FDA Finalizes Two Guidance Documents Related to Food Allergens

On January 6, 2025, FDA published two final food allergen-related guidance documents, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) and Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. These final versions reflect the agency’s consideration of stakeholder comments on draft versions of the guidance documents released in 2022. 

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act

This final fifth edition revises questions and answers to include, among other things, questions and answers related to allergen labeling for bulk foods, foods produced through genetic engineering, allergen-free ingredients, and dietary supplements. 

There were many changes between the draft and the final versions of this guidance, and therefore it is worth reviewing in full. Below are some highlights:

• FDA confirms that an ingredient derived from a major food allergen that does not contain protein from that allergen 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. FDA notes, as it did in the draft guidance, that lactose and ghee often contain residual protein from milk, and therefore must be labeled.
• While in the draft guidance, FDA stated the roots, leaves, stems, bark, or other parts that are distinct from the tree nut or other allergenic portion of a plant are not major food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, FDA states in the final guidance that a more nuanced assessment is required. If the ingredient is obtained or processed in a way that it contains residual protein from the major food allergen, then the ingredient is subject to the food allergen labeling requirements.
• FDA no longer considers coconut and cola/kola nut to be “tree nuts” for purposes of allergen labeling. The agency also now excludes the following from the list of ingredients it considers “tree nuts” for purposes of allergen labeling: beechnut, butternut, chestnut, chinquapin, ginkgo nut, hickory nut, palm nut, pili nut, and sheanut/shea nut. FDA further clarifies that only the tree nuts listed in this final guidance are considered major food allergens and that other tree nuts not listed in the table should not be included in the “Contains” statement, because they do not have a robust body of evidence to support designation as a major food allergen.
• FDA confirms that the Federal Food, Drug, and Cosmetic Act (FDCA) food allergen labeling requirements do not apply to packaged food products regulated by the USDA or alcohol products regulated by the Alcohol and Tobacco Tax and Trade Bureau, though they do apply to all packaged foods served or sold on airlines or other transportation carriers. The allergen labeling requirements apply only to foods intended to human consumption, and do not extend to pet food or animal feed, OTC drugs, cosmetics, or household cleaning products.
• FDA maintains that 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. The allergen declaration must be prominently placed on the actual container, and FDA provides an example image in the final guidance. Tanker vehicles (e.g., tanker trucks or tanker trains), however, are not considered “packages” that must be labeled.
• While FDA had historically interpreted “milk” as milk from domesticated cow, FDA now considers milk from domesticated goats, sheep, or other ruminants to be considered “milk” for purposes of allergen labeling. Milk and milk ingredients from animals other than cows should include the name of the animal source, such as “goat milk” and “whey (goat milk)” in the ingredient list or “Contains goat milk” in a separate “Contains” statement, or both.
• Similarly, while FDA historically interpreted “eggs” to mean eggs from the domesticated chicken, it now considers eggs from domesticated ducks, geese, quail, and other fowl to be “eggs” for purposes of allergen labeling. Egg and egg ingredients from birds other than chickens should include the name of the bird source, such as “duck egg” and “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate “Contains” statement, or both.
• For single-ingredient foods that are or contain protein derived from a major food allergen, the package is not required to include an ingredient list, so FDA recommends that the statement of identity identify the major food allergen source, or that a “Contains” statement be placed immediately above the manufacturer, packer, or distributor statement. For single-ingredients intended for further manufacturing where a “Contains” statement is used, FDA recommends that the “Contains” statement be on the front of the package near the statement of identity.
• FDA reiterates that unit containers in a multiunit or multicomponent retail food package must comply with food allergen labeling requirements, even though they are exempt from certain labeling requirements. A “Contains” statement should be used, near the statement of identity, if the unit container doesn’t bear an ingredient list. No labeling is required if the individual unit is an unlabeled inner sleeve intended solely to protect the product and doesn’t bear any written, printed, or graphic matter, such as sleeves of crackers.
• The final guidance confirms that all major food allergens in the product must be declared in the “Contains” statement and not just the major food allergens that are not already identified in the ingredient list.
• Regarding allergens that may be present unintentionally due to cross-contact during production, FDA states explicitly that the food allergen labeling requirements of the FDCA do not apply, and that “allergens present due to cross-contact are not to be declared in the ingredients list or the ‘Contains’ statement.”
• FDA addresses “allergen-free” claims in the final guidance, noting that there are no regulations defining such claims. FDA does expect an allergen-free claim to mean that there is none of the named major food allergen in the product, including unintended allergen presence due to cross-contact. Furthermore, a product with an allergen-free claim should not have an advisory statement saying, e.g., that the product “may contain” that same allergen.
• FDA also states that a product that declares an intentionally added major food allergen in the ingredient list or “Contains” statement should not also include that allergen in an advisory statement such as “may contain.”
• FDA adds a Q&A about thresholds. It states that the FDCA does not require FDA to establish a threshold level for any food allergen, and while the agency has examined thresholds, it has not established specific thresholds for any food allergens.
• Finally, FDA addresses allergen labeling for dietary supplements, including to provide visual examples of several ways to declare major food allergens in these products, including in the Supplement Facts label.

Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act

This final guidance outlines FDA’s approach to evaluating the public health importance of food allergens that are not among the nine major food allergens (non-listed allergens). FDA intends the guidance to assist the agency in evaluating whether to establish regulatory guidance or rules (e.g., labeling or other disclosure requirements), as the agency did with sesame labeling under certain circumstances prior to sesame becoming the ninth major food allergen.

While FDA continues to state in the final guidance that the focus of this guidance on evaluating the public health importance of food allergens is IgE-mediated food allergy, it now also notes that it is open to considering on a case-by-case basis food allergens acting through other mechanisms that may raise public health concerns. However, the rest of the final guidance remains largely the same compared to the draft, including the consideration of IgE-mediation as strong evidence that an allergen is of public health concern. FDA will use four scientific factors (evidence of IgE-mediated food allergy, the prevalence of an IgE-mediated food allergy in the U.S. population, the severity of IgE-mediated food allergic reactions, and the allergenic potency) to evaluate the public health importance of a non-listed food allergen. It is worth flagging that in addition to the eliciting doses for the major food allergens for 1% and 50% of the specific allergic population from the draft guidance, the final guidance also includes eliciting doses for 5% and 10% of the specific allergic population.

Overall, FDA will continue evaluate each allergen on a case-by-case basis based on “a robust identified body of evidence.” The agency will score the identified body of evidence based on a GRADE system to determine the strength of the evidence for each scientific factor.

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.