FDA weighs oversight changes after Juul, formula troubles

WASHINGTON (AP) — The head of the Food and Drug Administration said Tuesday he has commissioned an independent review of the agency's food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews.

The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country’s largest infant formula plant.

“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.”

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.

Califf has faced frustration from parents and politicians over the agency's handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency’s order last month. And the FDA recently backtracked further in court, saying it needed more time to review Juul’s application due to its “unique scientific issues.”

The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.

President Joe Biden tapped Califf for the FDA job largely...