[Federal Register Volume 90, Number 169 (Thursday, September 4, 2025)]
[Rules and Regulations]
[Pages 42699-42704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-16946]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 90, No. 169 / Thursday, September 4, 2025 /
Rules and Regulations
[[Page 42699]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2021-F-0366]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products
Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and
Streptococcus thermophilus
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Final amendment; order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulations to provide for the safe use of vitamin
D3 as a nutrient supplement in yogurt and other cultured
dairy products fermented with Lactobacillus delbrueckii, subspecies
bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus
thermophilus (S. thermophilus) at a level higher than is currently
permitted. We are taking this action in response to a food additive
petition filed by General Mills, Inc. (General Mills or petitioner). We
are also updating the reference for the vitamin D3
specifications.
DATES: This order is effective September 4, 2025. The incorporation by
reference of certain material listed in the order is approved by the
Director of the Federal Register as of September 4, 2025. Submit either
electronic or written objections and requests for a hearing by 11:59
p.m. Eastern Time on October 6, 2025. See section VIII for further
information on the filing of objections.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The https://www.regulations.gov electronic filing system
will accept objections until 11:59 p.m. Eastern Time at the end of
October 6, 2025. 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-2021-F-0366 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D3 in Yogurt and Other
Cultured Dairy Products Fermented with Lactobacillus delbrueckii,
subspecies bulgaricus, and Streptococcus thermophilus.'' 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; phone: 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Marissa Santos, Office of Pre-market
Additive Safety, Human Foods Program, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835; phone: 240-402-8160; or
[[Page 42700]]
Alexandra Beliveau, Office of Policy, Regulations, and Information,
Human Foods Program, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740; phone: 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 23, 2021 (86 FR 21675), we
announced that we filed a food additive petition (FAP 1A4827) submitted
on behalf of General Mills by Exponent, 1150 Connecticut Ave. NW, Suite
1100, Washington, DC 20036. The petition proposed that FDA amend the
food additive regulations in 21 CFR 172.380 to provide for the safe use
of vitamin D3 as a nutrient supplement at levels up to 178
international units (IU) vitamin D3 per 100 grams (g) in
``standardized yogurt and non-standardized milk-based yogurt
products.''
We consider the foods subject to this order to be yogurt and other
cultured dairy products fermented with L. delbrueckii, subsp.
bulgaricus, and S. thermophilus. While the petition refers to
``standardized yogurt and non-standardized milk-based yogurt
products,'' all yogurt is standardized. Yogurt is standardized under 21
CFR 131.200 and lower fat yogurt (i.e., reduced fat yogurt, low fat
yogurt, and nonfat yogurt) is standardized under 21 CFR 130.10.
Accordingly, we understand the petitioned uses to be yogurt and other
cultured dairy products fermented with L. delbrueckii, subsp.
bulgaricus, and S. thermophilus.
We note that, after the petition was submitted, FDA amended the
standard of identity for yogurt several times (see 88 FR 22907, April
14, 2023; 87 FR 76559, December 15, 2022; 87 FR 16394, March 23, 2022;
and 86 FR 31117, June 11, 2021). Of most relevance, in December 2022,
FDA reduced the minimum level of vitamin D fortification that, if
added, would be required for yogurt and lower fat yogurt from 25
percent Daily Value (DV) to 10 percent DV, explaining that a minimum of
25 percent DV (equal to 5 micrograms ([micro]g) per reference amount
customarily consumed (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 IU/100 g of food
(21 CFR 184.1950(c)(1)), equivalent to 3.8 [micro]g per RACC (see 87 FR
76559 at 76562). In reducing the minimum level of vitamin D
fortification to 10 percent DV, we reduced the vitamin D per RACC to 2
[micro]g. Consequently, until the issuance of this order, optional
vitamin D fortification in yogurt and lower fat yogurt has been
permitted in the range of 2 [micro]g to 3.8 [micro]g per RACC. This
order revises the upper limit. The limit of 178 IU/100 g proposed in
the petition is equivalent to 7.6 [micro]g per RACC. (One IU of vitamin
D is equivalent to 0.025 [micro]g of vitamin D.)
FDA is also updating the reference for specifications for vitamin
D3 established in Sec. 172.380(b) by incorporating by
reference the most recent monograph for vitamin D3 in the
14th edition of the Food Chemicals Codex, effective June 1, 2024 (FCC
14 vitamin D3 monograph). The current food additive
regulation for the use of vitamin D3 (Sec. 172.380)
indicates that the additive must meet the specifications in the 13th
edition of the FCC (FCC 13). Since we received the petition, the FCC
has been updated to the 14th edition (FCC 14). The specifications for
vitamin D3 from FCC 13 are identical to those in FCC 14.
