On stockpiling after FDA deeming regulations

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r055co

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And yet another State down the rabbit hole. I guess the sky isnt falling???? Aug 8th isnt even here yet and 5 states are already taxing vape stuff:

West Virginia Legislature Passes Massive New Tax on Vapor Products

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Pigs at the trough

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Robert Cromwell

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Wasn't someone asking about wanting a cheap Nemesis clone? Mountain Oak Vapors has them for $1.99 in their clearance section.
Sold out. At least they were a couple of days ago.
I got 2 of them a few weeks ago.

Edit:
checked and yep out, need to update their web site.
 
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Mazinny

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So you are saying the FDA is so dumb they can't visit joyetech, Evolve, eleaf, etc and see for themself is a new update has been released?

The FDA is evil NOT STUPID.
They can visit Evolv. But the rest are based in China. Good luck trying to enforce an US laws or regulations there.
Evolve will just move if necessary.

Something tells me the FDA will not crack down on Evolv. Evolv is one of four vendors ( Njoy, What a Smoke, and Four Elements are the others ) developing a 'A STABLE, TIGHTLY CONTROLLED, CHARACTERIZED, DATA-LOGGING ELECTRONIC NICOTINE DELIVERY SYSTEM' for the NIH.

Highly unlikely that anything they do is not coordinated with the FDA. Who knows, before it's all said and done, we may all be using an Evolv ecig.

SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research - Federal Business Opportunities: Opportunities

Department of Health and Human Services HHSN271201500072C To Evolv LLC $277.7k

FBODaily.com | FedBizOpps: FBO#5052 | 23-Sep-15 | AWD | A--Research and Development

Has anyone heard of any statements from Njoy or Evolv on the deeming regs since May 5 ?
 
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Mazinny

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Something tells me the FDA will not crack down on Evolv. Evolv is one of four vendors ( Njoy, What a Smoke, and Four Elements are the others ) developing a 'A STABLE, TIGHTLY CONTROLLED, CHARACTERIZED, DATA-LOGGING ELECTRONIC NICOTINE DELIVERY SYSTEM' for the NIH.

Highly unlikely that anything they do is not coordinated with the FDA. Who knows, before it's all said and done, we may all be using an Evolv ecig.

SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research - Federal Business Opportunities: Opportunities

Department of Health and Human Services HHSN271201500072C To Evolv LLC $277.7k

FBODaily.com | FedBizOpps: FBO#5052 | 23-Sep-15 | AWD | A--Research and Development

Has anyone heard of any statements from Njoy or Evolv on the deeming regs since May 5 ?

Btw, this is what John from Evolv said about the project prior to being issued the grant :

Just figured I'd pop in and give you all a heads up why I haven't been on the forums the past few weeks.

Back in April we applied for this NIH program

SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research - Federal Business Opportunities: Opportunities

to develop a standardized research e-cigarette, and Evolv is one of the finalists. I've had to put development efforts on that into high gear, as well as spend a lot of time researching and responding to various requests from NIH. They want to award early and then on top of that they want to compress the timeline further if possible. The grants aren't for a lot of money, but it is really important for the industry for us to get this right.

If vaping is going to survive, it is because we are demonstrably healthier than smoking. Demonstrably doesn't mean "I tried it and I feel better" and it doesn't mean RJR commissioning a study. It means actual medical researchers running actual medical research. Most of the e-cigarette studies that have been done thus far have been crap. Honestly, who can blame the researchers when the only tools they have are off the shelf devices. Nobody expects cancer researchers to work with X-ray glasses purchased from the back of a comic book, but "we went down to the local convenience stores and bought some Blu e-cigs" is the best that they can do right now.

Getting really well controlled, accurate, instrumented, documented devices that record and report into researchers' hands will let them draw accurate conclusions. For example, formaldehyde: you really can set up an e-cig to be a formaldehyde generating machine. You can also set them up to give you virtually none. The questions that really should be asked are "what controls formaldehyde production, where is the limit, and are people actually getting formaldehyde in day to day use" but until they have a good research device, that isn't an answerable question. (Incidentally, the answer to those particular questions seem to be "Temperature, somewhere between 430F and 450F" and "yes, but only some people.")

Also, this is NIH. I have a TON of respect for the National Institute of Health. This solicitation was the only one that I felt was asking the right questions, and I'd really like to see the people asking the right questions get rewarded with the best results. FDA is running a similar development and we did not apply for that one. "The government" is not monolithic.

