FDA shuts down red dye drama: Micro-Tracers' hearing plea rejected
Published Date: 8/5/2026
Rule
Summary
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.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FD&C Red No. 3 Delisted for Foods/Drugs
You will no longer be able to use FD&C Red No. 3 as an allowed color additive in food (including dietary supplements) starting January 15, 2027, and in ingested drugs starting January 18, 2028. The FDA concluded the data show FD&C Red No. 3 induces cancer in male rats and therefore amended the color additive listings to no longer provide for its safe use.
Stay Lifted; Compliance Dates Confirmed
If you make or sell foods, dietary supplements, or ingested drugs that use FD&C Red No. 3, the FDA lifted the administrative stay on August 5, 2026 and confirmed compliance deadlines of January 15, 2027 for food (including dietary supplements) and January 18, 2028 for ingested drugs. The FDA also denied the objector's requests for a public hearing, so the order and confirmed dates will stand.
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