Fda food allergies what you need to know

Companies can promote a food as non-dairy even if it contains casein, a milk protein.


Natural Flavoring Can Contain Food Allergens

The law allows ingredients to hide under the term «natural flavors» unless they are one of the top 8 food allergens. If you manage any other food allergy, you need to be be aware of natural flavoring.


Allergen Avoidance Lists

The FDA food allergen label law requires foods to state if they contain a top 8 food allergen (milk, egg, peanut, tree nut, wheat, soy, fish, crustacean shellfish). Foods that contain these allergens must tell so in plain English. But, there are numerous foods and products that are not covered by the law, so it is still significant to know how to read a label for allergens.

Items that may use «hidden» names:

  1. Prescription and over-the-counter medications
  2. Foods that are not regulated by the FDA
  3. Cosmetics and personal care products
  4. Pet food, toys and crafts

It is significant to read every label, every time. Use our guides to assist you discover hidden allergens in your products. Little travel-size cards are also available to print.


Kosher Labeling and Milk or Dairy Allergy

Find out how Kosher labels can and cannot assist you in determining if a product is safe for milk allergy.


The Food Allergen Labeling Consumer Protection Act

Frequently asked questions about the law and the loopholes everyone should know.

Discover out which foods are required to reveal top allergens on their ingredient labels, where allergens are allowed to be listed, and what statements love «may contain» really mean.


  1. Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program, at , or file a MedWatch voluntary report at
  2. Contact the consumer complaint coordinator in their area. The list of FDA consumer complaint coordinators is available at

Print & Share (PDF KB)

Spanish (Español)

Watch a video on Reducing the Risks of Food Allergies.

Each year, millions of Americans own allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms,some food allergies can cause severe reactions, and may even be life-threatening.

There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are significant measures to prevent serious health consequences.

Reporting Adverse Effects and Labeling Concerns

If you ponder that you or a family member has an injury or illness that you believe is associated with having eaten a specific food, including individuals with food allergies and those with celiac disease, contact your healthcare provider immediately.

Also, report the suspected foodborne illness to FDA in either of these ways:

Individuals can report a problem with a food or its labeling, such as potential misuse of “gluten-free” claims, to FDA in either of these ways:

  • Crustacean shellfish (e.g., crab, lobster, shrimp)
  • deaths
  • Fish (e.g., bass, flounder, cod)
  • Milk
  • severe lowering of blood pressure and shock (“anaphylactic shock”)
  • Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program, at , or file a MedWatch voluntary report at
  • 30, emergency room visits
  • Persons found to own a food allergy should be taught to read labels and avoid the offending foods.

    They should also be taught, in case of accidental ingestion, to recognize the early symptoms of an allergic reaction, and be properly educated on — and armed with — appropriate treatment measures.

  • suffocation by swelling of the throat
  • Tree nuts (e.g., almonds, walnuts, pecans)
  • Wheat
  • Eggs
  • Persons with a known food allergy who start experiencing symptoms while, or after, eating a food should initiate treatment immediately, and go to a nearby emergency room if symptoms progress.
  • Peanuts
  • constricted airways in the lungs
  • Contact the consumer complaint coordinator in their area.

    The list of FDA consumer complaint coordinators is available at

  • 2, hospitalizations
  • Soybeans

Severe Food Allergies Can Be Life-Threatening

Following ingestion of a food allergen(s), a person with food allergies can experience a severe, life-threatening allergic reaction called anaphylaxis.

This can lead to:

  1. severe lowering of blood pressure and shock (“anaphylactic shock”)
  2. constricted airways in the lungs
  3. suffocation by swelling of the throat

Each year in the U.S., it is estimated that anaphylaxis to food results in:

  1. 2, hospitalizations
  2. 30, emergency room visits
  3. deaths

Prompt istration of epinephrine by autoinjector (e.g., Epi-pen) during early symptoms of anaphylaxis may assist prevent these serious consequences.

