Data / Federal rules / 2026-15920

Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing

The Food and Drug Administration published this final rule in the Federal Register on August 5, 2026. It takes effect on January 15, 2027.

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What the agency says

The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted.

Key facts

Document number: 2026-15920
Type: Final rule
Action: Notification; response to objections and denial of public hearing requests; removal of administrative stay
Agency: Health and Human Services Department; Food and Drug Administration
Published: August 5, 2026
Takes effect: January 15, 2027
Dates: This order that published in the Federal Register of January 16, 2025 (90 FR 4628) with effective dates of January 15, 2027, and January 18, 2028, was administratively stayed by the filing of objections under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(e)(2)) as of February 18, 2025. FDA lifts the administrative stay as of August 5, 2026. The effective dates of January 15, 2027, and January 18, 2028, for amendatory instruction 4, for the order published on January 16, 2025 (90 FR 4628), are confirmed.
Docket: Docket No. FDA-2023-N-0437
Code of Federal Regulations: 21 CFR 74
Pages: 8

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Published in August 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.