Document ID: FDA-2000-P-0126-0111
Agency: fda
Document Type: Rule
Title: International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a PublicHearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the
Standard for Yogurt
Posted Date: 2022-12-15T05:00Z

[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Rules and Regulations]
[Pages 76559-76568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27040]

[[Page 76559]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 130 and 131

[Docket No. FDA-2000-P-0126 (formerly Docket No. 2000P-0658)]
RIN 0910-AI40

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of public hearing 
requests; removal of administrative stay.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) received 
objections and requests for a hearing from the International Dairy 
Foods Association (IDFA) and Chobani, Inc. (Chobani) on the 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,'' which published on June 11, 2021. The final 
rule revoked the standards of identity for lowfat yogurt and nonfat 
yogurt and amended the standard of identity for yogurt in numerous 
respects. We are denying the requests for a public hearing and 
modifying the final rule in response to certain objections. Therefore, 
the stay of the effectiveness for the final regulation is now lifted.

DATES: This rule is effective January 17, 2023. The compliance date of 
this final rule is January 1, 2024.

ADDRESSES: You may submit objections and request a hearing on new 
provisions added by this response to objections as follows. Please note 
that late, untimely filed objections 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 January 17, 2023. 
Objections 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 objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection 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 objections submitted to the Dockets 
Management Staff, FDA will post your objection, 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-2000-P-0126 for ``International Dairy Foods Association and 
Chobani, Inc.: Response to the Objections and Denial of the 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.'' 
Received objections, 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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections 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.

FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-2371, or Joan Rothenberg, 
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.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 341) directs the Secretary of Health and Human Services 
(Secretary) to issue regulations fixing and establishing for any food a 
reasonable definition and standard of identity whenever, in the 
judgment of the Secretary, such action will promote honesty and fair 
dealing in the interest of consumers. Under section 701(e)(1) of the 
FD&C Act (21 U.S.C. 371(e)(1)), any action for the amendment or repeal 
of any definition and standard of identity under section 401 of the 
FD&C Act for any dairy product (e.g., yogurt) must begin with a

[[Page 76560]]

proposal made either by FDA under our own initiative or by petition of 
any interested persons.
    In the Federal Register of June 11, 2021 (86 FR 31117), we issued a 
final rule amending the definition and standard of identity for yogurt 
((Sec.  131.200) (21 CFR 131.200)) and revoking the definitions and 
standards of identity for lowfat yogurt (21 CFR 131.203) and nonfat 
yogurt (21 CFR 131.206). This action was in response, in part, to a 
citizen petition submitted by the National Yogurt Association (NYA). 
The final rule modernized the yogurt standard to allow for 
technological advances while promoting honesty and fair dealing in the 
interest of consumers.
    The preamble to the final rule stated that the effective date of 
the final rule would be on July 12, 2021, except as to any provisions 
that may be stayed by the filing of proper objections (86 FR 31117 at 
31136). Pursuant to section 701(e) of the FD&C Act, the final rule 
notified persons who would be adversely affected by the final rule that 
they could file objections, specifying with particularity the 
provisions of the final rule deemed objectionable, stating the grounds 
therefor, and requesting a public hearing upon such objections. We gave 
interested persons until July 12, 2021, to file objections and request 
a hearing on the final rule.
    The IDFA and Chobani timely filed objections and requested a 
hearing with respect to several provisions in the final rule (see 
Objections and Request for Hearings submitted by Michael Dykes, 
President and Chief Executive Officer, International Dairy Foods 
Association, dated July 12, 2021, to the Dockets Management Staff, Food 
and Drug Administration (Comment ID FDA-2000-P-0126-0109) (IDFA 
objection) and Objection and Requests for Hearing submitted by Matthew 
Graziose, Director, Regulatory Affairs & Compliance, Chobani, dated 
July 12, 2021, to the Dockets Management Staff, Food and Drug 
Administration (Comment ID FDA-2000-P-0126-0108) (Chobani objection)). 
Section 701(e)(2) of the FD&C Act provides that, until final action is 
taken by the Secretary, the filing of objections operates to stay the 
effectiveness of those provisions to which the objections are made.
    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) are in effect pending final action under 
section 701(e) of the FD&C Act.

II. Standards for Granting a Hearing

    Specific criteria for granting a hearing are set out in Sec.  
12.24(b) (21 CFR 12.24(b)). Under that regulation, a hearing will be 
granted if the material submitted by the requester shows that: (1) 
there is a genuine and substantial factual issue for resolution at a 
hearing (a hearing will not be granted on issues of policy or law); (2) 
the factual issue can be resolved by available and specifically 
identified reliable evidence (a hearing will not be granted on the 
basis of mere allegations or denials or general descriptions of 
positions and contentions); (3) the data and information submitted, if 
established at a hearing, would be adequate to justify resolution of 
the factual issue in the way sought by the requester (a hearing will be 
denied if the data and information submitted are insufficient to 
justify the factual determination urged, even if accurate); (4) 
resolution of the factual issue in the way sought by the person is 
adequate to justify the action requested (a hearing will not be granted 
on factual issues that are not determinative with respect to the action 
requested, e.g., if the action would be the same even if the factual 
issue were resolved in the way sought); (5) the action requested is not 
inconsistent with any provision in the FD&C Act or any regulation 
particularizing statutory standards (the proper procedure in those 
circumstances is for the person requesting the hearing to petition for 
an amendment or waiver of the regulation involved); and (6) the 
requirements in other applicable regulations, e.g., 21 CFR 10.20, 
12.21, 12.22, 314.200, 514.200, and 601.7(a), and in the notice issuing 
the final regulation or the notice of opportunity for a hearing are 
met.
    A party seeking a hearing must meet a ``threshold burden of 
tendering evidence suggesting the need for a hearing'' (Costle v. 
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), citing 
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-621 
(1973)). An allegation that a hearing is necessary to ``sharpen the 
issues'' or to ``fully develop the facts'' does not meet this test 
(Georgia Pacific Corp. v. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If 
a hearing request fails to identify any or sufficient factual evidence 
that would be the subject of a hearing, there is no point in holding 
one. In judicial proceedings, a court is authorized to issue summary 
judgment without an evidentiary hearing whenever it finds that there 
are no genuine issues of material fact in dispute, and a party is 
entitled to judgement as a matter of law (see Rule 56, Federal Rules of 
Civil Procedure). The same principle applies to administrative 
proceedings (21 CFR 12.28, see Vermont Dep't of Pub. Serv. v. FERC, 817 
F.2d 127, 140 (D.C. Cir. 1987)).
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact ``concerning which a meaningful 
hearing might be held'' (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 
1085 (9th Cir. 1982) see also Cmty. Nutrition Inst. v. Young, 773 F.2d 
1356, 1364 (D.C. Cir. 1985)). Where the issues raised in the objection 
are, even if true, legally insufficient to alter the decision, an 
agency need not grant a hearing (see Cmty. Nutrition Inst. v. Young, 
773 F.2d 1356, 1364 (D.C. Cir. 1985); Dyestuffs and Chemicals, Inc. v. 
Flemming, 271 F.2d 281, 286 (8th Cir. 1959)). A hearing is justified 
only if the objections are made in good faith and if they raise 
``material' issues of fact'' (Pineapple Growers Ass'n, 673 F.2d at 
1085). A hearing need not be held to resolve questions of law and 
policy (see Kourouma v. FERC, 723 F.3d 274, 277-78 (D.C. Cir. 2013); 
Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. 
Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir. 1958)).
    Even if the objections raise material issues of fact, we need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality, such as collateral estoppel, can be validly 
applied to the administrative process (see Astoria Fed. Sav. & Loan 
Ass'n v. Solimino, 501 U.S. 104, 107-08 (1991); Pacific Seafarers, Inc. 
v. Pac. Far East Line, Inc., 404 F.2d 804, 809 (D.C. Cir. 1968), cert. 
denied, 393 U.S. 1093 (1969)). In explaining why these principles ought 
to apply to an agency proceeding, the U.S. Court of Appeals for the 
District of Columbia Circuit wrote: ``The underlying concept is as 
simple as this: justice requires that a party have a fair chance to 
present his position. But overall interests of administration do not 
require or generally contemplate that he will be given more than a fair 
opportunity'' (Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 
322 (D.C. Cir. 1972); see also Costle v. Pacific Legal Foundation, 445 
U.S. 198 at 215-17). In addition, under our regulations, we may 
determine upon review of an objection that the regulation should be 
modified or revoked (Sec.  12.26 (21 CFR 12.26)). If the modification 
or revocation is

[[Page 76561]]

consistent with the objector's request, there is no genuine and 
substantial issue of fact for resolution at a hearing and the hearing 
may be denied (Sec.  12.24(b)(1)).

