Food Allergies

Food allergies and other types of food hypersensitivities affect millions of Americans and their families.  Food allergies occur when the body’s immune system reacts to certain proteins in food. Food allergic reactions vary in severity from mild symptoms involving hives and lip swelling to severe, life-threatening symptoms, often called anaphylaxis that may involve fatal respiratory problems and shock. While promising prevention and therapeutic strategies are being developed, food allergies currently cannot be cured. Early recognition and learning how to manage food allergies, including which foods to avoid, are important measures to prevent serious health consequences.

To protect those with food allergies and other food hypersensitivities, the FDA enforces regulations requiring companies to list ingredients on packaged foods and beverages. For certain foods or substances that cause allergies or other hypersensitivity reactions, there are more specific labeling requirements.

The FDA provides guidance to the food industry, consumers, and other stakeholders on best ways to assess and manage allergen hazards in food. The FDA also conducts inspections and sampling to check that major food allergens are properly labeled on products and to determine whether food facilities implement controls to prevent allergen cross-contact (the inadvertent introduction of a major food allergen into a product) and labeling controls to prevent undeclared allergens during manufacturing and packaging. When problems are found, the FDA works with firms to recall products and provide public notification to immediately alert consumers. In addition, the FDA has the authority to seize and remove violative products from the marketplace or refuse entry of imported products.

Major Food Allergens:

Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This law identified the following eight foods as major food allergens:

• Milk
• Eggs
• Fish
• Shellfish
• Tree nuts
• Peanuts
• Wheat
• Soybeans

At the time of the law’s passage, the eight major allergens accounted for 90 percent of food allergies and serious allergic reactions in the U.S. FALCPA requires that foods or ingredients that contain a “major food allergen” be specifically labeled with the name of the allergen source. Congress passed this law to make it easier for consumers who are allergic to foods and their caregivers to identify and avoid foods that contain major food allergens. The FDA enforces the provisions of this law in most packaged food products. This includes dietary supplements but does not include meat, poultry, and egg products (which are regulated by the U.S. Department of Agriculture); alcoholic beverages subject to Alcohol and Tobacco Tax and Trade Bureau labeling regulations; raw agricultural commodities; drugs; cosmetics; and most foods sold at retail or food service establishments that are not pre-packaged with a label.

Food Labels and Allergens:

People with food allergies should read labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient already identifies that allergen’s food source name (for example, buttermilk). Otherwise, the allergen’s food source must be declared at least once on the food label in one of two ways.

The name of the food source of a major food allergen must appear:

In parentheses following the name of the ingredient.

Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

— OR —

Immediately after or next to the list of ingredients in a “contains” statement.

Example: “Contains wheat, milk, and soy.”

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

Consumers may also see advisory statements such as “may contain [allergen] or “produced in a facility that also uses [allergen].” These are used to address “cross-contact,” which can occur when multiple foods with different allergen profiles are produced in the same facility using shared equipment or on the same production line, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

FDA guidance for the food industry states that advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.

Other Allergens or Allergenic Substances:

More than 160 foods have been identified to cause food allergies in sensitive individuals. There are also several food ingredients that cause nonallergic hypersensitivity reactions in sensitive individuals that require specific labeling. For example, in addition to the eight major food allergens identified by law, the FDA monitors the food supply to determine if other allergens, food ingredients, or food additives pose a significant health risk and acts accordingly. Gluten, certain additives (e.g., yellow 5, carmine, sulfites), and emerging food allergens, such as sesame, are examples of other substances the FDA monitors and, in some cases, requires specific labeling for.

Gluten

Gluten describes a group of proteins found in certain grains (e.g., wheat, barley, and rye). In people with celiac disease, foods that contain gluten trigger an immune response that attacks and damages the lining of the small intestine. Such damage may not only limit the ability of celiac disease patients to absorb nutrients, leading to problems such as iron deficiency anemia, osteoporosis, and malnutrition, but it puts them at increased risk for potentially serious health problems, including intestinal cancers and autoimmune diseases such as diabetes. On August 2, 2013, the FDA issued a final rule defining “gluten-free” for food labeling, which helps consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content. On August 12, 2020, the FDA issued a final rule to establish compliance requirements for fermented and hydrolysed foods, or foods that contain fermented or hydrolyzed ingredients, bearing the “gluten-free” claim.

