Juul Labs Inc. has filed an application with the Food and Drug Administration (FDA) to continue selling its e-cigarettes in the US, Bloomberg reported.

Juul said in a statement that it is seeking authorisation for its device as well as its Virginia tobacco and menthol-flavoured pods with 3% and 5% nicotine concentrations. With its PMTA submission, Juul has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totalling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage, Juul said.
“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.
FDA spokeswoman Alison Hunt said in a statement the agency is aware of Juul’s disclosure, but it can’t comment on the status of any specific application. Generally, she said, the law requires the FDA to “consider the risks and benefits to the population as a whole, including users and non-users of tobacco products, including youth,” according to Bloomberg.
The deadline for companies to submit applications to remain on the market is now 9 September. That date was pushed back earlier this year as a result of the Covid-19 pandemic.