To Be or Coco-Not To Be: That’s One Question Answered in FDA’s Final Guidance Documents on Food Allergens

On January 6, 2025, FDA released two final guidance documents on food allergens: 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.

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

This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post.  Among other changes, the final fifth edition revises and updates questions and answers related to allergen labeling.  The most significant changes from the draft guidance are described below:

• Tree Nuts: FDA clarified that only 12 tree nuts are considered tree nuts for purposes of allergen labeling due to the “robust body of scientific evidence support[ing] their inclusion in the list.” These are listed in Table 1 of the final guidance:

1. 1. Almond
   2. Black walnut
   3. Brazil nut
   4. California walnut
   5. Cashew
   6. Filbert/Hazelnut
   7. Heartnut/Japanese walnut
   8. Macadamia nut/Bush nut
   9. Pecan
   10. Pine nut/Pinon nut
   11. Pistachio
   12. Walnut (English, Persian)

Missing from this list are several tree nuts that FDA had included in the “non-exhaustive” list in that draft guidance.  Notably, coconut is now omitted, meaning it is coco-not considered a tree nut for allergen labeling purposes. This is a significant turnaround from FDA’s historical position, prompting at least one FDA Law Blogger to wonder, “FDA, do think you just fell out a coconut tree? You exist in the context of all that came before you.”  The context here is that, for more than a decade, FDA has held that coconut is an allergen for labeling purposes.  In its previous final guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4), FDA specifically listed coconuts on its list of tree nuts that are major food allergens.  Failure to list coconut as an allergen has also been mentioned in several warning letters (see, e.g., here) and as the reason for several product recalls, including a recent Class I recall in April 2024 (see also, e.g., Class II recalls in 2018 and 2022 for listing coconut as an ingredient but failing to disclose coconut in the allergen statement).

In addition, FDA walked back its previous position on certain parts of a plant that bears tree nuts.  In its draft guidance document, FDA stated that roots, leaves, stems, bark, or other parts of the same plant that bears tree nuts, but which are distinct from the tree nut portion of plant, are not considered major food allergens.  The final guidance adds more nuance, confirming that an ingredient derived from other parts of the same plant that bears tree nuts (or other sources of major food allergens for that matter) are subject to food allergen labeling requirements only if the ingredient is or contains proteins from a major food allergen.

• Milk and Eggs: FDA has broadened its interpretation of both “milk” and “eggs,” which it historically interpreted as from a domesticated cow and from a domesticated chicken, respectively. For purposes of food allergen labeling, FDA now considers “milk” to include milk from domesticated cows, goats, sheep, or other ruminant animals.  Similarly, FDA now considers “eggs” to include eggs from domesticated chickens, ducks, geese, qual, and other fowl.
• Allergen-Free Claims: FDA addressed “allergen-free” claims, confirming that firms may make voluntary statements on product labeling that certain allergens are absent from the product. Although there are no regulations on the specific conditions to make such a claim, the claim must be truthful and not misleading.  Importantly, although the final guidance makes clear that food allergen labeling requirements do not apply to allergens that may be present unintentionally due to cross-contact (e.g., from the use of shared equipment during the production process), FDA expects that a product with an allergen-free claim contains none of the major food allergen, including unintended allergens due to cross-contact.

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

Under Section 201(qq) of the Federal Food, Drug, and Cosmetic Act, “major food allergens” include milk, eggs, peanuts, wheat, soybeans, fish, shellfish, tree nuts, and effective Jan. 1, 2023, sesame.  This final guidance describes FDA’s approach to evaluating food allergens not included in this nine-item list (i.e., non-listed allergens) to inform decisions on potential regulatory requirements for such allergens.

The final guidance largely matches FDA’s draft guidance from 2022, which focuses on immunoglobulin E antibody (IgE)-mediated food allergies.  In the final guidance, however, FDA stated that it also intends to evaluate food allergens acting through other mechanisms that may raise public health concerns.  Consistent with the draft guidance, FDA will continue to evaluate the public health importance of food allergens on a case-by-case basis, taking into account the four following scientific factors:

1. Evidence of IgE-mediated food allergy;
2. Prevalence of an IgE-mediated food allergy in the U.S. population;
3. Severity of IgE0mediated food allergic reactions; and
4. Allergenic potency.

In addition, FDA explained that it generally intends to evaluate additional data and information, including, for example, the prevalence and amounts of the food allergen in food that is not disclosed on the labeling, food product characteristics and production practices, and patient-centered studies or other patient-centered information, when applicable.

Any interested party may submit a citizen petition requesting that FDA evaluate the public health importance of a non-listed food allergen, establish regulatory requirements based on the public health importance of such an allergen, and/or disclose how it generally intends to evaluate the public health importance of such an allergen.