JUUL Labs says FDA Will Review Its E-Cigarette, Nicotine Cartridge Applications
“We will continue to follow the PMTA process and look forward to this next step”
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.
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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