Rule2026-19656
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
Primary source
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Published
September 25, 2026
Effective
September 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>2</INF> inactive bakers yeast as a source of vitamin D<INF>2</INF> in specific food categories. We are taking this action in response to a food additive petition filed by Lallemand Inc. (Lallemand or petitioner).
Full Text
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<title>Federal Register, Volume 91 Issue 185 (Friday, September 25, 2026)</title>
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Rules and Regulations]
[Pages 60796-60800]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2021-F-1157]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D2 Inactive Bakers Yeast
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulations to provide for the safe use of vitamin
D<INF>2</INF> inactive bakers yeast as a source of vitamin
D<INF>2</INF> in specific food categories. We are taking this action in
response to a food additive petition filed by Lallemand Inc. (Lallemand
or petitioner).
DATES: This order is effective September 25, 2026. See section VII for
further information on the filing of objections. Either electronic or
written objections and requests for a hearing on the final order must
be submitted by October 26, 2026.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept objections until 11:59 p.m. Eastern Time at the end of
October 26, 2026. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper 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-1157 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D<INF>2</INF> Inactive Bakers
Yeast.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Sean Fischer, Office of Pre-market
Additive Safety, Human Foods Program, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-1225; or Meadow Platt,
Office
[[Page 60797]]
of Policy, Regulations, and Information, Human Foods Program, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2378.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 29, 2021 (86 FR 74018), we
announced that we filed a food additive petition (FAP 1A4829) submitted
by Lallemand Inc. (Lallemand), 1620 rue Pr[eacute]fontaine, Montreal,
Quebec, H1W 2N8, Canada. The petition proposed that FDA amend the food
additive regulations in 21 CFR part 172 to provide for the safe use of
vitamin D<INF>2</INF> inactive bakers yeast, produced by exposing
bakers yeast (Saccharomyces cerevisiae) to ultraviolet (UV) light and
then using heat to inactivate the bakers yeast, as a nutrient
supplement in foods. The proposed use would allow for the safe use of
vitamin D<INF>2</INF> inactive bakers yeast as a source of vitamin
D<INF>2</INF> in the same foods and at the same use levels, on a
D<INF>2</INF> basis, for which D<INF>2</INF> mushroom powder is
currently authorized under Sec. 172.382.
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 D<INF>2</INF> and
vitamin D<INF>3</INF>. Vitamin D without a subscript represents vitamin
D<INF>2</INF>, vitamin D<INF>3</INF>, 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. 1 and 2).
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
generally recognized as safe (GRAS) with specific limitations as listed
in 21 CFR 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
Category of food food (as served) (IU/
100 g)
------------------------------------------------------------------------
Breakfast cereals................................ 350
Grain products and pasta......................... 90
Milk............................................. 42
Milk products.................................... 89
------------------------------------------------------------------------
IU: International Units.
Vitamin D is also affirmed as GRAS under Sec. 184.1950(c)(2) and
(3) for use in infant formula and margarine, respectively. Vitamin
D<INF>2</INF> 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
D<INF>3</INF> is an approved food additive under Sec. 172.380 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 21 CFR 130.10; breakfast cereals; grain-based bars; and yogurt and
other cultured dairy products fermented with Lactobacillus delbrueckii,
subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and
Streptococcus thermophilus (S. thermophilus). Vitamin D<INF>2</INF>
bakers yeast is an approved food additive under Sec. 172.381 for use
as a source of vitamin D<INF>2</INF> and as a leavening agent in yeast-
leavened baked goods and baking mixes and yeast-leavened baked snack
foods. Vitamin D<INF>2</INF> mushroom powder is an approved food
additive under Sec. 172.382 for use as a source of vitamin
D<INF>2</INF> in: (1) foods to which vitamin D<INF>2</INF>, vitamin
D<INF>3</INF>, and vitamin D<INF>2</INF> bakers yeast are currently
allowed to be added under Sec. Sec. 184.1950, 172.379, 172.380, and
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 (see Sec.
172.382(f)).
Vitamin D<INF>2</INF>, also known as ergocalciferol, is the
chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The
additive that is the subject of this petition is vitamin D<INF>2</INF>
inactive bakers yeast that is produced by exposing bakers yeast to UV
light, resulting in increased conversion of endogenous ergosterol to
ergocalciferol. Under section 402(a)(7) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), sources of irradiation, such as UV light, must
be used in accordance with a regulation or exemption in effect pursuant
to section 409 of the FD&C Act.
