Flavored E-Liquid PMTA Substantive Review Accepted by FDA
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 [...]
Premium Cigar Regulation and Substantial Equivalence Reevaluated by FDA
As the premium cigar industry barrels toward the Sept. 9, 2020 deadline to file Substantial Equivalence applications, many have been holding out hope for a last minute reprieve. Substantial Equivalence is part of the [...]
FDA PMTA Enforcement Deferment for Cigars but Not Vapes
In a letter to U.S. District Court Judge Paul Grimm, the FDA has requested permission to defer PMTA enforcement against manufacturers of premium cigars—but not vaping products. The deadline to submit Premarket Tobacco Applications for all deemed [...]
PMTA Process Looks to Favor JUUL
Juul Labs has filed its long-awaited PMTA, which includes no flavored products aside from tobacco and menthol pods. Juul filed six weeks before the Sept. 9 Premarket Tobacco Application deadline for all vaping products. Assuming the [...]