The Food and Drug Administration (FDA) blocked the sale of electronic cigarettes from Juul Labs Inc. in the United States on Thursday, 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 requests “lack sufficient evidence” to show that the sale of the products would be suitable 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 e-cigarette brands, including British American Tobacco Plc’s Vuse and Imperial Brands Plc’s Blu, had to meet a September 2020 deadline to submit applications to the FDA showing 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 increasing youth cigarette useFDA Commissioner Robert Califf said in a statement.
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 the data necessary to determine the relevant health risks.”, indicated Michele Mital, acting director of the Center for Tobacco Products of the FDA.
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 5% and 3% nicotine concentrations.
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.
Teen e-cigarette use skyrocketed with the rise in popularity of Juul in 2017 and 2018. Its use among high school students grew from 11.7% in 2017 to 27.5% in 2019, before fall back 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.