About 30,000 individuals require emergency treatment, and 150 die every year because of allergic reactions to food. 

A recent study conducted by the USA Food Safety and Inspection Service showed that over 2 percent of adults and 4 to 8 percent of children in the United States are affected with food allergies. Each year, there are more than 30,000 emergency visits, 2,000 hospitalizations, and close to 150 deaths. 

These numbers are quite startling, right? Currently, there exists no cure for food allergies. As businesses, it is essential to keep consumers informed about allergy-inducing foods to avoid any hazards. To protect customer safety and uphold right nutrition practices, FDA conducts regular inspections and lays down strict allergen labeling requirements that food manufacturers must comply with. 

While you might not have the time to go through lengthy research papers to understand the current labeling regulations, here we’ve compiled a free labeling regulations guide that can help you skip the jargon and find exactly what you’re looking for. Let’s get started. 

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Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of March 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations. Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

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Major Allergens

According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the term major allergens refer to the eight foods and their protein derivatives that cause more than 90% of food allergies and severe reactions in the USA. 

So, any packaged food containing the following allergens must declare the ingredients on its label to warn its consumers. 

What are the major food allergens to be aware of in 2024?

The Food Allergen Labeling and Consumer Protection Act of 2004 identified eight major food allergens that are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. It also added sesame to the FDA allergen list from January 1, 2023. Let’s take a close look at each of these allergens. 

1. Milk 

Milk is a commonly consumed product across all age groups but can quickly turn into a hidden disaster for those with milk allergies. Even a small amount of milk protein can trigger serious reactions from hives and wheezing to anaphylaxis. Food manufacturers must take additional effort to accurately label their products containing milk and milk derivatives. 

What are the milk labeling requirements in 2024?

1. If using the common name ‘milk’, all of the derived ingredients (e.g., whey, casein) must be mentioned in the ingredient list. 
2. You can also consider highlighting milk allergens by underlining, bolding or even using a “may contain” statement. 
3. Avoid using vague terms like “natural flavors” or “dairy products”, write them specifically. 

2. Eggs 

Eggs are a versatile food option – they are a huge part of your breakfasts, baked treats, and can be even enjoyed on their own. But food producers using eggs in their food production need to be responsible for accurate and transparent labeling. 

What are the egg labeling requirements in 2024?

1. Be straightforward and use the term “egg” in ingredient lists. Make sure to also mention other ingredients like egg whites, egg yolk, and lysozyme. 
2. Ensure to bold, underline the allergy-inducing ingredients or consider using a separate “may contain” statement to help consumers draw attention towards egg allergens. 
3. Lastly, use direct terms like “natural flavor”, “lecithin” or any other egg ingredients present. 

3. Fish 

Fish, often known as a source for delicious cuisine and vital nutrients, has its own share of allergens that won it a place in the FDA allergen list. Over two percent of adults and 0.5% of children are sensitive to fish allergens which can lead to eczema, nasal congestion, and much worse. 

What are the fish labeling requirements in 2024?

1. Make sure to specify the species involved in the making of the product. Rather than just mentioning the term “fish”, specify the species involved like bass, flounder, or cod. 
2. Avoid generic and broad terms but use specific words like fish, fish oil, and other ingredients so it helps consumers make informed choices. 
3. Always highlight and bold ingredient names or use a separate statement such as “may contain” if there are any fish allergens in the products. 

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4. Tree nuts 

Almost all tree nuts, from almonds to walnuts, are great for improving the culinary experience of our dishes. However, almost 1% of adults and children suffer from nut allergies across the globe. Tree nut allergies may look harmless, but they actually pose a serious health risk, leading to congestion, abdominal cramps, and even hives. This raises an alarming concern calling for producers to be aware of the food regulatory standards. 

What are the tree nut labeling requirements in 2024?

1. According to the FDA's Food Allergen Labeling and Consumer Protection Act, you need to clearly mention the specific type of tree nut present in your food product (e.g., almonds, cashews, pecans).
2. Avoid using broad terms like “mixed nuts” and be specific about each nut ingredient and derivative in the product. 
3. Use a “May contain” statement to highlight any kind of nut ingredients even in products like sauces and baked goods. 

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5. Fish & Crustacean Shellfish

The term crustacean shellfish refers to shellfish with a soft shell (prawns, lobsters, etc.) and doesn’t include molluscan shellfish (oysters, clams, mussels, etc.). We are sure crab crackers and shrimp scampi are everyone’s favorite. But for individuals with crustacean shellfish allergies, these allergens can trigger anything from a mild reaction to life-threatening anaphylaxis, histamine reaction, or chronic inflammatory conditions. 

What are the crustacean shellfish labeling requirements in 2024?

1. According to the US FALCPA requirements, it is essential to clearly identify the specific type of crustacean shellfish present such as crab, lobster, or shrimp.
2. Don’t use broad terms like “seafood” or “shellfish” rather write down every derivative and ingredient clearly so it enables customers to make informed choices. 
3. Use a “May Contain” statement to help emphasize the use of crustacean shellfish allergens to prevent any kind of allergic reactions. 

