The FDA misses its shot on Juul

Last month, the Food and Drug Administration sentenced Juul Labs to a death sentence without a trial. Now, after being prosecuted, the agency has suspended his execution as it apparently seeks evidence to support his conviction. Abusive is an understatement for this botched political success.

Democrats have been targeting Juul for some time, and its putative original sin was hooking young people on nicotine. He tried to appease critics by stopping sales of fruity flavors in stores and social media marketing. Last year, two-thirds of the roughly 20% of high school students who said they vaped nicotine used other brands.

But Democrats want another corporate skin on the wall. In 2019, a federal court, in response to a lawsuit filed by public health groups, ordered the FDA to conduct a safety review of e-cigarettes. Senate Democrats harassed the FDA to pull Juul from the market.

In May, eleven Democratic senators criticized FDA Commissioner Robert Califf for allowing “JUUL, arguably the company most responsible for the youth vaping epidemic” to remain “free to attack to children”. On June 21, Illinois Senator Dick Durbin called on Dr. Califf to step down if he was unwilling to take Juul off the market.

The next day, word got out that the FDA was planning to pull Juul from the market, and they did. The FDA claimed that Juul did not submit enough data to support the safety of its products, but the agency simply ignored the evidence. “The FDA has asserted [Juul] did not provide aerosol data measuring the toxicological impact of four chemicals. But [Juul] provided this data – 6,000 pages,” Juul said in a lawsuit. “If the FDA had performed a closer review (as it has done for other candidates), it would have seen data showing that these chemicals are not observable in the aerosol that JUUL users inhale. »

The DC Circuit Court of Appeals blocked the FDA’s death sentence, and on Tuesday the agency tacitly admitted to pulling the trigger too quickly. The agency said it determined during review of the litigation briefing materials that “there are scientific issues unique to this app that warrant further review.”

The FDA is suspending his execution while it reviews Juul’s safety evidence, which it should have done before its verdict. Yet the FDA made it clear that it was not canceling the execution, but simply putting it on hold. This suggests the FDA is considering looking for a legally defensible excuse to kick Juul out of business.

Juul argues in its lawsuit that the FDA was responding to political pressure, and that appears to be the case. The progressives and public health rebukes that caused the FDA to go after Juul are now criticizing its miss. Mr Durbin criticized the FDA for “continued incompetence”. Hired hitmen are of no use when they miss their target.

We supported Dr. Califf’s confirmation and released him during the infant formula fiasco since Abbott Laboratories manufacturing issues preceded it. But Juul’s move raises questions about its leadership and undermines the FDA’s credibility. If Americans think the FDA politicizes tobacco regulation, they won’t trust the vaccine agency.

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