Food Allergen “Advisory” Labeling

FALCPA’s labeling requirements do not apply to the potential or unintentional presence of major food allergens in foods resulting from “cross-contact” situations during manufacturing, e.g., because of shared equipment or processing lines.

In the context of food allergens, “cross-contact” occurs when a residue or trace quantity of an allergenic food becomes incorporated into another food not intended to contain it. FDA guidance for the food industry states that food allergen advisory statements, e.g., “may contain [allergen]” or “produced in a facility that also uses [allergen]” should not be used as a substitute for adhering to current excellent manufacturing practices and must be truthful and not misleading. FDA is considering ways to best manage the use of these types of statements by manufacturers to better inform consumers.

What To Do If Symptoms Occur

The appearance of symptoms after eating food may be a sign of a food allergy.

The food(s) that caused these symptoms should be avoided, and the affected person, should contact a doctor or health care provider for appropriate testing and evaluation.

  1. Wheat
  2. Eggs
  3. Peanuts
  4. Tree nuts (e.g., almonds, walnuts, pecans)
  5. Persons found to own a food allergy should be taught to read labels and avoid the offending foods. They should also be taught, in case of accidental ingestion, to recognize the early symptoms of an allergic reaction, and be properly educated on — and armed with — appropriate treatment measures.
  6. Persons with a known food allergy who start experiencing symptoms while, or after, eating a food should initiate treatment immediately, and go to a nearby emergency room if symptoms progress.
  7. Fish (e.g., bass, flounder, cod)
  8. Crustacean shellfish (e.g., crab, lobster, shrimp)
  9. Milk
  10. Soybeans

FDA’s Role: Labeling

To assist Americans avoid the health risks posed by food allergens, FDA enforces the Food Allergen Labeling and Consumer Protection Act of (the Act).

The Act applies to the labeling of foods regulated by FDA which includes every foods except poultry, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.

As a result, food labels assist allergic consumers identify offending foods or ingredients so they can more easily avoid them.

What Are Major Food Allergens?

While more than foods can cause allergic reactions in people with food allergies, the law identifies the eight most common allergenic foods.

These foods account for 90 percent of food allergic reactions, and are the food sources from which numerous other ingredients are derived.

The eight foods identified by the law are


Severe Food Allergies Can Be Life-Threatening

Following ingestion of a food allergen(s), a person with food allergies can experience a severe, life-threatening allergic reaction called anaphylaxis.

This can lead to:

  1. severe lowering of blood pressure and shock (“anaphylactic shock”)
  2. constricted airways in the lungs
  3. suffocation by swelling of the throat

Each year in the U.S., it is estimated that anaphylaxis to food results in:

  1. 2, hospitalizations
  2. 30, emergency room visits
  3. deaths

Prompt istration of epinephrine by autoinjector (e.g., Epi-pen) during early symptoms of anaphylaxis may assist prevent these serious consequences.

Food Allergen “Advisory” Labeling

FALCPA’s labeling requirements do not apply to the potential or unintentional presence of major food allergens in foods resulting from “cross-contact” situations during manufacturing, e.g., because of shared equipment or processing lines.

In the context of food allergens, “cross-contact” occurs when a residue or trace quantity of an allergenic food becomes incorporated into another food not intended to contain it. FDA guidance for the food industry states that food allergen advisory statements, e.g., “may contain [allergen]” or “produced in a facility that also uses [allergen]” should not be used as a substitute for adhering to current excellent manufacturing practices and must be truthful and not misleading. FDA is considering ways to best manage the use of these types of statements by manufacturers to better inform consumers.

What To Do If Symptoms Occur

The appearance of symptoms after eating food may be a sign of a food allergy.

The food(s) that caused these symptoms should be avoided, and the affected person, should contact a doctor or health care provider for appropriate testing and evaluation.

