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          Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic ActSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act
					
		
		April 2022


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2021-N-0553
	    	    		    Issued by:
		    Guidance Issuing Office
          Center 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.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, 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 Draft Guidance

Related Information

Food Allergies
	Food Allergens/Gluten-Free Guidance Documents & Regulatory Information


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

                                                                                  Content current as of:
      04/18/2022
         
                  
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