FDA Finalizes Two Food Allergen-Related Guidance Documents

Background

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the Federal Food Drug and Cosmetic Act (FFDCA) by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source.  FALCPA identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.  The Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), among over things, added sesame to the list as the ninth major food allergen recognized in the U.S.  

With this background, we will turn to each of the final guidance documents.

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

Following the passage of FALCPA, FDA issued a guidance document in question & answer (Q&A) format to clarify allergen labeling requirements for industry, which has been periodically updated.  In November 2022, FDA published a draft version of Edition 5 of the food labeling Q&A, providing new and revised questions and answers related to the labeling of food allergens.² With the publication of the Final Allergen Labeling Q&A, FDA has made several changes.  We summarize a selection of notable changes and takeaways below: 

• Tree Nuts: FDA has updated its list of nuts that are considered “tree nuts” for the purposes of allergen labeling, removing coconut, kola/cola nut, beechnut, butternut, chestnut, chinquapin, ginko nut, hickory nut, palm nut, pili nut, sheanut/shea nut from the list of tree nuts.  Because the agency no longer considers these “nuts” as “tree nuts,” they will not be subject to the requirements that exists for “major food allergens.”  In a departure from the draft guidance, the list of tree nuts in Table 1 is limited to those “for which a robust body of scientific evidence supports their inclusion in the list of tree nuts that FDA considers to be major food allergens.” (C.7.)   The following tree nuts are found in Table 1:
  • almond,
  • black walnut,
  • Brazil nut,
  • California walnut,
  • cashew,
  • filbert/hazelnut,
  • heartnut/Japanese walnut,
  • macadamia nut/bush nut,
  • pecan,
  • pine nut/pinon nut
  • pistachio, and
  • walnut (English, Persian).

Only the tree nuts listed in Table 1 are subject to the requirements for “major food allergens” regarding labeling regardless of whether used as a color, flavor, or processing aid and must be labeled in the ingredient statement or the allergen information statement.  FDA confirms that other tree nuts that are not listed in Table 1 (such as coconut and kola nut) should not be included in the “Contains” statement, even if they are used as ingredients, because they are not major food allergens.  (C.8).  These tree nuts used as ingredients but not in Table 1 would still be required to be listed by common or usual name in the ingredient list unless an exception applies. 