Therefore, we are amending Sec. 172.380(b) by adopting, and
incorporating by reference, the FCC 14 vitamin D3 monograph.
In addition, the petitioner subsequently stated that the specifications
provided in the petition for vitamin D3 comply with FCC 14
(Ref. 1).
Vitamin D is essential for human health. Vitamin D comprises a
group of fat-soluble seco-sterols and occurs in many forms. The two
major physiologically relevant forms are vitamin D2 and
vitamin D3. Vitamin D without a subscript represents vitamin
D2, vitamin D3, or both. The major function of
vitamin D is the maintenance of blood serum concentrations of calcium
and phosphorus by enhancing the absorption of these minerals in the
small intestine. Vitamin D deficiency can lead to abnormalities in
calcium and bone metabolism, such as rickets in children or
osteomalacia in adults. At high levels in the diet, vitamin D may be
toxic. Excessive intake of vitamin D elevates blood plasma calcium
levels (hypercalcemia) by increased intestinal absorption or
mobilization from the bone that can lead to vascular and tissue
calcification, with subsequent damage to the heart, blood vessels, and
kidneys (Refs. 2 through 4).
To ensure that vitamin D is not added to the U.S. food supply at
levels that could raise safety concerns, FDA affirmed vitamin D as GRAS
with specific limitations as listed in Sec. 184.1950. Under Sec.
184.1(b)(2), an ingredient affirmed as GRAS with specific limitations
may be used in food only within such limitations, including the
category of food, functional use of the ingredient, and level of use.
Any addition of vitamin D to food beyond those limitations set out in
Sec. 184.1950 requires a food additive regulation. Vitamin D is
affirmed as GRAS for use in certain foods as a nutrient supplement (as
defined under 21 CFR 170.3(o)(20)) under Sec. 184.1950(c)(1), in
accordance with Sec. 184.1(b)(2), as the sole source of added vitamin
D only within the following specific limitations:
------------------------------------------------------------------------
Maximum levels
in food (as
Category of food served) (IU/
100 g)
------------------------------------------------------------------------
Breakfast cereals....................................... 350
Grain products and pasta................................ 90
Milk.................................................... 42
Milk products........................................... 89
------------------------------------------------------------------------
Vitamin D is also affirmed as GRAS under Sec. 184.1950(c)(2) and
(3) for use in infant formula and margarine. Vitamin D2 is
an approved food additive under Sec. 172.379 for use as a nutrient
supplement in edible plant-based beverages intended as milk
alternatives, edible plant-based yogurt alternatives, soy beverage
products, soy-based butter substitute spreads, and soy-based cheese
substitutes and soy-based cheese substitute products. Vitamin
D3 is an approved food additive under Sec. 172.380 for use
for use as a nutrient supplement in certain calcium-fortified 100
percent fruit juices and fruit juice drinks; meal replacement and
other-type bars that are represented for special dietary use in
reducing or maintaining body weight; soy-protein based meal replacement
beverages that are represented for special dietary use in reducing or
maintaining body weight; certain cheese and cheese products; certain
meal replacement beverages that are not intended for special dietary
use in reducing or maintaining body weight; foods represented for use
as a sole source of nutrition for enteral feeding; milk that contains
more than 42 IU vitamin D per 100 g and that meets the requirements for
foods named by use of a nutrient content claim and a standardized term
in accordance with Sec. 130.10; breakfast cereals; and grain-based
bars. Vitamin D2 bakers yeast is an approved food additive
under Sec. 172.381 for use as a source of vitamin D2 and as
a leavening agent in yeast-leavened baked goods and baking mixes and
yeast-leavened baked snack foods. Vitamin D2 mushroom powder
is an approved food additive under Sec. 172.382 for use as a source of
vitamin D2 in: (1) foods to which vitamin D2,
vitamin D3, and vitamin D2 bakers yeast are
currently allowed to be added under Sec. Sec. 184.1950, 172.379,
172.380, and
[[Page 42701]]
172.381, excluding cheese and cheese products, foods represented for
use as a sole source of nutrition for enteral feeding, infant formula,
milk and milk products, margarine, and grain-based bars; (2) fruit
smoothies; (3) vegetable juices; (4) extruded vegetable snacks; (5)
certain soups and soup mixes; and (6) plant protein products.
