[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Rules and Regulations]
[Pages 16394-16395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05804]


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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


Milk and Cream; Petition for an Administrative Stay of Action: 
Definitions and Standards of Identity for Yogurt, Lowfat Yogurt, and 
Nonfat Yogurt

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; notification of administrative stay.

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SUMMARY: The Food and Drug Administration (FDA or we) is providing 
notice of a stay of the effectiveness of certain provisions of a final 
rule published in the Federal Register of June 11, 2021. The final rule 
amended the definition and standard of identity for yogurt and revoked 
the definitions and standards of identity for lowfat yogurt and nonfat 
yogurt. FDA is publishing this notification in response to objections 
timely filed in accordance with regulatory requirements.

DATES: FDA is administratively staying certain provisions in the final 
rule published on June 11, 2021 (86 FR 31117). FDA will publish a 
document in the Federal Register lifting the stay or taking further 
action as needed.

ADDRESSES: For access to the docket, 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, between 9 a.m. and 4 p.m., Monday through Friday. Publicly 
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Joan Rothenberg, Center for Food 
Safety and Applied Nutrition, Office of Regulations and Policy, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2021 (86 FR 31117), FDA issued 
a final rule (the 2021 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). The 2021 final rule's 
effective date was July 12, 2021. Pursuant to section 701(e) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)), the 
2021 final rule notified persons who would be adversely affected by the 
2021 final rule that they could file objections, specifying with 
particularity the provisions of the 2021 final rule deemed 
objectionable, stating the grounds therefor, and requesting a public 
hearing upon such objections.
    The International Dairy Foods Association (IDFA) and Chobani timely 
filed objections and requests for a hearing with respect to several 
provisions in the 2021 final rule (see Objections and Request for 
Hearings submitted by Michael Dykes, DVM, 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) and Objection and Requests for Hearing submitted 
by Matthew Graziose, Ph.D., 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)). Section 
701(e)(2) of the FD&C Act provides that, until final action is taken by 
the Secretary, the filing of objections

[[Page 16395]]

operates to stay the effectiveness of those provisions to which the 
objections are made. We established the definition and standard of 
identity for yogurt in 1981 (1981 final rule) (46 FR 9924 at 9939, 
January 30, 1981). The 2021 final rule amended some provisions in the 
definition and standard of identity and maintained others. Staying the 
effectiveness of these provisions results in the corresponding 
requirements in the 1981 final rule remaining in effect. This notice 
provides clarification on which provisions of the 2021 final rule have 
been stayed and which requirements of the 1981 final rule are in effect 
pending final action under section 701(e) of the FD&C Act.

