Rule2022-28428
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Primary source
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Published
January 5, 2023
Effective
January 5, 2023
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>3</INF> as a nutrient supplement in breakfast cereals and grain- based bars (e.g., breakfast bars, granola bars, rice cereal bars), and to update the reference for the Vitamin D<INF>3</INF> specifications. We are taking this action in response to a petition filed by Kellogg Company (Kellogg).
Full Text
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<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
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[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 745-749]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28428]
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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. 88, No. 3 / Thursday, January 5, 2023 / Rules
and Regulations
[[Page 745]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2019-F-3519]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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>3</INF> as a nutrient supplement in breakfast cereals and grain-
based bars (e.g., breakfast bars, granola bars, rice cereal bars), and
to update the reference for the Vitamin D<INF>3</INF> specifications.
We are taking this action in response to a petition filed by Kellogg
Company (Kellogg).
DATES: This rule is effective January 5, 2023. The incorporation by
reference of certain material listed in the rule is approved by the
Director of the Federal Register as of January 5, 2023. See section
VIII for further information on the filing of objections. Either
electronic or written objections and requests for a hearing on the
final rule must be submitted by February 6, 2023.
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
February 6, 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:
<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-2019-F-3519 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D<INF>3</INF>.'' 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 objections. 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 objections 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: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1204, 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
In the Federal Register of August 12, 2019 (84 FR 39785), we
announced that we filed a food additive petition (FAP 9A4823) submitted
on behalf of Kellogg by Hogan Lovells US LLP, Columbia Square, 555
Thirteenth St. NW,
[[Page 746]]
Washington, DC 20004. The petition proposed that FDA amend the food
additive regulations in Sec. 172.380 (21 CFR 172.380) to provide for
the safe use of vitamin D<INF>3</INF> as a nutrient supplement in: (1)
breakfast cereals as defined in Sec. 170.3(n)(4) (21 CFR 170.3(n)(4))
at levels up to 560 international units (IU) vitamin D<INF>3</INF> per
100 grams (g) and (2) grain-based nutrition bars at levels up to 400 IU
vitamin D<INF>3</INF> per 100 g. (One IU of vitamin D is equivalent to
0.025 micrograms ([micro]g) of vitamin D. We also note that while the
petition uses ``grain-based nutrition bars,'' we consider this to refer
to the same category of food products as ``grain-based bars'' (e.g.,
breakfast bars, granola bars, rice cereal bars), which is used
elsewhere in existing FDA regulations (see 21 CFR 172.780 and 101.12);
therefore, for consistency of terminology, we are using ``grain-based
bars.'') FDA is also updating the reference for specifications for
vitamin D<INF>3</INF> established in Sec. 172.380(b) by incorporating
by reference the most recent edition of the Food Chemicals Codex (FCC).
The current food additive regulation for the use of vitamin
D<INF>3</INF> (Sec. 172.380) indicates that the additive must meet the
specifications in the 11th edition of the FCC (FCC 11). Since we
received the petition, the FCC has been updated to the 13th edition
(FCC 13). The specifications for Vitamin D<INF>3</INF> from FCC 11 are
identical to those in FCC 13. Therefore, we are amending Sec.
172.380(b) by adopting, and incorporating by reference, the most recent
edition of the FCC (FCC 13).
Vitamin D is essential for human health. 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 and/or
mobilization from the bone, and possibly associated with decreased
renal function and increased cardiovascular risk (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 Sec. 184.1950 (21 CFR 184.1950). Under Sec. 184.1(b)(2) (21 CFR
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 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.
Vitamin D is affirmed as GRAS for use in certain foods as a nutrient
supplement (as defined under Sec. 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, respectively. Vitamin
D<INF>2</INF> is an approved food additive under Sec. 172.379 (21 CFR
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;
and 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. Vitamin
D<INF>2</INF> baker's yeast is an approved food additive under Sec.