To support their petition, General Mills submitted dietary exposure
estimates to vitamin D from the proposed uses of vitamin D3,
as well as all naturally occurring dietary sources of vitamin D,
approved and affirmed uses of vitamin D under our food additive and
GRAS regulations, and dietary supplements. General Mills compared these
dietary exposure estimates to the Tolerable Upper Intake Level (UL) for
vitamin D established by the Institute of Medicine (IOM) of the
National Academies (now the National Academy of Medicine). General
Mills also submitted published scientific literature pertaining to
clinical studies on vitamin D.
II. Evaluation of Safety
To establish with reasonable certainty that a food additive is not
harmful under its intended conditions of use, we consider the projected
human dietary exposure to the additive, the additive's toxicological
data, and other relevant information (such as published scientific
literature) available to us. We compare the dietary exposure to the
additive from all food sources to an acceptable intake level
established by data. The dietary exposure is determined based on the
amount of the additive proposed for specific uses in foods and on data
regarding the amount consumed from all food sources of the additive. We
commonly use the 90th percentile dietary exposure for the consumer of a
food additive as a measure of high chronic dietary exposure.
A. Acceptable Daily Intake for Vitamin D
In 2011, the Standing Committee on the Scientific Evaluation of
Dietary Reference Intakes of the Food and Nutrition Board at the IOM
conducted an extensive review of relevant published scientific
literature to update established dietary reference intakes (DRIs) for
vitamin D; these DRIs are a family of nutrient reference values that
includes ULs (Ref. 5). Based on this information, the IOM revised the
ULs for vitamin D and published a report on their findings (Ref. 6). In
its 2011 assessment of vitamin D, the IOM established ULs for different
age groups, including total consumption from food, including dietary
supplements, and water:
------------------------------------------------------------------------
UL IU/per person/day (p/d) Age group
------------------------------------------------------------------------
1,000.............................. infants 0 months to 6 months of
age.
1,500.............................. infants 6 months to 12 months of
age.
2,500.............................. children 1-3 years of age.
3,000.............................. children 4-8 years of age.
4,000.............................. adolescents aged 9-18 years of age
and adults.
------------------------------------------------------------------------
The IOM considers the UL as the maximum daily intake level of a
nutrient that is likely to pose no health hazard risk for almost all
individuals in the general population when the nutrient is consumed
over long periods of time. The UL is determined using a risk assessment
approach developed specifically for nutrients. The dose-response
assessment, which concludes with an estimate of the UL, is built upon
three toxicological concepts commonly used in assessing the risk of
exposures to chemical substances: no-observed-adverse-effect level,
lowest-observed-effect level, and application of an uncertainty factor.
We considered the ULs established by the IOM relative to the cumulative
dietary exposure estimates as the primary basis for assessing the
safety of the petitioned uses of vitamin D3. We also
reviewed published scientific literature on the safety of vitamin D
submitted in the petition, as well as other relevant published studies
available to FDA.
B. Dietary Exposure Estimate for Vitamin D
General Mills presented a dietary exposure estimate to vitamin D
from the proposed uses, as well as a cumulative dietary exposure
estimate that included existing sources of vitamin D. General Mills
also provided an adjusted cumulative dietary exposure estimate that
included vitamin D2 in mushroom powder. In this scenario,
General Mills added the per capita dietary exposure to vitamin
D2 in mushroom powder to their mean and 90th percentile
cumulative dietary exposure to vitamin D from existing sources and the
proposed uses of vitamin D3. We note that this is not an
appropriate method to estimate the cumulative dietary exposure,
particularly for those individuals at the 90th percentile. Furthermore,
General Mills' estimated cumulative dietary exposure did not include
the contribution to dietary exposure for vitamin D from the most recent
food additive petition approval, FAP 9A4823, for the use of vitamin
D3 as a nutrient supplement in breakfast cereals and grain-
based bars. Additionally, since the submission of General Mills'
petition, more recent National Health and Nutrition Examination Survey
(NHANES) food consumption data have become available. Therefore, FDA
conducted a dietary exposure estimate to vitamin D3 from the
proposed use in yogurt and other cultured dairy products fermented with
L. delbrueckii, subsp. bulgaricus, and S. thermophilus, as well as a
cumulative dietary exposure estimate to vitamin D from all existing
sources of vitamin D (i.e., naturally-occurring, approved and affirmed
GRAS sources of vitamin D, and dietary supplements), including the
approved use of vitamin D2 in mushroom powder and the
approved uses of vitamin D3 in breakfast cereals and grain-
based bars, and the proposed uses using food consumption data from the
combined 2015-2018 NHANES (Ref. 1). Furthermore, FDA also incorporated
the estimated dietary exposure to 25-hydroxyvitamin D into the
cumulative estimate to account for discrepancies seen between dietary
intake and blood serum levels of vitamin D (Ref. 1).
