Food allergies are a serious health issue that can lead to severe reactions, even threatening human lives. One of the best ways to protect individuals with food allergies is to ensure that allergens are clearly labeled on food packaging. In the following article, GOL will provide you with information about the FDA regulations regarding allergen labeling in food.

What are Food Allergies?

Food allergies and various types of food sensitivities impact millions of individuals and their families. Food allergies occur when the body’s immune system reacts to certain proteins in food. Allergic reactions vary in severity, ranging from mild symptoms like hives and swollen lips to severe and life-threatening symptoms, often referred to as anaphylaxis, which can involve respiratory and circulatory issues leading to fatal shock. While promising preventive and treatment strategies are being developed, food allergies cannot currently be cured. Early identification and learning how to manage food allergies, including knowing which foods to avoid, are crucial measures to prevent serious health consequences.

When a person with a food allergy consumes the allergenic food, their immune system produces IgE antibodies. These antibodies attach to mast cells in the body and release chemical mediators, such as histamine. These chemical mediators cause allergic symptoms, including:

• Feeling dizzy or lightheaded
• Rash
• Itching
• Swelling
• Runny nose
• Stuffy nose
• Difficulty breathing
• Wheezing
• Nausea
• Vomiting
• Diarrhea
• Anaphylaxis

Food allergies can occur in anyone, at any age.

Regulations for Allergen Labeling in Food

To safeguard individuals with food allergies and other hypersensitivities, the FDA enforces regulations requiring companies to list ingredients on packaged foods and beverages. For certain types of foods, allergens, or other hypersensitivity reactions, there are specific labeling requirements.

The FDA provides guidance to the food industry, consumers, and other stakeholders on the best practices for assessing and managing allergy-related risks in food. The FDA also conducts inspections and sampling to check if major food allergens are accurately labeled on products and to determine whether food facilities have implemented controls to prevent allergen cross-contact (the unintentional introduction of a major food allergen into a product) and labeling controls to prevent undisclosed allergens during manufacturing and packaging. When issues are identified, the FDA collaborates with companies to recall products and issues public notices to immediately alert consumers. Additionally, the FDA has the authority to detain and remove non-compliant products from the market or refuse the importation of such products.

Major Food Allergy

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) was enacted by Congress. This legislation categorized eight foods as major food allergens, namely milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act became law, officially designating sesame as the 9th major food allergen acknowledged by the United States. This modification took effect on January 1, 2023. All FDA regulations applicable to major food allergens, encompassing labeling and manufacturing requirements, now extend to sesame as of January 1, 2023. Products already in interstate commerce, such as those on retail shelves before January 1, 2023, are not required to be withdrawn from the market or re-labeled. Consequently, consumers should be mindful that certain products may not immediately display allergen labeling for sesame. Throughout this transitional phase, the FDA advises consumers to consult the manufacturer or distributor listed on the food product if uncertain about whether a particular food item contains or may contain sesame.

Upon the enactment of FALCPA, the eight major allergens constituted 90% of food allergies and severe allergic reactions in the United States. FALCPA mandates that foods or ingredients containing a “major food allergen” must bear specific labels indicating the allergen source. This legislation was passed by Congress with the aim of simplifying the process for individuals with food allergies and their caregivers to identify and steer clear of foods containing major food allergens. The FDA is responsible for enforcing these regulations in the majority of packaged food products, excluding meat, poultry, and egg products (regulated by the U.S. Department of Agriculture), alcoholic beverages subject to Alcohol and Tobacco Tax and Trade Bureau labeling rules, raw agricultural commodities, highly refined oils, drugs, cosmetics, and most foods sold at retail or food service establishments that lack pre-packaged labels.

Individuals with allergies need to understand the definition of major allergens for allergen labeling purposes. For instance, the FDA defines “milk” as milk from domesticated cows; nonetheless, the proteins in cow’s milk closely resemble those in milk from goats, sheep, deer, and buffalo. Similarly, individuals with egg allergies should note that, for allergen labeling purposes, the FDA interprets “eggs” as eggs from chickens, despite the proteins in chicken eggs bearing similarity to those in eggs from ducks, geese, quail, and other birds. Those with milk or egg allergies are advised to consult their healthcare provider before consuming milk or eggs from other animals.

As of now, the FDA has not established a threshold level for any allergens. A threshold refers to a value below which it is unlikely for a food-allergic individual to experience adverse effects.

Food labels and Allergens

Individuals with food allergies should carefully read labels and steer clear of foods they are allergic to. The law mandates that food  and nutrition facts labels clearly indicate the food source of all major food allergens used in the food’s production. This requirement is satisfied if the common or usual name of an ingredient already specifies the allergen’s food source name (e.g., buttermilk). Additionally, the law necessitates the declaration of the type of tree nut (e.g., almonds, pecans, walnuts), species of fish (e.g., bass, flounder, cod), and Crustacean shellfish (e.g., crab, lobster, shrimp). The allergen’s food source must be declared at least once on the food label in either of two ways.

