More than a year after Health Secretary Robert F. Kennedy Jr. held a nationally covered press conference to announce a plan to phase out petroleum-based synthetic food dyes from the U.S. food supply, the Food and Drug Administration has yet to produce the core scientific and regulatory documents that would make such a phase-out legally binding and durable, the Associated Press reported Wednesday. Instead of going through the formal federal rulemaking process — the legally mandated mechanism for major policy changes — FDA leaders have relied on a strategy of sweeping public announcements, voluntary industry pledges, and non-traditional publication venues, a review of the agency’s recent actions shows.
The food-dyes episode, which began in March 2025, has become emblematic of the FDA’s new operational posture. At the time, FDA Commissioner Marty Makary opened the Kennedy press conference by declaring the agency was “removing all petroleum-based food dyes” from American foods. Only in the final minutes of the event did Kennedy clarify that the government had “an understanding” with food manufacturers to voluntarily abandon the chemicals. The FDA later posted an online list of companies that had made the pledge. But the agency’s website still carries its long-standing scientific conclusion that “the totality of scientific evidence” does not establish a link between synthetic dyes and health problems. “If FDA has changed its position, then FDA should document why and pursue a ban,” said Susan Mayne, a Yale University public health expert and a former director of the FDA’s food program.
A spokesperson for Kennedy defended the approach. “FDA engaged industry early in this effort to encourage timely changes while continuing its scientific and regulatory work,” said Emily Hilliard of the U.S. Department of Health and Human Services. “The agency maintains its role in evaluating safety and will continue to use its regulatory authorities, guidance, and review processes as appropriate.”
The announcement-first strategy has extended beyond food dyes. Last May, Makary and then-vaccine chief Dr. Vinay Prasad published an article in a subscription-only medical journal announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under 65 and children without underlying health conditions. Vaccine manufacturers seeking approval for those groups would need to conduct large-scale studies that many experts regard as infeasible in the current post-pandemic environment. Makary and Prasad bypassed the FDA’s outside vaccine advisory panel, which had traditionally been consulted on major immunization decisions. Makary has said the panels are often biased and require too much time and cost to convene.
“We had all of this experience looking at the safety of how these vaccines work, and then these two cowboys come and say: ‘We’re going to make this policy,’” said Dr. Kathryn Edwards, a retired vaccine scientist at Vanderbilt University who previously led the FDA’s vaccine advisory committee.
Federal law requires the FDA to refrain from making major policy announcements in news releases, speeches, or other informal settings. Major changes are supposed to be published first in the Federal Register, giving consumers, experts, and companies an opportunity to comment and suggest revisions. The administration’s departure from that process has not yet produced the flood of industry litigation that might be expected. Former FDA chief counsel Dan Troy said the silence from drugmakers reflects a practical calculation about the administration’s willingness to use its power. “Does the government have the ability to basically bully companies? Yes, and I think we’re seeing that,” Troy said.
Edwards agreed. “Ultimately, you need the FDA to license your product,” she said. “If you’re going to try and buck the FDA — especially in this environment — the likelihood of your product getting a positive review is going to be pretty low.”
The power dynamic has been on display in other agency actions. Earlier this year, the FDA briefly refused to consider a new mRNA flu shot from Moderna, reversing course only after pushback from the company and from the White House. The agency has also begun publicly releasing rejection letters for drugs it declines to approve, information that was previously treated as confidential. Last month an unnamed drugmaker filed a formal petition challenging the practice, calling the FDA’s move “arbitrary and capricious” — the same language used in many successful legal challenges to the agency.
The lack of formal rulemaking may also limit the staying power of the administration’s health policies. “Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy said. With more than two years remaining in President Donald Trump’s term, however, the approach shows no signs of changing.