Federal Register, Volume 90 Issue 9 (Wednesday, January 15, 2025)

[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3878-3880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00754]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5716]

High-Protein Yogurt; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA or we) is requesting
information and data about the manufacturing processes and ingredients
used to make certain dairy products referred to as high-protein yogurt,
Greek yogurt, or Greek-style yogurt in this document. We are taking
this action, in part, because the yogurt standard of identity may not
align with certain manufacturing processes and ingredients used to
concentrate protein to manufacture these products. We intend to use the
information and data to help determine what type(s) of actions, if any,
should be taken.

DATES: Either electronic or written comments on the notice must be
submitted by April 15, 2025.

ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered. The
https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of April 15, 2025.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.

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-2024-N-5716 for ``High-Protein Yogurt; Request for Information.''
Received comments, those filed in a timely manner (see ADDRESSES), 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://

[[Page 3879]]

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.

FOR FURTHER INFORMATION CONTACT: Yan Peng, Office of Nutrition and Food
Labeling, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2371, or Holli Kubicki,
Office of Policy, Regulations, and Information, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the
authority to establish definitions and standards of identity (SOIs) for
foods whenever such action would promote honesty and fair dealing in
the interest of consumers (see section 401 of the FD&C Act (21 U.S.C.
341)). SOIs specify the ingredients, both mandatory and optional, of a
standardized food, and sometimes describe the amount or proportion of
each ingredient. Many SOIs also prescribe a method of production.
The yogurt SOI is stated at 21 CFR 131.200. There is not a separate
SOI for high-protein yogurt, Greek yogurt, or Greek-style yogurt. For
purposes of this document, high-protein yogurt, Greek yogurt, or Greek-
style yogurt (collectively referred to in this document as ``high-
protein yogurt'') generally refers to a dairy product cultured with, at
minimum, Lactobacillus delbrueckii, subspecies bulgaricus, and
Streptococcus thermophilus, which has undergone a manufacturing method
to increase the protein level.
In recent years, the yogurt industry has raised concerns that the
existing, single yogurt SOI does not accommodate the current practices
or technologies to manufacture high-protein yogurt. Specifically, FDA
received comments from the yogurt industry during the FDA 2019 Public
Meeting on Horizontal Approaches to Food Standards of Identity
Modernization (84 FR 45497, August 29, 2019 (Docket No. FDA-2018-N-
2381)), and after the reopening of comments on the FDA 2005 proposed
rule titled Food Standards; General Principles and Food Standards
Modernization (85 FR 10107, February 21, 2020 (Docket No. FDA-1995-N-
0062)), advocating for an additional SOI for strained, high-protein
yogurt (which some comments referred to as Greek yogurt). The comments
stated that a new SOI for strained, high-protein yogurt should include
language that describes the authentic straining process, the
characteristics of the product, and the distinguishing compositional
nutritional elements of the product.
We understand that since high-protein yogurt was introduced to the
U.S. market, this category continues to expand substantially in product
availability and variety, along with innovations in formulations and
manufacturing processes.
We also understand that there are different methods used by
industry to increase the protein level of yogurt, some of which may not
be consistent with the yogurt SOI. One method is to concentrate yogurt
after culturing to remove liquid whey by a straining process (Refs. 1
and 2). The straining process can be done in a traditional way using
cheesecloth, but is more commonly done commercially using a centrifugal
separator (Refs. 1 and 2). Many yogurt manufacturers that use the
straining process to make high-protein yogurt add cream after culturing
and straining to achieve the desired fat content specified for the
product. These manufacturers state that cream must be added after
culturing and straining due to a variety of challenges that occur if
cream is added before culturing, including reduced production
efficiency due to clogging of centrifugal separators by fat, loss of
fat in acid whey, and reduced ability to recycle acid whey with high
fat content.
Another method is the addition of milk-protein ingredients to milk
prior to culturing (Refs. 1 and 2). This method is also known as the
protein-fortified method, which allows for the production of high-
protein yogurt on the same processing equipment used for yogurt not
fortified with milk-protein ingredients, without the need for liquid
whey removal after culturing (Refs. 1 and 2).
Yet another method is to concentrate protein in milk before or
after culturing (e.g., membrane ultrafiltration (Refs. 1 and 2)). (We
note that FDA granted a temporary permit to Chobani to market test
certain yogurt products deviating from the yogurt SOI by using
ultrafiltered nonfat milk as a basic dairy ingredient before culturing
(88 FR 18322, March 28, 2023).

