Rule2023-26095
Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt; Small Entity Compliance Guide; Availability
Primary source
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Published
November 28, 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 guidance for industry entitled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt-- Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to explain the actions a small entity must take to comply with FDA's regulations after recent changes made by our 2021 final rule titled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," 2022 final rule titled "International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," and 2023 final order titled "International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt."
Full Text
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<title>Federal Register, Volume 88 Issue 227 (Tuesday, November 28, 2023)</title>
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[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Rules and Regulations]
[Pages 83024-83026]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26095]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 130 and 131
[Docket No. FDA-2023-D-4722]
Milk and Cream Products and Yogurt Products; Final Rule To Revoke
the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the
Standard for Yogurt; Small Entity Compliance Guide; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Milk and Cream
Products and Yogurt Products; Final Rule To Revoke the Standards for
Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt--
Small Entity Compliance Guide.'' The small entity compliance guide
(SECG) is intended to explain the actions a small entity must take to
comply with FDA's regulations after recent changes made by our 2021
final rule titled ``Milk and Cream Products and Yogurt Products; Final
Rule To Revoke the Standards for Lowfat Yogurt
[[Page 83025]]
and Nonfat Yogurt and To Amend the Standard for Yogurt,'' 2022 final
rule titled ``International Dairy Foods Association and Chobani, Inc.:
Response to the Objections and Requests for a Public Hearing on the
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt
and To Amend the Standard for Yogurt,'' and 2023 final order titled
``International Dairy Foods Association: Response to the Objections and
Requests for a Public Hearing on the Final Rule To Revoke the Standards
for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for
Yogurt.''
DATES: The announcement of the guidance is published in the Federal
Register on November 28, 2023.
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:
<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-4722 for ``Milk and Cream Products and Yogurt Products;
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt
and To Amend the Standard for Yogurt; Small Entity Compliance Guide.''
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.
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 SECG to the Office
of Nutrition and Food Labeling, Product Evaluation and Labeling Branch,
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 SECG.
FOR FURTHER INFORMATION CONTACT: Vivien Yan Peng, Office of Nutrition
and Food Labeling (HFS-820), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2371; or Jessica Ritsick, Office of Regulations and
Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Milk and Cream Products and Yogurt Products; Final Rule To
Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend
the Standard for Yogurt; Small Entity Compliance Guide.''
In the Federal Register of June 11, 2021 (86 FR 31117), we issued a
final rule titled ``Milk and Cream Products and Yogurt Products; Final
Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To
Amend the Standard for Yogurt'' (2021 final rule). The 2021 final rule
amended title 21 of the Code of Federal Regulations at parts 130 and
131 (21 CFR parts 130 and 131) by revoking the standards of identity
for lowfat yogurt and nonfat yogurt and amending the standard of
identity for yogurt in numerous respects. In brief, we revoked the
standards for lowfat yogurt and nonfat yogurt. Consequently, lowfat
yogurt and nonfat yogurt became covered under the general definition
and standard of identity in 21 CFR 130.10, which sets out requirements
for foods that deviate from other standardized foods due to compliance
with a nutrient content claim. The 2021 final rule also amended the
standard of identity for yogurt by making certain technical changes,
established functional classes of safe and suitable ingredients,
replaced the list of nutritive sweeteners with the term ``nutritive
carbohydrate sweeteners,'' and permitted and required certain
statements about cultures under certain conditions.
[[Page 83026]]
The International Dairy Foods Association (IDFA) and Chobani, Inc.,
timely filed objections and requested a hearing with respect to several
provisions in the 2021 final rule. In the Federal Register of March 23,
2022 (87 FR 16394), we issued a notice providing clarification on which
provisions of the final rule were stayed and which requirements of the
previous final rule that we issued in 1981 (46 FR 9924) were in effect
pending final action. We completed our evaluation of the objections,
and, on December 15, 2022, we published a final rule denying requests
for a hearing with respect to all but one of the objections, providing
modifications to certain provisions in the 2021 final rule, and
announcing that the stay of effectiveness of provisions for which
hearings were denied was lifted (87 FR 76559) (2022 final rule). The
2022 final rule did not address IDFA's objections and request for a
hearing on the acidity requirement of yogurt, and we instead addressed
this in a proposed order sent to IDFA and posted to the docket for
public review.
We did not receive any response to the proposed order, and on April
14, 2023, we published a final order, ``International Dairy Foods
Association: Response to the Objections and Requests for a Public
Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and
Nonfat Yogurt and Amend the Standard for Yogurt'' (88 FR 22907) (2023
final order). The 2023 final order modified the acidity requirement in
21 CFR 131.200(a) of the 2021 final rule.
Manufacturers must begin complying with the rule for products
labeled on or after January 1, 2024.
We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule would have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
explain the actions that a small entity must take to comply with the
rule.
We are issuing this SECG consistent with our good guidance
practices regulation (21 CFR 10.115). The SECG represents 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
This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the SECG at <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</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>. Use the
FDA website listed in the previous sentence to find the most current
version of the guidance.
Dated: November 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26095 Filed 11-27-23; 8:45 am]
BILLING CODE 4164-01-P
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