Amid Infant Formula Disaster, Juul Fiasco, FDA Seeks Outside Review

Robert Califf, Commissioner of the Food and Drug Administration, speaks during the Federal COVID Response Hearing on Capitol Hill on June 16, 2022 in Washington, DC.
Enlarge / Robert Califf, Commissioner of the Food and Drug Administration, speaks during the Federal COVID Response Hearing on Capitol Hill on June 16, 2022 in Washington, DC.

The Food and Drug Administration has commissioned an external review of its dietary and tobacco control programs following high-profile debacles, including sloppy oversight of e-cigarettes, including Juul products, and a severe nationwide shortage of infant formulas and specialties that left many parents struggling and a few babies in the hospital.

“The agency faced a series of challenges that tested our regulatory frameworks and strained agency operations, prompting me to take a closer look at the way we do business,” FDA Commissioner Robert Califf said in a statement on Tuesday.

Califf commissioned the Reagan-Udall Foundation, which will work with anonymous outside experts, to conduct evaluations of the agency’s Human Foods program and the Center for Tobacco Products. The foundation is a private, nonprofit organization appointed by Congress to support and advise the FDA. The foundation’s assessment will review the “processes and procedures, resources, and organizational structure” of both FDA programs, and the foundation will report back to the agency within 60 days, Califf said.

The FDA has faced intense criticism on various fronts for various issues, which Califf largely inherited. Although he briefly served as FDA commissioner during the Obama era, Califf did not join the agency in that role until February 2022. In the five months since, he has frequently defended the work of the agency, but admitted that there was still a lot to do. .

“We have the safest food in the world,” Califf said during a congressional hearing on Wednesday. “Every expert I’ve spoken to – the CDC is watching this carefully – has said our food is as safe as it’s ever been. … That doesn’t mean it can’t be much better and that there are no major issues. So, you know, that’s why we’re doing this top-down review and planning to make some significant changes.”

Formula Shortage

In announcing the review, Califf noted that the agency’s food watchdog “has been underscored by the growing diversity and complexity of the country’s food and supply chain systems.” He also acknowledged that “fundamental questions about structure, function, funding and leadership need to be addressed”, as do the agency’s “inspection activities”.

In a previous congressional hearing focused on the infant formula shortage, Califf struggled to clearly explain the leadership structure of the food program or the chain of command up from regional staff who inspect commercial plants.

Additionally, lawmakers criticized the agency for being slow to respond to a whistleblower’s complaint filed last year about serious problems at one of the largest formula factories in the United States, the Abbott factory in Sturgis, Michigan. When the FDA finally investigated the plant earlier this year, inspectors found deadly bacteria that had previously been linked to childhood illnesses and one death. Amid reports of a second linked infant death, the factory closed in February, largely spurring the nationwide shortage. The shutdown then sent federal officials rushing to gather supplies, airlift millions of containers from overseas and provide advice to parents faced with empty shelves.

Vaping struggles

Meanwhile, the agency has also struggled to regulate the burgeoning vaping industry, including synthetic nicotine and cannabis products. The FDA recently reported that it was trying to review approximately one million applications for non-tobacco nicotine products.

Earlier this month, the FDA made an embarrassing reversal in its decision to force e-cigarette maker Juul out of the US market. The agency initially refused the vaping giant’s application for marketing authorization at the end of June. But a federal court quickly blocked the denial, leaving Juul products on the market, at least temporarily. Then the FDA suspended the denial, saying “there are scientific issues unique to the Juul app that warrant further review.”

The FDA has made progress in regulating tobacco products, Califf said, “but even greater challenges lie ahead as we determine how the agency will handle complex policy issues and determine enforcement activities for a number growing number of new products that could potentially have significant consequences for public health.”

Califf acknowledged that implementing significant structural changes that may arise from the external evaluation may take time. “But,” he said, “I am committed to responding to them and communicating them to the public in a timely manner.”

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