The PMTA process is so costly and time consuming, that well meaning small vaping businesses will not be able to afford it, allowing the major tobacco companies to be its sole survivors.
Last July, a court case which had been brought about by anti-tobacco and health groups following the announcement of the initial PMTA delay (to 2022), had resulted in a ruling requiring e-cig manufacturers to submit their PMTAs by May 2020.
To this effect, Reynolds, has submitted over 150,000 pages of documentation, including information on the composition, design and manufacturing process associated with its product, Vuse, as well as safety data. The tobacco company has pointed out that it has worked with a team of over 100 people in order to get all the filing in order.
This is a clear indicator of what the vaping industry has long been pointing out: the licensing process is so costly and time consuming, that well meaning small vaping businesses will not be able to afford it, allowing the major tobacco companies to be the sole benefitters and survivors of the PMTA process.
The VTA lawsuit against the amended PMTA deadline
To this effect, last August the Vapor Technology Association (VTA) filed a lawsuit in response to the PMTA ruling in an attempt to reverse it. The industry group called the expedited deadline, “arbitrary” and pointed out that it is “impossible to meet for thousands of small and mid-sized vapor businesses.”
“The stark facts set forth in the complaint are that, even with unlimited resources, there are not enough labs, there are not enough subjects, and there are not enough hours in the day to properly conduct the scientific inquiries that FDA only just laid out … by the May 2020 deadline,” said the VTA.
To date, the PMTA deadline has been changed five times
The vaping association which represents about 800 companies, pointed out that up until now the FDA has set five different PMTA deadlines. “It is time for FDA to stop moving the goalposts and changing the rules in the middle of the game to the detriment of our manufacturers and small businesses,” said VTA executive director Tony Abboud in a statement. “FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette,” he added.
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