Juul Labs Inc. has filed an application with the Food and Drug Administration to continue selling its e-cigarettes in the United States, the company announced Thursday, a highly anticipated milestone that will determine the fate of the once-highflying company.
Juul said it is seeking authorization for its device as well as its Virginia tobacco and menthol-flavored pods with 3 percent and 5 percent nicotine concentrations. Mango, mint, and other flavors that the company stopped offering last year after facing regulatory scrutiny for allegedly attracting minors weren’t included.
Chief executive K.C. Crosthwaite said in a statement that the application is a key part of Juul’s efforts to move past those controversies and remain on the market as an alternative for smokers of traditional cigarettes.
Juul said it included more than 110 studies in its application, including research on the public-health effects of its products and whether cigarette smokers transition to them. Smoking tobacco is the top cause of preventable death. Juul has said its products could help the world’s 1 billion smokers switch.
Questions about underage vaping will be critical in the regulatory review, not only for Juul, but for all companies that plan to submit a so-called Premarket Tobacco Product Application. An annual national survey of youth tobacco use by the FDA and the Centers for Disease Control and Prevention has shown a surge in vaping among kids and teens, with more than 5 million reporting they had used an e-cigarette device in the past 30 days in 2019.
The United States is Juul’s largest market, and gaining the FDA’s authorization is crucial to its business. Juul has said that it never marketed to minors and has taken a number of voluntary actions to curb youth use. It said its application addresses underage e-cigarette use in detail.
“Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” chief regulatory officer Joe Murillo said in the statement.
FDA spokeswoman Alison Hunt said in a statement the agency is aware of Juul’s disclosure, but it can’t comment on the status of any specific application. Generally, she said, the law requires the FDA to “consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, including youth.”
The uproar over teenage vaping has caused Juul’s fortunes to decline. Juul still makes the top-selling e-cigarette in the United States, but the company’s value has shrunk, it cut jobs, and sales are down after it pulled many of its most popular products. Authorization from the FDA could give the company a needed boost and help remove some of the shadows that have hung over the wider vaping industry.
The FDA earlier allowed all e-cigarette products that were on the market by Aug. 8, 2016, to continue being sold on the premise they would eventually be subject to review by the agency. The grace period was granted out of concern that removing all vaping products from the marketplace before they could be reviewed might damage public health by stripping smokers of a cigarette alternative.
The deadline for companies to submit applications to remain on the market is now Sept. 9. That date was pushed back earlier this year as a result of the COVID-19 pandemic, after an earlier legal battle over the timing between the industry, regulators and anti-tobacco groups.
Companies must convince the FDA that their e-cigarette products are appropriate for the protection of public health, meaning they can benefit adult smokers without attracting minors or nonsmokers. Juul has been sharply focused on the FDA application of late, hiring executives with science and health care backgrounds and relocating its headquarters from San Francisco to Washington, D.C.
For regulators, balancing the risks and rewards will be a delicate question. Juul’s published research suggests its products can convert cigarette smokers. But the brand has also become a hit with teens. The 2019 National Youth Tobacco survey identified Juul as the most popular e-cigarette brand among middle-school and high-school students.
Ahead of the submission, Juul last fall hired Crosthwaite and Murillo from Altria Group Inc., the US tobacco giant that invested $12.8 billion for a 35 percent stake in Juul in December 2018. Altria has since marked down the value of its Juul holdings, and the deal between the two companies is under scrutiny by US antitrust officials. Altria has said that it doesn’t believe that the deal harms competition.
Juul’s critics, including the Campaign for Tobacco-Free Kids, called on the FDA to reject Juul’s application. Michael R. Bloomberg, the majority owner of Bloomberg LP, the parent company of Bloomberg News, is funding a multiyear partnership with the organization focused on stopping teen vaping, with an emphasis on flavors.
Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes, said she was disappointed that Juul is seeking permission to continue selling menthol, a flavor thought to make it easier to entice minors to use tobacco products.
“If Juul really cared about protecting our youth or about initiating youth through its products, it wouldn’t be submitting menthol,” Berkman said.
The FDA has sought to ban menthol cigarettes but backed off an attempt to prohibit the flavor in e-cigarettes last year.
Juul and other e-cigarette makers that submit applications by the Sept. 9 deadline can keep selling their products for up to one year while the FDA reviews their submissions, the agency has said. In the meantime, Juul said it plans to continue sharing its research in academic journals, conferences and one-on-one meetings. It also plans to pursue regulatory approvals in other countries.