FDA Lorillard comments to the FDA deeming regs
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Ok, some quick analysis of the Lorillard comments.
First off, this is a quick analysis of what I believe, don't blame anyone else for this. Thanks.
They start out with the general points as follows:
1. Chemical/toxicological lab analyses show that electronic cigarette users are exposed to
fewer and much lower levels of harmful constituents than with conventional cigarettes.
I agree.
2. Research on health effects is in early stages but the acute effects of electronic cigarettes
are minimal and significantly less than with conventional cigarettes.
I agree with the conclusion, being early is subjective.
3. Nicotine-containing electronic cigarettes are addictive, but users may be less dependent
on them than smokers are on conventional cigarettes.
Has it really been proven that nicotine in itself is addictive? Where is the scientific proof of this? How does this compare to perfectly legal activities such as drinking a soda or coffee, both of which contain caffeine? I think a blanket statement such as this, leaves a lot to be desired.
4. Electronic cigarettes are associated with a significant reduction in number of
conventional cigarettes smoked per day and may help some smokers quit.
This could be more precise, but in a global sense, gets a pass.
5. Users are almost exclusively current/former smokers; dual use is common but often
temporary as smokers transition away from smoking conventional cigarettes; and
use by adolescents is low; there is no evidence that electronic cigarettes are a gateway to
smoking.
I'll accept this statement, I have no reason to argue with it.
So they are already off to a mixed review to me. Some truth is better than no truth, but I'd still prefer the whole truth. I do appreciate it is not a complete slam to the use of e-cigarettes wholesale though.
As for the recommended actions the FDA should take regarding regulating electronic cigarettes from them I find the following. It is very hard for me to support much of anything this company would like to see happen.
They would like to leave the battery and the charger out of the regulations. There aren't any other exceptions, and I find it extremely ironic that the first fear, I would have with the hardware of almost any electronic cigarette is the battery used in it. Sure the risk is minute when compared to say a typical bic lighter, but given unlimited resources, that is one of the first places I'd look to improve in the industry. Accidents are accidents, I agree, but less of them would certainly be a worthy endeavor. It affects more products than just e-cigarettes also. Is the hardware the real issue with the FDA, and if so, should it be? Personally I think this is a costly waste of resources and manpower. Therefore I cannot support it.
Does this mean that you can't sell replacement parts without filing a form for each part of every device you sell? I can't support that either.
Why make it harder to invent products 10 years from now, than it is today?
Warning labels, based on science? Nope, I don't see that happening ever. I mean they state there is at worst minimal impact to ones health using the product. So then you want to scare the people away from them.
I read the paper as this ... You might get addicted to this, though your already likely addicted to smoking, and by switching over to this new product you can go from negative impact on your health to improved or even minimal impact, and you now want to scare me away from using the new product because I might need to use it, and therefore won't appease the abstinence crowd. I get it, I cannot win ... the logic behind this is absurd also.
So though there are good points in the paper they wrote, and no its not all bad, however there are pitfalls and dangers in just accepting what they had to say as absolute truth. They give facts and their subjective opinion, but then ask for things not based on either, but instead based on the political landscape of what they think will be best for the the business they run.
I cannot say I blame them, but what is best for them, might not be what is best for most of us.
First off, this is a quick analysis of what I believe, don't blame anyone else for this. Thanks.
They start out with the general points as follows:
1. Chemical/toxicological lab analyses show that electronic cigarette users are exposed to
fewer and much lower levels of harmful constituents than with conventional cigarettes.
I agree.
2. Research on health effects is in early stages but the acute effects of electronic cigarettes
are minimal and significantly less than with conventional cigarettes.
I agree with the conclusion, being early is subjective.
3. Nicotine-containing electronic cigarettes are addictive, but users may be less dependent
on them than smokers are on conventional cigarettes.
Has it really been proven that nicotine in itself is addictive? Where is the scientific proof of this? How does this compare to perfectly legal activities such as drinking a soda or coffee, both of which contain caffeine? I think a blanket statement such as this, leaves a lot to be desired.
4. Electronic cigarettes are associated with a significant reduction in number of
conventional cigarettes smoked per day and may help some smokers quit.
This could be more precise, but in a global sense, gets a pass.
5. Users are almost exclusively current/former smokers; dual use is common but often
temporary as smokers transition away from smoking conventional cigarettes; and
use by adolescents is low; there is no evidence that electronic cigarettes are a gateway to
smoking.
I'll accept this statement, I have no reason to argue with it.
So they are already off to a mixed review to me. Some truth is better than no truth, but I'd still prefer the whole truth. I do appreciate it is not a complete slam to the use of e-cigarettes wholesale though.
