Finally, some positive news for the vapor industry. The much anticipated premarket tobacco product applications (PMTA) for the Leap pod system and Leap Go disposable were delivered to the U.S. Food and Drug Administration (FDA) on Tuesday. E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, is seeking authorization for the marketing and sale of its wide-ranging portfolio of Leap and Leap Go vapor products.
“We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.
“At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”
The submission of PMTAs by EAS plays an integral role in supporting the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health, according to a press release. The collective 75,000+ page PMTA submissions for Leap and Leap Go are the result of months of hard work and investigation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies.
In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products, according to the release.