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

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 74

Compared with

The Food and Drug Administration has published 100 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

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.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2023-N-0437 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register