Those of us in the vape industry are well aware of the looming May 2020 PMTA deadline for deemed tobacco products on the market. The date had been moved numerous times through numerous FDA heads and judges. Most recently Judge Grimm moved the date to May 2020. The date had been extended into 2022 thanks to Scott Gottlieb then acting FDA commissioner. Moving the goal posts is a popular tactic of regulators.
Well it’s changing yet again, this time to September 2020. “Amid extended Covid19 Panic” A Maryland federal judge on Friday said that he would grant a 120-day extension to the deadline.
On the industry side, the pandemic has disrupted supply chains, including shuttering factories abroad that manufacture vape products. The FDA said it has received 15 letters from groups representing thousands of market players requesting a 180-day deadline extension in light of COVID-19 disruptions.
Perfectly reasonable in my opinion for this extension amid the COVID19 Pandemic. The FDA is clearly short staffed for dealing with this pandemic. I personally don’t believe the FDA would have been prepared for the PMTA’s before this pandemic, but I digress.
It’s a bit of a double edge sword in my opinion. It’s only being extended to due a lack of FDA resources. The chances of them taking this extension time to streamline the PMTA process or maybe finally roll out that help for small business that Sec Azar promised months ago, are slim to none in my mind.
When September comes I feel like we’re still going to be in the exact same spot we are right now with costly and burdensome regulations, miles of red tape and still no help for small businesses. I would LOVE for FDA to prove me wrong but…. come on.
*UPDATE AS OF 4/9/20
It appears this still has a few more steps to go through before it’s finalized and the date is actually moved.