree nut or other allergenic portion of a plant are not major food allergens, and therefore are not subject to the food allergen labeling requirements. For example, food allergen labeling requirements do not apply to wheatgrass or coconut sugar from coconut sap.
• Food allergen labeling requirements apply to ingredients from major food allergens produced in other sources through the use of genetic engineering when they contain proteins derived from a major food allergen or are produced using the major food allergen’s DNA sequence.
• A major food allergen that has been unintentionally incorporated into a food due to cross-contact is not subject to the allergen labeling requirements. FDA acknowledges, as is has in prior iterations of this guidance, that cross-contact may result from causes such as customary methods of growing and harvesting crops and the use of shared storage, transportation, or production equipment. The agency emphasizes the importance of controlling cross-contact through cGMPs and under FSMA’s hazard analysis and risk-based preventive controls regulations, but notes that when such measures cannot completely eliminate cross-contact, some manufacturers have chosen to use advisory statements to alert allergic consumers to the potential for cross-contact.
• Food allergen labeling requirements apply to bulk containers such as reusable totes or containers of bulk food that are shipped business-to-business for further processing.
• Unit containers in a multiunit or multicomponent retail food package are not exempt from allergen labeling requirements. If the unit container does not bear an ingredient list, a “Contains” statement must be used, and FDA suggests placing this statement near the statement of identity. But no labeling is needed, including allergen labeling, if the individual unit is an unlabeled inner sleeve meant solely for protection of the product (sometimes called a “package liner”) that does not contain any written, printed, or graphic matter.
• The label of a food made with an incidental additive containing a major food allergen is required to declare the food source of the major food allergen.
• A “Contains” statement should not include food allergens other than the major food allergens or food substances that are not food allergens to which individuals may be sensitive. For example, “Contains: mustard” or “Contains: gluten” should not be used.
• Fish includes cartilaginous fish, such as shark, rays, and skates.
• Coconut is still considered a tree nut.
• A major food allergen declared within the Supplement Facts label does not need to be declared elsewhere on the dietary supplement label. When the dietary supplement label does not include an ingredient list, the “Contains” statement should be printed outside and immediately after, or adjacent to, the Supplement Facts label.
• Food allergen labeling requirements apply to all packaged foods served or sold onboard airlines and other transportation carriers.
• Food allergen labeling requirements do not apply to pet foods, animal feeds, cosmetics, or household cleaning products.

FDA also finalized the fourth edition of the guidance and plans to move questions and answers from the fifth edition to the final guidance document after reviewing comments and incorporating any needed changes from stakeholders. Interested stakeholders have until January 29, 2023 to submit comments on the fifth edition of the questions and answers.

It is worth noting that the Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls draft guidance is expected to be released by year’s end.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.