Document ID: FDA-2019-F-3519-0002
Agency: fda
Document Type: Rule
Title: Food Additives Permitted for Direct Addition to Food for Human Consumption;  Vitamin D3
Posted Date: 2023-01-05T05:00Z

[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 [www.gpo.gov]
[FR Doc No: 2022-28428]

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 Rules and Regulations
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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 
D3 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 D3 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 https://www.regulations.gov 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:
     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-2019-F-3519 for ``Food Additives Permitted for Direct Addition to 
Food for Human Consumption; Vitamin D3.'' 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 objections. 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 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: 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 D3 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 D3 per 
100 grams (g) and (2) grain-based nutrition bars at levels up to 400 IU 
vitamin D3 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 D3 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 
D3 (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 D3 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 
D2 and vitamin D3. Vitamin D without a subscript 
represents vitamin D2, vitamin D3, 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 
D2 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 D3 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 
D2 baker's yeast is an approved food additive under Sec.  
172.381 (21 CFR 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 (21 
CFR 172.382) for use as a source of vitamin D2 in foods to 
which vitamin D2, vitamin D3, and vitamin 
D2 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 D3, 
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 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

    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 
D3; (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 
D3. 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 D2 mushroom powder was approved under Sec.  172.382 
for use as a source of vitamin D2 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 D3 from the petitioned uses and (2) a 
cumulative dietary exposure for vitamin D from all existing sources, 
including the approved uses of vitamin D2 in mushroom 
powder, and the petitioned uses for vitamin D3 (Ref. 3).
    FDA performed the dietary exposure estimate for vitamin 
D3 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 D3 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 D3 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 D3 
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 D3 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 D2 
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 D3. 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 D3 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 D3 as a nutrient 
supplement in breakfast cereals, as defined in Sec.  170.3(n)(4), at a 
level up to 560 IU vitamin D3 per 100 g and in grain-based 
bars at a level up to 400 IU vitamin D3 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 
D3 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, 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, 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 D3. 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 D3 (Sec.  172.380) indicates that the 
additive must meet the specifications in the FCC 11. The petitioner 
indicated that the vitamin D3 petitioned in FAP 9A4823 
complies with the specifications in the monograph for vitamin 
D3 in FCC 11. Since we received the petition, the FCC has 
been updated to the 13th edition (FCC 13). The specifications for 
vitamin D3 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 
D3 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:/
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 
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 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. 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/.
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: https://www.frontiersin.org/articles/10.3389/fendo.2018.00373/full.
* 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: https://www.ncbi.nlm.nih.gov/books/NBK56070/ 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: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3985821/pdf/nut144654.pdf.
* 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.

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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 D3 meets the specifications of ``Vitamin 
D3,'' 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: https://www.usp.org. 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 
www.archives.gov/federal-register/cfr/ibr-locations.html or email 
[email protected].
    (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