I vote for the date the final rule is published! I want the DNA40 with temperature regulation to be grandfathered in.
Good news indeed--for a change.
FDA Boehner asks FDA to move Grandfathering date to April 2014 or time of final rule
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I vote for the date the final rule is published! I want the DNA40 with temperature regulation to be grandfathered in.
Good news indeed--for a change.
My personal opinion is that mods and atties should not be considered either tobacco or pharma products. They're something never seen before and I can't understand why they aren't put in a class all their own. Why do they have to be lumped in with existing products when they don't fit in either category? In my mind vaping is a new invention and should be recognized as such.
- Apr 2, 2009
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If the grandfather date is changed to 2014 (or in 2015/16 when the Final Rule is issued), all e-cig manufacturers would have to submit SE reports (in 2016/17/18) to document that all of their products are the same as the products they sold in 2014/15. If they don't submit an SE report (or if FDA rejects an SE report), the product would be banned.
It will be interesting to see what happens in the scramble prior to final rule. I could see vendors/manufacturers needing advice to design products that would make future SE reports easier. Knowledge of earlier SE requests and what was accepted and what was rejected and why on both accounts, would be valuable information for them. Would you be available for a consulting job?
It's all about money, power, and politics. They tried to get them under control under the pharma umbrella. That failed. Now they are going for the tobacco umbrella. They don't care what they are classified as just as long as they are responsible for regulating them.
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They can only be considered tobacco products if the nicotine is sourced from tobacco. If another source is found or someone develops a reasonably priced synthetic nicotine the FDA would have to start over as the courts have already said they cannot regulate it as a drug.
Any bets that someone is already hard at work on this? E--cigarettes are already an over $2 billion market and growing.
This is Tobacco Controls worst nightmare, a non tobacco nicotine source.
excellent!
It is being reported in the media now:
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans
Republicans call for change to FDA rules proposal on e-cigarettes.
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News
well done indeed!
It is being reported in the media now:
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans
Republicans call for change to FDA rules proposal on e-cigarettes.
House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News
well done indeed!
Nice find, Anja!! I liked the link to the black market survey too Tends to drive home the point.
Tends to drive home the point.
They can only be considered tobacco products if the nicotine is sourced from tobacco. If another source is found or someone develops a reasonably priced synthetic nicotine the FDA would have to start over as the courts have already said they cannot regulate it as a drug.
Any bets that someone is already hard at work on this? E--cigarettes are already an over $2 billion market and growing.
This is Tobacco Controls worst nightmare, a non tobacco nicotine source.
Fully synthetic nicotine by means of chemistry alone is unlikely, IMO. However, biosynthetic nicotine is a real possibility and may even become cheaper than that derived from tobacco. What I mean by this is to genetically engineer some microorganism with the genes necessary for synthesizing nicotine, the same approach used today for large-scale manufacture of insulin. Unfortunately, such a development would most likely come out of some Big Pharmafia outfit and may not necessarily be good for vaping.
Dropped Boeher an email today for his letter to the FDA. I am sure I could of put in a lot more but tried to stay on one topic.
Honorable Speaker of the House Congressman Boehner,
I would like to extend my thanks to you and your fellow republicans regarding your letter to the FDA regarding the deeming of e-cigarettes. While I see your letter helpful, by pushing the grandfathering date back to April 2014 would help the industry greatly as the 2007 date would of removed all but the worst products from the market and as such reduce the effectiveness of e-cigarettes to reduce smoking in our state and country.
The area that concerns me is how can the FDA “deem” a product that contains no tobacco as a tobacco product in the first place? I also wonder why they are pushing so hard to control e-cigarettes. Is it to benefit the pharmaceutical industries, which most of them are from? Or is it to protect the tobacco industry?
While I was a smoker since I was 12 years old and I am broaching xx, I was given an e-cigarette on Thanksgiving Day last year. This was the last day that I smoked! I was able to totally replace the habit of smoking thanks to the e-cigarette. I did use it for about 6 months heavily and slowly dropped the amount of nicotine I was consuming, today if I use the device it is with 0 nicotine and mostly to prevent relapse back to traditional cigarettes. I have personally converted 30+ people to e-cigarettes and each and every one of them quit smoking with the device. Again one must inquire of why the FDA, CDC, etc. has taken the stance they have.
There have been countless peer reviewed studies about e-cigarettes with sound scientific processes that show that e-cigarettes are 95 – 100 times “safer” than traditional cigarettes and there have been some studies that have shown some flaws but behind the flaws is still a large reduction in harm done to the user. There have been studies that show that second hand vaper has no risk and the one study I will include a link to is from Igor Burstyn at Drexel university. This study compares vaper with the OSHA standards and shows that all tested substances were well below the standards. BMC Public Health | Abstract | Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks
I can provide many links to the studies of e-cigarettes and the effects of nicotine that show that there is little reason for the FDA to need to regulate them and ask you to consider this when the deeming comes to the floor for a vote.
Respectfully,
Painter_
Honorable Speaker of the House Congressman Boehner,
I would like to extend my thanks to you and your fellow republicans regarding your letter to the FDA regarding the deeming of e-cigarettes. While I see your letter helpful, by pushing the grandfathering date back to April 2014 would help the industry greatly as the 2007 date would of removed all but the worst products from the market and as such reduce the effectiveness of e-cigarettes to reduce smoking in our state and country.
The area that concerns me is how can the FDA “deem” a product that contains no tobacco as a tobacco product in the first place? I also wonder why they are pushing so hard to control e-cigarettes. Is it to benefit the pharmaceutical industries, which most of them are from? Or is it to protect the tobacco industry?
While I was a smoker since I was 12 years old and I am broaching xx, I was given an e-cigarette on Thanksgiving Day last year. This was the last day that I smoked! I was able to totally replace the habit of smoking thanks to the e-cigarette. I did use it for about 6 months heavily and slowly dropped the amount of nicotine I was consuming, today if I use the device it is with 0 nicotine and mostly to prevent relapse back to traditional cigarettes. I have personally converted 30+ people to e-cigarettes and each and every one of them quit smoking with the device. Again one must inquire of why the FDA, CDC, etc. has taken the stance they have.
There have been countless peer reviewed studies about e-cigarettes with sound scientific processes that show that e-cigarettes are 95 – 100 times “safer” than traditional cigarettes and there have been some studies that have shown some flaws but behind the flaws is still a large reduction in harm done to the user. There have been studies that show that second hand vaper has no risk and the one study I will include a link to is from Igor Burstyn at Drexel university. This study compares vaper with the OSHA standards and shows that all tested substances were well below the standards. BMC Public Health | Abstract | Peering through the mist: systematic review of what the chemistry of contaminants in electronic cigarettes tells us about health risks
I can provide many links to the studies of e-cigarettes and the effects of nicotine that show that there is little reason for the FDA to need to regulate them and ask you to consider this when the deeming comes to the floor for a vote.
Respectfully,
Painter_
Ditto and kudos Anja! So... boys and girls, PLEASE take 30 seconds out of your day and send a thank you email to the author, Steven Nelson. His email address is located below the advert on the article page. You would be surprised how few congratulatory emails writers receive.
At this point, he's probably afraid that the STUPID FDA will cause a ban of whatever e-cig he might find appealing!
Andria
One other thought on this, if e-cigarettes take over the market with a non-tobacco sourced nicotine the tobacco growers will go under, might be worth pointing this out to the tobacco growing states. Chemically the same but e-cigarettes can't use it.
Maybe (hint) some vendor like Provape (USA) might send him a kit, tank and some sample e-liquid. ;-)
- Apr 2, 2009
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Kent wrote
Unless the grandfather date is changed from 2007, there won't be any scramble on SE reports, as I only knew three companies that marketed e-cigs in 2007 (NJOY, Crown and Ruyan) and those products (if resurrected from the dead) cannot compete against Altria's MarkTen, Reynolds' Vuse, Lorillard's blu, or NJOY's King (which would submit new tobacco product applications for those products and likely be approved by FDA).
But if the grandfather date is changed from 2007 to 2014 or later (or even to 2013), the FDA would grant the manufacturers at least a year (probably two) after the Final Rule is issued to submit SE Reports. If the new grandfather date is 2014, I'd anticipate several thousand SE Reports being filed (mostly for bottles of flavored e-liquid and for PVs and their components).
Please note that an SE Report only has to be filed with FDA once for each different product (e.g. to demonstrate that a 2016/17 product is nearly identical to a 2014 product). The FDA still hasn't processed the vast majority of SE Reports (for cigarettes, smokeless tobacco and RYO) that were submitted back in 2011.
Importantly, if the grandfather date is changed from 2007 to 2014, nobody will be submitting new tobacco product applications for e-cigs for the foreseeable future (just as no new tobacco product applications have been submitted to FDA for cigarettes or smokeless tobacco since 2009). The entire e-cig regulatory game will shift away from new product applications (which only a several companies can afford to submit, most of which are Big Tobacco) to SE reports for lots of existing vapor products.
The grandfather date would end all product innovation for e-cigs for the foreseeable future (until/unless e-cig manufactures submit new tobacco product application for an e-cig, and the FDA approves them).
It will be interesting to see what happens in the scramble prior to final rule. I could see vendors/manufacturers needing advice to design products that would make future SE reports easier. Knowledge of earlier SE requests and what was accepted and what was rejected and why on both accounts, would be valuable information for them. Would you be available for a consulting job?
Unless the grandfather date is changed from 2007, there won't be any scramble on SE reports, as I only knew three companies that marketed e-cigs in 2007 (NJOY, Crown and Ruyan) and those products (if resurrected from the dead) cannot compete against Altria's MarkTen, Reynolds' Vuse, Lorillard's blu, or NJOY's King (which would submit new tobacco product applications for those products and likely be approved by FDA).
But if the grandfather date is changed from 2007 to 2014 or later (or even to 2013), the FDA would grant the manufacturers at least a year (probably two) after the Final Rule is issued to submit SE Reports. If the new grandfather date is 2014, I'd anticipate several thousand SE Reports being filed (mostly for bottles of flavored e-liquid and for PVs and their components).
Please note that an SE Report only has to be filed with FDA once for each different product (e.g. to demonstrate that a 2016/17 product is nearly identical to a 2014 product). The FDA still hasn't processed the vast majority of SE Reports (for cigarettes, smokeless tobacco and RYO) that were submitted back in 2011.
Importantly, if the grandfather date is changed from 2007 to 2014, nobody will be submitting new tobacco product applications for e-cigs for the foreseeable future (just as no new tobacco product applications have been submitted to FDA for cigarettes or smokeless tobacco since 2009). The entire e-cig regulatory game will shift away from new product applications (which only a several companies can afford to submit, most of which are Big Tobacco) to SE reports for lots of existing vapor products.
The grandfather date would end all product innovation for e-cigs for the foreseeable future (until/unless e-cig manufactures submit new tobacco product application for an e-cig, and the FDA approves them).
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I know all of that
What I was addressing was the bold part in the Boehner letter: "...that the grandfather date for them be set at either April 25, 2014 (the date the proposed deeming regulation was published) or the date the final rule is published."... and your reference in your one post to a possible "...2015/2016 final rule". And the 'scramble' that would happen with manufacturers mainly, of attempting to push proposed designs into reality before that prior rule, so as to set a 'predicate product' that might be easier to duplicate for future products and SE applications for those products.
For example, Joyetech might want to integrate the Evolv rDNA-40 temperature control into their eGrip, or Kanger - which seems they're already into production but not sales - to get pure nickel coils to use with the rDNA-40, before 'final rule'. But those are just a few examples. Someone with a thorough knowledge of the SE process - what has been accepted, what has not, what is the FDA looking for, what they would reject out of hand, etc. is something that would be valuable for manufacturers to know.
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