As expected the PMTA deadline has been delayed leaving the US vaping industry in an even bigger state of turmoil.
Yesterday was the deadline day for all pre market tobacco applications [PMTAs] to be assessed by the Food and Drugs Administration [FDA].
Without one, either under FDA review or approved, NO vape product from mods to e-liquid can be legally sold in America.
At the time of writing NO product has been approved, but almost 5 million PMTAs have been denied.
The FDA has stated it will be pushing vape products that hold the market share to the front of the queue, and most of those, including JUUL, have links to, or are owned by Big Tobacco…quelle surprise.
PMTA Deadline Delayed – Protecting the Kids…
As the clock ticked down yesterday, industry insiders and vape advocates across the states were constantly refreshing the FDA’s PMTA web page to see what the decision was.
As I suggested in Wednesday’s vape news, the decision was to delay, an anti-climax to say the least.
Acting FDA Commissioner Janet Woodcock, M.D said the agency was working on clearing the backlog and crowed they’d already denied 93% of applications and issued close to a million refuse to file orders.
The good lady of course found the time to bring up the so called ‘teen vape epidemic’ adding:
We’ve made significant progress in the months since, working diligently to better understand these products and, as of today, taking action on about 93% of the total timely-submitted applications.
This includes issuing Marketing Denial Orders (MDO) for more than 946,000 flavored ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.
Flavored ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them.
However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.
I’m sure you’re as sick as I am having to bang on about the myth that is the ‘teen vaping epidemic‘…but look, that’s how they’re justifying the destruction of the vaping industry in the US as we know it.
Read the real facts: Teen Vaping and Smoking – The Cold Hard Facts Revealed
PMTA Deadline Delayed – What’s Next?
The September 9th 2021 PMTA decision day was ordered by Judge Grimm last year.
The FDA has wriggled a bit suggesting it wasn’t a deadline at all…things that make you go ummm…
According to anti-vaper Matthew Myers, president of the Campaign for Tobacco Free Kids, if the FDA doesn’t get its act together it could go back to the courts.
It was Myers along with others, that forced the PMTA deadline and he was unhappy to say the least telling the media:
While FDA has said it has ruled on 93% of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic.
Every day those products remain on the market, our kids remain in jeopardy.
It is very frustrating that this problem has been allowed to fester for more than a decade.
There needs to be a resolution and a resolution quickly.
He said if what he calls the ‘major applications‘ are not dealt with soon he will:
…have no choice but to go back to the court to have the court enforce its order requiring FDA to begin to remove any product not authorized.
Fighting words from little Matty lol.
It’s the FDA’s “Highest Priority”
Woodcock promised a speedy resolution adding:
We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard.
Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.
Her statement is yet another government piece of gobbledygook that is as clear as mud and open to interpretation.
There’s still hundreds of thousands of PMTAs to plough through and there’s no FDA time limit set.
Based on that I reckon little Matty is sat with his lawyers right now…
On hearing of the PMTA deadline was delayed, the politicians were upset too – no bad thing – with leading anti-vaper Sen. Dick Durbin more than a little angry at the PMTA deadline delay saying:
FDA’s years-long failure to regulate e-cigarettes has led millions of kids who never would have picked up a tobacco product to begin vaping.
While I am pleased FDA has rejected all e-cigarette applications to date for failing to show a health benefit, it is unacceptable to delay evaluation of e-cigarettes most responsible for hooking children, like JUUL.
More like Dick Head than Durbin…but I digress…
Greg Conley, the president of the American Vaping Association, spoke to Alex Norcia at Filter Magazine and he was equally furious:
America’s tobacco and nicotine regulatory system is broken beyond repair.
It is absolutely absurd that the same agency that found time to ban over 6 million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares.
Even worse, after spending five-plus years peddling false hope to businesses across America, the FDA now cannot even be bothered to grant formal extensions to the remaining pending applicants.
This decision brings even more uncertainty on the day FDA had previously pledged to provide the public with answers.
If smoking rates go up in 2022 and beyond, do not blame the tobacco industry.
This predictable result will entirely be the fault of elected officials and regulators who have utterly failed to protect public health.
I totally agree mate.
As I’ve said often, there’s blood on their hands.
So now we wait…
I still reckon JUUL will get through, and that will be where the fun starts 😉
Read the statement in full: FDA Makes Significant Progress in Science-Based Public Health Application Review