Federal Register #3C0323

FDA Denies Objections to Repeal of FD&C Red No. 3 Regulations

This notice details the FDA's response to objections from Micro-Tracers, Inc. regarding the repeal of regulations for FD&C Red No. 3: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Micro-Tracers, Inc. (objector) - Products/Regulated Substances: - FD&C Red No. 3 (color additive for food and ingested drugs) - Key Details: - FDA reviewed and denied objections and requests for a public hearing from Micro-Tracers, Inc. - The administrative stay on the repeal's effective date was lifted, confirming the removal of FD&C Red No. 3 from approved uses in food and ingested drugs. - No procurement, products, or services are being solicited or awarded in this notice. - The action is regulatory, not a purchasing opportunity.

Description

The Food and Drug Administration (FDA) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc., regarding the order granting a color additive petition (3C0323). The petition requested the repeal of regulations allowing the safe use of FD&C Red No. 3 in food and ingested drugs. After review, FDA concluded that the objections do not justify a hearing and has lifted the administrative stay of the effective date for the repeal. The order confirms the effective date as January 15, 2027, and denies the requests for a public hearing.

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