FDA Proposed regulation is available
- Thread starter Jake6731
- Start date
- th_trl_thread_readers 0
- Status
am I missing something... or is this deeming reg, simply unworkable
Like dead in the water, unworkable.
Manufacturers have 2 years to apply for SE
They can also release new products during those 2 years
Each product requires SE approval
Products can stay on the market pending approval
how many products do you think have been released since 2007?
I mean, every mod variation(including color) would need it's own SE, every Atty(including resistance variation), tank(including ml and color variations), liquid(by flavor and strength)
That sounds like thousands, if not tens of thousands, of products... add to that all the products that will be piled on to that in the next 2 years...
It will take the FDA literally DECADES to go through all of those. based on the rate they've gotten to existing SE applications.
Like dead in the water, unworkable.
Manufacturers have 2 years to apply for SE
They can also release new products during those 2 years
Each product requires SE approval
Products can stay on the market pending approval
how many products do you think have been released since 2007?
I mean, every mod variation(including color) would need it's own SE, every Atty(including resistance variation), tank(including ml and color variations), liquid(by flavor and strength)
That sounds like thousands, if not tens of thousands, of products... add to that all the products that will be piled on to that in the next 2 years...
It will take the FDA literally DECADES to go through all of those. based on the rate they've gotten to existing SE applications.
Last edited:
Just one more comment: I don't see how anyone can say "It could be worse". The best you can hope for is that the FDA has a loose interpretation in the approval process, or that it is still 2 years away. We really don't know how these regs are going to pan out. Of course the media is going to report on the obvious things that nobody can disagree with, ie: ban sales to minors.
But taken literally these regulations do in fact ban the vast majority of e-cigarette products on the market.
But taken literally these regulations do in fact ban the vast majority of e-cigarette products on the market.
Greg Conley ("PlaceboEffect" on ECF) has been tweeting about the deemings as he reads the document. Here's a link to his twitter profile page w/ his tweets, which I believe anyone can access even if you're not on twitter: https://twitter.com/GregTHR
I'm not seeing where accessories are being covered. It's all about the juice. This is from page 131:
I'm going to submit that your AP contact isn't fully informed on the application process and on how FDA tends to interpret "functionally the same." As an example, if a cigarette manufacturer changes to a different *glue* to apply to the paper surrounding a cigarette, it makes that cigarette a new product, and it cannot go into production until the FDA approves it (or not) as a "substantially equivalent" product.
True, but there is also language saying that attys and cleros are parts of the device and subject to regulation
As Hamburg said at the press briefing yesterday, these proposed regulations "are foundational."
And: Will have to check the Deemings to see how FDA defines "components," "parts," and "accessories." Do NOT assume that you and FDA are defining them in the same way.
I think it's too muddy to mess with to be honest. I honestly believe hardware (except for all in one cigalikes) will go untouched. The FDA already lost once. They are going for the easy choke. Regulate the nic. Tax the nic. Game won in their eyes.
I think the simple fact that you can vape zero nic muddies the waters way too much to mess with hardware.
so, if we were keeping score. 5 good, 3 bad, 1 ugly. that's way better than my average night at a bar trying to pick up the wimmens.
i beat the spread!!!!!
keep in mind, when submitting for approval, there are loopholes that allow a supplier/vendor to operate while the application is being reviewed. what may most likely happen is that the FDA is about to be hit with a super huge backlog of applications for vendors, products, technologies, etc. and they can all be sold while the application is sitting in the bottom of a stack for years on end. by the time the application is reviewed, it may not even apply anymore.
i take this out of another 'vice' industry in casinos. there are people and establishments that technically do not have licenses, but they are allowed to operate because 10 years ago they submitted an application and it just hasnt been reviewed yet. if suppliers are smart, they'll all coordinate so every manufacturer submits an application at the same time.
it lets the FDA cover their collective butts by saying vendors need to apply for review, and it keeps the cash flowing. and thats what this is all aboot. keeping that money rollin in.
Last edited:
wait... Vape Shops would be bared from letting people try eliquids?!?!
...?!
That's the main reason I buy liquids from shops vs the internet
...?!
That's the main reason I buy liquids from shops vs the internet
And of the bad, #1 (marketing to youth) is technically a neutral. I haven't seen too much of that to begin with. While I'd have no objection to enforcing that, it doesn't seem to be of much impact to begin with.
right... i tried to explain to him as much.
I'm going to have to call him back... I hadn't seen the reg before he called me, it was news to me and he was relating what he gathered from it.
yeah, that was more of a deferral, so it's iffy to me as well.
