Virginia-based vaping retailer and e-liquid manufacturer AVAIL Vapor announced today that a PMTA for a flavored e-liquid submitted by AVAIL has been accepted by the FDA for substantive review.
All vaping manufacturers must submit PMTAs (Premarket Tobacco Applications) by Sept. 9 for products they intend to sell on the legal market after that date.
AVAIL says the application is the first of “numerous applications that AVAIL plans to file” before the deadline, “which will enable AVAIL to provide a wide-ranging flavor portfolio” to customers. The company did not release the names of all products submitted, but confirmed that its mixed berry flavor Mardi Gras was among them.
Today’s announcement from AVAIL marks the first known example of a flavored, bottled e-liquid (or open-system vaping product of any kind) being accepted for further study by federal regulators. Reaching the substantive review stage means that the products submitted may remain on the market for up to one year, or until the agency issues a final decision on whether they may be legally marketed.
Jim McDonald – Vaping360 – August 11, 2020.