To support their petition, Lallemand noted that the petitioned food
uses and maximum use levels for vitamin D<INF>2</INF> inactive bakers
yeast are the same, on a vitamin D<INF>2</INF> basis, as those for
vitamin D<INF>2</INF> mushroom powder approved under Sec. 172.382.
Therefore, Lallemand concluded that the petitioned use of vitamin
D<INF>2</INF> inactive bakers yeast would not increase the cumulative
dietary exposure to vitamin D and referenced FDA's cumulative dietary
exposure estimate for vitamin D in FAP 8A4821 (85 FR 41916, July 13,
2020). Lallemand compared the dietary exposure estimate to the
Tolerable Upper Intake Level (UL) for vitamin D established by the
Institute of Medicine (IOM) (now the National Academy of Medicine).
Lallemand also submitted published scientific literature pertaining to
clinical studies on vitamin D.
II. Evaluation of Safety
A. Vitamin D
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
[[Page 60798]]
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.
1. 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. Based on this information, the IOM revised the ULs for
vitamin D and published a report on their findings (Ref. 3). In their
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
(NOAEL), lowest-observed-effect level (LOEL), 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
D<INF>2</INF>. 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 (Ref. 4).
2. Dietary Exposure Estimate for Vitamin D
Lallemand stated that the petitioned food uses and maximum use
levels for vitamin D<INF>2</INF> inactive bakers yeast are the same, on
a vitamin D<INF>2</INF> basis, as those for vitamin D<INF>2</INF>
mushroom powder authorized under Sec. 172.382. Lallemand concluded
that the petitioned uses of vitamin D<INF>2</INF> inactive bakers yeast
would not increase the dietary exposure to vitamin D and therefore, it
did not perform a new dietary exposure estimate for vitamin D from the
petitioned uses. Because Lallemand considered the petitioned uses as
substitutional for those in Sec. 172.382, they referenced FDA's
cumulative dietary exposure estimate for vitamin D in FAP 8A4821 (85 FR
41916), which resulted in the promulgation of Sec. 172.382.
We note that the cumulative dietary exposure estimate referenced by
Lallemand does not include the contribution to dietary exposure to
vitamin D from FAP 9A4823 (88 FR 745, January 5, 2023) for the use of
vitamin D<INF>3</INF> as a nutrient supplement in breakfast cereals at
levels up to 560 IU/100 g and in grain-based bars at levels up to 400
IU/100 g. This estimate also does not include the contribution to the
dietary exposure to vitamin D from the use of vitamin D<INF>3</INF> 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/100 g from FAP 1A4827 (90 FR 42699, September 4,
2025). Furthermore, we note that the cumulative dietary exposure
estimate referenced by Lallemand used food consumption data from the
2011-2014 National Health and Nutrition Examination Survey (NHANES),
and more recent NHANES food consumption data are available (Ref. 5).
The current cumulative eaters-only dietary exposure estimate to
vitamin D (i.e., cumulative dietary exposure to vitamin D for consumers
of any or all foods petitioned for use) from all existing sources was
discussed in FAP 1A4827 (90 FR 42699). Since the uses of vitamin
D<INF>2</INF> inactive bakers yeast are substitutional for those in
Sec. 172.382, the cumulative eaters-only dietary exposure estimate
would not change from that estimated in FAP 1A4827 (90 FR 42699).
For the overall U.S. population 1 year of age and older, the
estimated cumulative dietary exposure at the 90th percentile from all
food sources of vitamin D, including the proposed uses and background
sources, is 3,170 IU/p/d. The estimated 90th percentile cumulative
dietary exposure from all food sources of vitamin D is 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 to 8
years. Estimated dietary exposures for adolescents, teenagers, and
adults ranged from 1960 IU/p/d to 3930 IU/p/d. The estimated cumulative
dietary exposure to vitamin D 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 (Ref. 5).
B. Safety of the Petitioned Uses of Vitamin D2 Inactive Bakers Yeast
FDA reviewed and evaluated the information submitted by Lallemand
regarding the safety of UV light-treated inactive bakers yeast. FDA
concludes that the use of UV light to produce vitamin D<INF>2</INF>
inactive bakers yeast does not pose a safety concern, since the UV
light treatment has been shown not to produce any new components of
toxicological concern that could be introduced into the diet (Ref. 4).
