Juul And Rivals, Given 10 Months To Submit FDA Application, Face B

Article from Forbes.com
Juul And Rivals, Given 10 Months To Submit FDA Application, Face Battle To Keep Selling E-Cigs

Juul is confident in the “content and quality” of its planned application, company spokesman Ted Kwong told Forbes. “Our growing body of evidence as well as our industry-leading actions to combat underage access and use will ensure adult smokers continue to have a true alternative to cigarettes, the leading cause of preventable death worldwide.”

Until 2016, e-cigarettes were freely able to enter the market without premarket approval. The FDA announced its deeming rule that May which extended its regulatory jurisdiction over tobacco products to also include e-cigarettes and vape pens. The policy came with a requirement for existing e-cigarette manufacturers to submit applications by 2018, but then-FDA Commissioner Scott Gottlieb extended the deadline to 2022.

The court order takes the review process timeline out of the FDA’s hands. The agency proposed the ten-month deadline itself, but only did so as part of the lawsuit—the anti-tobacco plaintiffs has suggested four months. In its previous actions to regulate e-cigarettes, the FDA had bent “about as far backwards as an agency could bend over for industry,” said Desmond Jenson, a senior staff attorney at the Public Health Law Center who focuses on tobacco control policy. Jenson said the reduced time should not catch Juul and its rivals off guard because “the specter of premarket review has always been looming.”

Ex-FDA Chief Gottlieb Doubts Juul’s Chances

Still, Juul and e-cigarette manufacturers will be put through the wringer earlier than they would have liked. Tobacco control experts are divided on whether the companies can survive the process. Gottlieb, who made cracking down on vaping companies a hallmark of his two-year tenure before he resigned in April, speculated on CNBC last month that Juul would struggle to get its products approved if it received a 10-month deadline due to the company’s unsavory history of youth use. A CDC report found that more than one in five high schoolers and about 5% of middle schoolers used e-cigarettes in 2018, up from 11.7% and 3.3% the previous year.

Gottlieb’s statements have attracted significant buzz in the tobacco control community, said Eric Lindblom, an FDA official during the Obama administration. Lindblom, who directs the tobacco control program at Georgetown Law, says the hurdle may be easier—what Juul needs to do is prove it’s changed. “The trick for Juul is to come out and say, ‘we've got our product, we’ve reconfigured the product, we are going to market it entirely different ways.’”

Juul, more than other e-cigarette companies, has complied voluntarily with the FDA on marketing, Lindblom said. The company, which attracted flak early on for apparently marketing to teenagers, shut down its Facebook and Instagram accounts last November.

Success on the application will depend on a company’s ability to prove its e-cigarette products provide more public health benefit than harm. Some tobacco control experts don’t think Juul can achieve this. “In order for the FDA to find that Juul’s products have a benefit, all of the damage that they've done in terms of youth initiation would have to be erased by benefits to adult users—and that just isn't the case,” Jenson said.

FDA approval is only the first step to sufficiently regulating the e-cigarette industry, experts agreed. Internet sales remain poorly regulated, Jenson said, while Lindblom noted the youth vaping problem could be addressed through nicotine reduction and a ban on flavored vaping.“I just wouldn't hold your breath waiting for either of those rules,” Lindblom said.