Based on FDA's conservative estimate of cumulative dietary
exposure, the proposed use of vitamin D3 in yogurt and other
cultured dairy products fermented with L. delbrueckii, subsp.
bulgaricus, and S. thermophilus will not be expected to significantly
increase the dietary exposure to vitamin D in all subpopulations.
However, we determined that based on data obtained from combined NHANES
surveys for the years 2011 to 2018, there was an increase in dietary
exposure to vitamin D in adults 71 years and older due to an increase
in the consumption of dietary supplements containing vitamin D by this
subpopulation (Ref. 1). Yet, there still are vitamin D deficiency
concerns for the general population, including those 71 years of age
and older (Refs. 7 and 8). We recognized that our traditional approach
when estimating the dietary exposure could limit additional
fortification of foods with vitamin D if based on the vitamin D dietary
supplement consumption patterns of adults aged 71 years and older.
Therefore, FDA refined the dietary exposure estimate to vitamin D for
this subpopulation; it combined our conservative estimate of cumulative
dietary exposure to vitamin D from conventional foods with the
assumption that all users in the subpopulation of adults 71 years and
older will consume a daily dietary supplement containing vitamin D at
the Recommended Dietary
[[Page 42702]]
Allowance (RDA) (Ref. 1). We believe this approach still provides a
conservative estimate of cumulative dietary exposure for this
subpopulation because it assumes all individuals in the subpopulation
consume a supplement containing vitamin D at the RDA, when, based on
data from the combined 2015-2018 NHANES survey, approximately 40
percent of the individuals surveyed in this subpopulation did not
report taking a supplement containing vitamin D.
For the overall U.S. population 1 year of age and older, we
estimated the cumulative dietary exposure at the 90th percentile from
all food sources of vitamin D, including the proposed uses and
background sources, to be 3,170 IU/p/d. We estimated the 90th
percentile cumulative dietary exposure from all food sources of vitamin
D to be 944 IU/p/d for infants 0 to 6 months, 1230 IU/p/d for infants 6
to 12 months, 1720 IU/p/d for children 1 to 3 years, and 1910 IU/p/d
for children 4-8 years, and our estimates for adolescents, teenagers,
and adults less than 71 years ranged from 1960 IU/p/d to 3930 IU/p/d.
We estimated the 90th percentile cumulative dietary exposure from all
food sources of vitamin D, including the proposed uses and background
sources, for adults 71 years and older to be 2,732 IU/p/d using our
refined approach. In summary, the estimated cumulative dietary exposure
to vitamin D3 at the 90th percentile from the petitioned
uses and background sources is below the IOM ULs for all population
groups for which ULs were established.
C. Safety of the Petitioned Use of Vitamin D3 in Yogurt and Other
Cultured Dairy Products Fermented With L. delbrueckii, Subsp.
bulgaricus, and S. thermophilus
We reviewed and evaluated the information submitted by General
Mills regarding the safety of the dietary exposure to vitamin
D3 from the proposed uses. General Mills submitted reports
of scientific studies published after the 2011 IOM report and concluded
that these publications support a conclusion that the proposed uses of
vitamin D3 are safe.
We reviewed the published reports of scientific studies on vitamin
D submitted by General Mills, as well as other relevant published
studies available to us since our previous evaluations of food additive
petitions for fortifying a variety of foods with vitamin D, which
resulted in FDA revising related regulations several times (88 FR 745,
January 5, 2023; 85 FR 41916, July 13, 2020; 81 FR 46578, July 18,
2016; 77 FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 FR
69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June
22, 2005; 68 FR 9000, February 27, 2003). These studies did not raise
any new safety concerns regarding the current or proposed uses of
vitamin D. The most recent food additive petition concerning vitamin D
resulted in our amendment of the food additive regulations in Sec.
