The U.S. Food and Drug Administration has issued a warning letter to Juul Labs for marketing what it called "unauthorized" modified risk tobacco products by "engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school".
The FDA had also threatened to fine the company for its practices and even went as far as to threaten possible seizures of its products if it does not immediately rectify its marketing practices.
The FDA's warning letter also raises issues with certain statements made by those attending a July U.S. congressional hearing where a panel grilled Juul over a "holistic health education" camp it funded, as part of efforts to market its products directly to school-aged children.
Last year, 3.6 million middle and high school students across the country used e-cigarettes, up 1.5 million from the previous year, the FDA reported.
Krishnamoorthi's letter followed a two-day hearing in July, after which the committee concluded that "JUUL appears to be violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes".
"Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful."
A spokesperson for JUUL told UPI, "We are reviewing the letters and will fully cooperate", but did not have further comment on the details of either letter.
"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.
Under FDA rules, all companies that sell any kind of tobacco products, or in this case products that contain nicotine, should seek regulatory approval before distribution.
"Juul has maintained that its products are meant to convert adult smokers to what it described in the past as a less-harmful alternative".
The FDA has given JUUL 15 days to provide a written response to the agency's concerns. "We need to do all we can to protect the public from tobacco-related disease and death, and prevent e-cigarettes from becoming an on-ramp to nicotine addiction for a generation of youth". The teens, who were in 9 grade at the time, said that to make the seminars a "safe space" where kids could speak openly, teachers are asked to leave the room. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. "With respect to our work to tackle the youth e-cigarette epidemic, we remain committed to our oversight of e-cigarettes and to keeping them out of the hands of youth".
And they continue to be the most used tobacco product among USA teens.