The US Food and Drug Administration (FDA) on Thursday banned the e-cigarette maker Juul from selling nicotine products in the US, dealing a massive blow to the California-based company.

“Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action,” the FDA said in a statement on Thursday, announcing the ban.

Also read | Supreme Court scraps New York gun law, making it easier to carry firearms

“The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%,” the agency added, detailing the products banned.

The FDA’s decision comes after a two-and-a-half-year long review of scientific evidence and public health data submitted by Juul wherein the agency judged whether Juul products helped smokers quit and whether the health benefits to smokers outweighed the potential harm to new e-cigarette users who had never smoked.

Also read | Monkeypox outbreak a pandemic, says independent global health body WHN

After a lengthy review, the FDA found that the Juul’s application “lacked sufficient evidence” to demonstrate that its products provided a net public health benefit to the US.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said, commenting on Thursday’s decision.

Also read | As monkeypox outbreak widens in US, how concerned should you be?

“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” Califf added.

However, it should be noted that the new ban only applies to the ” commercial distribution, importation and retail sales” of Juul products, and does not affect individual consumers already in possession of and actively using Juul products.