Drug Control

FDA Reverses Ban on Juul E-Cigarettes, Allowing Continued Sales Pending Review

Main image to the post FDA Reverses Ban on Juul E-Cigarettes, Allowing Continued Sales Pending Review

The Food and Drug Administration (FDA) has reversed its ban on Juul e-cigarettes. The agency is now reviewing new court decisions and updated information provided by the vape maker.

The FDA first ordered Juul to stop selling its products in 2022. However, the products remained on shelves pending an appeal. During this time, Juul maintained its status as the No. 2 e-cigarette maker in the U.S.

The FDA says Juul's products are now back under agency review. However, the agency emphasized that this new status does not indicate that the products will be fully cleared.

The FDA is barred by federal statutes 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. However, its 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 (CDC).

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 CDC reported that e-cigarette use had grown nearly 50% between January 2020 and December 2022. During that period, Juul trailed only Vuse among e-cig brands.

There are now signs that 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. The company also reported that smokeless products now account for nearly 40% of its total revenue.

In a statement, Juul said it appreciated the FDA's latest decision. The company added that 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, the initial FDA ruling significantly disrupted the company's finances. This prompted 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.

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May 21, 2023 | 05:09