As for the recommended actions the FDA should take regarding regulating electronic cigarettes from them I find the following. It is very hard for me to support much of anything this company would like to see happen.
They would like to leave the battery and the charger out of the regulations. There aren't any other exceptions, and I find it extremely ironic that the first fear, I would have with the hardware of almost any electronic cigarette is the battery used in it. Sure the risk is minute when compared to say a typical bic lighter, but given unlimited resources, that is one of the first places I'd look to improve in the industry. Accidents are accidents, I agree, but less of them would certainly be a worthy endeavor. It affects more products than just e-cigarettes also. Is the hardware the real issue with the FDA, and if so, should it be? Personally I think this is a costly waste of resources and manpower. Therefore I cannot support it.
Does this mean that you can't sell replacement parts without filing a form for each part of every device you sell? I can't support that either.
Why make it harder to invent products 10 years from now, than it is today?
Warning labels, based on science? Nope, I don't see that happening ever. I mean they state there is at worst minimal impact to ones health using the product. So then you want to scare the people away from them.
I read the paper as this ... You might get addicted to this, though your already likely addicted to smoking, and by switching over to this new product you can go from negative impact on your health to improved or even minimal impact, and you now want to scare me away from using the new product because I might need to use it, and therefore won't appease the abstinence crowd. I get it, I cannot win ... the logic behind this is absurd also.
So though there are good points in the paper they wrote, and no its not all bad, however there are pitfalls and dangers in just accepting what they had to say as absolute truth. They give facts and their subjective opinion, but then ask for things not based on either, but instead based on the political landscape of what they think will be best for the the business they run.
I cannot say I blame them, but what is best for them, might not be what is best for most of us.
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OK, i think we sort of agree then.
I take the public document as VERY positive... but don't trust it all that much.
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I suspect that statement was meant in a global/collective sense rather than referring to individual vapers. Example: Take a random population 1,000 vapers...assumed to be former smokers. Some of that 1,000 may continue with dual use, but certainly not all of them. Overall, the 1,000 vapers will be consuming some cigarettes, though less than if they hadn't taken up vaping.
Actually I see your point there. Thank you for pointing it out. Edited original post to reflect that.
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I'm disappointed but not surprised. Parrots don't think, only 'parrot'.
And I'm amazed by the unparallelled amount of accurate information to be found here on every conceivable aspect of e-cigs, and the patience and perseverance of the many knowledgeable and friendly people in here who gently and endlessly counter error with fact. In my experience there are few really egregious misconceptions that flourish long here. Anything really significant that's a more a matter of opinion regarding ecigs gets debated long and hard without being allowed to devolve into mean flame wars. And our really expert members are active and available; they provide reliable and solid info very regularly.
I've participated in any number of forums - ECF, IMHO, is remarkable on all counts.
Truly an amazing machine.
as a comparison to Lorillards response to the FDA here is Innokins response. they both want the FDA to either reconsider and delay or,take other actions as apposed to trying to treat the use of vapor products the same as smoked tobacco. however when taken as a whole i get a different impression overall from each comment. if i had to give grades Innokin gets A+ and,Lorillard gets a C+. Innoken gets to the point and explains their positions of their points with clarity. Lorillards comments are couched in to much legalize sounding rhetoric and, a lot of innuendo hidden between the lines. does that make sense? that's my take anyway.
http://www.innokin.com/uploads/140808/Comments.pdf
regards
mike
http://www.innokin.com/uploads/140808/Comments.pdf
regards
mike
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as a comparison to Lorillards response to the FDA here is Innokins response. they both want the FDA to either reconsider and delay or,take other actions as apposed to trying to treat the use of vapor products the same as smoked tobacco. however when taken as a whole i get a different impression overall from each comment. if i had to give grades Innokin gets A+ and,Lorillard gets a C+. Innoken gets to the point and explains their positions of their points with clarity. Lorillards comments are couched in to much legalize sounding rhetoric and, a lot of innuendo hidden between the lines. does that make sense? that's my take anyway.
http://www.innokin.com/uploads/140808/Comments.pdf
regards
mike
Still reading but, based on a quick skim... and considering who each company is... I'd go A+ and A respectively.
Your kidding!
Did you read the part about certifying manufactures, products and devices? This sugar coated document is designed to maintain their monopoly and drive out competitors.
Did you read the part about certifying manufactures, products and devices? This sugar coated document is designed to maintain their monopoly and drive out competitors.
No, not kidding. Honestly, I don't get that from their document at all. In fact it plainly requests the opposite by suggesting the Pre-market date be moved to the present. As a matter of fact, registering/certifying manufacturing is one of the few things i think the FDA, SHOULD do, as soon as reasonably possible.
Innokin, also advocates for such regulations... But they go a step further...