III. Analysis of Objections and Response to Hearing Requests

    Under section 701(e) of the FD&C Act and 21 CFR part 12, subpart B, 
of our regulations, we have considered the objections and requests for 
a hearing and our conclusions are as follows:
    The submission from IDFA contains five numbered objections, and 
IDFA requests a hearing on each of them. In addition, Chobani submitted 
one objection and request for a hearing. We address each objection 
below, as well as the evidence and information filed in support of 
each. For purposes of clarity, we have maintained the objection numbers 
assigned by IDFA and Chobani.
    IDFA's objections were directed at several provisions in Sec.  
131.200(a) of the final rule: (1) the requirement to achieve either a 
titratable acidity of not less than 0.7 percent, expressed as lactic 
acid, or a pH of 4.6 or lower prior to the addition of bulky flavoring 
ingredients; (2) those portions of Sec.  131.200(a), (b), and (c) that 
prohibit the addition of pasteurized cream after culturing; (3) the 
provision in Sec.  131.200(d)(8)(ii) that would require a yogurt with 
added vitamin D to contain at least 25 percent Daily Value (DV) vitamin 
D per Reference Amount Customarily Consumed (RACC); (4) the requirement 
that yogurt contain not less than 3.25 percent milkfat; and (5) the 
exclusion of safe and suitable ``non-nutritive sweeteners'' from 
paragraph (d)(2) as an optional ingredient and the limitation of their 
use to only those instances where the product bears an expressed 
nutrient content claim as part of the product name, such as ``reduced 
calorie yogurt'' or ``reduced sugar yogurt,'' under Sec.  130.10 (21 
CFR 130.10).
    In addition, Chobani objected to the provision in Sec.  131.200(b) 
as it does not allow for ultrafiltered milk to be used as a basic dairy 
ingredient, and Chobani requested a hearing.

A. IDFA Titratable Acidity and pH Objections

    In this objection, IDFA asserted that the final rule's requirement 
that yogurt has either a titratable acidity of not less than 0.7 
percent, expressed as lactic acid, or a pH of 4.6 or lower before the 
addition of bulky flavoring ingredients (such as fruits and fruit 
preparations), is not practical and does not reflect consumer taste 
preferences or current industry practice for yogurt manufacturing. IDFA 
stated that the requirement will not promote honesty and fair dealing 
in the interest of consumers. IDFA asserted that the requirement should 
be a titratable acidity of not less than 0.6 percent, expressed as 
lactic acid, measured in the white mass of the yogurt, or a pH of 4.6 
or lower measured in the finished product within 24 hours after 
filling. IDFA requested a hearing on the following issues: (1) whether 
a requirement that titratable acidity or pH be reached prior to the 
addition of bulky flavors in the manufacturing process is consistent 
with the basic nature and essential characteristics of yogurt; (2) 
whether a requirement that prohibits yogurt from being filled at a pH 
of 4.8 or less and reaching a pH of 4.6 or below within 24 hours after 
filling is consistent with the basic nature and essential 
characteristics of yogurt; and (3) whether a minimum titratable acidity 
requirement of 0.7 percent is in the interest of consumers and 
necessary to maintaining the basic nature and essential characteristics 
of yogurt.
    We have addressed this objection and request for a hearing in a 
letter and proposed order sent to IDFA pursuant to Sec.  12.24(d). We 
are issuing the proposed order to deny IDFA's request for a hearing 
with respect to pH pursuant to Sec.  12.24(b)(1), and also deny the 
request for a hearing with respect to titratable acidity pursuant to 
Sec.  12.24(b)(1). A copy of the proposed order is available in Docket 
No. FDA-2000-P-0126 (formerly Docket No. 2000P-0658). (See instructions 
for accessing the docket.)

B. IDFA Objection to the Requirement That Cream Be Added Before 
Culturing

    IDFA objected to Sec.  131.200(a), (b), and (c) insofar as they 
prohibit the addition of pasteurized cream after culturing and asked 
FDA to stay such provisions. The final rule under Sec.  131.200(a) 
requires that pasteurized cream, if used as a basic dairy ingredient 
under Sec.  131.200(b) or an optional dairy ingredient under Sec.  
131.200(c), be added before culturing with a characterizing bacterial 
culture that contains the lactic acid-producing bacteria, Lactobacillus 
delbrueckii subsp. bulgaricus and Streptococcus thermophilus. IDFA 
requested that we revise the final rule to allow for pasteurized cream 
to be added after culturing.
    IDFA contended that the addition of pasteurized cream after 
culturing is consistent with the basic nature and essential 
characteristics of yogurt and requested a hearing on this issue. IDFA 
explained that ``milkfat is not critical to the basic nature and 
properties of yogurt, in large part because the yogurt cultures do not 
act on the milkfat during the culturing process, so the addition of a 
milk-derived ingredient like cream after culturing does not alter the 
key characteristics of the product'' (IDFA objection at page 6). Even 
if milkfat is not acted upon during the culturing process, it does not 
follow that any milk-derived ingredient will not be acted upon during 
the culturing process and therefore will not change the characteristics 
of the end product depending on whether it is added before or after 
culturing. IDFA's argument appears to be based on the assumption that 
cream is comprised entirely of milkfat. We note that IDFA did not 
provide any evidence in its objection that cream is comprised entirely 
of milkfat and that other components are not present.
    In fact, cream is comprised of several components other than 
milkfat. These components include lactose and protein (Refs. 1 to 3). 
Under 21 CFR 131.3(a), cream used in the manufacture of yogurt is only 
required to have a minimum of 18 percent milkfat. While the milkfat 
content of cream above this minimum may vary, lactose and protein are 
still present. For example, heavy whipping cream has been reported to 
have fat content of 36.8 percent, lactose content of 3.2 percent, and 
protein content of 2.2 percent (see Ref. 1). Whole milk--which IDFA 
does not dispute should be included in culturing (IDFA objection page 
6)--has been reported to have fat content of 3.8 percent, lactose 
content of 4.9 percent, and protein content of 3.2 percent. While the 
milkfat content of these two dairy ingredients is very different, the 
lactose content and protein content are similar. The lactose in cream 
can be fermented and impact the characteristics of the end product 
(Ref. 3), as is the case in the production of sour cream (see 21 CFR 
131.160(a)).
    IDFA acknowledges that lactose and protein are subject to action by 
yogurt cultures during fermentation and impact the characteristics of 
yogurt. IDFA states, on page 6 of its objection, that ``addition of 
milk and milk-derived ingredients that contain significant amounts of 
lactose, proteins and amino acid peptides, which are indeed subjected 
to action by yogurt cultures during fermentation, do play a role in 
providing the unique organoleptic characteristics of yogurt.'' IDFA 
further states, on page 7, that ``the main contribution to the unique 
flavor and aroma of plain, unflavored yogurt derives from the 
homofermentative metabolism of lactose in the milk and the lactose-
containing milk-derived ingredients by the two defining thermophilic 
(or more accurately, ``thermotolerant'') yogurt cultures L.

