The battle to save vaping in America has begun with a lawsuit filed aimed at delaying the current PMTA deadline.
The Vapor Technology Association and the Vapor Stockroom say the new date of May 20th 2020 for ALL vape products to receive FDA approval is not only an impossible task for all companies involved, but will devastate the US vape industry threatening the lives of millions.
OK, I wrote all about PMTAs in the piece: Vaping In America Faces Total Devastation As Anti-Vape Legislation Is Moved Forward. In a nutshell, ALL vape companies wishing to sell ANY product in the USA must supply the FDA with page after page of scientific documents and other red-tape proving the product is for want of a better word – safe.
As I showed in the article, with each PMTA costing up to $460,000 each – this new regulation and the pathway to approval is so expensive it’s extremely likely to mean hundreds of vape businesses will be forced to shut down at the loss of thousands of jobs.
Add to that the removal of pretty much the majority of vape products on the market and its easy to see how many smokers and vapers lives could be lost.
The VTA is a trade organization that has around 800 members including JUUL, SMOK, Joyetech, Suorin and Innokin to name just a few. The organization’s mission is:
- Promote greater public health through smart regulations and responsible public policies
- Transform the public debate around the vapor industry and dispel distorted and misleading information about vapor products
- Keep the vapor market open and competitive across the board
- Protect small business owners and their employees by ensuring the long-term viability of the vapor industry
And by filing this lawsuit, they’re doing just that.
So What Exactly Is the Lawsuit Hoping To Achieve?
As it stands right now the FDA hasn’t even bothered to release official guidelines [rather than draft] as to what exactly companies need to do! In other words the vape industry is still in the dark as to exactly what the FDA requires!
And as the clock ticks down to the deadline date – even with a year added to May 2020 for products that have submitted PMTAs to remain on sale – there’s simply not enough time to get the testing and paperwork submitted.
And that’s not the only problem!
The VTA says what’s more alarming is the simple fact given there are 3 million-plus vape products out there, there aren’t enough labs and scientists in existence to test every single product! Now that’s not only moving the goalposts – it’s filling the goal with an impregnable wall of reinforced concrete!
BREAKING: Today VTA and Vapor Stockroom filed a lawsuit against the FDA over its unreasonable and arbitrary Pre-Market Tobacco Application (“PMTA”) process and the recently grossly accelerated PMTA filing deadline. READ MORE: https://t.co/yE8r5Btoim pic.twitter.com/9j2k65NCLq
— Vapor Technology Association (@VaporTechAssoc) August 14, 2019
A complete ban on vaping in America by the back door springs to mind.
Plaintiffs are taking action to require FDA to publish and complete the long-promised “foundational rules” describing the specific requirements for PMTAs.
In addition, Plaintiffs are asking the court to enjoin FDA from enforcing the May 2020 PMTA deadline or taking enforcement action against companies that do not have a PMTA on file until a reasonable period of time after the actual foundational rules are finalized.
With over 3 million vapor products registered with FDA, the arbitrary May 2020 PMTA deadline which FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses, particularly in the absence of a draft or final PMTA Rule.
Any final PMTA Rule must allow sufficient time to conduct the many complex and time-consuming tests and studies currently being required by FDA.
It makes perfect sense to me, however such is the anti-vaping fervour over in the states the pessimist in me thinks this one might not go the distance.
But hey, fingers crossed it does and you can read the full lawsuit: Vapor Technology Association, et al. vs. Food & Drug Administration, et al here.
FDA Admits PMTAs Could Harm Public Health
Tony Abboud is the Executive Director of the VTA and he says the FDA has failed at every step over the rushed PMTA deadline:
FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful.
The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act.
Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health.
To be clear, no business could rationally have been expected to start conducting complex PMTA testing before FDA finally published its PMTA guidance document on June 11, 2019, the day before it asked the Court to impose a 10-month PMTA deadline.
Absolutely and as I keep saying, this moving of the deadline leaving vape companies with impossible tasks to get FDA approval could be seen as a banning vaping through the back door.
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.
FDA’s actions, if unchecked, will shut down an entire industry that has developed to challenge the combustible cigarette.
Whatever FDA calls its ‘rules of the road’ simply cannot be relied upon in the absence of a real PMTA rulemaking process that gives all stakeholders the opportunity for notice and comment, not just those interested parties that file lawsuits.
Let’s wish them luck and of course we’ll be keeping a close eye on this one.
As of the time of writing the FDA hasn’t responded to the lawsuit.