FDA announces plan to phase out synthetic dyes, but rulemaking has stalled

In one of his first major announcements as health secretary, Robert F. Kennedy Jr. called a news conference to unveil a plan to “phase out” synthetic food dyes, drawing attention to how the FDA is moving away from formal rulemaking for some public health changes. FDA Commissioner Marty Makary opened by describing the agency’s intent, saying it was “removing all petroleum-based food dyes” from U.S. foods, but the plan’s details came into focus later at the event. Kennedy said the government had “an understanding” with foodmakers to voluntarily stop using the chemicals, and an FDA statement indicated a “national standard and timeline” would follow.

More than a year after the conference, Susan Mayne — a Yale University public health expert who previously directed the FDA’s food program — said the agency had not produced the detailed, scientific regulatory documents needed to establish a safety issue with the widely used dyes at the center of the effort. She contrasted the absence of formal regulatory output with the continued presence of the FDA’s longtime position online that “the totality of scientific evidence” does not show a link between synthetic dyes and health problems. If, as Mayne put it, “FDA has changed its position,” she argued, “then FDA should document why and pursue a ban.”

FDA’s current approach, as described in the reporting, has emphasized a public online list of manufacturers who have pledged to phase out the chemicals rather than issuing the kinds of documents associated with new regulations. A spokesperson for Kennedy said the administration has used “multiple approaches” to make progress on food dyes “than at any point in the past.” Emily Hilliard, of the U.S. Department of Health and Human Services, said the agency “engaged industry early in this effort to encourage timely changes” while continuing “its scientific and regulatory work,” and she said FDA would use its regulatory authorities, guidance and review processes as appropriate.

The reporting also tied the dyes effort to a broader pattern in which some FDA policy shifts appear first outside traditional rulemaking channels. The story said changes from Makary and his deputies have appeared first in subscription-only medical journal articles, television interviews and online posts, including moves affecting COVID-19 vaccines and other therapies. It noted that, traditionally, major changes would be published in the Federal Register, allowing consumers, experts and companies a chance to comment.

The story said industry pushback has been limited so far, even as FDA historically faced hundreds of lawsuits over alleged failures to follow legally required steps for new regulations and guidelines. Industry observers pointed to what they described as the administration’s willingness to pressure drugmakers, including on drug pricing concessions sought by Donald Trump. Dan Troy, a former FDA chief counsel, said the government appears to have the ability to pressure companies and that “we’re seeing that,” arguing that the FDA’s leverage can shape how regulated companies respond to policy shifts.

The FDA’s approach has included high-profile changes in vaccine decisions that, according to the reporting, bypassed outside experts traditionally consulted on major decisions. One example described Makary and vaccine chief Dr. Vinay Prasad, who published a medical journal article last May announcing the FDA would no longer routinely approve COVID-19 shots for healthy adults under 65 and children without underlying health problems. The reporting said the decision would require manufacturers to conduct large studies that many experts say may not be feasible, and it reported criticism that the shift happened without advisory panel input. Dr. Kathryn Edwards, who previously led the FDA’s vaccine panel, said “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.’”

Edwards and other experts cited in the reporting also suggested that vaccine manufacturers may hesitate to challenge the FDA because companies need the agency’s approval to market products. The story said Edwards, a retired vaccine scientist at Vanderbilt University, told the outlet: “Ultimately, you need the FDA to license your product,” adding that if companies try to buck the agency “the likelihood of your product getting a positive review is going to be pretty low.”

The reporting further suggested that some recent FDA changes may be easier to reverse because they have not gone through the process of formalizing them in federal rules or guidelines. Troy said “Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” according to the story. It also pointed to signs that at least some companies may raise objections as the FDA continues to adjust practices, including a petition filed earlier this year by an unnamed drugmaker challenging the FDA’s release of rejection letters for declined drugs and noting the agency provided a brief explanation of its legal authority.

That petition, the story said, does not carry the force of a lawsuit, but it invokes language used in legal challenges to the agency, including claims that FDA action was “arbitrary and capricious.” Taken together, the dyes announcement and the broader regulatory pattern described in the reporting frame a central question about how FDA policy shifts translate into enforceable rules—and what that means for the evidence and input that typically accompany major changes affecting consumer health.