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Amid Infant Formula Disaster and Juul Fiasco, FDA Seeks Third-Party Validation

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Increase / Robert Califf, Commissioner of the Food and Drug Administration, speaks at a hearing on the federal response to COVID on Capitol Hill June 16, 2022 in Washington, DC.

The Food and Drug Administration has ordered an external review of its food and tobacco programs following high-profile setbacks, including the mismanagement of e-cigarettes, primarily Juul products, and severe shortages of infant and specialty formulas across the country. left many parents in despair and some babies in the hospital.

“The agency has encountered a number of issues that have tested our regulatory framework and put the agency’s operations at risk, prompting me to take a closer look at how we do business,” FDA Commissioner Robert Kaliff said Tuesday.

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

The FDA has faced harsh criticism on various fronts due to various issues that Kaliff has largely inherited. Although he briefly served as FDA commissioner during the Obama era, Kaliffe did not return to the agency in that role until February 2022. In the five months since then, he has frequently defended the agency’s work, but acknowledged that there is plenty of room for improvement. .

“We have the safest food in the world,” Kaliff said at a congressional hearing on Wednesday. “Every expert I’ve talked to — the CDC is following this closely — has said that our food is safer than ever… That doesn’t mean it can’t be much better and there aren’t serious problems. So, you know, that’s why we’re doing this top-down review and plan to make significant changes.”

Formula deficiency

In announcing the review, Kaliff noted that the agency’s food oversight is “highlighted by the growing diversity and complexity of national food systems and supply chains.” He also acknowledged that “fundamental questions about the structure, functions, funding and leadership” as well as the agency’s “inspection activities” need to be addressed.

In previous congressional hearings on infant formula shortages, Kaliffe struggled to clearly explain the food program’s leadership structure, or chain of command from regional personnel who inspect commercial establishments.

In addition, lawmakers have criticized the agency for being slow to respond to a whistleblower complaint filed last year about serious problems at one of the largest mixing plants in the US, Abbott’s plant in Sturgis, Michigan. When the FDA finally examined the plant earlier this year, inspectors found deadly bacteria that had already been linked to childhood illness and death. Amid reports of a second linked infant death, the plant closed in February, largely triggering a nationwide shortage. The closure subsequently forced federal officials to stockpile, airlift millions of containers from overseas, and issue guidance to parents faced with empty shelves.

The fight against vaping

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

Earlier this month, the FDA embarrassingly backtracked on its decision to force e-cigarette maker Juul out of the US market. The agency initially denied the vaping giant’s request for a marketing authorization at the end of June. But a federal court quickly blocked the denial, leaving Juul products on the market, at least temporarily. The FDA then put the denial on hold, saying “there are scientific issues unique to the Juul app that require further consideration.”

According to Kaliff, the FDA has made progress on tobacco product regulation, “but even bigger challenges lie ahead as we determine how the agency will address complex policy issues and determine enforcement efforts for a growing number of new products that could potentially have serious consequences.” for society.” health.”

Kaliff acknowledged that significant structural changes that may result from an external evaluation may take time to materialize. “But,” he said, “I intend to address them in a timely manner and bring them to the attention of the public.”

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