In addition, we reviewed and evaluated the information submitted by
Lallemand regarding the safety of the dietary exposure to vitamin
D<INF>2</INF> from the proposed uses of vitamin D<INF>2</INF> inactive
bakers yeast. Lallemand submitted reports of scientific studies
published after the 2011 IOM report and issuance of the July 13, 2020,
final order (85 FR 41916) for the uses of vitamin D<INF>2</INF>
mushroom powder. Lallemand concluded that these publications support a
conclusion that the proposed uses of vitamin D<INF>2</INF> are safe.
We reviewed the published reports of scientific studies on vitamin
D submitted by Lallemand, 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 (90 FR
42699, September 4, 2025; 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; and 68 FR 9000, February 27,
2003). The 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 authorize the use of vitamin
D<INF>3</INF> as a nutrient supplement in yogurt and other cultured
dairy products
[[Page 60799]]
fermented with L. delbrueckii, subsp. bulgaricus, and S. thermophilus
at levels up to 178 IU vitamin D<INF>3</INF> per 100 g (90 FR 42699).
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 D<INF>2</INF>. 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. Considering that the
petitioned uses of vitamin D<INF>2</INF> inactive bakers yeast are
substitutional on a vitamin D<INF>2</INF> basis for the currently
approved uses of vitamin D<INF>2</INF> mushroom powder, FDA concluded
that the petitioned uses of vitamin D<INF>2</INF> inactive bakers yeast
are not expected to increase the overall dietary exposure to vitamin D.
Therefore, we conclude that the proposed uses of vitamin D<INF>2</INF>
inactive bakers yeast are 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 uses of vitamin D<INF>2</INF> inactive bakers
yeast, produced using UV light, as a source of vitamin D<INF>2</INF>
within the limits proposed by Lallemand.
IV. Public Disclosure
In accordance with Sec. 171.1(h) (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.
V. Analysis of Environmental Impact
As stated in the December 29, 2021 (86 FR 74018) Federal Register
notification of petition for FAP 1A4829, the petitioner claimed that
this action is categorically excluded under 21 CFR 25.32(k) because it
is to ``approve a food additive petition for substances added directly
to food that are intended to remain in food through ingestion by
consumers and that are not intended to replace macronutrients in
food.'' We further stated that, if FDA determines the categorical
exclusion applies, neither an environmental assessment nor an
environmental impact statement is required. We did not receive any new
information or comments regarding this claim of categorical exclusion.
We considered the petitioner's claim of categorical exclusion and
determined that this action is categorically excluded under 21 CFR
25.32(k). Therefore, neither an environmental assessment nor an
environmental impact statement is required.
VI. 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.
VII. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
VIII. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 409 of the 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.
IX. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA has verified the website
addresses in this document, please note that websites are subject to
change over time.
* 1. Office of Dietary Supplements. ``Vitamin D--Fact Sheet for
Consumers.'' U.S. Department of Health and Human Services, National
Institutes of Health, Nov. 2022, <a href="https://ods.od.nih.gov/factsheets/Vitamind-Consumer/">https://ods.od.nih.gov/factsheets/Vitamind-Consumer/</a>.
* 2. Pilz, S., et al. ``Rationale and Plan for Vitamin D Food
Fortification: A Review and Guidance Paper.'' Frontiers in
Endocrinology, vol. 9, 2018, article 373, <a href="https://www.frontiersin.org/articles/10.3389/fendo.2018.00373/full">https://www.frontiersin.org/articles/10.3389/fendo.2018.00373/full</a>.
* 3. IOM Committee to Review Dietary Reference Intakes for Vitamin
D and Calcium. Dietary Reference Intakes for Calcium and Vitamin D,
edited by A.C. Ross et al., National Academies Press, 2011, <a href="https://www.ncbi.nlm.nih.gov/books/NBK56070/">https://www.ncbi.nlm.nih.gov/books/NBK56070/</a>.
* 4. FDA Memorandum from A. Khan, Toxicology Review Branch,
Division of Food Ingredients, to S. Fischer, Regulatory Management
Branch,
[[Page 60800]]
Division of Food Ingredients, August 25, 2026.
* 5. FDA Memorandum from R. Shah, Chemistry Evaluation Branch,
Division of Food Ingredients, to S. Fischer, Regulatory Management
Branch, Division of Food Ingredients, August 25, 2026.
6. Parva, N.R., et al. ``Prevalence of Vitamin D Deficiency and
Associated Risk Factors in the US Population (2011-2012).'' Cureus,
vol. 10, no. 6, 2018, article e2741, <a href="https://doi.org/10.7759/cureus.2741">https://doi.org/10.7759/cureus.2741</a>.
