The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.

The fifth edition of the draft guidance has been updated to include new questions and answers intended to address a new major food allergen, sesame, as well as questions related to allergen labeling for bulk foods, foods produced through genetic engineering, ingredients containing allergen proteins, and allergen statements with respect to dietary supplements and pet food/animal feed.   The complete allergen labeling requirements are set forth in Section 403(w)(1) of the Food, Drug, and Cosmetics Act (21 U.S.C. 343(w)(1)).  Key takeaways from the new draft guidance include the following:

Sesame Designated a New Major Allergen

• Effective January 1, 2023, sesame is now designated as a “major allergen,” bringing the total number of major allergens to nine.  The eight other major allergens are milk (from domesticated cows), eggs (from domesticated chickens), peanuts, wheat, soybeans, fish, crustacean shellfish, and tree nuts. 

Labeling of Bulk Containers / Multiunit Packages

• Food ingredients and finished foods, including those sold in bulk, that contain a major food allergen (including those used to make dietary supplements, such as liquids, solids, powders, capsules, softgels, and tablets) must comply with the allergen labeling requirements.

• The food allergen labeling requirements apply to bulk containers such as reusable totes or containers of bulk food shipped for further processing, labeling, or repacking between manufacturers, repackers, or distributors.  While such shipments may be exempt from other food labeling requirements, there is no exemption for allergen labeling. 

• Unit containers in a multiunit or multicomponent retail good package must also comply with allergen labeling requirements. However, no labeling is needed if the individual unit is in an unlabeled inner sleeve intended for the protection of the food product.

Labeling of Spice Mixes

• Although spice mixes may be declared simply as “spices” on the finished product label, if a major food allergen might be present as an incidental additive in the spice mix, it must be declared as a major food allergen, either parenthetically after the term “spice” in the ingredient list, in a separate “Contains” statement, or both.  The same allergen labeling requirement applies to food products that contain seasoning mixes. 

Definition of “Fish”

• For purposes of allergen labeling, FDA defines “fish” as being from one of three categories: (1) jawless fish, such as hagfish and lampreys; (2) bony fish, such as trout, flounder, bass, salmon, tilapia, cod, mackerel, tuna, and grouper; and (3) cartilaginous fish, such as shark, rays, and skates.

Proteins From Major Food Allergens Produced Through Genetic Engineering

• Proteins from major food allergens, produced in other sources through the use of genetic engineering, are subject to the food allergen labeling requirements.  An example of such a product would be protein that is derived from cow milk but produced via fermentation in a non-milk food source, such as a genetically engineered strain of yeast, which should be declared as “Contains milk-derived protein” or “[ingredient name] (milk-derived protein).”

“Contains” Statements / Ingredient Statements

• While a “Contains” statement is not required if the major food allergens are declared in the ingredient list, if a product also includes a “Contains” statement, then the food source of all major food allergens are to be declared in the “Contains” statement, even if they are also declared in the ingredient list.  “Contains” statements may only declare the presence of major food allergens and not any food allergens which individuals may only be sensitive to (e.g., gluten).

• If an ingredient is derived from several different species of an allergenic source, each source must be declared on the label. However, if a food product contains multiple ingredients that are, or contain, the same major food allergen, the name of the food source is required to be declared only once in the ingredient statement (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen).

• Products including incidental additives containing a major food allergen are required to declare the food source of the major food allergen.

Dietary Supplements

• Allergen labeling requirements apply to dietary supplement ingredients, which include any dietary ingredients, source ingredients, excipients, fillers, artificial colors, flavors, sweeteners, and binders.

• For dietary supplements, major food allergens may be declared within a Supplement Facts panel. If 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.

Allergen Labeling Exemptions

• Allergen labeling requirements apply only to human food, including packaged foods served or sold onboard airlines or other transportation carriers, and to dietary supplements, which are considered human food. Pet food, animal feed, over-the-counter drugs, cosmetics, and household cleaning products are all exempt from the food allergen labeling requirements.

• With respect to tree nuts, the roots, leaves, stems, bark, or other parts that are distinct from the tree nut portion of the plant are not major food allergens. For example, if a dietary supplement is derived from the leaves of the Ginkgo biloba L. plant, not the Ginkgo nut (or any other tree nut), the food allergen labeling requirements with respect to tree nuts would not apply to the dietary supplement labeling.

• Major food allergens that have been unintentionally incorporated into a food due to cross-contact are not subject to the allergen labeling requirements. While 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, FDA has established preventive controls as well as good manufacturing practices to protect food against food allergen cross-contact in the current cGMP guidelines. FDA does note that if such measures cannot eliminate cross-contact, manufacturers will often use advisory statements to alert allergic consumers to the potential for cross-contact.

• Ingredients derived from a major food allergen that do not contain proteins are not subject to the allergen labeling requirements. In order to be exempt from this labeling requirement, a company’s processing technology must reliably produce a protein-free ingredient that the company can ensure does not contain protein. The guidance further clarifies that food ingredients (including flavors, colors, highly refined oils) and incidental additives that do not contain a protein from a major food allergen are also not subject to the food allergen labeling requirement. However, if an oil that is derived from a major food allergen is not highly refined, then the source of the oil is required to be declared.