[[Page 76562]]

bulgaricus and S. thermophilus.'' Thus, by IDFA's own admission, the 
characteristics of yogurt are impacted by whether components of cream 
are added before or after culturing.
    Since 1981, cream has not been permitted to be added after 
culturing in the manufacture of yogurt. None of the evidence provided 
by IDFA specifically examines the addition of cream after culturing in 
the manufacture of yogurt and compares the end product to yogurt 
manufactured with cream added before culturing. To justify a change in 
the production of yogurt from how it has been produced for 40 years, 
IDFA would have needed to provide evidence that the addition of cream--
not merely the addition of milkfat--does not impact the characteristics 
of yogurt from how it has been produced and sold to consumers. The 
publications cited by IDFA (Refs. 4 to 7) do not address impacts on the 
characteristics of yogurt from the use of cream, and more specifically 
from the use of cream after culturing. Moreover, the expert witness 
testimony described in appendix 8 of IDFA's objection is specifically 
about the addition of milkfat to yogurt and not about the addition of 
cream to yogurt. We conclude that the data and information submitted, 
if established at a hearing, would not be adequate to justify 
resolution of the factual issue in the way sought by IDFA. The data and 
information submitted are insufficient to justify the factual 
determination urged, even if accurate. Therefore, under Sec.  
12.24(b)(3), we deny IDFA's request for a hearing on whether the 
addition of pasteurized cream after culturing is consistent with the 
basic nature and essential characteristics of yogurt.
    Additionally, IDFA did not provide evidence to support its 
assertion that the addition of pasteurized cream after culturing does 
not affect the texture of yogurt. We are denying IDFA's request for a 
hearing with respect to this issue as it based on mere allegations or 
denials and not on any available and specifically identified reliable 
evidence (see Sec.  12.24(b)(2)). We note that evidence (Ref. 8) 
gathered by FDA indicates that adding cream before culturing increases 
the yogurt's viscosity and firmness, and decreases the serum 
separation, contributing to the characteristic texture of yogurt. When 
cream is added after culturing, the fat globules do not serve a 
structure-building function but are only present in the structure as a 
filling substance (Refs. 8 and 9). The force that would be necessary to 
blend pasteurized cream homogeneously through the yogurt if it were 
added after culturing, as well as the additional moisture present in 
pasteurized cream, could affect the texture of the yogurt. Thus, given 
the absence of evidence to support IDFA's contention and available 
evidence to the contrary, the data and information submitted are 
inadequate to justify the resolution of the factual issue in the way 
sought by IDFA (see Sec.  12.24(b)(3)).
    We further note that adequacy of either factual issue (i.e., impact 
of addition of cream after culturing on taste, aroma, and flavor and 
impact of addition of cream after culturing on texture) is not 
sufficient to justify amending the standard of identity to permit the 
addition of cream after culturing. Both factual issues must be resolved 
in the way sought by IDFA to justify such an amendment. Accordingly, we 
also deny IDFA's request for a hearing under Sec.  12.24(b)(4).
    IDFA stated that allowing the addition of pasteurized cream after 
culturing improves production efficiency and reduces manufacturing 
costs. While we recognize the importance of these issues for yogurt 
manufacturers, impacts on production efficiency and manufacturing costs 
do not present genuine and substantial issues of fact as they are not 
material to whether a food standard promotes honesty and fair dealing 
in the interest of consumers--which is the basis under the law for 
establishing food standards (21 U.S.C. 341). Historically, we have 
determined the requirements of food standards issued under section 401 
of the FD&C Act based on whether the requirements would prevent 
economic adulteration, maintain the integrity of food (i.e., basic 
nature and essential characteristics), or ensure that products meet 
consumer expectations about the food.
    We note that interested parties can submit a Temporary Marketing 
Permit (TMP) application in accordance with 21 CFR 130.17 for the 
addition of pasteurized cream after culturing in yogurt and lower fat 
yogurt. As discussed above, given FDA regulations have required since 
1981 that cream be added before and not after culturing when used in 
the manufacture of yogurt, a TMP would allow parties to gather 
appropriate supporting data to support that the addition of cream after 
culturing is consistent with the basic nature and essential 
characteristics of yogurt and lower fat yogurt.

C. IDFA Objection to the Optional Addition of Vitamin D

    IDFA objected to the provision in Sec.  131.200(d)(8)(ii), which 
requires that, if added, vitamin D must be present in such quantity 
that the food contains not less than 25 percent DV per RACC within 
limits of current good manufacturing practices. IDFA requested that the 
provision be modified to lower the minimum added vitamin D level to 10 
percent DV per RACC. Alternatively, IDFA requested a hearing on the 
amount of vitamin D in yogurt that would be consistent with consumer 
expectations and the basic nature and characteristics of yogurt that 
contains added vitamin D, and aligned with current regulatory 
limitations.
    In support of its proposed modification, IDFA asserted that a 
minimum vitamin D threshold of 25 percent DV per RACC conflicts with 
the level authorized by our generally recognized as safe (GRAS) 
regulation for vitamin D, which sets the limit for vitamin D in milk 
products at 89 International Units (IU) per 100 grams (g) of food (21 
CFR 184.1950(c)(1)), equivalent to 3.8 micrograms (mcg) per RACC. In 
addition, IDFA asserted that the required level of vitamin D provided 
for in the final rule is unreasonably high in light of the basic nature 
of yogurt and does not promote the interests of consumers.
    We acknowledge that, under the minimum vitamin D threshold in the 
final rule, yogurt with added vitamin D must contain at least 5 mcg per 
RACC and therefore would be above the maximum threshold of 3.8 mcg per 
RACC permitted under our GRAS regulation. This effectively prevents 
manufacturers from fortifying their yogurt products with vitamin D and 
is not what we intended under the final rule. We note that vitamin D is 
identified as a nutrient of public health concern under the Dietary 
Guidelines for Americans, 2020-2025.
    We agree with IDFA's proposal to modify Sec.  131.200(d)(8)(ii) to 
set a minimum level of vitamin D at 10 percent DV per RACC. This level 
equates to a minimum of 2 mcg per RACC. Thus, there would be a range of 
2 to 3.8 mcg per RACC within which manufacturers could comply with the 
GRAS regulation and also optionally fortify yogurt with vitamin D under 
the yogurt standard of identity. A minimum amount of 2 mcg per RACC is 
the minimum amount at which the Agency deems a food to be a ``good 
source'' of vitamin D (see our nutrient content claim regulation under 
21 CFR 101.54(c)(1)). The minimum in Sec.  131.200(d)(8)(ii) applies to 
nonfat yogurt, lowfat yogurt, and reduced fat yogurt under Sec.  
130.10. Consequently, yogurt and lower fat yogurt products containing 
added vitamin D under the modified final rule will continue to be a 
good source of vitamin D for consumers.

[[Page 76563]]

    We note that a minimum of 10 percent DV per RACC, or 2 mcg per 
RACC, is similar to the minimum under the standard of identity before 
it was amended in 2021 by the final rule. From 1982 to 2021, vitamin D 
addition to yogurt was permitted at a level of 400 IU per quart (see 47 
FR 41519 at 41520 and 41524, September 21, 1982). This amount equates 
to approximately 1.74 mcg per RACC. Thus, modifying the standard of 
identity to require a minimum vitamin D level of 10 percent DV per 
RACC, results in a similar amount of vitamin D as was previously 
permitted under the standard and does not alter the characteristics of 
yogurt with respect to fortification with this nutrient.
    We find that our own analysis and the information provided by IDFA 
in their objection present sufficient grounds for amending the standard 
of identity under Sec.  131.200(d)(8)(ii) such that yogurt is required 
to contain at least 10 percent DV per RACC of vitamin D, within limits 
of current good manufacturing practices, when vitamin D is added. This 
amendment is consistent with IDFA's proposed modification. Therefore, 
we are denying IDFA's request for a hearing regarding the amount of 
vitamin D in yogurt because there is not a genuine and substantial 
issue of fact for resolution at a hearing (Sec.  12.24(b)(1)).

