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[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
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