First PMTA from an Indie Vape Manufacturer Submitted


E-Alternative Solutions (EAS) has submitted Premarket Tobacco Applications for its closed-system vape products to the FDA.

The company is the first vaping manufacturer not owned by a major tobacco company to announce a PMTA submission. All of the big tobacco companies that sell vaping products in the U.S. have submitted applications, the most recent being Imperial Brands’ application for myblu.

The EAS PMTAs submitted were for the company’s Leap device and pods and its Leap Go disposable product. Leap products are primarily sold in convenience stores, and are designed to compete with popular pod and disposable products from JUUL, NJOY, and similar tobacco industry products. EAS also sells a line of CBD products.

Since the FDA’s January 2020 guidance prohibiting sales of prefilled pods in flavors other than tobacco and menthol, EAS suspended its sales of fruit- and candy-flavored Leap pods, although it continues to sell the disposable Leap Go in mint and mango flavors. The company has submitted all of its flavors for FDA approval. But because only currently marketed products may remain on sale after the Sept. 9 PMTA submission deadline while the agency reviews the application, the candy and fruit Leap pods will remain unavailable until (and if) the PMTA is approved.

Read full article here.

Jim McDonald – Vaping 360 – June 23, 2020.

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