The 8 Major Food Allergens According to the FDA

According to the Food Allergy Research & Resource Program, the original eight major food allergens accounted for about 90% of all food allergic reactions in the United States. The U.S. Food and Drug Administration (FDA) has specific regulations, established through the Food Allergen Labeling and Consumer Protection Act (FALCPA), to help consumers identify and avoid these common triggers.

Quick Summary

The FDA established a list of eight major food allergens through FALCPA, which must be declared on food labels for consumer safety. The list includes milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy. Recognizing these allergens is crucial for managing and preventing allergic reactions.

Key Points

• FDA's 'Big 8': The FDA initially identified milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans as the eight major food allergens.

• FALCPA Mandate: The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 requires manufacturers to clearly label these allergens.

• Life-Threatening Reactions: These eight allergens are responsible for the majority of severe food allergic reactions, including anaphylaxis.

• Allergy vs. Intolerance: A food allergy is an immune system response, while a food intolerance is a digestive issue, with allergies generally posing a greater risk.

• Labeling is Crucial: Clear labeling, mandated by FALCPA, allows individuals with allergies to effectively avoid trigger foods in packaged products.

• FASTER Act Expansion: It's important to note that the FDA has since added sesame to the list, expanding the 'Big 8' to the 'Big 9'.

Understanding the FDA's Regulation of Food Allergens

For individuals with food allergies, accurate food labeling is a critical tool for preventing serious and potentially life-threatening reactions. The U.S. Food and Drug Administration (FDA) is the regulatory body responsible for overseeing the labeling requirements for food products sold in the United States. Its framework for allergen labeling was initially established by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This law mandated that food manufacturers clearly identify the presence of eight specific food allergens, which were responsible for the vast majority of food allergy cases at the time.

The Original 'Big 8' Major Allergens

The list of eight major food allergens covered by FALCPA includes the following food groups:

• Milk: A common trigger, particularly in young children, milk allergy is a reaction to the proteins found in cow's milk. It can be found in a wide variety of foods beyond just dairy products, including baked goods, sauces, and processed meats.
• Eggs: The second most common food allergy in children, an egg allergy is a reaction to the protein in egg yolks or whites. Many children may outgrow this allergy, but strict avoidance is necessary until a medical professional confirms it is safe to reintroduce.
• Fish: Allergic reactions to finned fish, such as cod, salmon, and tuna, are more common in adults than children. Unlike some other allergies, fish allergy often develops later in life and tends to persist.
• Crustacean Shellfish: This category includes animals like crab, lobster, and shrimp. It is one of the most potent and common food allergens, especially among adults. A person allergic to crustacean shellfish may not necessarily be allergic to molluscan shellfish (e.g., clams, oysters), but cross-reactions are possible.
• Tree Nuts: This group includes a variety of nuts such as almonds, walnuts, pecans, pistachios, and cashews. A tree nut allergy can be severe, and cross-contamination is a significant concern. Some people allergic to one type of tree nut may also react to others.
• Peanuts: Although a legume, peanuts are classified as a major food allergen due to the severity and high prevalence of allergic reactions. Peanut allergies are often life-long and can cause severe, anaphylactic responses.
• Wheat: A wheat allergy is an immune system reaction to proteins found in wheat. It is distinct from celiac disease, which is an autoimmune disorder triggered by gluten. Wheat is a ubiquitous ingredient in many food products.
• Soybeans: Another legume, soy is a common allergen, particularly in infants, though many outgrow it. It can be found in many processed foods, including tofu, soy sauce, and edamame.

It is important to note that since FALCPA's inception, an additional food allergen has been recognized by the FDA. In 2021, the FASTER Act added sesame to the list of major food allergens, effective January 1, 2023, expanding the 'Big 8' to the 'Big 9'. While the article focuses on the original eight, this change highlights the dynamic nature of allergen awareness and regulation.