Color and Food Additives

Some individuals may have hypersensitivity reactions to a color additive. For example, FD&C Yellow No. 5, widely found in beverages, desserts, processed vegetables, drugs, makeup, and other products, may cause symptoms such as itching and hives in some people. The FDA requires all products containing FD&C Yellow No. 5 to identify it on their labels so consumers who are sensitive to the dye can avoid it. Color additives made from cochineal extract and carmine, which are derived from insects, have been identified as allergenic substances that must be declared on the label of all food and cosmetic products. Various sulfiting agents, including sodium bisulfite, are allowed as food ingredients. But due in part to adverse reactions to them, such as asthma in sensitive individuals, they must be declared on food labels when present in food and the concentration in the food is ≥10 parts per million total sulfur dioxide.

Sesame

Because sesame is not one of the eight major food allergens, manufacturers do not have to list it as an allergen based on the requirements of FALCPA, although in most cases it must appear in the ingredient statement. An exception is when sesame is part of a natural flavoring or spice. Another exception is when sesame is not in the common or usual name of a food (e.g., tahini, which is made from sesame seeds). Because sesame allergies in the U.S. population appear to have increased and severe reactions have been reported, the FDA issued a Request for Information to gather additional information on the prevalence and severity of sesame allergies in the United States to determine if additional steps are needed. In November 2020, to help consumers who are allergic or sensitive to sesame to avoid these products, the FDA issued a draft guidance to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame.

FDA Activities

The FDA takes several measures to make sure that consumers are protected from ingredients and foods they may be allergic to. These include establishing regulatory requirements, providing industry guidance, conducting surveillance, and taking regulatory actions when appropriate.

Guidance Documents and FDA Regulations:

The FDA issues guidance documents to provide industry with its current thinking about various issues. Many FDA guidance documents contain information about allergens. Certain food safety regulations also contain provisions related to allergens and other ingredients that may cause sensitivities.

Inspections:

The FDA’s “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” rule (cGMP & PC rule, 21 CFR part 117) establishes requirements applicable to establishments that manufacture, process, pack, or hold human food. The cGMP & PC rule includes requirements for allergen preventive controls to prevent allergen cross-contact in manufacturing and packaging and to prevent undeclared allergens. For example, the FDA requires facilities to put written procedures in place to control allergen cross-contact between products that contain allergens and those that are not supposed to contain them and to ensure that the products are accurately labeled with respect to allergens. The FDA inspects food manufacturers according to the applicable requirements of 21 CFR part 117 to determine whether allergen cross-contact has been minimized or prevented and whether a food facility has appropriate controls for allergen labeling.

Monitoring:

The FDA monitors reports of food allergic reactions and reports related to ingredients and food hypersensitivities (including gluten) that come into the FDA Consumer Complaint System. The FDA looks at every complaint to determine the appropriate course of action. Based on an evaluation of the potential safety concern, the FDA may take regulatory action(s) to improve product safety and protect the public health, communicate new safety information to the public, or, in certain cases, remove a product from the market.

The FDA also receives reports from industry regarding undeclared allergens through the Reportable Food Registry (RFR). For example, from September 2009 to September 2014, about one-third of foods reported to the FDA through the RFR as serious health risks involved undeclared allergens. Of the major food allergens, milk represents the most common cause of recalls due to undeclared allergens. The five food types most often involved in food allergen recalls were bakery products, snack foods, candy, dairy products, and dressings (such as salad dressings, sauces, and gravies). Within the candy category, the FDA has received many reports of undeclared milk in dark chocolate products, highlighting this food type as a higher risk product for consumers allergic to milk.

