FDA’s New Approach: Big Announcements on Food Dyes and Vaccines, but Few Official Rules

The U.S. Food and Drug Administration (FDA) is making headlines with bold promises to remove artificial food dyes from the nation’s food supply and to change how COVID-19 vaccines are approved. But critics say the agency is skipping the usual steps required by law to make those changes official.

When Robert F. Kennedy Jr., the current health secretary, held a news conference to announce a plan to “phase out” synthetic food dyes, the event was full of fanfare. FDA Commissioner Dr. Marty Makary opened the briefing by saying his agency was “removing all petroleum-based food dyes” from American foods. But the details only emerged in the final moments, when Kennedy revealed that the government had reached a voluntary agreement with foodmakers to stop using the chemicals. An FDA statement promised a “national standard and timeline” would follow soon.

That was more than a year ago. Since then, the FDA has not published any of the detailed scientific documents needed to prove that the half-dozen widely used synthetic dyes pose a health risk. Instead, the agency maintains an online list of manufacturers that have pledged to phase out the dyes on their own.

This pattern — announce first, figure out the rules later — is not limited to food dyes. It reflects how the Trump administration is handling many health priorities. Rather than going through the slow, legally required process of federal rulemaking, which can take years and stretch across multiple presidencies, officials are using quicker methods: news conferences, op-eds, television interviews, and online posts.

What Experts Say About Skipping the Rulemaking Process

“It speaks volumes that the administration has yet to produce a document articulating the scientific basis for the voluntary request,” said Dr. Susan Mayne, a public health expert at Yale University and former director of the FDA’s food program. She pointed out that the FDA’s own website still states that “the totality of scientific evidence” does not show a link between synthetic dyes and health problems. “If FDA has changed its position, then FDA should document why and pursue a ban,” Mayne added.

Under federal law, the FDA is supposed to avoid making major policy announcements in news releases, speeches, or other informal settings. Traditionally, significant changes are first published in the Federal Register, a government journal that allows consumers, experts, and companies to read the proposal and submit comments or suggested revisions. This process ensures transparency and gives stakeholders a voice.

But the current administration has bypassed that step repeatedly. For example, new restrictions on COVID-19 vaccines and other therapies were announced in medical journal op-eds and TV interviews before any formal rulemaking took place.

How This Affects You: What It Means for Your Food and Your Health

For everyday readers, these changes may feel confusing or concerning. When the FDA announces it is removing food dyes, many people assume that means a legal ban is in place. But without formal rulemaking, the “ban” is really a request — and companies can choose whether to follow it.

This matters because food dyes are found in thousands of products, from breakfast cereals and candies to salad dressings and medicines. Some studies have linked synthetic dyes to behavioral issues in children, including hyperactivity. However, the FDA has long maintained that the current evidence does not prove a direct cause-and-effect relationship. If the agency has changed its scientific opinion, experts say it must explain why.

Similarly, changes to vaccine approval policies can affect whether healthy adults under age 65 and children can get COVID-19 shots. Last May, Makary and Dr. Vinay Prasad, then the FDA’s vaccine chief, published a medical journal article announcing that the agency would no longer routinely approve COVID-19 vaccines for healthy adults under 65 and children without underlying health conditions. To win approval for that group, vaccine makers would need to conduct large, expensive studies — which many experts say may not be possible in today’s post-pandemic world.

Why Companies Aren’t Fighting Back (Yet)

One surprising aspect of this new approach is that the powerful companies regulated by the FDA have not mounted a strong legal challenge. Over the decades, the FDA has faced hundreds of lawsuits from drugmakers, pharmacies, tobacco companies, and others accusing the agency of failing to follow the legally required steps for new regulations.

So why the silence now?

“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.”

Experts say the FDA holds enormous power over the companies it regulates. “Ultimately, you need the FDA to license your product,” said Dr. Kathryn Edwards, a retired vaccine scientist at Vanderbilt University who previously led the FDA’s vaccine advisory panel. “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.”

Edwards and other experts also note that the FDA bypassed its own outside advisory panels when making recent vaccine decisions. Those panels, made up of independent scientists and public health experts, were traditionally consulted on major vaccine policy changes. Makary has said the panels are often biased and take too much time and money 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,’” Edwards said.

However, there have been moments of pushback. Earlier this year, the FDA briefly refused to consider a new mRNA flu shot from Moderna. The agency reversed its decision after the company and the White House pushed back.

Could These Changes Be Reversed?

Some experts point out that because the administration is not using formal rulemaking, many of these changes could be easily undone by a future president.

“Anything that this administration does that they don’t embody in law can easily be undone by a future administration,” Troy said.

That includes new, stricter standards for approving CAR-T therapies — a type of cancer treatment that uses a patient’s own immune cells — which were previously approved based on early results. Without formal rules, those standards could vanish with a change in leadership.

Still, there are signs that some companies may be willing to object. Last year, the FDA began releasing rejection letters for drugs it declined to approve. Previously, those letters were considered confidential company property. Last month, an unnamed drugmaker filed a formal petition challenging the practice, noting that the FDA provided “only a two-sentence explanation addressing its purported legal authority” to release the letters. While the petition is not a lawsuit, it uses the same language as past legal challenges, calling the FDA’s action “arbitrary and capricious.”

Practical Takeaways for Readers

– Food dyes are not legally banned. The FDA has only asked manufacturers to voluntarily phase them out. Check ingredient labels if you want to avoid synthetic dyes like Red 40, Yellow 5, and Blue 1.

• Vaccine policies may change again. If you are a healthy adult under 65 or a parent of a child without underlying health conditions, future COVID-19 shot approvals may be affected. Stay informed through trusted health sources.
• The FDA’s scientific position on dyes has not changed. The agency still states that current evidence does not prove synthetic dyes cause health problems. If that changes, experts say the FDA must provide clear scientific documentation.
• These policies may not last. Because many changes are not enshrined in federal rules, a future administration could reverse them quickly.
• You can still submit comments. Even though the FDA is skipping formal rulemaking for some changes, the traditional process still exists for other regulations. If you have concerns about a proposed rule, you can submit a public comment on Regulations.gov.

The Bottom Line

The FDA’s new playbook — big announcements, voluntary agreements, and informal policy changes — is faster than traditional rulemaking, but it raises serious questions about transparency, scientific integrity, and legal authority. For now, consumers should pay close attention to what is actually being enforced versus what is simply being announced. And experts warn that without formal regulations, the health policies that affect your food, your medicine, and your family’s well-being could shift as quickly as the headlines.

Source: MedPage Today