7. Corpas, E., et al. ``Vitamin D and Calcium Deficiency in the
Elderly.'' Endocrinology of Aging: Clinical Aspects in Diagrams and
Images, edited by E. Corpas et al., Academic Press, 2021, pp. 103-130,
<a href="https://doi.org/10.1016/B978-0-12-819667-0.00004-4">https://doi.org/10.1016/B978-0-12-819667-0.00004-4</a>.
List of Subjects in 21 CFR Part 172
Food additives, 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.
0
2. Add Sec. 172.383 to subpart D to read as follows:
Sec. 172.383 Vitamin D2 Inactive Bakers Yeast.
Vitamin D<INF>2</INF> inactive bakers yeast may be safely used in
foods as a source of vitamin D<INF>2</INF> under the following
conditions:
(a) Vitamin D<INF>2</INF> inactive bakers yeast is the substance
produced by exposing bakers yeast (Saccharomyces cerevisiae) to
ultraviolet light, resulting in the photochemical conversion of
endogenous ergosterol in bakers yeast to vitamin D<INF>2</INF> (also
known as ergocalciferol or 9,10-seco(5Z,7E,22E)-5,7,10(19),22-
ergostatetraen-3-ol), and then inactivating the bakers yeast using
heat.
(b) Vitamin D<INF>2</INF> inactive bakers yeast can be used alone
or in combination with conventional bakers yeast.
(c) Vitamin D<INF>2</INF> inactive bakers yeast meets the following
specifications:
(1) Moisture, less than 7 percent.
(2) Negative for Salmonella, Staphylococcus aureus, Escherichia
coli, and Pseudomonas aeruginosa.
(3) Coliforms, less than 10 colony forming units per gram (CFU/g).
(4) Total plate count, less than 3,000 CFU/g.
(5) Yeasts and molds, less than 300 CFU/g.
(6) Lead, not more than 0.5 milligrams per kilogram (mg/kg).
(7) Arsenic, not more than 0.3 mg/kg.
(8) Cadmium, not more than 0.5 mg/kg.
(9) Mercury, not more than 0.1 mg/kg.
(d) To assure safe use of the additive, the label or labeling of
the food additive container shall bear, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act,
adequate directions for use to provide a final product that complies
with the limitations prescribed in paragraph (e) of this section.
(e) Vitamin D<INF>2</INF> inactive bakers yeast may be used as a
source of vitamin D<INF>2</INF> in food as follows:
Table 1 to Paragraph (e)
------------------------------------------------------------------------
Maximum level of
Category of food vitamin D2
------------------------------------------------------------------------
Breakfast cereals............................... 350 IU/100 g.
Edible plant-based beverages marketed as milk 84 IU/100 g.
alternatives.
Edible plant-based products marketed as yogurt 89 IU/100 g.
alternatives.
Extruded vegetable snacks....................... 80 IU/28 g.
Fruit smoothies................................. 100 IU/240 mL.
100% fruit juices that are fortified with 100 IU/240 mL.
greater than or equal to 330 mg of calcium per
240 mL, excluding fruit juices that are
specially formulated or processed for infants.
Fruit juice drinks that are fortified with 100 IU/240 mL.
greater than or equal to 100 mg of calcium per
240 mL, excluding fruit juice drinks that are
specially formulated or processed for infants.
Grain products and pastas....................... 90 IU/100 g.
Meal replacement bars or other-type bars that 100 IU/40 g
are represented for special dietary use in
reducing or maintaining body weight..
Meal replacement beverages that are not intended 500 IU/240 mL.
for special dietary use in reducing or
maintaining body weight and that are
represented for use such that the total amount
of vitamin D provided by the product does not
exceed 1,000 IU per day.
Plant protein products.......................... 80 IU/85 g.
Soups and soup mixes, except for soup and soup 100 IU/245 mL.
mixes that are subject to regulation by the
U.S. Department of Agriculture under the
Federal Meat Inspection Act or the Poultry
Products Inspection Act.
Soy-based spreads marketed as butter 330 IU/100 g.
alternatives.
Soy-based products marketed as cheese and cheese- 270 IU/100 g.
product alternatives.
Soy beverage products........................... 89 IU/100 g.
Soy-protein based meal replacement beverages 140 IU/240 mL.
(powder or liquid) that are represented for
special dietary use in reducing or maintaining
body weight.
Vegetable juices................................ 100 IU/240 mL.
Yeast-leavened baked goods and baking mixes and 400 IU/100 g.
yeast-leavened baked snack foods.
------------------------------------------------------------------------
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19656 Filed 9-24-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 25, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.