• “Contains” Statement: In a separate Q&A, FDA reaffirmed that the “Contains” statement cannot be used to alert consumers to the presence of food allergens other than the major food allergens or other foods to which individuals may be sensitive (D.10), but notes that “FDA does not object to voluntary statements about other allergen information that are separate from the “Contains” statement as long as they are truthful and not misleading.”  FDA does not address its earlier position that it previously identified coconut, kola nut, and other nuts in the list of tree nuts and that many companies have included these nuts in the allergen information statement.  Companies should consult with their legal counsel on the appropriate timeframe for removing from allergen information statements coconut and other nuts that are no longer viewed by FDA as tree nuts.  
• Major Food Allergen-Derived Ingredient: Relatedly, FDA has changed its position on whether ingredients derived from other parts of a plant that bears tree nuts (e.g., roots, leaves, stems) or other sources of major food allergens, from “no” to “it depends” on whether the ingredient contains proteins from the major food allergen.  (B.6).   FDA explains that if the ingredient is obtained or processed in such a way that it contains residual protein from the major food allergen, then the ingredient would be subject to the food allergen labeling requirements.  Elsewhere in the guidance, FDA further explains that if your major food allergen-derived ingredient is processed using technology that reliably produces a protein-free ingredient, and you can demonstrate that the ingredient does not contain protein, then you do not need to declare the major food allergen on the label.  (B.7).  As in the draft guidance, FDA also notes that because residual protein from milk is often present in ghee and lactose, allergen labeling is typically required for those ingredients.  FDA also repeatedly highlights that manufacturers can petition FDA to exempt certain ingredients from allergen labeling requirements through FDA’s Food Allergen Labeling Exemption Petitions and Notification Processes. 
• “Milk” and “Egg” Definition: FDA historically interpreted “milk” as milk from a domesticated cow and “eggs” to mean eggs from the domesticated chicken.  FDA now considers milk from domesticated goats, sheep, or other ruminants also to be “milk,” and eggs from domesticated ducks, geese, quail and other fowl to be “eggs” for the purposes of allergen labeling.  (C.1-C.4).  Milk and milk ingredients from animals other than cows and egg and egg ingredients from birds other than chickens should include the name of the specific animal source (e.g., “goat milk” or “duck egg”) in the ingredient list or in a separate “Contains” statement, or both.  
• Ingredients Derived through Technology: FDA reaffirms its position first announced in the 2022 Draft Q&A regarding ingredients derived through genetic engineering – expanded to also include ingredients derived from “other technologies” – that result in the production of the allergenic protein from a novel source (e.g., a whey protein that can be derived via fermentation).  (B.16).  FDA states these proteins are subject to the definition of “major food allergen,” explaining, “We consider these proteins to be ‘derived from’ major food allergens because they are produced in a manner that uses the major food allergen’s DNA sequence.”  FDA recognizes “additional information may be helpful in some cases to make the relationship to the source ingredient clear, such as ‘Contains milk-derived protein.’”
• Ingredient Declaration: FDA reiterated that foods made from two or more ingredients must declare the common or usual name of each ingredient, except those ingredients exempted by 21 CFR 101.100, like incidental additives.  However, although incidental additives are exempt from being declared in the ingredient list, they are not exempt from the food allergen labeling requirements.  (D.8).  Likewise, although spices may be declared simply as “spices” on the finished product label, if a major food allergen is present in a spice mix ingredient and the major food allergen is an incidental additive in the finished food, it must be declared on the label of the finished food either in the ingredient statement or the “Contains” statement.  (B.4).  For example, when wheat is used as a carrier for spice it could be declared in the ingredient statement as “spice (wheat)” or in the “Contains” statement.
• Allergen Cross-Contact and Allergen Advisory Statements: FDA added several statements to the Final Allergen Labeling Q&A regarding allergen-cross contact, emphasizing that major food allergens that have been unintentionally incorporated in a food as the result of cross-contact cannot be declared in the ingredient list or the “Contains” statement.  (D.8; D.11).  In previous versions of the Q&A, FDA referred to agricultural comingling as an example of allergen cross-contact.  However, FDA has eliminated agricultural comingling as an example of cross-contact and replaced it with an explanation focused on production practices: “Allergens may be unintentionally present in a food as a result of practices such as improper rework addition, product carry-over due to use of common equipment and production sequencing, or the presence of an allergenic product above exposed product lines.  This is often referred to as unintended allergen presence.”  (D.11).  FDA also added a footnote explaining the term “unintended allergen presence” was adopted to describe the presence of a food allergen due to cross-contact.  FDA reiterated that an allergen advisory statement, such as “may contain [allergen],” is not a substitute for adherence to current good manufacturing practices or food allergen preventive controls.  (D.12; D.15).
• Thresholds: FDA added additional detail to its Q&A regarding “thresholds,” stating that the food allergen labeling requirements do not require FDA to establish a threshold level for any food allergen, adding that FDA has examined the topic of thresholds but has not established specific thresholds for any food allergens.  (A.4).  
• Allergen-Free Claims: FDA added a new Q&A on “allergen-free” claims (D.13), stating that there are no regulations defining specific “allergen-free” claims, but if such a claim is used, it must be truthful and not misleading.  According to the Q&A, this means FDA would expect there to be no allergen in the product, including unintended allergen presence due to cross-contact, and that the product does not also have an advisory statement including the same allergen.   
• Bulk Containers: FDA confirmed that although bulk containers may be exempt from other mandatory food labeling requirements, the exemptions do not apply to major food allergens.  (B.3; B.4).  Bulk containers, including those used for foods that will be used by an establishment to manufacture other foods, must bear allergen information statements even if they do not contain the other required label statements such as an ingredient statement or manufacturing statement.  FDA provided a visual example of how allergen information must be “prominently placed” on the container.   FDA adds that the agency does not consider tanker vehicles to be “packages” that must be labeled. 
• Dietary Supplements: FDA confirmed that dietary supplement ingredients are subject to the food allergen labeling requirements and addresses issues including how and where the allergens should be declared on the dietary supplement label by adding visual examples.  (E.1 – E.7). 
• Clarity on Legal Authority to Amend the Definition of Major Food Allergen: FDA states the agency “cannot alter the statutory list of the nine major food allergens, but the law allows FDA to require labeling for food allergens other than those designated as ‘major food allergens,’ when appropriate.”  (A.3).  Section 403(x) of the FD&C Act provides FDA with this authority.  (A.3).  While FDA does not provide an example in the Q&A, the agency relied on this authority when issuing the regulation that requires carmine/cochineal extract to be labeled as such when it is added to foods rather than the generic labeling and using terms such as “artificial color” or “color added” that is available for other colors that are not subject to certification.³ The Q&A makes clear that only Congress can amend the definition of “major food allergen” and that if the agency wants to pursue additional labeling requirements for other allergens, it must issue a regulation under 403(x).  A separate guidance document, discussed below, establishes the criteria FDA will consider when determining if additional labeling is advisable for other food allergens. 

