FDA pulls regulatory changes after formula, Juul problems

FDA pulls regulatory changes after formula, Juul problems
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WASHINGTON (AP) — The head of the Food and Drug Administration has called for an overhaul of the agency’s food and tobacco programs after months of criticism over infant formula shortages and reviews of e-cigarettes.

Tuesday’s announcement came as FDA Commissioner Robert Califf sought to shake off several controversies that have dominated his second stint leading the agency, including a delayed response to contamination problems at the nation’s largest baby formula plant.

Califf said in a statement that the agency’s food program “must answer fundamental questions about structure, function, funding and leadership.” The agency’s tobacco control center, which regulates traditional cigarettes and vaping products, said it faces challenges related to policy and enforcement issues with “a growing number of new products that have potentially significant public health consequences.”

The Reagan-Udall Foundation — a nongovernmental research group created by Congress to support the FDA’s work — will agree to deliver expert assessments within 60 business days of both food and tobacco transactions, Califf said. Experts are expected to consult with outside groups as well as FDA staff to gather broad input. The FDA noted that Califf and his team have already begun meeting with outside stakeholders.

The review announcement comes a day before Calif is scheduled to testify before the Senate agriculture committee about the FDA’s food safety oversight.

More than two dozen consumer groups urged Califf to appoint an official to oversee all FDA food operations, which are scattered across multiple centers responsible for nutrition standards, plant inspections and animal nutrition. But Califf said in an interview with The Associated Press that he believes more fundamental changes are needed.

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

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

Parents and politicians are also the agency’s a final decision Banning all e-cigarettes from Juul, the leading US vaping company. A federal court quickly blocked the agency’s order. After the FDA withdrew later in court, it said it needed more time to review Juul’s application because of “unique scientific issues.”

The FDA has struggled to review millions of other applications from vaping companies over the past two years, claiming many missed regulatory deadlines.

Califf again cited financial issues, pointing out that the FDA cannot collect user fees from vaping companies that introduce their products. The agency sought this authority from Congress.

“I don’t think anyone expected that 6.7 million vaping product applications would come in during a pandemic that strained the entire agency,” Califf said.

Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes in use. synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over these products, which take advantage of a legal loophole for regulation.

Sen. Dick Durbin, a Democrat from Illinois, suggested that Calif resign if the agency cannot quickly remove such products.

President Joe Biden He touched Caliph for the FDA job, largely because of his previous experience at the agency, which he led briefly during the Obama administration. Califf, a cardiologist and respected researcher, planned to focus his time at the FDA on combating medical misinformation and streamlining the agency’s information systems.

But these efforts have been overshadowed by new controversies, including political anger lack of formulaforced the United States air transport millions of containers of formula from Europe. The FDA recently said it would help foreign manufacturers stay in the U.S. market longer to diversify the supply chain here.

Califf previously predicted the formula shortage could last into July. He said Tuesday that retail sales data showed that supplies were improving, with both U.S. manufacturing and imports rising.

“What you’re going to see is a gradual departure from the status quo as more and more formulas become available,” Califf said.

In May, Califf He testified before Congress about missteps that slowed the agency’s response to contamination problems that led to shortages at a Michigan formula plant. Although many of the problems occurred before Califf took office, he struggled to explain who was responsible for food safety in the FDA bureaucracy.

FDA’s food program has a byzantine management structure, with a director for food and a separate deputy commissioner for “food policy and response.” The deputy commissioner focuses more on safety, but does not have direct authority over food center workers or regional workers who inspect plants.

“You have serious structural leadership problems,” Rep. Rosa DeLauro said Califfe during the hearing.

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

“A report containing recommendations to maintain the status quo is unacceptable,” he said.

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

Despite the recent controversy, some experts say Calif is doing well, given the growing polarization around the issues and products the FDA oversees.

“Leading the FDA is becoming as difficult, if not more complex, than leading a cabinet-level executive branch,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated a pretty politically charged environment, and he’s done it with remarkable skill.”


Follow Matthew Perrault on Twitter: @AP_FDAwriter


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

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