D. IDFA Objection to the 3.25 Percent Minimum Milkfat Requirement

    IDFA also objected to the requirement in Sec.  131.200(a) that 
yogurt contain not less than 3.25 percent milkfat. IDFA asserted that 
the 3.25 percent minimum milkfat requirement is not consistent with the 
basic nature and essential characteristics of yogurt, nor does it 
reflect current industry practices. IDFA further asserted that the 
requirement creates naming anomalies and restricts innovation and the 
use of flavoring ingredients. IDFA requested that we modify the final 
rule to include a minimum total fat content of >3.0 g per RACC instead 
of the 3.25 percent milkfat minimum (5.5 g per RACC). IDFA requested a 
hearing on whether ``(1) a 3.25 percent milkfat minimum is critical to 
the basic nature and characteristics of yogurt; and (2) whether fat/
oils from nondairy ingredients, particularly flavoring ingredients, 
could contribute to variances in the taste, texture, color, or aroma of 
yogurt and is inconsistent with the basic nature and essential 
characteristics of the food'' (IDFA objection at page 15).
    In support of its contention that milkfat does not contribute to 
the basic nature and essential characteristics of yogurt and that no 
minimum milkfat requirement is needed, IDFA relied on the discussion in 
its second objection (i.e., the requirement that cream be added before 
culturing). IDFA stated that if a hearing were granted, it would 
provide evidence ``demonstrating that milkfat is not critical to the 
basic nature and characteristics of yogurt, in large part because the 
yogurt cultures do not act on the milkfat during the culturing 
process'' (Id.). IDFA further stated that it would present ``testimony 
by experts in yogurt production and presentation of scientific 
publications by subject matter experts demonstrating the results of 
sensory and analytical chemistry research conducted that has identified 
the specific compounds that contribute most to the unique flavors and 
aromas of yogurt and how they are derived predominantly through lactose 
fermentation'' (Id.).
    The discussion in IDFA's second objection is about whether milkfat 
is fermented and whether the end product is impacted by the addition of 
milkfat after culturing rather than before culturing. The second 
objection does not address whether a reduction of milkfat in the end 
product changes the characteristics of yogurt. The evidence described 
by IDFA similarly focuses on whether milkfat is acted upon during the 
culturing process and not on whether the absence of milkfat from the 
end product affects the basic nature and essential characteristics of 
yogurt. Even if it is true that components other than milkfat 
contribute most to the flavor and aroma of yogurt, this does not 
preclude the possibility that milkfat also contributes to the flavor 
and aroma or other essential characteristics of yogurt. In this 
objection, the issue is whether a reduction of milkfat from the 3.25 
percent minimum in the end product affects the basic nature and 
essential characteristics of yogurt, not whether milkfat is acted upon 
during culturing or whether other components affect the essential 
characteristics of yogurt.
    The publications cited by IDFA do not support that a reduction in 
milkfat in the end product does not affect the basic nature and 
essential characteristics of yogurt. References 5, 6, and 7 speak 
solely to the metabolic activity of the fermentation organisms on the 
components of the yogurt base (carbohydrates, proteins, lipids). The 
impact of the microorganisms on the fat component appears to be 
measurable (see Ref. 7, Table 7.11 on Page 578) but potentially minimal 
in comparison to other components produced by the fermentation of 
lactose. The publications do not address the physical presence of fat 
on the characteristics of the end product. Routray and Mishra (Ref. 4) 
review the influence of fat content on the persistence of volatile 
flavor compounds, the distribution of flavor compounds throughout the 
yogurt matrix, and the necessity of fat replacers to achieve similar 
texture and flavor release. Additionally, they discuss the importance 
of fat as a structuring material in yogurt.
    Moreover, statements made by IDFA in its objection support that 
milkfat contributes to the basic nature and essential characteristics 
of yogurt. In its second objection, IDFA states, ``milkfat has an 
impact on the organoleptic characteristics of yogurt regardless of 
whether added before or after fermentation'' (Id. at page 7). In this 
objection IDFA asserts, ``yogurt made with milkfat indeed has volatile 
fatty acids and other compounds that contribute to flavor and aroma'' 
(Id. at page 12) and ``milkfat does not need to be present in the 
fermented dairy ingredients to contribute to the basic and essential 
characteristics of yogurt'' (Id. at page 13). Thus, by IDFA's own 
admissions, milkfat contributes to the characteristics of yogurt.
    IDFA made additional arguments about consumer preferences for lower 
fat yogurt products and the absence of a milkfat requirement from the 
Codex Standard for Fermented Milks. The claim that most consumers 
prefer lower fat yogurt products to yogurt does not address the issues 
of whether consumers who purchase yogurt, rather than lower fat yogurt, 
expect it to contain milkfat or whether the 3.25 percent minimum 
milkfat requirement ensures that yogurt has the characteristics 
consumers expect and that distinguish it from lower fat yogurt. Even if 
most consumers prefer lower fat yogurt products, the 3.25 percent 
minimum milkfat requirement does not prohibit the marketing of these 
products when labeled with their respective nutrient content claims. 
Evidence demonstrating that total fat is of greater significance to 
consumers than milkfat also would not address these issues. Regarding 
the absence of a milkfat minimum from the Codex standard, the Codex 
standard is an international standard and does not reflect yogurt 
products sold in the United States or American consumers' expectations 
about yogurt.
    Since the yogurt and lowfat yogurt standards of identity were 
established in 1981, yogurt and lowfat yogurt sold in the United States 
have been required to have a minimum of 3.25 percent and 0.5 to 2 
percent milkfat, respectively. Reduced fat yogurt has been required to

[[Page 76564]]

