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December 12, 2005; Updated July 18, 2006

Information for Consumers:

Food Allergen Labeling And Consumer Protection Act of 2004

Questions and Answers

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 learn to recognize the allergens

they must avoid. (See Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282, Title II).

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

for consumers.

General

1. What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004?

2. Why did Congress pass this Act?

3. When does FALCPA become effective?

4. What is a "major food allergen?"

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

6. How serious are food allergies?

7. Does FALCPA apply to imported foods as well?

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

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

Labeling

10. How will food labels change as a result of FALCPA?

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

After January 1, 2006, will I still find products on the supermarket or grocery shelf without the

improved labeling?

12.

13. Does FALCPA require the use of a "may contain" statement in any circumstance?

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

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

16. Can food manufacturers ask to have a product exempted from the new labeling requirements?

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

18. How will FDA make sure food manufacturers adhere to the new labeling regulations?

19. What is cross-contact?

20. Are mislabeled food products removed from the market?

Gluten

21. Why is there a concern about gluten?

22. What does FALCPA require with regard to gluten?

23. What has FDA done in response to the FALCPA mandate?

Advice for Consumers

24. How can I avoid foods to which I'm allergic?

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

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?

26.

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

restaurants?

27.

28. When will consumers see the food labels change?

29. Where can I find more information on food allergens?

General

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What is the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004?

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.

1.

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 1999, 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.

2.

When does FALCPA become effective?

FALCPA applies to food products that are labeled on or after January 1, 2006.

3.

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.

4.

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

Yes. More than 160 foods have been identified to cause food allergies in sensitive individuals. However, the eight major food

allergens identified by FALCPA account for over 90 percent of all documented food allergies in the U.S. and represent the

foods most likely to result in severe or life-threatening reactions.

5.

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 30,000 consumers require emergency room treatment and 150 Americans die each year because of

allergic reactions to food.

6.

Does FALCPA apply to imported foods as well?

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

7.

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 2005, 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 help develop

FDA's policy on food allergens and to implement FALCPA.

FDA held a second public meeting in August 2005 to obtain expert comment and consultation from stakeholders to help 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 important 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."

8.

Will FDA establish a threshold level for any allergen?

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

9.

Labeling

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:

10.

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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 place the word "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.

11.

After January 1, 2006, will I still find 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 long as the products were labeled before January 1, 2006. Therefore, FDA

advises consumers with allergies to always read a product's ingredient statement in conjunction with any "contains"

statement.

12.

Does FALCPA require the use of a "may contain" statement in any circumstance?

No. Advisory statements are not required by FALCPA.

13.

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.

14.

Are there any foods exempt from the new labeling requirements?

Yes. Under FALCPA, raw agricultural commodities (generally fresh 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.

15.

Can food manufacturers ask to have 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.

16.

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. 343(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. 343(w)(6) for Exemptions from Food Allergen Labeling.

17.

How will FDA make sure 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.

18.

19. What is cross-contact?

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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 occur when multiple foods are produced in the same facility. It may occur 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 1999

and 2001. In 2002, recall actions nearly doubled, rising from 68 to 116. 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.

20.

Gluten

Why is there a concern about gluten?

Gluten describes a group of proteins found in certain grains (wheat, barley, and rye.) It is of concern because people with

celiac disease cannot tolerate it. Celiac disease (also known as celiac sprue) is a chronic digestive disease that damages the

small intestine and interferes with absorption of nutrients from food. Recent findings estimate that 2 million people in the U.S.

have celiac disease or about 1 in 133 people.

21.

What does FALCPA require with regard to gluten?

FALCPA requires FDA to issue a proposed rule that will define and permit the voluntary use of the term "gluten free" on the

labeling of foods by August 2006 and a final rule no later than August 2008.

22.

What has FDA done in response to the FALCPA mandate?

FDA held a public meeting in August 2005 to obtain expert comment and consultation from stakeholders to help 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.

23.

Advice for Consumers

How can I avoid foods to which I'm allergic?

FDA advises consumers to work with health care providers to find 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.

24.

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 able 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 have 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.

25.

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 particular

foods to ask questions about ingredients and preparation when eating at restaurants or any place outside the consumer's

home.

26.

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.

27.

When will consumers see the food labels change?

FALCPA applies to food products that are labeled on or after January 1, 2006, so FDA anticipates that consumers will begin

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, 2006, during which it is likely that consumers will see packaged food on store shelves

28.

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and in consumers' homes without the revised allergen labeling.

Where can I find more information on food allergens?

See the following websites for additional information on food allergens:

Food and Drug Administration: Information about Food Allergens

U.S. Department of Agriculture: Food Safety and Inspection Service

The National Institute of Health: National Institute of Allergies and Infectious Diseases

The National Library of Medicine: MedlinePlus Food Allergy

29.

Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer

Protection Act of 2004 October 5, 2005

Food Allergens

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