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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2021-N-0553]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# SUMMARY:

                        The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (                        *i.e.,*                         milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act).                    

# DATES:

                        The announcement of the guidance is published in the                         **Federal Register**                         on January 7, 2025.                    

# ADDRESSES:

You may submit either electronic or written comments on FDA guidances at any time as follows:

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on                      https://www.regulations.gov. 
      - If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

### Written/Paper Submissions

Submit written/paper submissions as follows:
      -  Mail/Hand Delivery/Courier (for written/paper submissions):                      Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                
      - For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

*Instructions:*                     All submissions received must include the Docket No. FDA-2021-N-0553 for “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at                     *https://www.regulations.gov*                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.                
      - Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.                      Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with  21 CFR 10.20  and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see  80 FR 56469 , September 18, 2015, or access the information at:                      https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. 

*Docket:*                     For access to the docket to read background documents or the electronic and written/paper comments received, go to                     *https://www.regulations.gov*                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.                

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

                    Submit written requests for single copies of the guidance to the Division of Chemical Contaminants, Office of Post-Market Assessment, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the                     **SUPPLEMENTARY INFORMATION**                     section for electronic access to the guidance.                

# FOR FURTHER INFORMATION CONTACT:

Stefano Luccioli, Office of Post-Market Assessment, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1283; or Alexandra Beliveau, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

#                     SUPPLEMENTARY INFORMATION:                          ( print page 1164)    

## I. Background

We are announcing the availability of a guidance for FDA staff and interested parties entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

                    In the                     **Federal Register**                     of April 19, 2022 (87 FR 23181), we announced the availability of a draft guidance for FDA staff and stakeholders entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” We gave interested parties until August 17, 2022, to submit comments for us to consider before beginning work on the final version of the guidance.                

This guidance finalizes the approach we generally intend to take when evaluating the public health importance of a non-listed food allergen. The guidance specifies the scientific factors and 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. It also describes 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.

Food allergy can be broadly defined as an adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food. A food allergen is the food or component(s) (often a protein) of a food that elicits specific immunologic reactions. While many different types of food allergies have been identified, food allergies that are most studied and understood clinically are those due to immunoglobulin E antibodies (IgE) that cause the body to release inflammatory chemicals. The most severe and immediately life-threatening food allergies are those that are mediated by IgE and are capable of triggering anaphylaxis, which can be fatal. The focus of this guidance is primarily IgE-mediated food allergy. However, we recognize that food allergens acting through other mechanisms may raise public health concerns. We intend to evaluate the public health importance of these allergens on a case-by-case basis. We will also continue gathering scientific data and other information on food allergens acting through other mechanisms to help inform possible future action on these allergens, which may include future guidance or communications to the public.

                    In general, the regulatory framework of the FD&C Act and our regulations implementing the FD&C Act broadly apply to the production of food that is or contains a food allergen through statutory and regulatory provisions regarding: (1) food labeling; (2) food production (                    *e.g.,*                     manufacturing, processing, packing, and holding food); and (3) the safety of substances added to food. Under section 403(w) of the FD&C Act (21 U.S.C. 343(w)), a food is misbranded if it contains a major food allergen and fails to declare that major food allergen as specified on its label using the major food allergen's common or usual name. Section 201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defines a “major food allergen,” in part, as any of the following: milk, eggs, fish (                    *e.g.,*                     bass, flounder, or cod), Crustacean shellfish, tree nuts (                    *e.g.,*                     almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.                

We considered all comments received during the comment period before developing the final guidance. Some comments on the draft guidance requested that we expand the scope of the guidance to cover non-IgE-mediated food allergies and to describe the potential regulatory options available to FDA. Other comments recommended that FDA define specific targets for each evaluation factor laid out in the framework. We have modified the final guidance where appropriate. Changes to the guidance include:
    - Clarifying that evidence of non-IgE-mediated reactions can be useful as supplemental data in an evaluation of the public health importance of a food allergen;
    - Incorporating updated text and a revised reference to reflect the recent publication of the Food and Agricultural Organization of the United Nations and World Health Organization's Expert Committee meeting report; and
    - Expanding the discussion regarding prevalence data when a food is not regularly consumed in the United States.

## II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 10 have been approved under OMB control number 0910-0191. The collections of information in 21 CFR part 101 have been approved under OMB control number 0910-0381. The collections of information in section 403(w) of the FD&C Act have been approved under OMB control number 0910-0792. The collections of information in 21 CFR part 117 have been approved under OMB control number 0910-0751. The collections of information for Form FDA 3800 have been approved under OMB control number 0910-0645. The collections of information for Form FDA 3500 have been approved under OMB control number 0910-0291. The collections of information in 21 CFR 70.25, 71.1, 170.36, 171.1, 172, 173, 179, and 180 have been approved under OMB control number 0910-0016.

## III. Electronic Access

                    Persons with access to the internet may obtain the guidance at                     *https://www.fda.gov/​FoodGuidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents*, or                     *https://www.regulations.gov*. Use the FDA websites listed in the previous sentence to find the most current version of the guidance.                

Dated: December 27, 2024.

Kimberlee Trzeciak,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2024-31529 Filed 1-6-25; 8:45 am]

BILLING CODE 4164-01-P