2025-16045: Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date

Federal Register, Volume 90 Issue 160 (Thursday, August 21, 2025) [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 [www.gpo.gov] [FR Doc No: 2025-16045] ----------------------------------------------------------------------- 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. -----------------------------------------------------------------------

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 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, 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