U.S. FDA warns Juul over its marketing practices

Juul boxes on display

Juul boxes on display

No vaping product has been federally reviewed to be less harmful than traditional tobacco products.

The FDA is also raising questions about Juul's "Make the Switch" campaign, which the agency worries presents Juul as "a safer alternative to cigarettes" - despite the fact that the FDA has not authorized such a message.

The in-school presentations central to the FDA's latest concerns came to light during a Congressional hearing held July 24 and 25, titled "Examining JUUL's Role in the Youth Nicotine Epidemic". The students said a Juul representative was invited to address the school as part of an assembly on mental health and addiction issues.

Juul says it discontinued its school programs - which were meant to discourage underage use - last September.

The rise of e-cigarettes has led to a 20 percent increase in teen vaping between 2017 and 2018, with at least 3.6 million teen users nationwide. The company now has 15 days to respond to the FDA and detail the steps it's taken to right its wrongs.

E-cigarettes have been on the USA market for more than a decade, but the FDA didn't gain the authority to regulate them until 2016. The industry is under mounting scrutiny due to a surge in teenage vaping and recent deaths that public-health officials have connected to inhaling vapor from e-cigarettes.

Most experts agree the aerosol from e-cigarettes is less harmful than cigarette smoke because it doesn't contain most of the cancer-causing byproducts of burning tobacco. "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".

Juul has been at the center of almost every news story about the still mysterious lung illnesses that have cropped up in hundreds of cases around the country.

In the letter to Juul CEO Kevin Burns, FDA regulators said they were "troubled" by a number of other points raised at the congressional hearing.

"[Juul] 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", the letter reads.

Federal officials have been pushing Juul - the biggest player in the United States e-cigarette market - to modify its marketing since past year, amid a startling increase in youth vaping. The FDA has proposed regulations on e-cigarettes that would restrict their sales in most stores, though they have not been finalized.

Three days after the Centers for Disease Control announced that five people have died of severe lung illnesses linked to vaping and reported cases have more than doubled to 450, First Lady Melania Trump tweeted that she is "deeply concerned" about teen e-cigarette use. Juul's failure to get such authorization, the FDA said, means that the company sold and marketed "adulterated" products.

Last year, the agency had requested documents from Juul to examine the high rates of youth use and had conducted a surprise inspection at Juul's San Francisco headquarter, seizing documents.

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".

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