Deeming Regulations Are In Effect
- Thread starter Bob Chill
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The FDA firmly stands behind the GF date being set by Congress with no way to change it unless they do:
"What is the grandfather date?
Congress wrote and passed the tobacco Control Act, which states that any tobacco product on the market as of February 15, 2007 is eligible for grandfather status (this includes products that were in test markets).
Otherwise, any products introduced or modified after that date are considered "new" tobacco products and must submit a premarket application to the FDA through one of the three available pathways"
Cole Bishop is a major step in completely changing the landscape of the entire reg package. That is the first chance we get at Congress doing anything to the date. Cole Bishop has survived thus far but the big test comes this fall when the Senate gets involved. Do they strip it or not? I mean they got what they want with age restrictions and labeling. Changing the GF date doesn't exactly = "harming the children" any more than if they don't. There hasn't been much opposition to Cole Bishop either. It has passed with a decent majority and not just squeaking by.
It really makes no sense to force a thriving 8 year old industry that has only improved upon itself since inception back to the drawing board.
"What is the grandfather date?
Congress wrote and passed the tobacco Control Act, which states that any tobacco product on the market as of February 15, 2007 is eligible for grandfather status (this includes products that were in test markets).
Otherwise, any products introduced or modified after that date are considered "new" tobacco products and must submit a premarket application to the FDA through one of the three available pathways"
Cole Bishop is a major step in completely changing the landscape of the entire reg package. That is the first chance we get at Congress doing anything to the date. Cole Bishop has survived thus far but the big test comes this fall when the Senate gets involved. Do they strip it or not? I mean they got what they want with age restrictions and labeling. Changing the GF date doesn't exactly = "harming the children" any more than if they don't. There hasn't been much opposition to Cole Bishop either. It has passed with a decent majority and not just squeaking by.
It really makes no sense to force a thriving 8 year old industry that has only improved upon itself since inception back to the drawing board.
The figures that reach into the millions people talk about are not for any one single product. Here's where the millions come from... let's assume you're a juice manufacturer and you offer 6 different flavors. There's 6 applications already. But, let's say you offer 6 nicotine strengths as well (let's say 0, 3, 6, 12, 18, and 24... a common assortment of strengths). Technically, even though the only difference is the nicotine level, now you're manufacturing a grand total of 36 juices. Now, let's say you also offer 3 common PG/VG ratios. You just jumped up to 108 different juices, all requiring their own application. Assuming a lowball cost of $100k each, well, you're up to 10.8 million dollars, for six juices and their basic variations.
Assuming the manufacturer of these juices does all this, manages to shell out all that cash and gets all their juice approved (which they are now locked into manufacturing the exact same juice, because any tiny change results in creating a new product that will need approval), what will we put it in? If you make a box mod, for example, you have to prove it'll work with every conceivable combination of tank, battery, etc that you could possibly put on it.
With things as they are now, I think what we'll end up with is a small number of devices much simpler than what we have now. I think an AIO device (when I say that, I'm thinking of a box mod with a built-in, non replaceable battery and a built-in, non replaceable tank) could be the best we could hope for.
Hopefully not only am I wrong about all this, but something will happen where we won't have to worry about this mess...
Your forgetting the two biggest game (corrupt) players standing to loose multi billions throughout the near future if the masses switched to vaping or would damn near be the end "IF" there were American, (evidently american lungs are different than Europeans) scientific study's published concluding that vaping is a MUCH safer alternative
Oct 19
You know what is funny to me is when FDA and CDC say that vaping is a gateway to smoking, they have it ... backwards. Smoking is a gateway to Vaping 
They just don't get it, they have it so backwards. Kids are going to try smoking regardless of laws and regs, but those that get hooked on smokes may go to vaping, which is much better.
They just don't get it, they have it so backwards. Kids are going to try smoking regardless of laws and regs, but those that get hooked on smokes may go to vaping, which is much better.
That will be great news for folks that feel that they need something better than what is on the market right now.
I could not imagine but, I am sure that they are out there and also willing to spend big bucks compared to what I spent on very nice gear during the sales leading up to 08/08. Win situation for all involved.
I'll still buy stuff that I might like as long as it remains available and would represent an improvement to my pile of stuff. Which means just about anything that works. 
From Halo CEO Jeff Stamler's declaration filed in his company's suit against the FDA:
"...FDA estimates that it will take “an average of 1,500 hours to complete a PMTA.”
...Thus, to maintain half of Nicopure’s current product portfolio, Nicopure would have to invest approximately 1.8 million hours (equal to 75,000 days or 205.5 years) in preparing PMTAs.
1. Even if Nicopure eliminated 80% of its products in response to the Deeming Rule, submitting PMTAs for the remaining 20% would take approximately 720,000 hours (equal to 30,000 days or 82.2 years) to complete.
2. A dedicated team of 10 employees would take nearly a decade to complete that task if all 10 team members worked 24 hours a day, 7 days a week, 365 days a year—yet FDA has allotted only 2 years for compliance.
Personally, I find this more a more compelling argument than the financial cost against implementing the deeming regs. IOW, even if you have all the money in the world you haven't got the time!
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The combination of various technology and virtually unlimited flavors make ecigs a gigantic square peg trying to be fit in a tiny circle.
Eliquid has it the hardest. The most sensible way would be to simply have GRAS nic base/pg/vg/flavoring and then operate like the food and drink business. Manufacturing, ingredients, and strength could easily be standardized through guidelines. Stay inside of those and you can sell your stuff. Period. End of problem. The chances of this happening are pretty much zero but it's still the most logical.
We've rehashed this before many times but my above paragraph is the only way to allow any semblance of an eliquid market that we have today. The other way out is moving the GF date. Then the SE pathway becomes pretty much wide open.
