FDA Sends Warning Letter To Vaping Company Juul

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Specifically, "our review of testimony from the July 24-25, 2019 House Subcommittee hearing, documents from FDA's inspection of Juul's headquarters, Juul's submissions to the agency, and Juul's website, revealed that your firm has engaged in labeling, advertising, and/or other activities directed to consumers, in which JUUL explicitly and/or implicitly has represented that Juul products are free of a substance, have a reduced level of or exposure to a substance, and/or that Juul products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products", states the letter signed by Anthony Villa, senior regulatory counsel for the FDA Center for Tobacco Products. "In addition, we're troubled about several issues related to JUUL's outreach and marketing practices that came to light in a recent Congressional hearing".

For example, the company reportedly presented information about its e-cigarettes to school kids.

According to the FDA, even if Juul's products are found to be safer than cigarettes, the company still needed to demonstrate to the agency using scientific evidence to prove that fact.

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", Acting FDA Commissioner Dr. Ned Sharpless said in a statement.

PHILIP FUHRMAN: He mentioned that the FDA was about to come out and say that Juul was 99% safer than cigarettes. In a statement provided to Engadget, a Juul spokesperson said, "We are reviewing the letters and will fully cooperate".

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"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. The FDA said it found that Juul illegally sold or distributed its products as "modified risk tobacco products without an FDA order in effect that permits such sale or distribution".

The FDA points to a letter written by the Juul chief executive officer in which it was claimed that smokers could enjoy Juul products without the harm associated with traditional smoking.

As many as 450 people across 33 USA states were hospitalized with lung illnesses related to use of the electronic devices, health officials announced on Saturday.

'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. This ought to be closely regulated by the Food and Drug Administration.

In response to Durbin's criticism, FDA spokeswoman Stephanie Caccomo said in an emailed statement on Friday that the agency looks forward to "engaging with Senator Durbin, along with all members of Congress, on this ongoing and very serious situation". "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".

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