[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Draft Guidance for Industry; Availability; Agency Information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availability of a draft guidance for industry entitled ``Labeling of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 This draft
guidance, when finalized, will provide our recommendations on best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 This draft guidance does not address the naming and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DATES: Submit either electronic or written comments on the draft
guidance by May 7, 2025 to ensure that we consider your comment on the
draft guidance before we begin work on the final version of the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collection of information in the draft guidance by March 10, 2025.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