  1. Wheat
  2. Eggs
  3. Peanuts
  4. Tree nuts (e.g., almonds, walnuts, pecans)
  5. Persons found to own a food allergy should be taught to read labels and avoid the offending foods. They should also be taught, in case of accidental ingestion, to recognize the early symptoms of an allergic reaction, and be properly educated on — and armed with — appropriate treatment measures.
  6. Persons with a known food allergy who start experiencing symptoms while, or after, eating a food should initiate treatment immediately, and go to a nearby emergency room if symptoms progress.
  7. Fish (e.g., bass, flounder, cod)
  8. Crustacean shellfish (e.g., crab, lobster, shrimp)
  9. Milk
  10. Soybeans

FDA’s Role: Labeling

To assist Americans avoid the health risks posed by food allergens, FDA enforces the Food Allergen Labeling and Consumer Protection Act of (the Act).

The Act applies to the labeling of foods regulated by FDA which includes every foods except poultry, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.

As a result, food labels assist allergic consumers identify offending foods or ingredients so they can more easily avoid them.

What Are Major Food Allergens?

While more than foods can cause allergic reactions in people with food allergies, the law identifies the eight most common allergenic foods.

These foods account for 90 percent of food allergic reactions, and are the food sources from which numerous other ingredients are derived.

The eight foods identified by the law are

  • Face, tongue, or lip swelling
  • When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date.

    However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  • In parentheses following the name of the ingredient.
    Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

    OR

  • Soybeans
  • What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  • What about food prepared in restaurants? How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods. However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  • Wheat
  • Are there any foods exempt from the new labeling requirements?

    Yes.

    Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  • What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens. They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  • What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  • Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes. FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  • Tingling or itchy sensation in the mouth
  • Abdominal cramps
  • Coughing or wheezing
  • Eggs
  • Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  • Milk
  • Tree nuts (e.g., almonds, walnuts, pecans)
  • Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes.

    FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  • Does FALCPA require the use of a «may contain» statement in any circumstance?

    No. Advisory statements are not required by FALCPA.

  • Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  • How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S.

    suffer from food allergies. Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  • When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  • Peanuts
  • But I don’t understand what some of the terms mean. How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid.

    For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  • Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens. In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  • How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  • FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings.

    The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report). This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling).

    The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them. FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  • Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  • Vomiting and/or diarrhea
  • Dizziness and/or lightheadedness
  • Hives
  • Loss of consciousness
  • What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product.

    Fda food allergies what you need to know

    It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility. It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  • Are mislabeled food products removed from the market?

    Yes. A food product that contains an undeclared allergen may be subject to recall.

    In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  • Difficulty breathing
  • Swelling of the throat and vocal cords
  • Crustacean shellfish (e.g., crab, lobster, shrimp)
  • FALCPA identifies only 8 allergens.

    Aren’t there more foods consumers are allergic to?

    Yes. More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  • Fish (e.g., bass, flounder, cod)
  • How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction. In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen.

    A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  • Flushed skin or rash
  • Immediately after or next to the list of ingredients in a “contains” statement.
    Example: “Contains Wheat, Milk, and Soy.”
  • How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement.

    For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  • How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  • After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes.

    FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  • Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

These eight foods, and any ingredient that contains protein derived from one or more of them, are designated as “major food allergens’ by FALCPA.

Mild Symptoms Can Become More Severe

Initially mild symptoms that happen after ingesting a food allergen are not always a measure of mild severity.

In fact, if not treated promptly, these symptoms can become more serious in a extremely short quantity of time, and could lead to anaphylaxis.

Know the Symptoms

Symptoms of food allergies typically appear from within a few minutes to 2 hours after a person has eaten the food to which he or she is allergic.

Allergic reactions can include:

  1. What about food prepared in restaurants? How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods.

    However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  2. What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens. They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  3. How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction.

    In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen. A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  4. How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  5. Abdominal cramps
  6. Tingling or itchy sensation in the mouth
  7. FALCPA identifies only 8 allergens.

    Aren’t there more foods consumers are allergic to?

