FDA Swedish Match submitting 100,000 page MRTP application for General Snus to FDA

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alisa1970

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Go for the trifecta - link something from Media Matters :facepalm: but never, ever, actually read or listen to Beck or Limbaugh.

...or actually read the article from "The Nation".

The Weight of the Poor: A Strategy to End Poverty | The Nation

If organizers can deliver millions of dollars in cash benefits to the ghetto masses, it seems reasonable to expect that the masses will deliver their loyalties to their benefactors. At least, they have always done so in the past.
 
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Jman8

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Sorry, but playing a little catch up on this thread, and this is where I left off. Did glance at posts after this and don't think this came up directly again.

Are you imagining people will have personal distillers for nicotine or there will be tons of people rebuilding old ego's or RBA's? I don't think most people build their own coils as it is and it's certanly not going to attract mainstream smokers to swith to vaping if there's that high of a learning curve required to start.

What I imagine black market to be for eCigs, is as much innovation as there is today, minus the openly promoting it on 'public' airwaves. I still think through much of what's online, you'll be able to find where, who, how much type questions answered. Internet would have to change drastically for me to conclude otherwise.

I think there will be technological advancements with eCigs that would happen with current type of market, but will happen just as well under black market, and will mean whatever we think of as 'available devices' today aren't what it will be say 3 years from now. It will arguably be far better, and what that is exactly would be virtually unknown to 99% of people most interested in this topic from a technical pov.

So, it comes back to how available will nicotine be.

One thing with prohibition against alcohol and another herbal substance was that anyone could make/grow it and it was in a useable form. I don't think that's true for nicotine. It would require importation / underground labs that are not that easy to hide. When something needs to be smuggled in, the quality becomes variable and the price esculates possibly higher than taxes would do. The more demand and active a black market is, the criminal charges are also increased - the major players eventually are criminals willing to take the risk.

On your final point, I would also just add that the major players would also be people (organizations) spending millions (possibly billions) in their investment to make sure they stay major players.

Labs wouldn't be easy to hide, but neither would they be impossible. Plus the people that are paid to notice them could theoretically be (I would say decent chance of being) bought off.

IMO, going in this direction takes a different mindset from consumer on the politics. Arguably, those who are most likely to benefit from a black market could be pushing for that right now. And under the black market scenario, it could be most vocal opponent of eCigs ever being legal again, who appears wonderful on the surface (i.e. state leader of CDC) could be bought off and making a ton of money off the black market. Making sure underground labs are never investigated.

For sure some people would get busted.
Very likely quality of product would take a hit (especially if we are assuming quality in 2014 was 'great').
But market would still be meeting demand, making a profit, and have no end in sight.

If you feel aware of a product, any product at all, that has been regulated out of existence and yet still has a demand, I'd be very interested in hearing what that is. I'm willing to claim you won't be able to name one. And of the things I can think of that require a lab to be produced, that product is rather plentiful. Already have very harsh penalties for users, who happen to be rather nuts in justifying their need to obtain the product, whereas nicotine usage strikes as about as low on the totem poll as one could go for such an item. For it to get raised on that proverbial totem poll, it would mean a vastly different proposal than the one that FDA just put out. Some here seem to think that's inevitable and is months away. I would argue that it is questionable (at best) and if it were to arise, is at the very least 5 years away, likely closer to 10. Major players in the black market would already be ahead of the game, and again, theoretically could be part of the reason why 'harsh regulations' are being pushed thru. I'm yet to see a harsh regulation with regards to eCigs. Public usage bans would be the only thing I can think of that comes closest, and I'm including FDA proposed regulations in that assertion.

I can remember when most prescription drugs were available on line > 10 yrs ago direct from the manufacturers plant (India, Thailand, etc) with ease. They couldn't search all packages, right? Well eventually they figured out ways to stop almost all shipments. Scammers also got into it to such an extent it was nearly impossible to figure out which factories were legit and which weren't. There were forums like ECF comparing which ones were which. A lot of people got sugar pills. Some got nothing. Some just got notices of confiscated pkgs. All of them paid a MUCH higher price than if they used a legit prescription and those prices are high enough.

