Deeming Regulations have been released!!!!

[The Ocelot]

Dopamine | Psychology Today

So, Step one:
Reduce Dopamine and make people even dumber.
Reduce Dopamine and increase Addictive nature.
Reduce Dopamine and increase odds of Parkinson's Disease.
Reduce Dopamine and reduce expectation or Rewards or Pleasure.

Step 2:
Reduce availability of Nicotine to Reduce Dopamine to further control the people.

Sorry but Smoker Levels have been Dropping
This generation has more issues than the last
The last has more issues than the one before
Descent is as high as in past generations
Dissatisfaction in Government is as high as ever in recent history
Government is doing a job of meeting their goal of Controlling the People - regardless of dumbing down America.

Maybe they have been following their own advice

Perhaps it is time to stop repeating the Same Failed experiment over and over and expecting different results.

Little Happy fellow in the middle of Turmoil..... That's me, I vape..........The rest, They just found out they missed their chance.

Thank you:
Fraudulent Dooming Antagonist
Criminal Thieving Politicians
and
Crap Distributing Coercionist

I have a better response to SSRIs.

ETA: They don't teach cursive writing anymore. That may seem inconsequential, but ponder the implications.

 

[The Ocelot]

Gee, they could've just used me to test the Oxycontin...

No kidding. There was some medication I took at one point that in the PI sheet said something about attraction to potential abusers. I know that's incorrect, but that was the gist of it. I was thinking where do I sign up?

 

[The Ocelot]

Hopefully Ocelot will see this and tell you where to find the info. This is what was posted earlier.

Just Google beagles and whatever substance you're interested in; or do research on the substance. I first came across the beagle/pg studies when I was doing a deep search into pg. You may have to read a lot of abstracts, since they don't always indicate the methodology in the title.

 

[vapingisconfusing43]

I'm not sure I understand it correctly but it seems like they'll be treating e-cigarette as cigarette? Is that bad thing? not sure

 

[Mazinny]

And it wouldn't be for very long. Unless it was mandated by gov't.

Dietary supplements ? Homeopathic remedies ?

 

[The Ocelot]

Thank you! Where is the quote from the FDA? This sickens me - I had NO IDEA they did this. I'm a HUGE dog lover (currently have 3) and this is appalling.

"[The] FDA shares an interest in reducing the reliance on animal-based studies, and the Agency is committed to the three "Rs" of reduction, refinement, and replacement in animal testing. Although we are hopeful that in vitro assays and computer models can ultimately help to replace much of the need for animal testing, there are still many areas for which non-animal testing is not yet a scientifically valid and available option."

It's in the FRIA - a great read when you're tired of Jane Austen. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

Grab a bottle of wine and pad the top of your desk. You'll be drunk and slamming your head down in no time.

 

[The Ocelot]

I'm not sure I understand it correctly but it seems like they'll be treating e-cigarette as cigarette? Is that bad thing? not sure

The FDA is holding ecigs to a higher standard than tobacco cigarettes. With the new Deeming Regulations any tobacco product on the market after February 15, 2007 is a "new product" and must submit a pre-marketing tobacco application (PMTA) that is very expensive. Tobacco cigarettes were on the market before 02/15/07. so they are "grandfathered" in, meaning they don't have to submit a PMTA proving that the product is in the interest of public health.

It's a bad thing if you want to have a wide choice of vaping products.

 

[Oliver]

Just so you know, ECF was mentioned in the FRIA:

The comments stated that nearly all these businesses are small, and that they account for 65,000 jobs. A comment also noted that the Electronic Cigarette Forum has nearly 1,700 e-cigarette and e-liquid businesses (including importers) on record, not including the hundreds of manufacturers of hardware components.

"Comments pointed out that vape shops have been sprouting up everywhere; some have “vape bars.” Comments state that over 1,000 or over 5,000 such shops are listed on vaporsearchusa.com. In comments, the CEO of Vape World is cited as saying there are more than 3,500 independent vape shops in the U.S. Comments cited industry analysts estimating that there are 5,000 to 10,000 vape shops in the U.S. In comments, an individual from a trade association is said to estimate that there are 14,000 to 16,000 brick and mortar vape shops in the U.S. The Tobacco Vapor Electronic Cigarette Association estimates that brick and mortar stores will sell more than $1 billion in vaping equipment and products in 2014.

"The comments also state that the e-cigarette (or ENDS) industry in the U.S. has roughly doubled every year since its inception. Although the companies are small, they are growing. Comments cited industry estimates that current U.S. sales of e-cigarette (or ENDS) products were expected to be between $2.2 and $3 billion in 2014 and expected to pass $10 billion by 2017."

