Food Allergy & Anaphylaxis
Food Allergen Labeling & Consumer Protection Act (FALCPA)
The Food Allergen Labeling and Consumer Protection Act (FALCPA) identifies eight major food allergens in the U.S.: milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. Other countries, however, have an expanded list of major allergens. Canada, for example, identifies mustard and sulphites as major allergens, while the European Union includes sesame and lupin. Although FALCPA applies only to packaged foods regulated by FDA (both domestic and imported), the USDA (through its Food Safety Inspection Service, or FSIS) has made it clear that, in order to achieve consistency, the agency would also follow the FALCPA labeling requirement for USDA-regulated products. The requirements under FALCPA also apply to items packaged by foodservice establishments and offered for human consumption; FALCPA would not apply, however, to food items placed in a wrapper, container, or box in response to a customer’s order e.g., a fast-food establishment.14
FALCPA requires that major allergens be declared, in plain English, on ingredient labels. What is more, in the case of tree nuts, fish, and shellfish, the particular allergen must be declared e.g., walnut, salmon, shrimp, etc. (A complete list of tree nuts, along with a link to a complete list of seafood items, can be seen in an FDA Guidance for Industry document.) The FALCPA requirements do not apply to any other food not identified as one of the eight major allergens even though they have been shown to cause allergic reactions (e.g., sesame, mustard, and other types of seeds).
Manufacturers can comply with the FALCPA requirement in one of three ways:
1) by listing the allergen, in plain English, in the ingredient list itself e.g., INGREDIENTS: Rice, sugar, freeze-dried strawberries, wheat, malt flavoring, milk …
2) by listing the allergen, in plain English, in a parenthetical immediately after the scientific ingredient term e.g., sodium caseinate (milk), semolina (wheat), albumin (egg) …
3) by having a separate “Contains” statement immediately after or adjacent to the list of ingredients (in a font size at least as large as the ingredient list) e.g., “Contains milk and soy”.
Examples of Allergen Labeling
FALCPA creates a mechanism for companies to obtain an exemption from allergen labeling requirements where: 1) scientific evidence establishes that a food ingredient does not contain allergenic protein, or 2) the FDA determines that the ingredient does not cause an allergic response that poses a risk to human health. There is also a statutory exemption for all highly refined oils, which are generally safe for consumers with food allergy. Companies that do not comply with FALCPA could be subject to civil or criminal penalties under the Federal Food, Drug, and Cosmetic Act. FDA also has the authority to seize packaged food products that are not FALCPA-compliant, along with the authority to request that the food product be recalled by the manufacturer or distributor in the case of an undeclared allergen. Food protection specialists should also be aware that consumers who suspect that an FDA-regulated food product is not FALCPA-compliant can report the product via an FDA consumer complaint center. Consumers can also take it upon themselves to pay a private food laboratory to conduct an allergen analysis of a food product.Although FALCPA has greatly improved the ability of food-allergic individuals and their families to read and interpret food labels, the law does not regulate the use of precautionary allergen statements, sometimes termed supplemental allergen labeling, such as “may contain”, “manufactured in a shared facility”, and “processed on the same equipment”. Consumers often feel as if these types of statements are confusing and misleading, and sometimes criticize companies for using them on food labels. While FDA has been studying the “may contain” issue for a number of years, standardization of the statements, along with guidance for their use, appears unlikely in the near future.
The FDA has control over:
- Packaged foods
- Conventional foods
- Vitamins and dietary supplements
- Infant formula and infant foods
- Medical foods
FALCPA law does not apply to:
- Prescription drugs
- Over-the-counter drugs
- Personal care items such as cosmetics, shampoo, mouthwash, toothpaste or shaving cream.
- Any food product regulated by the USDA, which includes meat, poultry, or certain egg products.
- Any product regulated by the Alcohol, Tobacco Tax and Trade Bureau (ATTB). This includes alcoholic drinks, spirits, beer and tobacco products.
- Any restaurant foods or foods that are placed in a wrapper or container in response to a person's order for that food. This includes street vendors, festival foods, fast food restaurants.
- Kosher labeling
- Pet foods, supplements, and supplies
The Food Safety Modernization Act (FSMA) placed greater importance on the control of major food allergens. The new law requires manufacturing facilities to identify and evaluate known or reasonably foreseeable hazards, and develop a written analysis of the hazards. For the purpose of FSMA, a hazard includes biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives, whether these hazards occur naturally, may be unintentionally introduced, or intentionally introduced through an act of terrorism. Along with a written analysis of hazards, facilities are also required to develop preventive control procedures, practices, and processes to significantly minimize or prevent the hazards identified in the written analysis. The law specifies that these preventive control measures may include a food allergen control program.
FASTER Act of 2021
Under the FASTER Act of 2021, sesame is being added as the 9th major food allergen effective January 1, 2023. Until that time, manufacturers do not have to list it as an allergen, 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). 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. The guidance is intended to help protect consumers who are allergic to sesame by encouraging manufacturers to identify all ingredients that contain sesame right now. 
 Food Allergen Labeling and Consumer Protection Act of 2004. Public Law 108-282, Title II. https://www.fda.gov/food/food-allergensgluten-free-guidance-documents-regulatory-information/food-allergen-labeling-and-consumer-protection-act-2004-falcpa
 Food Allergy Canada. Accessed July, 2013 at
 The Anaphylaxis Campaign (U.K.). Accessed July, 2013 at
 United States Department of Agriculture. New Food Allergen Labeling Laws (August 2006, revised). Accessed July, 2013 at
 Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance. Accessed July, 2013 at
 Food and Drug Administration. What is the Food Allergen Labeling and Consumer Protection Act of 2004. https://www.fda.gov/industry/fda-basics-industry/what-food-allergen-labeling-and-consumer-protection-act-2004
 Food and Drug Administration. Food Labeling and Nutrition. Food Allergies (Sesame). FASTER Act of 2021. https://www.fda.gov/food/food-labeling-nutrition/food-allergies
FDA recently issued a final rule allowing the use of the term “gluten-free” on food labels where the food product contains less than 20 parts-per-million (ppm) of gluten.