As the title says, the FDA PMTA carnage begins as it refuses to allow 55,000 vape products to be sold on the open market.
Many fear this could spell the beginning of the end for vaping in the USA as we know it, especially with the deadline for decisions on PMTAs looming on September 9th this year.
The FDA is currently ploughing through over 2million PMTA applications – including from JUUL – and insiders are not hopeful many will get through the mountain of expensive red tape.
Back in 2019 I wrote the article: Forget Flavour Bans the PMTA Process Is the REAL Threat To US Vapers – and that doom laden forecast looks like coming true.
I also showed back then how the FDA shifted the goalposts on PMTA’s in the article: Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward.
That piece explains more about what Pre-Market Tobacco Product Applications entail, and show they can cost up to $460,000 for each application and need to have a mountain of detailed scientific paperwork attached.
OK, that’s how we got here, so who are the 3 unfortunate vape companies involved, and why has the FDA refused the PMTA applications?
FDA PMTA Carnage Begins
JD Nova Group LLC, Great American Vapes and VaporSalon are named by the FDA as:
Failing to Provide Evidence They Appropriately Protect Public Health
Acting FDA Commissioner Janet Woodcock, M.D. said in a statement:
Congress gave the FDA the authority to regulate tobacco products to protect the public from the harmful effects of tobacco use through science-based regulation.
Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death.
The good lady has of course failed to recognise e-liquids and vape devices DO NOT contain tobacco…so much for the ‘science‘.
And of course, Woodcock couldn’t help but mention the ‘menace‘ to the youth of America that vaping apparently presents adding:
We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed.
For the record, the so called youth vape epidemic has shown to be a falsehood so many times now it’s becoming embarrassing.
Despite all the data and research showing vaping is considerably safer than smoking and the very best cessation aid, the FDA is still pandering to idiotic anti-vape groups and sound bite hungry ignorant politicians.
As I’ve said before, it beggars belief and is bordering on criminal.
FDA PMTA Carnage Begins – Reactions To the FDA’s Denial Of PMTAs
As you can imagine, the rabid anti-vaping Bloomberg funded mums army were positively crowing at the announcement.
Parents Against Vaping were popping corks on hearing the FDA PMTA carnage begins and tweeted:
Pleased that @FDATobacco denied 55 thousand flavored product applications from JD Nova Group, Great American Vapes, and Vapor Salon. But it’s just a first step: FDA must deny @JUULvapor and ALL other flavored ecigs including menthol by September 9th. https://t.co/f307WJajvT
— ParentsAgainstVaping (@ParentsvsVape) August 27, 2021
I’d expect nothing less from those morons, and it will be VERY interesting to see if the FDA approves JUUL…I have a sneaky feeling it will lol.
The Washington Post was able to glean the reaction from our old ‘frenemy‘ and former FDA big boss Scott Gottlieb.
He literally blamed the vape companies saying:
Many companies had ample time, and the benefit of guidances that we issued, to provide a path toward compliance, so they could demonstrate their value as tools that could help current smokers quit combustible tobacco.
Many of them chose to fight the laws Congress enacted, and the FDA, and they didn’t invest in demonstrating the public health benefits that they asserted.
My reaction to that is it rhymes with anchor…
Guy Bentley from Comsumer Freedom tweeted:
FDA bans 55,000 flavored e-cigarette products, crippling three vape companies.
FDA claims applicants failed to demonstrate they are a net benefit to public health.
No worries though, people can just switch back to smoking!
Exactly…just imagine if the same ridiculous and expensive red tape was applied to lit tobacco…
The only winners here will be Big Tobacco who’s products kill and Big Pharma who’s smoking cessation aids don’t work.
I hate to be a doom and gloom merchant, but I agree totally with fellow vape writer Jim McDonald who wrote:
All of the products were “flavored”—by which the FDA means flavored with anything but tobacco flavorings.
In its explanation, the agency seems to signal that no flavored open-system products (bottled e-liquid) will be authorized.
That’s exactly the kind of “regulation” that anti-vaping organizations like the Campaign for Tobacco-Free Kids and grandstanding politicians like many state attorneys general have demanded.
Extremely worrying times yet again for vaping in America.
The three companies involved do have the option of applying again – one wonders if they will given the cost.
And of course, it goes without saying, our hearts go out to all of the company’s staff who are now staring at job losses and all the misery that entails.
As we edge closer to the September 9th 2021 deadline and the FDA PMTA carnage begins, I fear yet more will suffer the same fate – abhorrent and criminal to say the least.
Read the full FDA decision.