JUUL Labs says FDA will review its e-cigarette, nicotine cartridge applications

The Food and Drug Administration has notified JUUL Labs that its Premarket Tobacco Product applications for its e-cigarette device and nicotine cartridges will undergo a "substantive scientific review", according to an announcement by the company on Tuesday.

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JUUL Labs filed the applications last month in an effort to continue to sell its e-cigarette products despite scrutiny over its impact on underage children.

The company’s submission includes "comprehensive scientific evidence for the JUUL Device and JUULpods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5%, 3% and information on data-driven measures to address underage use of its products.

“We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement.

A spokesperson for the FDA did not immediately return FOX Business's request for comment.

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The move comes on the heels of a recent peer-reviewed study from Stanford University's School of Medicine, where researchers found that teens and young adults who use electronic cigarettes are at "a substantially increased risk of COVID-19."

The study noted that young people who had used both cigarettes and e-cigarettes in the previous 30 days were almost five times as likely to experience COVID-19 symptoms such as coughing, fever, tiredness and difficulty breathing as those who never smoked or vaped. Depending on which nicotine products they used and how recently, young people who vaped or smoked, or both, were 2.6 to nine times more likely to receive COVID-19 tests than nonusers.

“Now is the time,” Dr. Bonnie Halpern-Felsher, the study's author, said. “We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for COVID-19 and other lung disease.”

The data was collected in a survey conducted in May that included 4,351 participants ages 13 to 24 who lived in all 50 U.S. states, the District of Columbia and three U.S. territories.

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JUUL added that it committed to resetting the vapor industry last year by seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to "combat underage use and transition adult smokers from combustible cigarettes."

As part of that process, the company noted that it "reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence."

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