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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1163-1164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31529]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Evaluating the Public Health Importance of Food Allergens Other 
Than the Major Food Allergens Listed in the Federal Food, Drug, and 
Cosmetic Act; Guidance for FDA Staff and Interested Parties; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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:

[[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
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