You can see a lot of hints of this work in the 200. The device we're proposing as the standard research e-cigarette is not the 200. You don't need to pay for an accurate clock, megabytes of data storage or extra sensors. Researchers don't need to pay for 200 watts. It is 100% an Evolv product.

Just in the course of developing and characterizing this research e-cig we'll be able to put a lot of unanswered questions to bed.

I think I am over the most time-critical portions of it (the actual device development and research I enjoy, the reams and reams of forms, paperwork, proposals, counter-proposals and all that... not so much) so hopefully I'll be back around here with more regularity.

I'm happy to talk about this to the degree that I can.
 

Robert Cromwell

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Btw, this is what John from Evolv said about the project prior to being issued the grant :

Just figured I'd pop in and give you all a heads up why I haven't been on the forums the past few weeks.

Back in April we applied for this NIH program

SBIR Topic 156b Development of a Standardized Electronic Cigarette for Clinical Research - Federal Business Opportunities: Opportunities

to develop a standardized research e-cigarette, and Evolv is one of the finalists. I've had to put development efforts on that into high gear, as well as spend a lot of time researching and responding to various requests from NIH. They want to award early and then on top of that they want to compress the timeline further if possible. The grants aren't for a lot of money, but it is really important for the industry for us to get this right.

If vaping is going to survive, it is because we are demonstrably healthier than smoking. Demonstrably doesn't mean "I tried it and I feel better" and it doesn't mean RJR commissioning a study. It means actual medical researchers running actual medical research. Most of the e-cigarette studies that have been done thus far have been crap. Honestly, who can blame the researchers when the only tools they have are off the shelf devices. Nobody expects cancer researchers to work with X-ray glasses purchased from the back of a comic book, but "we went down to the local convenience stores and bought some Blu e-cigs" is the best that they can do right now.

Getting really well controlled, accurate, instrumented, documented devices that record and report into researchers' hands will let them draw accurate conclusions. For example, formaldehyde: you really can set up an e-cig to be a formaldehyde generating machine. You can also set them up to give you virtually none. The questions that really should be asked are "what controls formaldehyde production, where is the limit, and are people actually getting formaldehyde in day to day use" but until they have a good research device, that isn't an answerable question. (Incidentally, the answer to those particular questions seem to be "Temperature, somewhere between 430F and 450F" and "yes, but only some people.")

Also, this is NIH. I have a TON of respect for the National Institute of Health. This solicitation was the only one that I felt was asking the right questions, and I'd really like to see the people asking the right questions get rewarded with the best results. FDA is running a similar development and we did not apply for that one. "The government" is not monolithic.

You can see a lot of hints of this work in the 200. The device we're proposing as the standard research e-cigarette is not the 200. You don't need to pay for an accurate clock, megabytes of data storage or extra sensors. Researchers don't need to pay for 200 watts. It is 100% an Evolv product.

Just in the course of developing and characterizing this research e-cig we'll be able to put a lot of unanswered questions to bed.

I think I am over the most time-critical portions of it (the actual device development and research I enjoy, the reams and reams of forms, paperwork, proposals, counter-proposals and all that... not so much) so hopefully I'll be back around here with more regularity.

I'm happy to talk about this to the degree that I can.

Yep, but I really do not expect the FDA to approve a 200 watt device...
Perhaps why they came out with the 75 watt chipset?

I still am expecting cigalike types with prefilled cartridges to be the choice of the FDA.

Again, I hope I am wrong.
 

Yiana

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Yep, but I really do not expect the FDA to approve a 200 watt device...
Perhaps why they came out with the 75 watt chipset?

I still am expecting cigalike types with prefilled cartridges to be the choice of the FDA.

Again, I hope I am wrong.

I hope you're wrong too, but I wouldn't hold my breath unfortunately. :oops:
 

Mazinny

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Yep, but I really do not expect the FDA to rightapprove a 200 watt device...
Perhaps why they came out with the 75 watt chipset?

I still am expecting cigalike types with prefilled cartridges to be the choice of the FDA.

Again, I hope I am wrong.
Maybe you're right, but as a betting man i'd bet Evolv has a decent chance of having an FDA approved product when it's all said and done. They've already been working on this for a good while now and the NIH grant doesn't hurt.
 

crxess

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