In a surprising reversal, the US Food and Drug Administration (FDA) on Thursday, July 6, lifted its ban on Juul e-cigarettes, allowing the products to remain on shelves as the agency conducts a further review of the company's applications (via NBC News).
Reversal After Initial Ban
This latest update marks a significant shift after the FDA initially ordered Juul to remove its products from the market in June 2022 due to concerns about the potential health risks associated with the company's e-liquid pods.
The FDA cited insufficient evidence regarding genotoxicity and the possibility of harmful chemicals leaching from the pods.
Despite the ban, Juul products continued to be sold pending appeal, maintaining the company's position as the second-largest e-cigarette maker in the US, behind Vuse.
CHICAGO, IL - SEPTEMBER 13: Electronic cigarettes and pods by Juul, the nation's largest maker of vaping products, are offered for sale at the Smoke Depot on September 13, 2018 in Chicago, Illinois. The Food and Drug Administration (FDA) has ordered e-cigarette product makers to devise a plan to keep their devices away from minors, declaring use by teens has reached an "epidemic proportion". Photo by Scott Olson/Getty Images
Juul's Application Back in Review
The FDA's decision to rescind the marketing denial orders (MDOs) is not an authorization or denial of Juul's products but rather returns the applications to pending status for further review.
In a statement, Juul expressed gratitude for the FDA's reconsideration, emphasizing its commitment to engaging in a science- and evidence-based process with the agency.
The company remains "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 statement said.
The initial FDA ban in 2022 had a considerable impact on Juul's finances, prompting a bailout from two of its largest investors. Despite this setback, Juul has managed to retain a significant share of the e-cigarette market.
The overall e-cigarette market has also experienced notable growth. The Centers for Disease Control and Prevention (CDC) reported an almost 50% increase in e-cigarette use between January 2020 and December 2022. However, this growth appears to be outpaced by the rise of smokeless tobacco products like nicotine pouches.
A new study from South Korea shows that switching from traditional smoking to vaping may increase the risk of developing lung cancer.Photo by GUILLEM SARTORIO/AFP via Getty Images
A new study from South Korea shows that switching from traditional smoking to vaping may increase the risk of developing lung cancer.
The surge in e-cigarette use, especially among young people, remains a pressing public health concern. Vaping among high school students peaked at roughly 28% in 2019, fueling fears of a new generation becoming addicted to nicotine.
While the rescission of the MDOs allows Juul to continue selling its products, it does not guarantee future authorization. The FDA reiterated that all e-cigarette products, including Juul's, must receive FDA authorization to be legally marketed.
