FDA today formally rejected marketing applications for all current Juul Labs products, confirming yesterday’s leaked report. The agency has issued Marketing Denial Orders (MDOs) for the JUUL device, and Virginia Tobacco and Menthol flavored refill pods in both 3 and 5 percent strengths.
The order takes effect immediately. The FDA could, if it chose to, begin enforcement against Juul Labs and retailers selling JUUL at any time.
The agency based its decision on the flimsiest of grounds, claiming in a press release that Juul Labs’ Premarket Tobacco Application (PMTA) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
Jim McDonald – Vaping360 – 2022-06-23.
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