The FDA's Response?

[Response]: While an estimate of the number of ENDS manufacturers was developed for the required Paperwork Reduction Act burden analysis, we did not estimate the number of manufacturers for the PRIA due to the high level of uncertainty. As the comments describe, the industry is in a state of flux; during the time that the proposed rule was in review, and since the proposed rule was published, the ENDS industry has grown and additional vape shops have opened. The comments on the number of ENDS manufacturers did not provide concrete data sources, but rather industry estimates for which the bases were not given. In the case of non- retail manufacturers, comments did not always specify whether the cited numbers included both domestic and foreign manufacturers, or only domestic manufactures. Therefore, considerable uncertainty remains as to the number of domestic non-retail manufactures. Similarly, comments did not address the number of non-retail importers.

They were given data, but decided it didn't meet the criteria they just invented. So instead they decided to do this:

In the RIA for this final rule, based on logo counts from trade association websites and FDA listening sessions, we estimate that there are 168 to 204 manufacturers of ENDS products, other than retailers who mix their own e-liquids, selling goods in the US market. We also estimate that there are 14 importers of ENDS products.

"Based on logo counts from trade association websites and FDA listening sessions (I'm guessing CASAA)" they think they have accurate information? I mean, logo counts?? WTH.

Shouldn't that read, "Based on logo counts from trade association websites, we estimate that there are 168 to 204 manufacturers of ENDS products that have logos and are members of trade associations?"

Damn. I thought long and hard at the time as to whether we should submit our actual database of names but, given the private nature of said list, and the difficulty of obtaining permission from vendors to submit their information, I thought sending the aggregate statistics would be sufficient.

Seems I made a mistake

However, that said: I'm more than a little shocked that these businesses haven't made themselves known to the FDA by themselves.

At least now we know the criteria by which the FDA judges a business to exist: You have to have a logo, and you have to be member of a trade association.

I just read that a little over 1000 businesses are now members of SFATA. I presume they all have logos.

And I realise not all these are manufacturers - except that per the FDA definitions: If you're importing hardware from China, you're a manufacturer; and if you stick your own label on a product, that's a new product, so I assume that also makes you a manufacturer.

 

[The Ocelot]

Damn. I thought long and hard at the time as to whether we should submit our actual database of names but, given the private nature of said list, and the difficulty of obtaining permission from vendors to submit their information, I thought sending the aggregate statistics would be sufficient.

Seems I made a mistake

However, that said: I'm more than a little shocked that these businesses haven't made themselves known to the FDA by themselves.

At least now we know the criteria by which the FDA judges a business to exist: You have to have a logo, and you have to be member of a trade association.

I just read that a little over 1000 businesses are now members of SFATA. I presume they all have logos.

And I realise not all these are manufacturers - except that per the FDA definitions: If you're importing hardware from China, you're a manufacturer; and if you stick your own label on a product, that's a new product, so I assume that also makes you a manufacturer.

It's so inconceivable. The device I am using now is composed of 5 components from 5 different companies. By the FDA calculations it would cost 13 million to bring the same device to market. Plus, since I built the coil and screwed it all together, I'm a tobacco product manufacturer.

ETA: If any business wants a logo, drop me a line.

 

[Oliver]

It so inconceivable. The device I am using now is composed of 5 components from 5 different companies. By the FDA calculations it would cost 13 million to bring the same device to market. Plus, since I built the coil and screwed it all together, I'm a tobacco product manufacturer.

Yeah, it's totally clear that FDA wants open systems gone. They don't want any fuzzy boundaries around the products - the products they see remaining on the market need to have highly quantified performance. It's hard to see this leading to a vigorous market of products competing for the attentions of vapers/smokers.

And this vigor is EXACTLY the reason for vaping's success. It's quite mad that the FDA doesn't see this, and is so glib about destroying it.

 

[Sugar_and_Spice]

I would imagine to do business in the US they would be filing IRS income and tax forms per however they formed their businesses..ie...LLC, corporate, sole proprietor, etc. And also each state would require some sort of License to operate, so the response of the FDA is just pure NOT wanting to look at the facts and do whatever research is needed to acquire these stats. Even Ray Charles can see that.

 

[The Ocelot]

Yeah, it's totally clear that FDA wants open systems gone. They don't want any fuzzy boundaries around the products - the products they see remaining on the market need to have highly quantified performance. It's hard to see this leading to a vigorous market of products competing for the attentions of vapers/smokers.

