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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2021-N-0553
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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
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, 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
- Stakeholders 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 (“applicable stakeholders”) 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.