FDA Issues Draft Guidance on Evaluation Process for Recognition of Additional Regulated Food Allergens

FDA released a draft guidance document on how additional allergens may be added to the group of major food allergens ( milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame).  The document )Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug,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) provides the approach for evaluating non-listed allergens including:

• 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.

A concern from a manufacturing perspective is that with the FASTER Act of 2021 which added sesame to the list of regulated food allergens, it opened the door to potential other food allergens being added to the list.  This draft guidance provides the evaluation process for this to occur.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-fda-staff-and-stakeholders-evaluating-public-health-importance-food-allergens-other
Draft Guidance for FDA Staff and Stakeholders: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug,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

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.

Link to PDF
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