2025-19166: Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date

Federal Register, Volume 90 Issue 188 (Wednesday, October 1, 2025) [Federal Register Volume 90, Number 188 (Wednesday, October 1, 2025)] [Rules and Regulations] [Page 47229] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2025-19166] ======================================================================== Rules and Regulations Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. ======================================================================== Federal Register / Vol. 90, No. 188 / Wednesday, October 1, 2025 / Rules and Regulations [[Page 47229]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2021-C-0522] Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date

Agency

Food and Drug Administration, HHS.

Action

Final amendment; order; confirmation of effective date. -----------------------------------------------------------------------

Summary

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.

Dates

The effective date of August 29, 2025, for the order published in the Federal Register of July 15, 2025 (90 FR 31586), is confirmed.

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 final order 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

Stephen DiFranco, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2710; or Keronica Richardson, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

Supplementary Information

In the Federal Register of July 15, 2025 (90 FR 31586), we amended the color additive regulations to add Sec. 73.168 (21 CFR 73.168) ``Gardenia (genipin) blue,'' to provide for the safe use of gardenia (genipin) blue at levels consistent with GMP in sport drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. In the Federal Register of August 6, 2025 (90 FR 37793), we published a correction to the order clarifying the appropriate specification for methanol and amending the codified language of the regulation. We gave interested persons until August 14, 2025, to file objections or requests for a hearing (90 FR 31586 at 31587). We received no objections or requests for a hearing on the order. Therefore, we find that the effective date of the order that published in the Federal Register of July 15, 2025, should be confirmed. List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Foods, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the July 15, 2025, order. Accordingly, the amendments issued thereby became effective August 29, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-19166 Filed 9-30-25; 8:45 am] BILLING CODE 4164-01-P