In the midst of a disaster for infant formula, Juul failure, the FDA is seeking an external assessment

In the midst of a disaster for infant formula, Juul failure, the FDA is seeking an external assessment

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

The Food and Drug Administration has commissioned an external review of its food and tobacco programs in the wake of high-profile debates – including confused oversight of e-cigarettes, particularly Juul products, and a severe nationwide shortage of infant and specialty blends that left many parents in chess and some babies in the hospital.

“The agency has faced a number of challenges that have tested our regulatory framework and underscored the agency’s activities, which has led me to take a closer look at how we conduct business,” FDA Commissioner Robert Califf said in a statement Tuesday.

Califf commissioned The Reagan-Udall Foundation, which will work with unnamed external experts, to conduct evaluations of the agency’s Human Foods Program and Center for Tobacco Products. The foundation is a private non-profit organization tasked by Congress to support and advise the FDA. The foundation’s evaluation will examine the “processes and procedures, resources and organizational structure” of the two FDA programs, and the foundation will report initial findings to the agency within 60 days, Califf said.

The FDA has faced intense criticism on various fronts for various problems, which Califf has largely inherited. Although he had briefly held the position of FDA commissioner during the Obama era, Califf first joined the agency in the role in February 2022. During the five months since then, he has often defended the agency’s work, but admitted that there is a lot of room for improvements.

“We have the safest food in the world,” Califf said in a congressional hearing Wednesday. “Every expert I’ve talked to – the CDC monitors this closely – said that our food is as safe as it has ever been. … That does not mean it can not get much better and that there are no major problems. So, you know, that’s why we’re doing this top-down review and planning to make significant changes. “

Lack of formula

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

In a previous congressional hearing focused on the lack of infant formula, Califf had struggled to clearly explain the leadership structure of the food program or chain of command that moved up from regional personnel inspecting commercial facilities.

In addition, lawmakers have criticized the agency for being reluctant to respond to a whistleblower’s complaint filed last year about serious problems at one of the largest formula factories in the United States – Abbott’s Sturgis, Michigan plant. When the FDA finally examined the facility earlier this year, inspectors discovered deadly bacteria that were already linked to infantile diseases and one death. Amid reports of another infant death, the facility closed in February, which largely spurred the nationwide shortage. The closure then sent federal officials in the process of gathering supplies, airing millions of containers from abroad and providing guidance to parents facing empty shelves.

Vaping matches

Meanwhile, the agency has also struggled to regulate the mushroom steam industry, including synthetic nicotine and cannabis products. The FDA recently reported that they are trying to review around one million applications for non-tobacco nicotine products.

Earlier this month, the FDA took an embarrassing backstory in its decision to force e-cigarette maker Juul out of the US market. The agency first rejected the vaping giant’s marketing authorization request in late June. But a federal court quickly blocked the denial, leaving Juul products on the market, at least temporarily. The FDA then suspended the refusal, saying that “there are scientific problems unique to the Juul application that warrant further assessment.”

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

Califf acknowledged that it may take time to implement the significant structural changes that may emerge from the external evaluation. “But,” he said, “I am obliged to address them and communicate them to the public in a timely manner.”

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