Vendors to spend how much for FDA PMTAs?

[Tommy-Chi]

I guess I kind of felt the same about preppers. However, I've been changing my mind about that over this past year. Since May, that change has accelerated. What has happened to vaping has opened my eyes for sure, as I explore the effects of government overreach in other areas of the lives of US citizens.

Stockpiling vaping supplies is my first experience with prepping. I have mixed feelings about it. The good: I am prepared for any eventuality. The bad: that I must be prepared for any eventuality.

I dabbled in prepping once. I have 100 - N95 masks in case there is a minor airborne outbreak of some sort. For $30 it seemed like an insignificant act.

In Sept 2015, after joining ECF and seeing the FDA(Fed), County(Cook) and City(Chicago) jump all over vaping I decided to mount my own defense. Without all of you ECF members, I would not have known where to start.

A huge Thank You to everyone with the knowledge for pointing us newer members in the right direction.

 

[Lessifer]

Also consider that the numbers listed are an estimated average per application. Much of the application is clinical and market research, so there's hiring scientists to perform the studies, and they'll be expensive so you'll want to do all of your products at once. At least that's how it is in my head. As in, it would cost you 2 million to have the studies done, and you could do up to 4 products in that study, but if you chose to only do 1 product, it would still be the 2 million.

 

[Tommy-Chi]

Also consider that the numbers listed are an estimated average per application. Much of the application is clinical and market research, so there's hiring scientists to perform the studies, and they'll be expensive so you'll want to do all of your products at once. At least that's how it is in my head. As in, it would cost you 2 million to have the studies done, and you could do up to 4 products in that study, but if you chose to only do 1 product, it would still be the 2 million.

Yep, prices will be reduced IF AND ONLY IF they can share a process with smaller vendors on how to reduce the costs of clinical testing.

I worked for a biotech in Silicon Valley that specialized in batch processing in genomics.

 

[Truthdog]

The FDA regs are impossible to comply with, period. Population level impacts are nearly impossible to quantify -and on so many different devices for each liquid! However, their overreach is their Achille's heel, and we must take advantage. The court proceedings will likely take years, and I am optimistic about their eventual success, but we should act now.

I am finally learning how to build coils and stockpiling RTAs and RDAs. Next comes DIY liquid.

But really, the election is our one chance to have leverage, and I am NOT talking Presidential, but Congress. We are the boss of our Congressperson, and Congress is at home until Labor Day. Invite them (and a local reporter) to the best (cleanest) vape shop or Mfgr you know. Discuss the issues (health, jobs, innovation, choice) with them in front of the reporter and ask them to change the law governing Vaping. First change the 2/15/2007 date, that will eliminate PMTAs for all existing products. Then change the regulatory regime to recognize harm reduction and substantially lower risk. It is doable.

Anyone that wants to set this up,let me know. I will give you the email of the scheduler to ask for a meeting. We can lose this war, by sitting on the couch and cussing out the government, all the while not realizing the we are the government. We should reclaim it and demand they respond to us.

(Stepping off soapbox). Sorry, I am just frustrated as I see real action work on issues everyday, we just have to all pull in the same direction.

Thnx

 

[Eskie]

There is one other path this could take. If a couple of the big boys can jam through a PMTA to approval, it will allow lots to pile on with SE applications, which while not fun, are way better than a PMTA. There may be more loopholes in 500 pages of regulations that challenges can be mounted, providing someone has the deep pockets to do it.

 

[WillyZee]

Take ProVape for example ... they have only 5 devices.

I doubt they will submit a PMTA on any of them

The FDA wants open tank vaping gone to pave the way for BT cigalikes

 

[Vandal]

Take ProVape for example ... they have only 5 devices.

I doubt they will submit a PMTA on any of them

The FDA wants open tank vaping gone to pave the way for BT cigalikes

I think we all are pretty sure this is the case. BT has come out and said they want open systems gone and it's a pretty sure bet that the FDA will see it done. I'm afraid anyone besides BT submitting a PMTA will be wasting their time and money.

 

[bnrkwest]

The FDA regs are impossible to comply with, period. Population level impacts are nearly impossible to quantify -and on so many different devices for each liquid! However, their overreach is their Achille's heel, and we must take advantage. The court proceedings will likely take years, and I am optimistic about their eventual success, but we should act now.

