WASHINGTON (AP) 鈥� In one of his first major announcements as health secretary, called a news conference to unveil a plan to 鈥減hase out鈥� .
Food and Drug Administration Commissioner opened the event by saying his agency was 鈥渞emoving all petroleum-based food dyes” from U.S. foods. But the specifics did not become clear until the final minutes, when Kennedy revealed that the government had 鈥渁n understanding鈥� with foodmakers to voluntarily A 鈥渘ational standard and timeline鈥� for completing the process would soon follow, according to an
More than a year later, the FDA has not introduced any of the detailed, scientific regulatory documents needed to establish a safety issue with the half-dozen widely used dyes. Instead, the FDA maintains an online list of manufacturers that have pledged to
The administration鈥檚 handling of food dyes reflects its approach to a number of health priorities. Instead of using the time-consuming process of federal rulemaking, which can stretch across multiple administrations, officials working under Republican have found a quicker approach: Announce sweeping changes first and deal with the regulations later.
鈥淚t speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,鈥� said Susan Mayne, a Yale University public health expert and former director of the FDA鈥檚 food program. Meanwhile, the FDA’s website continues to carry the government’s that 鈥渢he totality of scientific evidence鈥� does not show a link between synthetic dyes and health problems.
鈥淚f FDA has changed its position, then FDA should document why and pursue a ban,鈥� Mayne said.
A spokesperson for Kennedy said the administration has used 鈥渕ultiple approaches鈥� to quickly make more progress on food dyes 鈥渢han at any point in the past.鈥�
鈥淔DA engaged industry early in this effort to encourage timely changes while continuing its scientific and regulatory work,鈥� said Emily Hilliard of the U.S. Department of Health and Human Services. 鈥淭he agency maintains its role in evaluating safety and will continue to use its regulatory authorities, guidance, and review processes as appropriate.鈥�
The lack of initiative in drafting new regulations is particularly striking at the FDA. Under federal law, the agency is supposed to refrain from making major policy announcements in news releases, speeches or other informal settings.
But a string of changes from Makary and his deputies have appeared first in articles in subscription-only articles, television interviews or online posts, including new restrictions on and other therapies.
Traditionally, those changes would be published first in the Federal Register, giving consumers, experts, and companies a chance to comment and suggest revisions to FDA proposals.
FDA has faced little pushback from industry
Almost as surprising as the agency鈥檚 shift away from rulemaking is the fact that the powerful companies FDA regulates have put up little resistance.
The FDA has faced hundreds of lawsuits over the decades 鈥� from drugmakers, pharmacies, tobacco companies and others 鈥� that accused the agency of failing to follow the legally required steps for new regulations and guidelines.
But drugmakers and other multibillion-dollar companies are sitting on the sidelines, at least for now.
Industry observers point to the administration’s unusual willingness to pressure drugmakers, including on sought by Trump.
鈥淒oes the government have the ability to basically bully companies?鈥� asked Dan Troy, the FDA鈥檚 former chief counsel. 鈥淵es, and I think we鈥檙e seeing that.鈥�
One of the biggest FDA changes came last May, when Makary and then-vaccine chief Dr. Vinay Prasad announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under age 65 and children without underlying health problems. To win approval for that group, vaccine manufacturers would need to conduct large studies that many experts say may not be feasible in today’s post-pandemic environment.
As with other vaccine decisions, Makary and Prasad bypassed the agency鈥檚 outside experts, who had traditionally been consulted on major decisions involving the shots. Makary says are often biased and take too much time and money to convene.
鈥淲e had all of this experience looking at the safety of how these vaccines work, and then these two cowboys come and say: 鈥榃e鈥檙e going to make this policy鈥�,鈥� said Dr. Kathryn Edwards, who previously led the FDA鈥檚 vaccine panel.
Edwards and other experts say the lack of pushback from vaccine manufacturers may reflect the tremendous power the FDA holds over them.
鈥淯ltimately, you need the FDA to license your product,鈥� said Edwards, a retired vaccine scientist at Vanderbilt University. 鈥淚f you鈥檙e going to try and buck the FDA — especially in this environment 鈥� the likelihood of your product getting a positive review is going to be pretty low.鈥�
Earlier this year, the FDA briefly refused to consider from Moderna. The agency after pushback from the company and the White House.
Recent FDA changes may have little staying power
There may be other reasons why normally litigious companies are not challenging the agency.
Some FDA initiatives have the potential to benefit companies, including a program that awards to drugs the Trump administration.
Even seemingly burdensome changes may have little staying power because the agency is not going through the process to enshrine them in federal rules or guidelines. That includes stringent new standards to win approval for that were previously approved for various forms of cancer, based on early results.
鈥淎nything that this administration does that they don鈥檛 embody in law can easily be undone by a future administration,鈥� Troy said.
Still, with more than two years remaining under Trump, there are signs at least some companies may be willing to raise objections.
The FDA last year began releasing rejection letters for drugs it declined to approve. Previously, that information was considered confidential and the property of drugmakers.
Last month, an unnamed drugmaker filed a formal petition challenging the practice, noting the FDA had provided 鈥渙nly a two-sentence explanation addressing its purported legal authority鈥� to release the letters.
The petition does not carry the force of a lawsuit, but it invokes the same language as numerous legal challenges to the agency, calling the FDA鈥檚 action 鈥渁rbitrary and capricious.鈥�
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