FDA issues final and draft guidance on allergen labeling requirements

Background

FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 FASTER Act, among other things, adds sesame to the list of major food allergens effective January 1, 2023, which will make it the ninth major food allergen recognized in the U.S.

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. With this latest edition (Edition 5), FDA has issued two guidance documents: a draft guidance¹, that contains new and updated Q&As and (2) a final guidance², which preserves the Q&As from the previous edition (Edition 4) that were not changed. As explained in more detail below, new and updated topics discussed in the draft guidance include the labeling of sesame, milk, and eggs; the labeling of major food allergens for dietary supplement products; and precautionary allergen labeling, among others.

Summary of the Draft Guidance

Unlike previous editions of the guidance, questions and answers now appear in five distinct sections, labeled A-E: A) General Information, B) Foods that Fall Under the Food Allergen Labeling Requirements of the FD&C Act, C) Food Sources, D) Food Allergen Labeling Requirements, and E) Dietary Supplements. A summary of the key Q&As follow below.

• Sesame: Throughout the draft guidance, FDA amended references to the “major food allergens” to include sesame in response to the passage of the FASTER act.

• Bulk Containers and Multicomponent Foods: Although bulk containers may be exempt from other mandatory food labeling requirements, FDA makes clear in draft questions B.2 and B.3 that these exemptions do not apply to major food allergens. FDA states that bulk labeling is especially important for food manufacturers in particular as they “need to know if any major allergens are present in the food ingredients they use to manufacturer other products.” FDA also states the labeling exemption in 101.100(d)(2) does not apply to allergen information that “must be prominently placed on the container with such conspicuous so as to render it likely to be read.” Additionally, FDA clarifies that multiunit or multicomponent retail food packaging would not be exempt from allergen labeling requirements. However, an inner sleeve used for the protection of a product that does not contain any written, printed, or graphic matter, does not need to include allergen labeling. (D.3).

• Spices Mixes and Seasoning Mixes: With the addition of sesame to the list of major food allergens, FDA has added several new questions concerning spice mixes and blends. (B.4a-b, B.5). In B.4, FDA poses questions concerning spices in two parts: “How do I declare spice mixes in the ingredient list of the finished product and how do I declare an incidental additive that might contain an allergen that is present in a spice mix?” and “How do I declare seasoning mixes in the ingredient list of the finished product?.” FDA explains that if a major food allergen is included as an incidental additive, it still must be declared. Additionally, for a finished product, the major food allergen would need to be declared either parenthetically after the term spice or in a separate “contains” statement.” If sesame is used in a spice blend, its name should be declared in a “Contains” statement or in a parenthetical after the collective term “spice” or “spices” in the ingredient list. (B.5).

• Fish – FDA provides additional guidance concerning which fish it considers allergenic in B.8. Fish are broken into three categories 1) jawless fish, 2) bony fish, and 3) cartilaginous fish. (B.8).

• Pet Food, Drugs, Cosmetics, Household Cleaning Products – FDA confirms that pet foods and animal feeds, prescription or over-the-counter drugs, cosmetics, or household cleaning products are not subject to food allergen labeling requirements as the requirements were only intended for human foods. (B.11; B.12).

• Foods Packaged for Airlines and Other Transportation Carriers – FDA states that foods served on transportation carriers are subject to allergen labeling requirements as well as all other labeling requirements. (B.13).

• Genetic Engineering – Food ingredients that include proteins derived from a major food allergens (e.g., through chemical, biochemical, mechanical, fermentation, or bioengineering processes) require allergen labeling under the FD&C Act. (B. 14). FDA provides as an example a cow milk protein produced via fermentation in a non-milk food source, such as a genetically engineered strain of yeast. The protein by fermentation may be identical, or sufficiently similar, to the protein in milk such that it could be capable of causing allergic reactions. The food ingredients should be declared in a way that makes the relationship to the source allergen clear (e.g., “Contains milk-derived protein” or “[ingredient name] (milk-derived protein)”).

• Food Source Identification – In this section, FDA gives additional information on the term that must be used to declare major food allergens on the label. The draft guidance would limit “milk” to the lacteal secretion of cows, “eggs” to eggs from domesticated chickens, and would contain a list of tree nuts that provides both the common and usual name and botanical name. In the Federal Register announcing the draft guidance, FDA is specifically seeking comment on how “milk” and “eggs” should be declared, as explained below.

• • Milk: The regulatory definition of “milk” is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” For the purposes of allergen labeling, FDA has historically interpreted “milk” as “milk from the domesticated cow.” (C.1). However, FDA is aware that other forms of milk, such as sheep and buffalo milk, are becoming more prominent in the marketplace. FDA is seeking public comment on revising the interpretation, what the new interpretation should be, and the potential impact of a new interpretation.

• • Eggs: Like the term milk, FDA is seeking public comment concerning its current interpretation of the term eggs. Currently, FDA interprets eggs to mean “eggs from the domesticated chicken.” (C.2). FDA is seeking public comment because of the wide variety of eggs, such as turkey, duck, goose, and guinea eggs, which can be purchased and used as and in human food.

