Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
Key claim: FDA denied Micro-Tracers’ objections and public-hearing requests on the repeal of FD&C Red No. 3 authorizations in food and ingested drugs and lifted the administrative stay on the effective date of the delisting.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Denying objections and lifting the administrative stay converts the Red No. 3 delisting from a contested order into a final, operative rule, starting the clock for manufacturers to reformulate food and ingested drug products. For patients and consumers, this locks in removal of a synthetic color additive from covered products; for industry, it fixes compliance deadlines that had been paused during the objections process.