Years after the U.S. Food and Drug Administration issued marketing denial orders for Juul Labs, it announced this week that it would authorize the marketing of five Juul vaping products.
“Today the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for the Juul System,” said a Wednesday press release from the company. “As part of our 2020 applications, we submitted over 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science.”
In its own press release, the FDA said it authorized marketing for five of Juul’s e-cigarette products through the premarket tobacco product application (PMTA) pathway: the JUULdevice, Virginia Tobacco flavor JUULpods (3% and 5% nicotine concentration) and Menthol flavor JUULpods (3% and 5% nicotine concentration). These products can now be marketed to people age 21 and older.
According to the FDA, it determined after an “extensive scientific review” of Juul’s products that they meet the standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the United States. That standard requires the FDA to consider risks to the U.S. population, including adults who currently smoke.
Juul has argued that its products help draw current smokers away from traditional cigarettes.
“While more than two million Americans have switched completely away from combustible tobacco using JUUL, we’re focused on making the cigarette obsolete,” the company said. “And for us, that mission is non-negotiable: we’re the only company in the U.S. market with a vapor MGO that doesn’t also sell cigarettes.”
However, the FDA noted in its release that the authorization “does not mean these tobacco products are safe, nor are they ‘FDA approved.” It went on to say that “there is no safe tobacco product.”
Audacy reported three summers ago that on the Juul marketing denial orders and Jull CEO Joe Murillo’s plan to override the decision. Those marketing denial orders required Juul to stop selling and distributing vaping products.
Per the FDA, the U.S. Court of Appeals for the D.C. Circuit entered a temporary administrative stay of the marketing denial order for Juul Labs Inc. on June 24, 2022. Then, on July 5, 2022, the FDA administratively stayed the marketing denial order.
“The agency has determined that there are scientific issues unique to the JUUL application that warrant additional review,” it said regarding that action. “This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it.”
While Juul, a popular brand of vaping devices, has been facing the FDA challenge in recent years, Americans have still been vaping. Data released by the U.S. Centers for Disease Control and Prevention earlier this year indicates that the percentage of adults who used electronic cigarettes increased from 4.5% in 2019 to 6.5% in 2023. This May, Audacy reported that traditional cigarette smoking hit a record low among students in 2024.
“I want to attribute it to more health awareness and younger generation,” Detroit Medical Center Clinical Psychologist Dr. L.A. Barlow told Audacy. “They’re just a little bit more in tune with their health. And back years ago, it was kind of cool to smoke. Nowadays that’s not considered cool anymore.”
Still, the CDC said that more than 10% of adults aged 18 to 20 in the U.S. used vaping devices as of 2023. That figure rose to 15.5% among adults aged 21 to 24.
“We’re really concerned about youth vaping for a few reasons,” said Dr.
Pamela Ling director of the UCSF Center for Tobacco Control Research and Education, told Audacy last December. “One is that after vapes were introduced by 2018, we had a huge rise in the numbers of young people vaping. And even though those numbers have now come down somewhat, vapes are by far the most common tobacco product used by young people, far more than cigarettes.”
She also addressed health concerns related to vaping. At least one California lawmaker wasn’t happy to hear the news about Juul this week and cited health concerns as his reason.
“Juul is Big Tobacco with sleeker marketing. It is outrageous and dangerous that the FDA would approve Juul e-cigarettes for sale while in the same breath conceding that the reversal of the ban ‘does not mean these tobacco products are safe,’ especially when we know these products pose a particular threat to the health and safety of young people whom Juul has targeted with predatory marketing,” said Congressman DeSaulnier (D-Calif.)
There’s another issue at play too, as explored in a new report covered by KNX News this week: vape litter.
“Our report found is that vape waste is actually increasing. We’re now throwing away 5.7 vapes each second in this country,” explained Fiona Hines, legislative advocate for CALPRIG. “That’s about 500,000 vapes each year and if you were to line them all up in a row that would stretch the length of the U.S. three times.”