FDA weighs oversight changes after formula, Juul concerns


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WASHINGTON (AP) — The FDA chief has asked for a review of food and tobacco management programs after months of criticism over their handling of infant formula shortages and reviews of e-cigarettes.

The announcement on Tuesday came as FDA Commissioner Robert Califf is trying to overcome several controversies that have dominated his second tenure at the agency, including a delay in responding to contamination concerns at the nation’s largest infant formula plant.

“Fundamental questions about structure, function, funding and leadership need to be addressed” in the agency’s food program, Kaliff said in a statement. The agency’s Tobacco Center, which regulates traditional cigarettes and vaping products, is facing policy and enforcement challenges due to “an increasing number of new products that have the potential to have serious public health implications,” he said.

Kaliffe said the Reagan-Udall Foundation, a nongovernmental research group created by Congress to support the work of the FDA, will convene experts to conduct an assessment within 60 business days of food and tobacco production. Experts are expected to consult with FDA staff as well as external groups to gather a wide range of opinions. Kaliff and his team have already begun meeting with outside stakeholders, the FDA said.

The announcement of the revision came a day before Kaliff was due to testify before the Senate Agriculture Committee about the FDA’s oversight of food safety.

More than two dozen consumer groups have called on California to appoint one official to oversee all FDA food operations, which are spread across multiple centers responsible for nutrition standards, plant testing and animal feed. But Kaliff said in an interview with The Associated Press that he believes more fundamental changes are needed.

“I don’t think structure itself is really the solution, or that leadership alone is the solution,” Kaliff said. “There is an ongoing concern that we need to really fix the fundamentals that include all of these elements.”

Kaliff said he agrees with criticism that the food program is underfunded compared to the FDA’s drug program, which receives more than $1 billion in user fees annually. The agency recently requested additional food funding and powers to help track supply chains to prevent future shortages.

Parents and politicians also expressed disappointment at how the agency handled the recent decision. ban all e-cigarettes from Juul, the leading e-cigarette company in the US. A federal court quickly blocked the agency’s order. Then the FDA backed down further in court, stating that he needed more time to review Juul’s application due to its “unique scientific challenges.”

The FDA has also struggled to process millions of other applications from vaping companies, resulting in numerous regulatory deadline violations over the past two years.

Kaliff again cited funding issues, pointing out that the FDA cannot charge users from vaping companies that submit their products. The agency has requested such powers from Congress.

“I don’t think anyone expected that there would be 6.7 million applications for vaping products during a pandemic that has put the entire agency under stress,” Kaliff said.

Last week, the Food and Drug Administration (FDA) announced that it would miss another 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 that used a legal loophole to circumvent regulation.

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

President Joe Biden contacted Kaliff to work for the FDA largely because of his previous experience with the agency, which he briefly headed during the Obama administration. A cardiologist and respected researcher, Kaliff planned to devote his time at the FDA to combat medical misinformation and optimize the agency’s data systems.

But these efforts have been marred by new controversies, including political outrage over the lack of formulas.which forced the US to airlift millions of containers of formula milk from Europe. Recently, the Food and Drug Administration (FDA) said it would help foreign manufacturers stay in the US market for the long haul as it seeks to diversify its formula supplies here.

Kaliff had previously predicted that the lack of mixtures could last until July. On Tuesday, he said retail sales data show shipments have improved on the back of higher U.S. production and imports.

“What you will see is a gradual exit from the current situation as more and more formulas become available,” Kaliff said.

In May, Kaliff testified before Congress. about the mistakes that slowed the agency’s response to pollution problems at a Michigan compounding plant causing shortages. While many issues arose before Califf got to work, he struggled to explain who was ultimately responsible for food safety within the FDA bureaucracy.

The FDA’s food program has an intricate leadership structure that has a director of food and a separate deputy commissioner for “food policy and response.” The Deputy Commissioner is more concerned with security matters, but has no direct authority over either food center staff or regional staff who inspect factories.

“You have serious problems with structural leadership,” Rep. Rosa DeLauro told Califf 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 credible.

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

Response to multiple crises is a standard part of the FDA’s guidance, which regulates industries that are estimated to account for one-fifth of all consumer spending in the US.

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

“The leadership of the FDA is becoming as complex, if not more so, than the leadership of the executive department at the cabinet level,” said Daniel Carpenter, professor of public administration at Harvard University. “I think Kaliff handled a rather difficult political situation and he did it with remarkable skill.”


Follow Matthew Perrone on Twitter: @AP_FDAwriter


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

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