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.^[1] Other countries, however, have an expanded list of major allergens. Canada, for example, identifies mustard and sulphites as major allergens^[2], while the European Union includes sesame and lupin.^[3] 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.^[4] 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.^[5]) 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.^[6] 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

FSMA

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. ^[7]

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.^[6] 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

FSMA

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. ^[7]

Food Program Guidance Under Development

FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact

Food Labels

When it comes to food allergies, strict avoidance of the food is the only way to prevent an allergic reaction. To ensure foods are safe for your needs, reading food labels is a requirement.

No Label, Do Not Eat!

It is important that children learn from an early age that they must read labels. This practice will help the child to become his or her own advocate and navigate through life safely. 

The Food Allergen Labeling and Consumer Protection Act of 2004 requires that foods containing major food allergens be listed in plain English in the ingredient list, in parentheses within the ingredient list, or after the word “contains.” It does not require companies to declare that something “may” or “might” contain, or is “processed in a shared facility” with, any of the major food allergens. 

We recommend visiting the FAACT food allergens section of this Web site to learn more about your particular allergy, hidden ingredients, alternatives, and label reading. 

Be aware of “may contain” items on a food label. Research has shown that these products very often contain low levels of the listed allergen. Likewise, be aware that some goods are labeled as “may contain” because a company cannot guarantee the total absence of an allergen, not due to some real concern that the allergen is present in small amounts.  Quantification of the exact amount of allergen in these foods is not commercially available. 

Studies are ongoing to determine just how “safe” very low levels of allergens are. Many items that are labeled “may contain” do contain parts per million of the allergen (e.g., drops of liquid in an Olympic-sized swimming pool) but other products may contain higher levels. Some individuals may tolerate these low levels better than others. There is ongoing research to better understand the risk that such tiny amounts may pose for people with food allergies, called an allergen threshold. In a few years, the policy of “strict avoidance” may change as medical professionals learn whether patients might be able to tolerate trace exposure and threshold levels are better defined. For now, strict avoidance is the most conservative approach. 

Best Practices 

• Familiarize yourself on current federal laws and resources that assist food-allergic individuals with product labeling:
  • Food Allergen Labeling and Consumer Protection Act of 2004
  • Q & A – Food Allergen Labeling and Consumer Protection Act of 2004
  • Food Allergens - FAACT
  • Slideshow with Audio: How to Read an Ingredient Label (AllergyHome)
  • Food Allergens – “How to Read a Label” (Kids with Food Allergies) 

• If a product does not have a label, it should not be eaten.

• Read labels each and every time before eating any food product.  Ingredients can change over time, or may vary depending upon the size of the product (e.g. jumbo vs snack size). 

• Statements advising that products may/might contain or are made in shared facilities with a food allergen are purely voluntary. Most companies do try to be helpful and highlight where there may be a possible risk. However, a product should not be considered “safe” just because it does not list these “maybe’s.” 

• Call the company to inquire about how their products are processed, their cleaning methods, and how items are packaged. 

• Seeking out products produced in a “dedicated” facility can add an additional level of security to ensure that food is safe. 

• Do a search on “allergy friendly” products to generate a list of allergy friendly food companies. 

• Carefully check items that are labeled “nut.” The U.S. Food and Drug Administration (FDA) classifies several items as “tree nuts” that are fruits, not tree nuts. These include coconut, lichee nut, shea nut, and Ginko nut. If you have tree nut allergies, talk with your board-certified allergist about whether to avoid these foods. 

• Only crustacean shellfish (e.g. crabs, shrimp, lobster, or crayfish) and not mollusks (eg. clams, mussels, scallops, or squid) are required to be labeled on packaged goods. 

• The labeling law applies only to foods regulated by the FDA.  Meat products, poultry products, and egg products that are regulated by USDA are not required to follow these labeling guidelines.  Contact the manufacturer if there are any questions about possible allergens. 

• Kosher labeling such as parve (or pareve) do not guarantee they are free of allergen and should not be relied upon in choosing allergy-safe foods. 

• Educate teachers, family members, your child, and yourself on the dangers of candies and foods manufactured during the holidays. Often times, candies are manufactured on shared lines that process allergens or may actually contain the allergen itself. 

• Pet foods often contain allergens, such as nuts, seeds, seafood, soy, etc. Use caution when feeding pets, and keep pet food out of reach of children with allergies. 

• Shampoos, soaps, medications, and other personal care products can contain allergens or items derived from allergens. Use caution when purchasing these products and always check the ingredients prior to use. Many of these products do not pose harm to food-allergic individuals. If this situation arises, discuss this with your physician to see if it is safe to use these products.  

• For products labeled non-dairy, check the ingredients list to ensure a derivative, or another form of dairy, is not present. 

• Allow children to participate in label reading at the grocery store. This will help build their confidence and help them make informed decisions, as they get older. 