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There are numerous edible fishes and shellfishes, we’ve included only common species in the lists below. 

You may refer to the FDA’s seafood list for the complete set of related ingredient names.

Also read: Seafood Labeling Requirements Across the World

6. Wheat

Wheat is another common food allergen according to the FD&C Act. Since it is the foundation of several staple foods across the globe, there are chances for wheat allergens to exist in unexpected food items like sauces, baked products, and even processed foods to an extent. 

What are the wheat labeling requirements for 2024? 

1. As mentioned in the FDA Food Allergen Labeling and Consumer Protection Act it is essential to clearly mention the word “wheat” in the label. 
2. Avoid using generic terms like “cereal”, “starches”, or even “grains” but rather mention specific ingredients like “gluten” or “hydrolyzed wheat protein”. 
3. Lastly, make sure you bold or underline wheat allergens or you can even use the “May Contain” statement to mention the wheat allergens.

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Wheat refers to any plant species of the genus Triticum, and it includes the following grains:

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7.  Peanuts 

Peanuts are a rich source of protein. However, they can instantly turn food into a threat for individuals with peanut allergies which can lead to itching, dizziness, and loss of consciousness. Peanut allergies affect up to 2% of children and up to 0.5% of adults, making it a significant public health concern. 

What are the peanut labeling requirements for 2024? 

1. Be specific about ingredients used in the product. Mention ingredients precisely on the labels rather than just identifying them as “peanuts”. 
2.  Make sure to avoid broad terms instead use terms like “peanut oil, peanut butter, including other derivatives”. 
3. Use a “May Contain” statement to highlight the presence of any peanut allergies in the product. 

8.  Soybeans

Soybeans are yet another protein rich ingredient that plays a crucial role in several foods we consume every day. Although they seem like a harmless legume soy allergies almost affect 0.2% of adults and 0.5% of children globally. Soy allergies can cause esophagus inflammation, vomiting, runny nose, and more.  

What are the soybean labeling requirements for 2024? 

1. Clearly mention all ingredients such as “soy” or any derived ingredients such as “soy milk, tofu, lecithin, hydrolyzed soy protein, and other such ingredients. 
2. Avoid ambiguous labeling practices and using broad terms like “vegetable oils” or “vegetable protein” and be specific about each individual soy ingredient. 
3. Always bold, underline, or use a “May Contain” statement to emphasize the presence of soy allergies in the product. 

9.  Sesame 

Sesame got added as the ninth allergen under the Food Allergy Safety, Treatment, Education, and Research Act (FASTER), and became effective on January 1st, 2023. While it’s just a little tiny seed that is sprinkled on bagels or your hummus, it can lead to severe allergic reactions and can even be life-threatening, leading to esophagitis and enterocolitis syndrome. 

What are the sesame labeling requirements for 2024? 

1. The FASTER act mandates clearly identifying sesame and any other derived ingredient such as tahini, sesame oil, hulled sesame, or any other ingredient. 
2. Avoid using broad terms such as “seeds” or “species” and offer clear and concise information on your labels. 
3. Consider using a “May Contain” or even bold or underline the presence of sesame allergens. 

Exemptions

The FALCPA applies to most packaged food products, but you’re exempted from making a declaration if your product is:

• A raw agricultural commodity like fresh fruits or vegetables. 
  

• Not pre-packaged with a label. This includes foods wrapped or placed in containers upon the consumer’s request or at the point of purchase. 
  

• Highly refined oil made from the foods listed above or a product derived from these oils.
  

Note: If your products aren’t regulated by the FALCPA, i.e. meat products, poultry, egg, and alcoholic beverages, check out the allergen regulations laid down by the relevant organizations. 

Other Allergenic Substances

In addition to identifying eight major allergens, the FDA has also identified more than 160 substances that cause adverse reactions and pose significant health risks to individuals. 

This section lists other allergenic substances that require specific labeling according to the FALCPA. 

1. Gluten

Gluten is a group of proteins in certain grains like wheat, barley, and rye. It triggers the immune response that leads to the damage of the lining surrounding the small intestine in people who have celiac disease. 

Such damage will cause malnutrition and leave them at a high risk of developing life-threatening diseases like cancers in the long term. 

That’s why the FDA has laid down stringent standards and labeling regulations for “gluten-free” products. 

2. Color & Food Additives

Substances that impart color to foods, drugs, cosmetics, or the human body are called color additives. They’re found in your fruit punch and add vibrancy to your bland morning cereal.

Although most color additives are very safe when used properly, some individuals can have allergic reactions to certain color additives. 

FD&C Yellow No. 5 (tartrazine) is widely found in beverages, desserts, and processed vegetables. It may cause symptoms like hives and itching in some individuals, so you must identify it on the labels of your food products. 

Color additives derived from carmine or cochineal extracts may lead to *anaphylaxis and must be declared on food labels. 

Food additives like sulfiting agents cause asthma in some individuals. So, you must declare them if their concentration exceeds 10 million parts per million of sulfur dioxide present in the food.

*life-threatening allergic reaction that is characterized by nausea, vomiting, breathing difficulties, and shock.

