FDA Announces Steps to Phase Out Synthetic Color Additives

On April 22, 2025, the U.S. Food and Drug Administration (FDA) announced a series of actions aimed at phasing out all “petroleum-based synthetic dyes” from the nation’s food supply. Notably, the actions regarding most of the color additives at issue will be voluntary, though strongly encouraged by FDA and the U.S. Department of Health and Human Services (HHS). The announcement was delivered at a press conference by FDA Commissioner Marty Makary. HHS Secretary Robert F. Kennedy Jr., NIH Director Jay Bhattacharya, West Virginia Governor Patrick Morrisey, and other Make America Healthy Again (MAHA) advocates spoke at the event.

Under these measures, FDA will: 

1. Establish a National Standard and Timeline: Encourage the food industry to transition from “petrochemical-based dyes.” Secretary Kennedy clarified in a Q&A at the press conference that there is no formal agreement for industry to phase out these color additives, but companies are encouraged to participate voluntarily.
2. Revoke Authorization of Specific Color Additives: Initiate a process to revoke the authorizations of Citrus Red No. 2 and Orange B within the coming months, which we understand are generally no longer used in the U.S. food supply.
3. Eliminate Remaining Synthetic Color Additives: Work with industry to eliminate six synthetic color additives—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—by the end of 2026. 
4. Authorize New Natural Color Additives: Authorize four new “natural” color additives in the next few weeks and expedite the approval of other “natural” color additives. More specifically, FDA will fast-track its review of pending color additive petitions for new or additional uses of calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract. FDA has not yet provided details regarding its fast-track review process more generally, including its application to other “natural” color additives.
5. Conduct Research with NIH: Partner with NIH to conduct research on the impact of food additives on children’s health and development. At the press conference, Secretary Kennedy discussed this initiative and NIH Director Bhattacharya explained NIH will empower scientists to ask the questions that are often considered “taboo.”
6. Accelerate Removal of FD&C Red No. 3: Request that industry remove FD&C Red No. 3 sooner than the respective January 15, 2027 or January 18, 2028 deadlines for food and ingested drugs under FDA’s order to revoke FD&C Red No. 3 authorization.  

FDA also noted that it will be taking additional steps to issue guidance and provide regulatory flexibilities regarding this topic. 

While Secretary Kennedy said that the threat of a patchwork of state bills regarding color additives brought food companies to the table to support a voluntary phase-out of synthetic color additives, FDA’s actions do not amount to federal preemption of such bills. Kennedy also encouraged the MAHA advocates in the room to redouble efforts to keep the pressure on at the state level, declaring, “We’re going to get rid of the dyes. Then one by one we’re going to get rid of every ingredient and additive in [] food that we can legally address.” 

The FDA/HHS joint press release quotes Secretary Kennedy as stating: “For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent…These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end.” 

Commissioner Makary acknowledged in the press conference that no one ingredient accounts for the chronic disease epidemic, and that these actions do not constitute a “silver bullet,” but rather “one important step.”