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

Like the Final Food Allergen Labeling Q&A, the Final Non-Listed Food Allergen Guidance revises and finalizes the draft version of the guidance that also was published for public comment in 2022.⁴ The purpose of this guidance is to provide the framework for the FDA evaluation of whether a food allergen is of public health importance that would warrant additional oversight such as labeling.  Since FALCPA was enacted in 2004, FDA has received several requests to evaluate a non-listed food as a “food allergen of public health importance” and establish regulatory requirements.  In the final guidance, FDA outlines the approach it will take, either in response to a citizen petition or on FDA’s own initiative, in assessing whether the underlying data support classifying the allergen as one of public health importance.  

The final guidance remains largely unchanged from the draft, substantively.  FDA will evaluate each allergen based on “a robust identified body of evidence.”  Using a GRADE system (“Grading of Recommendations Assessment, Development, and Evaluation”), FDA will consider whether there is evidence of an Immunoglobin E (IgE)-mediated allergic reaction, prevalence, severity, and potency when evaluating the public health importance of a food allergen.  Some notable changes from the draft guidance include the following: 

• Allergens other than IgE-mediated food allergens: Like the draft guidance, the Final Non-Listed Food Allergen is primarily focused on IgE-mediated food allergens.  However, FDA provides some flexibility in the final guidance, recognizing that food allergens acting through other mechanisms may raise public health concerns, and thus will be evaluated on a “case-by-case basis.” 
• Additional Eliciting Dose Responses: Although the draft guidance identified only the eliciting doses for 1% and 50% of the specific allergic population (ED01 and ED50), the final Non-Listed Food Allergen Guidance also includes eliciting doses for 5% and 10% of the specific allergen population (ED05 and ED10).
• Revised Definitions: FDA made some editorial changes to the definitions found in Table 1, including adding definitions for IgE-mediated food allergy (“Food allergy that is mediated by an immune response involving IgE antibody”) and “non-listed food allergen” (“A food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nus, wheat, peanuts, soybeans, and sesame) listed in the FD&C Act.”).

Notably, however, like the draft guidance, the Final Non-Listed Allergen Guidance is merely establishing the framework and process that the agency plans to follow for future evaluations of non-listed food allergens; it does not identify the scientific or legal standards that would be applied (e.g., the actual prevalence in the population of the allergen or severity of the reactions) or the type of regulatory framework that would be appropriate when the agency concludes the allergen is of public health importance.

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Please contact us if you have any questions.  We will continue to monitor developments related to food allergens. 

Authored by Martin Hahn, Anneke Altieri.