Would you join an organized movement of vapers?

[Plastic Shaman]

As the thread I linked shows, the FDA itself thinks the application process will be that bad.

Here is another link you might want to take a look at if you haven't already...
http://www.e-cigarette-forum.com/fo...ing-why-deeming-reg-would-ban-all-e-cigs.html

I know electronic cigarettes are not going to be able to use the "substantial equivalence" route...
But the process to apply for Premarket Review of New tobacco Products is said by many to be even worse.

Well, administrative processes are always cumbersome, but companies with enough resources make it through.

I don't disagree that the SE pathway will probably not be a viable option, but there is still the premarket review. Some people say it will be worse. The FDA doesn't think so:

For tobacco products already on the market at the time of the final rule, much of the information required to support a PMTA may be obtained from previously published research on similar products. Therefore, FDA expects that a large portion of applications may be reviewed with no or minimal new nonclinical or clinical studies being conducted to support an application. In contrast, several nonclinical and clinical studies may be required for market authorization of a new product for which there is little to no understanding of its potential impact. The range of hours involved to compile these two types of applications would be quite variable.

Also, there's this funny exception:

Respondents are manufacturers and other persons who, to obtain an exemption from the required warning statement requirement, would be required to certify to FDA that their product does not contain nicotine, that the company has data to support that assertion, and, therefore, the product does not warrant the proposed addictiveness warning

…


To obtain this exemption, a manufacturer would be required to certify to FDA that its product does not contain nicotine, that the company has data to support that assertion, and, therefore, the product does not warrant the proposed addictiveness warning. For any product that obtains this exemption, the proposed section requires that the product bear the message: “This is product derived from tobacco.” The parties that package and label such products would share responsibility for ensuring that this alternative statement is included on product packages and in advertisements. While FDA is not aware of any currently marketed tobacco products that do not contain nicotine, the proposed rule would permit companies to obtain an exemption from this warning requirement in the event that such tobacco products are developed in the future.


Even though the FDA obviously wants to regulate all tobacco products or things that are part of a tobacco product, I think that you could get away with a loophole here.
Here's how it would work. A juice manufacture only makes and bottles zero nic juice. It applies for the exemption so the rules don't apply to the juice. Then it buys nicotine from a company that sells it. This it then bottled and sold separately. Now they aren't manufacturing anything. Maybe I'm reading it wrong, but I think it could work.

Looking at my loophole again, I don't know if not having to apply for the warning would allow them to get away from the application process. Idk, have to wade through all the stuff a little more.

 

[Plastic Shaman]

It's not just vapers, but all of the people who know a smoker and care deeply that they quit smoking.
That's a lot of people, if we can reach them somehow.


But it was written long before anyone knew about electronic cigarettes.
Things have changed since then.

And the FSPTCA should be changed accordingly.

I guess we just have differing opinions here. I'm pretty cynical about the efficacy of the political process and don't see these things as realistic.

 

[DC2]

I guess we just have differing opinions here. I'm pretty cynical about the efficacy of the political process and don't see these things as realistic.

Fair enough.

And trust me, I can understand one having that perspective.
In fact it is one I generally share for the most part.

But it's the passion that we all share that makes me feel there is some hope there.

 

[philoshop]

PlasticShaman, you make a lot of very valid points. You have to remember why this is even an issue: BT is losing money, and this means the states are losing money as well, because people aren't using cigarettes as much.
BT is using a government regulatory system to get back what they're losing, and government is allowing them to do so because they have a stake in it.
Loopholes and other workarounds within the deeming regulations will likely be relatively short-lived. A protracted battle in the US court system that is funded by the vaping community will be similarly short-lived. The deeper pockets will prevail.

OTOH, changing the perception of vaping in the minds of the public will eventually have an effect on the minds of the politicians. (Well, at least some of them. )
There will be regulation of some sort because government is very good at finding problems to fit solutions. Change the problem through education, and they'll be forced to rethink their 'solution'.

 

[CES]

administrative processes are cumbersome, horrendously so. Only huge companies (not mom-n-pop or small companies) are likely to have the resources to make it through. For example, here's a link to discussion about the modified risk tobacco product application for snus

http://www.e-cigarette-forum.com/forum/fda-regulations/597824-what-mrtp-application-looks-like.html

Well here it is, the publicly viewable modified risk tobacco product (MRTP) application by Swedish Match for their Snus product.

There's 1.79gb worth of files altogether (reportedly over 100k pages) so no-one (apart from the FDA is going to read it), but it's very interesting to see the introductory documents and the overall content of what they submitted as contributing evidence.

(emphasis mine)

 

[AndriaD]

I haven't seen anything on the forum about it today, but has anyone noticed that yesterday's election means that Republicans now control both houses of the the legislature?

To me, this shows very clearly that Americans are tired of "progressive" politics! I think this is very good news for the vaping world! It's the progressives behind much of the ANTZ efforts, with their ivory tower "perfect world" ideals of having everyone everywhere completely quit all nicotine use. I sent an email to my own congressman, Rep. Woodall (who was also re-elected yesterday), and I received a personalized response from Rep. Woodall, that he does not support any further federal regulation of e-cigarettes; that if any further regulation is needed, it should be enacted at the state and local level. In other words, .... OUT, FDA!

Senators are a big deal, but they seem to think they're a much bigger deal than they really are -- because it's the Representatives who control the money! And all regulations cost money, for implementation. When the FDA finally releases their "final" regulation suggestions to congress, given that it's now controlled by non-progressives, I would not be at all surprised if congress told the FDA to go fly a kite, they have bigger things to worry about than e-cigarettes.

Andria

 

[The Cloud Minder]

Would you join an organized movement of vapers?
-
If we get guns, I'm in.

