FDA weighs oversight changes after formula, Juul issues

WASHINGTON (AP) — The head of the Food and Drug Administration has called for a review of the agency’s food and tobacco programs after months of criticism over their approach to baby food shortages and e-cigarette reviews.

Tuesday’s announcement comes as FDA Commissioner Robert Califf tries to break through several controversies that have dominated his second stint in running the agency, including the delayed response to contamination issues at the nation’s largest infant formula plant.

“Fundamental questions about its structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s Tobacco Center, which regulates traditional cigarettes and vaping products, faces challenges in navigating policy and enforcement issues from “an increasing number of new products that could potentially have significant public health implications,” he said.

Califf said the Reagan-Udall Foundation — a nongovernmental research group created by Congress to support the work of the FDA — would convene experts to provide assessments within 60 business days of both food and tobacco operations. The experts are expected to consult with FDA staff, along with outside groups to gather a wide range of opinions. Califf and his team have already begun meeting with outside stakeholders, the FDA noted.

The review announcement comes a day before Califf is due to testify before the Senate Agriculture Committee on the FDA’s oversight of food safety.

More than two dozen consumer groups have called on Califf to appoint one official to oversee all of the FDA’s food operations, which are spread across multiple centers responsible for nutritional standards, plant inspections and animal nutrition. But Califf told The Associated Press in an interview that he believes more fundamental changes are needed.

“I don’t think structure alone is really the solution, or leadership alone is the solution,” Califf said. “There’s a constant concern out there that we really need to fix the foundations, including all of these elements.”

Califf said he agreed with criticism that the food program is underfunded compared to the FDA drug program, which receives more than $1 billion in user fees to the industry annually. The agency recently sought more food funding and authority to monitor supply chains to prevent future shortages.

Parents and politicians have also expressed frustration at the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the leading US vaping company. A federal court quickly blocked the agency’s order. FDA then returned further in court, saying it needed more time to review Juul’s application because of the “unique scientific issues”.

The FDA has also struggled to review millions of other applications from vape companies, missing multiple regulatory deadlines in the past two years.

Califf again cited funding issues, pointing out that the FDA cannot collect user fees from vaping companies that submit their products. The agency has asked Congress for that authority.

“I don’t think anyone expected there would be 6.7 million uses for vaping products coming in during a pandemic that put pressure on the entire agency,” Califf said.

Last week, the FDA announced it would miss a new deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to circumvent the regulations.

sen. Dick Durbin, an Illinois Democrat, suggested Califf should step down if the agency can’t remove such products quickly.

President Joe Biden Tapped Califf for the job at the FDA largely because of his previous experience with the agency, which he briefly led during the Obama administration. Califf, a cardiologist and respected researcher, planned to spend his time at the FDA fighting medical misinformation and streamlining the agency’s data systems.

But those efforts have been overshadowed by newer controversies, including political outrage over the shortage of formulasthat forced the US to air millions of containers with formula from Europe. Recently, the FDA said it would help foreign manufacturers stay in the U.S. market for the long haul, in an effort to diversify formula offerings here.

Califf previously predicted that the formula shortage could last until July. He said on Tuesday that retail data shows inventories have improved with an increase in both US production and imports.

“What you’re going to see is a gradual climb out of the current situation as more and more formula becomes available,” Califf said.

Califf testified before Congress in May about missteps that delayed the agency’s response to contamination issues at the Michigan formula plant that caused the shortage. While many of the issues arose before Califf started work, he struggled to explain who was ultimately responsible for food safety within the FDA bureaucracy.

The FDA’s food program has a byzantine leadership structure with a director for food and a separate deputy commissioner for “food policy and response.” The deputy commissioner is more focused on safety but has no direct authority over food center staff or regional plant inspecting personnel.

“You have serious structural leadership problems,” Representative Rosa DeLauro told Califf during the hearing.

DeLauro, a Democrat in Connecticut, said Tuesday that the FDA’s evaluation must include input from non-FDA experts and advocacy groups to be credible.

“A report with recommendations to maintain the status quo is unacceptable,” she said in an emailed statement.

Responding to multiple crises is a standard part of leading the FDA, which regulates industries that account for an estimated one-fifth of all U.S. consumer spending.

Despite the recent controversies, some experts say Califf has done a good job given the increasing polarization around the issues and products overseen by the FDA.

“Running the FDA becomes as complicated as, perhaps more complicated than, running a cabinet-level executive department,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated in quite a politically charged environment and he has done it with remarkable skill.”


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.