The Food and Drug Administration last month sentenced Joule Labs to death without trial. Now having a trial, the agency has stayed his execution, while it explicitly asks for evidence to support his conviction. It is an understatement to slander this shoddy political hit.
Democrats have targeted Juul for some time, and its original original sin was hooking up to youth on nicotine. It tried to reassure critics by withholding the sale of fruit flavors in stores and social-media marketing. Last year, two-thirds of the nearly 20% of high-school seniors who reported vaping nicotine used other brands.
But Democrats want another business to bang on the wall. In 2019, a federal court, in response to a lawsuit from public-health groups, ordered the FDA to conduct a safety review of e-cigarettes. Senate Democrats are chasing the FDA to take Juul off the market.
Eleven Democratic senators in May slammed FDA Commissioner Robert Calif for allowing children to remain “free to hunt” for “JUUL, the company arguably most responsible for causing the youth vaping epidemic.” On June 21, Illinois Sen. Dick Durbin asked Dr. Calif to step down if he was not prepared to remove Juul from the market.
Word leaked out the next day that the FDA planned to order Juul off the market, and that’s what happened. The FDA claimed that Juul did not present enough data to support the safety of its products, but that the agency simply ignored the evidence. “FDA Claims” [Juul] Did not provide aerosol data measuring the toxic effects of the four chemicals. but [Juul] provided that data—6,000 pages of it,” says Juul in a lawsuit. “If the FDA had conducted a more thorough review (as it did for other applicants), it would have data showing that those chemicals cannot be seen in the aerosols that JUUL users inhale.”
The DC Circuit Court of Appeals overturned the FDA’s death penalty, and on Tuesday the agency admitted to quietly pulling the trigger too quickly. The agency said it determined during its review of litigation briefing materials that “there are scientific issues unique to this application that warrant additional review.”
The FDA is putting its execution on hold while it reviews Juul’s safety evidence, which it should have done before its decision. Yet the FDA clarified that it is not stopping the execution – only keeping it on hold. This suggests that the FDA is planning to seek a legally defendable excuse to put Juul out of business.
Juul argued in his lawsuit that the FDA was responding to political pressure, and it certainly looks like it. The progressive and public-health scolding who spurned the FDA to leave after Juul is now criticizing its blown hit. Mr Durbin slammed the FDA for “ongoing incompetence”. Hired hit men are not useful when they miss their target.
We backed Dr. Calif’s confirmation and have since slackled off during baby formula failure
‘ The problems of construction were in front of him. But the Juul drive-by questions his leadership and undermines the credibility of the FDA. If Americans think the FDA is politicizing tobacco regulation, they won’t trust the agency on vaccines.
Wonderland: The administrative state has created an ideological divide that will take a long time to undo. But a recent decision on climate change may help revive the pivotal role that real politics played when America was founded. Images: Reuters/Getty Images Composite: Mark Kelly
opinion | FDA has issued Juul. but missed your hit
photo:
Mario Tama / Getty Images
The Food and Drug Administration last month sentenced Joule Labs to death without trial. Now having a trial, the agency has stayed his execution, while it explicitly asks for evidence to support his conviction. It is an understatement to slander this shoddy political hit.
Democrats have targeted Juul for some time, and its original original sin was hooking up to youth on nicotine. It tried to reassure critics by withholding the sale of fruit flavors in stores and social-media marketing. Last year, two-thirds of the nearly 20% of high-school seniors who reported vaping nicotine used other brands.
But Democrats want another business to bang on the wall. In 2019, a federal court, in response to a lawsuit from public-health groups, ordered the FDA to conduct a safety review of e-cigarettes. Senate Democrats are chasing the FDA to take Juul off the market.
Eleven Democratic senators in May slammed FDA Commissioner Robert Calif for allowing children to remain “free to hunt” for “JUUL, the company arguably most responsible for causing the youth vaping epidemic.” On June 21, Illinois Sen. Dick Durbin asked Dr. Calif to step down if he was not prepared to remove Juul from the market.
Word leaked out the next day that the FDA planned to order Juul off the market, and that’s what happened. The FDA claimed that Juul did not present enough data to support the safety of its products, but that the agency simply ignored the evidence. “FDA Claims” [Juul] Did not provide aerosol data measuring the toxic effects of the four chemicals. but [Juul] provided that data—6,000 pages of it,” says Juul in a lawsuit. “If the FDA had conducted a more thorough review (as it did for other applicants), it would have data showing that those chemicals cannot be seen in the aerosols that JUUL users inhale.”
The DC Circuit Court of Appeals overturned the FDA’s death penalty, and on Tuesday the agency admitted to quietly pulling the trigger too quickly. The agency said it determined during its review of litigation briefing materials that “there are scientific issues unique to this application that warrant additional review.”
The FDA is putting its execution on hold while it reviews Juul’s safety evidence, which it should have done before its decision. Yet the FDA clarified that it is not stopping the execution – only keeping it on hold. This suggests that the FDA is planning to seek a legally defendable excuse to put Juul out of business.
Juul argued in his lawsuit that the FDA was responding to political pressure, and it certainly looks like it. The progressive and public-health scolding who spurned the FDA to leave after Juul is now criticizing its blown hit. Mr Durbin slammed the FDA for “ongoing incompetence”. Hired hit men are not useful when they miss their target.
We backed Dr. Calif’s confirmation and have since slackled off during baby formula failure
Abbott Laboratories
‘ The problems of construction were in front of him. But the Juul drive-by questions his leadership and undermines the credibility of the FDA. If Americans think the FDA is politicizing tobacco regulation, they won’t trust the agency on vaccines.
Wonderland: The administrative state has created an ideological divide that will take a long time to undo. But a recent decision on climate change may help revive the pivotal role that real politics played when America was founded. Images: Reuters/Getty Images Composite: Mark Kelly
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Appeared in the print edition, July 8, 2022.