[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11449-11451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Statements; Draft Guidance for Industry; Availability; Agency 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availability of a draft guidance for industry entitled ``Labeling of 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 The draft guidance, when finalized, will 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 This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by April 24, 2023 to ensure that FDA considers your comment on 
the draft guidance before it begins work on the final version of the 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collection of information in the draft guidance by April 24, 2023.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:
     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-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 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.

[[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, [email protected].

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:
     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.
     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)).
     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 https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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