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FDA Reverses Ban on Juul E-Cigarettes

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The Food and Drug Administration announced Thursday that it has reversed its ban on Juul e-cigarettes while it reviews new court decisions and evaluates updated information provided by the vape maker.

In 2022, the FDA initially ordered Juul to cease selling its products, but the company has continued to keep its items on the market pending an appeal. During this period, Juul has maintained its position as the second-largest e-cigarette maker in the United States.

The FDA now states that Juul’s products are back under agency review. However, the agency emphasized that this new status does not guarantee they will be fully approved. Federal statutes prevent the FDA from disclosing additional information regarding the review process.

Juul achieved significant success during the initial surge in e-cigarette use over a decade ago. However, this success raised concerns about introducing a new generation to nicotine addiction. According to the Centers for Disease Control and Prevention (CDC), vaping reached a peak of approximately 28% among high school students in 2019.

While Juul has faced financial challenges, the sales of e-cigarettes and other alternative nicotine products have continued to grow. The CDC reported last year that e-cigarette use had increased nearly 50% between January 2020 and December 2022, with Juul trailing only Vuse in market share among e-cigarette brands.

Now, there are indications that the growth of e-cigarettes is being outpaced by smokeless tobacco products. Philip Morris, the current owner of nicotine pouch-maker Zyn, recently reported a 21% increase in its smokeless category from the previous year, now accounting for nearly 40% of the firm’s total revenue, according to Barron’s.

In a statement, Juul expressed appreciation for the FDA’s latest decision and expressed hope to “re-engage with the agency on a science- and evidence-based process to pursue marketing authorization” for its products. The company remains confident in the quality of its applications and believes that a thorough review will demonstrate that its products meet the statutory standard of being appropriate for the protection of public health.

Despite Juul’s ongoing appeal of the 2022 ban, the initial FDA ruling significantly impacted the company’s finances, leading to a bailout from two of its largest investors, as reported by The Wall Street Journal.

To date, the FDA has granted official approval to only 23 e-cigarette products, produced by just three companies, for marketing to consumers.