    Yes. More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  8. What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  9. In parentheses following the name of the ingredient.
    Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

    OR

  10. Are there any foods exempt from the new labeling requirements?

    Yes. Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  11. FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings.

    The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report). This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling).

    The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them. FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  12. Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  13. But I don’t understand what some of the terms mean.

    How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid. For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  14. What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility. It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  15. How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S.

    suffer from food allergies. Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  16. Dizziness and/or lightheadedness
  17. After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes. FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  18. Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes.

    FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  19. Flushed skin or rash
  20. Hives
  21. Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes. FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  22. Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  23. Immediately after or next to the list of ingredients in a “contains” statement.
    Example: “Contains Wheat, Milk, and Soy.”
  24. Are mislabeled food products removed from the market?

    Yes.

    A food product that contains an undeclared allergen may be subject to recall.

    Fda food allergies what you need to know

    In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  25. How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  26. Coughing or wheezing
  27. How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  28. Face, tongue, or lip swelling
  29. Swelling of the throat and vocal cords
  30. Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  31. When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date. However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  32. Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens.

    In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  33. Does FALCPA require the use of a «may contain» statement in any circumstance?

    No. Advisory statements are not required by FALCPA.

  34. Vomiting and/or diarrhea
  35. Loss of consciousness
  36. What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  37. When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  38. Difficulty breathing
  39. Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

About Other Allergens

Persons may still be allergic to — and own serious reactions to — foods other than the eight foods identified by the law.

So, always be certain to read the food label’s ingredient list carefully to avoid the food allergens in question.

How Major Food Allergens Are Listed

The law requires that food labels identify the food source names of every major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient (e.g., buttermilk) that is a major food allergen already identifies that allergen’s food source name (i.e., milk). Otherwise, the allergen’s food source name 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:

These eight foods, and any ingredient that contains protein derived from one or more of them, are designated as “major food allergens’ by FALCPA.

Mild Symptoms Can Become More Severe

Initially mild symptoms that happen after ingesting a food allergen are not always a measure of mild severity.

In fact, if not treated promptly, these symptoms can become more serious in a extremely short quantity of time, and could lead to anaphylaxis.

Know the Symptoms

Symptoms of food allergies typically appear from within a few minutes to 2 hours after a person has eaten the food to which he or she is allergic.

Allergic reactions can include:

  1. What about food prepared in restaurants? How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods. However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  2. What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens.

    They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  3. How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction. In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen. A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  4. How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  5. Abdominal cramps
  6. Tingling or itchy sensation in the mouth
  7. FALCPA identifies only 8 allergens. Aren’t there more foods consumers are allergic to?

    Yes. More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  8. What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  9. In parentheses following the name of the ingredient.
    Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

    OR

  10. Are there any foods exempt from the new labeling requirements?

    Yes.

    Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  11. FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings. The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report).

    This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling). The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them.

    FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  12. Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  13. But I don’t understand what some of the terms mean. How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid.

    For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  14. What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility.

    It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  15. How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S. suffer from food allergies. Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  16. Dizziness and/or lightheadedness
  17. After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes.

    FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  18. Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes. FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  19. Flushed skin or rash
  20. Hives
  21. Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes.

    FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  22. Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  23. Immediately after or next to the list of ingredients in a “contains” statement.
    Example: “Contains Wheat, Milk, and Soy.”
  24. Are mislabeled food products removed from the market?

    Yes.

    A food product that contains an undeclared allergen may be subject to recall. In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  25. How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  26. Coughing or wheezing
  27. How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  28. Face, tongue, or lip swelling
  29. Swelling of the throat and vocal cords
  30. Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  31. When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date.

    However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  32. Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens. In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  33. Does FALCPA require the use of a «may contain» statement in any circumstance?

    No.

    Advisory statements are not required by FALCPA.

