FDA Commissioner Robert Califf said that the marketing denial order announced on Thursday represents the agency’s “commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.” In response, Juul Labs asked the appeals to nix the “extraordinary and unlawful” order.
The company said in its filing that the FDA “cannot credibly argue that there is a critical and urgent public interest” in removing its products from the market right now “rather than after this Court reviews FDA’s action,” according to Axios.
Juul — which markets itself as an alternative to cigarettes for adult smokers — sells nicotine capsules smoked through a small device. Sales surged nearly 800% between 2017 and 2018, causing Juul to gain a 68% market share in the e-cigarette category. The Wall Street Journal first broke news on the FDA’s ban of the product earlier this week.
“The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market,” the outlet explained.
Indeed, over the past four years, the FDA has been seeking ways to regulate e-cigarettes — especially for younger consumers.
“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” former FDA Commissioner Scott Gottlieb said in 2018. “While we remain committed to advancing policies that promote the potential of e-cigarettes to help adult smokers move away from combustible cigarettes, that work can’t come at the expense of kids. We cannot allow a whole new generation to become addicted to nicotine.”
At the same time, state governments began hitting Juul with lawsuits over its marketing practices, claiming that the company was intentionally encouraging young people to buy its devices.
The state of North Carolina sued the company in 2019 for “designing, marketing, and selling its e-cigarettes to attract young people and for misrepresenting the potency and danger of nicotine in its products.” One year later, a complaint from the commonwealth of Massachusetts argued that the company “engaged in unfair and deceptive acts and practices” by “selling nicotine products to children, adolescents, and other consumers younger than the minimum legal sales age.”
After reviewing Juul’s permanent tobacco product application, the FDA decided that the documents “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” Accordingly, Juul devices and four types of pods will receive the FDA’s “highest enforcement priorities.”
“In addition to ensuring that JUUL complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers,” a statement from the agency said. “Specifically, the FDA notes that all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action.”
Tim Meads contributed to this report.
This report has been updated to include additional information.