I'm might have too much faith but they FDA would lose the fight in court trying to classify an atty/tank/battery is a tobacco product. They're going to have their hands full enough as it is just with the nic part of it. I'm confident hardware simply won't be touched. It's not necessary to do it. Beyond a random battery fire (which happens all the time with other products like laptops), they pose no health hazard unless used improperly.
This process will definitely be a pick and choose the correct battles. And there's only one. The nic. The industry starts and stops there except for the few that go zero nic.
I'm pretty sure they mean you can can't give away stuff to take with you. Things like setting up booths in concerts and things like that. Sampling in house will likely be fine. Just like beer and wine tasting in stores across the country.
There's a huge loophole there anyway. B&M's can just sell you a 1ml bottle for a nickle and drip away. For less than a buck you can try enough to make your tongue forget how to taste.
Possibly, but they could just charge you $0.01 and be on the sunny side of the law. The fact that there's a Take a Penny dish right by where you pay for that? Not their problem.
Or they could do it free if they put out no-nic liquids. Since nic does alter flavor and throat hit, I'd prefer the $0.01 charge to try liquids.
Let me tell you a story about the FDA;
In 2009 I bought a kr808-d from a small local shop here in Richmond Virginia for three times what it worth because I didnt want to have to wait to quit smoking. Shortly after that I found ecf and discovered that better options were out there.
Both my wife and myself saw the enormous potential for e-cigs and started our own company Zap Electronic cigarettes. We pooled our collective savings and made our first order then set about getting a website up and running and applying for vendor status.
We decided to sell 901's kits with no cuts offs for 19.99 as well as re-branded ejuice.We had a favorable video review from a reviewer and word started to get out. Business was booming enough that we sold out within a months time and rolled all of our profits into a new order.
We werent getting rich by any means, just growing our business.My wife and I still worked full time and did this because we believed in the product and its ability to help people. The second order from China came through and sold out even faster than the first so we took all of the money again and placed an order for 15k from China. We started with an initial investment of 5k and months of my free time.
That last order from China never made it as the FDA seized it in New York, then destroyed it and sent us a bill to the tune of 800 dollars.
The seizure was later ruled illegal by Judge Leon BUT it was handled on a case-by-case basis instead of class action. Huge companies like N-Joy were able to afford the attorneys fees but many of the smaller companies were not and ended up going under. One vendor I know lost 250k in merchandise.Imagine trying to recover from a loss that huge.For most of us it would be impossible. 15k was enough to crush our hopes and dreams along with all of our hard work.It affected our marriage for awhile as well.
To those thinking the FDA is your friend.THEY ARENT AND NEVER HAVE BEEN. Showing up late for the party is completely understandable but refusing to do your homework and getting your facts straight isnt and neither is condemning those of us who have been around long enough to know better.
If it looks good on paper now expect the FDA to twist it into something unrecognizable to support their irrational war against e-cigs and ensure that only the largest and most well funded companies (ie big tobacco, Njoy, Blu etc) survive.
In 2009 I bought a kr808-d from a small local shop here in Richmond Virginia for three times what it worth because I didnt want to have to wait to quit smoking. Shortly after that I found ecf and discovered that better options were out there.
Both my wife and myself saw the enormous potential for e-cigs and started our own company Zap Electronic cigarettes. We pooled our collective savings and made our first order then set about getting a website up and running and applying for vendor status.
We decided to sell 901's kits with no cuts offs for 19.99 as well as re-branded ejuice.We had a favorable video review from a reviewer and word started to get out. Business was booming enough that we sold out within a months time and rolled all of our profits into a new order.
We werent getting rich by any means, just growing our business.My wife and I still worked full time and did this because we believed in the product and its ability to help people. The second order from China came through and sold out even faster than the first so we took all of the money again and placed an order for 15k from China. We started with an initial investment of 5k and months of my free time.
That last order from China never made it as the FDA seized it in New York, then destroyed it and sent us a bill to the tune of 800 dollars.
The seizure was later ruled illegal by Judge Leon BUT it was handled on a case-by-case basis instead of class action. Huge companies like N-Joy were able to afford the attorneys fees but many of the smaller companies were not and ended up going under. One vendor I know lost 250k in merchandise.Imagine trying to recover from a loss that huge.For most of us it would be impossible. 15k was enough to crush our hopes and dreams along with all of our hard work.It affected our marriage for awhile as well.
To those thinking the FDA is your friend.THEY ARENT AND NEVER HAVE BEEN. Showing up late for the party is completely understandable but refusing to do your homework and getting your facts straight isnt and neither is condemning those of us who have been around long enough to know better.
If it looks good on paper now expect the FDA to twist it into something unrecognizable to support their irrational war against e-cigs and ensure that only the largest and most well funded companies (ie big tobacco, Njoy, Blu etc) survive.
Last edited:
- Status
Similar threads
- Locked
