As vape giant JUUL files it’s PMTA anti-vaping groups are calling on the FDA to reject the application.
Without a Pre Market Tobacco Application no vape company will be able to legally sell any product in America.
JUUL has submitted a batch of scientific evidence covering the device and two pods, the Virginia Tobacco and Menthol flavours at both 5% and 3% nicotine strengths.
Given the company has been labelled as the cause of the alleged teen vaping epidemic in the US, the company has also supplied the FDA with ‘data-driven measures to address underage use of its products.’
It has put together 125,000 pages of information and used evidence from 110 studies on underage vaping as part of its submission.
Juul Labs CEO K.C. Crosthwaite said:
In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use.
Our PMTA submission is a key part of that approach.
Joe Murillo, Chief Regulatory Officer at Juul Labs said:
Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use.
We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.
As you have gathered the hysterical anti-vaping brigade has got their collective knickers in a twist and are screaming from the rooftops lol.
Parents Against Vaping E-cigarettes [PAVE] co-founder Meredith Berkman said:
If Juul really cared about protecting our youth or about initiating youth through its products, it wouldn’t be submitting menthol.
You just can’t win with a collection of Karens screeching ban all the vaping things it would seem…tsk tsk Neil lol…
JUUL Files PMTA – Deadline Is Getting Closer
No matter what you might think about the brand I really hope the FDA judges the PMTA on merit and not on JUUL’s ‘controversial’ rise to prominence.
All vape companies wishing to sell vape devises and e-liquid in the US have until September 9th 2020 to submit an individual PMTA for every single flavour or product.
Once submitted the item can then be left on sale for 12 months or until the FDA rules otherwise.
One thing is clear, time is running out with barely a handful of vape companies submitting PMTAs, whilst a number of tobacco companies selling vape kits have submitted.
I have a feeling it’s going to be carnage come deadline day and unless the big Chinese vaping manufacturers don’t sort it out soon they will simply not be able to sell ANY products in America.
Read more about the FDA PMTA process.
More vaping news on Wednesday…