  34. Vomiting and/or diarrhea
  35. Loss of consciousness
  36. What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  37. When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  38. Difficulty breathing
  39. Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

About Other Allergens

Persons may still be allergic to — and own serious reactions to — foods other than the eight foods identified by the law.

So, always be certain to read the food label’s ingredient list carefully to avoid the food allergens in question.

How Major Food Allergens Are Listed

The law requires that food labels identify the food source names of every major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient (e.g., buttermilk) that is a major food allergen already identifies that allergen’s food source name (i.e., milk). Otherwise, the allergen’s food source name 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:

  • What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility. It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  • How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction.

    In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen. A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  • FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings. The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report).

    This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling). The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them.

    FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  • When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  • How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  • What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens. They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  • Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens.

    In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  • How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement.

    Fda food allergies what you need to know

    For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  • FALCPA identifies only 8 allergens. Aren’t there more foods consumers are allergic to?

    Yes. More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  • Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  • Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes.

    FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  • Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  • How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S. suffer from food allergies.

    Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  • How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  • In parentheses following the name of the ingredient.
    Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

    OR

  • What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  • Immediately after or next to the list of ingredients in a “contains” statement.
    Example: “Contains Wheat, Milk, and Soy.”
  • Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  • Are there any foods exempt from the new labeling requirements?

    Yes.

    Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  • What about food prepared in restaurants? How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods.

    However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  • But I don’t understand what some of the terms mean. How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid.

    For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  • Does FALCPA require the use of a «may contain» statement in any circumstance?

    No. Advisory statements are not required by FALCPA.

  • When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date.

    However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  • What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  • Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes.

    FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  • Are mislabeled food products removed from the market?

    Yes. A food product that contains an undeclared allergen may be subject to recall. In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  • After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes.

    Fda food allergies what you need to know

    FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  • Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

Other Resources

The Food Allergen Labeling and Consumer Protection Act (FALCPA) will improve food labeling information for the millions of consumers who suffer from food allergies.

The Act will be especially helpful to children who must study to recognize the allergens they must avoid.

The following questions and answers will be useful in answering questions about FALCPA, food allergen labeling, gluten, and advice for consumers.

  • What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  • Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens.

    In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  • When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  • What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens.

    They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  • FALCPA identifies only 8 allergens. Aren’t there more foods consumers are allergic to?

    Yes.

    Fda food allergies what you need to know

    More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  • How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S. suffer from food allergies. Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  • Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  • FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings.

    The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report). This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling).

    The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them. FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  • Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  • How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  • Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  • After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes. FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  • Does FALCPA require the use of a «may contain» statement in any circumstance?

    No.

    Advisory statements are not required by FALCPA.

  • Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes. FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  • Are there any foods exempt from the new labeling requirements?

    Yes. Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  • Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes.

    FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  • What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  • How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  • What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility. It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  • Are mislabeled food products removed from the market?

    Yes. A food product that contains an undeclared allergen may be subject to recall. In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  • How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction.

    In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen. A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  • But I don’t understand what some of the terms mean.

    Fda food allergies what you need to know

    How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid. For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  • What about food prepared in restaurants?

    How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods. However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  • How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  • When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date. However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  • Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

  • Choosing Safe Foods: How to Read Labels So You Can Avoid Food Allergens

    The only way to prevent allergic reactions is to avoid the foods you (or your child) are allergic to.

    It is significant to know how to identify those foods, as well as to understand how foods are labeled in the U.S.

    Other Resources

    The Food Allergen Labeling and Consumer Protection Act (FALCPA) will improve food labeling information for the millions of consumers who suffer from food allergies. The Act will be especially helpful to children who must study to recognize the allergens they must avoid.

    The following questions and answers will be useful in answering questions about FALCPA, food allergen labeling, gluten, and advice for consumers.

  • What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of ?

    FALCPA is an amendment to the Federal Food, Drug, and Cosmetic Act and requires that the label of a food that contains an ingredient that is or contains protein from a «major food allergen » declare the presence of the allergen in the manner described by the law.