172.380 to increase the use level of vitamin D3 in breakfast
cereals to 560 IU/100 g and expand the use to include vitamin
D3 at levels up to 400 IU/100 g in grain-based bars (88 FR
745, January 5, 2023). The earlier food additive petitions also
resulted in amendments of the food additive regulations to allow for
the safe use of vitamin D as a nutrient supplement in certain foods.
We consider the ULs established by the IOM relative to the dietary
exposure estimates as the primary basis for assessing the safety of the
petitioned uses of vitamin D3. Using our traditional
approach, FDA's cumulative dietary exposure estimate to vitamin D from
all food sources at the 90th percentile for the U.S. population was
below the IOM ULs for all subpopulation groups except for adults 71
years of age and older. As noted previously, FDA refined its approach
to reflect the current recommended daily intake levels for vitamin D
for adults 71 years of age and older, which resulted in a 90th
percentile dietary exposure to vitamin D of 2,732 IU/p/d, which is
below the IOM UL for this subpopulation. Because the estimated dietary
exposure at the 90th percentile to vitamin D from all current and
proposed food sources for each population group is less than the
corresponding IOM UL for that population group, we conclude that
dietary exposure to vitamin D3 from the proposed use as a
nutrient supplement in yogurt and other cultured dairy products
fermented with L. delbrueckii, subsp. bulgaricus, and S. thermophilus
is safe (Ref. 4).
III. Conclusion
Based on the relevant data available to FDA and information in the
petition, we conclude that there is reasonable certainty that no harm
will result from the use of vitamin D3 as a nutrient
supplement in yogurt and other cultured dairy products fermented with
L. delbrueckii, subsp. bulgaricus, and S. thermophilus at levels up to
178 IU vitamin D3 per 100 g. Additionally, we are amending
Sec. 172.380(b) by adopting, and incorporating by reference, the FCC
14 vitamin D3 monograph.
IV. Incorporation by Reference
A. FCC 14 Vitamin D3 Monograph
FDA is incorporating by reference the monograph for vitamin
D3 from the Food Chemicals Codex, 14th edition, effective
June 1, 2024, which was approved by the Office of the Federal Register
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The FCC 14
vitamin D3 monograph sets forth a standard for purity and
identity for vitamin D3. The monograph provides
specifications and analytical methodologies to identify the substance
and establish acceptable purity criteria.
You may purchase a copy of the material from the U.S. Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; phone: 1-800-
227-8772; website: https://www.usp.org/. You may inspect a copy at
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852; phone: 240-402-7500,
between 9 a.m. and 4 p.m., Monday through Friday.
B. Context on FCC Editions
The current food additive regulation for the use of vitamin
D3 (Sec. 172.380) indicates that the additive must meet the
specifications in the FCC 13. The petitioner indicated that the vitamin
D3 petitioned in FAP 1A4827 complies with the specifications
in the monograph for vitamin D3 in FCC 12. Since we received
the petition, the FCC has been updated to the 14th edition (FCC 14).
The specifications for vitamin D3 in FCC 14 are identical to
those in FCC 12 and FCC 13. In addition, the petitioner subsequently
stated that the specifications provided in the petition for vitamin
D3 comply with FCC 14 (Ref. 1). Therefore, we are amending
Sec. 172.380(b) by adopting, and incorporating by reference, the
specifications for vitamin D3 in FCC 14 in place of FCC 13.
V. Public Disclosure
In accordance with 21 CFR 171.1(h), the petition and the documents
that we considered and relied upon in reaching our decision to approve
the petition will be made available for public disclosure (see FOR
FURTHER INFORMATION CONTACT). As provided in Sec. 171.1(h), we will
delete from the documents any materials that are not available for
public disclosure.
VI. Analysis of Environmental Impact
As stated in the April 23, 2021, Federal Register notification of
petition for FAP 1A4827 (86 FR 21675), the petitioners claimed a
categorical
[[Page 42703]]
exclusion from preparing an environmental assessment or environmental
impact statement under 21 CFR 25.32(k) because vitamin D3 is
intended to remain in food through ingestion by consumers and is not
intended to replace macronutrients in food. We further stated that if
FDA determines a categorical exclusion applies, neither an
environmental assessment nor an environmental impact statement is
required. We have not received any new information or comments
regarding this claim of categorical exclusion. We have considered the
petitioner's claim of categorical exclusion and have determined that
this action is categorically excluded under Sec. 25.32(k) (Ref. 9).
Therefore, neither an environmental assessment nor an environmental
impact statement is required.
VII. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Objections
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348). This
order is not a statement regarding compliance with other sections of
the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C.
