U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. 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
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-N-0553
Issued by:
Guidance Issuing Office
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. 

Download the Guidance

Related Information 

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-N-0553.

Back to Top