172.381 (21 CFR 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 (21
CFR 172.382) for use as a source of vitamin D<INF>2</INF> in foods to
which vitamin D<INF>2</INF>, vitamin D<INF>3</INF>, and vitamin
D<INF>2</INF> baker's 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,
and margarine; fruit smoothies; vegetable juices; extruded vegetable
snacks; certain soups and soup mixes; and plant protein products.
To support their petition, Kellogg submitted dietary exposure
estimates of vitamin D from the proposed uses of vitamin D<INF>3</INF>,
as well as all naturally occurring dietary sources of vitamin D,
currently approved and affirmed uses of vitamin D under our food
additive and GRAS regulations, and dietary supplements. Kellogg
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).
Kellogg also submitted published scientific literature pertaining to
human 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 for 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 dietary exposure for the 90th percentile consumer of a
food additive as a measure of high chronic dietary exposure (Ref. 3).
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 (DRI) for
vitamin D; these DRIs are a family of nutrient reference values that
[[Page 747]]
includes ULs (Ref. 4). Based on this information, the IOM revised the
ULs for vitamin D and published a report on their findings (Ref. 5). In
their 2011 assessment of vitamin D, the IOM established the following
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 D<INF>3</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.
B. Dietary Exposure Estimate for Vitamin D
Kellogg provided mean and 90th percentile eaters-only dietary
exposure estimates for vitamin D for the overall U.S. population and
eight population subgroups from the: (1) proposed uses of vitamin
D<INF>3</INF>; (2) current food sources of vitamin D (including
approved food additive and affirmed GRAS uses as a food ingredient,
naturally occurring sources of vitamin D, and dietary supplements); and
(3) the combined current and proposed food uses. Kellogg noted that
dietary exposure was not estimated for infants 0-6 months as this age
group is not expected to consume breakfast cereals or grain-based bars.
Additionally, Kellogg indicated that dietary exposure was not estimated
for infants 6-12 months for grain-based bars for the same reason;
however, they were included in the exposure estimate for breakfast
cereals (Ref. 3).
Kellogg presented the dietary exposure estimates to vitamin D from
the proposed and existing uses. However, Kellogg did not provide an
overall dietary exposure from all proposed uses, but instead provided
separate dietary exposures for each of the petitioned uses of vitamin
D<INF>3</INF>. Kellogg then estimated a cumulative dietary exposure to
vitamin D by adding the dietary exposures from each of the proposed
uses and that from the existing uses. While the estimates of dietary
exposures to each of the proposed and the existing uses of vitamin D
are important to consider, it is not appropriate to estimate a
cumulative dietary exposure by summing all the values because the
populations of consumers for each of the food uses are not the same.
Additionally, since the submission of the current petition by Kellogg,
vitamin D<INF>2</INF> mushroom powder was approved under Sec. 172.382
for use as a source of vitamin D<INF>2</INF> in certain foods (see
Section I. Background). As a result, Kellogg did not include these uses
in its cumulative dietary exposure estimate. Therefore, FDA conducted
dietary exposure estimates to determine: (1) the overall dietary
exposure to vitamin D<INF>3</INF> from the petitioned uses and (2) a
cumulative dietary exposure for vitamin D from all existing sources,
including the approved uses of vitamin D<INF>2</INF> in mushroom
powder, and the petitioned uses for vitamin D<INF>3</INF> (Ref. 3).
FDA performed the dietary exposure estimate for vitamin
D<INF>3</INF> from the proposed uses in breakfast cereals and grain-
based bars using the combined 2011-2014 National Health and Nutrition
Examination Survey. FDA also estimated a cumulative dietary exposure
for vitamin D that includes all existing sources of vitamin D (i.e.,
naturally occurring sources, approved and affirmed GRAS food uses of
vitamin D, and dietary supplements) and Kellogg's proposed uses for
vitamin D<INF>3</INF> in breakfast cereals and grain-based bars.
Furthermore, FDA also included dietary exposure to the vitamin D
metabolite, 25-hydroxyvitamin D, in the cumulative estimate to account
for discrepancies seen between dietary intake and blood serum levels of
vitamin D (Ref. 3).
