E-Alternative Solutions Submits Premarket Tobacco Product Applications to U.S. FDA for Leap® and Leap Go® Vapor Products
Submissions made ahead of September 2020 filing deadline
E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, announced today that it has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) 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. 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.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “From an industry perspective, the PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with FDA will help build a strong future for both the vapor industry and adult consumers.”
EAS continues to establish a leadership role in the creation of sensible industry standards and regulations as member of the Board of Directors of both the National Association of Tobacco Outlets (NATO) and the Vapor Technology Association (VTA), where EAS led the initiative to formulate the VTA marketing standards for membership. The company continues to advance the interests of the industry’s consumers, manufacturers, wholesalers, small business owners, and entrepreneurs.
About E-Alternative Solutions
Founded in 2014, E-Alternative Solutions (EAS) develops, markets and distributes retail products for adults seeking alternative brands that fit their lifestyle vision. EAS’s business pillars of understanding the marketplace, putting its partners first, and providing reliable regulatory analyses have positioned it as a respected leader in emerging industries. EAS is a member of both the Vapor Technology Association (VTA) and National Association of Tobacco Outlets (NATO) Board of Directors, and prioritizes compliance with applicable federal, state and local laws and regulations regarding e-vapor and products containing CBD. EAS is dedicated to a world beyond.
CONTACT : easmedia@yr.com
Ellene Hu : ehu@ealternativesolutions.com