https://www.fda.gov/media/117410/download
This is an important document for reference when food allergen control including labeling requirements. It covers topics such as labeling bulk materials, spice mixes, and ingredients derived from those containing allergens.
FDA also released a guidance document on how additional allergens may be added to the list of allergens.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
January 2025
Docket Number:
FDA-2022-D-0099
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-allergen-labeling-edition-5
Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5)
January 2025
Docket Number:
FDA-2022-D-0099
Issued by:
Human Foods Program
As originally enacted in 1938, section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that the label of a food that is fabricated from two or more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 certain 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” (section 201(qq) of the FD&C Act (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 definition of major food allergen in section 201(qq) of the FD&C Act to include sesame.
This is a revision of the fifth edition of this guidance document that adds the questions and answers from the draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), that are now being finalized. 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.
For more information related to food allergens, please see Food Allergens/Gluten-Free Guidance Documents & Regulatory Information.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’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.
Human Foods Program
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 certain 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” (section 201(qq) of the FD&C Act (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 definition of major food allergen in section 201(qq) of the FD&C Act to include sesame.
This is a revision of the fifth edition of this guidance document that adds the questions and answers from the draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), that are now being finalized. 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.
For more information related to food allergens, please see Food Allergens/Gluten-Free Guidance Documents & Regulatory Information.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’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.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-fda-staff-and-interested-parties-evaluating-public-health-importance-food-allergens-other
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act
January 2025
Docket Number:
FDA-2021-N-0553
Issued by:
Human Foods Program
This guidance is intended for:
FDA staff who are responsible for evaluating, on FDA’s initiative or in response to a citizen petition submitted in accordance with 21 CFR 10.30, the public health importance of a non-listed food allergen (“interested FDA staff”), which for the purpose of this guidance means a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act); and
Interested parties who intend to submit a citizen petition asking FDA to establish regulatory requirements based on the public health importance of a non-listed food allergen (“petitioners”) or who are interested in how FDA generally intends to evaluate the public health importance of such food allergens.
This guidance addresses substances that are currently consumed in food or have previously been consumed in food, within or outside the United States, such that there is a body of information about adverse reactions experienced by consumers who ingest the substance. This guidance does not address the potential that a substance that would be new to the food supply might be a food allergen. This guidance also does not address scientific research regarding potential cross-reactivity to a known food allergen and how this research could help determine whether a substance in food could be a food allergen.
This guidance describes the approach we generally intend to take when we evaluate the public health importance of a non-listed food allergen by specifying:
The scientific factors that we generally intend to consider when evaluating the public health importance of a non-listed food allergen;
Other information, relevant to the labeling and production of food containing the food allergen, that we generally intend to consider when evaluating the public health importance of a non-listed food allergen; and
Our recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 guidance documents means that something is suggested or recommended, but not required.
Interested parties who intend to submit a citizen petition asking FDA to establish regulatory requirements based on the public health importance of a non-listed food allergen (“petitioners”) or who are interested in how FDA generally intends to evaluate the public health importance of such food allergens.
This guidance addresses substances that are currently consumed in food or have previously been consumed in food, within or outside the United States, such that there is a body of information about adverse reactions experienced by consumers who ingest the substance. This guidance does not address the potential that a substance that would be new to the food supply might be a food allergen. This guidance also does not address scientific research regarding potential cross-reactivity to a known food allergen and how this research could help determine whether a substance in food could be a food allergen.
This guidance describes the approach we generally intend to take when we evaluate the public health importance of a non-listed food allergen by specifying:
The scientific factors that we generally intend to consider when evaluating the public health importance of a non-listed food allergen;
Other information, relevant to the labeling and production of food containing the food allergen, that we generally intend to consider when evaluating the public health importance of a non-listed food allergen; and
Our recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 guidance documents means that something is suggested or recommended, but not required.
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