have milkfat content between the minimum for yogurt and the maximum for 
lowfat yogurt since the 1990s when the general definition and standard 
of identity under Sec.  130.10 was established (see 58 FR 2431 at 2446, 
January 6, 1993). Thus, for 40 years, consumers have been accustomed to 
yogurt and lowfat yogurt containing milkfat; and for nearly 30 years, 
consumers have been accustomed to reduced fat yogurt containing 
milkfat. A review by FDA of products on the market sold as ``yogurt'' 
found that the vast majority contain at least 3.25 percent milkfat 
(Ref. 10). IDFA has not presented information that these products would 
retain the characteristics consumers expect and that distinguish the 
foods if they were changed to contain no milkfat or less milkfat than 
the amount required.
    Because the data and information submitted by IDFA are insufficient 
to justify that a reduction of milkfat from the 3.25 percent minimum 
does not affect the basic nature and essential characteristics of 
yogurt, we deny IDFA's request for a hearing on whether the 3.25 
percent milkfat minimum is critical to the basic nature and essential 
characteristics of yogurt under Sec.  12.24(b)(3).
    IDFA also requested a hearing on whether fat or oils from nondairy 
ingredients, particularly flavoring ingredients, could contribute to 
variances in the taste, texture, color, or aroma of yogurt and is 
inconsistent with the basic nature and essential characteristics of the 
food. In the preamble to the final rule, we explained that nondairy 
fats or oils can contribute to variances in the taste, texture, color, 
or aroma of yogurt if they replace the milkfat in yogurt (86 FR 31117 
at 31121). IDFA responded in its objection that non-dairy fats and oils 
are not part of the allowed optional ingredients and that, if a fat 
source is not part of a flavoring ingredient (e.g., coconut flakes, 
cacao), it may not be added. We agree with this interpretation and 
therefore interpret IDFA's request for a hearing to pertain to whether 
the addition of non-milkfat from flavoring ingredients is inconsistent 
with the basic nature and essential characteristics of yogurt and lower 
fat yogurt.
    To the extent that the request pertains to the addition of non-
milkfat from flavoring ingredients in addition to the milkfat required 
for yogurt under Sec.  131.200 and lower fat yogurt under Sec.  130.10, 
we agree that addition of non-milkfat from flavoring ingredients should 
be permitted and is consistent with the basic nature and essential 
characteristics. The final rule permits the addition of flavoring 
ingredients, including fat-containing flavoring ingredients under Sec.  
131.200(d)(3). However, as explained in IDFA's objection, the final 
rule does not permit the addition of fat-containing flavoring 
ingredients to lower fat yogurt under Sec.  130.10 since the nutrient 
content claims for ``nonfat,'' ``lowfat,'' and ``reduced fat'' limit 
the amount of fat that products may contain and the limit has already 
been met by milkfat. IDFA explained that lowerfat yogurt products are 
consequently precluded from containing flavoring ingredients such as 
coconut and cacao.
    We agree that this limitation may restrict innovation and prevent 
the manufacture and sale of lowerfat yogurt products that consumers 
expect. Accordingly, we are modifying Sec.  130.10 to add new paragraph 
(e) to permit fat-containing flavoring ingredients in nonfat yogurt, 
lowfat yogurt, and reduced fat yogurt. These products are still 
required under Sec.  130.10 (a) to contain milkfat in the amount 
corresponding to the nutrient content claims in their names; however, 
the modified rule permits fat from flavoring sources to be added above 
the fat content of the nutrient content claim. Such products must be 
labeled with the nutrient content claim corresponding to their milkfat 
content and a descriptor of the flavoring ingredient (e.g., ``lowfat 
yogurt with cashews''). The descriptor should describe in plain 
language the identity of the flavoring ingredient (e.g., cashews, 
chocolate chips, coconut).
    We are also modifying the final rule to permit yogurt with milkfat 
content between the upper limit for reduced fat yogurt (2.44 percent) 
and the minimum requirement for yogurt (3.25 percent). New paragraph 
(g) under Sec.  131.200 specifies that yogurt may contain less than 
3.25 percent milkfat but at least 2.44 percent milkfat and that such 
products must be labeled with a statement of the milkfat percentage 
rounded to the nearest half percent (e.g., ``2.5 percent milkfat''). 
Under Sec.  131.200(d)(3), such products are permitted to contain 
flavoring ingredients that increase the total fat content. These 
modifications to Sec.  131.200 address the gap in milkfat allowance 
identified by IDFA in its objection (IDFA objection at pages 13-14) and 
allow the manufacture and sale of yogurt products with milkfat not 
previously covered by the final rule or the 1981 final rule.
    As a consequence of our modifications to Sec.  130.10 and Sec.  
131.200, manufacturers may produce yogurt products with any amount of 
milkfat within the specified limits and with additional fat content 
from flavoring ingredients. This introduces flexibility into the 
standards of identity and provides new opportunities for innovation as 
requested by IDFA. An amendment to replace the 3.25 percent minimum 
milkfat requirement with >3.0 grams of fat per RACC requirement is not 
needed to accomplish these purposes. The modified final rule also 
allows manufacturers to produce yogurt products with less saturated 
fat, consistent with recommendations in the Dietary Guidelines for 
Americans 2020-2025, since the total fat content can exceed the limit 
for the nutrient content claim and milkfat need not be increased to 
3.25 percent. Yogurt products will continue to be named according to 
the milkfat limits in the final rule (i.e., ``yogurt,'' ``reduced fat 
yogurt,'' ``lowfat yogurt,'' and ``nonfat yogurt''). These names have 
been in place for decades and have distinguished yogurt products from 
each other and are recognized by consumers. While the ingredient 
statement may indicate that dairy ingredients are present, it does not 
explicitly inform consumers that milkfat is present or in what 
quantity. Because we agree with IDFA that non-milkfat from flavoring 
ingredients should be permitted in yogurt and lower fat yogurt above 
the minimum milkfat requirements and have modified the final rule 
accordingly, IDFA's request for a hearing is denied under Sec.  
12.24(b)(1) as there is no genuine and substantial issue of fact for 
resolution at a hearing.
    To the extent that IDFA's request for a hearing pertains to the 
addition of non-milkfat from flavoring ingredients as a replacement for 
milkfat in yogurt and lower fat yogurt, we deny IDFA's request for a 
hearing under Sec.  12.24(b)(3) because the data and information 
submitted are insufficient to justify that use of fat and oils from 
nondairy flavoring ingredients to replace milkfat in yogurt is 
consistent with the basic nature and essential characteristics of 
yogurt. First, as explained above, IDFA has not submitted information 
sufficient to justify that a reduction in milkfat does not affect the 
basic nature and essential characteristics of yogurt. IDFA also has not 
presented evidence that consumers who purchase lower fat yogurt 
products (other than nonfat yogurt) do not expect them to contain 
milkfat or that their lower milkfat levels do not contribute to their 
characteristics. Second, IDFA stated in its objection that it would 
present examples and sales volumes demonstrating that fat from nondairy 
ingredients is consistent with the basic

[[Page 76565]]

nature and essential characteristics of many flavored yogurts on the 
market today and accepted by consumers. It is unclear what examples 
IDFA would present and whether such examples would be representative of 
the market. It is also unclear what is meant by ``sales volumes'' and 
how sales of certain products would demonstrate consumer acceptance. 
Nevertheless, yogurt, lowfat yogurt, and nonfat yogurt prior to and 
after publication of the final rule have been required to contain 
certain milkfat content. Thus, examples and sales of products on the 
market would not pertain to products that contain fat or oils from non-
dairy flavoring ingredients as a replacement for milkfat and would not 
be sufficient to justify the factual determination urged by IDFA.

E. IDFA Objection to the Exclusion of Safe and Suitable Non-Nutritive 
Sweeteners

    IDFA objected to the exclusion of safe and suitable ``non-nutritive 
sweeteners'' from Sec.  131.200(d)(2) as an optional ingredient and to 
the limitation of the use of non-nutritive sweeteners to products 
bearing a nutrient content claim as part of the name or statement of 
identity. IDFA asserted that ``[t]he use of non-nutritive sweeteners is 
consistent with the basic nature of a sweetened yogurt'' (IDFA 
objection at page 16) and requested a hearing on ``whether the use of 
safe and suitable non-nutritive sweeteners is consistent with the basic 
nature or essential characteristics of sweetened `yogurt' '' (Id. at 
page 20). IDFA requested that we modify Sec.  131.200(d)(2) to replace 
``nutritive carbohydrate sweeteners'' with ``sweeteners,'' thereby 
permitting both nutritive and non-nutritive sweeteners in the 
manufacture of yogurt (Id.).
    In support of its contention that the use of non-nutritive 
sweeteners is consistent with the basic nature and essential 
characteristics of yogurt, IDFA referenced our conclusion in the 2009 
proposed rule that yogurt could be sweetened with non-nutritive 
sweeteners ``without adversely affecting the basic nature and essential 
characteristics of yogurt'' (Id.). IDFA also pointed to our enforcement 
discretion policy since 2009 (74 FR 2443 at 2455) regarding the use of 
non-nutritive sweeteners in yogurt labeled without a nutrient content 
claim, such as ``reduced calorie,'' as part of the name of the food. 
IDFA explained that yogurt products containing non-nutritive sweeteners 
without a nutrient content claim as part of the name of the food have 
been sold during this period of enforcement discretion and are commonly 
found on the market today.
    Our rationale in the final rule for permitting the use of non-
nutritive sweeteners only when making a nutrient content claim was to 
be consistent with the intention of the regulatory framework of Sec.  
130.10 after the Nutritional Labeling and Education Act (NLEA). We 
explained in the final rule that non-nutritive sweeteners should only 
be permitted when making a nutrient content claim and therefore when 
the product is subject to the general definition and standard of 
identity in Sec.  130.10 (86 FR 31117 at 31128). We believed that this 
approach would address the comments we received to the proposed rule 
(74 FR 2443) concerning the presence and disclosure of artificial 
sweeteners while also providing manufacturers flexibility to make 
modified yogurt products with non-nutritive sweeteners.
    Upon consideration of IDFA's objection, we agree that non-nutritive 
sweeteners should be permitted in yogurt without being labeled with a 
nutrient content claim. We acknowledge that, since the publication of 
the proposed rule, we have exercised enforcement discretion for yogurt 
products containing non-nutritive sweeteners as an optional ingredient 
and that do not bear a nutrient content claim as part of the statement 
of identity. During this 12-year period, we did not encounter any 
consumer issues or receive information that the use of non-nutritive 
sweeteners was inconsistent with what consumers expect or that such use 
adversely impacted the characteristics of the food. Disclosure of non-
nutritive sweeteners in the ingredient statement appears to have been 
adequate to notify consumers of their presence. We note that non-
nutritive sweeteners are declared by their common or usual names and 
therefore their presence is explicitly stated. We further note that 
nutrient content claims such as ``reduced calorie'' or ``reduced 
sugar'' do not necessarily inform consumers that non-nutritive 
sweeteners are present and may indicate that other modifications to the 
food have been made (e.g., a ``reduced calorie'' nutrient content claim 
could also be met by reducing fat or lactose). In light of this 
information, we conclude that the use of non-nutritive sweeteners in 
yogurt products that do not bear a nutrient content claim is consistent 
with the basic nature and essential characteristics of yogurt and 
promotes honesty and fair dealing in the interest of consumers.
    Upon further consideration, we find the limitation on non-nutritive 
sweeteners to only those products labeled with nutrient content claims 
to be inconsistent with our public health goals and policies. The 
Dietary Guidelines for Americans 2020-2025 encourage consumers to limit 
their intake of added sugar. The sugar content of food, including 
yogurt, is often reduced by replacing sugar with non-nutritive 
sweeteners. Thus, the use of non-nutritive sweeteners in yogurt may 
help reduce added sugar intake. Although non-nutritive sweeteners are 
currently permitted in products with a nutrient content claim, such as 
``reduced calorie'' or ``reduced sugar,'' the products must achieve a 
level of sugar reduction, e.g., 25 percent less calories or sugar, to 
qualify for the nutrient content claim (see Sec.  101.60). Thus, if 
sugar reduction falls below this threshold (e.g., 25 percent less 
calories or sugar), then the products are not permitted to contain non-
nutritive sweeteners. We seek to encourage sugar reduction even at 
lower levels as cumulatively these changes can make a difference in 
public health. Permitting non-nutritive sweeteners in yogurt is also 
consistent with our public health goals and policies, which seek to 
improve nutrition and encourage the development of more healthful 
foods.
    For the reasons explained above, we are modifying Sec.  
131.200(d)(2) to permit ``sweeteners'' as optional ingredients in 
yogurt, consistent with IDFA's request. Accordingly, IDFA's request for 
a hearing is denied under Sec.  12.24(b)(1) as there is no genuine and 
substantial issue of fact for resolution at a hearing.

