PMTA FDA Regulations in the United States

The biggest hurdle comes later this year when Juul and other e juice companies must submit an application to the Food and Drug Administration seeking permission to remain on the market.
Crosthwaite, CEO of Juul, says he is “very excited” to make its case. He plans to submit scientific studies showing Juul products can be a beneficial alternative for smokers, and will highlight the company’s plans to limit vaping by minors.
In his nine months at the helm, Crosthwaite has joined President Donald Trump at the White House and testified before a House committee. He declined to elaborate on any additional meetings he’s had.
The shift hasn’t been painless. Juul slashed about 40% of its workforce through two rounds of cuts, and remaining employees have had to adapt quickly as the company grappled with the public furor around vaping.
“If we have an employee who doesn’t agree that earning the license to operate is important or building trust with stakeholders is important, then this is probably the place they shouldn’t be,” Crosthwaite said. “We firmly believe that that is the right approach and that is the path we’re pursuing.”
Juul’s market share declined about 10% over the past year, even as it still represents 60% of sales in convenience stores and similar outlets, according to market research firm IRI. Crosthwaite says he’s OK with a shrunken business as long as it is pursuing the right strategies.
First-quarter sales reached $394.2 million, according to a financial disclosure viewed by Bloomberg News. If the trend holds for the year, Juul could surpass the $1.3 billion in sales recorded in 2018, while still falling short of the $2 billion seen last year.
Michael R. Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. He is the majority owner of Bloomberg LP, the parent company of Bloomberg News.