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Amid controversies, FDA seeks advice on food and tobacco operations

A shortage of infant formula emerged after the shutdown of an Abbott Nutrition manufacturing plant in February for safety reasons, and the subsequent recall of the formula. (Michael Conroy/AP)
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The head of the Food and Drug Administration said Tuesday he is asking outside experts to conduct a comprehensive evaluation of the agency’s food and tobacco programs, which in recent months have endured sharp criticism involving two high-profile issues: the infant-formula shortage and e-cigarettes, particularly the vaping company Juul.

FDA Commissioner Robert M. Califf, while not mentioning those controversies, said in a statement that “the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations, prompting me to take a closer look at how we do business.”

The statement is a significant concession from someone who has steadfastly defended the agency during congressional hearings and public appearances.

Califf said the Reagan-Udall Foundation, a nonprofit created by Congress that works closely with the FDA, will work with external experts to look at the procedures and organizational structures of the food and tobacco centers.

The infant-formula shortage emerged after an Abbott Nutrition manufacturing plant was shut down in February for safety reasons and the company recalled the formula. As part of its scrutiny of e-cigarettes, the FDA recently ordered Juul’s vaping products off the market, then suspended the ban temporarily.

On food, Califf said experts will scrutinize the Center for Food Safety and Applied Nutrition and related offices. While the food supply is safe, he said, “the program has been stressed by the increasing diversity and complexity of the nation’s food systems and supply chain.”

Califf said “fundamental questions about the structure, function, funding and leadership need to be addressed” about the agency’s food efforts. He said food-inspection activities also need to be reviewed, given challenges caused by the coronavirus pandemic.

For months, members of Congress and the public have accused the FDA of being too slow in picking up on problems at the Abbott plant in Michigan. A letter from a whistleblower that reported problems at the plant, mailed in October, did not reach top FDA officials until February.

Steven Solomon, director of the FDA’s Center for Veterinary Medicine, already is leading an internal review on FDA actions and the infant-formula shortage. The external evaluation will be broader; Califf said in hearings on Capitol Hill last month that he planned to consider a reorganization of agency food operations.

The Abbott plant was shuttered after the agency raised concerns the factory might have been tainted with the cronobacter bacteria, which killed two infants and sickened two others. But the source of the infection — whether the formula or something else — has not been confirmed. The FDA is investigating reports of other infant deaths but has not tied them to the plant.

On tobacco, Califf said the agency has made important progress but added that “even greater challenges lie ahead” as the agency deals with an increasing number of novel products that could affect public health.

In June, the FDA’s Center for Tobacco Products denied Juul’s applications to continue selling its e-cigarette device and prefilled cartridges in menthol and tobacco flavors. The FDA said Juul had provided inadequate or conflicting information on the safety of its products and ordered the company to pull them off the market.

Juul said the FDA mishandled the application and missed or overlooked thousands of pages of data included in the submission. The company got an emergency stay from a federal appeals court delaying the FDA ban.

On July 5, the FDA tweeted that it had suspended the ban pending an internal review, outraging anti-vaping advocates and some lawmakers.

“Not two weeks after ordering Juul off the market, the FDA backtracked and halted its own decision,” Sen. Richard J. Durbin (D-Ill.) said on the Senate floor.

Durbin also is urging the agency to take a tougher line against vaping products that use synthetic nicotine products, including the disposable Puff Bar, which is popular among teenagers. Last week, the FDA said it sent two warning letters to manufacturers for illegally marketing synthetic nicotine products without authorization.