Document ID: FDA-2017-F-3717-0003
Agency: fda
Document Type: Rule
Title: Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3
Posted Date: 2018-09-20T04:00Z

[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Rules and Regulations]
[Pages 47557-47560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20375]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2017-F-3717]

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulation for vitamin D3 to replace the 
current Reference Daily Intake (RDI) percentage values of calcium in 
100 percent fruit juices and fruit juice drinks with absolute values 
and to update the reference for vitamin D3 specifications. 
We are taking this action in response to a food additive petition filed 
by the Juice Products Association.

DATES: This rule is effective September 20, 2018. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by October 22, 2018. The Director of the Federal Register 
approves the incorporation by reference of certain publications listed 
in the rule as of September 20, 2018. See the ADDRESSES section and the 
OBJECTIONS section IX of this document for further information on 
filing objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before 
October 22, 2018. The https://www.regulations.gov electronic filing 
system will accept objections until midnight Eastern Time at the end of 
October 22, 2018. Objections received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is 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-2017-F-3717 for ``Food Additives Permitted for Direct Addition to 
Food for Human Consumption; Vitamin D3 Final Rule.'' 
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.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We 
will review this copy, including the claimed confidential information, 
in our consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of July 26, 2017 (82 FR 34615), amended 
August 22, 2017 (82 FR 39711), we announced that we filed a food 
additive petition (FAP 7A4818) submitted on behalf of the Juice 
Products Association by Hogan

[[Page 47558]]

Lovells US LLP, Columbia Square, 555 Thirteenth Street NW, Washington, 
DC 20004. The petition proposed to amend the food additive regulations 
in Sec.  172.380 (21 CFR 172.380), Vitamin D3, to replace 
the currently specified minimum RDI percentage values of calcium in 
calcium-fortified 100 percent fruit juices and fruit juice drinks with 
absolute values. Specifically, Sec.  172.380(c)(1) currently provides 
for the use of vitamin D3 at a level not to exceed 100 
International Units (IU) per 240 milliliters (mL) in 100 percent fruit 
juices that are fortified with greater than or equal to 33 percent of 
the RDI of calcium per 240 mL, excluding fruit juices that are 
specifically formulated or processed for infants. In addition, Sec.  
172.380(c)(2) provides for the use of up to 100 IU of vitamin 
D3 per 240 mL in fruit juice drinks that are fortified with 
greater than or equal to 10 percent of the RDI of calcium per 240 mL, 
excluding fruit juice drinks that are specifically formulated or 
processed for infants. The petitioner proposed to replace the RDI 
percentage values of calcium in 100 percent fruit juices and fruit 
juice drinks in these regulations with the absolute values of added 
calcium of 330 milligrams (mg) and 100 mg per 240 mL, respectively. The 
petitioner also requested that we update the reference for 
specifications for vitamin D3 in Sec.  172.380(b) from the 
9th edition of the Food Chemicals Codex (FCC 9) to the 10th edition 
(FCC 10).

II. Evaluation of Petition

    Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 348(i)) states that we shall, by regulation, establish 
the procedure for amending or repealing a food additive regulation, and 
that this procedure shall conform to the procedure provided in section 
409 of the FD&C Act. Our regulations specific to administrative actions 
for food additives provide that the Commissioner of Food and Drugs, on 
his own initiative or on the petition of any interested person, may 
propose the issuance of a regulation amending or repealing a regulation 
pertaining to a food additive (Sec.  171.130(a) (21 CFR 171.130(a))). 
The regulations further provide that any such petition must include an 
assertion of facts, supported by data, showing that new information 
exists with respect to the food additive or that new uses have been 
developed or old uses abandoned, that new data are available as to 
toxicity of the chemical, or that experience with the existing 
regulation or exemption may justify its amendment or repeal. New data 
submitted as a food additive petition must be furnished in the form 
specified in 21 CFR 171.1 and 171.100 for submitting such petitions 
(Sec.  171.130(b)).
    In the Federal Register of February 27, 2003 (68 FR 9000), we 
issued the regulations at Sec.  172.380(c)(1) and (2) permitting the 
use of vitamin D3 in calcium fortified 100 percent fruit 
juices and fruit juice drinks. We took that action in response to a 
food additive petition (FAP 2A4734) from the Minute Maid Co. (Minute 
Maid). Minute Maid petitioned for vitamin D3 to be allowed 
to be added to calcium-fortified 100 percent fruit juices and fruit 
juice drinks so that the calcium and vitamin D levels are comparable to 
the levels in milk. When we issued these regulations in 2003, the RDI 
for calcium was 1,000 mg; however, in the Federal Register of May 27, 
2016 (81 FR 33742), we issued a final rule which, among other things, 
redefined the RDI of calcium for adults and children 4 years of age and 
older to 1,300 mg (21 CFR 101.9(c)(8)(iv)). Because of the change in 
the RDI for calcium, the minimum level of added calcium in 100 percent 
fruit juice that may be fortified with vitamin D3 increased 
from 330 mg to 430 mg and in fruit juice drinks from 100 mg to 130 mg.
    The Juice Products Association stated that the proposed revision of 
Sec.  172.380 to specify absolute values of calcium on a mg/mL basis 
rather than a percentage of RDI is needed to maintain the relative 
parity between fortified 100 percent fruit juices and fruit juice 
drinks and many dairy products. Without this change, the petitioner 
stated that 100 percent fruit juices with vitamin D3 would 
have higher calcium levels than milk. The petitioner also stated that 
the higher levels of calcium resulting from the redefined RDI for 
calcium present formulation challenges and may adversely impact the 
taste of the juice or juice drink, which could deter consumers from 
selecting calcium and vitamin D fortified juices. Therefore, the 
petitioner proposed that Sec.  172.380 be amended to express the 
allowable added calcium levels on a mg basis consistent with the 
calcium levels before the revision of the RDI for calcium. In doing so, 
the allowable levels of calcium and vitamin D in 100 percent fruit 
juices and juice drinks would again be comparable to the levels in 
milk.
    Because the petitioner sought to revise the existing regulation to 
restore the amount of calcium fortification required to levels on par 
with milk, without introducing new uses for vitamin D3 or 
changing the levels of vitamin D3 and calcium that were 
considered when the regulations were established, there is no increase 
in dietary exposure to vitamin D3 or to calcium. Therefore, 
we have determined that there are no safety concerns as a result of the 
proposed amendment.
    Additionally, the current regulation for the use of vitamin 
D3 in food (Sec.  172.380) indicates that the additive must 
meet the specifications in the 9th edition of the Food Chemicals Codex 
(FCC 9). The petitioner requested that we update the specifications for 
vitamin D3 in Sec.  172.380 by replacing the existing FCC 9 
reference with the 10th edition of the Food Chemicals Codex (FCC 10), 
the most recent edition at the time the petition was submitted. The 
specifications for vitamin D3 in FCC 10 are identical to 
those in FCC 9. However, since we received the petition, FCC has been 
updated to the 11th edition (FCC 11). The specifications for vitamin 
D3 in FCC 11 are identical to those in FCC 10. Therefore, we 
are amending Sec.  172.380 by adopting the specifications for vitamin 
D3 in FCC 11 in place of FCC 9, because FCC 11 is the most 
current version.

