The FDA also issued a letter to JUUL requesting more information its marketing practices and its impact on public health. Juul commands three-quarters of the US e-cigarette market, with sales growing 783% between June 2018 and this year to $942.6 million, Wells Fargo reported.
In response, the agency sent Juul a warning letter over unauthorized marketing as well as a letter of concern (PDF), which included a request for reams of documents "regarding JUUL's marketing, advertising, promotional, and education campaigns, as well as certain product development activity".
According to CBC Canada, the FDA alleges that Juul's labeling and marketing of the e-cigarette devices lead consumers to believe they are safer than regular cigarettes and pose less of a risk for tobacco-related diseases.
The FDA gave JUUL 15 days to respond with a corrective action plan for the illegal marketing activities, and 30 days to provide the documents and information about its broader marketing and product design programs. "JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth", said Acting FDA Commissioner Dr. Ned Sharpless, in a statement.
The letter also sought documents related to JUUL's efforts to commission research by outside contractors (including, reportedly, an organization that has worked for other tobacco companies) and academic scientists.
Reached for comment, a spokesperson for Juul said the company is reviewing the letter and plans to "fully cooperate".
"Common sense says if you do not know what you are smoking, don't smoke it, and right now we don't know what you are smoking in a lot of these vaping substances", the New York Democrat said.
"Juul has maintained that its products are meant to convert adult smokers to what it described in the past as a less-harmful alternative".
Mr. Cuomo said he has ordered the state health department to issue emergency regulations that mandate that vape and tobacco shops post warning signs to address the increasing number of cases of respiratory illnesses and the e-cigarette youth epidemic.
The problem here is that the FDA requires that a "modified risk tobacco product" must be given certification before being advertised as such.
E-cigarette makers now have to submit pre-market product applications to the FDA by May 2020, the result of a federal lawsuit filed by advocacy groups against the federal agency past year.
The first vaping product to enter the USA market was a Ruyan e-cigarette imported by Mark Weiss, founder of e-cigarette company NJOY.
"Witnesses testified, for example, that Juul advertising saturated social-media channels frequented by underage teens and that Juul used influencers and discount coupons to attract new customers", a letter, signed by Center for Tobacco Products director Mitchell Zeller, states.