After it was sued, the agency admits that it ignored key evidence.
The Food and Drug Administration last month gave Juul Labs what amounted to a death sentence without a trial. Now after being sued, the agency has stayed its execution while it apparently seeks evidence to support its conviction. Abusive is an understatement for this botched political hit.
Democrats have targeted Juul for some time, and its putative original sin was hooking young people on nicotine. It tried to assuage critics by stopping sales of fruity flavors in stores and social-media marketing. Last year two-thirds of the roughly 20% of high-school seniors who reported vaping nicotine used other brands.
But Democrats want another business pelt on the wall. In 2019 a federal court, in response to a lawsuit by public-health groups, ordered the FDA to conduct a safety review of e-cigarettes. Senate Democrats have been hounding the FDA to pull Juul from the market.
Eleven Democratic Senators in May slammed FDA Commissioner Robert Califf for allowing “JUUL, the company arguably most responsible for causing the youth vaping epidemic” to remain “free to prey upon children.” On June 21 Illinois Sen. Dick Durbin called on Dr. Califf to step down if he wasn’t willing to yank Juul from the market.
The next day word leaked that the FDA planned to order Juul off the market, and so it did. The FDA claimed Juul hadn’t submitted sufficient data to support its products’ safety, but the agency had merely ignored the evidence. “FDA claimed [Juul] did not provide aerosol data measuring the toxicological impact of four chemicals. But [Juul] did provide that data—6,000 pages of it,” Juul says in a lawsuit. “Had FDA done a more thorough review (like it did for other applicants), it would have seen data showing that those chemicals are not observable in the aerosol that JUUL users inhale.”
The D.C. 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 in the course of reviewing litigation briefing materials that “there are scientific issues unique to this application that warrant additional review.”
The FDA is staying its execution while it reviews Juul’s safety evidence, which it should have done before its verdict. Yet FDA made clear it’s not calling off the execution—merely putting it on hold. This suggests that the FDA is planning to look for a legally defensible pretext to drive Juul out of business.
Juul argues in its lawsuit that the FDA was responding to political pressure, and it sure looks that way. Progressives and public-health scolds who prodded FDA to go after Juul are now criticizing its blown hit. Mr. Durbin slammed the FDA for “ongoing incompetence.” Hired hit men aren’t useful when they miss their targets.
We supported Dr. Califf’s confirmation and cut him slack during the baby formula fiasco since Abbott Laboratories’ manufacturing problems preceded him. But the Juul drive-by raises questions about his leadership and undermines the FDA’s credibility. If Americans think the FDA is politicizing tobacco regulation, they won’t trust the agency on vaccines.
Editorial Board – Wall Street Journal – 2022-07-07
Want More Investigative Content?
