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FDA weighs oversight changes after Juul, formula troubles

Robert Califf
Posted at 2:56 PM, Jul 19, 2022

The head of the Food and Drug Administration is commissioning an independent review of the agency's food and tobacco programs. Robert Califf's announcement follows months of criticism over his agency's handling of the baby formula shortage and e-cigarette reviews.

Califf is trying to push past several controversies that have dominated his second stint running the agency. Califf says a non-governmental research group will convene experts to deliver the evaluations within 60 business days. The agency has been hammered for the delayed response to contamination problems at the country's largest infant formula plant. It also has been criticized over its handling of a recent decision to ban all e-cigarettes from Juul.

“Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. The agency’s tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues from “an increasing number of novel products that could potentially have significant consequences for public health.”

According to the Associated Press, Califf said the non-profit Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations.