US Federal Register - FDA Rules · August 05, 2026

Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing on FD&C Red No. 3 Repeal

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

FDA denies Micro-Tracers' objections to the repeal of FD&C Red No. 3 color additive regulations and lifts the administrative stay on the effective date.

Low obligation Product class Pharmaceuticals Other Regulated Products United States Pharmaceuticals

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.

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