The Role of FALCPA in Allergen Labeling

FALCPA requires food manufacturers to label the presence of any of the major food allergens on their packaging in a clear and easy-to-read format. This is typically done in one of two ways:

• In the ingredients list: The name of the major food allergen is followed by the name of the allergen in parentheses, e.g., 'albumin (egg)'.
• In a separate 'Contains' statement: A line is included immediately after or adjacent to the ingredients list that clearly states the allergens present, e.g., 'Contains: Milk, Soy'. This mandatory labeling significantly reduces the risk of accidental exposure for people with allergies, though cross-contamination in manufacturing facilities remains a concern.

Managing the Eight Major Food Allergens

Managing a food allergy involves more than just reading labels. It requires constant vigilance and a comprehensive understanding of the risks associated with certain foods and food preparation environments. Those with food allergies must be proactive in communicating their needs, especially when eating at restaurants or others' homes. For individuals with severe allergies, carrying an epinephrine auto-injector is a standard practice to treat anaphylaxis.

Allergy vs. Intolerance: A Key Distinction

Understanding the difference between a food allergy and a food intolerance is crucial. A food allergy is an immune system response that can cause severe, life-threatening symptoms, while a food intolerance is a digestive issue that is generally not life-threatening. The following table compares these two conditions based on common symptoms, speed of onset, and diagnosis methods.

Feature	Food Allergy	Food Intolerance
Immune Response	Yes, involves the immune system (IgE-mediated reactions).	No, does not involve the immune system.
Symptom Speed	Rapid onset, typically within minutes to two hours.	Delayed onset, can take hours or even days.
Common Symptoms	Hives, swelling, wheezing, vomiting, anaphylaxis.	Gas, bloating, diarrhea, stomach cramps, headache.
Severity	Can be life-threatening (anaphylaxis).	Generally not life-threatening.
Diagnosis	Skin prick tests, blood tests (IgE).	Elimination diets, breath tests, stool tests.

Conclusion

Navigating life with a food allergy requires careful attention to detail and a thorough understanding of which foods pose a risk. The FDA's identification of the major food allergens—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans (now plus sesame)—provides a vital framework for both manufacturers and consumers. By mandating clear and consistent labeling, FALCPA empowers individuals to make safe dietary choices. Adherence to strict avoidance, combined with awareness of symptoms and emergency preparedness, is the best strategy for managing food allergies and preventing severe reactions.

For more detailed information on living with food allergies, consult authoritative sources such as the American College of Allergy, Asthma & Immunology (ACAAI) or the Food Allergy Research & Education (FARE) website.

Further Reading

For more information on the FDA's allergen labeling regulations, visit the official page on the topic. U.S. Food and Drug Administration Website

Frequently Asked Questions

What is the primary law governing allergen labeling in the US?

The primary law is the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which requires manufacturers to declare the presence of major food allergens on packaging.

Are all food allergies regulated by the FDA?

No, while there are over 160 foods that can cause allergic reactions, the FDA regulations specifically focus on the major food allergens that cause the most severe reactions.

How can I tell if a packaged food contains a major allergen?

Manufacturers are required to list major allergens in plain language within the ingredients list or in a clear 'Contains' statement immediately following the ingredients.

Is a wheat allergy the same as celiac disease?

No, a wheat allergy is an immune reaction to wheat proteins, while celiac disease is an autoimmune disorder triggered by gluten, a specific protein found in wheat, barley, and rye.

What is the difference between fish and shellfish allergies?

Fish allergies are a reaction to finned fish like cod or salmon, while shellfish allergies are a reaction to crustaceans like shrimp and crab. It is possible to be allergic to one and not the other.

Does highly refined soy oil need to be labeled as an allergen?

No, the FDA does not require highly refined soy oil to be labeled as an allergen because the refining process removes the allergenic protein.

Why is it important to carry epinephrine if you have a severe food allergy?

Epinephrine is the primary treatment for anaphylaxis, a life-threatening allergic reaction that can cause impaired breathing and a drop in blood pressure. It must be administered promptly.

Did the FDA add any allergens to the 'Big 8' list?

Yes, in 2021, the FASTER Act added sesame as the ninth major food allergen, with labeling requirements taking effect in 2023.

Do people with peanut allergies need to avoid tree nuts?

There is a high rate of co-allergy, so many individuals with peanut allergies are also allergic to tree nuts. An allergist should provide guidance, but often, avoidance of all tree nuts is recommended to prevent reactions.