• In parentheses following the name of the ingredient. Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”
• Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”

FALCPA’s labeling requirements encompass retail and food-service establishments that package, label, and offer products for human consumption. However, these requirements do not apply to foods placed in a wrapper or container (e.g., paper or a box for a sandwich) after a customer’s order at the point of purchase.

Consumers may come across advisory statements like “may contain [allergen]” or “produced in a facility that also uses [allergen].” Such statements are not legally required and can be utilized to address unavoidable “cross-contact,” provided manufacturers have implemented good manufacturing processes in their facility. These precautions aim to prevent cross-contact, which may occur when various foods with different allergen profiles are produced in the same facility using shared equipment or the same production line, leading to ineffective cleaning or the generation of dust or aerosols containing an allergen.

FDA guidance and regulations for the food industry emphasize that advisory statements should not serve as a substitute for adhering to current good manufacturing practices. Additionally, these statements must be truthful and not misleading.

FDA Regulations on other Allergens or Allergenic Substances

Over 160 foods have been identified as potential triggers for food allergies in individuals with sensitivity. Additionally, there are various food ingredients that can induce non allergic hypersensitivity reactions in sensitive individuals, necessitating distinct labeling. Besides the major food allergens stipulated by law, the FDA actively oversees the food supply to assess whether other allergens, food ingredients, or additives present a notable health risk, taking appropriate measures. Examples of substances the FDA monitors, and in certain instances mandates specific labeling for, include gluten, specific additives (such as yellow 5, carmine, sulfites), and other emerging food allergens supported by new scientific findings.

Gluten

Gluten refers to a collection of proteins present in specific grains, such as wheat, barley, and rye. In individuals with celiac disease, the consumption of gluten-containing foods triggers an immune response that damages the lining of the small intestine. This damage not only hampers the absorption of nutrients, leading to issues like iron deficiency anemia, osteoporosis, and malnutrition but also elevates the risk of severe health complications, including intestinal cancers and autoimmune diseases like diabetes.

The FDA places a significant emphasis on safeguarding the public health of consumers with food allergies and conditions like celiac disease. On August 2, 2013, the FDA introduced a final rule establishing the definition of “gluten-free” for food labeling. This standard provides assurance to consumers, particularly those living with celiac disease, that products labeled as “gluten-free” adhere to a specified criterion regarding gluten content. Subsequently, on August 12, 2020, the FDA issued another final rule outlining compliance requirements for fermented and hydrolyzed foods, as well as those containing fermented or hydrolyzed ingredients, carrying the “gluten-free” claim. Following the release of gluten-free labeling regulations and guidelines, ongoing efforts involve outreach to food manufacturers to ensure adherence to the stipulated requirements for products labeled as “gluten-free.”

Color and Food Additives

Color additives in food may elicit hypersensitivity reactions in certain individuals. For instance, FD&C Yellow No. 5, commonly present in beverages, desserts, processed vegetables, drugs, makeup, and various products, can lead to symptoms like itching and hives in some people. To ensure the well-being of consumers sensitive to this dye, the FDA mandates that all products containing FD&C Yellow No. 5 explicitly state it on their labels.

Color additives derived from cochineal extract and carmine, obtained from insects, have been recognized as allergenic substances that must be disclosed on the labels of all food and cosmetic products. While various sulfiting agents, including sodium bisulfite, are permissible as food ingredients, their inclusion on food labels is obligatory when present in concentrations of ≥10 parts per million total sulfites. This requirement is influenced, in part, by observed adverse reactions, such as asthma in sensitive individuals, associated with these sulfiting agents. 

FDA Testing and Monitoring Activities

The FDA employs various measures to ensure the protection of consumers from ingredients and foods that may trigger allergies. These measures encompass the establishment of regulatory requirements, the provision of industry guidance, ongoing surveillance, and the implementation of regulatory actions when deemed necessary.

FDA’s Inspections

The FDA’s “Current Good Manufacturing Practice, HACCP, and Risk-Based Preventive Controls for Human Food” rule (CGMP & PC rule, 21 CFR part 117) outlines requirements applicable to establishments involved in the manufacturing, processing, packing, or holding of human food. This rule incorporates allergen preventive controls to mitigate allergen cross-contact during manufacturing and packaging, as well as to prevent the occurrence of undeclared allergens. For instance, the FDA mandates facilities to implement written procedures to manage allergen cross-contact between products containing allergens and those intended to be allergen-free, ensuring accurate allergen labeling. The FDA conducts inspections of food manufacturers in accordance with the stipulations of 21 CFR part 117 to assess the extent to which allergen cross-contact is minimized or prevented and whether the facility has appropriate controls for allergen labeling.

FDA’s Monitoring

The FDA actively monitors reports of food allergic reactions and complaints related to ingredients and food hypersensitivities, including gluten, through the FDA Consumer Complaint System. Each complaint is thoroughly examined to determine the necessary course of action. Depending on the evaluation of potential safety concerns, the FDA may implement regulatory actions to enhance product safety, communicate new safety information to the public, or, in certain cases, remove a product from the market.

