Last March the FDA issued its much-anticipated guidelines with regards to new restrictions on vaping products. The draft had been released just weeks before Commissioner Scott Gottlieb’s set exit, and was infact one of Gottlieb’s priorities following the backlash he faced for the alleged increase in teen vaping, which many conveniently blamed on the PMTA delay.
This guidance had called for the ban of flavoured products with the exception of tobacco, mint or menthol-flavored e-cigarettes, from retail stores that minors can access easily, such as convenience stores or gas stations.
The PMTA had already been moved a year forward
Gottlieb had been repeatedly criticised for the PMTA delay, which has been blamed for helping fuel the alleged rise in teen vaping.
Additionally, the document had also announced that the infamous PMTA deadline which the FDA has been heavily criticised for, was now to be moved a year forward from 2022 to 2021. Back in March U.S. Rep. Nita Lowey had repeatedly called out Gottlieb for the delay, saying that it was a “big, big whopping mistake” and that it helped fuel the alleged rise in teen vaping.
Meanwhile last Friday, a court case which had been brought about by anti-tobacco and health groups after the FDA had announced the PMTA delay, has resulted in a ruling requiring e-cig manufacturers to submit their PMTAs by May 2020.
“Given the uncertainty in the efficacy of e-cigarettes as smoking cessation devices, the overstated effects that a shorter deadline may have on manufacturers, the industry’s recalcitrance, the continued availability of e-cigarettes and their acknowledged appeal to youth, and the clear public health emergency, I find that a deadline is necessary,” U.S. District Judge Paul Grimm wrote in his order.
The FDA in favour of the ruling
The new FDA Commissioner Ned Sharpless, said that the FDA is in favour of this ruling. “Today’s ruling is an important step forward for public health,” said Sharpless in an emailed statement. “The FDA stands ready to accelerate review of these products and will continue its vigorous enforcement and public education efforts to protect kids from e-cigarettes.”
Read Further: Bloomberg