FDA on Top Allergen Labels: Coconut Off List, Milk Sources Expand

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in Food Allergy, Food Allergy News, Milk & Egg, Peanut & Tree Nut
Published: January 17, 2025
Photo: Getty Coconut (right) is now off the FDA’s list of tree nut allergens.

The U.S. Food and Drug Administration has expanded its definition of milk and eggs as major allergens in updated guidance for allergen labeling. The FDA also changes the list of tree nuts that are considered major allergens, notably removing coconut.

“These changes are designed to improve the quality of life for people living with food allergies,” says Eleanor Garrow-Holding, president and CEO of the food allergy nonprofit FAACT

The federal agency released its Guidance for Industry: Questions and Answers Regarding Food Allergens (Edition 5) in early January 2025.

The Federal Food Drug & Cosmetic Act requires packaged foods to clearly label the top 9 allergens and the Food and Drug Administration enforces the law. The regulation spells out that ingredients that are major food allergens must be listed in the ingredients or in an adjacent ‘contains’ statement.

The requirements include the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the FASTER Act of 2021. 

But those requirements have been subject to varying interpretations and levels of compliance, which can lead to misleading, confusing information for food-allergic consumers. The revised guidelines explain the FDA’s current thinking that follows feedback on its draft guidance on allergen labeling. That was issued in November 2022.

“When it comes to labeling, our food allergy community needs as much information and clarity as possible so they can make appropriate, safe food choices,” Garrow-Holding says.

Food safety consultant Dr. Steven Gendel views the update as a positive for consumers. “The changes and additions are clearly responses to areas of confusion. It is to be hoped that these will help promote clarity and uniformity.”

Milk & Egg: Not Just Cows, Chickens

The regulator’s final guidance to industry broadens the sources for the major food allergens “milk” and “eggs”. 

The FDA had interpreted milk from a domesticated cow as “milk” for required labels on packaged foods. But the new interpretation includes milk from domesticated cows, goats, sheep, and other ruminants.

The guidance says that the label should specify the milk source in the ingredient and contains statement. For example, the label should read, “goat milk” or “contains goat milk”, the FDA guidance states.

The sources of eggs has also expanded. Eggs from domesticated chickens had been the only eggs under the allergen label requirement. But the final guidance now places domesticated chickens, ducks, geese, quail and other fowl under the definition of “eggs” for allergen labeling. As with milk, the FDA says the species should be included in the ingredient list. For example, “quail egg”.

Updating the definitions of milk and eggs to include more species is a positive change, says Gendel, a former allergen coordinator and food safety risk assessor at the FDA. For example, the previous standard meant “goat milk” would be listed as such in the ingredient list. But “Milk” would not be included in the “Contains” statement for a product made with goat milk. So it was confusing for consumers, he explains.

Coconut Off the Tree Nut List

The FDA guidance revises its list of tree nuts that are classified as major food allergens. The tree nuts that must meet the allergen labeling requirements are now: 

  • Almond
  • Brazil nut
  • Cashew
  • Filbert/hazelnut
  • Macadamia/bush nut
  • Pecan
  • Pine nut
  • Pistachio
  • Walnut (black, California, Heartnut/Japanese, English, Persian)

The nuts not on the revised list should not be included on a label’s ‘Contains’ statement. The FDA guidance states that other tree nuts were excluded from the list because they, “do not have a robust body of evidence to support inclusion as a major food allergen.” 

One notable exclusion is coconut. Botanically, it is not actually a tree nut, but rather a fruit. However, the FDA had long classified it as among the tree nuts listed for allergen labeling requirements.

“For years, consumers have voiced their frustrations about coconut being included in tree nut labeling,” Garrow-Holding says. While a minority are diagnosed allergic to coconut, allergy experts say medical data do not show an increased risk for coconut allergy among those with tree nut allergies.

The inclusion meant an extra call asking specifically if the “tree nut” listed in the “may contain” statement was coconut, Garrow-Holding notes. (Those customers who have a coconut allergy will still need to ensure a product is free of coconut.) 

Also excluded from the list of tree nuts considered major food allergens: beech nut, butternut, cola/kola nut, chestnut, chinquapin, ginkgo nut, hickory nut, palm nut, pili nut, and shea nut.

However, within the ingredients list, coconut and those tree nuts that are not considered major allergens still must be listed by their common name. (This is in keeping with the Code of Federal Regulations Section 101.4 on food labeling.)

FDA Allergen Labeling: Shellfish Reminder

The labeling guidance also clarifies which types of shellfish the FDA considers to be major food allergens. 

Mollusks, which are a type of shellfish including oysters, clams, mussels and scallops, do not fall under the shellfish definition for labeling. Shellfish that are considered major allergens are crustaceans, such as crab, lobster and shrimp, the document states. 

This distinction is not new, as the allergen was specifically listed as “Crustacean shellfish” in the 2004 FALCPA legislation. However, Gendel says the exclusion of mollusks does create confusion, especially since molluscan shellfish are among the regulated allergens in other parts parts of the world

Cleaning Up Free-From Claims

The FDA addresses the use of voluntary “free-from” claims on products indicating that they do not include certain major allergens. 

The guidance says the allergen-free declaration on a package should only be used if the product truly does not include any of the named food allergen. That includes unintended residue from cross-contact. 

The FDA also notes that a product claiming to be “free-from” should not have an advisory statement about the same allergen. “For example, a product that has a ‘may contain milk’ statement should not also bear a ‘milk-free claim,’” the guidance states. 

While that may sound obvious, Gendel notes that the use of free-from statements has been continuing source of confusion. The questions addressing “free-from” and advisory statements “seem intended to provide much-needed clarity.”

Garrow-Holding agrees, “This will minimize misleading and confusing product labeling.”

The January 2025 guidance includes updated clarifications and visuals about several aspects of allergen labeling. Some other topics it addresses include, specifics about highly refined oils, labels for bulk containers, and labeling requirements for supplements. 

Garrow-Holding is glad to see years of discussions among manufacturers, the FDA, USDA, food industry and food allergy nonprofits (including FAACT) come to fruition.

“These changes were created to support our community, which is exciting,” she says.

Visit the Federal Register for more information about the guidance, along with information and links to provide comments.

Related Reading:
Milk Allergy: 3 Families on Life with One of the Toughest Allergens
Are Coconuts Safe With Tree Nut Allergy?
Experts Seek Global Allergy Labeling, Revised Top Allergens List
Egg Allergy Life: Learning to Skate Around a Sneaky Allergen