Testing:

The FDA conducts periodic surveys and sampling assignments to gather information about specific foods. For example, in 2013 and 2014, the FDA conducted a survey to estimate the prevalence of undeclared milk allergen in dark chocolate products. A second survey of samples collected in 2018 and 2019 was conducted to understand the extent to which dark chocolate bars and dark chocolate chips labeled as “dairy free” contained levels of milk that would be potentially hazardous to consumers with milk allergies. In 2015 and 2016, the FDA conducted sampling of a variety of foods to determine compliance with “gluten-free” labeling requirements.

To test for allergens in foods, the FDA uses enzyme-linked immunosorbent assay (ELISA) testing, through which antibodies attach to various allergens. The FDA tests food samples using two different types of ELISA kits before confirming the results. Other allergen testing methodologies include the DNA-based polymerase chain reaction and mass spectrometry. The FDA has developed the xMAP food allergen detection assay that can rapidly detect up to 14 allergens, including all major allergens except fish, with one sample. The FDA is currently evaluating the use of this new assay for future sampling assignments.

Regulatory Action:

The FDA can carry out a number of regulatory actions if a food label lacks required allergen information for a food ingredient, if a food product is found to inadvertently contain a food allergen due to cross-contact, or if a food product does not qualify to be labeled as “gluten-free.” The FDA considers such products misbranded or adulterated, depending on the circumstances, and subject to enforcement actions such as recalls, import refusal, and seizure. The agency may also issue warning letters to facilities making such foods, or may place foods imported from other countries on import alert for these violations. When there is a problem that justifies a recall, firms generally recall such food products from the marketplace voluntarily. Consumers can learn what products have been recalled recently on the FDA’s website, or by signing up External Link Disclaimer to receive Recalls, Market Withdrawals and Safety Alerts emails.

What to Do If Symptoms of an Allergic Reaction Occur:

Symptoms of food allergies typically appear from within a few minutes to a few hours after a person has eaten the food to which he or she is allergic. A severe, life-threatening allergic reaction is called anaphylaxis.

Symptoms of allergic reactions can include:

• Hives
• Flushed skin or rash
• Tingling or itchy sensation in the mouth
• Face, tongue, or lip swelling
• Vomiting and/or diarrhea
• Abdominal cramps
• Coughing or wheezing
• Dizziness and/or light headedness
• Swelling of the throat and vocal cords
• Difficulty breathing
• Loss of consciousness

People with a known food allergy who begin experiencing any of these symptoms should stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention. Some of these symptoms are not always due to a food allergen. So, it is important to seek proper care and diagnosis from a healthcare provider to determine if the symptoms or reaction experienced was due to a food allergen.

Reporting Adverse Reactions and Labeling Concerns:

If you think that you or a family member has had an allergic reaction or injury that might be associated with a problem of having eaten a particular food product, discuss this with your healthcare provider. If a product has unclear labeling or you believe contains an allergen that isn’t labeled, the FDA would like to know. Keep any food packages because they may contain important information. You may want to contact the manufacturer about the problem. Also, report the problem to the FDA in either of these ways:

Consumers and manufacturers can submit reports detailing product reactions or labeling concerns to an FDA Consumer Complaint Coordinator for the state where the food was purchased. You can also call FDA at 1-888-SAFEFOOD.

Consumers can submit a report using FDA’s Med Watch Online reporting form for consumers.

Reports submitted to the FDA should include as much information as possible:

• Who is reporting the incident and who was affected? Please provide names, addresses, and phone numbers.
• The name and address of the place where the product was purchased
• A clear description of the reaction, including:
  • Date the reaction occurred.
  • All symptoms experienced.
  • How long after you ate or drank the product that the reaction occurred.
  • Medications used to treat symptoms.
  • Whether the reaction required further medical care, and if so, what kind. Please provide contact information for the doctor or hospital.
• A complete description of the product, including:
  • Date of purchase.
  • Any codes or identifying marks on the label or container, such as lot number, expiration date, and UPC code.
  • Photos of the product, label, ingredient statement, and lot code.

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