III. Incorporation by Reference

    FDA is incorporating by reference the monograph from Food Chemicals 
Codex, 11th ed., 2018, pp. 1243-1244 (vitamin D3), which is 
approved by the Director of the Office of the Federal Register. You may 
purchase a copy of the material from the United States Pharmacopeial 
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, 
http://www.usp.org/. Copies also may be examined at FDA's Main Library, 
10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 
20993, 301-796-2039.
    The FCC monograph establishes the standard for purity and identity 
for vitamin D3. The monograph provides specifications and 
analytical methodologies used to identify the substance and establish 
acceptable purity criteria. To ensure that only food grade vitamin 
D3 is used in foods listed in Sec.  172.380, the additive 
must meet the specifications and identity in the FCC monograph.

IV. Conclusion

    Based on data and information in the petition, we conclude that 
amending the food additive regulations in the regulation for vitamin 
D3 to replace the current RDI percentage values of calcium 
in 100 percent fruit juices and fruit juice drinks with absolute values 
is safe and appropriate. Thus, the RDI percentage values of calcium in 
100 percent fruit juices and fruit juice drinks in these regulations 
are replaced with the absolute values of added calcium of

[[Page 47559]]

330 mg and 100 mg per 240 mL, respectively. Consequently, we are 
amending the food additive regulations as set forth in this document.
    Additionally, the current regulation for the use of vitamin 
D3 in food (Sec.  172.380) indicates that the additive must 
meet the specifications in FCC 9. The more current version is FCC 11, 
which contains specifications for vitamin D3 that are 
identical to those in FCC 9. We are amending Sec.  172.380 by adopting 
the specifications for vitamin D3 in FCC 11 in place of FCC 
9.

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 July 26, 2017, Federal Register notice of filing (82 FR 
34615). We stated in the notice of filing that we had determined, under 
21 CFR 25.30(i), that this action ``is of a type that does not 
individually or cumulatively have a significant effect on the human 
environment because the amendments are administrative in nature'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. Upon further consideration, we determined that 
FAP 7A4818 is not solely administrative in nature as this revision has 
the potential to lead to manufacturing changes. Consequently, the 
action being requested is neither a correction nor technical change and 
the original categorical exclusion (21 CFR 25.30(i)) is not 
appropriate. Therefore, we have 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 because the added 
vitamin D3 and calcium will remain in the fruit juice and 
fruit juice drinks through ingestion by consumers and neither food 
additive is intended to replace macronutrients. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

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. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 409 of the FD&C 
Act. 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) to (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. 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.

IX. 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.

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 paragraphs (b) and (c)(1) through 
(2) to read as follows:

Sec.  172.380  Vitamin D3.

* * * * *
    (b) Vitamin D3 meets the specifications of ``Vitamin 
D3,'', Food Chemicals Codex, 11th ed., copyright 2018, pp. 
1243-1244, 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 United States Pharmacopeial Convention, 12601 Twinbrook 
Pkwy., Rockville, MD 20852 (internet address http://www.usp.org). 
Copies may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    (c) * * *
    (1) At levels not to exceed 100 International Units (IU) per 240 
milliliters (mL) in 100 percent fruit juices (as defined under Sec.  
170.3(n)(35) of this chapter) that are fortified with greater than or 
equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit 
juices that are specially formulated or processed for infants.
    (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks 
(as defined under Sec.  170.3(n)(35) of this chapter) that

[[Page 47560]]

are fortified with greater than or equal to 100 mg of calcium per 240 
mL, excluding fruit juice drinks that are specially formulated or 
processed for infants.
* * * * *

    Dated: September 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20375 Filed 9-19-18; 8:45 am]
BILLING CODE 4164-01-P