The Food and Drug Administration (FDA) authorized Juul Labs to keep its e-cigarettes on the U.S. market this week, reported The Wall Street Journal. The FDA’s decision comes five years after Juul first submitted its products for federal review.
In its decision, FDA determined that “the products’ benefit to adult cigarette smokers outweighed any potential public-health risks, including to young people, a spokeswoman for the Department of Health and Human Services said. The move gives the green light to Juul’s original vaporizer, along with refill cartridges in tobacco and menthol flavors,” wrote the WSJ.
Juul Chief Executive K.C. Crosthwaite said the FDA’s decision “validates our science and the efficacy in switching smokers.”
“Juul Labs has been dedicated to building trust in our products for nearly a decade since we first entered the U.S. market. This work continues to be driven by our mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We will continue to drive innovation in the vapor industry through our in-house product design, research and development, and science teams in Silicon Valley and North Carolina. We are proud of the quality control capabilities we enjoy with Maryland-sourced e-liquid and pod filling in Wisconsin and Tennessee,” Juul said in a statement.
In 2018, Altria Group Inc. announced a $12.8 billion investment in Juul. Altria’s investment represented a 35% economic interest in Juul, valuing the company at $38 billion in 2018. Juul remains fully independent and has access to Altria’s infrastructure and services. Altria provides Juul access to its premier tobacco products’ retail shelf space, allowing Juul’s tobacco and menthol-based products to appear alongside combustible cigarettes.
In January of this year, FDA authorized the marketing of 20 Zyn nicotine pouch products through the premarket tobacco product application (PMTA) pathway after an extensive scientific review. This is “the first time the agency has authorized products commonly referred to as nicotine pouches,” it said.