A man examines the FDA list of allergens to assure he has properly labeled his products for compliance regarding FDA food allergens.
Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

A Definitive Guide to FDA Food Allergens: The Complete List

Mar 25, 2024

The FDA List of Allergens establishes a guidepost that helps the Administration regulate food and beverage companies in how — and what — ingredients are listed on their packages.

When it comes to food, allergic reactions vary in severity from mild symptoms to more severe, life-threatening anaphylaxis. For this reason, with certain foods or substances that cause allergies or other allergic reactions, there are specific labeling requirements enforced by FDA that companies should be aware of.

What Are FDA Food Allergens?

According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), a food allergen is an ingredient in any food or beverage that triggers a mild to severe immune system response in reaction to certain proteins that are present in the ingredient.

Due to the prevalence, potential severity, and threat to public safety that these allergens represent, FDA has established guidance for the food industry and its consumers on how to identify and manage allergen hazards in both food and beverages.

How Is the FDA List of Allergens Used?

FDA updates and uses their allergen list to help conduct inspections and establish various labeling controls to prevent undeclared allergens during the manufacturing and packaging process of foods or ingredients. They will sample products to check that FDA Food Allergens are properly labeled on products and even determine if food facilities are implementing proper controls to prevent allergen cross-contact for items on the list.

When food safety issues are identified in relation to the presence of a food allergen, FDA enforces product recalls and will immediately notify the public, or may even issue an Import Alert, seize and remove violative products from the marketplace, or simply refuse entry of imported products.

The FDA List of Allergens: 9 Major Regulated Foods

There are now 9 major FDA food allergens that together cause more than 90% of food allergies in the U.S.

Each year, these foods cause about 30,000 consumers with food allergies to need emergency room care. Worse, 150 individuals die each year due to severe reactions from food allergens.

It is for this reason FDA enforces any packaged food containing these allergens to declare the ingredients on its label to warn its consumers.

Here is the current list of Major FDA Food Allergens:

Crustaceans

Crustacean shellfish consist of softshell seafoods that are non molluskan. They are aquatic animals that have jointed legs, a hard shell, and no backbone. Some foods in this group are:

  • Lobster
  • Shrimp
  • Crab
  • Crayfish
  • Prawn
  • Krill

Fish

Allergies to finned fish is more common in adults than children and affects roughly 1% of the world’s population. Some of the fish FDA closely monitors and regulates as allergens are:

  • Haddock
  • Cod
  • Tilapia
  • Tuna
  • Salmon
  • Perch
  • Flounder

Peanuts

Despite its name, a peanut is actually a legume, not a nut. Although there are four main varieties of peanuts, all peanuts come from the same plant, Arachis Hypogaea. The most common variety is the Runner. This peanut makes up 80% of what is grown in the U.S. and is what most manufacturers use to create peanut butter and peanut confections.

Tree Nuts

Tree Nuts is a broad category that covers many foods that are used as ingredients and those that are not. FDA & the FALCPA considers the following foods as allergens under the Tree Nut category:

Milk

When it comes to Milk, most allergens arise out of the proteins Whey and Casein. Though most commonly associated with cow’s milk, allergic reactions can occur with other common milks such as goat, sheep, and buffalo.

Unlike an intolerance that doesn’t involve the immune system, milk allergies are most common in children and can be as mild as nausea to severe and life-threatening as anaphylaxis.

Eggs

Chicken eggs are the most common cause of an egg allergy, the proteins found in the whites and yolk triggering a mild to severe reaction. However, other animal eggs, such as duck, turkey, or even quail, may cause a consumer’s immune system to overreact.

Wheat

When FDA talks about “wheat” they refer to any plant species of the genus Triticum. This genus includes the following grains:

  • Spelt
  • Kamut
  • Triticale
  • Semolina
  • Einkorn
  • Emmer
  • Common Wheat
  • Durum Wheat

Sesame

Sesame allergy is growing at a much faster rate in the U.S. than other food allergies and is estimated to be as common as fish allergies, soy, and even some tree nut allergies. Due to the rapid growth of sesame allergy, this seed is officially the ninth major food allergen recognized by FDA.

Soybeans

Like peanuts, soybeans are a legume that are used in a variety of common foods such as tofu, soy sauce and milk, natto, and miso.

Allergic reactions to soy are generally mild and, although rare, severe and potentially life-threatening reactions do occur.

Labeling Requirements for FDA Food Allergens

The Administration requires that all food labels identify any source of major FDA food allergens that are used to make the food in the package. This requirement is considered met if the common name of an ingredient identifies that allergen’s food source name.

FDA also requires that the type of tree nut, the species of fish, and species of crustacean to be clearly named.

There are two ways an allergen’s food source can be declared on the label:

  1. In parentheses following the name of the ingredient. Ex: flour (wheat), whey (milk), and lecithin (soy).
  2. Immediately after or next to the ingredient list in a clear and prominent contains statement. Ex: “Contains wheat, milk, and soy.”

How to Assure Compliance With FDA Food Allergens

Registrar Corp has spent 20 years assisting over 30,000 companies each year navigate the complexities of FDA compliance across 190+ countries. We know how to help you meet the stringent federal labeling requirements and prepare your products for the U.S. market.

With our Label Review service, you have the ongoing support of a professional label compliance partner.

Discover how quick and easy it is to gain and maintain compliance with FDA food allergen labeling requirements.

 


Frequently Asked Questions

Does the FDA consider coconut an allergen?

FDA recognizes coconut as a tree nut, and thus an allergen that must be declared. This can be confusing for some, as coconuts are technically considered to be fruits and there are few instances of people being allergic to both true tree nuts and palm coconuts.

Does the FDA consider sesame an allergen?

Yes. As of 2023, sesame is the ninth major FDA food allergen as recognized in the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, a federal law passed in 2021.

How does the FDA differentiate between food sensitivities and food allergies?

A food sensitivity or intolerance does not involve the immune system. A food allergy occurs when immune cells bind with certain proteins found in a particular food and trigger a mild to severe histamine response.

Author


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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