Juul labs Inc. announced on Thursday that it has submitted an application to the food and drug administration to continue selling e-cigarettes in the United States, which will determine the ultimate fate of the once brilliant enterprise.Juul said it was seeking sales approval for its products, as well as Virginia tobacco and peppermint pods with nicotine concentrations of 3% and 5% respectively. Juul stopped offering mango, mint and other flavors last year after regulatory scrutiny for suspected guiding minors to smoke.
Juul's chief executive, K.C. crosswaite, said in a statement that the application is the key to Juul's efforts to get rid of the controversy and remain in the market as a traditional cigarette substitute.
Juul said the company had conducted more than 110 studies in its application, including studies on the impact of its products on public health and whether traditional smokers would overuse their products. Juul said its products could help one billion smokers worldwide quit smoking.
Today, the issue of minors smoking e-cigarettes is the key to regulatory review, not just for Juul, but for all companies planning to submit so-called pre market tobacco product applications. According to the annual survey on tobacco use among adolescents conducted by the U.S. Food and Drug Administration (FDA) and centers for Disease Control and Prevention (CDC), the number of children and adolescents using e-cigarettes has soared. In 2019, more than 5 million people reported using e-cigarette devices in the past 30 days.
The U.S. is Juul's largest market, and obtaining FDA authorization is critical to its business development. Juul said the company has never marketed its products to minors and has taken initiatives to limit the use of e-cigarettes by teenagers. Juul said its application addressed in detail the problem of minors using e-cigarettes.
"Juul laboratories has invested all the necessary resources to provide the best possible PMTA to address tobacco use among minors, based on rigorous scientific research and data-driven measures," Juul chief regulatory officer Joe Murillo said in a statement
FDA spokesman Alison hunt said in a statement that the FDA was aware of Juul's disclosure but could not comment on the details of the application. Hunt said that in general, the law requires the FDA to "take into account the risks and benefits of (a product) to the entire population, including users and non users of tobacco products, as well as adolescents."
Juul's wealth has shrunk as a result of riots caused by teenagers smoking e-cigarettes. Although Juul is still the best-selling e-cigarette in the United States at present, after removing many of its most popular products, the company's market value has declined, and there are layoffs, and product sales have also declined. The FDA's authorization may boost Juul's business and help to remove some of the shadows over the e-cigarette industry.
Previously, the FDA approved that all electronic cigarette products sold on the market before August 8, 2016 can continue to be sold, provided that these products are ultimately subject to FDA review. This grace period is given because it is considered that the complete withdrawal of all e-cigarette products from the market before they are reviewed may lead to the loss of a cigarette substitute for smokers, thereby harming public health.
At present, the deadline for tobacco companies to submit applications for approval of products on the market is September 9. Due to the covid-19 pandemic, earlier this year, the tobacco industry, regulators and anti tobacco groups fought a legal battle over timing, which was later postponed.
Tobacco companies must convince the FDA that their e-cigarette products can protect public health, which means they can benefit adult smokers without inducing minors or non-smokers. Juul has been closely monitoring FDA applications recently, hiring executives with scientific and medical backgrounds, and moving its headquarters from San Francisco to Washington.
Balancing risk and reward is a delicate issue for regulators. Research published by Juul shows that their products can change the habits of smokers. But the brand is also popular with teenagers. According to the 2019 National Youth Tobacco Survey, Juul is the most popular e-cigarette brand among middle school and high school students.
Juul's critics, including participants in the smoke-free children's movement, have called on the FDA to reject Juul's application. Meredith Berkman, co-founder of the anti e-cigarette parents alliance, said she was disappointed that Juul was seeking permission to continue to sell menthol e-cigarettes, which are considered a spice more likely to attract minors to use tobacco products.
"If Juul was really caring and protecting our young people, the company wouldn't offer menthol," Berkman said
The FDA tried to ban menthol cigarettes, but last year it gave up trying to ban the spice in e-cigarettes.
The FDA said Juul and other e-cigarette manufacturers submitted applications before the September 9 deadline, and their products could continue to be sold for a year while the FDA reviewed their applications. At the same time, Juul said the company plans to continue sharing its research results in academic journals, conferences and one-on-one seminars, as well as seeking regulatory approval from other countries.