II. Issues for Consideration and Request for Information

FDA is issuing this request for information to better understand
the current marketplace for high-protein yogurt products. In
particular, FDA is interested in information that would help us
determine whether there is a need for updating an existing, or
establishing a new standard of identity for these products to promote
honesty and fair dealing in the interest of consumers. We also request
information and data about the various manufacturing processes and
ingredients used to make high-protein yogurt. We specifically invite
comment in response to the questions below. Please explain your answers
and provide references and data, if possible.
1. We seek input from all interested parties related to consumers'
understanding and expectations of high-protein yogurt, and the current
industry practices and innovations. We are also interested in data and
other information regarding usage of the various names for high-protein
yogurt.
2. If pasteurized cream is added after culturing, please specify
the point at which cream is added during the manufacturing process
(e.g., time, temperature, pH). What are the typical amount and the
effects of adding pasteurized cream after culturing on yogurt
attributes that are required by the SOI (e.g., pH, milk solids not fat
level, level of live cultures, including Lactobacillus delbrueckii
subsp. bulgaricus and Streptococcus thermophilus)? Please specify with
data. What adjustments are needed, if any, to meet the levels required
by the yogurt SOI?
3. How are the characteristics of yogurt impacted by the point at
which cream is added during the manufacturing process relative to
culturing (i.e., adding cream to milk before culturing compared to
adding cream after culturing)? Please explain and provide data (e.g.,
pH, sensory properties, compositions, levels of live cultures) to
compare the yogurt made by adding cream before culturing versus adding
cream after culturing.
4. There are different ways to achieve high-protein content in
high-protein yogurt, such as membrane concentration of milk protein
before culturing, straining of cultured yogurt after culturing,
membrane separation of yogurt after culturing, or milk protein
fortification. How do the high-protein yogurts made with these
different processes differ in characteristics (e.g., pH, sensory
properties, compositions, levels of live cultures, nutrient profile)?

[[Page 3880]]

Please explain and specify which characteristics differ.
4.a. Membrane filtration (often ultrafiltration) can be used to
concentrate milk prior to culturing. What are the specifications of the
ultrafiltered milk (e.g., concentration factors; filtered milk pH;
compositions, such as total solids, protein, lactose, fat, minerals,
vitamins; other pertinent information) used to manufacture high-protein
yogurt?
4.b. Straining after culturing removes a portion of the liquid whey
from the cultured yogurt to increase protein content in the finished
yogurt product. What is the concentration factor or weight ratio of
liquid whey versus concentrated yogurt after straining? What are
important processing parameters, such as temperature, during the
straining process? What are the characteristics of the liquid whey from
the yogurt straining process and the concentrated yogurt (e.g., pH;
levels of live cultures; compositions, including total solids, total
protein, whey protein, casein, lactose, fat, minerals, vitamins; other
pertinent information)?
4.c. Membrane filtration of yogurt after culturing removes liquid
whey to concentrate yogurt. What is the typical concentration factor or
weight ratio of permeate (liquid whey) versus retentate (concentrated
yogurt) after membrane filtration? What are important processing
parameters, such as temperature, during the membrane filtration
process? What are the characteristics of the liquid whey and
concentrated yogurt after membrane filtration (e.g., pH; levels of live
cultures; compositions, including total solids, total protein, whey
protein, casein, lactose, fat, minerals, vitamins; other pertinent
information)?
4.d. Dairy protein fortification can also be used to increase the
protein level in yogurt. Please describe the types of protein
ingredient(s) (e.g., whey protein, casein protein, milk protein,
caseinate) added during the manufacturing process to increase the
protein level in yogurt. How are the dairy protein ingredients added
(e.g., timing of the addition during processing, amounts added)? How
are the characteristics of yogurts impacted by fortifying with
different types of protein ingredients? Please explain and provide data
(e.g., pH, sensory properties, levels of live cultures, composition) to
compare the yogurts made by fortifying with different types of protein
ingredients.
5. As indicated earlier in this document, high-protein yogurt is
also known as or referred to under different names, such as Greek
yogurt and Greek-style yogurt. Please provide relevant data and
information regarding usage of the various names for high-protein
yogurt (e.g., Greek yogurt and Greek-style yogurt). Please also provide
relevant data and information regarding the inclusion of the
manufacturing process in the names for high-protein yogurt (e.g.,
``strained yogurt,'' ``strained Greek yogurt,'' ``ultrafiltered
yogurt''). Examples of relevant data and information may include
specific firm practices, trade conventions, and consumer studies.

III. References

The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.

1. Chandan, R.C. and A. Kilara, editors, 2013, Manufacturing Yogurt
and Fermented Milks, Second Edition, John Wiley & Sons, Inc.
Available at https://doi.org/10.1002/9781118481301.
2. *J[oslash]rgensen, C.E., R.K. Abrahamsen, E. Rukke, et al.
``Processing High-Protein Yoghurt--A Review,'' International Dairy
Journal, 88: 42-59, 2019. Available at https://doi.org/10.1016/j.idairyj.2018.08.002.

Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00754 Filed 1-14-25; 8:45 am]
BILLING CODE 4164-01-P