[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Proposed Rules]
[Pages 70918-70919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2023-F-4332]


Kerry Ingredients and Flavours Ltd.; Filing of Food Additive 
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Kerry Ingredients and 
Flavours Ltd., proposing that the food additive regulations be amended 
to provide for the safe use of vitamin D<INF>3</INF> as a nutrient 
supplement in powdered drink mixes added to water or carbonated water, 
excluding drinks or drink mixes that are specially formulated or 
processed for infants.

DATES: The food additive petition was filed on April 26, 2023.

ADDRESSES: For access to the docket to read background documents or 
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: Lane A. Highbarger, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1204.

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that 
we have filed a food additive petition (FAP 2A4834), submitted on 
behalf of Kerry Ingredients and Flavours Ltd. by Hogan Lovells US LLP, 
Columbia Square, 555 13th Street NW, Washington, DC 20004. The petition 
proposes to amend the food additive regulations in 21 CFR 172.380 
``Vitamin D<INF>3</INF>,'' to provide for the safe use of vitamin 
D<INF>3</INF> as a nutrient supplement in powdered drink mixes added to 
water or carbonated water at levels not to exceed 180 international 
units per 360 milliliters (mL) as consumed, excluding drinks or drink 
mixes that are specially formulated or processed for infants (Refs. 1 
and 2). If calcium is added, calcium is present at levels greater than 
or equal to 150 milligrams of calcium per 360 mL as consumed (Refs. 1 
and 2).
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because the substance is intended to 
remain in food through ingestion by consumers and is not intended to 
replace macronutrients in food. In addition, the petitioner has stated 
that, to their knowledge, no extraordinary circumstances exist that 
would warrant an environmental assessment (see 21 CFR 25.21). If FDA 
determines a categorical exclusion applies, neither an environmental 
assessment nor an environmental impact statement is required. If FDA 
determines a categorical exclusion does not apply, we will request an 
environmental assessment and make it available for public inspection.

References

    The following references are on display at 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. 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. Emails from M. Gradison, to L. Highbarger, March 8, 2023, and 
March 30, 2023.
2. FDA Memorandum from L. Highbarger, Regulatory Review Branch, 
March 30, 2023.


[[Page 70919]]


    Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22613 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P