F. Chobani Objections Regarding Ultrafiltered Milk

    Chobani requested we permit the use of ultrafiltered (UF) milk as a 
basic dairy ingredient in yogurt. They objected to Sec.  131.200(b) 
because it does not include UF milk as a basic dairy ingredient and 
therefore Sec.  131.200(a) does not permit UF milk as a basic dairy 
ingredient in yogurt. Chobani provided several reasons for objecting to 
the exclusion of UF milk from Sec.  131.200(b). We interpret these 
reasons as follows: (1) the use of UF milk as a basic dairy ingredient 
is consistent with the basic nature and essential characteristics of 
yogurt; (2) the use of UF milk as a basic dairy ingredient is safe; (3) 
the use of UF milk as a basic dairy ingredient will result in products 
with health benefits and that are as nutritious or more nutritious than 
yogurt produced without UF milk; (4) use of UF milk as a basic dairy 
ingredient will improve the efficiency of yogurt-making; (5) permitting 
use of UF milk would be consistent with other dairy standards of 
identity; and (6)

[[Page 76566]]

permitting the use of UF milk would be consistent with international 
standards for yogurt. Despite these various reasons, Chobani requested 
a hearing on only two issues: (1) the minimum lactose content as a 
substrate for bacterial cultures to develop the characteristics of 
``yogurt;'' and (2) nutritional comparisons of products made from UF 
milk to that of traditional ``yogurt'' and other dairy foods.
    Related to its first request for a hearing, Chobani stated, 
``ultrafiltered milks can be used as the basic ingredient in yogurt 
making, with additional dairy ingredients added to reach a level of 
lactose that can be fermented to reach the titratable acidity/pH 
requirements for yogurt and result in the minimum level of 
characterizing bacterial cultures (Lactobacillus delbrueckii ssp. 
Bulgaricus and Streptococcus thermophilus) as specified by the 
standard'' (Chobani objection at page 2). Chobani did not cite any 
evidence to support this contention. Furthermore, while the acidity of 
yogurt and characterizing bacterial culture content are important 
characteristics of yogurt, they are not the only essential 
characteristics of yogurt that should be maintained by the use of UF 
milk. The organoleptic characteristics and texture of yogurt should 
also be maintained. Chobani's objection referred to sensory quality, 
but did not provide any evidence to support that the sensory quality of 
yogurt is unaffected by the lactose content of UF milk or by the use of 
UF milk more generally. In sum, Chobani did not provide any evidence of 
the minimum lactose content, whether from UF milk or UF milk and other 
basic dairy ingredients combined, that would be necessary to maintain 
the characteristics of yogurt. We deny Chobani's first request for a 
hearing under Sec.  12.24(b)(2) because the material submitted by 
Chobani does not show that this factual issue can be resolved by 
available and specifically identified reliable evidence.
    Chobani did not present any information on the lactose content of 
UF milk that would be used as a basic dairy ingredient in yogurt 
making. As we noted in the final rule, fluid UF milk and its dried 
products are distinctly different from milk and dried milk, 
respectively (86 FR 31117 at 31125). The process of ultrafiltration 
selectively removes not only water, but also lactose, minerals, and 
water-soluble vitamins, resulting in a compositionally different 
ingredient (86 FR 31117 at 31125). Depending on the pore size of the 
membrane(s) used, ultrafiltration can be used to process milk to 
concentrate casein and whey proteins and to partially remove lactose 
and water-soluble minerals and vitamins. Milk may be UF until a desired 
protein concentration is reached and, depending on the processing 
conditions (e.g., use of diafiltration), can result in removal of the 
majority of lactose and water-soluble minerals and vitamins. The amount 
of lactose is commonly and significantly reduced in UF milk (Ref. 11). 
We understand from this information that the final composition of UF 
milk, including the lactose content, can vary significantly and we 
cannot infer a certain composition and lactose content in UF milk in 
yogurt making. Thus, even if Chobani presented evidence of the minimum 
lactose content necessary to maintain the characteristics of yogurt, 
Chobani has not provided evidence that UF milk used in yogurt making 
would contain this level and therefore maintain the characteristics of 
yogurt. We deny Chobani's first request for a hearing under Sec.  
12.24(b)(4) because resolution of the factual issue in the way sought 
by Chobani is not adequate to justify amending the final rule to permit 
UF milk as a basic dairy ingredient.
    UF milk has many constituents, only one of which is lactose. The 
other constituents--protein, minerals, vitamins, and water--vary in UF 
milk and are different than the levels in milk. Differences in these 
constituents may affect the basic nature and essential characteristics 
of yogurt when UF milk is used as a basic dairy ingredient in the 
manufacture of yogurt. Chobani has not provided any evidence that these 
differences will not change the basic nature and essential 
characteristics of yogurt. As such, we further deny Chobani's first 
request for a hearing under Sec.  12.24(b)(4). Even if Chobani provided 
evidence sufficient to justify that the lactose content of UF milk that 
would be used in yogurt-making maintains the characteristics of yogurt, 
Chobani has not shown that the content of other components in UF milk 
used in yogurt making do not impact the basic nature and essential 
characteristics of yogurt.
    To the extent the studies cited in references 1 and 2 of Chobani's 
objection (Refs. 12 and 13) are intended to support its first request 
for a hearing, we deny the request for a hearing under Sec.  
12.24(b)(3). Neither publication quantifies the amount of lactose 
necessary to produce products with the characteristics of yogurt. The 
publication by Uduwerella showed that it was possible to use UF milk to 
produce products with a pH less than 4.6 (without the addition of 
lactose), but stated that the physical characteristics (texture) of the 
yogurt were different than yogurt produced without UF milk. In the 
publication by Valencia, the use of UF milk resulted in a product with 
a higher pH than the maximum pH in the standard of identity (i.e., pH 
of 4.6). We note also that the publications were limited in the 
characteristics of yogurt examined. The publication by Uduwerella did 
not examine the impact of UF milk on taste, and the publication by 
Valencia did not examine the impact of UF milk on taste or texture. 
Both publications were about the manufacture of Greek-style yogurt 
rather than the manufacture of yogurt in general. We conclude that 
these referenced articles are not adequate to determine the minimum 
lactose content to manufacture products with the characteristics of 
yogurt. They also are not adequate to determine whether UF milk used in 
yogurt making would have sufficient lactose or would otherwise be 
sufficient for use as a basic dairy ingredient such that products would 
have the characteristics of yogurt.
    Chobani also requested a hearing on ``nutritional comparisons of 
products made from UF milk to that of traditional `yogurt' and other 
foods in the Dairy group'' (Id.). We interpret ``traditional `yogurt' 
'' to mean yogurt that is produced without UF milk as a basic dairy 
ingredient. Chobani explained in its objection that ``Products made 
from ultra-filtered milks can deliver the same type and amounts of 
essential vitamins and minerals that consumers have come to expect from 
yogurts--including a good source of calcium, a good source of 
phosphorous, excellent source of vitamin B12 and an excellent source of 
protein'' (Id.). Chobani further explained that ``Yogurts made from 
ultrafiltered milk can deliver levels of magnesium and potassium which 
are consistent with other foods which count towards Americans overall 
consumption of dairy for the purposes of dietary monitoring and 
guidelines development'' (Id.). Chobani did not provide any evidence of 
the nutrient content of UF milk and therefore has not shown that the 
nutritional comparisons can be made by available and specifically 
identified reliable evidence (Sec.  12.24(b)(2)).
    Even if we assume the truth of Chobani's statements (i.e., that 
yogurt made with UF milk as a basic dairy ingredient has the same or 
better level of nutrients than yogurt made without UF milk as a basic 
dairy ingredient or has similar levels of nutrients as other dairy 
foods), such finding would not be a sufficient basis for modifying the 
final rule to permit UF milk as a basic dairy ingredient in yogurt. 
Chobani must

