UNITED STATES
FDA to review Juul products

Juul Labs has received confirmation from the FDA that its Premarket Tobacco Product Applications (PMTA) is moving to the substantive review phase, according to the company website.

The Food and Drug Administration (FDA) will now review and evaluate the company’s Juul System, an electronic nicotine delivery system product. The submission to the FDA includes comprehensive scientific evidence for the Juul device and its accompanying Juul pods in Virginia Tobacco and Menthol flavours as well as information on measures to address underage usage of the products, reads the statement on the Juul website.
Juul Labs had come under fire for its marketing strategies last year and is now seeking to work with regulators, legislators and public health officials to combat underage use and focus on the transition for adult smokers from combustible cigarettes. According to the announcement, the company has reduced its product portfolio, built up its science and evidence-based capabilities, and supported the US Administration’s final flavour policy for ENDS 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 Joe Murillo, Chief Regulatory Officer at Juul Labs.

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