On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.”
Recall that in January, the FDA announced that it was banning Red No. 3, a popular petroleum-based food and drug coloring, due to studies showing that it caused cancer in male rats, which rendered it unsafe under the Delaney Clause. The ban required food and ingested drug manufacturers to remove Red No. 3 from their products by January 15, 2027, or January 18, 2028, respectively. We discussed the FDA’s ban on Red No. 3 here.
In April, the U.S. Department of Health and Human Services (HHS) and the FDA announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. The plan included a request that food companies remove Red No. 3 sooner than the 2027deadline previously required. Our discussion of this plan is available here.
Now, the FDA “encourages food manufacturers to, as soon as is practicably possible, reformulate to stop using FD&C Red No. 3 in foods, including dietary supplements, with the goal of completing phase out before the January 15, 2027, deadline.”
The FDA also announced its approval of the use of another color additive – gardenia (genipin) blue – in food. This marks the fourth color derived from natural sources approved by the FDA for use in foods over the last two months. The others include: galdieria extract blue, calcium phosphate, and butterfly pea flower extract.
Key Takeaways
- The FDA encourages food manufacturers to phase out Red No. 3 ahead of the January 15, 2027 deadline and as soon as is practicably possible.
- To facilitate this phase-out, the FDA approved a fourth natural color additive: gardenia (genipin) blue.
We are continuing to monitor updates and developments in this area. If you have questions related to the FDA’s ban on petroleum-based food dyes, please contact the authors, Orla Thompson and Kayla Rubin.