I honestly do not think this is applicable to the nicotine market that could ensue, but do think it is worth further discussion. We are, at the very least, 5 years away from this. I say it never happens, but if I were to concede on that position, then I would say 10 to 15 years away, with a whole lot of stuff that either could happen or would need to happen (politically) for it to be 10 years away (or sooner).

The other route would be to go to the dark net, use a VPN / TOR. Again, not something the mainstream is willing or can do. There's a sizeable portion of ECF that won't even deal with FaceBook and many of those (IMO) are a target market for vaping > 45 with decades of smoking history.

I bolded the part I bolded, because clearly black market for nicotine wouldn't be mainstream. Yet, while eCigs here in 2014 are getting to be a part of mainstream, some of what all of us have been dealing with is a balancing act of making them much more known (for what they actually are) and more accepted, balanced against idea that items that are too well known tend to attract regulations. But point I'm raising here is that eCigs right now aren't exactly mainstream. It isn't obvious to most people in mainstream that eCigs are the better/healthier choice.

While there are a number of reasons (from various perspectives) of why a black market could exist, one of those, from certain consumers' perspective, would be political. What I keep hearing much of the time I bring up black market is that it would only result in the 'bad' politics/legalities. I grant that will happen. Is arguably happening right now with current market, but I grant it could get worse under black market. But, and this is a huge but, things can go the other way. It could attract more users, more intellectual thought about actual risks vs. propaganda, and more people wanting to 'fight for the cause.' All aimed at making it legal, and making it a suitable alternative to smoking. Arguably, things may need to get worse in the market for the mainstream to sit up and take notice and realize that black market is for sure not the way to dealing with this issue. Right now, it is plausibly an acceptable outcome to the mainstream cause they don't know any different.

Some (here) seem to think regulators/law enforcement will get to a point where eCigs, or rather nicotine, will be enforced so well that demand is down to a couple thousand people on the planet, who are able to avoid jail. I very strongly disagree with that position. Perhaps it is a wait and see proposition, but I'd rather address this version of worst case scenario with reason and experience of all other things ever to be on the black market, then with some fearful/emotional response that IMO, is not based in the shared reality that we live in.

Especially given the fact that currently (and for next 5 years at very least) we are nowhere near this situation.

Do a google search on "liquid nicotine" that doesn't go beyond 2006, and let me know how much data you pull up. At one point, not too long ago, it was 'not really existing.' And yet, it has technically always existed. It can't be banned (according to FSPTCA), and in 2005 the controls were very very very very strict. I say all this cause it could revert back to that, and even that was - product is still available, can be found, but needs consumers to go through proper channels. Make the current channels show up as 'improper' and new channels will emerge.
 

Jman8

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The reality is that BT bought into vaping as placeholders. They contributed nothing to the research and development of the industry. Vaping was pioneered by small and medium sized business by ex-smokers to help other smokers to quit and that's a very important difference in the way cigarette manufacturers have treated smoking in the past. Yet it's these businesses that the FDA is comfortable regulating out of business and turn over to an industry that has done nothing to deserve it, has a history of lying, manipulating and decieving Congress, the FDA and the public for profit to the extent that extreme measures like the Master Settlement and the Tobacco Act were required in the first place. That's asking for trouble.

I wanted to like the post this came from (the short little book). Lots of great points made, most of which I and many here fully agree with. But for me it would meaning liking this sort of statement as well.

I as a vaper (dual user) like that BT is in the game. I am yet to purchase a BT made device, but have tried it, thought it 'okay.'

Even this paragraph I read points I either like or find hard to disagree with, such as "yet, it's these businesses that the FDA is comfortable regulating out of business." Speaking about small and medium sized vendors/manufacturers. The FDA is obviously backwards on this matter.

Yet FDA, right now, is not the only major player in the game (as it exists right now). They made a proposal, and one that stands a decent chance of becoming 'final rule' for vaping market. Yet, what exactly that rule is, no one knows for sure. How that rule will be enforced, no one may ever know. And what does the vaping market look like say 5 years from now, is so diverse in speculation, it is impossible to pin point who is most accurate. Likely won't even know 1 year after final rule(s) are in effect.