And this vigor is EXACTLY the reason for vaping's success. It's quite mad that the FDA doesn't see this, and is so glib about destroying it.

I've posted this more than once. The FDA pulled a partial quote and used it as a negative, that was inaccurate. In 2014 Wells Fargo conducted an equity survey about Burgeoning Vapors/Tanks Category Not to be Underestimated. They, or their puppeteers, know the market is there.

http://www.vaporworldexpo.com/PDFs/Tobacco_Talk_Vapors_Tanks_ March 2014.pdf

 

[The Ocelot]

I would imagine to do business in the US they would be filing IRS income and tax forms per however they formed their businesses..ie...LLC, corporate, sole proprietor, etc. And also each state would require some sort of License to operate, so the response of the FDA is just pure NOT wanting to look at the facts and do whatever research is needed to acquire these stats. Even Ray Charles can see that.

You lost me baby girl, what are you tying into?

 

[GunMonkeyINTL]

Damn. I thought long and hard at the time as to whether we should submit our actual database of names but, given the private nature of said list, and the difficulty of obtaining permission from vendors to submit their information, I thought sending the aggregate statistics would be sufficient.

Seems I made a mistake

...

No worries, bro.

It wouldn't have mattered if you had been able to show that there were over 150,000 domestic vape shops, supporting an average of 15 full-time employees making $50k per year each.

The FDA was going to structure the metrics, therefore crafting the statistics, to meet the goal of their narrative. Facts are irrelevant to the self-righteous.

 

[Kent C]

Dietary supplements ? Homeopathic remedies ?

What about them? Some work, some by placebo effect...

 

[Sugar_and_Spice]

You lost me baby girl, what are you tying into?

This You posted:
↑
Just so you know, ECF was mentioned in the FRIA:

The comments stated that nearly all these businesses are small, and that they account for 65,000 jobs. A comment also noted that the Electronic Cigarette Forum has nearly 1,700 e-cigarette and e-liquid businesses (including importers) on record, not including the hundreds of manufacturers of hardware components.

"Comments pointed out that vape shops have been sprouting up everywhere; some have “vape bars.” Comments state that over 1,000 or over 5,000 such shops are listed onvaporsearchusa.com. In comments, the CEO of Vape World is cited as saying there are more than 3,500 independent vape shops in the U.S. Comments cited industry analysts estimating that there are 5,000 to 10,000 vape shops in the U.S. In comments, an individual from a trade association is said to estimate that there are 14,000 to 16,000 brick and mortar vape shops in the U.S. The Tobacco Vapor Electronic Cigarette Association estimates that brick and mortar stores will sell more than $1 billion in vaping equipment and products in 2014.

"The comments also state that the e-cigarette (or ENDS) industry in the U.S. has roughly doubled every year since its inception. Although the companies are small, they are growing. Comments cited industry estimates that current U.S. sales of e-cigarette (or ENDS) products were expected to be between $2.2 and $3 billion in 2014 and expected to pass $10 billion by 2017."

The FDA's Response?

[Response]: While an estimate of the number of ENDS manufacturers was developed for the required Paperwork Reduction Act burden analysis, we did not estimate the number of manufacturers for the PRIA due to the high level of uncertainty. As the comments describe, the industry is in a state of flux; during the time that the proposed rule was in review, and since the proposed rule was published, the ENDS industry has grown and additional vape shops have opened. The comments on the number of ENDS manufacturers did not provide concrete data sources, but rather industry estimates for which the bases were not given. In the case of non- retail manufacturers, comments did not always specify whether the cited numbers included both domestic and foreign manufacturers, or only domestic manufactures. Therefore, considerable uncertainty remains as to the number of domestic non-retail manufactures. Similarly, comments did not address the number of non-retail importers.

They were given data, but decided it didn't meet the criteria they just invented. So instead they decided to do this:

In the RIA for this final rule, based on logo counts from trade association websites and FDA listening sessions, we estimate that there are 168 to 204 manufacturers of ENDS products, other than retailers who mix their own e-liquids, selling goods in the US market. We also estimate that there are 14 importers of ENDS products.

And

Damn. I thought long and hard at the time as to whether we should submit our actual database of names but, given the private nature of said list, and the difficulty of obtaining permission from vendors to submit their information, I thought sending the aggregate statistics would be sufficient.

Seems I made a mistake

However, that said: I'm more than a little shocked that these businesses haven't made themselves known to the FDA by themselves.

At least now we know the criteria by which the FDA judges a business to exist: You have to have a logo, and you have to be member of a trade association.

