The FDA Misses Its Hit on Juul


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The Food and Drug Administration sentenced Juul Labs to death without a trial last month. Now, after being sued, the agency has stayed her execution while it appears to seek evidence to support its conviction. Abusive is an understatement for this botched political hit.

Democrats have been targeting Juul for some time, and his perceived original sin was seducing young people with nicotine. It tried to appease critics by halting in-store sales of fruity flavors and social media marketing. Last year, two-thirds of the approximately 20% of high school graduates who reported vaping nicotine used other brands.

But the Democrats want another deal on the wall. In 2019, in response to a lawsuit by public health groups, a federal court ordered the FDA to conduct a safety review of e-cigarettes. Senate Democrats have been hunting the FDA to take Juul off the market.

Eleven Democratic senators in May criticized FDA Commissioner Robert Califf for allowing “JUUL, the company arguably most responsible for causing the teenage vaping epidemic,” to “remain free to exploit children.” . On June 21, Illinois Senator Dick Durbin called for Dr. Califf to resign unless he is willing to take Juul off the market.

The next day, news broke that the FDA planned to take Juul off the market, and they did. The FDA claimed Juul didn’t provide enough data to prove the safety of its products, but the agency simply ignored the evidence. “FDA claims [Juul] did not provide aerosol data measuring the toxicological effects of four chemicals. but [Juul] provided that data — 6,000 pages of it,” Juul says in a lawsuit. “Had the FDA conducted a more thorough review (as they have done with other applicants), they 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 quietly admitted that it pulled the trigger too quickly. The agency said it found, in the course of reviewing litigation briefing materials, that “there are scientific issues unique to this application that require additional review.”

The FDA is staying her execution while she reviews Juul’s safety evidence, which she should have done before her verdict. But the FDA made it clear that they are not canceling the execution, just putting it on hold. This suggests that the FDA plans to look for a legally defensible excuse to put Juul out of business.

Juul argues in its lawsuit that the FDA responded to political pressure, and it sure looks like it. Progressive and healthcare rants that pushed the FDA to prosecute Juul are now criticizing his annihilated hit. Mr. Durbin criticized the FDA for “continued incompetence”. Hired assassins are of no use if they miss their targets.

We supported the confirmation of Dr. Califf and let him go during the baby food fiasco, preceded by Abbott Laboratories’ manufacturing problems. But the Juul drive-by raises questions about its leadership and undermines the FDA’s credibility. If Americans think the FDA is politicizing tobacco regulation, they won’t trust the agency on vaccines.

Wonderland: The administrative state has created ideological divisions that cannot be reversed for a long time. But an updated judgment on climate change could help revive the critical role that substantive politics played at the time of America’s founding. Images: Reuters/Getty Images Composite: Mark Kelly

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Appeared in the print edition on July 8, 2022.

https://www.wsj.com/articles/the-fda-botches-its-hit-on-juul-labs-robert-califf-lawsuit-11657224457 The FDA Misses Its Hit on Juul

Alley Einstein

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