Eliquid has it the hardest. The most sensible way would be to simply have GRAS nic base/pg/vg/flavoring and then operate like the food and drink business. Manufacturing, ingredients, and strength could easily be standardized through guidelines. Stay inside of those and you can sell your stuff. Period. End of problem. The chances of this happening are pretty much zero but it's still the most logical.
We've rehashed this before many times but my above paragraph is the only way to allow any semblance of an eliquid market that we have today. The other way out is moving the GF date. Then the SE pathway becomes pretty much wide open.
This paragraph in the newly released FAQ's is a bit interesting:
"I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength? Can I bundle similar products into one, or just a few, applications?
Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.
FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product. "
I'm not sure how much difference in cost having multiple flavors under 1 PMTA would be. Each ratio of pg/vg/nic would be redundant with flavors being the complicated part.
IMHO- the smartest thing to do right now would be a collaborative effort with a single ratio/strength of unflavored would be worth testing the PMTA process well before 2018. A couple big juice makers could form another company with the sole purpose of trying to get unflavored approved. This would spread the cost. It's a high risk/high return scenario. Maybe a big juice company could give it a shot by themselves. Somebody needs to try the most simple form of juice first before anybody wastes time on flavored.
If the FDA shot down unflavored then everyone else could just pack it up and shut it down because it would be clear at that point that the FDA has no intention of allowing anything. It would open the doors for another lawsuit because the FDA keeps repeating that they aren't "banning anything".
"I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength? Can I bundle similar products into one, or just a few, applications?
Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.
FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product. "
I'm not sure how much difference in cost having multiple flavors under 1 PMTA would be. Each ratio of pg/vg/nic would be redundant with flavors being the complicated part.
IMHO- the smartest thing to do right now would be a collaborative effort with a single ratio/strength of unflavored would be worth testing the PMTA process well before 2018. A couple big juice makers could form another company with the sole purpose of trying to get unflavored approved. This would spread the cost. It's a high risk/high return scenario. Maybe a big juice company could give it a shot by themselves. Somebody needs to try the most simple form of juice first before anybody wastes time on flavored.
If the FDA shot down unflavored then everyone else could just pack it up and shut it down because it would be clear at that point that the FDA has no intention of allowing anything. It would open the doors for another lawsuit because the FDA keeps repeating that they aren't "banning anything".
Maybe someone will get on that, once the FDA actually releases their guidance on the ENDS PMTA process. Of course that will be draft guidance, so maybe they shouldn't start right away. I mean, the normal procedure is Draft Guidance, then 90-180 comment period, then 1-2 years until release of Final Guidance, so they could start maybe in February 2018. 6 months is long enough to do longitudinal studies, right?
That will be great news for folks that feel that they need something better than what is on the market right now.
I could not imagine but, I am sure that they are out there and also willing to spend big bucks compared to what I spent on very nice gear during the sales leading up to 08/08. Win situation for all involved.
So basically your just concerned about your needs ?
glad to see your all set for the years to come ...................
The main goal should be to help better inform smokers with the desire to want to quite, that there is a safer alternative "choice" out there and help support the right to have the opportunity for years to come.
Times are changing, smart cars, everyone uses lio battery operated smartphones but yet still relies on a 200 year old idea for smoking that they know damn well right is going to put them into an early grave.You should be able to by a starter kit at your local gas station for gods sake.
Should have used the word smartcig from the beginning .............
Times are changing, smart cars, everyone uses lio battery operated smartphones but yet still relies on a 200 year old idea for smoking that they know damn well right is going to put them into an early grave.You should be able to by a starter kit at your local gas station for gods sake.
Should have used the word smartcig from the beginning .............
I'm only on page 2 so please excuse if these have been noted.
Misthug is no longer shipping to the US.
Ecig.com is requiring photo I'd verification. My order went through but at the end they said I needed to email them a copy of my photo id which I'm not going to do so I don't know if I'll get my order or not.
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I'm in good shape for a while so probably won't order again for a while. I've thought a bunch about what I'm willing to do in regards to age verification. Since I have a small warehouse of tanks I probably won't order any more possibly forever. Mods and nic base are probably the only 2 things I'm going to order. I think I'll most likely just order from 2 different companies and will be as selective as possible for who I choose to do business with.
All excellent points, but no juice maker will have any basis for knowing whether any open system mods will be approved and, if so, which ones. Each juice would have to be tested with an array of devices it might be used in. This seems virtually impossible and there's no point in seeking approval of any juice unless there's a reason to think the FDA will approve at least one open system mod and atomizer. But the FDA has already given a strong signal that it will be difficult to get open system devices approved.
Now, it might be possible to get a semi-open system approved--i.e., one with the atomizer permanently attached in such a way as to allow filling, coil changes and cleaning. Then the only variable would be the juice.
Considering this and other bizarre requirements, one might be tempted to think that the FDA is making it easy for their regulations to be struck down...
Yea, that's been on all our minds for sure. Cole Bishop would solve a lot of problems. The FDA specifically stated that Congress will have to change the GF date. They might just do that. Personally, i think 99% of current vapers could be totally satisfied with tech and liquid as of 8/8. More importantly, so would any smoker who puts effort into switching. Many of us did it with clearos or even early cigalike adopters. The simple evod sealed the deal for me.I totally agree, but bighawkdance does have some good points.
No. I could not imagine anyone actually needing more than a 200w device to quit smoking. Staying smoke free is what vaping is all about after all. The hobby aspect of it is not as important as being able to quit smoking and stay smoke free. I have been at this quite awhile and have helped many not only on this forum but other places as well to be able to continue vaping. I was the very first person to start collecting and sending vaping supplies to military overseas. That all started with me. So, you better think again before calling me a selfish vaper Could not be further from the truth.
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