ARTICLE COURTESY OF GLOBENEWSWIRE
RICHMOND, Va., Aug. 11, 2020 (GLOBE NEWSWIRE) — via NetworkWire — AVAIL Vapor, LLC, a leading premium U.S. retailer, announced today that it has received its first Premarket Tobacco Application (PMTA) acceptance from the U.S. Food and Drug Administration (FDA) for its e-liquid nicotine products. Blackbriar Regulatory Services, LLC, led the highly strategic regulatory process for AVAIL’s submission. The application now moves to the substantive scientific review, during which the FDA will determine if AVAIL has scientifically proven that its nicotine vaping products are appropriate for the protection of public health. This is one of numerous applications that AVAIL plans to file prior to the FDA’s September 9, 2020, PMTA submission deadline, which will enable AVAIL to provide a wide-ranging flavor portfolio to meet the needs of adults seeking alternative choices to combustible tobacco products.
“We started mapping out our regulatory framework and PMTAs in 2015, before nicotine vaping products became subject to the FDA’s tobacco authority,” stated AVAIL Chairman James Xu. “We couldn’t be more pleased that the years of hard work, investment and dedication have gotten us to this point. Our end goal is to seek an FDA marketing order, which will allow us to continue to keep our products on the market for those adult smokers looking for alternatives to traditional tobacco products.”
In order for nicotine vaping products to remain on the market after the FDA’s September 9 PMTA submission deadline, companies must submit a viable PMTA with the intent of seeking an FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. Since AVAIL’s inception, the company has remained committed to being a highly responsible industry leader through compliance, transparency and marketing practices while continuing to provide adult consumers with high-quality nicotine alternatives.
About AVAIL
Richmond, Virginia-based AVAIL is a premium retailer that offers a broad array of products online and in its 97 stores across 12 states. The company delivers on the promise of quality and transparency. Information on AVAIL products is available through its retail stores and on the web at www.availvapor.com.