E-Alternative Solutions (EAS) is committed to making sure retailers understand the importance of FDA’s PMTA process. Which vapor products on your shelf will meet FDA expectations?
This June, E-Alternative Solutions (EAS) is submitting Premarket Tobacco Applications to the U.S. Food & Drug Administration (FDA) for a wide-ranging portfolio of Leap® Leap Go® vapor products. EAS is submitting its applications nearly 3 months ahead of the deadline, which demonstrates its commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarettes. The company continues to hold itself to the highest possible standards and remains committed to prioritizing harm reduction as the vapor category continues to evolve.
Spanning more than 75,000 pages, EAS submissions for Leap and Leap Go are the result of months of hard work and dedication to support the proposition that these products are appropriate for the protection of public health. EAS’s team of researchers and scientists conducted extensive analyses to arrive at this conclusion. More specifically, areas of investigation included characterization of the e-liquid and vapor generated from the Leap and Leap Go products, stability of the products over time, physical characteristics of the products, toxicological formula reviews, toxicology testing, clinical 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.
It’s critical to remember that FDA does not plan to publish information related to the status of pending PMTAs or even to notify the general public as to which product applications were submitted. Because of this, the duty falls on retailers to inquire with vapor partners, like EAS, about the status of their PMTAs. Retailers should ask their partners for, by way of example, evidence of their initial submission, letters of acceptance, and/or letters of filing to assess whether their partners will be able to continue selling vapor SKUs after September 9, 2020. Retailers should also ask for consistent, transparent communication from vapor partners while individual PMTAs are under review.
For retailers, this process should definitively settle questions of which vapor products can legally remain on the market. The forthcoming PMTAs deadline should facilitate a new era of regulatory clarity, and EAS will be there with retailers every step of the way so they know what this means for their business.
CLICK HERE to request more information about Leap and Leap Go vapor products.
This post is sponsored by EAS