The FDA first ordered JUUL to stop selling its products in 2022, declaring that there was insufficient evidence that the e-cigarettes met public health standards. However, the vapes remained on shelves as the company went through the appeals process. Following additional review and after gaining “more experience with various scientific issues regarding e-cigarette products,” the FDA says in its latest news release that it is rescinding the ban on JUUL products. Rescission of the ban is not an authorization or denial of the company’s applications for full approval, and does not indicate whether the applications may be authorized or denied in the future, the agency says. E-cigarette use among youth spiked back in 2017 and 2018, according to the Centers for Disease Control and Prevention (CDC). That surge was “primarily driven by JUUL,” said Deirdre Lawrence Kittner, PhD, MPH, director of CDC’s Office on Smoking and Health. By 2019, more than half (53.3 percent) of high school students and roughly a quarter (24.3 percent) of middle school students reported having tried a tobacco product. E-cigarettes were the most commonly cited product used by high school and middle school students. In 2020, however, the FDA and CDC released new data showing a declined in e-cigarette usage among American youth. JUUL is among the top five selling e-cigarette brands, along with Vuse, Elf Bar, NJOY, and Breeze Smoke. The CDC said that e-cigarette monthly unit sales had “increased by 46.6%—from 15.5 million units in January of 2020, to 22.7 million units in December of 2022.” In a statement, JUUL says it appreciates the FDA’s decision and looks forward to working with the agency to obtain 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.The U.S. Food and Drug Administration (FDA) is reversing its ban on JUUL Labs, Inc. e-cigarettes while it reviews court cases and more information provided by the company.
