Allergen labeling might seem straightforward, but it’s one of the most common sources of labeling errors and recalls. With FDA allergen requirements evolving—including the addition of sesame and the removal of coconut from the major allergen list—here’s a practical refresher to help you stay compliant and avoid costly mistakes.
If you manufacture food products regulated by the U.S. Food and Drug Administration (FDA), allergen labeling isn’t optional. It’s a critical part of compliance and consumer safety.
Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), manufacturers were originally required to declare eight major food allergens. The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act added sesame as the ninth major allergen, effective January 1, 2023.
Clear, accurate allergen labeling helps protect consumers, reduces the risk of recalls, and keeps your products compliant.
The 9 Major Food Allergens
FDA-regulated foods sold in interstate commerce must declare the presence of any major food allergen ingredient—or a protein derived from one of these allergens:
- Milk
- Egg
- Wheat
- Peanuts
- Soybeans
- Sesame
- Fish*
- Crustacean shellfish*
- Tree nuts*
* The specific species or type must be declared for fish, crustacean shellfish, and tree nuts. See Allergen-Specific Labeling Tips below for additional details.
Key Exemptions to Know
- Highly refined oils (such as refined soybean or peanut oil) are exempt because processing removes allergenic proteins.
- Unrefined oils (such as cold-pressed or expeller-pressed oils) are not exempt.
- Molluscan shellfish (such as oysters, clams, mussels, and scallops) are not considered major allergens under FALCPA, but they must still be declared in the ingredient statement when used as ingredients.
- Meat, poultry, and certain egg products regulated by USDA are not covered by FALCPA, though similar allergen labeling practices are typically followed
How to Declare Allergens on Labels
You have two options for declaring allergens:
- Include the allergen directly in the ingredient statement.
- Add a “Contains” statement immediately following the ingredient statement.
The examples below illustrate acceptable allergen declaration methods.
Example 1: Allergens declared within the ingredient statement
INGREDIENTS: Peanut Butter (Peanuts, Salt), Oats, Sugar, Canola Oil, Whey (Milk), Lecithin (Soy).
Example 2: Allergens declared in a separate “Contains” statement
INGREDIENTS: Peanut Butter (Peanuts, Salt), Oats, Sugar, Canola Oil, Whey, Lecithin.
CONTAINS: Peanuts, Milk, Soy.
As shown in the examples above, allergens must be identified whenever the common or usual name of the ingredient does not clearly identify the allergen source. For example:
- Modified food starch (when derived from wheat) → wheat must be declared.
- Whey → milk must be declared.
Tip: Either the singular or plural form of an allergen is acceptable in an ingredient or “Contains” statement (e.g., “peanut” or “peanuts,” “egg” or “eggs”).
Allergen-Specific Labeling Tips
Some allergens have additional declaration requirements:
Milk
- “Milk” is sufficient when the source is cow’s milk.
- Milk from other animals must be identified by species (e.g., goat milk, sheep milk).
Egg
- “Egg” is sufficient when the source is a chicken egg.
- Eggs from other birds must be identified by species (e.g., duck egg, quail egg).
Wheat
- For allergen labeling purposes, “wheat” includes all Triticum species, even when the ingredient name does not contain the word “wheat.”
- Examples include spelt, durum, semolina, einkorn, emmer, and triticale.
Soybeans
- “Soybean,” “soy,” and “soya” are all acceptable terms.
- Use terminology consistently and ensure the source is clearly identified.
Fish and Crustacean Shellfish
- The specific species must be declared in either the ingredient statement or the Contains statement.
- Examples: salmon, tuna, shrimp, and crab.
Tree Nuts
- The specific nut type must be declared; a generic statement such as “tree nuts” is not sufficient.
- Examples: almond, cashew, walnut, pistachio, pecan, and macadamia.
What About “May Contain” Statements?
FALCPA requires labeling for allergens that are intentionally added, but not for accidental cross-contact.
That’s where precautionary statements come in, such as:
- “May contain peanuts”
- “Processed in a facility that also processes milk”
- “Manufactured on shared equipment with tree nuts”
These statements are voluntary and are not standardized or specifically defined by FDA regulations. They should only be used when there is a real risk. They are not a substitute for proper allergen controls.
Why This Matters
Your customers rely on labels to make safe food choices. Getting allergen labeling right helps you:
- Prevent accidental exposure
- Protect consumer health
- Avoid costly recalls
- Stay compliant
- Build trust with your customers
Best practice: Regularly review ingredient specifications, supplier documentation, formulations, and labels to ensure all allergen sources are accurately identified and declared.
Disclaimer
FDA regulations and guidance can change over time. Be sure to review current FDA guidance and consult regulatory experts to stay compliant.
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