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Former FDA official calls Juul ban sloppy: politics and retaliation, not following science

Former FDA official calls Juul ban sloppy: politics and retaliation, not following science

2022-07-22

The U.S. Food and Drug Administration has ordered an external review of its procedures amid a series of controversies over its handling of a nationwide shortage of infant formula and a ban on Juul e-cigarettes.


FDA Commissioner Robert Califf has called for a review of the FDA's food and tobacco program after months of criticism against the agency.


Peter Pitts, a former FDA deputy commissioner of external affairs, said the call for a review was a powerful move by Califf at a time when the FDA was not making excuses for its failure.


"I don't believe in excuses, it doesn't promote public health," Pitts said on NewsNation rush hour.


After determining that the FDA ignored thousands of pages of evidence from Juul refuting the FDA's findings about its products, Pitts pointed out that the FDA's ban on the sale of Juul e-cigarettes in the United States was sloppy.


Banning Juul but not similar products from other brands is what Pitts called a political and retaliatory move, accusing the FDA of not following science.


Parents and politicians also expressed dismay at the agency's recent decision to ban all e-cigarettes from Juul, the nation's leading e-cigarette company. A federal court quickly blocked the agency's order. The FDA then pulled it further back in court, saying it needed more time to review Juul's application because of its unique scientific issues.


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


Califf raised the funding challenge again, noting that the FDA cannot charge user fees to vaping companies that submit products. The agency has asked Congress to grant that authority.


Last week, the FDA announced it would miss another deadline to clear thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to grant the agency authority over the products, which exploit loopholes in the law to circumvent regulation.


Claims by some that shortages of infant formula have led some parents to rush to find food for their children have also been mishandled by the FDA. An Abbott infant formula plant in Michigan was shut down after the FDA found its product was contaminated, sparking a shortage.


Recently, the FDA said it would help foreign manufacturers stay in the U.S. market long-term to diversify the supply of formulations here.


Califf had previously predicted that formula shortages could continue into July. He said on Tuesday that retail data showed an improvement in supply as U.S. production and imports increased.


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