  • Why did Congress pass this Act?

    Congress passed this Act to make it easier for food allergic consumers and their caregivers to identify and avoid foods that contain major food allergens. In fact, in a review of the foods of randomly selected manufacturers of baked goods, ice cream, and candy in Minnesota and Wisconsin in , FDA found that 25 percent of sampled foods failed to list peanuts or eggs as ingredients on the food labels although the foods contained these allergens.

  • When does FALCPA become effective?

    FALCPA applies to food products that are labeled on or after January 1,

  • What is a «major food allergen?»

    FALCPA identifies eight foods or food groups as the major food allergens.

    They are milk, eggs, fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), tree nuts (e.g., almonds, walnuts, pecans), peanuts, wheat, and soybeans.

  • FALCPA identifies only 8 allergens. Aren’t there more foods consumers are allergic to?

    Yes. More than foods own been identified to cause food allergies in sensitive individuals. However, the eight major food allergens identified by FALCPA account for over 90 percent of every documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.

  • How serious are food allergies?

    It is estimated that 2 percent of adults and about 5 percent of infants and young children in the U.S.

    suffer from food allergies. Approximately 30, consumers require emergency room treatment and Americans die each year because of allergic reactions to food.

  • Does FALCPA apply to imported foods as well?

    FALCPA applies to both domestically manufactured and imported packaged foods that are subject to FDA regulation.

  • FDA held public meetings on allergens and gluten; what were the outcomes of those meetings?

    FDA held two meetings.

    The first meeting, a Food Advisory Committee Meeting held in June , evaluated FDA’s draft report, «Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food.» See Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food (Draft Report). This draft report was written to assist develop FDA’s policy on food allergens and to implement FALCPA.

    FDA held a second public meeting in August to obtain expert comment and consultation from stakeholders to assist FDA develop a regulation to define and permit the voluntary use on food labeling of the term «gluten-free» (Public Meeting On: Gluten-Free Food Labeling).

    The meeting focused on food manufacturing, analytical methods, and consumer issues related to reduced levels of gluten in food. Information presented during and following the meeting provided FDA significant and relevant data regarding current industry practices in the production of foods marketed as «gluten-free,» challenges faced by manufacturers of «gluten-free» foods, and consumer perceptions and expectations of what «gluten-free» means to them.

    FDA is using this information to develop its proposal on the use of the term «gluten-free.»

  • Will FDA establish a threshold level for any allergen?

    FDA may consider a threshold level for one or more food allergens.

  • How will food labels change as a result of FALCPA?

    FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways.

    The first option for food manufacturers is to include the name of the food source in parenthesis following the common or usual name of the major food allergen in the list of ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement.

    For example:

    Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk), eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)

    The second option is to put the expression «Contains» followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients.

    For example:

    Contains Wheat, Milk, Egg, and Soy

  • Will the ingredient list be specific about what type of tree nut, fish, or shellfish is in the product?

    FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts); the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

  • After January 1, , will I still discover products on the supermarket or grocery shelf without the improved labeling?

    Yes. FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so endless as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product’s ingredient statement in conjunction with any «contains» statement.

  • Does FALCPA require the use of a «may contain» statement in any circumstance?

    No.

    Advisory statements are not required by FALCPA.

  • Are flavors, colors, and food additives subject to the allergen labeling requirements?

    Yes. FALCPA requires that food manufacturers label food products that contain ingredients, including a flavoring, coloring, or incidental additive that are, or contain, a major food allergen using plain English to identify the allergens.

  • Are there any foods exempt from the new labeling requirements?

    Yes. Under FALCPA, raw agricultural commodities (generally unused fruits and vegetables) are exempt as are highly refined oils derived from one of the eight major food allergens and any ingredient derived from such highly refined oil.

  • Can food manufacturers enquire to own a product exempted from the new labeling requirements?

    Yes.