Additionally, the FDA receives reports from the industry regarding undeclared allergens via the Reportable Food Registry (RFR). Between September 2009 and September 2014, approximately one-third of foods reported to the FDA through the RFR as serious health risks were associated with undeclared allergens. Milk, among the major food allergens, was the most common cause of recalls due to undeclared allergens. Bakery products, snack foods, candy, dairy products, and dressings (such as salad dressings, sauces, and gravies) were the five most frequently implicated food types in allergen-related recalls. Within the candy category, the FDA received numerous reports of undeclared milk in dark chocolate products, highlighting dark chocolate as a higher-risk product for consumers allergic to milk.

FDA’s testing

The FDA conducts periodic surveys and sampling assignments to collect information about specific foods. For instance, in 2013 and 2014, the FDA conducted a survey aiming to estimate the prevalence of undeclared milk allergen in dark chocolate products. Another survey, involving samples collected in 2018 and 2019, sought to understand the extent to which dark chocolate bars and dark chocolate chips labeled as “dairy-free” contained levels of milk that could pose potential hazards to consumers with milk allergies. In 2015 and 2016, the FDA carried out sampling of various foods to assess compliance with “gluten-free” labeling requirements.

To detect allergens in foods, the FDA utilizes enzyme-linked immunosorbent assay (ELISA) testing, wherein antibodies attach to various allergens. The FDA employs two types of ELISA kits to test food samples, confirming results through multiple methods. Alternative allergen testing methodologies include DNA-based polymerase chain reaction and mass spectrometry. The FDA has developed the xMAP food allergen detection assay, capable of simultaneously detecting 16 allergens, including sesame, in a single analysis. This design allows for expansion to target additional food allergens, enhancing the FDA’s ability to monitor the food supply for undeclared allergens and take necessary action when identified.

Regulatory Action

The FDA has the authority to implement various regulatory actions if a food label lacks the required allergen information for a food ingredient, if a food product is discovered to inadvertently contain a food allergen due to cross-contact, or if a food product does not meet the criteria for being labeled as “gluten-free.” Depending on the circumstances, the FDA considers such products misbranded or adulterated, subjecting them to enforcement actions such as recalls, import refusal, and seizure. The agency may issue warning letters to facilities producing such foods or place foods imported from other countries on import alert for these violations. In cases warranting a recall, companies typically voluntarily remove such food products from the market.

You can find more detailed information on: What importers need to know about FSVP regulations for Food Safety

Some notes on compliance with allergen labeling regulations

• Understanding the FDA Regulations on Nutrition Fact Label 
• Ensure that the allergen statement is no smaller in size than the ingredients list.
• Utilize the same terminology as employed for the major 8 allergens. For instance, if a product contains butter, the allergen statement should read, “Contains: Milk,” not “Contains: Butter.” Even if the latter statement is accurate, the recognized allergen is milk, not butter.
• In situations where there is a suspicion that consumers may not recognize a particular ingredient as an allergen (e.g., casein), it is advisable to explicitly declare the allergen in a “contains” claim (e.g., “Contains: Milk”).
• If the product contains tree nuts, fish, or crustacean shellfish, it is imperative to specify the particular ingredient falling within that category.

Compliance with FDA regulations on allergen labeling is a crucial responsibility for food manufacturing or trading businesses. This practice helps safeguard the health of consumers, including those with food allergies.

GOL is a company specializing in FDA registration services. We have the expertise and experience to assist businesses in understanding FDA regulations on allergen labeling and ensuring accurate compliance. If you need advice on FDA regulations regarding allergen labeling, please contact GOL. We are always willing to help ensure that your products are safe for consumers.

FDA Issues Guidances on Food Allergen Labeling Requirements

Today, the U.S. Food and Drug Administration (FDA) released two guidance documents addressing food allergen labeling requirements to assist the food industry in complying with regulations to disclose major food allergens on FDA-regulated food labels. Food labels play a crucial role in safeguarding consumers with food allergies, enabling them to avoid ingredients to which they may be allergic or sensitive by identifying specific allergen labeling and reviewing the ingredient list.

One of the guidance documents is a draft titled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5); Guidance for Industry.” This draft guidance supersedes the previous edition (Edition 4) and contains new and revised questions and answers related to food allergen labeling, including provisions in the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

FALCPA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining “major food allergen” and mandating that foods or ingredients containing a major food allergen be specifically labeled with the allergen source’s name. The law identifies eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Effective January 1, 2023, the FASTER Act adds sesame to the list of major food allergens, making it the ninth recognized major food allergen in the U.S.

The draft guidance includes:

• New questions and answers on food allergen labeling requirements, covering topics such as sesame, milk, and eggs labeling; major food allergen labeling in dietary supplement products; and other technical labeling issues.
• Revised questions and answers to update and clarify information from earlier editions of the final guidance, including tree nuts, fish, and crustacean shellfish labeling.
• Illustrations demonstrating examples of labeling requirements.

Additionally, the FDA issued a final guidance with the same title to retain the questions and answers from the previous edition (Edition 4) with only editorial changes, such as renumbering the questions and reorganizing the guidance’s information.

Reference:

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Food Allergies

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