E-Alternative Solutions Receives Acceptance and Filing Letters from U.S. FDA for Premarket Tobacco Product Applications for Leap® and Leap Go® Vapor Products
EAS submissions move to Substantive Review phase
E-Alternative Solutions (EAS), an independent, family-owned innovator of consumer-centric brands, announced today that the U.S. Food and Drug Administration (FDA) has issued Acceptance and Filing Letters for its Premarket Tobacco Product Applications (PMTAs) for its Leap® and Leap Go® vapor products. This notification moves the EAS submissions to the Substantive Review phase of the PMTA process.
“This milestone represents an important step forward for EAS as we support our mission of producing high-quality vapor products that serve as an alternative to combustible cigarettes with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, President and CEO of EAS. “FDA Acceptance and Filing Letters are a testament to the strength and thoroughness of our applications, which we believe will meet FDA’s requirements. We want to thank FDA for the prompt turnaround on these materials given the challenging circumstances, and we look forward to partnering with the Agency as we move forward in the process.”
The Acceptance Letters follow the administrative review of EAS’s filings to ensure that the submissions met the baseline criteria for review. The Filing Letters are the result of a preliminary scientific review that ensures that the applications include the necessary ingredients and health analyses. FDA will now conduct a Substantive Review to assess whether the Leap and Leap Go products are appropriate for the protection of public health. If successful, this phase will result in Marketing Orders from FDA authorizing the continued marketing and sale of these products.
Click the links below to view EAS’s Letters of Acceptance and Filing for Leap and Leap Go vapor products.
Leap Letter of Acceptance
Leap Letter of Filing
Leap Go Letter of Acceptance
Leap Go Letter of Filing
“The Substantive Review is where our months of hard work assembling more than 100,000 pages of evidence will pay off in supporting our proposition that the Leap and Leap Go products are appropriate for the protection of public health,” said Chris Howard, Vice President, General Counsel and Chief Compliance Officer at EAS. “We are looking forward to continued collaboration with FDA in the weeks and months to come and remain optimistic that the PMTA process will result in Marketing Orders.”
EAS is committed to leadership in the vapor industry and transparency throughout the PMTA process. The company believes that openness throughout this process will help maintain open communications between EAS and valued wholesale and retail partners as they navigate a new era of regulation. As a member of the Board of Directors of both the National Association of Tobacco Outlets (NATO) and the Vapor Technology Association (VTA), EAS remains committed to establishing high standards for the vapor industry through a fair and honest PMTA process that accommodates the needs of the industry at large.
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.
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