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WASHINGTON (AP) — 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. Food and Drug Administration Commissioner Marty Makary opened the event by saying his agency was “removing all petroleum-based food dyes” from U.S. foods. However, the specifics became clear only at the end when Kennedy revealed that the government had “an understanding” with foodmakers to voluntarily stop using the chemicals, with a “national standard and timeline” to follow, according to an FDA statement.
More than a year later, the FDA has not introduced any detailed regulatory documents necessary 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 phase out the chemicals.The administration’s handling of food dyes reflects its approach to various health priorities. Rather than employing the lengthy process of federal rulemaking, which can span multiple administrations, officials under Republican President Donald Trump have opted for a quicker strategy: announce sweeping changes first and address the regulations later.
“It speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,” said Susan Mayne, a Yale University public health expert and former director of the FDA’s food program. The FDA's website continues to state that “the totality of scientific evidence” does not indicate a link between synthetic dyes and health issues.
“If FDA has changed its position, then FDA should document why and pursue a ban,” Mayne added.
A spokesperson for Kennedy noted that the administration has utilized “multiple approaches” to make progress on food dyes “more than at any point in the past.”
“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 lack of initiative in drafting new regulations is particularly notable at the FDA. Under federal law, the agency is supposed to refrain from making significant policy announcements in informal settings such as news releases and speeches.
However, numerous changes from Makary and his deputies have been announced first in subscription-only medical journals, television interviews, or online posts, including new restrictions on COVID-19 vaccines and other therapies.
Traditionally, such changes would be published first in the Federal Register, allowing consumers, experts, and companies to comment and suggest revisions to FDA proposals.
Almost as surprising as the agency’s shift away from rulemaking is the minimal resistance from the powerful companies the FDA regulates.
The FDA has faced hundreds of lawsuits over the decades from drugmakers, pharmacies, tobacco companies, and others, accusing the agency of failing to follow legally required steps for new regulations and guidelines.
Yet, drugmakers and other multibillion-dollar companies have remained largely passive, at least for now.
Industry observers attribute this to the administration's unusual willingness to exert pressure on drugmakers, including on drug pricing concessions sought by Trump.
“Does the government have the ability to basically bully companies?” asked Dan Troy, the FDA’s former chief counsel. “Yes, and I think we’re seeing that.”
One significant change came last May when Makary and then-vaccine chief Dr. Vinay Prasad published a medical journal article announcing that the FDA would no longer routinely approve COVID-19 shots for healthy adults under age 65 and children without underlying health conditions. Vaccine manufacturers would need to conduct large studies to gain approval for that demographic, a requirement that many experts deem unfeasible in today’s post-pandemic landscape.
As with other vaccine decisions, Makary and Prasad bypassed the agency’s external experts, who have traditionally been consulted on major decisions regarding the shots. Makary argues that FDA advisory panels are often biased and require too much time and resources 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, who previously led the FDA’s vaccine panel.
Edwards and other experts suggest that the lack of pushback from vaccine manufacturers may stem from the substantial power the FDA wields over them.
“Ultimately, you need the FDA to license your product,” Edwards, a retired vaccine scientist at Vanderbilt University, noted. “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.”
Earlier this year, the FDA briefly refused to consider a new mRNA flu shot from Moderna, only to reverse its decision following pushback from the company and the White House.
There may be additional reasons why typically litigious companies are not challenging the agency.
Some FDA initiatives could benefit companies, including a program that provides expedited reviews for drugs favored by the Trump administration.
Even seemingly burdensome changes may lack longevity because the agency is not following the process to codify them in federal rules or guidelines. This includes stringent new standards for CAR-T therapies that had previously received approval for various cancers based on early results.
“Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy explained.
Nonetheless, with more than two years remaining under Trump, signs indicate that some companies may soon voice objections.
The FDA began releasing rejection letters for drugs it declined to approve last year. Previously, that information was kept confidential and considered the property of drugmakers.
Last month, an unnamed drugmaker filed a formal petition contesting this practice, noting that the FDA had provided “only a two-sentence explanation addressing its purported legal authority” to release the letters.
The petition does not hold the weight of a lawsuit but invokes similar language as multiple legal challenges against the agency, labeling the FDA’s action as “arbitrary and capricious.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