II. Objections and Requests for Hearing

    IDFA's objections were directed at several provisions in Sec.  
131.200(a) of the 2021 final rule. IDFA objected to the requirement in 
Sec.  131.200(a) that yogurt, before the addition of bulky flavoring 
ingredients, has either a titratable acidity of not less than 0.7 
percent, expressed as lactic acid, or a pH of 4.6 or lower. This 
provision of the 2021 final rule is stayed. FDA notes that the 
definition and standard of identity established in 1981 included a 
minimum titratable acidity requirement of 0.9 percent, but that 
provision was stayed by the filing of objections in 1981 (47 FR 41519 
at 41523, September 21, 1982). Consequently, no minimum titratable 
acidity requirement or maximum pH requirement is in effect.
    IDFA also objected to the provision that yogurt, before the 
addition of bulky flavoring ingredients, contains not less than 3.25 
percent milkfat and the provision requiring pasteurized cream, if used 
as a basic dairy ingredient under Sec.  131.200(b) or an optional dairy 
ingredient under Sec.  131.200(c), to be added before culturing. These 
provisions of the 2021 final rule are stayed. However, a minimum 
milkfat of 3.25 percent before the addition of bulky flavors and the 
requirement that cream be included in the culturing process remain in 
effect under the definition and standard of identity established in the 
1981 final rule.
    Chobani objected to the exclusion of ultrafiltered milk from the 
basic dairy ingredients in Sec.  131.200(b). This provision is stayed 
insofar as it prohibits the use of ultrafiltered milk. However, the 
provision in the 1981 final rule remains in effect with respect to the 
use of ultrafiltered milk. This means that ultrafiltered milk may not 
be used as a basic dairy ingredient in the manufacture of yogurt. 
Because we received no objections to the use of ultrafiltered milk as 
an optional dairy ingredient under Sec.  131.200(c) of the 2021 final 
rule, ultrafiltered milk may be used to increase the milk solids, not 
fat content, of the food above 8.25 percent, provided that the ratio of 
protein to total nonfat solids of the food and the protein efficiency 
ratio of all protein present is not decreased as a result.
    IDFA also objected to provisions in Sec.  131.200(d) for other 
optional ingredients. These provisions included Sec.  131.200(d)(2), 
which limits the use of sweeteners to nutritive carbohydrate 
sweeteners, and Sec.  131.200(d)(8)(ii), which requires a minimum 
vitamin D content of 25 percent Daily Value (DV) per reference amount 
customarily consumed (RACC) if vitamin D is added. Both provisions in 
the 2021 final rule are stayed. Optional vitamin D addition has been 
permitted since 1982 at a level of 400 international units per quart 
(see 47 FR 41519 at 41520 and 41524); this limitation on vitamin D 
addition remains in effect. The prohibition on the use of sweeteners 
other than nutritive carbohydrate sweeteners remains in effect under 
the 1981 final rule's definition and standard of identity. Because we 
received no objections to permitting the use of all safe and suitable 
nutritive carbohydrate sweeteners, nutritive carbohydrate sweeteners 
are no longer limited to those listed under Sec.  131.200(c)(2) in the 
1981 final rule.
    This notification does not constitute a determination that a 
hearing is justified on any objections or requests for hearing that 
have been filed (21 CFR 12.23). Until FDA makes such a determination 
and issues a notice under 21 CFR 12.28, 12.26, or 12.35, we intend to 
exercise enforcement discretion with respect to the following:
    <bullet> Addition of vitamin D to yogurt under Sec.  131.200 and 
lower fat yogurt products under Sec.  130.10 (21 CFR 130.10) such that 
the food contains at least 10 percent DV per RACC, within limits of 
current good manufacturing practices.
    <bullet> Use of nonnutritive sweeteners in yogurt under Sec.  
131.200 and lower fat yogurt products under Sec.  130.10 that are not 
labeled with a statement of identity that includes an expressed 
nutrient content claim consistent with the use of nonnutritive 
sweeteners.
    <bullet> Use of bulky flavor ingredients in lower fat yogurt 
products under Sec.  130.10 that increase the total fat content above 
the level specified in Sec.  101.62(b) (21 CFR 101.62(b)) for the 
expressed nutrient content claim in the statement of identity, provided 
that the level of milkfat in the product is consistent with the level 
specified in Sec.  101.62(b) and the statement of identity also 
includes a descriptor of the bulky flavor ingredient (e.g., ``lowfat 
yogurt with coconut'').
    Under this enforcement discretion, we do not intend to take action 
with respect to yogurt and lower fat yogurt products that meet these 
criteria provided that the products otherwise conform to the definition 
and standard of identity under Sec.  131.200 or Sec.  130.10.

III. Provisions Stayed

    Pursuant to section 701(e) of the FD&C Act, we hereby announce that 
the following provisions of the 2021 final rule are stayed by the 
objections filed:
    1. The requirement in Sec.  131.200(a) that yogurt, before the 
addition of bulky flavoring ingredients, has either a titratable 
acidity of not less than 0.7 percent, expressed as lactic acid, or a pH 
of 4.6 or lower.
    2. The requirement in Sec.  131.200(a) that yogurt, before the 
addition of bulky flavoring ingredients, contains not less than 3.25 
percent milkfat.
    3. The prohibition in Sec.  131.200(a), (b), and (c) on adding 
pasteurized cream after culturing.
    4. The exclusion of ultrafiltered milk from the basic dairy 
ingredients in Sec.  131.200(b).
    5. The limitation on the use of sweeteners in Sec.  131.200(d)(2) 
to nutritive carbohydrate sweeteners.
    6. The requirement in Sec.  131.200(d)(8)(ii) that vitamin D, if 
added, 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.

IV. Effective/Compliance Dates

    This document hereby confirms the effective date of the 2021 final 
rule as July 12, 2021, and the compliance date as January 1, 2024, 
except with respect to the provisions in Sec.  131.200(a), (b), (c), 
(d)(2), and (d)(8)(ii) stated above, which are stayed.

    Dated: March 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05804 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P