 

[Alien Traveler]

I haven't seen anything on the forum about it today, but has anyone noticed that yesterday's election means that Republicans now control both houses of the the legislature?

To me, this shows very clearly that Americans are tired of "progressive" politics! I think this is very good news for the vaping world! It's the progressives behind much of the ANTZ efforts, with their ivory tower "perfect world" ideals of having everyone everywhere completely quit all nicotine use. I sent an email to my own congressman, Rep. Woodall (who was also re-elected yesterday), and I received a personalized response from Rep. Woodall, that he does not support any further federal regulation of e-cigarettes; that if any further regulation is needed, it should be enacted at the state and local level. In other words, .... OUT, FDA!

Senators are a big deal, but they seem to think they're a much bigger deal than they really are -- because it's the Representatives who control the money! And all regulations cost money, for implementation. When the FDA finally releases their "final" regulation suggestions to congress, given that it's now controlled by non-progressives, I would not be at all surprised if congress told the FDA to go fly a kite, they have bigger things to worry about than e-cigarettes.

Andria

Do you really think republicans do not want nice money from vaping taxation? On the level of tobacco? For their states?

 

[Plastic Shaman]

I haven't seen anything on the forum about it today, but has anyone noticed that yesterday's election means that Republicans now control both houses of the the legislature?

To me, this shows very clearly that Americans are tired of "progressive" politics! I think this is very good news for the vaping world! It's the progressives behind much of the ANTZ efforts, with their ivory tower "perfect world" ideals of having everyone everywhere completely quit all nicotine use. I sent an email to my own congressman, Rep. Woodall (who was also re-elected yesterday), and I received a personalized response from Rep. Woodall, that he does not support any further federal regulation of e-cigarettes; that if any further regulation is needed, it should be enacted at the state and local level. In other words, .... OUT, FDA!

Senators are a big deal, but they seem to think they're a much bigger deal than they really are -- because it's the Representatives who control the money! And all regulations cost money, for implementation. When the FDA finally releases their "final" regulation suggestions to congress, given that it's now controlled by non-progressives, I would not be at all surprised if congress told the FDA to go fly a kite, they have bigger things to worry about than e-cigarettes.

Andria

Everyone keeps saying that this industry cannot win against all the money from big pharma and tobacco. Who do you think the Republicans take money from? The fact is that all politicians are basically the same now since they are all controlled by campaign finances. You can believe that they are your savior if you want, but I promise you'll be disappointed as your position is different from that of their donors. This is not a priority for them and on a personal level, I doubt they care.

Also, as I've kept saying, the legislation passed with a good majority. The Republicans didn't put up a fight. Even among them, looking like they are openly opposed to tobacco safety is political suicide. I know most people here disagree with me, but this is not a popular position and I doubt it will be for a long time. Until studies are done deeming that vaping is fairly safe (if indeed it is) and showing that it's not luring in youth (which it probably is) people are going to feel that it needs to be heavily regulated.

 

[LMS62]

Would you join an organized movement of vapers?
-
If we get guns, I'm in.

No worries.....I'll bring the guns! lol

 

[Plastic Shaman]

administrative processes are cumbersome, horrendously so. Only huge companies (not mom-n-pop or small companies) are likely to have the resources to make it through. For example, here's a link to discussion about the modified risk tobacco product application for snus

http://www.e-cigarette-forum.com/forum/fda-regulations/597824-what-mrtp-application-looks-like.html



(emphasis mine)

Right, it's a tough process. I'm not trying to say that things will be fine. Based on what other people have claimed, that there are really large companies that have recently popped up, then they should be OK.

 

[AndriaD]

Everyone keeps saying that this industry cannot win against all the money from big pharma and tobacco. Who do you think the Republicans take money from? The fact is that all politicians are basically the same now since they are all controlled by campaign finances. You can believe that they are your savior if you want, but I promise you'll be disappointed as your position is different from that of their donors. This is not a priority for them and on a personal level, I doubt they care.

Also, as I've kept saying, the legislation passed with a good majority. The Republicans didn't put up a fight. Even among them, looking like they are openly opposed to tobacco safety is political suicide. I know most people here disagree with me, but this is not a popular position and I doubt it will be for a long time. Until studies are done deeming that vaping is fairly safe (if indeed it is) and showing that it's not luring in youth (which it probably is) people are going to feel that it needs to be heavily regulated.

I will take taxation over senseless regulation by those who know nothing of the things they're trying to regulate, any day of the week! The gov't requires a certain amount of money in order to operate, that is a given, and if they can't get that money from tobacco, they will have to get it elsewhere. I'm a big fan of putting some of the 'sin tax' burden on those food items that convey empty calories and no nutritive value whatsoever -- those are far worse health culprits in America, with all the obesity everywhere. But some of the tax burden IS going to fall on e-cigarettes, just because they're gradually replacing tobacco smoking; fighting against THAT would be stupid and utterly pointless -- a gov't without money cannot operate.

What I object to, far more than taxation, is the idea of them outlawing or "regulating" any part of vaping for some stupid reason that makes no sense to anyone but bureaucrats, just because they don't understand it! I do think the Repubs are greedy, so greedy that they'll be more in favor of letting all of it remain legal, as long as there is some financial benefit in it -- the MSA payments have a few more years to run, but after that, why would they have any interest in propping up Big Tobacco? I think they'll be kicked to the curb the day after the last MSA payment is made, and I think BT knows this too, which is why they're --very belatedly -- trying to get some skin in the e-cig game. If yesterday's elections had gone to the progressives, we'd have elected a whole lot more people who want to save us from ourselves -- all the Repubs want is our money, and frankly, that just makes more SENSE than a bunch of glowing-eyed idealists who want us all to be PURE, who will save us from ourselves despite our kicking and screaming to just be left alone!

Andria