The whole BT being in the game point is for me a diatribe. For now, I'll just again reiterate that I like it, and it is reality going forward. Thinking BT will get out of the game is as realistic as thinking FDA will stop regulating. So, that would be a second major player that's in the game. Science would be a third major player in the game. BV would be a 4th major player. And yet none of them are as big as the collective consumers in the game, who will have highest influence on where market will stand 5 years from now.

Getting back to topic of this thread, at least as it relates to the side tangent, I still do not understand why filing applications for NPT or MRTP product would be lots of money. I feel I left door wide open for Bill G. to explain that, and instead felt like response was 'take my word for it.' That it would be lots of money is corruption. Unless someone wishes to explain the details and answer to the questions, I'm calling it as I see it, it is (scientific) corruption. I also don't understand why small and medium sized businesses would seek to comply. I get that they'd face plausible legal issues if they did not. Possibly being run out of business. But if no 'common person' is able to explain or truly understand justification for $300,000 per application, then I think the risk is entirely worth it to continue business as usual, for surely that markup, if not corruption, isn't applicable to that business. Anyway, this point I'm making does lead me to making further points about black market inevitability, but again, I am saying I do not understand why a smaller business would seek to comply with FDA. Maybe someday, soon, I'll change my tune on this, but pretty sure that won't happen in next 2 years unless someone can reasonably explain the $300,000 per application. Thus far, I haven't seen anyone come close.

As a consumer-stakeholder, I think I, or we, have good enough reason to understand why.
 

Jman8

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About 85% of the public thinks ST is just as harmful, or more harmful then smoking. I would guess the number of electronic cigarette users that are misinformed about ST are not much different then that of the the general public, especially for newbies and folks who don't venture out of the new gadget, best liquid section of the vaping world.

Making a larger point based on this quote, but I truly think it is one of the biggest issues of them all. If I ask someone reading this thread to point out the harm of combustible tobacco, I believe they will readily find it. And could link me to that data in seconds. Yet, if I go look at that data, it will be from either the same sources or very similar sources, that are getting the word out on the harm/danger of eCigs.

My point being that people do not question, a whole lot, the veracity of smoking harms/kills. They accept it as fact. If I write a post like this, I'll get reminded of someone's relative that died, and the poster that watched them die, and how I am mistaken if I think smoking is harmless.

I think 'smoking kills' is precisely the meme we are up against with regards to politics of vaping (or any other alternative product). I say, let that product take over as number one consumer product, and both along the way (already occurring) and while on top, it will be shown, by science, to be utterly dangerous. People will be shown as dying from it. I don't see this as a maybe proposition, but a guarantee. 100% guarantee.

I fully accept that vaping is less harmful than smoking. And I think all vapers accept the notion that vaping is not harmless. However, and I truly think this is the crux of the matter and deals with 'public good' points (and counterpoints), the degree to which the level of (unknown) harm can be exploited, it absolutely will be.

I think the harm data around smoking has been cooked to make sure everyone agrees that it is harmful (highly dangerous) and that having anyone comparing a product to smoking is a red herring. I don't think anything I say, or all the vapers combined might say, will change this meme (the belief that smoking kills). Fact is, most vapers accept the meme, no questions asked, or 'there is no debate to be had.' I think the reasonable answer going forward is to scrutinize the heck out of the smoking data, and make determinations of vaping harm as a result of that updated, and honest, data, so that vaping can be seen more accurate (truly mild). But alas, we aren't caught up in that game, and the current one does appear to serve us to some degree in the immediate term.

So it is what it is, but I just want to be clear that I dislike the game that has us seemingly playing on the same side as FDA/CDC while not really scrutinizing what is truly at the crux of the matter.
 

SleeZy

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Interesting.
Well, snus has been banned in the European Union except for Sweden (that's the influence of "public health" for you....) but in Sweden it is widely accepted. Sweden has the lowest rate of smoking and of smoking-related illness in the entire EU.

We only entered the EU if we still were allowed to sell snus. EU wanted to ban snus in sweden aswell, but we wouldn't have joined EU then.
Now they kind of want to ban snus in another way. They've removed the ingredientlists and you can't mark what kind of flavour the snus is. So sooner or later they will say just like they do with e-liquid "we don't know what's in it". Ofc you don't since you for some odd reason decided to ban ingredient lists. /facepalm
 

AgentAnia

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Making a larger point based on this quote, but I truly think it is one of the biggest issues of them all. If I ask someone reading this thread to point out the harm of combustible tobacco, I believe they will readily find it. And could link me to that data in seconds. Yet, if I go look at that data, it will be from either the same sources or very similar sources, that are getting the word out on the harm/danger of eCigs.

