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

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

The Food and Drug Administration commissioned an external review of its food and tobacco programs following high-profile debacles, including failed oversight of e-cigarettes, including Juul products, and a Terrible disaster nationwide shortage of infant and specialty formula that has left many parents scrambling and some babies in 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 how we do business. 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 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."

Shortage of formula

In announcing the review, Califf noted that the agency's food oversight "has been accentuated 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".

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

In addition, 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. United, 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.