    FALCPA provides mechanisms by which a manufacturer may request that a food ingredient covered by FALCPA may be exempt from FALCPA’s labeling requirements. An ingredient may be exempt if it does not cause an allergic response that poses a risk to human health or if it does not contain allergenic protein.

  • What does FDA require in order for a product to be exempt?

    FALCPA states that any person can petition the Secretary of Health and Human Services for an exemption either through a petition process or a notification process.

    The petition process requires scientific evidence (including the analytical method used to produce the evidence) that demonstrates that such food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

    The notification process must include scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the production method specified in the notification) does not contain allergenic protein.

    If either the petition or the notification is granted by the Secretary, the result is that the ingredient in question is not considered a «major food allergen» and is not subject to the labeling requirements.

    For a list of the notifications for exemptions FDA has received, see: Inventory of Notifications Received under 21 U.S.C.

    (w)(7) for Exemptions from Food Allergen Labeling; for a list of the petitions for exemptions FDA has received, see: Inventory of Petitions Received under 21 U.S.C. (w)(6) for Exemptions from Food Allergen Labeling.

  • How will FDA make certain food manufacturers adhere to the new labeling regulations?

    As a part of its routine regulatory functions, FDA inspects a variety of packaged foods to ensure that they are properly labeled.

  • What is cross-contact?

    Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may happen when multiple foods are produced in the same facility.

    It may happen due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.

  • Are mislabeled food products removed from the market?

    Yes. A food product that contains an undeclared allergen may be subject to recall. In addition, a food product that is not properly labeled may be misbranded and subject to seizure and removed from the market place.

    The number of recalls due to undeclared allergens (8 of the most common allergens only) remained steady between and In , recall actions almost doubled, rising from 68 to This rise may be attributed to the increased awareness of food allergies among consumers and manufacturers and increased attention from FDA inspectors to issues related to food allergy in manufacturing plants.

  • How can I avoid foods to which I’m allergic?

    FDA advises consumers to work with health care providers to discover out what food(s) can cause an allergic reaction.

    In addition, consumers who are allergic to major food allergens should read the ingredient statement on food products to determine if products contain a major allergen. A «Contains _______ » statement, if present on a label, can also be used to determine if the food contains a major food allergen.

  • But I don’t understand what some of the terms mean. How will I know what they are?

    FALCPA was designed to improve food labeling information so that consumers who suffer from food allergies — especially children and their caregivers — will be capable to recognize the presence of an ingredient that they must avoid.

    For example, if a product contains the milk-derived protein casein, the product’s label would own to use the term «milk» in addition to the term «casein» so that those with milk allergies would clearly understand the presence of an allergen they need to avoid.

  • What about food prepared in restaurants? How will I know that the food I ordered does not contain an ingredient to which I am allergic?

    FALCPA only applies to packaged FDA-regulated foods. However, FDA advises consumers who are allergic to specific foods to enquire questions about ingredients and preparation when eating at restaurants or any put exterior the consumer’s home.

  • How will FALCPA apply to foods purchased at bakeries, food kiosks at the mall, and carry out restaurants?

    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 in response to a consumer’s order — such as the paper or box used to provide a sandwich ordered by a consumer.

  • When will consumers see the food labels change?

    FALCPA applies to food products that are labeled on or after January 1, , so FDA anticipates that consumers will start to see new labels on or after that date. However, FDA cautions consumers that there will be a transition period of undetermined length after January 1, , during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

  • Where can I discover more information on food allergens?

    See the following websites for additional information on food allergens:

  • Choosing Safe Foods: How to Read Labels So You Can Avoid Food Allergens

    The only way to prevent allergic reactions is to avoid the foods you (or your child) are allergic to.

    It is significant to know how to identify those foods, as well as to understand how foods are labeled in the U.S.


    Cross-Contact or Cross-Contamination of Foods with Allergens

    What is cross-contact?

    Fda food allergies what you need to know

    How can you prevent allergic reactions from cross-contact?


    RELATED VIDEO: