FDA Swedish Match submitting 100,000 page MRTP application for General Snus to FDA
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From the Senate HELP hearing, the CDC guy (aka church lady) - 1.6 million attempts to quit fromone NRTthe "tips" program, 100k actual quits - well, for now or as reported....
There are many links with some of the 'arguments against' the main ANTZ point/junk science but not all. That would be nice.
This is good:
The Ultimate List of E-Cig Studies: Are E-Cigs Actually Safe? *Updated 2/16/14 » onVaping
But this has NIH in the title somewhereand is 'comprehensive':
Achieving appropriate regulations for electronic cigarettes
I just discovered this handy site full of quotes
Vaping Quotes
In my dream world, where altruism and capitalism are friendlier terms, Swedish Match would offer, for a nominal and affordable fee, a template of their application to small businesses so they could get 100,000 pages in during the two-year period.... Perhaps a sliding scale depending on additional information and/or tips provided with it. As with consumers, divide and conquer works to defeat so if all pertinent industries outside BT would pull together in a joint effort to see all of their individual products allowed on the market, then purely competitive capitalism could take over from there to overtake BT. Just a rather foolish thought.
OK- I'm not really part of this discussion, but was reading this thread, and a thought came to me.
Is there any reason why small ecig vendors and manufacturers couldn't have a "template" much like the Swedish Match one, and simply create the relevant charts/graphs and info to apply to their product? I mean, juice is a pretty simple concoction, and the studies and impact statements wouldn't change at all.
Inundate the FDA with millions of applications that will take, what, 10 years to wade through and approve or deny? From what I understand, simply submitting an application gives ecig businesses the ability to continue making/selling their product until such time that the application is either rejected or allowed.
That would do 2 things - overwhelm the FDA so that they are unable to meet their own requirements, and buy a good deal of time (maybe enough for public opinion to turn on them) so that effectively regulations mean nothing.
Is there any reason why small ecig vendors and manufacturers couldn't have a "template" much like the Swedish Match one, and simply create the relevant charts/graphs and info to apply to their product? I mean, juice is a pretty simple concoction, and the studies and impact statements wouldn't change at all.
Inundate the FDA with millions of applications that will take, what, 10 years to wade through and approve or deny? From what I understand, simply submitting an application gives ecig businesses the ability to continue making/selling their product until such time that the application is either rejected or allowed.
That would do 2 things - overwhelm the FDA so that they are unable to meet their own requirements, and buy a good deal of time (maybe enough for public opinion to turn on them) so that effectively regulations mean nothing.
My understanding is ...
It seems it should be that way, but my understanding is that there are several things causing problems with that. There is quite a list that adds up to filing charges up front and from guessimates, they are starting at over $100k per product - meaning ingredient differenes. 6mg eliquid is different from 12mg. Every ingredient change requires all new studies and reports spedific to that.
I don't think anyone has seen how the FDA intends to treat other components such as mods, attys, tanks, drip tips and non tobacco parts that are essential (not accessories). That's unwritten. The only other consumer non-useable (not sure what to call them) the FDA has regulated before are medical devices.
Basically since these are all considered new products and a good share of what is expected hasn't been written yet, it would be impossible to have a template. They are treating each eliquid ingredient unique even if it might have been part of someone elses eliquid. The manufacturer still has to prove their grape flavor, in the percentage they use, won't attract kids or non-smokers or people who have quit to start smoking again or cause harm in second hand vapor. This isn't including doing the other studies such as enviromental and manufacturing practices.
There is no guarentee that the FDA will accept an application either. They could just send it back without registering it for some reason. The fee is not refundable. If that happens, the product needs to be pulled from the market immediatley just the same as if the FDA had rejected the application. New filling fees are required to resubmit. So there isn't a guarentee of 2 years. I've heard some speculate the FDA could reject all applications without registering them for consideration based on an unknown technicality.
You might want to read the SBA's letter to the FDA if you haven't already since they sum it up nicely (IMO).
But that's why there's no template possible right now with the way the FDA is planning to address products as if they are all new. Add to that is the fact that a lot of what will be required is unknown.
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But if one manufacturer gets an approval, then it would seem that any other could file as an equivalent - it just seems to me that there should be some way to either use a loophole in the process (can't tell me the FDA has made their process so air-tight; it's government we're talking about), or find some way to completely choke it (ala Cloward-Piven - use their own strategy against them).
My pick:
"When buying and selling are controlled by legislation, the first things to be bought and sold are legislators."
- P J O'Rourke
I wish. There's a FDA legal blog and they talked about the FDA making an exception to batch a bunch of products in to regulation once before. They made an exception that enviromental studies weren't required. That was considered a big whoop, and a one time thing. That's not going to help oodles here.
And like I said (you posted while I was editing) a lot of it isn't written (to our knowledge). A complaint the SBA brought up was that many of these components are already being regulated by other agencies and technically, you could say the same for flavors too (even if it's not for inhalation, the FDA isn't interested in OUR health or safety - just "the public's").
It's hard to wrap a rational brain around. That's why it's basically a ban without a ban. The only ones who could navigate the system are the tobacco companies that have experience with it, and oh yea, also seemed to have advanced, insider access to regulations.
