Last week, Marty Makary, the U.S. Food and Drug Administration (FDA) Commissioner, alongside Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., proclaimed the administration’s desire to phase out the use of eight synthetic food dyes by the end of 2026.
It is important to note that the announcement was a request for food manufacturers and fell short of an official ban. The press conference, held Tuesday, offered little detail on how this would be implemented, aside from noting the agency would first revoke authorization of two little-used colorants in the coming weeks: Citrus Red No. 2 and Orange B.
“What we can predict is they did say that they plan to revoke the status of Citrus Red No. 2 and [Orange B], which are two colorants people have kind of forgotten to exist,” said John Johnson, FDA-focused senior counsel at D.C.-based firm Shook, Hardy and Bacon. “We should see something like we did with Red No. 3, where the FDA should be putting something in the Federal Register and going through that process.”
The announcement also insinuated that the HHS had secured industry support on this initiative; however, given responses from industry groups like the Consumer Brands Association and the International Association of Color Manufacturers (IACM), that “agreement” Kennedy pointed to likely has a few remaining points of contention.
“Fundamental changes to the composition of the U.S. food supply require ample time and execution,” the IACM said in a statement. “The aggressive voluntary timeline posed by the FDA to phase out FD&C colors, which are safe, highly regulated food ingredients, would be highly disruptive, disregarding the need to transition supply chains, shore up agricultural resources, and transform manufacturing infrastructure.”
Johnson also emphasized that point and added some context to the administration’s initial focus on removing two colors. He explained that Citrus Red No. 2 has one single purpose – “to color the outside of oranges that are intended for consumption, not for processing” – and added that “it’s a colorant that’s not really been used in ages.”
“We know the administration’s desire. How they will seek to effectuate that is unknown,” Johnson said. “[This] may also be part of the larger regulatory [motivation], where the administration has expressed the desire to revoke 10 regulations for any new one added. Removing a colorant that’s not really used anymore may free up space for other desired goals, but that’s pure conjecture.”
As the IACM pointed out, Johnson also called the timeline to implement this change into question. Having worked with companies for over nearly 15 years, counseling through all areas of FDA compliance including recall notices and life-cycle assessments, Johnson stated that the end-of-2026 deadline is very fast. He said regulators need to be mindful of available supply, manufacturing lead times and necessary food safety testing to ensure substitutes maintain a product’s purpose and integrity.
“Members of industry would need to tell us about what supply is out there, lead times on manufacturing and formulations. One needs to think about is you can’t just simply switch colorants. You need to make sure that the other stuff is available and it can do what you need it to do.”