FDA Lifts Stay on FD&C Red No. 3 Ban in Food and Drugs
The agency rejected a request for a public hearing from Micro-Tracers, Inc., clearing the way for the repeal of the color additive's safe use regulations.
The Food and Drug Administration has lifted the administrative stay on the repeal and delisting of regulations allowing the safe use of FD&C Red No. 3 in food, dietary supplements, and ingested drugs. The move follows the agency's conclusion that objections submitted by Micro-Tracers, Inc. did not raise material issues of fact that would justify a public hearing.
Micro-Tracers had sought a hearing based on the potential applicability of the DES Proviso to the use of the additive in color-coded tracers for medicated animal feed. The FDA rejected this argument, stating that the DES Proviso cannot exempt the additive unless a proponent demonstrates that its use will not adversely affect animals and that no residue remains in edible portions after slaughter.
No approved regulatory method exists for FD&C Red No. 3, and Micro-Tracers failed to provide the necessary data to establish such a method. Consequently, the DES Proviso does not exempt the additive's use in animal feed tracers from the Delaney Clause.
Compliance dates for the repeal are now confirmed for January 15, 2027, and January 18, 2028. The administrative stay, which had been in place since February 18, 2025, was officially lifted on August 5, 2026.