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 2,730 IU/p/d. Additionally, the estimated
90th percentile dietary exposure to vitamin D from all food sources for
infants 6 to 12 months of age is 1,060 IU/p/d. In summary, the
cumulative dietary exposure to vitamin D<INF>3</INF> at the 90th
percentile from the petitioned and background sources is below the IOM
UL for all population groups for which ULs were established.
C. Safety of the Petitioned Uses of Vitamin D3
We reviewed and evaluated the information submitted by Kellogg
regarding the safety of the dietary exposure to vitamin D<INF>3</INF>
from the proposed uses in grain-based bars and breakfast cereals.
Kellogg 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 D<INF>3</INF> are safe.
We reviewed the published reports of scientific studies on vitamin
D submitted by Kellogg, 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 (85 FR
41916, July 13, 2020; 81 FR 46578, July 18, 2016; 79 FR 46993, August
12, 2014; 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 for a new use of
vitamin D resulted in our amendment of the food additive regulations in
Sec. 172.382 to allow for the safe use of vitamin D<INF>2</INF>
mushroom powder in specific food categories (85 FR 41916). The earlier
food additive petitions also resulted in amendments of the food
additive regulations to allow
[[Page 748]]
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>3</INF>. Depending on the age group,
the IOM ULs for vitamin D for the U.S. population 4 years and older
range from 3,000 IU/p/d to 4,000 IU/p/d. FDA's cumulative dietary
exposure estimate for vitamin D from all food sources, including the
proposed uses, at the 90th percentile for the U.S. population 1 year of
age and older is estimated to be no greater than 2,740 IU/p/d, which is
below the IOM ULs for all population groups 4 years and above.
Estimated dietary exposure to vitamin D from all food sources for
infants 6 months to 12 months of age is 1,060 IU/p/d, and for children
aged 1 year to 3 years old is 1,730 IU/p/d. These estimates are below
the respective IOM UL of 1,500 IU/p/d for infants 6 months to 12 months
of age, and 2,500 IU/p/d for children aged older than 1 year to 3 years
old (Ref. 6).
Because the estimated 90th percentile dietary exposure to vitamin D
from all current and proposed food uses for each population group is
less than the corresponding IOM UL for that population group, we
conclude that dietary exposure to vitamin D<INF>3</INF> from the
proposed uses as a nutrient supplement in breakfast cereals and grain-
based bars are safe (Ref. 6).
III. Conclusion
Based on the relevant data available to FDA and information in the
petition, we conclude that there is a reasonable certainty that no harm
will result from the use of vitamin D<INF>3</INF> as a nutrient
supplement in breakfast cereals, as defined in Sec. 170.3(n)(4), at a
level up to 560 IU vitamin D<INF>3</INF> per 100 g and in grain-based
bars at a level up to 400 IU vitamin D<INF>3</INF> per 100 g.
Additionally, we are amending Sec. 172.380(b) by adopting, and
incorporating by reference, the most recent edition of the FCC (FCC
13).
IV. Incorporation by Reference
FDA is incorporating by reference the monograph for vitamin
D<INF>3</INF> from the Food Chemicals Codex, 13th ed., 2022, which was
approved by the Office of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You may purchase a copy of the
material from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852, 1-800-227-8772, <a href="https://www.usp.org/">https://www.usp.org/</a>. You may
inspect a copy at Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500, between 9 a.m. and 4 p.m., Monday through Friday. On our own
initiative, we have revised Sec. 172.380 to state that the referenced
material can be found at FDA's Dockets Management Staff instead of
FDA's Main Library. This change reflects a recent decision regarding
the location of referenced materials cited in FDA regulations.
