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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1139-1141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31535]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1102]

Labeling of Plant-Based Alternatives to Animal-Derived Foods: 
Draft Guidance for Industry; Availability; Agency Information 
Collection Activities; Proposed Collection; Comment Request

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availability of a draft guidance for industry entitled ``Labeling of 
Plant-Based Alternatives to Animal-Derived Foods.'' This draft 
guidance, when finalized, will provide our recommendations on best 
practices for naming and labeling of certain plant-based foods that are 
marketed and sold as alternatives for animal-derived foods (plant-based 
alternative foods), especially in the absence of a common or usual name 
for the product. This draft guidance does not address the naming and 
labeling of plant-based milk alternatives; FDA is providing 
recommendations regarding these products in a separate guidance 
document.

DATES: Submit either electronic or written comments on the draft 
guidance by May 7, 2025 to ensure that we consider your comment on the 
draft guidance before we begin work on the final version of the 
guidance. Submit electronic or written comments on the proposed 
collection of information in the draft guidance by March 10, 2025.

ADDRESSES: You may submit comments on any guidance 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

[[Page 1140]]

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-2022-D-1102 for ``Labeling of Plant-Based Alternatives to Animal-
Derived Foods: Draft Guidance for Industry; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment 
Request.'' 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 Office 
of Nutrition and Food Labeling (HFS-800), 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: 
    With regard to the draft guidance: Andrea Krause, Office of 
Nutrition and Food Labeling (HFS-820), Human Foods Program, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2371; or Lauren Kleinman, Office of Policy, Regulations, and 
Information, Human Foods Program, Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2378.
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Labeling of Plant-Based Alternatives to Animal-Derived 
Foods.'' This draft guidance is intended to provide our recommendations 
on best practices for naming and labeling of certain plant-based foods 
that are marketed and sold as alternatives for animal-derived foods 
(plant-based alternative foods), especially in the absence of a common 
or usual name for the product. Consumer demand for plant-based 
alternative foods has increased and FDA is committed to helping ensure 
consumers understand the foods they buy, to help them make informed 
dietary choices. The scope of this draft guidance includes plant-based 
alternatives to eggs, seafood, poultry, meat, and dairy (excluding 
plant-based milk alternatives) that fall under FDA jurisdiction. (In 
the Federal Register of February 23, 2023 (88 FR 11449), we announced 
the availability of a draft guidance entitled ``Labeling of Plant-based 
Milk Alternatives and Voluntary Nutrient Statements: Draft Guidance for 
Industry.'' When finalized, the guidance will provide FDA's view on the 
naming of plant-based food products that are marketed and sold as 
alternatives to milk (plant-based milk alternatives) and our 
recommendations on the use of voluntary nutrient statements. The draft 
guidance entitled ``Labeling of Plant-based Milk Alternatives and 
Voluntary Nutrient Statements: Draft Guidance for Industry'' is 
available online at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-labeling-plant-based-milk-alternatives-and-voluntary-nutrient-statements.)
    We are issuing the draft guidance consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.

[[Page 1141]]

    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft 
Guidance for Industry
OMB Control Number 0910-0381--Revision
    The draft guidance, once finalized, will provide recommendations on 
best practices for naming and labeling of certain plant-based 
alternative foods. Industry's use of these recommendations for naming 
and labeling plant-based alternative foods will help ensure consumers 
understand the nature of individual plant-based alternative foods, 
including differences among these products, and have the information 
they need to make informed purchasing decisions.
    Standards of identity have not been established for plant-based 
alternative foods. As such, plant-based alternative foods are non-
standardized foods and must be labeled with their common or usual name, 
or in the absence thereof, a statement of identity that accurately 
describes the food. See 21 CFR 101.3(b). Many plant-based alternative 
foods are novel foods and do not have common or usual names established 
by common usage. Currently, products appear to be identified in 
multiple ways, sometimes inconsistently across the category. Thus, the 
purpose of this guidance is to provide our recommendations on best 
practices for naming and labeling of certain plant-based foods that are 
marketed and sold as alternatives for animal-derived foods.
    Description of respondents: Respondents to this information 
collection are manufacturers, packers, and distributors of plant-based 
alternative foods that are marketed and sold in the United States. 
Respondents are from the private sector (for-profit businesses).
    We estimate the burden of this collection of information as 
follows:

                                                    Table 1--Estimated Third-Party Disclosure Burden
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                                                                             Number of                         Average
                        Activity                            Number of     disclosures  per   Total annual    burden per     Total hours    Total capital
                                                           respondents       respondent       disclosures    disclosure                    costs \1\ \2\
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Labeling recommendations in ``Labeling of Plant-Based              160                  5             800             1             800      $1,231,200
 Alternatives to Animal-Derived Foods''................
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\1\ One-time relabeling costs.
\2\ There are no operating and maintenance costs associated with this collection of information.

    The estimates in table 1 are based on our experience with similar 
labeling programs. We estimate that each year 160 manufacturers will 
relabel their products following recommendations found in the draft 
guidance. We estimate that each manufacturer will relabel 5 products 
for 800 total annual disclosures (160 manufacturers x 5 labels). Each 
disclosure will take an estimated 1 hour to complete for an annual 
third-party disclosure burden of 800 hours (800 disclosures x 1 hour). 
We estimate that there will be an annual capital cost of $1,231,200 
associated with relabeling. This is the cost of designing a revised 
label and incorporating it into the manufacturing process. We believe 
that this will be a one-time burden per respondent.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA website 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. 2024-31535 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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