Innokin actually advocates regulations that would end Mechanical mods, RDAs and RBAs...
I was loving their comments too... right up until:
meaning every device would require a circuit board, as well as sensors (possibly even in the atomizer) and no device could feature a rebuild-able coil.
And it only gets worse from there...
God, it almost makes me sick to say this but...
on review of both documents:
Lorilard: A
Innokin: C
(That's generously combining the 'A' that is most of the document with the giant 'F' that is advocating the removal of their biggest competition... and the products I use everyday)
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i am not going to hold that against Innokin. its a perfectly reasonable argument considered from a safety point of view. my opinion is the FDA knows this and will use it to tighten the screws. absent from both these comments is the FDA must make it perfectly clear when one goes beyond what would be acceptable and reasonable safety standards the end user assumes all responsibility. there has to be protection for vendors from people that will push vaping to the extremes. this way your so called cloud chasers can pursue there hobby and still source quality components. i know the people on the extreme end of vaping do a lot to create and innovate the market. that being said they have to assume the risks and,when doing so reap the rewards. i have no major concern with any DIY'er, they are the modern version of the ametuer radio crowd. with out ametuer radio we would not have wi-fi,cell phones,remotes,drones,the list goes on and on. from a practical joe blow average user point of view i can see where there concerns are being over looked.
regards
mike
Skoony,
I agree. They want massive paperwork. It was subtle but it was there. They are ready to roll over our little guys. It basically mimics what Carl Phillips' was saying in his comment with the exception of the millions of pages of paperwork. Crafty little lawyers.
I agree. They want massive paperwork. It was subtle but it was there. They are ready to roll over our little guys. It basically mimics what Carl Phillips' was saying in his comment with the exception of the millions of pages of paperwork. Crafty little lawyers.
i have seen that. the problem is every paper work condition of the regs they wholeheartedly support. thats where the devil in the details are.that means in their summary they seem to support lenient regs but,taken as a whole mean regulate away we have our paper work ready to go.
regards
mike
mike
I concur. I liked when Innokin stated that e-cigs should not be grouped with regular combustible tobacco. It is not burning tobacco. Beware of the lion in sheep's' clothing.
as a comparison to Lorillards response to the FDA here is Innokins response. they both want the FDA to either reconsider and delay or,take other actions as apposed to trying to treat the use of vapor products the same as smoked tobacco. however when taken as a whole i get a different impression overall from each comment. if i had to give grades Innokin gets A+ and,Lorillard gets a C+. Innoken gets to the point and explains their positions of their points with clarity. Lorillards comments are couched in to much legalize sounding rhetoric and, a lot of innuendo hidden between the lines. does that make sense? that's my take anyway.
http://www.innokin.com/uploads/140808/Comments.pdf
regards
mike
Thanks for posting these.
I greatly appreciated Innokins comments and examples on FDA's regulatory discretion - the degree to which they already 'bend the law' regarding HPHS for tobacco and in the food areas. It gives hope that they actually could implement reasonable regs if they decide to.
Someone mentioned restricting the maximum heat - I must say that the Innokin Iclear30 is the only product I have that shows this visually. When my 30 showed me an orange glow in the mirror I was soon aware that the top coil was red-hot and dry or too dry - before I noticed it in the taste or feal. I doubt they intended this but they have a silicone cup right where it shows this problem and its basically the wick not keeping up with 10 watts at low fluid levels. So I expect to ditch the 30 once i've used up the replacement atomizers I got for it. Would that be good enough you think? to show the user a visible glow (though not needing a mirror) when a coil is overheating? It is true that at least one harmful compound forms only during overheating. You could also put something like a thermiresistor near the coils that reduces current once it senses a given heat level - thats not as bad as the circuit board implied. I burned a lot of cartomizers when I used them - surely got some bad chemicals I didn't want - if theres a solution that works for a single-use carto it should be simple and cheap enough for other atomizers.
I don't know the substantial equivalence or new product pre-approval processes. Lorrilard proposes a benchmark product - a specific or ficticious e-cig that could allow many current products to claim equivalence from it. Couldn't that include sloppy specs - e.g. ranges that would work for many products? and innokin gives examples of relaxed equalence requirements like a new supplier of additive made to the same spec and minor package changed not requiring even equivalence submission. E.G. if a 'juice ' benchmark is 0-100% PG, 0-100%VG, 0-30% water, 0-50% natural and artificial flavors and 0-4% nicotine - then basically all juices could derive equalence from that? Again no idea the cost/time differential between them. What if they treated all the nicotine ranges and bottle sizes of a given flavor all as one product? e.g. 10% flavor1, 5% flavor2, 0-85% PG, 0-80%VG, 0-10% water, 0-4%Nic as the ingredient list for a bunch of juices all called "flavor12" but sold in 0-40mg levels in different bottle sizes and different P/V ratios?