I am finally learning how to build coils and stockpiling RTAs and RDAs. Next comes DIY liquid.

But really, the election is our one chance to have leverage, and I am NOT talking Presidential, but Congress. We are the boss of our Congressperson, and Congress is at home until Labor Day. Invite them (and a local reporter) to the best (cleanest) vape shop or Mfgr you know. Discuss the issues (health, jobs, innovation, choice) with them in front of the reporter and ask them to change the law governing Vaping. First change the 2/15/2007 date, that will eliminate PMTAs for all existing products. Then change the regulatory regime to recognize harm reduction and substantially lower risk. It is doable.

Anyone that wants to set this up,let me know. I will give you the email of the scheduler to ask for a meeting. We can lose this war, by sitting on the couch and cussing out the government, all the while not realizing the we are the government. We should reclaim it and demand they respond to us.

(Stepping off soapbox). Sorry, I am just frustrated as I see real action work on issues everyday, we just have to all pull in the same direction.

Thnx

I hope you can reach some vendors to do just that, we need to get in the news!

 

[Rossum]

I really wonder if anyone will submit anything, the FDA rules are so ridiculous.

I have little doubt that PMTAs will be submitted for Vuse, Mark 10, Blu, and maybe one or two others like that...

 

[Rossum]

It should be against the law to write regulations that kill an entire industry for no legitimate reason.

It IS against the law. The FDA is ignoring that. Hence the court challenges.

 

[Tempesta]

Wonder how much of this nonsense--state and federal-- violates the Interstate Commerce Clause of the Constitution?

I agree that the Congresspeople are the ones who can change things, if they are convinced that they will lose votes otherwise. Expecting either Presidential candidate to save vaping is totally unrealistic.

 

[Alien Traveler]

There is NO, NONE, as in ZERO chance that we see any e-liquid manufacturer remain viable after the FDA process moves forward.

No, not zero. Blu, Njoy...

 

[mostlyclassics]

Wonder how much of this nonsense--state and federal-- violates the Interstate Commerce Clause of the Constitution?

A multitude of court decisions over the last 80 years, most by the U.S. Supreme Court, have essentially repealed that clause.

Maybe a lawyer-type will come along to explain the whole dreary history.

 

[Rossum]

No, not zero. Blu, Njoy...

Does Blu make e-liquid?

I could see Njoy giving liquids a shot though.

 

[DC2]

Maybe a lawyer-type will come along to explain the whole dreary history.

I imagine @Kent C has a good book recommendation for those interested.

 

[Lessifer]

No, not zero. Blu, Njoy...

Does Blu make e-liquid?

I could see Njoy giving liquids a shot though.

I can see their closed systems maybe surviving, open e-liquid though, I doubt it. Unless they quickly develop a proprietary filling method.

 

[Alien Traveler]

Does Blu make e-liquid?

I could see Njoy giving liquids a shot though.

At least Blu need it. So, it will have it.

 

[ENAUD]

I can see their closed systems maybe surviving, open e-liquid though, I doubt it. Unless they quickly develop a proprietary filling method.

They could easily develop proprietary filling methods, proprietary atomizers, and even incorporate a digital code so that any atomizer developed will only work for so many puffs or mls consumed before needing replacement.

They would also be free to steal and incorporate the developments and ideas of the innovators and slowly introduce second and third generation products at their own pace

 

[DC2]

They would also be free to steal and incorporate the developments and ideas of the innovators and slowly introduce second and third generation products at their own pace

I don't see how it can happen that way.

Second and third generation products will NEVER meet the PMTA requirements.
Well, unless those requirements change of course.

But as currently written?
A snowball has a better chance in hell.

 

[Lessifer]

They could easily develop proprietary filling methods, proprietary atomizers, and even incorporate a digital code so that any atomizer developed will only work for so many puffs or mls consumed before needing replacement.

They would also be free to steal and incorporate the developments and ideas of the innovators and slowly introduce second and third generation products at their own pace

Proprietary filling method including carto/tank and bottle design, carto/tank and battery connection? Before 8/8/2016?