Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act
(Edition 5): Guidance for Industry
Draft Guidance
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit electronic comments to v.  Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number FDA-2022-D-0099 listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Carol D’Lima at the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2371or *******************.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
November 2022
Table of Contents
I. Introduction (3)
II. Questions and Answers (5)
A. General Information (5)
B.Types of Foods That Fall Under the Food Allergen Labeling Requirements of
the FD&C Act (6)
C. Food Sources (12)
D. The Food Allergen Labeling Requirements of the FD&C Act (15)
E. Dietary Supplements (21)
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Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act
(Edition 5): Guidance for Industry1
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.
I. Introduction
As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
requires 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 noncertified colors can be declared as such) (21 U.S.C. 343(i)).  However, consumers may be unfamiliar with the common or usual name of an ingredient and may not recognize that certain ingredients contain or are derived from a food allergen.  The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) was enacted in August 2004 and, in part, amended the FD&C Act by defining the term “major food allergen” (21 U.S.C. 321(qq)) and stating that foods regulated under the FD&C Act are misbranded unless they declare the presence of each major food allergen on the product label using the name of the food source from which the major food allergen is derived.  Section 403(w)(1) of the FD&C Act sets forth the requirements for declaring the presence of each major food allergen on the product label.  In addition, the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) (Public Law 117-11) was enacted in April 2021 and, in part, amended the
1 This guidance has been prepared by the Office of Nutrition and Food Labeling, Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.
3register for
definition of major food allergen in section 201(qq) of the FD&C Act to include sesame, effective January 1, 2023.
This is a revision of the fourth edition of a guidance document originally entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004” that contains revised and new questions and answers relating to food allergens, including questions and answers about FALCPA and the FASTER Act.  Editorial changes, such as renumbering and organizational changes have also been made in this revision.  FDA expects to continue to issue subsequent editions of this guidance document by revising existing questions and answers and by adding new questions and answers.
This draft guidance document accompanies the final guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).  FDA is issuing this draft guidance document to receive comments on the new and revised questions and answers, and, as appropriate, will move the questions and answers to the final guidance document, after reviewing comments and incorporating any changes to the question and answer, when appropriate.  Note that a question and answer that is in the final guidance document may be withdrawn and moved to a new or revised draft guidance doc
ument if FDA determines that the question and answer should be revised in some respect and reissued in draft for comment.  A question and answer also may be withdrawn and removed from the guidance documents if, for instance, the issue addressed in the question and answer is addressed elsewhere.  For ease of reference, a question and answer retains the same number when it moves from the draft guidance document to the final guidance document and we use the term “RESERVED” after some question numbers, where appropriate, to facilitate this process.
For more information related to allergens, please see
v/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Alle rgens/default.htm.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances 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 FDA guidances means that something is suggested or recommended, but not required.
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II. Questions and Answers
A.  General Information
A.1 What foods and food groups are designated as “major food allergens”?
Under section 201(qq) of the FD&C Act, a “major food allergen” is one of the following foods, from one of the following food groups, or an ingredient that contains protein derived from one of the following:
Foods Food Groups
Milk Fish (such as bass, flounder, cod)
Eggs Crustacean shellfish (such as
crab, lobster, shrimp)
Peanuts Tree nuts (such as almonds,
walnuts, pecans)
Wheat
Soybeans
Sesame
(effective date January 1, 2023)
A.2 RESERVED – See the final guidance “Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).”
A.3 RESERVED – See the final guidance “Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).”
A.4 RESERVED – See the final guidance “Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).”
A.5 RESERVED – See the final guidance “Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5).”
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