331(ll)) prohibits the introduction or delivery for introduction into
interstate commerce of any food that contains a drug approved under
section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exemptions in section 301(ll)(1) through (4)
of the FD&C Act applies. In our review of this petition, we did not
consider whether section 301(ll) of the FD&C Act or any of its
exemptions apply to food containing this additive. Accordingly, this
order should not be construed to be a statement that a food containing
this additive, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all food additive orders and
therefore should not be construed to be a statement of the likelihood
that section 301(ll) of the FD&C Act applies.
X. References
The following references marked with an asterisk (*) are on display
in 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 are also available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. 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. Memorandum from R. Shah, Chemistry Review Branch, Division of
Food Ingredients, Human Foods Program (HFP), FDA, to M. Santos,
Regulatory Review Branch, Division of Food Ingredients, HFP, FDA,
June 16, 2025.
* 2. National Institutes of Health, Office of Dietary Supplements,
``Vitamin D--Fact Sheet for Consumers,'' 2021. Available at https://ods.od.nih.gov/factsheets/Vitamind-Consumer/.
3. Pilz, S., W. Marz, K.D. Cashman, et al., ``Rationale and Plan for
Vitamin D Food Fortification: A Review and Guidance Paper,''
Frontiers in Endocrinology, 0, 2018. Available at https://www.frontiersin.org/articles/10.3389/fendo.2018.00373/full.
* 4. Memorandum from A. Khan, Toxicology Review Branch, Division of
Food Ingredients, HFP, FDA, to M. Santos, Regulatory Review Branch,
Division of Food Ingredients, HFP, FDA, June 17, 2025.
5. IOM Committee to Review Dietary Reference Intakes for Vitamin D
and Calcium; Ross, A.C., Taylor, C.L., Yaktine, A.L., et al.,
editors. ``Dietary Reference Intakes for Calcium and Vitamin D.''
Washington (DC): National Academies Press, 2011. Available at
https://www.ncbi.nlm.nih.gov/books/NBK56070/.
6. Taylor, C., Patterson, K., Roseland, J., et al., ``Including Food
25-Hydroxyvitamin D in Intake Estimates May Reduce the Discrepancy
between Dietary and Serum Measures of Vitamin D Status.'' Journal of
Nutrition, 144: 654-659, 2014. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985821/pdf/nut144654.pdf.
7. Parva, N.R., Tadepalli, S.T., Singh, P., et al. ``Prevalence of
Vitamin D Deficiency and Associated Risk Factors in the U.S.
Population (2011-2012).'' Cureus, June 5, 2018;10(6): e2741.
Available at https://doi.org/10.7759/cureus.2741.
8. Corpas, E., Vinales, K., Correa, R., et al. ``Vitamin D and
Calcium Deficiency in the Elderly.'' In Endocrinology of Aging:
Clinical Aspects in Diagrams and Images, 103-130, 2021. Available at
https://doi.org/10.1016/B978-0-12-819667-0.00004-4.
* 9. Memorandum from B. Ott, Environmental Review Team, Office of
Pre-Market Additive Safety, HFP, FDA, to M. Santos, Regulatory
Review Branch, Division of Food Ingredients, HFP, FDA, July 10,
2025.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
0
1. The authority citation for part 172 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
[[Page 42704]]
0
2. Amend Sec. 172.380 by revising paragraph (b) and adding paragraph
(c)(11) to read as follows:
Sec. 172.380 Vitamin D3.
* * * * *
(b) Vitamin D3 meets the specifications of Vitamin
D3, Food Chemicals Codex, 14th edition, effective June 1,
2024, which is incorporated by reference into this section. The
Director of the Federal Register approved this incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This
incorporation by reference (IBR) material is available for inspection
at the Food and Drug Administration (FDA) and at the National Archives
and Records Administration (NARA). Contact FDA at: the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday; phone: 240-402-7500; email:
[email protected]. For information on the availability
of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. This material may be
obtained from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852; phone 800-822-8772; email [email protected]; website:
https://www.usp.org.
(c) * * *
(11) At levels not to exceed 178 IU per 100 g in yogurt under Sec.
131.200 of this chapter, and lower fat yogurt under Sec. 130.10 of
this chapter, and other cultured dairy products fermented with
Lactobacillus delbrueckii, subsp. bulgaricus, and Streptococcus
thermophilus.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16946 Filed 9-3-25; 8:45 am]
BILLING CODE 4164-01-P