Home / Agencies / FDA / 2025-14339
Proposed Rule

Spoonbill Foundation; Filing of Food Additive Petition

Agency
FDA
Document Number
2025-14339
Published
July 29, 2025
Effective Date
-

Abstract

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by the Spoonbill Foundation, proposing that we amend our food additive regulations to provide for the safe use of 4'-phosphopantetheine (4'-PPT) as a nutrient in medical food.

Federal Register Source

This document is published by the Office of the Federal Register, National Archives and Records Administration. Access the full regulatory text, preamble, and docket comments below.

View Full Text on FederalRegister.gov →

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Frequently Asked Questions

What is the 2025-14339 Federal Register document?
Document 2025-14339 is a Proposed Rule published by the Food and Drug Administration in the Federal Register on July 29, 2025. The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by the Spoonbill Foundation, proposing that we amend our food additive regulations to provide for the safe use of 4'-phosphopantetheine (4'-PPT) as a nutrient in medical food. View the original at https://www.federalregister.gov/documents/2025/07/29/2025-14339/spoonbill-foundation-filing-of-food-additive-petition.
Is document 2025-14339 an economically significant rule?
No. Document 2025-14339 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.

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