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Final Rule

Listing of Color Additives; Myoglobin; Confirmation of Effective Date

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 February 19, 2025, for the final order that appeared in the Federal Register of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.

Key Dates
Citation: 90 FR 22627
The effective date of February 19, 2025, for the final order published in the Federal Register of January 17, 2025 (90 FR 5590) is confirmed.
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Topics:
Color additives Cosmetics Drugs Foods Medical devices

In Plain English

What is this Federal Register notice?

This is a final rule published in the Federal Register by Health and Human Services Department, Food and Drug Administration. Final rules have completed the public comment process and establish legally binding requirements.

Is this rule final?

Yes. This rule has been finalized. It has completed the notice-and-comment process required under the Administrative Procedure Act.

Who does this apply to?

Final amendment; order; confirmation of effective date.

When does it take effect?

This document has been effective since February 19, 2025.

Why it matters: This final rule amends regulations in 21 CFR Part 73.

Document Details

Document Number2025-09680
FR Citation90 FR 22627
TypeFinal Rule
PublishedMay 29, 2025
Effective DateFeb 19, 2025
RIN-
Docket IDDocket No. FDA-2022-C-0098
Pages22627–22627 (1 pages)
Text FetchedYes

Agencies & CFR References

CFR References:

Linked CFR Parts

PartNameAgency
21 CFR 73 Listing of Color Additives Exempt from C... -

Paired Documents

TypeProposedFinalMethodConf
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Related Documents (by RIN/Docket)

Doc #TypeTitlePublished
2025-01239 Final Rule Listing of Color Additives Exempt From C... Jan 17, 2025

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  • Contain only preamble/explanation without regulatory text

Official Document Text (469 words · ~3 min read)

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<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 73</CFR> <DEPDOC>[Docket No. FDA-2022-C-0098]</DEPDOC> <SUBJECT>Listing of Color Additives; Myoglobin; Confirmation of Effective Date</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order; confirmation of effective date. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is confirming the effective date of February 19, 2025, for the final order that appeared in the <E T="04">Federal Register</E> of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> The effective date of February 19, 2025, for the final order published in the <E T="04">Federal Register</E> of January 17, 2025 (90 FR 5590) is confirmed. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Mical Honigfort, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1278 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. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In the <E T="04">Federal Register</E> of January 17, 2025 (90 FR 5590), we amended the color additive regulations to add § 73.297 (21 CFR 73.297) “Myoglobin,” to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We gave interested persons until February 18, 2025, to file objections or requests for a hearing. We received no objections or requests for a hearing on the final order. Therefore, we find that the effective date of the final order that published in the <E T="04">Federal Register</E> of January 17, 2025, should be confirmed. <LSTSUB> <HD SOURCE="HED">List of Subjects in 21 CFR Part 73</HD> Color additives, Cosmetics, Drugs, Foods, Medical devices. </LSTSUB> <REGTEXT TITLE="21" PART="73"> 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 January 17, 2025, final order. Accordingly, the amendments issued thereby became effective February 19, 2025. </REGTEXT> <SIG> <DATED>Dated: May 22, 2025.</DATED> <NAME>Grace R. Graham,</NAME> Deputy Commissioner for Policy, Legislation, and International Affairs. </SIG> </SUPLINF> <FRDOC>[FR Doc. 2025-09680 Filed 5-28-25; 8:45 am]</FRDOC> </RULE>
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