Former FDA official calls handling of Juul ban ‘sloppy’

Health

(NewsNation) — The Food and Drug Administration has ordered an external review of its procedures, stemming from a series of controversies involving the handling of a nationwide baby formula shortage and the banning of Juul e-cigarettes.

FDA Commissioner Robert Califf has asked for the review of the FDA’s food and tobacco programs, following months of criticism aimed at the agency.

Former FDA Associate Commissioner for External Affairs Peter Pitts said calling for the review is a strong move by Califf during a time when the FDA is running out of excuses for its failures.

“I don’t believe in excuses, it doesn’t advance the public health,” Pitts said on NewsNation “Rush Hour.”

Pitts singled out the FDA’s banning of Juul e-cigarette sales in the U.S. as “sloppy” after it was determined the FDA overlooked thousands of pages of evidence from Juul that countered FDA findings about its product.

Banning Juul but not other brands of similar products is a move Pitts called “political” and “vindictive,” accusing the FDA of “not following the science.”

Parents and politicians also have expressed frustration 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. The FDA then 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.

Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from vaping companies who submit their products. The agency has asked Congress for that authority.

“I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.

Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a legal loophole to skirt regulation.

A baby formula shortage, which left some parents desperate to find food for their children, was also mishandled by the FDA, some allege. An Abbott baby formula plant in Michigan was shut down after the FDA found its products were contaminated, sparking the shortage.

Recently, the FDA said it would help foreign manufacturers stay on the U.S. market for the long term, in an effort to diversify the formula supply here.

Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data shows that supplies have improved with increases in both U.S. production and imports.

“What you’re going to see is a gradual climbing out of the current situation as more and more formula becomes available,” Califf said.

The Associated Press contributed to this report.

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