In a notable shift from traditional regulatory practices, the U.S. Food and Drug Administration under the Trump administration has increasingly relied on media announcements rather than formal rulemaking to enact health policy changes. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary have repeatedly unveiled sweeping initiatives through news conferences, op-eds, and television interviews, leaving the detailed regulatory work for later—or, in some cases, undone.
Food Dye Phase-Out: A Case Study
One of the first major announcements under Kennedy was a plan to “phase out” synthetic food dyes. At a news conference, Makary declared that the FDA was “removing all petroleum-based food dyes” from U.S. foods. However, specifics emerged only later, when Kennedy revealed that the government had reached an “understanding” with food manufacturers to voluntarily stop using these chemicals, with a “national standard and timeline” to follow. More than a year later, the FDA has not produced the scientific regulatory documents needed to establish a safety issue with the six widely used dyes. Instead, it maintains an online list of companies that have pledged to phase them out.
Susan Mayne, a Yale public health expert and former FDA food program director, noted that the administration has yet to articulate the scientific basis for its voluntary request. Meanwhile, the FDA’s website still states that “the totality of scientific evidence” does not link synthetic dyes to health problems. “If FDA has changed its position, then FDA should document why and pursue a ban,” Mayne said.
An HHS spokesperson defended the approach, stating that the administration has used “multiple approaches” to make progress on food dyes, engaging industry early while continuing scientific and regulatory work.
Bypassing Traditional Processes
Under federal law, the FDA is supposed to avoid making major policy announcements in informal settings. Yet, changes have appeared first in medical journal op-eds, TV interviews, or online posts, including new restrictions on COVID-19 vaccines. Traditionally, such changes would be published in the Federal Register for public comment.
Dan Troy, former FDA chief counsel, observed that the agency has faced little resistance from industry, despite its history of lawsuits over regulatory procedures. “Does the government have the ability to basically bully companies? Yes, and I think we’re seeing that,” he said.
Vaccine Policy Shifts
Last May, Makary and then-FDA vaccine chief Dr. Vinay Prasad published a journal article announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under 65 and children without underlying conditions. They bypassed the agency’s outside experts, with Makary arguing that advisory panels are biased and time-consuming. Dr. Kathryn Edwards, former FDA vaccine panel chair, criticized the move, saying, “We had all of this experience, and then these two cowboys come and say: ‘We’re going to make this policy.’” She noted that vaccine manufacturers may not push back due to the FDA’s power over product licensing.
Legal and Practical Concerns
Some FDA initiatives, such as ultrafast reviews for favored drugs, may benefit companies. However, the lack of formal rulemaking means changes can be easily reversed by a future administration. Troy remarked, “Anything that this administration does that they don’t embody in law can easily be undone.”
Signs of industry pushback are emerging. The FDA began releasing rejection letters for drugs it declined to approve, previously considered confidential. An unnamed drugmaker filed a petition challenging the practice, calling it “arbitrary and capricious.” While not a lawsuit, it echoes past legal challenges. The outcome remains uncertain, but the administration’s approach continues to reshape FDA policy through media rather than rulemaking.
