Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 1139-1141 [2024-31535]
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<![CDATA[
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Charlotte Conway, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–6768,
Charlotte.Conway@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
In the Federal Register of August 9,
2024 (89 FR 65368), FDA published the
notice of availability for a draft guidance
#294 entitled ‘‘Animal Food Ingredient
Consultation (AFIC),’’ giving interested
persons until September 9, 2024, to
comment on the draft guidance. FDA
received numerous comments on the
draft guidance, including comments
from the animal food and drug
industries, AAFCO, a veterinary
association, a State food and agriculture
department, and private citizens, and
those comments were considered as the
guidance was finalized. In response to
comments, the guidance was revised.
First, we clarified the scope of the AFIC
process as including any animal food
ingredient for which firms may have
otherwise utilized the AAFCO
ingredient definition process. We also
clarified that a proposed ingredient
name and definition should be included
in the consultation for FDA’s
consideration. We removed the
recommendation to submit a statement
of environmental risk. In addition, we
clarified that firms participating in the
AFIC process should not resubmit
information they have already provided
to FDA and added clarification
regarding what information interested
parties should include when providing
comments on pending AFICs through
the docket. Lastly, editorial changes
were made to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
August 9, 2024.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Animal Food
Ingredient Consultation (AFIC).’’ 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
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1139
information they conduct or sponsor.
FDA is issuing this guidance, as final,
that includes information collection
recommendations regarding animal food
ingredient consultations with FDA,
which are subject to review and
approval by OMB under the PRA. FDA
will implement the information
collection recommendations upon OMB
approval and will announce OMB
approval in the Federal Register.
Information collection pertaining to
animal food ingredient safety is
currently provided for in FDA
regulations in 21 CFR parts 570 and 571,
currently approved in OMB control
numbers 0910–0342 and 0910–0546,
respectively. Disclosures under 21 CFR
501.22 requiring animal food
manufacturers to declare the presence of
certified and noncertified color
additives in animal food product
labeling are also currently approved in
OMB control number 0910–0546.
However, upon our review of the latter
information collection, we note that
while we account for general reporting
activities applicable to animal food
ingredient regulations, we do not
discuss activities that may be
specifically attributable to animal food
ingredient consultations with FDA. We
also acknowledge that discontinuation
of the MOU with AAFCO may result in
an adjustment for some respondents
with regard to how they engage in
consultation with FDA. On December
19, 2024, FDA published a notice (89 FR
103838) under the PRA of its intent to
revise the information collection to
explicitly discuss animal food
ingredient consultations that we believe
are implicitly contemplated by the
existing regulations in 21 CFR parts 570
and 571 specifically to invite comment
on the associated burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. Electronic Access
Electronic Submissions
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
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
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31525 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
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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.
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 AnimalDerived Foods.’’ This draft guidance,
when finalized, will provide our
recommendations on best practices for
naming and labeling of certain plantbased 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.
SUMMARY:
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:
DATES:
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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 PlantBased 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
VerDate Sep<11>2014
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Jkt 265001
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-201509-18/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 selfaddressed 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, PRAStaff@fda.hhs.gov.
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 plantbased foods that are marketed and sold
as alternatives for animal-derived foods
(plant-based alternative foods),
especially in the absence of a common
PO 00000
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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 Plantbased 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 Plantbased Milk Alternatives and Voluntary
Nutrient Statements: Draft Guidance for
Industry’’ is available online at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/draftguidance-industry-labeling-plant-basedmilk-alternatives-and-voluntarynutrient-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.
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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
Activity
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Total capital
costs 1 2
Labeling recommendations in ‘‘Labeling of
Plant-Based Alternatives to Animal-Derived
Foods’’ ..........................................................
160
5
800
1
800
$1,231,200
1 One-time
2 There
relabeling costs.
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 × 5
labels). Each disclosure will take an
estimated 1 hour to complete for an
annual third-party disclosure burden of
800 hours (800 disclosures × 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.
ddrumheller on DSK120RN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, https://www.fda.gov/
FoodGuidances, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–3067]
Recommendations To Reduce the Risk
of Transmission of Disease Agents
Associated With Sepsis by Human
Cells, Tissues, and Cellular and
Tissue-Based Products; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
final guidance for immediate
SUMMARY:
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implementation entitled
‘‘Recommendations To Reduce the Risk
of Transmission of Disease Agents
Associated with Sepsis by Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps).’’ FDA is issuing this
guidance to provide establishments
making donor eligibility determinations
with recommendations to reduce the
risk of transmission of infections due to
sepsis by HCT/Ps. This notice is being
issued to respond to a public health
safety concern and to address the urgent
need for updated recommendations in
making a donor eligibility determination
when screening a donor for clinical
evidence of sepsis and clinical signs to
consider.
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
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
E:\FR\FM\07JAN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
