When FDA Commissioner Scott Gottlieb announced through a press release last Friday that the deeming regulations would get a 5-year extension, vapers around the nation breathed a heavy sigh of relief. After nearly two years of continuous criticism from the federal public health agency, Gottlieb’s brief and eloquent statement may have just saved vaping from total and complete annihilation.
According to the FDA deeming regulations, the original deadline for retailers to adhere to the Pre-Market Tobacco Applications (PMTA) process was to be this month in August of 2018. After a 3-month extension provided by the Trump Administration shortly after his surprise November victory, the vaping industry was still under constant threat of an FDA approval process that could cost millions of dollars per product.
Did FDA Commissioner Gottlieb just save vaping?
Facing industry-wide bankruptcy, vapers were pinning their hopes and dreams on an inexperienced president whose Tweets often inspire fierce debate regardless of political affiliation. On Friday, July 28, 2017, Trump and Gottlieb finally came through. Vape retailers and manufacturers would rest easy until November 2022.
“Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.”
-Per the FDA news release
Not only is the PMTA process too costly for most vape shop owners to afford, the FDA deeming regulations still remain relatively unclear as to how long the approval process will take. The statutes also fail to guarantee whether those who apply will be granted FDA approval in the end, even if they happen to be able to afford the million-dollar PMTA price tag.
Furthermore, all vapor products released to market since February 2007 would be affected by the PMTA process. With a predicate date that is more than ten years in the past, this means that nearly 99 percent of the entire American vaping industry will be affected.
In a single press release, FDA Chief Gottlieb managed to put an immediate, although temporary, kibosh on this whole devastating notion of out-of-control government regulation. Vaping will live to see another day – another five years of days, to be exact! Hell must have just frozen over.