Notice2023-03513
Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
February 23, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements: Guidance for Industry." The draft guidance, when finalized, will provide industry with our view on the naming of plant-based food products that are marketed and sold as alternatives to milk (plant-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. Industry's use of these recommendations for labeling plant-based milk alternatives will provide consumers with additional nutrition information to help them understand certain nutritional differences between these products and milk and make informed dietary choices. This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 88 Issue 36 (Thursday, February 23, 2023)</title>
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[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11449-11451]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-0451]
Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient
Statements; Draft Guidance for Industry; Availability; Agency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availability of a draft guidance for industry entitled ``Labeling of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 Milk Alternatives and Voluntary Nutrient Statements:
Guidance for Industry.'' The draft guidance, when finalized, will
provide industry with our 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. Industry's use of these recommendations
for labeling plant-based milk alternatives will provide consumers with
additional nutrition information to help them understand certain
nutritional differences between these products and milk and make
informed dietary choices. This draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by April 24, 2023 to ensure that FDA considers your comment on
the draft guidance before it begins work on the final version of the
guidance. Submit electronic or written comments on the proposed
collection of information in the draft guidance by April 24, 2023.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-D-0451 for ``Labeling of Plant-based Milk Alternatives and
Voluntary Nutrient Statements: Guidance for Industry; 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
[[Page 11450]]
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 draft guidance to
the Office of Nutrition and Food Labeling (HFS-800), Center for Food
Safety and Applied Nutrition, 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 draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Jeanmaire Hryshko, Center for
Food Safety and Applied Nutrition, Office of Nutrition and Food
Labeling (HFS-800), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371; or Meadow Platt, Center for Food
Safety and Applied Nutrition, Office of Regulations and Policy (HFS-
024), 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, <a href="/cdn-cgi/l/email-protection#643436253710050202240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="86d6d4c7d5f2e7e0e0c6e0e2e7a8eeeef5a8e1e9f0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
An increase in purchase and consumption of plant-based milk
alternatives has occurred over the last 10 years. Many products are
labeled with names that include the term ``milk.'' Plant-based milk
alternatives are made from liquid-based extracts of plant materials,
such as tree nuts, legumes, seeds, or grains. FDA has established a
standard of identity or compositional requirements for milk (see 21 CFR
131.110) but has not established standards of identity or compositional
requirements for plant-based milk alternatives. The composition,
including the nutrient profile, of these plant-based milk alternative
products varies depending on the plant source(s), processing methods,
and added ingredients.
We are committed to clear and transparent food labels that are
truthful and not misleading. We are also committed to using our tools
and authorities to empower consumers with information to quickly
ascertain the types of products they are purchasing for themselves and
their families and enhance their ability to make informed choices about
the foods they buy and eat. To further this goal, in the Federal
Register of September 28, 2018 (83 FR 49103), FDA issued a notice
requesting comment on the labeling of plant-based alternatives with
names that include the names of dairy foods. We invited comment on a
variety of issues, including how consumers use plant-based dairy
alternatives, how consumers understand terms included in the names of
plant-based dairy alternatives, and whether consumers are aware of and
understand differences between plant-based dairy alternatives and their
dairy counterparts. We received over 13,000 comments, which helped to
inform the development of this draft guidance.
We are announcing the availability of a draft guidance for industry
entitled ``Labeling of Plant-based Milk Alternatives and Voluntary
Nutrient Statements: Guidance for Industry.'' The draft guidance
provides our view on the naming of plant-based milk alternatives and
recommendations on voluntary nutrient statements for the labeling of
these products. The draft guidance does not address other plant-based
dairy alternatives such as plant-based cheese, yogurt, or kefir
alternatives. The draft guidance is limited to plant-based milk
alternatives because: (1) most comments and consumer research submitted
to the notice were limited to plant-based milk alternatives; (2) the
overall market for plant-based milk alternatives is greater than the
market for other plant-based dairy alternatives such as yogurts and
cheeses; and (3) data indicates that consumers may not understand the
nutritional differences between plant-based milk alternatives and a
potential public health concern may exist if plant-based milk
alternatives are substituted for milk.
We are issuing the draft guidance consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking 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 alternate 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.
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 Milk Alternatives and Voluntary Nutrient
Statements: Guidance for Industry
OMB Control Number 0910-0381
This draft guidance, once finalized, provides recommendations on
the naming of plant-based milk alternatives and on voluntary nutrient
statements for the labeling of these products. The draft guidance's
recommendations for labeling plant-based beverages that are used in
place of milk will provide consumers with additional nutrition
information to help them compare these products to milk and make
informed dietary choices.
We estimate the burden of this collection of information as
follows:
[[Page 11451]]
Table 1--Estimated Third-Party Disclosure Burden
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Total
Number of Number of Total annual Average capital
Activity respondents disclosures per disclosures burden per Total hours costs \1\
respondent disclosure \2\
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Labeling recommendations in ``Best Practices for Labeling of 56 6 336 1 336 $500,000
Plant-based Milk Alternatives''............................
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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 56 manufacturers will
relabel their products following recommendations found in the draft
guidance. We estimate that each manufacturer will relabel 6 products
for 336 total annual disclosures (56 manufacturers x 6 labels). Each
disclosure will take an estimated 1 hour to complete for an annual
third-party disclosure burden of 336 hours (336 disclosures x 1 hour).
We estimate that there will be an annual capital cost of $500,000
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. Other Issues for Consideration
Although FDA welcomes comments on any aspect of the guidance, we
particularly invite comment on the following:
<bullet> The voluntary nutrient statement recommendations provided
in section III.2 of the draft guidance. We acknowledge that the
labeling of some plant-based milk alternatives may have space
constraints that limit listing of multiple nutrients in the voluntary
nutrient statement. Therefore, we are interested in comments about the
placement of and possible space constraints for the voluntary nutrient
statement on product labels.
<bullet> FDA is recommending nutrient disclosure statements on the
labels of plant-based milk alternatives that contain less of the
following nutrients compared to milk: calcium, protein, vitamin A,
vitamin D, magnesium, phosphorus, potassium, riboflavin, and vitamin
B12. We chose these specific nutrients because the Dietary Guidelines
for Americans identifies the Dairy Group as being a key contributor of
those nutrients and to align with the nutritional standards set by the
U.S. Department of Agriculture's (USDA) Food and Nutrition Service for
fluid milk substitutes served in the National School Lunch Program,
School Breakfast Program, and Child and Adult Care Food Program (USDA
criteria) (see 7 CFR 210.10(d)(3), 220.8(d), and 226.20(g)(3)).
<bullet> For the purpose of this draft guidance, are the USDA
criteria that identifies minimum levels of nutrients for fluid milk
substitutes the most appropriate criteria to use? If yes, why? If not,
what criteria (i.e., nutrients and nutrient levels, minimums versus
ranges of nutrient levels, etc.) should we consider and why? Please
provide information, research, and data to help us understand your
reasoning.
IV. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements">https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03513 Filed 2-22-23; 8:45 am]
BILLING CODE 4164-01-P
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