They already have a web submission of ingredients and it accepts flavors like "The Flavor Apprentice, Granny Smith Sour Apple" - they don't want the chemical breakdown of the flavor. But they all have the PG,VG, water, Nic - and it seems the flavor products and proportion of each would be the same whether its 6mg 50/50 15ML or 24mg 80/20 50ML.
I expect the politicians want to tell their constituents that this stuff is being regulated. But they won't give the FDA nearly the funds to do what the proposal implies and any decent turnaround time.
I greatly appreciated Innokins comments and examples on FDA's regulatory discretion - the degree to which they already 'bend the law' regarding HPHS for tobacco and in the food areas. It gives hope that they actually could implement reasonable regs if they decide to.
Someone mentioned restricting the maximum heat - I must say that the Innokin Iclear30 is the only product I have that shows this visually. When my 30 showed me an orange glow in the mirror I was soon aware that the top coil was red-hot and dry or too dry - before I noticed it in the taste or feal. I doubt they intended this but they have a silicone cup right where it shows this problem and its basically the wick not keeping up with 10 watts at low fluid levels. So I expect to ditch the 30 once i've used up the replacement atomizers I got for it. Would that be good enough you think? to show the user a visible glow (though not needing a mirror) when a coil is overheating? It is true that at least one harmful compound forms only during overheating. You could also put something like a thermiresistor near the coils that reduces current once it senses a given heat level - thats not as bad as the circuit board implied. I burned a lot of cartomizers when I used them - surely got some bad chemicals I didn't want - if theres a solution that works for a single-use carto it should be simple and cheap enough for other atomizers.
I don't know the substantial equivalence or new product pre-approval processes. Lorrilard proposes a benchmark product - a specific or ficticious e-cig that could allow many current products to claim equivalence from it. Couldn't that include sloppy specs - e.g. ranges that would work for many products? and innokin gives examples of relaxed equalence requirements like a new supplier of additive made to the same spec and minor package changed not requiring even equivalence submission. E.G. if a 'juice ' benchmark is 0-100% PG, 0-100%VG, 0-30% water, 0-50% natural and artificial flavors and 0-4% nicotine - then basically all juices could derive equalence from that? Again no idea the cost/time differential between them. What if they treated all the nicotine ranges and bottle sizes of a given flavor all as one product? e.g. 10% flavor1, 5% flavor2, 0-85% PG, 0-80%VG, 0-10% water, 0-4%Nic as the ingredient list for a bunch of juices all called "flavor12" but sold in 0-40mg levels in different bottle sizes and different P/V ratios?
They already have a web submission of ingredients and it accepts flavors like "The Flavor Apprentice, Granny Smith Sour Apple" - they don't want the chemical breakdown of the flavor. But they all have the PG,VG, water, Nic - and it seems the flavor products and proportion of each would be the same whether its 6mg 50/50 15ML or 24mg 80/20 50ML.
I expect the politicians want to tell their constituents that this stuff is being regulated. But they won't give the FDA nearly the funds to do what the proposal implies and any decent turnaround time.
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Call me a conspiracy theorist if you must, but it seems to me that big tobacco in our corner regarding e-cigs does not help our cause. To me it seems like big tobacco is trying to protect a potential market to replace the declining sales of coffin nails... On the other hand, the FDA is clearly in the pocket of big tobacco and big pharma, so maybe there is some traction to that. It just seems to me that all of us are here because we wanted to get away from cigarettes. It also seems to me that our fight against the FDA is not just about e-cigs but NRTs in general and the habitual classification of such harm reducing products as traditional cigarettes... Please correct me if I'm wrong.
Big tobacco opposing FDA regulations doesn't seem like anything more than protecting the income from the peddling of death by said companies... That's my opinion, and you know what they say about opinions... They're like ***holes, everyone has one.
Big tobacco opposing FDA regulations doesn't seem like anything more than protecting the income from the peddling of death by said companies... That's my opinion, and you know what they say about opinions... They're like ***holes, everyone has one.
Just a point of clarification, I was referring to NRT's (Nicotine Reduction Therapy) in the same manner as smokeless tobacco products which is not what I was making a reference to. I apologize, so much information, not enough time to absorb it all 
For the people who put time and thought into their comments before submitting them, that was an uncalled for cheap shot.
I forgot. I have seen reference to pipe tobacco - and realize some of it is actually roll-your-own relabeled as pipe. But I've seen no mention of regulating pipes. There must be a lot of small pipe-makers, though not as many as 30 years ago. How do they call our atomizer a component and not a pipe? Not clear if they want to regulate hookah hardware.
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