FDA Publishes New Guidelines on Allergens and Food Labeling

The U.S. Food and Drug Administration has released two new guidance documents covering food labeling for allergens and the FDA’s nine major allergens list. 

Included in the documents are revisions on what is now considered “tree nuts.” As of January 7th, the FDA no longer considers coconuts to be tree nuts for the purpose of allergens labeling. Other nuts removed from the list include beech nut, butternut, chestnut, chinquapin, ginkgo nut, hickory nut, pili nut, and shea nut. The tree nuts that remain on the FDA’s major food allergens list are limited to:

• Almond
• Black walnut
• Brazil nut
• California nut
• Cashew
• Hazelnut/Filbert
• Heartnut/Japanese walnut
• Macadamia nut/Bush nut
• Pecan
• Pine nut/Pinon nut
• Pistachio
• Walnut (English, Persian)

The document states that only these tree nuts must be cited on food labels under the food allergen labeling requirements of action 403(w) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). All other tree nuts “do not have a robust body of evidence to support inclusion as a major food allergen, they should not be included in the “contains" statement even if they are used as ingredients because the “contains” statement is reserved for major food allergens," the document reads.

Under the FDA’s current definition, the “Big 9” major food allergens include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

Another revision expands the definitions of “milk” and “eggs” in the context of food allergens. Under the revision, “milk” now includes milk from domesticated cows, goats, sheep, and other ruminants. Previously, the FDA had interpreted “milk” to only include cow milk. The new guidelines state that milk and milk ingredients from animals other than cows should include the type of animal source in a separate “contains” statement.

Similarly, the document also states that “eggs” should now refer to eggs from domesticated ducks, geese, quail, and other fowl, and not solely eggs from chickens. The label should include the type of bird on a separate “contains” statement if it is not a chicken.

One of the new documents states that any interested party can ask the FDA to evaluate the public health importance of a non-listed food allergen. Interested parties should identify the evidence that shows it meets the scientific factors that the FDA uses when evaluating the public health importance of non-listed food allergens, including the prevalence and severity of the food allergen, the FDA stated.   

“150 Deaths Annually”

In January 2023, the Centers for Disease Control reported that 5.8% of children and 6.2% of adults have a food allergy. 

According to Johns Hopkins Medicine, food allergens cause 30,000 cases of anaphylaxis, 2,000 hospitalizations, and 150 deaths every year.

Food allergens are the number one cause of food safety recalls and alerts. In 2023, out of 313 food recalls and alerts issued by the FDA and U.S. Department of Agriculture, 49.3% dealt with undeclared allergens on packaging.

In a recent Rootwurks webinar, How to Prevent Allergens and Safeguard Your Company, MenuTrinfo CEO and Founder Betsy Craig called food allergens an “epidemic” in the United States, where they affect 32 million people, according to a 2019 estimate.

“That 32 million doesn’t just affect them. It affects their families too. So about 85 million Americans pay attention to what’s on the label or what’s on the menu for themselves or someone they love.”

When contamination prevention fails

One of the four guidelines issued earlier this week covers the corrective actions needed when contamination prevention for food-contact services (FCS) fails. These include conducting adequate root cause investigations following a pathogen contamination and applying a sanitizing treatment when remediating a pathogen contamination event, among others.

The document's guidelines are intended for the manufacturers of low-moisture ready-to-eat foods, indulging powdered infant formula, drink mixes, and milk powders, to name a few. 

Also this week, the FDA published a draft guidance dealing with the labeling of plant-based foods that are alternatives to animal foods. The draft guidance covers best practices for naming these products “to help ensure that consumers understand the nature or source of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions.”

To learn more about how to master allergen control in food manufacturing, check out our online course "Allergen Management Training for Food Safety," available on our online store for only $34.99.