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April 6, 2006

A more recent version of this guidance issued in October 2006. Below is an earlier version.

Guidance for Industry

Questions and Answers Regarding Food Allergens, including

the Food Allergen Labeling and Consumer Protection Act of

2004 (Edition 3)*

Final Guidance

Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

For questions regarding this document, contact Rhonda R. Kane at the Center for Food Safety and Applied Nutrition (CFSAN) at

301-436-2371 or email rhonda.kane@fda.hhs.gov.

Additional copies are available from:

Office of Nutritional Products, Labeling, and Dietary Supplements, HFS-800

Center for Food Safety and Applied Nutrition

Food and Drug Administration

5100 Paint Branch Parkway

College Park, MD 20740

http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Food Safety and Applied Nutrition

April 6, 2006

Guidance for Industry

Questions and Answers Regarding Food Allergens, including

the Food Allergen Labeling and Consumer Protection Act of

2004 (Edition 3)

This guidance represents the current thinking of the Food and Drug Administration on this topic. It does not create or

confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be

used if such approach satisfies the requirements of the applicable statute and regulations. If you wish to discuss an

alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the

appropriate FDA staff, call the telephone number listed on the title page of this document.

I. Introduction

As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act required that the label of a food that is

fabricated from two or more ingredients declare each ingredient by its common or usual name (except that spices, flavorings, and

colors could be declared as a class.) Although ingredient declarations complying with section 403(i) provide some information to

food allergic consumers, in some cases, the common or usual name of an ingredient may be unfamiliar to consumers and many

consumers do not recognize that certain ingredients contain or are derived from a food allergen. This situation led, at least in part, to

the enactment of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Pub. L. 108-282).

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This is a revision of the second edition of a guidance document that contains questions and answers relating to food allergens,

including questions and answers about the Food Allergen Labeling and Consumer Protection Act. FDA expects to continue to issue

subsequent editions of this guidance document by adding new questions and answers to the guidance; new questions and answers

will be identified by the date that they are added to the guidance.

FDA's guidance documents, including this document, do not establish legally enforceable responsibilities. Instead, guidance

documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific

regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested

or recommended, but not required.

II. Questions and Answers

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

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August

2004, and addresses, among other issues, the labeling of foods that contain certain food allergens.

1.

When do the labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA) become

effective for packaged foods sold in the United States?

All packaged foods regulated under the Federal Food, Drug, and Cosmetic Act (FFD&C Act) that are labeled on or after

January 1, 2006, must comply with FALCPA's food allergen labeling requirements.

2.

Must products with labels that do not comply with FALCPA be removed from the market place once the new labeling

law is effective?

No. FALCPA does not require any action with respect to products labeled before January 1, 2006.

3.

What is a "major food allergen?"

Under FALCPA, a "major food allergen" is an ingredient that is one of the following five foods or from one of the following

three food groups or is an ingredient that contains protein derived from one of the following:

milk

egg

fish

Crustacean shellfish

tree nuts

wheat

peanuts

soybeans

4.

Does FALCPA provide any specific direction for declaring the presence of ingredients from the three food groups

that are designated as "major food allergens (i.e., tree nuts, fish, and Crustacean shellfish?")

Yes. FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or

walnuts). The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or

shrimp).

5.

Are there food allergens other than those directly addressed by FALCPA?

Congress designated eight foods or food groups as "major food allergens." These foods or food groups account for 90

percent of all food allergies. Although there are other foods to which sensitive individuals may react, the labels of packaged

foods containing these other allergens are not required to be in compliance with FALCPA.

6.

What types of foods are covered by the FALCPA labeling requirements?

FALCPA's requirements apply to all packaged foods sold in the U.S. that are regulated under the Federal Food, Drug, &

Cosmetic Act, including both domestically manufactured and imported foods. FDA regulates all foods except meat products,

poultry products, and egg products.

7.

Are fresh fruits and vegetables in their natural state subject to FALCPA's requirements?

No. Raw agricultural commodities such as fresh fruits and vegetables in their natural state are not affected by FALCPA.

8.

Does FALCPA affect the labeling of packaged meat, poultry, and egg products regulated by the U.S. Department of

Agriculture (USDA)?