The FCC monograph sets forth a standard for purity and identity for
vitamin D<INF>3</INF>. The monograph provides specifications and
analytical methodologies to identify the substance and establish
acceptable purity criteria. The current food additive regulation for
the use of vitamin D<INF>3</INF> (Sec. 172.380) indicates that the
additive must meet the specifications in the FCC 11. The petitioner
indicated that the vitamin D<INF>3</INF> petitioned in FAP 9A4823
complies with the specifications in the monograph for vitamin
D<INF>3</INF> in FCC 11. Since we received the petition, the FCC has
been updated to the 13th edition (FCC 13). The specifications for
vitamin D<INF>3</INF> in FCC 13 are identical to those in FCC 11.
Therefore, we are amending Sec. 172.380(b) by adopting, and
incorporating by reference, the specifications for vitamin
D<INF>3</INF> in FCC 13 in place of FCC 11.
V. 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.
VI. Analysis of Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the August 12, 2019, Federal Register notice of petition for
FAP 9A4823 (84 FR 39785). We stated that we had determined, under 21
CFR 25.32(k), that this action is of a type that does not individually
or cumulatively have a significant effect on the human environment such
that neither an environmental assessment nor an environmental impact
statement is required. We have not received any new information or
comments that would affect our previous determination.
VII. Paperwork Reduction Act of 1995
This final rule 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 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:/
<a href="http://www.regulations.gov">www.regulations.gov</a>.
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
final rule 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
final rule 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.
[[Page 749]]
Furthermore, this language is included in all food additive final rules
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 <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. 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. National Institutes of Health, Office of Dietary Supplements,
``Vitamin D--Fact Sheet for Consumers,'' 2021. Available at: <a href="https://ods.od.nih.gov/factsheets/Vitamind-Consumer/">https://ods.od.nih.gov/factsheets/Vitamind-Consumer/</a>.
2. 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, 9, 2018. Available at: <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. FDA Memorandum from R. Shah, Chemistry Review Branch, Division
of Food Ingredients, to L. Highbarger, Regulatory Review Branch,
Division of Food Ingredients, October 13, 2022.
* 4. Institute of Medicine Committee to Review Dietary Reference
Intakes for Vitamin D and Calcium; Ross, A.C., C.L. Taylor, A.L.
Yaktine, et al., editors. ``Dietary Reference Intakes for Calcium
and Vitamin D.'' Washington (DC): National Academies Press, 2011.
Available at: <a href="https://www.ncbi.nlm.nih.gov/books/NBK56070/">https://www.ncbi.nlm.nih.gov/books/NBK56070/</a> NBK56070/.
5. Taylor, C., K. Patterson, J. Roseland, 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: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985821/pdf/nut144654.pdf">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985821/pdf/nut144654.pdf</a>.
* 6. FDA Memorandum from S.A. Assimon, Toxicology Review Branch,
Division of Food Ingredients, to L. Highbarger, Regulatory Review
Branch, Division of Food Ingredients, October 14, 2022.
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.
0
2. Amend Sec. 172.380 by revising paragraph (b) and adding paragraphs
(c)(9) and (10) to read as follows:
Sec. 172.380 Vitamin D3.
* * * * *
(b) Vitamin D<INF>3</INF> meets the specifications of ``Vitamin
D<INF>3</INF>,'' Food Chemicals Codex, 13th edition, effective June 1,
2022, which is incorporated by reference. The Director of the Office of
the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852; website: <a href="https://www.usp.org">https://www.usp.org</a>. Copies may be
examined at the FDA or 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, 240-402-7500.
For information on inspecting this material at NARA, visit
<a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a> or email
<a href="/cdn-cgi/l/email-protection#deb8acf0b7b0adaebbbdaab7b1b09eb0bfacbff0b9b1a8"><span class="__cf_email__" data-cfemail="096f7b2760677a796c6a7d6066674967687b68276e667f">[email protected]</span></a>.
(c) * * *
(9) At levels not to exceed 560 IU per 100 g in breakfast cereals
(as defined under Sec. 170.3(n)(4) of this chapter).
(10) At levels not to exceed 400 IU per 100 g in grain-based bars
(e.g., breakfast bars, granola bars, rice cereal bars).
Dated: December 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28428 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P
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