The Food and Drug Administration (FDA) blocked on Thursday the sale of the electronic cigarettes of Juul Labs Inc. in the United States, which could be a death blow for the San Francisco company, which was once a success.
Following a nearly two-year review of scientific and public health data submitted by the company, the agency said the applications “lack sufficient evidence” to show that the sale of the products would be appropriate for public health.
Some of the findings raised concerns due to insufficient data and conflicts, such as the possibility of potentially harmful chemicals leaching from Juul pods, according to the agency.
Juul and other brands of electronic cigarettesWhat Vuse -of British American Tobacco Plc- and Blu -of Imperial Brands Plc-, had to meet the deadline of September 2020 to submit applications to the FDA showing that the products had a net benefit for public health.
The agency had to judge whether each product was effective in getting smokers to quit and, if so, whether the benefits outweighed the potential harm to the health of new e-cigarette users who had never smoked, such as teenagers.
“The agency has devoted significant resources to reviewing the products of companies that represent the majority of the US market. We recognize … that many have played a disproportionate role in the increase in youth cigarette use,” FDA Commissioner Robert Califf said in a statement Thursday.
Juul provided no evidence to show that the products meet the agency’s standards and raised “significant questions,” the FDA said.
“The FDA is issuing these marketing denial orders in the absence of data necessary to determine relevant health risks,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products.
Juul did not respond to a Reuters request for comment.
The company had applied for approval for its vaping device and tobacco- and menthol-flavored pods that had nicotine concentrations of 5 percent and 3 percent.
E-cigarette makers have been selling products in the United States for years without being officially authorized by the FDA, as regulators have repeatedly delayed deadlines for companies to comply with federal guidelines.
The use of electronic cigarettes by teens skyrocketed with Juul’s rise in popularity in 2017 and 2018. Usage among high school students grew from 11.7% in 2017 to 27.5% in 2019, before falling again to 11.3% in 2021, a federal survey showed.
In 2020, the FDA banned all flavors except tobacco and menthol for cartridge e-cigarettes like Juul. The company pulled all other flavors, including mint and mango, in late 2019 following regulatory scrutiny and outcry from anti-smoking advocates.
The administration of President Joe Biden has been looking at other ways to help people quit smoking in an effort to reduce preventable cancer deaths.
This week, the government said it plans to propose a rule setting a maximum level of nicotine in cigarettes and other products to make them less addictive.