9.

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FALCPA's requirements apply only to those foods regulated by the Food and Drug Administration under the FFD&C Act. We

recommend that producers of meat products, poultry products, and egg products regulated by USDA contact the appropriate

USDA agency regarding the labeling of such products.

May the terms "soybean," "soy," and "soya" be considered synonyms for the term "soybeans" for the purpose of

satisfying the FALCPA labeling requirements?

Yes. "Soybean," "soy," and "soya" are reasonable synonyms for the common or usual name "soybeans," and any one of

these terms may be used to identify the food source of the major food allergen "soybeans."

10.

When is it appropriate to use the term "soybeans" versus a synonym in food labeling?

Packaged foods that are made using soybeans as an ingredient or as a component of a multi-component ingredient (e.g., soy

sauce or tofu) should continue to use the word "soybeans" as the appropriate common or usual name for this ingredient to

identify properly the ingredient (e.g., "soy sauce (water, wheat, soybeans, salt)").

11.

May the singular term "peanut" be substituted for the plural term "peanuts," and may the singular terms (e.g.,

almond, pecan, or walnut) be used to describe the different types of "tree nuts" (e.g., almonds, pecans, or walnuts)

to satisfy the labeling requirements of FALCPA?

Yes. FDA believes that "peanut" is an acceptable substitute for "peanuts" and that the names of the different types of tree

nuts may be expressed in either the singular or plural form for the purpose of satisfying the FALCPA labeling requirements.

12.

May a "Contains" statement on a food label provided in accordance with FALCPA list only the names of the food

sources of the major food allergens that are not already identified in the ingredient list for a packaged food?

No. If a "Contains" statement is used on a food label, the statement must include the names of the food sources of all major

food allergens used as ingredients in the packaged food. For example, if "sodium caseinate," "whey," "egg yolks," and

"natural peanut flavor" are declared in a product's ingredients list, any "Contains" statement appearing on the label

immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present

(e.g., "Contains milk, egg, peanuts") in the same type (i.e., print or font) size as that used for the ingredient list..

13.

Is there more than one way to word a "Contains" statement used to declare the major food allergens in a packaged

food?

Yes. The wording for a "Contains" statement may be limited to just stating the word "Contains" followed by the names of the

food sources of all major food allergens that either are or are contained in ingredients used to make the packaged product.

Alternatively, additional wording may be used for a "Contains" statement to more accurately describe the presence of any

major food allergens, provided that the following three conditions are met:

The word "Contains" with a capital "C" must be the first word used to begin a "Contains" statement. (The use of

bolded text and punctuation within a "Contains" statement is optional.)

a.

The names of the food sources of the major food allergens declared on the food label must be the same as those

specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus plural

terms (e.g., walnut versus walnuts) and the synonyms "soy" and "soya" may be substituted for the food source name

"soybeans."

b.

If included on a food label, the "Contains" statement must identify the names of the food sources for all major food

allergens that either are in the food or are contained in ingredients of the food.

c.

14.

Is there a penalty for non-compliance with FALCPA?

Yes. A company and its management may be subject to civil sanctions, criminal penalties, or both under the Federal Food,

Drug, and Cosmetic Act if one of its packaged food products does not comply with the FALCPA labeling requirements. FDA

may also request seizure of food products where the label of the product does not conform to FALCPA's requirements. In

addition, FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or

distributor.

15.

Does FALCPA require food manufacturers to label their products with advisory statements, such as "may contain

[allergen]" or "processed in a facility that also processes [allergen]?"

No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of

unintentional ingredients in food products resulting from the food manufacturing process. FALCPA does require FDA to submit

a report to Congress, a part of which assesses the use of, and consumer preferences about, advisory labeling. In earlier

guidance, FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for

adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain

[allergen]" must be truthful and not misleading.

16.

17. Does FALCPA require FDA to set so-called thresholds for any food allergen?

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FALCPA does not require FDA to establish a threshold level for any food allergen. It is not unlikely, however, that FDA will at

some point need to consider a threshold level for one or more food allergens in the context of reviewing a petition or a

notification submitted to request that an ingredient be exempt from FALCPA's labeling requirements.

[Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of

cross-contact subject to FALCPA's labeling requirements?

No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the

result of cross-contact. In the context of food allergens, "cross-contact " occurs when a residue or other trace amount of an

allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Crosscontact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage,

transportation, or production equipment.

18.

[Added April, 2006] What information has been added to the 2005 FDA Food Code related to food allergens?

FDA's Food Code is a model code available for adoption by local, state, and other jurisdictions to apply to all food

establishments at the retail level that provide food directly to consumers, including: restaurants, grocery stores,

supermarkets, hospitals, nursing homes, child care centers, and temporary food establishments.

The following new food allergen information has been added to the 2005 Food Code:

A definition of "major food allergen," which is consistent with the definition in the Food Allergen Labeling and Consumer

Protection Act of 2004 (FALCPA) [Paragraph 1-201.10(B)].

A new provision under Demonstration of Knowledge [Subparagraph 2-102.11(C)(9)] specifying that the person in

charge of a food establishment shall have an understanding of the foods identified as major food allergens and the

symptoms that a major food allergen could cause in a sensitive individual. This additional element is significant because

nationally recognized certifiers of food managers who provide training and testing of such managers consult these

elements when the certifiers routinely upgrade their training and testing programs.

Integration of FALCPA's labeling provisions to reflect the additional requirements that apply to food that is packaged at

the retail level [Subparagraph 3-602.11(B)(5)].

Additional background information on food allergens in Annex 4, including common characteristics of a food allergic

response and detailed information regarding the requirements of FALCPA.

19.

[Added April, 2006] Do retail and foodservice establishments have to comply with FALCPA's labeling requirements?

FALCPA's labeling requirements extend to foods packaged by a retail or foodservice establishment that are offered for

human consumption. However, FALCPA's labeling requirements do not apply to foods provided by a retail food establishment

that are placed in a wrapper or container in response to a consumer's order - such as the paper or box used to convey a

sandwich that has been prepared in response to a consumer's order.

20.

[Added April, 2006] Do the FALCPA requirements apply regardless of whether a jurisdiction has adopted the 2005

FDA Food Code?

Yes. Although the 2005 FDA Food Code contains provisions to integrate FALCPA's requirements into the model code as well

as additional food allergen information in its Annexes, FALCPA is a federal law that amends the Federal Food, Drug, &

Cosmetic Act (FFDCA). Thus, regardless of whether a jurisdiction has adopted the 2005 Food Code, FALCPA's requirements

apply to all packaged foods in interstate commerce, both domestically manufactured and imported, sold in the U.S. that are

regulated under the FFDCA. FDA regulates all foods except meat products, poultry products, and certain egg products.

FALCPA is specifically preemptive, which means that other governmental entities (such as those at the state or local level)

may not adopt labeling requirements that are different from those in FALCPA.

21.

[Added April, 2006] Does FALCPA address the use of advisory labeling (such as "may contain") by a retail or food

service establishment?

No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of

unintentional ingredients in food products resulting from the manufacturing of the ingredients or the preparation and packaging

of the food in a retail or food service establishment. All food labeling, including advisory labeling, must be truthful and not

misleading. See FDA's 1996 Notice to Manufacturers.

22.

[Added April, 2006] Are molluscan shellfish considered a major food allergen under FALCPA?

No. Under FALCPA, Crustacean shellfish (such as crab, lobster, or shrimp), and ingredients that contain protein derived from

Crustacean shellfish, are major food allergens, but molluscan shellfish (such as oysters, clams, mussels, or scallops) are not.

23.

[Added April, 2006] Does FDA intend to issue additional guidance for retail and foodservice establishments on the

proper handling of food allergens?

As stipulated in FALCPA, FDA is engaged in an on-going effort to work with the Conference for Food Protection on the

24.

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development of guidelines for retail and foodservice establishments on the proper handling and labeling of food allergens.

*

This is a revision of the second edition of the FDA guidance "Questions and Answers Regarding Food Allergens, including the Food

Allergen Labeling and Consumer Protection Act of 2004 ," which FDA issued on December 14, 2005.

A more recent version of this guidance issued in October 2006.

Guidance Documents | Food Allergens

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