FDA Approves First Disposable Vape

Recently, the first disposable vape device passed the PMTA approval process. The NJOY Daily Rich Tobacco and the NJOY Daily Extra Rich Tobacco disposable vapes have now both been approved for sale. A majority of NJOY’s other flavors have been given MDOs, or marketing denial orders. Two menthol flavors, like many other menthol vapes, have not been given a verdict and are still under consideration by the FDA.

Both disposables are relatively high in nicotine concentration - the Daily Rich Tobacco comes in 4.5% nicotine (45mg) and the Daily Extra Rich Tobacco comes with 6% nicotine (60mg).

This is not NJOY’s first device to be approved by the FDA - the NJOY Ace and its tobacco flavored pods were approved in April, 2022. Other products authorized by the FDA include the Vuse Solo, Vuse Ciro, Vuse Vibe, Logic Pro, and the Logic Power.

Overall, the FDA has leaned towards approving closed systems with tobacco flavored products while issuing denial orders towards open systems and flavored products. The exception are menthol flavored products, which are generally undecided as the FDA is moving to ban menthol cigarettes as well.

Though the FDA has been quite slow to work on pending PMTA applications, progress has recently sped up - possibly due to demand for increased transparency on the process by vaping and anti-vaping advocates alike.

References:

FDA Roundup: June 10, 2022

FDA Grants PMTA Approval to Additional NJOY Products | Convenience Store News