And like I said (you posted while I was editing) a lot of it isn't written (to our knowledge). A complaint the SBA brought up was that many of these components are already being regulated by other agencies and technically, you could say the same for flavors too (even if it's not for inhalation, the FDA isn't interested in OUR health or safety - just "the public's").
It's hard to wrap a rational brain around. That's why it's basically a ban without a ban. The only ones who could navigate the system are the tobacco companies that have experience with it, and oh yea, also seemed to have advanced, insider access to regulations.
I think Rolygate is accepting submissions, if you happen to have any favorites to add.
Cloward-Piven didn't actually work. Their intent was to overwhelm the Welfare system until it collapsed and then in the wake, establish socialism. What happened is the gov't expanded the welfare state to meet the new demands. Thereby establishing more socialism, but not at the level Cloward or Piven wanted.
If you attempt to overwhelm the FDA, they'll just ask for more money and more people and will likely get both - as did the Center for Tobacco Control - see Zeller's opening comments in the webinar. Once just a few people, now hundreds.
If they ban ecigs, everyone should return to smoking* and encourage everyone they know to do so as well*. The stats will show failure and they might rethink.
* .... or report, every chance you get, that you have, even though you haven't
Ahh, but it's been (and being) used in other ways as well (or attempted), and slowly, the goal IS being met. One needs only to look at what's happening right now on the southern border to see what's next. While not revolutionary, with patience, CP strategies can work.
If you attempt to overwhelm the FDA, they'll just ask for more money and more people and will likely get both - as did the Center for Tobacco Control - see Zeller's opening comments in the webinar. Once just a few people, now hundreds.
If they ban ecigs, everyone should return to smoking* and encourage everyone they know to do so as well*. The stats will show failure and they might rethink.
* .... or report, every chance you get, that you have, even though you haven't
Possibly - although either way the government's happy.
Reporting smoking would be in sales and that could take a few years to show up. UGH.
I went through the footnotes in the Economic Impact again. At the time that was written, they said they didn't even have the 2012 figures (yikes) and so most the economic data is derived from a percieved percentage of cigar sales - if that makes sense. I'm thinking there's been enough time that the 2012 economic census should be available by now. I'm also thinking there should be additional metrics they could use for a greater understanding of the market (including Herzog?).
I see this as a major blind spot. They have no clue what they are regulating (intentionally or not). Talk about a recipie for unintentional consequences ... Does anyone have even a reasonable guessimate of the number of eliquids / variations or number of b&m's (should be easier with tax/payroll data), or number of onlne stores, it might even be possible to guessimate some Chinese vendors if they thought it might help to preserve the market? Maybe someone has been looking at this by now ... there were some wild figures thrown around with the CTA #2...
I went through the footnotes in the Economic Impact again. At the time that was written, they said they didn't even have the 2012 figures (yikes) and so most the economic data is derived from a percieved percentage of cigar sales - if that makes sense. I'm thinking there's been enough time that the 2012 economic census should be available by now. I'm also thinking there should be additional metrics they could use for a greater understanding of the market (including Herzog?).
I see this as a major blind spot. They have no clue what they are regulating (intentionally or not). Talk about a recipie for unintentional consequences ... Does anyone have even a reasonable guessimate of the number of eliquids / variations or number of b&m's (should be easier with tax/payroll data), or number of onlne stores, it might even be possible to guessimate some Chinese vendors if they thought it might help to preserve the market? Maybe someone has been looking at this by now ... there were some wild figures thrown around with the CTA #2...
The economics of Beck?
Crazy Talk and American Politics: or, My Glenn Beck Story - The Chronicle Review - The Chronicle of Higher Education
That's the ultimate crazy.
Crazy Talk and American Politics: or, My Glenn Beck Story - The Chronicle Review - The Chronicle of Higher Education
That's the ultimate crazy.
Yeah.
I remember that "oral tobacco causes mouth cancer" stuff from years ago. Together with horrible, nasty pictures.
At the time, both I and my (then) husband smoked. He started using oral tobacco, and I clearly told him "That is not good for you!"
(remember: we were both smokers!)
My reasoning was as follows: If I smoke, I may get lung cancer and die. That is ok. And if they cut me open (while alive), nobody can see the scar. It will be under my clothing. But if I get mouth cancer, and they cut half my face off, no, I do not want to live looking like that. - And neither should he.
Well, my ex-husband went back to smoking. Which pleased me greatly at the time. After all, who wants to be disfigured?
- Such is the effect of those false warnings. And - as I know now - this effect is precisely the intention.
And no, I am not making this up. I once told my (then) husband to go back to smoking, because mouth cancer is nasty and disfiguring.
Yes, I fell for the lies
The economics of Beck?
Crazy Talk and American Politics: or, My Glenn Beck Story - The Chronicle Review - The Chronicle of Higher Education
That's the ultimate crazy.
Nothing to to with Beck, everything with Marx.
The percentage of smokers is the stat - not affected by sales, but not sure how they get it. Probably polling/surveys.
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