[[Page 76567]]

demonstrate that the use of UF milk as a basic dairy ingredient is 
consistent with the basic nature and essential characteristics of 
yogurt. If we assume that some or all of these nutrients contribute to 
the basic nature and essential characteristics of yogurt, the other 
essential characteristics of yogurt (e.g., taste and texture) must 
nevertheless be addressed. Hence, we also deny Chobani's second request 
for a hearing under Sec.  12.24(b)(4) because resolution of the factual 
issue in the way sought by Chobani would not be adequate to justify 
amending Sec.  131.200(b) to include UF milk as a basic dairy 
ingredient.
    Chobani made additional arguments with respect to safety, 
efficiency, and consistency with other foods standards, but did not 
request a hearing on them. Nevertheless, we address these arguments 
here. With respect to safety, Chobani asserted that approaches to using 
UF milk in the manufacture of yogurt ``result in no deleterious effects 
to safety'' (Id.).
    We agree that UF milk is safe for use in the manufacture of yogurt 
and note that the final rule permits UF milk in the manufacture of 
yogurt as an optional dairy ingredient to increase the milk solids, not 
fat content (Sec.  131.200(a) and (c)). There is no genuine and 
substantial issue of fact with respect to the safety of UF milk in 
yogurt.
    Chobani also asserted that using UF milk can result in greater 
production efficiency. While we recognize that operational efficiency 
is beneficial to a manufacturer, is not material to whether a food 
standard promotes honesty and fair dealing in the interest of consumers 
under section 401 of the FD&C Act and therefore does not present a 
genuine and substantial issue of fact.
    Chobani also stated that permitting UF milk in yogurt would create 
consistency with U.S. and international standards for dairy foods. 
Regarding U.S. standards, Chobani stated that use of UF milk is already 
permitted in cheesemaking. Although we issued a proposed rule in 2005 
to permit the use of UF milk in standardized cheeses and related cheese 
products (70 FR 60751), we have not finalized the rule. However, cheese 
and yogurt are different foods. Assuming that the use of UF milk as an 
ingredient in cheese or certain cheeses is consistent with the basic 
nature and essential characteristics of cheese or certain cheeses, it 
does not follow that the use of UF milk as a basic dairy ingredient in 
yogurt is consistent with the basic nature and essential 
characteristics of yogurt.
    Finally, Chobani asserted that permitting the use of UF milk in the 
yogurt standard of identity would be consistent with international 
standards for yogurt. It is unclear to which international standards 
Chobani is referring. International standards do not reflect yogurt 
products sold in the United States or reflect American consumers' 
expectations about yogurt and therefore their existence is not a 
sufficient basis for amending our standards. Chobani has not provided 
evidence that harmonization with international standards promotes 
honesty and fair dealing in the interest of American consumers.
    Since the filing of their objection on July 22, 2022, Chobani 
submitted an application for a Temporary Marketing Permit (TMP) in 
accordance with Sec.  130.17 to market test lower fat yogurt deviating 
from the general definition and standard of identity (Sec.  130.10) and 
yogurt deviating from the yogurt standard of identity (Sec.  131.200) 
by using UF milk as a basic dairy ingredient under Sec.  131.200(b). 
This will allow Chobani to gather appropriate supporting data to 
present to us in the future. As of November 2022, we are continuing to 
consider Chobani's TMP application.

IV. Summary and Conclusions

    After evaluating the objections from IDFA, we are denying the 
requests for a hearing discussed in sections III.B-E. With respect to 
the request for a hearing on the provision in Sec.  131.200(a) of the 
final rule requiring either a minimum titratable acidity or a maximum 
pH, we have issued a proposed order to IDFA under Sec.  12.24(d) 
proposing to deny the request for a hearing under Sec.  12.24(b)(1). We 
are denying the requests for a hearing with respect to vitamin D 
addition and the use of non-nutritive sweeteners because we agree with 
IDFA's proposed modifications and so there are no genuine and 
substantial issues of fact for resolution at a hearing (Sec.  
12.24(b)(1)). We have modified Sec.  131.200(d)(8) to permit vitamin D 
addition such that yogurt contains at least 10 percent DV per RACC of 
vitamin D, within limits of current good manufacturing practices. We 
have also modified Sec.  131.200(d)(2) to permit both nutritive 
sweeteners and non-nutritive sweeteners, under the term ``sweeteners,'' 
as optional ingredients in yogurt.
    We are denying IDFA's request for a hearing with respect to the 
addition of cream after culturing under Sec.  12.24(b)(2), (3), and (4) 
due to insufficiency of the evidence submitted by IDFA. We also deny 
IDFA's requests for a hearing with respect to the 3.25 percent minimum 
milkfat requirement and the use of fat-containing flavoring ingredients 
to replace milkfat in yogurt and lower fat yogurt under Sec.  
12.24(b)(3) because the data and information submitted by IDFA are 
insufficient to justify that milkfat does not contribute to the basic 
nature and essential characteristics of yogurt and lower fat yogurt. 
However, we have modified the final rule to permit fat-containing 
flavoring ingredients in lower fat yogurt above the required minimum 
milkfat content and to permit the manufacture of yogurt with milkfat 
content less than 3.25 percent but at least 2.44 percent. These 
modifications are made to Sec.  130.10(e) and Sec.  131.200(g), 
respectively. Thus, insofar as IDFA's objection regarding the use of 
fat-containing flavoring ingredients pertains to increasing the fat 
content above the required minimum milkfat content of lower fat yogurt, 
we deny IDFA's objection under Sec.  12.24(b)(1) as there is no genuine 
and substantial issue of fact for resolution at a hearing.
    We are also denying Chobani's requests for a hearing with respect 
to the use of UF milk as a basic dairy ingredient in yogurt. The 
requests are denied under Sec.  12.24(b)(2), (3), and (4) as explained 
above.
    We have completed our evaluation of the objections in sections 
III.B-F and provided our bases under Sec.  12.24(b) for denying the 
requests for a hearing stated therein. We conclude that this document 
constitutes final action on these objections under Sec.  12.28(d). 
Therefore, notice is given that these objections and requests for a 
hearing do not form a basis for further stay of the effectiveness of 
the final rule announced in the Federal Register of March 23, 2022 (87 
FR 16394). Accordingly, we are ending the stay of the final rule, 
except with respect to the provision of Sec.  131.200(a) requiring a 
minimum titratable acidity or maximum pH, and amending certain portions 
of Sec.  130.10 and Sec.  131.200 as described. This final rule is 
effective as of [DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 
Objections to and requests for hearing on the amendments may be 
submitted under Sec. Sec.  12.20 through 12.22 in accordance with Sec.  
12.26.

