The Food and Drug Administration announced Thursday that it has reversed its ban on Juul e-cigarettes while it reviews new court decisions and considers updated information provided by the vape maker.
The FDA first ordered the company to stop selling its products in 2022, but they have stayed on shelves pending an appeal. Juul has maintained its status as the No. 2 e-cigarette maker in the U.S. during this time.
Now, the FDA says Juul’s products are back under agency review — although it emphasized that this new status was not an indication they would be fully cleared.
It said federal statutes barred it from disclosing additional information.
Juul became one of the highest-profile successes of the initial burst in e-cigarette use more than a decade ago. That success was beset by concerns that e-cigarettes were introducing a new generation of people to nicotine addiction. Vaping reached a peak of approximately 28% among all high school students in 2019, according to the Centers for Disease Control and Prevention.
While Juul has since entered a period of financial retrenchment, sales of e-cigarettes and other alternative nicotine products have continued to grow.
Last year, the Centers for Disease Control and Prevention reported e-cigarette use had grown nearly 50% between January 2020 and December 2022. During that period, the agency said, Juul trailed only Vuse among e-cig brands.
Now there are signs e-cigarette growth is being surpassed by smokeless tobacco products.
Philip Morris, which now owns nicotine pouch-maker Zyn, recently reported that its smokeless category increased 21% from a year ago and that it now accounts for nearly 40% of the firm’s total revenue, Barron’s reported.
In a statement, Juul said it appreciated the FDA’s latest decision, adding it now looks forward to “re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization” for its products.
“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health,” the company said.
Even as Juul has pursued its appeal of the 2022 ban, that initial FDA ruling significantly disrupted the company’s finances, prompting a bailout from two of its largest investors, The Wall Street Journal has reported.
To date, the FDA has given only 23 e-cigarette products, made by just three companies, official approval to be marketed to consumers.