Data has indicated that many allergic individuals have unknowingly tolerated very small amounts of allergens that were not labeled (e.g., products that get labeled “may contain” after some time on the market).  If this happens, discuss this with your physician if it may be safe to continue to include the food in the diet.

References

[1] 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 Labels

When it comes to food allergies, strict avoidance of the food is the only way to prevent an allergic reaction. To ensure foods are safe for your needs, reading food labels is a requirement.

No Label, Do Not Eat!

It is important that children learn from an early age that they must read labels. This practice will help the child to become his or her own advocate and navigate through life safely. 

The Food Allergen Labeling and Consumer Protection Act of 2004 requires that foods containing major food allergens be listed in plain English in the ingredient list, in parentheses within the ingredient list, or after the word “contains.” It does not require companies to declare that something “may” or “might” contain, or is “processed in a shared facility” with, any of the major food allergens. 

We recommend visiting the FAACT food allergens section of this Web site to learn more about your particular allergy, hidden ingredients, alternatives, and label reading. 

Be aware of “may contain” items on a food label. Research has shown that these products very often contain low levels of the listed allergen. Likewise, be aware that some goods are labeled as “may contain” because a company cannot guarantee the total absence of an allergen, not due to some real concern that the allergen is present in small amounts.  Quantification of the exact amount of allergen in these foods is not commercially available. 

Studies are ongoing to determine just how “safe” very low levels of allergens are. Many items that are labeled “may contain” do contain parts per million of the allergen (e.g., drops of liquid in an Olympic-sized swimming pool) but other products may contain higher levels. Some individuals may tolerate these low levels better than others. There is ongoing research to better understand the risk that such tiny amounts may pose for people with food allergies, called an allergen threshold. In a few years, the policy of “strict avoidance” may change as medical professionals learn whether patients might be able to tolerate trace exposure and threshold levels are better defined. For now, strict avoidance is the most conservative approach. 

Best Practices 

• Familiarize yourself on current federal laws and resources that assist food-allergic individuals with product labeling: 

* Food Allergen Labeling and Consumer Protection Act of 2004
* Q & A – Food Allergen Labeling and Consumer Protection Act of 2004
* Food Allergens - FAACT
* Slideshow with Audio: How to Read an Ingredient Label (AllergyHome)
* Food Allergens – “How to Read a Label” (Kids with Food Allergies) 

• If a product does not have a label, it should not be eaten.

• Read labels each and every time before eating any food product.  Ingredients can change over time, or may vary depending upon the size of the product (e.g. jumbo vs snack size). 

• Statements advising that products may/might contain or are made in shared facilities with a food allergen are purely voluntary. Most companies do try to be helpful and highlight where there may be a possible risk. However, a product should not be considered “safe” just because it does not list these “maybe’s.” 

• Call the company to inquire about how their products are processed, their cleaning methods, and how items are packaged. 

• Seeking out products produced in a “dedicated” facility can add an additional level of security to ensure that food is safe. 

• Do a search on “allergy friendly” products to generate a list of allergy friendly food companies. 

• Carefully check items that are labeled “nut.” The U.S. Food and Drug Administration (FDA) classifies several items as “tree nuts” that are fruits, not tree nuts. These include coconut, lichee nut, shea nut, and Ginko nut. If you have tree nut allergies, talk with your board-certified allergist about whether to avoid these foods. 

• Only crustacean shellfish (e.g. crabs, shrimp, lobster, or crayfish) and not mollusks (eg. clams, mussels, scallops, or squid) are required to be labeled on packaged goods. 

• The labeling law applies only to foods regulated by the FDA.  Meat products, poultry products, and egg products that are regulated by USDA are not required to follow these labeling guidelines.  Contact the manufacturer if there are any questions about possible allergens. 

• Kosher labeling such as parve (or pareve) do not guarantee they are free of allergen and should not be relied upon in choosing allergy-safe foods. 

• Educate teachers, family members, your child, and yourself on the dangers of candies and foods manufactured during the holidays. Often times, candies are manufactured on shared lines that process allergens or may actually contain the allergen itself. 

• Pet foods often contain allergens, such as nuts, seeds, seafood, soy, etc. Use caution when feeding pets, and keep pet food out of reach of children with allergies. 

• Shampoos, soaps, medications, and other personal care products can contain allergens or items derived from allergens. Use caution when purchasing these products and always check the ingredients prior to use. Many of these products do not pose harm to food-allergic individuals. If this situation arises, discuss this with your physician to see if it is safe to use these products.  

• For products labeled non-dairy, check the ingredients list to ensure a derivative, or another form of dairy, is not present. 

• Allow children to participate in label reading at the grocery store. This will help build their confidence and help them make informed decisions, as they get older. 

Data has indicated that many allergic individuals have unknowingly tolerated very small amounts of allergens that were not labeled (e.g., products that get labeled “may contain” after some time on the market).  If this happens, discuss this with your physician if it may be safe to continue to include the food in the diet.  

References

[1] 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