V. 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

[[Page 76568]]

display at https://www.regulations.gov because they have copyright 
restriction, or they are available as published articles and books. 
Please contact either person identified in the FOR FURTHER INFORMATION 
CONTACT section to schedule a date to inspect references without 
asterisks. Some may be available at the website address, if listed. FDA 
has verified the website addresses, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

1. Chandan, R.C. (2015). ``Dairy Processing and Quality Assurance: 
An Overview.'' In: Dairy Processing and Quality Assurance (Eds. R.C. 
Chandan, A. Kilara, and N.P. Shah), Wiley Blackwell.
2. Deosarkar, S.S., C.D. Khedkar, S.D. Kalyankar, and A.R. Sarode 
(2016). ``Cream: Types of Cream.'' In: Encyclopedia of Food and 
Health (Eds. B. Caballero, P.M. Finglas, and F. Toldr[aacute]), 
Academic Press.
3. Narvhus, J.A. and R.K. Abrahamsen (2022). ``Cultured Cream.'' In: 
Encyclopedia of Dairy Sciences (Third Ed.), (Eds. P.L.H. McSweeney 
and J.P. McNamara), Academic Press.
4. Routray, W. and H.N. Mishra (2011), ``Scientific and Technical 
Aspects of Yogurt Aroma and Taste: A Review.'' Comprehensive Reviews 
in Food Science and Food Safety, 10:208-220.
5. Vedamuthu, E.R. (2013). Starter Cultures for Yogurt and Fermented 
Milks. In: Manufacturing Yogurt and Fermented Milks (Eds. R.C. 
Chandan and A. Kilara), Wiley-Blackwell.
6. Chandan, R.C. and O'Rell, K. (2013). ``Principles of Yogurt 
Processing.'' In: Manufacturing Yogurt and Fermented Milks (eds R.C. 
Chandan and A. Kilara), Wiley-Blackwell.
7. Tamime, A.Y. and R.K. Robinson, (2007). Tamime and Robinson's 
Yoghurt: Science and Technology.
8. Sodini, I. and P.S. Tong, (2013). ``Milk and Milk-Based 
Ingredients.'' In: Manufacturing Yogurt and Fermented Milks (Eds. 
R.C. Chandan and A. Kilara), Wiley-Blackwell.
9. Schkoda, P., A. Hechler, and J. Hinrichs, (2001). ``Improved 
Texture of Stirred Fermented Milk by Integrating Fat Globules into 
the Gel Structure.'' Milchwissenschaft, 56:85-89.
10. * FDA Memorandum, Juan, WenYen (2022). ``Documentation for the 
Analysis of Milkfat Content per Reference Amount Customarily 
Consumed (RACC) in Products Sold as `Yogurt'.''
11. * U.S. Dairy Export Council, ``Ultrafiltered Milk Spec Sheet.'' 
(2005) Available at: https://www.thinkusadairy.org/resources-and-insights/resources-and-insights/product-resources/ultrafiltered-milk-spec-sheet.
12. Uduwerella, G., J. Chandrapala, and Vasiljevic, T. (2018). 
``Preconcentration of Yoghurt Base by Ultrafiltration for Reduction 
in Acid Whey Generation During Greek Yoghurt Manufacturing.'' 
International Journal of Dairy Technology, 71: 71-80.
13. Valencia A.P., A. Doyen, S. Benoit, et al. (2018). ``Effect of 
Ultrafiltration of Milk Prior to Fermentation on Mass Balance and 
Process Efficiency in Greek-Style Yogurt Manufacture.'' Foods, 
7(9):144.

List of Subjects

21 CFR Part 130

    Food additives, Food grades and standards.

21 CFR Part 131

    Cream, Food grades and standards, Milk, Yogurt.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
130 and 131 are amended as follows:

PART 130--FOOD STANDARDS: GENERAL

0
1. The authority citation for part 130 continues to read as follows:

    Authority:  21 U.S.C. 321, 336, 341, 343, 371.

0
2. In Sec.  130.10, redesignate paragraphs (e) and (f) as paragraphs 
(f) and (g) and add new paragraph (e) to read as follows:

Sec.  130.10  Requirements for foods named by use of a nutrient content 
claim and a standardized term.

* * * * *
    (e) Yogurt with modified milkfat and fat-containing flavoring 
ingredients. Fat-containing flavoring ingredients may be added to 
yogurt for which the milkfat content has been modified in accordance 
with the expressed nutrient content claim regulations in Sec.  
101.62(b) of this chapter. The name of the food includes the term ``__ 
yogurt,'' the blank being filled in with the nutrient content claim in 
Sec.  101.62(b)(1)(i), (b)(2)(i), or (b)(4)(i) of this chapter 
corresponding to the milkfat content, and a descriptor of the fat-
containing flavoring ingredient(s).
* * * * *

PART 131--MILK AND CREAM

0
3. The authority citation for part 131 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 343, 348, 371, 379e.

0
4. In Sec.  131.200:
0
a. Lift the stay for paragraphs (a), (b), (c), (d)(2), and (d)(8)(ii);
0
b. Revise paragraphs (d)(2) and (d)(8)(ii);
0
c. Redesignate paragraphs (g) and (h) as paragraphs (h) and (i);
0
d. Add new paragraph (g).
0
e. In newly redesignated paragraph (i) introductory text, remove ``in 
this paragraph (h)'' and add in its place ``in this paragraph (i)'' and
    The revisions and addition read as follows:

Sec.  131.200  Yogurt.

* * * * *
    (d) * * *
    (2) Sweeteners.
* * * * *
    (8) * * *
    (ii) If added, vitamin D must be present in such quantity that the 
food contains not less than 10 percent Daily Value per Reference Amount 
Commonly Consumed (RACC) thereof, within limits of current good 
manufacturing practices.
* * * * *
    (g) Yogurt containing less than 3.25 percent milkfat. (1) Yogurt 
may contain less than 3.25 percent milkfat and at least 2.44 percent 
milkfat. If the milkfat content is below 2.44 percent, the product is 
considered a modified food and is covered under Sec.  130.10 of this 
chapter.
    (2) Yogurt with milkfat content less than 3.25 percent and at least 
2.44 percent milkfat, must be labeled with the following two phrases in 
the statement of identity, which must appear together:
    (i) The word ``yogurt'' in type of the same size and style.
    (ii) The statement ``__ percent milkfat,'' the blank being filled 
in with the nearest half percent to the actual milkfat content of the 
product. This statement of milkfat content must appear in letters not 
less than one-half of the height of the letters in the phrase specified 
in paragraph (g)(2)(i) of this section, but in no case less than one-
eighth of an inch in height.
    (3) Yogurt with milkfat less than 3.25 percent and at least 2.44 
percent milkfat must comply with this standard, except that it may 
deviate as described in Sec.  130.10 (b), (c), and (d) of this chapter.
* * * * *

    Dated: December 2, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-27040 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P