FDA weighs regulatory changes after formula, Juul issues

FDA weighs regulatory changes after formula, Juul issues
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WASHINGTON (AP) — The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs after months of criticism for how they have handled the shortage of baby food and e-cigarette reviews.

Tuesday’s announcement comes as FDA Commissioner Robert Califf is trying to navigate several controversies that have dominated his second term as the agency’s head, including the delayed response to contamination issues at the country’s largest infant formula plant.

“Fundamental issues of structure, function, funding and governance 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 vapor products, faces challenges in managing policy and enforcement issues from “an increasing number of novel products that could have potentially significant public health consequences,” he said.

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

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

More than two dozen consumer groups have urged Califf to appoint an official to oversee all FDA food operations, which are spread across multiple 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 that structure alone is really the solution, or that leadership alone is the solution,” Califf said. “There’s a constant concern out there that we really need to fix the fundamentals that hold all of these elements.”

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

Parents and politicians have also expressed frustration with the agency’s handling of a recent decision Ban all Juul e-cigarettes, the leading US vaping company. A federal court quickly blocked the agency’s order. FDA then traced back continued 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, resulting in several missed regulatory deadlines over the past two years.

Califf again cited funding issues, noting 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 anticipated that 6.7 million applications for vaping products would be received during a pandemic that is weighing on the entire agency,” Califf said.

Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes they are using Synthetic Nicotine. FDA officials specifically asked Congress to give the agency authority over these products, which had used a loophole to circumvent regulation.

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

President Joe Biden tapped Califf for the FDA job primarily because of his previous experience at the agency, which he briefly headed during the Obama administration. As a cardiologist and respected researcher, Califf planned to focus his time at the FDA on combating medical misinformation and streamlining the agency’s data systems.

But those efforts have been eclipsed by more recent controversies, including political outrage over the deficiency formulawhat forced the US to do it airlift million containers of baby food from Europe. Recently, the FDA said it would help foreign manufacturers stay in the US market long-term to diversify formula offerings here.

Califf previously predicted the formula shortage could last through July. He said on Tuesday retail sales data show supply has improved as both US production and imports rose.

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

In May, California testified before Congress about missteps that slowed the agency’s response to contamination issues at the Michigan formula plant that triggered the shortage. While many of the issues arose before Califf began his job, he struggled to explain who in the FDA bureaucracy was ultimately responsible for food safety.

The FDA’s food program has a Byzantine governance structure in which there is a Director of 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 staff who inspect facilities.

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

DeLauro, a Connecticut Democrat, said Tuesday the FDA’s assessment must include input from non-FDA experts and stakeholders to be credible.

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

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

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

“Governing the FDA becomes as complicated, perhaps more complicated, than running a cabinet-level executive department,” said Daniel Carpenter, professor of government science at Harvard University. “I think Califf has navigated a fairly strained political environment, and he’s 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 Institute’s Department of Science Education. The AP is solely responsible for all content.

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