3. Sesame

More than 300,000 Americans suffer an allergic reaction from sesame and may prove to be fatal even if it’s ingested only in small quantities.

That’s why the Food Allergy Safety, Treatment, Education, and Research (FASTER) act has declared it a major allergen, effective from 2023. 

Until then, you’re exempt from listing sesame as an ingredient in natural spices and flavorings. But a voluntary declaration in parentheses following the spice or flavor can potentially save the lives of your consumers.

Allergen Labeling Requirements

This section explains how to declare allergens on a food package and answers some of the most pressing questions on the labeling requirements. 

1. Allergen Declaration

You can declare major allergens in your label in one of the following ways:

1. Include the food source of a major food allergen in parentheses following the ingredient’s name
Here’s an example of a correct allergen declaration:

Ingredients: Whey (milk), lecithin (soy), and flour (wheat)

Note: If the common name of an ingredient includes the name of the major food allergen, you needn’t include the food source of the major allergen in parentheses. For example, buttermilk. 

2. Use a “Contains” statement immediately after or next to the ingredient list to declare major allergens. 

This statement must always begin with a capital “C" and the usage of punctuations and bold lettering is optional. Here’s an example of a correct allergen declaration with a “Contains” statement:

CONTAINS WHEAT, SOY, AND MILK

Note: If your product is manufactured in a facility where it might be exposed to traces of other major allergens due to cross-contact or contamination, you must issue an advisory statement like:

MAY CONTAIN TRACES OF TREE NUTS

Declaration of Allergens from Food Groups

The table below shows the procedure for the declaration of ingredients from the three allergen food groups, i.e. Tree nuts, fish, and crustacean shellfish.

2. Placement of Information

Ingredient lists and allergens appear on the Principal Display Panel (PDP) or Information Panel (IP). 

3. Type Size 

As allergens are declared immediately after the list of ingredients or with it, they must be no less than 1/16” in height. 

Note: The letter height is the equivalent of a lowercase or uppercase “O.”

Frequently Asked Questions Regarding Allergen Labeling Requirements

1. Are single-ingredient foods containing major allergens exempt from the FALCPA?

No. Single-ingredient foods that are major allergens or contain proteins derived from them must identify the food source (eg. all-purpose wheat flour) or use a “Contains” statement to list allergens.

Note: 

1. If you’re using a “Contains” statement, place it immediately above the manufacturers, distributors, or packers statement. 

2. If the single-ingredient food is intended for further manufacturing, place the “Contains” statement on the PDP. 

2. Can singular terms be substituted for plural terms in the declaration and still satisfy FALCPA requirements?

Yes, you may use singular terms like almond, pecan, or walnut for different types of tree nuts and still satisfy the labeling requirements of FALCPA.

3. Can I use synonyms for the term “soybean”?

“Soy,” “Soya,” and “Soybean” are acceptable synonyms and satisfy FALCPA’s labeling requirements. 

However, you must stick to using “soybeans” if your product is made of soy (e.g., soy sauce) or contains soy as a component of a multi-component ingredient (e.g., tofu)

Exemption from Allergen Declaration

You may file a petition with the Secretary to exempt your ingredients from the allergen labeling requirements. 

Once the petition is filed, the Secretary must post it publicly within 14 days and approve or deny it within 180 days of its receipt, unless there’s an agreement for mutual extension of time. 

In your petition, you must provide scientific evidence and describe the analytical method used to prove that your product doesn’t contain allergenic protein and adversely affect human health. 

Note: You’re exempt from filing a petition if:

• You’ve already filed a notification that shows your product doesn’t contain any allergenic proteins.
  
• The Secretary has already approved your ingredient as non-allergenic under a pre-market or notification program. 

How to label your food products according to the FDA regulations? 

According to the US Food and Drug Administration regulations, here are two methods you can use to label your food products: 

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Method A 

Under this method, you must ensure that the name of the major food allergen (source) appears prominently on the label. It must follow with the name of the ingredient, such as: 

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Lecithin (soy), flour (wheat), natural flavor (sesame), seeds (sesame), and spices (sesame)

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Method B

Under this method, you must ensure that the food allergen appears immediately after or next to the list of ingredients in a “May contains” or “Contains” statement. Example: “Contains soy milk”.

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Make your food labeling requirements faster with ComplyAI

Unlisted allergens or mislabeled ingredients can attract expensive food recalls for brands, which can lead you to massive financial losses and reputational damage.  Depending on the size of your company and the scale of production, you could easily be paying more than $10 million in rollback costs. 

With Artwork Flow’s ComplyAI feature, you can effortlessly review, scan, and proof your labels seamlessly. With ComplyAI you can build your own rule books according to your regulatory requirements, run QA checks, and meet your regulatory guidelines with ease. 

Let’s suppose that you have the ingredient sesame part of one of your food products. All you have to do is build your own rulebook using “sesame” as the preferred keyword, amongst other requirements. Our tool will instantly highlight the absence of the preferred word in your label copy and allow you to instantly rectify the copy and avoid costly food recalls. 

Never worry about your food labels anymore, automate your label compliance with ComplyAI. Book a demo today and make your food labels FDA compliant with Artwork Flow.