Rule2025-19166
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 1, 2025
Effective
August 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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.
Full Text
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<title>Federal Register, Volume 90 Issue 188 (Wednesday, October 1, 2025)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19166]
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Rules and Regulations
Federal Register
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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.
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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</html>Indexed from Federal Register on October 1, 2025.
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