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FDA weighs regulatory changes by formula, Juul issues

WASHINGTON (AP) – The head of the Food and Drug Administration has requested a review of the agency’s food and tobacco programs after months of criticism over their handling of the lack of formula for babies and reviews of e-cigarettes.

Tuesday’s announcement comes as FDA Commissioner Robert Califf tries to push past several controversies that have dominated his second term in office, including the delayed response to pollution problems at the country’s largest breast milk substitute.

“Basic issues of structure, function, funding and management need to be addressed”[ads1]; 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 consequences for public health,” he said.

Califf said the Reagan-Udall Foundation – a non-governmental research group set up by Congress to support the FDA’s work – would convene experts to deliver evaluations within 60 business days of both food and tobacco operations. Experts are expected to consult with FDA staff along with external groups to gather a wide range of opinions. Califf and his team have already begun meeting with external stakeholders, the FDA noted.

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

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

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

Califf said he agreed with the criticism that the food program has been underfunded compared to the FDA’s drug program, which receives more than $ 1 billion annually in industrial user fees. The agency recently sought more food funding and authority to help track supply chains to avert future shortages.

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

The FDA has also struggled to review millions of other applications from vaping companies, which has led to more people missing regulatory deadlines in the past two years.

Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from arms companies that ship their products. The agency has asked Congress for this authority.

“I don’t think anyone foresaw that there would be 6.7 million vaping product applications coming in during a pandemic that stressed the entire agency,” Califf said.

Last week, the FDA announced that it would ignore 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 these products, which had used a legal loophole for skirt regulation.

Sen. Dick Durbin, an Illinois Democrat, suggested that Califf should resign if the agency could not quickly remove such products.

President Joe Biden intercepted Califf for the FDA job mainly because of his previous experience at the agency, which he briefly headed under the Obama administration. A cardiologist and respected researcher, Califf plans to focus his time at the FDA on combating medical malpractice and streamlining the agency’s computer systems.

But this effort has been overshadowed by recent controversies, including political outrage over the lack of formulawhich has forced the United States into the air millions of containers of formula from Europe. Recently, the FDA said it would help foreign manufacturers stay in the US market for the long term, in an effort to diversify its formula offering here.

Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data shows that supplies have improved with increases in both U.S. production and imports.

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

In May, Califf testified before Congress about missteps that slowed the agency’s response to pollution problems at the formula factory in Michigan that triggered the shortage. While many of the problems occurred before Califf took the job, he struggled to explain who was ultimately responsible for food safety in the FDA’s bureaucracy.

The FDA’s food program has a Byzantine leadership structure in which there is a director of food and a separate deputy director of “food policy and response.” The deputy manager has a more safety focus, but has no direct authority over food center employees or regional personnel who inspect facilities.

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

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

“A report that includes recommendations to preserve the status quo is unacceptable,” she said in an email.

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

Despite the recent controversy, some experts say Califf has done a good job, given the growing polarization around the issues and products that the FDA monitors.

“Leading the FDA is becoming as complicated as, perhaps more complicated than, leading an executive department at the cabinet level,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated a fairly politically charged environment, and he has done so with remarkable skill.”


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. AP is solely responsible for all content.

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