My point being that people do not question, a whole lot, the veracity of smoking harms/kills. They accept it as fact. If I write a post like this, I'll get reminded of someone's relative that died, and the poster that watched them die, and how I am mistaken if I think smoking is harmless.

I think 'smoking kills' is precisely the meme we are up against with regards to politics of vaping (or any other alternative product). I say, let that product take over as number one consumer product, and both along the way (already occurring) and while on top, it will be shown, by science, to be utterly dangerous. People will be shown as dying from it. I don't see this as a maybe proposition, but a guarantee. 100% guarantee.

I fully accept that vaping is less harmful than smoking. And I think all vapers accept the notion that vaping is not harmless. However, and I truly think this is the crux of the matter and deals with 'public good' points (and counterpoints), the degree to which the level of (unknown) harm can be exploited, it absolutely will be.

I think the harm data around smoking has been cooked to make sure everyone agrees that it is harmful (highly dangerous) and that having anyone comparing a product to smoking is a red herring. I don't think anything I say, or all the vapers combined might say, will change this meme (the belief that smoking kills). Fact is, most vapers accept the meme, no questions asked, or 'there is no debate to be had.' I think the reasonable answer going forward is to scrutinize the heck out of the smoking data, and make determinations of vaping harm as a result of that updated, and honest, data, so that vaping can be seen more accurate (truly mild). But alas, we aren't caught up in that game, and the current one does appear to serve us to some degree in the immediate term.

So it is what it is, but I just want to be clear that I dislike the game that has us seemingly playing on the same side as FDA/CDC while not really scrutinizing what is truly at the crux of the matter.

Every smoker -- and every vaper -- should read Michael McFadden's book, Dissecting Anti-Smokers' Brains. He uses real, unadulterated facts and figures to expose the lies and half-truths ANTZ have been brainwashing the public with for decades. It's scary, and while I in principle have agreed with him since the 60's, it certainly has opened my eyes to just how deceptive and dangerous they are.
 

aikanae1

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I wanted to like the post this came from (the short little book). Lots of great points made, most of which I and many here fully agree with. But for me it would meaning liking this sort of statement as well.

I as a vaper (dual user) like that BT is in the game. I am yet to purchase a BT made device, but have tried it, thought it 'okay.'

Even this paragraph I read points I either like or find hard to disagree with, such as "yet, it's these businesses that the FDA is comfortable regulating out of business." Speaking about small and medium sized vendors/manufacturers. The FDA is obviously backwards on this matter.

Yet FDA, right now, is not the only major player in the game (as it exists right now). They made a proposal, and one that stands a decent chance of becoming 'final rule' for vaping market. Yet, what exactly that rule is, no one knows for sure. How that rule will be enforced, no one may ever know. And what does the vaping market look like say 5 years from now, is so diverse in speculation, it is impossible to pin point who is most accurate. Likely won't even know 1 year after final rule(s) are in effect.

The whole BT being in the game point is for me a diatribe. For now, I'll just again reiterate that I like it, and it is reality going forward. Thinking BT will get out of the game is as realistic as thinking FDA will stop regulating. So, that would be a second major player that's in the game. Science would be a third major player in the game. BV would be a 4th major player. And yet none of them are as big as the collective consumers in the game, who will have highest influence on where market will stand 5 years from now.

Getting back to topic of this thread, at least as it relates to the side tangent, I still do not understand why filing applications for NPT or MRTP product would be lots of money. I feel I left door wide open for Bill G. to explain that, and instead felt like response was 'take my word for it.' That it would be lots of money is corruption. Unless someone wishes to explain the details and answer to the questions, I'm calling it as I see it, it is (scientific) corruption. I also don't understand why small and medium sized businesses would seek to comply. I get that they'd face plausible legal issues if they did not. Possibly being run out of business. But if no 'common person' is able to explain or truly understand justification for $300,000 per application, then I think the risk is entirely worth it to continue business as usual, for surely that markup, if not corruption, isn't applicable to that business. Anyway, this point I'm making does lead me to making further points about black market inevitability, but again, I am saying I do not understand why a smaller business would seek to comply with FDA. Maybe someday, soon, I'll change my tune on this, but pretty sure that won't happen in next 2 years unless someone can reasonably explain the $300,000 per application. Thus far, I haven't seen anyone come close.