I just read that a little over 1000 businesses are now members of SFATA. I presume they all have logos.

And I realise not all these are manufacturers - except that per the FDA definitions: If you're importing hardware from China, you're a manufacturer; and if you stick your own label on a product, that's a new product, so I assume that also makes you a manufacturer.

Sorry I didn't quote these in the first place....note to self.....wake up fully before posting.

 

[The Ocelot]

This You posted:
↑
Just so you know, ECF was mentioned in the FRIA:

The comments stated that nearly all these businesses are small, and that they account for 65,000 jobs. A comment also noted that the Electronic Cigarette Forum has nearly 1,700 e-cigarette and e-liquid businesses (including importers) on record, not including the hundreds of manufacturers of hardware components.

"Comments pointed out that vape shops have been sprouting up everywhere; some have “vape bars.” Comments state that over 1,000 or over 5,000 such shops are listed onvaporsearchusa.com. In comments, the CEO of Vape World is cited as saying there are more than 3,500 independent vape shops in the U.S. Comments cited industry analysts estimating that there are 5,000 to 10,000 vape shops in the U.S. In comments, an individual from a trade association is said to estimate that there are 14,000 to 16,000 brick and mortar vape shops in the U.S. The Tobacco Vapor Electronic Cigarette Association estimates that brick and mortar stores will sell more than $1 billion in vaping equipment and products in 2014.

"The comments also state that the e-cigarette (or ENDS) industry in the U.S. has roughly doubled every year since its inception. Although the companies are small, they are growing. Comments cited industry estimates that current U.S. sales of e-cigarette (or ENDS) products were expected to be between $2.2 and $3 billion in 2014 and expected to pass $10 billion by 2017."

The FDA's Response?

[Response]: While an estimate of the number of ENDS manufacturers was developed for the required Paperwork Reduction Act burden analysis, we did not estimate the number of manufacturers for the PRIA due to the high level of uncertainty. As the comments describe, the industry is in a state of flux; during the time that the proposed rule was in review, and since the proposed rule was published, the ENDS industry has grown and additional vape shops have opened. The comments on the number of ENDS manufacturers did not provide concrete data sources, but rather industry estimates for which the bases were not given. In the case of non- retail manufacturers, comments did not always specify whether the cited numbers included both domestic and foreign manufacturers, or only domestic manufactures. Therefore, considerable uncertainty remains as to the number of domestic non-retail manufactures. Similarly, comments did not address the number of non-retail importers.

They were given data, but decided it didn't meet the criteria they just invented. So instead they decided to do this:

In the RIA for this final rule, based on logo counts from trade association websites and FDA listening sessions, we estimate that there are 168 to 204 manufacturers of ENDS products, other than retailers who mix their own e-liquids, selling goods in the US market. We also estimate that there are 14 importers of ENDS products.

And


Sorry I didn't quote these in the first place....note to self.....wake up fully before posting.

No worries, I've had a few glasses of wine tonight.

It seems that no matter how the data was presented, whatever the FDA gathered or was reported to them, they did some major cherry picking. As GunMonkey said the FDA structured the metrics, therefore crafting the statistics, meeting the goal of their narrative.

Aside: Nice turn of the phrase GunMonkey.

 

[Sugar_and_Spice]

It's so inconceivable. The device I am using now is composed of 5 components from 5 different companies. By the FDA calculations it would cost 13 million to bring the same device to market. Plus, since I built the coil and screwed it all together, I'm a tobacco product manufacturer.

ETA: If any business wants a logo, drop me a line.

Correct me if I am wrong, but wouldn't you have to try and sell 'your product' before the FDA would deem you a tobacco manufacturer? slowly backs out of the room........

 

[Sugar_and_Spice]

No worries, I've had a few glasses of wine tonight.

It seems that no matter how the data was presented, whatever the FDA gathered or it was reported to them, they did some major cherry picking. As GunMonkey said the FDA structured the metrics, therefore crafting the statistics, meeting the goal of their narrative.

Aside: Nice turn of the phrase GunMonkey.

Yes, I agree, but my post was meant to say if the FDA had actually done a little bit of work and researched this type of data, they wouldn't have to look very far to answer those types of questions.
Their total lack of responsibility for their justifications is just appalling.

 

[The Ocelot]

Correct me if I am wrong, but wouldn't you have to try and sell 'your product' before the FDA would deem you a tobacco manufacturer? slowly backs out of the room........

I think selling would be the absolute test, but if I built a coil for someone in trade...who knows.