This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notification of petition.
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 D3 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.
The food additive petition was filed on April 26, 2023.
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.
Lane A. Highbarger, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1204.
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 D3,” to provide for the safe use of vitamin D3 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.
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.
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