• • Tree Nuts: FDA has updated its list of examples of nuts that are considered “tree nuts” for the purposes of allergen labeling. (C.5, Table 1). Recognizing that hundreds of types of tree nuts exist, FDA notes that the list is not exhaustive. The changes from the list provided in Edition 4 include specifically identifying the different varieties of Walnuts and their scientific names (Black, walnut, Heartnut/Japanese), adding two new types of tree nuts (Cola nut/Kola nut and palm nut) and removing one type of tree nut (Lichee nut).  Elsewhere in the draft guidance, FDA clarified that foods and dietary supplements derived from roots, leaves, stems, or bark of the same plant that bears tree nuts are not subject to allergen labeling requirements because these parts of the plant are not major food allergens.

• Food Source Labeling: FDA has added several new questions regarding where and how a food source of an allergen must be declared.

• • First, FDA clarified that if a food source is declared in the ingredient list and a “Contains” statement is also used, then the food source of all of the major food allergens present in the food are to be declared in the “Contains” statement, even if they are declared in the ingredient list. (D.1).

• • Second, if an ingredient is derived from several different species of an allergenic source, each source must be declared on the label. (D.4).

• • Finally, if the food 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. (D.5). For example, if the ingredient list identifies sodium caseinate and nonfat dry milk (which are both derived from milk), the declaration of “milk” as part of the name “nonfat dry milk” would be sufficient.

• Major Food Allergen-Derived Ingredient – FDA added a new Q&A regarding allergen-derived ingredients such as lactose and ghee. (D.8). FDA explained, “If a major food allergen-derived ingredient is processed using technology that reliably produces an ingredient that does not contain allergen proteins, and you can ensure that the ingredient does not contain protein, then you would not have to declare the major food allergen on the label.” FDA uses ghee and lactose as an example of residual protein products which would require allergen labeling. FDA further emphasizes in the next Q&A that food ingredients and incidental additives that do not contain a protein from a major food allergen (e.g., highly refined soybean oil) are not subject to the food allergen labeling requirements. (D.9). Additionally, 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. (D.11).

• Incidental Additives – Although you do not have to list incidental additives in the ingredient list, if an incidental additive contains a major food allergen, then you would have to declare the food source of the major food allergen. (D.10).

• Non-major food allergens – FDA clarifies that the “Contains” statement is limited for major allergens and may not be used to alert consumers to the presence of food allergens other than the major food allergens and food substances that are not food allergens to which individuals may be sensitive (D.12). However, such information may be included in a separate statement on the label such as, “Other Allergen Information: mustard.”

• Precautionary Labeling – FDA also provided more color on the role of precautionary labeling. In prior editions of the guidance (and current D.14 of the final guidance), FDA stated that advisory labeling, such as “may contain [allergen],” is not a substitute for adherence to good manufacturing practices and, when used by a facility, food allergen preventive controls. FDA has added two new Q&As in the draft guidance that touch on precautionary labeling.

• • First, FDA notes that a major food allergen that has been unintentionally incorporated in a food as the result of cross-contact is not subject to the food allergen labeling requirements. FDA explained further that allergen-cross contact is recognized as a potential hazard for consumers, but when food allergen preventive controls and good manufacturing practices to protect food against food allergen cross-contact “are not able to completely eliminate allergen cross-contact, some manufacturers have chosen to include allergen advisory statements to warn consumers about potential allergen cross-contact.” (D.13)

• • Second, D.15 poses the question “I repackage bulk ingredients for retail sale. Sometimes I package spices and peanuts on the same equipment. Can I label my product ‘may contain peanuts.’” FDA’s response emphasizes the need for the facility to follow current good manufacturing practices to prevent allergen cross-contact and, if applicable, conduct a hazard analysis and implement a food safety plan that may include allergen controls for proper labeling and the prevention of allergen cross-contact. FDA stated: “While advisory labeling that is truthful and not misleading may be acceptable in certain circumstances, please note that advisory labels cannot be used in lieu of good manufacturing practices in lieu of good manufacturing practices and preventive controls.”

• Dietary Supplements – FDA also added seven new questions specific to Dietary Supplements, a topic that has not been addressed in previous editions of the guidance. (E.1 – E.7). The Q&As confirm that dietary supplement ingredients are subject to the food allergen labeling requirements and address issues including how and where the allergens should be declared on the dietary supplement label.

Next Steps

Comments on the draft guidance are due January 30, 2022. Please contact us if you have any questions.

Authored by Martin Hahn, Elizabeth Fawell, Anneke Altieri, and Molly Mulligan.

References

1 FDA, “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry (Draft Guidance),” published November 2022, available at https://www.fda.gov/media/163454/download.

2 See FDA, “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),” published November 2022, available at https://www.fda.gov/media/117410/download.