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.
The Food and Drug Administration has commissioned an outside review of its food and tobacco programs after high-profile debacles – including botched surveillance of e-cigarettes, particularly Juul products, and a severe nationwide shortage of infant formula and specialty foods left many parents in Difficulties and some babies back in the hospital.
“The agency has faced a number of challenges that have tested our regulatory framework and strained the agency’s operations, prompting me to take a closer look at how we do business,” said FDA Commissioner Robert Califf in a statement on Tuesday.
Califf hired the Reagan-Udall Foundation, which will work with unnamed outside experts, to conduct assessments of the agency’s Human Foods Program and the Center for Tobacco Products. The Foundation is a private non-profit organization mandated by Congress to provide assistance and advice to the FDA. The foundation’s assessment will review the “processes and procedures, the resources and the organizational structure” of the two FDA programs, and the foundation will report initial results to the agency within 60 days, Califf said.
The FDA has been heavily criticized on various fronts for various issues, which Califf has largely inherited. Although he briefly held the position of commissioner of the FDA during the Obama era, Califf did not rejoin the agency in that capacity until February 2022. In the five months since, he has frequently defended the agency’s work, but acknowledged there is plenty of room for improvement.
“We have the safest food in the world,” Califf said at a congressional hearing on Wednesday. “Every expert I spoke to — the CDC monitors this carefully — said our food is as safe as ever. … That doesn’t mean it can’t be much better and that there aren’t any major problems. You know, that’s why we’re doing this top-down review and plan to make significant changes.”
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Announcing the review, Califf noted that the agency’s food oversight “has been stressed by the increasing diversity and complexity of the country’s food systems and supply chain.” He also acknowledged that “fundamental issues of structure, function, funding and governance” need to be addressed, as well as the agency’s “inspection work”.
In a previous congressional hearing that focused on the infant formula shortage, Califf struggled to clearly explain the food program’s governance structure, or the chain of command that ascended from regional personnel inspecting commercial facilities.
In addition, lawmakers have 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 plants in the US – Abbott’s plant in Sturgis, Michigan. When the FDA finally examined the facility earlier this year, inspectors discovered deadly bacteria that have already been linked to infant illnesses and deaths. Amid reports of a second related infant death syndrome, the plant closed in February, greatly fueling the nationwide shortage. The closure then prompted federal officials to scramble to gather supplies, airlift millions of containers from abroad and provide guidance to parents standing in front of empty shelves.
Vaping Battles
Meanwhile, the agency has also struggled to regulate the burgeoning vaping industry, including synthetic nicotine and cannabis products. The FDA recently reported that it is trying to review around one million applications for tobacco-free nicotine products.
Earlier this month, the FDA made an embarrassing step backwards in its decision to ban vape maker Juul from the US market. The agency initially rejected the vaping giant’s application for market approval in late June. But a federal court quickly blocked the denial, leaving Juul products on the market, at least temporarily. Then the FDA suspended the rejection, saying that “there are scientific issues unique to the Juul application that warrant additional review.”
The FDA has made strides in regulating tobacco products, Califf said, “but even greater challenges lie ahead in determining how the agency will address complex policy issues and establish enforcement actions for a growing number of novel products that have potentially significant consequences.” for the public could have health.”
Califf acknowledged that it could take time to implement the significant structural changes that the external assessment could result in. “But,” he said, “I aim to address them and share them with the public in a timely manner.”