FDA Regulations and innovations....

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Kent C

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SmokeyJoe posted this in the Evolv thread in APV Discussions and I got ok to post it here as well.

http://vaping.com/news/exclusive-in...rom-evolv?_ga=1.67047788.375002566.1413519349

Most here will know about the new dna 40 board that has 'temperature protection'. This isn't to promote it or discuss all the technical aspects of such an innovation, but to show how it relates and how the creators see it relating to regulations.

Here's part of what I relayed to SJ: (John and Brandon, of course from Evolv)

John: ...So, we’re attacking the vapor integrity in the DNA40, and really we’re doing this much earlier because we were kind of pushed into it by the FDA. We need to come up with a regulatory framework where we can guarantee that we know what’s in the vapor stream, or we’re never going to see an approvable product. But, we see there’s a finite number of things to solve before the e-cigarette is as good or better than a tobacco cigarette.

Brandon: Let’s talk a little bit about the open system too. One of the things that this does is it facilitates an open system. John’s belief, and I tend to stand behind it, is that, we can regulate these on a component by component basis saying, “Okay, flavour in A, flavour in B, flavour in C, don’t break down below this temperature”. We need to remember that big tobacco are pushing for this to be regulated as a complete closed system. because if you have a closed system you can control everything and then you have to buy your cartridges from Vuse or whoever. So, if we have devices which can control accurately, then juice makers can have a list of ingredients they can use, and still be able to make their 250 juices from those ingredients.

Me:
... it might be interesting to have it posted in the 'Regulations' subforum, as well. I still have hope that something along the lines of Azim Chowdhury's 'baseline predicate product' as an alternative for a grandfathered product, could possibly interest the FDA (esp. if they lose another court case :) where it is these type of 'improvements' that would fit into their public health orientation when vaping is looked at as either an inevitability or in the highly improbable result, that they actually consider it a true harm reducer. AND, it will show them that perhaps, unlike the tobacco companies (although I don't buy into that completely) that the vaping community actually 'thinks' more about these things than just getting our next nicotine hit. lol

I'm uncertain if this is worthy of discussion or just worth posting this part - as such innovations would seem to point to Azim's idea of the FDA establishing a baseline predicate product. Azim on that idea: "Rather than requiring that companies find a specific predicate product on their own, the FDA could establish threshold specifications (e.g., product standards) for a baseline e-cigarette against which companies could make the case that their products are substantially equivalent."
http://www.khlaw.com/webfiles/What_To_Expect.pdf

And from SJ's piece it seems there is more to come from Evolv and no doubt from other innovators as well, of course. It would be a shame to 'freeze' the industry at this point with the final rule on deeming and smokers, and ex-smokers and to an extent 'bystanders' will be the worse off because of it. Regulations, as Senator Burr said in the HELP committee hearing, shouldn't squash innovation.

Sen. Burr: “If we kill technology and innovation, which is, in essence, what some are attempting to do at the beginning, it’s not going to play a role in reducing the amount of Americans who smoke,” he said. “I can remember when opportunities for harm reduction were the goal, but the technology wasn’t there … well now, the technology is there, and how quickly we’ve moved to the point where harm reduction is no longer a goal.”
 

Oliver

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It's beyond me to comment on whether or not Evolv can affect the actions of the regulators. But the logic behind getting a product to market before regulators announce their final rule seems sound.

I've got to say, I was thoroughly impressed by their approach, and their clear desire to support the continuation of open systems. It makes perfect sense that temperature-protection would be an absolute requirement by regulators. I'll defer to others on the likelihood of regulators to take their technology into account in the final rule, however.
 

SeniorBoy

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Actually in addition to the thoughts in this thread we also have a "convergence" of two very significant events today and not tomorrow so to speak. The release of the DNA40 and the Dr. Farsalinos Crowd Funding study. Dr. F has already indicated he will use a DNA40 to conduct part of his tests. How far he goes with the testing is of course dependent on funding. I just did a back of the napkin calculation and unfortunately the Dr. F study is currently around 7k behind the goal of 72K. I'm disappointed that more vendors have not stepped up to the plate and contributed since they are the primary target for his funding.

I certainly don't wish to infer or suggest that this "convergence" will impact the FDA final regs. That issue/prediction is beyond my pay grade :) But, I'm hopeful and rather confident that it will certainly interest the FDA. Assuming the Dr. F study reaches a satisfactory level of funding, I think it will be published before the Deming becomes the law of the land and or the inevitable legal action is resolved. The additional data from Evolv is likely to appear far far sooner rather than later. I view all of this as a good thing for the Vaping community. Someday we may all look back on these events which I noted and perhaps realize that indeed, we were all a party to these events and they were in fact very significant. Only time will tell.

:)
 
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