FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

Allergen Labeling Requirements

Allergen Statements are required on nearly every canned food, even when it appears obvious. (Tuna: Contains Tuna)

Allergen Statements are required on nearly every canned food, even when it appears obvious. (Tuna: Contains Tuna)

What You Need to Know:

  • All packaged food products under FDA jurisdiction are subject to allergen labeling requirements.

  • The 8 major allergens are: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans.

  • A “Contains” statement is the most straightforward way to declare allergens.

Applicable and Exempt Foods

Packaged foods for sale in the US which were labeled after January 1st, 2006 must have an allergen statement. This includes single-ingredient packaged foods (i.e. canned tuna)

Fresh fruits and vegetables do not require an allergen statement.

Highly refined oils derived from one of the eight major allergens do not need to comply with FALCPA allergen labeling requirements (e.g. soybean oil, peanut oil)

If you believe that an allergen containing ingredient should not require an allergen warning (because it will not elicit an allergic response) then you may submit a petition to exempt that ingredient from allergen labeling.

Building a Compliant Allergen Label

Know Your Ingredients: Make a comprehensive list of all ingredients, flavors additives, and colors in your product and any allergens they may contain. Inspect the product label on all ingredients in your product and write down any allergen claims that are listed.

Next, write your allergen statement based on the information you collected. Remember, your product contains all of the allergens which are in the ingredients that you use. You can show a product’s allergen content in two ways:

Option #1: Name the allergens in the ingredients list

Option #1: Name the allergens in the ingredients list

Option #2: Use a “Contains” statement

Option #1: Include the name of the allergen in the ingredients list in parentheses after the applicable ingredient.

Option #2: Use a “contains” statement. This should be located immediately adjacent to the list of ingredients.

Processed in a Facility That Also Processes…

It’s not uncommon to see an allergen statement like this on a packaged food. But what does it mean?

According to the FDA this is known as a May Contains claim. This type of claim is not required, nor is it recommended by the FDA.

So what if a food company produce their product in an facility that also processes other allergens? It shouldn’t matter that other allergens are present in the facility — proper cleaning and production should prevent any allergen cross contact.

Double Check Your Allergen Label:

Consider the following before printing new packaging:

  • Make sure the size of the allergen statement is no smaller than the ingredients list.

  • Use the same wording as the major 8 allergens. For example, an allergen statement for a product containing butter should say, Contains: Milk, not Contains: Butter. Even though the second statement is true, the name of the allergen is milk (not butter).

  • If you suspect that a consumer may not know that a particular ingredient is an allergen (e.g. casein) then it’s best to declare the allergen specifically in a “contains” claim (e.g. “Contains: Milk).

  • If the product includes either tree nuts, fish, or crustacean shellfish then you must specify the specific ingredient that falls within that category. For example,

Ultimately, what matters is that your allergen statement is truthful and not misleading.


Tree Nut Allergens

This category includes:

  • Almond

  • Beech nut

  • Brazil Nut

  • Butternut

  • Cashew

  • Chestnut

  • Chinquapin

  • Coconut

  • Filbert/Hazelnut

  • Ginko Nut

  • Hickory Nut

  • Lichee Nut

  • Macadamian Nut

  • Pecan

  • Pine Nut

  • Pili Nut

  • Pistachio

  • Sheanut

  • Walnut

wheat allergens

Wheat includes the following species:

  • Dommon wheat

  • Durum wheat

  • Club wheat

  • Spelt

  • Semolina

  • Einkorn

  • Emmer

  • Khorasan wheat

  • Triticale

Crustacean Shellfish Allergens

When stating a crustacean shellfish allergen, be sure to list the specific species in which the allergen occurs. For example,

Contains: Crustacean Shellfish (Lobsters)

Also, note that Molluskan shellfish (mollusks) are not one of the 8 required allergens regulated by FALCPA.