Rule2025-16045

Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; 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
August 21, 2025
Effective
June 26, 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 June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive at levels consistent with good manufacturing practice (GMP) in: ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips.

Full Text

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<title>Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025)</title>
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[Federal Register Volume 90, Number 160 (Thursday, August 21, 2025)]
[Rules and Regulations]
[Page 40704]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2024-C-0971]


Listing of Color Additives Exempt From Certification; Butterfly 
Pea Flower Extract; 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 June 26, 2025, for the final order that appeared in 
the Federal Register of May 12, 2025. The final order amends the color 
additive regulations to provide for the expanded safe use of butterfly 
pea flower extract as a color additive at levels consistent with good 
manufacturing practice (GMP) in: ready-to-eat cereals, crackers, snack 
mixes, hard pretzels, plain potato chips (restructured or baked), and 
plain corn chips, tortilla chips, and multigrain chips.

DATES: The effective date of June 26, 2025, for the final order 
published in the Federal Register of May 12, 2025 (90 FR 20101), 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, Office of Food 
Chemical Safety, Dietary Supplements, and Innovation, Human Foods 
Program, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2710 or Meridith L. Kelsch, 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 May 12, 2025 (90 
FR 20101), we amended the color additive regulations at Sec.  73.69 (21 
CFR 73.69) ``Butterfly pea flower extract,'' to provide for the 
expanded safe use of butterfly pea flower extract as a color additive 
at levels consistent with GMP in: ready-to-eat cereals, crackers, snack 
mixes, hard pretzels, plain potato chips (restructured or baked), and 
plain corn chips, tortilla chips, and multigrain chips.
    We gave interested persons until June 11, 2025 (90 FR 20101 at 
20101) to file objections or requests for a hearing. We explained that, 
to file an objection, persons must, among other things, specify with 
particularity the provision(s) of the regulation to which they object 
and the grounds for the objection (Id. at 20103). Within each 
objection, persons also must specifically state whether they request a 
hearing (Id.). We received one comment about labeling of the color 
additive, but the comment did not meet the requirements to be 
considered an objection under 21 CFR 12.22(a)(2) or (3). Therefore, we 
find that the effective date of the final order that published in the 
Federal Register of May 12, 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 May 12, 2025, final order. Accordingly, the 
amendments issued thereby became effective June 26, 2025.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16045 Filed 8-20-25; 8:45 am]
BILLING CODE 4164-01-P


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Indexed from Federal Register on August 21, 2025.

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