Navigating the New FDA Food Allergen Labeling Guidelines: Key Changes and Their Impact

The U.S. Food and Drug Administration (FDA) has recently taken steps to address consumer concerns by updating its allergen labeling guidelines. Released in January 2025, the revised guidance provides significant updates, including the removal of coconut from the list of major allergens and expanded definitions for milk and egg sources. Additionally, the guidelines clarify the shellfish classification and set standards for “free-from” claims.

Key Developments in Allergen Labeling

1. Coconut Removed from Major Allergen List

One of the most significant changes is the FDA’s decision to exclude coconut from the list of major tree nut allergens. Coconut, while botanically a fruit, was previously categorized as a tree nut, a classification that often confused consumers and caused additional concerns.

• Consumer Impact: The change is set to alleviate concerns for individuals with tree nut allergies, as they often question the safety of consuming coconut products. Though some people with tree nut allergies may still have coconut allergies, the change is intended to help differentiate these categories of allergens.
• The Current List of Tree nuts now includes: Almond, Brazil Nut, Cashew, Filbert/Hazelnut, Macadamia Nut / Bush nut, Pecan, Pine Nut / Pinon Nut, Pistachio, Walnut (including Black Walnut, California Walnut, English Walnut, Japanese Walnut/Heartnut, and Persian Walnut)

2. Expanded Definitions for Milk and Egg Sources

The updated guidelines significantly broaden the sources of milk and eggs that must be declared in food labeling:

• Milk: Labels must now specify the type of milk used in products, which can include cow’s, goat’s, sheep’s milk, and others. Manufacturers are now required to specify the animal source in both the ingredient list and the ‘Contains’ statement. For instance, a product containing goat milk should be labeled as “goat milk” in the ingredients and “Contains goat milk” in the allergen statement.
• Eggs: Similarly, the definition of eggs has expanded from simply considering chicken eggs to encompassing those from ducks, quail, and other fowl. Labels should reflect this by indicating the specific source, like “duck eggs.”

This detailed labeling ensures consumers can make more informed choices, helping those with specific allergies better understand the ingredients in the products they are consuming.

3. Clarifying Shellfish Labeling Sources

Another important update pertains to the classification of shellfish allergens. The guidance clarifies that mollusks, such as oysters and clams, are not categorized under the major shellfish allergens. Instead, the FDA’s major allergens for shellfish are now specified as crustaceans, including shrimp, crab, and lobster.

• Why It Matters: This distinction is crucial for consumers with shellfish allergies. In many parts of the world, molluscan shellfish are treated as regulated allergens, and this warning may not exist in the U.S. Despite molluscan shellfish not being designated as major food allergens under the Food, Drug & Cosmetic Act, the FDA emphasizes the importance of transparent labeling practices. Manufacturers are encouraged to clearly declare the presence of molluscan shellfish in their products to inform and protect consumers who may have sensitivities or allergies to these foods.

4. The Importance of “Free-From” Claims

The FDA also tackled the sometimes-confusing use of “free-from” claims on food products in its revised guidance. This segment of the update emphasizes that:

• Products making allergen-free claims must genuinely lack the specified allergen, including unintended residues stemming from cross-contact. For example, a product labeled as “milk-free” cannot also carry a “may contain milk” advisory.

This rule aims to minimize misleading information on product packaging. Clearer guidelines mean consumers can trust the “free-from” claims they see on product labels, which is particularly crucial for those with severe allergies.

What Consumers Can Do

Consumers should take proactive steps to safeguard their health in the face of these changes:

• Stay Informed: Regularly check food labels for the source and product information reflected in the updated guidelines. As manufacturers revise their labeling processes to comply with the new guidance, they may change ingredient sourcing, potentially reformulate products to comply effectively with the new guidelines, and revise consumer labels and packaging. Be allergy aware and check labels for specific ingredients.
• Communicate Your Needs: When dining out or purchasing food, being vocal about your allergies can help ensure that adequate measures are taken to protect your health.
• Verify Claims: Always scrutinize packaging for “free-from” claims to ensure they correspond with your dietary restrictions, especially as manufacturers adjust to the new expectations.
• Review the FDA Guidelines: Guidance for Industry (Edition 5) includes important information, including specifics on what products must be labeled, what products are exempt, and examples of how product labeling may change to reflect the new requirements and recommendations.   The “Guidance For Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) can be found here.
• Ask Your Allergist:  Oklahoma Allergy & Asthma Clinic’s allergists are here to help.  Our website provides a wealth of information on Food Allergies, and our team is equipped to help you better understand and handle specific food allergens that affect you and your family.

The FDA guidance covers foods and packaged foods for humans (and applies to facilities serving packaged foods, including airlines).  It does not cover animal food, over-the-counter medications, cosmetics, or cleaning products.