Home / Agencies / HHS / 2025-19166
Final Rule

Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date

Agency
HHS
Document Number
2025-19166
Published
October 1, 2025
Effective Date
August 29, 2025

Abstract

The Food and Drug Administration (FDA or we) is confirming the effective date of August 29, 2025, for the order that appeared in the Federal Register of July 15, 2025. The order amends the color additive regulations to provide for the safe use of gardenia (genipin) blue as a color additive, at levels consistent with good manufacturing practice (GMP), in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy.

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 2025-19166 Federal Register document?
Document 2025-19166 is a Final Rule published by the Department of Health and Human Services in the Federal Register on October 1, 2025, with an effective date of August 29, 2025. The Food and Drug Administration (FDA or we) is confirming the effective date of August 29, 2025, for the order that appeared in the Federal Register of July 15, 2025. The order amends the color additive regulations to provide for the safe use of gardenia (genipin) blue as a color additive, at levels consistent with good manufacturing practice (GMP), in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. View the original at https://www.federalregister.gov/documents/2025/10/01/2025-19166/listing-of-color-additives-exempt-from-certification-gardenia-genipin-blue-confirmation-of-effective.
Is document 2025-19166 an economically significant rule?
No. Document 2025-19166 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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