The FDA has now released its PTMA guidance and, as expected, it does nothing more than play into the hands of Big Tobacco…
The FDA’s PTMA guidance is now official, following pressure from federal courts to tackle the “issue” of teen vaping. With the PTMA now in place, vape manufacturers now have 10 months to submit their respective PTMA applications or face going out of business.
“The FDA’s ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protect kids from the dangers of nicotine and tobacco-related disease and death. The FDA is committed to providing a solid, science-based regulatory foundation to ensure that ENDS products authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner Ned Sharpless, M.D.
He added: “The final guidance issued today provides companies seeking to market e-cigarette and ENDS products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product. There are no authorized e-cigarettes currently on the market and we encourage companies to use this valuable document now as a guide to submit applications. At the same time, the public can be assured that the FDA has been and will continue to take all necessary actions to protect children as part of our Youth Tobacco Prevention Plan, including maintaining our focus on enforcement actions and policies aimed at ensuring e-cigarettes aren’t being marketed to, sold to or used by kids.”
It’s also worth noting that NO vape companies have ever submitted a PTMA and around 99.9% of them will not inside the next 10 months. Why? Simple: the application process costs millions of dollars, and most vape companies don’t have that kind of cash…
In fact, the ONLY companies that will be able to submit PTMA applications are Big Tobacco – brands like Philip Morris. Furthermore, Philip Morris is the ONLY company to so far submit a PTMA application for its IQOS vaping device. And that thing is terrible.
The #1 Problem With The PTMA Guidance
The number one issue with the PTMA bill is the cost associated with it; individual applications cost millions. And if you have to do 10 or 20? Yeah, that’s going to cost you around $20 million. And even the biggest vape brands don’t have that kind of cash lying around.
But the fun doesn’t end there; the PTMA application process, while costing millions, can take up to TWO YEARS to process. And even when it’s been processed, there are ZERO guarantees that your product will pass. Oh, and the FDA doesn’t do refunds, either.
The net result of all of this, if it’s allowed to happen, is that hundreds of US vape companies will go out of business; thousands of people will lose their jobs, and America will look utterly stupid in the eyes of nations like the UK that are now actively embracing vaping as the #1 tool for killing smoking within a generation.
Is The FDA Actually On Vaping’s Side?
The knee-jerk reaction to bring forward the PTMA date, a whole two years, thanks to the work of “entities” like the American Academy of Paediatrics (AAP), American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative, was recently described by the FDA as “counter-productive”.
What does this mean? Well, it seems as if the FDA is aware of the health benefits associated with vaping and doesn’t want the entire industry killed overnight. The federal courts aren’t playing ball, however, and are pushing for the PTMA rules to take effect in 10 months’ time.
The FDA’s counter to the court was simple, yet effective: shutting down the vaping industry would have dire effects for America’s public health, forcing tens of thousands of vapers back to smoking. Crazy. I never thought the FDA would be fighting in the vaping industry’s corner. But this is now what’s happening; and, I guess, you could maybe call that progress.
And yet, despite all this, it’s looking likely that the PTMA will come into effect as scheduled by the federal court, meaning ALL vape companies will have to submit applications to stay in business.
“Preparing and satisfying a PMTA is no easy task, with applications that are millions of pages long, costing millions in resources, and requiring significant scientific support,” financial analyst Ryan Tompkins said, according to Convenience Store News. “It is highly likely now that, with the PMTA deadline being brought forward further, small vapor manufacturers would not be able to satisfy the requirements and will need to remove their products from the market.”
The Elephant In The Room…
All of this is very depressing, as I’m sure you’re well aware. But the thing that stings the most is that cigarettes have never been scrutinized like this – not once! They were simply grandfathered in and allowed to kills hundreds of thousands of people a year ad infinitum.
But as soon as we have a truly remarkable product that benefits public health, stops decades-long smoking habits overnight, and is 95% safer than smoking, the federal court and FDA step in to REMOVE IT from the market!? You honestly couldn’t make this stuff up…
Why does vaping – and not smoking – have to prove its benefit to public health? How is that EVEN a question? Vaping has been shown time and time again to be 95% safer than smoking. If the federal government ACTUALLY cared about your well-being, and your kid’s well being, it would do what it should have done decades ago – ban cigarettes.
But, no, that’ll never happen. Not while the federal government is actively sharing in the profitability of Big Tobacco. And if that doesn’t make your blood boil, nothing will. Millions of jobs, millions of peoples’ health, sold down the river for nothing more than the fact that the federal government is addicted to Big Tobacco profits.
Will this kill vaping in the USA? Officially, yes. But then there’ll be a black market, powered by imports from China, that the FDA and Feds do not have the resources to police. People will go to jail because of this, and for what? Providing a safer alternative to smoking? Utter insanity.
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