As a consumer-stakeholder, I think I, or we, have good enough reason to understand why.

Thank you, I think you out wrote my little book only spread out.

It's not that I want to see BT removed from ecigs. I just know that the way business operates today, there are incentives to become a monopoly. They can't compete with minor businesses.

There's been a number of speculations on the costs of an application, I think some from the FDA too. There are clinical studies that need to be performed for each product. The FDA doesn't accept a study without it being performed on the specific product and even a change of manufacturer could trigger a need for a new product application. There's quite a list of documentation required. I know there is a supplimental publication that lists these. There are still specifications that need to be written which is what the SBA letter addressed.

When I was doing research of cancer there's a host of 'raw materials' that are no longer available in the US, many go through various problems with importation, some due to abuse, some not. HGH was one, bio phosphates are another. There were forums tracking them down over at lef.org (including former prostrate cancer forums) and that's all I can remember right now. It's been a few years. A lot of pharmacetical grade suppliments need to be ordered from overseas because they also have better controls of getting what you expect. Kinda weird. Regulations in the US tend to water down and devalue products. Elsewhere it tends to upgrade them and give an assurance of quality. Although I suspect the latter is changing.
 

Maurice Pudlo

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I like cars and California, unfortunately there is CARB, I like reptiles, unfortunately there is USDA, I like vaping, unfortunately there is the FDA, I like guns, unfortunately there are douchbags galore who think not one of the above should be part of my persuit of happiness without some form of regulation that effectively removes the fun factor.

I can readily purchase a diesel truck that'll haul 3500 pounds of crap and use it as a daily commuter vehicle in California but heaven help me if I put a turbocharger on a 1.5l.

I like reptiles in general, but all across the country there are laws and/or restrictions in place that makes owning them problematic at best and impossible at worst. A list of snakes can't be transported across state lines now thanks to the USDA so if you have to move (say your in the military) guess who's not taking Mr. Snuggles?

I like vaping, yet look where this stuff is going...it isn't as if we harm others with our little pastime activity.

Lastly I like guns, I like shooting, I like the guns themselves, I like that if my life were in danger I can at the very least have a chance to be as well armed as my assailant. However I can't own a .50cal BMG in California, as if a crook is going to commit a crime with such a thing, I can't buy a whole slew of 1911 style pistols because the design doesn't pass their drop test, does anyone realize just how much a 1911 costs, people don't drop $700 to $1000 handguns all that often.

The longer I live here the more frustrated I am with people who think they have some vision of how everyone else should live their lives. What happened to the days when folks just minded their own business?

When might we expect the FDA to stop by and check out the family recipes, I have some sourdough starter that's been alive for going on oh I don't know, 20 years maybe, I'm not sure it passes today's food safety standards but it makes some damn nice bread.

I mix my own liquids, can I just print out ECF and send that in to the FDA? I'm not sure I can afford to print it all out, but hey, it would be fun.

Maurice
 

Kent C

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I like cars and California, unfortunately there is CARB, I like reptiles, unfortunately there is USDA, I like vaping, unfortunately there is the FDA, I like guns, unfortunately there are douchbags galore who think not one of the above should be part of my persuit of happiness without some form of regulation that effectively removes the fun factor.

Some of the reasons I left and won't move back to California. Still, California sets a lot of 'trends' that tend to go Federal. The Feds would love to have California type gun control. And likely the other things as well.
 

Maurice Pudlo

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Some of the reasons I left and won't move back to California. Still, California sets a lot of 'trends' that tend to go Federal. The Feds would love to have California type gun control. And likely the other things as well.

I will be going back, with any luck I will not have to interact with many people though. How I grew up there and didn't come out a Liberal I have no idea.

Does anyone know if the requests for FDA product approval are available via open records or anything similar? Couldn't hurt to piggyback on some of the research done by others to reduce costs across the board.

Maurice
 
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