Deeming Regulations have been released!!!!

mikepetro

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I have a question, if anyone has any thoughts. So, starting yesterday there are different rules for what retailers and manufacturers can do. A manufacturer can put together items that come in a kit, a retailer cannot. However, businesses don't have to register as a retailer or a manufacturer until December. So... who knows if a store is a retailer or a manufacturer between now and December?
Do they make "retail" sales? A shill buying something at consumer quantities would likely be enough to to generate harassment.
 
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r055co

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I have a question, if anyone has any thoughts. So, starting yesterday there are different rules for what retailers and manufacturers can do. A manufacturer can put together items that come in a kit, a retailer cannot. However, businesses don't have to register as a retailer or a manufacturer until December. So... who knows if a store is a retailer or a manufacturer between now and December?

What I plan on doing is making time to hang out at my local B&M's. I will be answering questions, assembling and even show how to build. Employees are bound to regulations but we're not.

Every Vaper really needs to make some time and do this, seriously!

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DC2

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I'm not sure if this has been posted in this thread so please humor me:

"This is the theme of the amici curiae brief sixteen of us have just filed in the Nicopure Labs et al versus FDA legal case..."

A must read for those of us who enjoy diving down into the weeds :)

The full Clive Bates Blog post
And for those not interested in diving down into the weeds...
THE CLAIMED BENEFITS OF THE DEEMING RULE ARE MORE LIKELY TO BE COSTS. THE MOST IMPORTANT COSTS HAVE NOT BEEN ASSESSED. THE REGULATORY IMPACT ANALYSIS IS UNSOUND AND THE RULE IS UNJUSTIFIED

All of the usual suspects who have supported us through the years.

The scientists, doctors, researchers, philosophers.
And Bill Godshall.
:)
 

SeniorBoy

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All of the usual suspects who have supported us through the years.
The scientists, doctors, researchers, philosophers.
And Bill Godshall.
:)

:) AND try this headline for a carefully crafted (post meds) perspective:

Jeff Nesbit, Former Associate Commissioner of the Food and Drug Administration supports the Nicopure Labs/Right to be Smoke-Free Coalition legal challenge to the Final Deeming Rule!


...tada!
 

bigdancehawk

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I'm not sure if this has been posted in this thread so please humor me:

"This is the theme of the amici curiae brief sixteen of us have just filed in the Nicopure Labs et al versus FDA legal case..."

A must read for those of us who enjoy diving down into the weeds :)

The full Clive Bates Blog post
The brief does a nice job of pointing out that the FDA exaggerated the benefits of the deeming while ignoring and/or minimizing the potential harms. However, in denying CASAA's motion for leave to file a brief, the judge stated as her reason that CASAA intended to present information which isn't in the regulatory record. The Bates brief relies on several sources which are not in the record, notably the RCP's report. I hope that doesn't prove to be a major detriment.
 

snork

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The brief does a nice job of pointing out that the FDA exaggerated the benefits of the deeming while ignoring and/or minimizing the potential harms. However, in denying CASAA's motion for leave to file a brief, the judge stated as her reason that CASAA intended to present information which isn't in the regulatory record. The Bates brief relies on several sources which are not in the record, notably the RCP's report. I hope that doesn't prove to be a major detriment.
Speaking of the record, I could have sworn that there was a period of public comment and I could have sworn that many thousands of vapers and businesses commented with everything from personal experience to scientific fact. The FDA truly ignored it, but it *is* part of the regulatory record, is it not?
 

Shawn Hoefer

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December 7, 1941 - a day that will live in infamy. Roughly 3000 sailors, soldiers, marines, and civilians were killed when Japan attacked Pearl Harbor.

Another day that will live in infamy? August 8, 2016. That's when the FDA implemented their over-reaching, unconstitutional Deeming Regulations on vapor products.

Many will be outraged by this comparison. I don't blame them. I'm having a rough time writing it. Please read on...

It is estimated, by one of the FDA's own reports, that vapor products could save the lives of 21% (or more) of current smokers, if given the opportunity to switch. It is further estimated that 1 in 5 Americans still smoke (20%). The current population of the US is roughly 319 million. 20% of 319 million is a bit over 63 million. 21% of 63 million is around 13 million.

13 million people that do not have to die of cancer and heart disease and COPD and emphysema.

13 MILLION people that FDA has condemned to a slow, miserable, painful, expensive death.

The FDA claims that they're doing it to save the children... to protect youth. Yet, youth smoking has plummeted! Even if this was not the case, the there are estimated to be 23 million youth (12-17) in the US. Of that 23 million, 7% are smoking. That's 1.6 million youth.

Yet the FDA is willing to throw 13 million Americans under the proverbial bus to potentially save 1.6 million youth. Simultaneously, they are removing one of the more effective cessation methods from the market, jeopardizing their chances of quitting in the future as well as avoiding much of the damage they might be inflicting on themselves, now.

How much damage? 95% according to the Royal College of Physicians. The very same agency that spoke up on the dangers of smoking years before the FDA got the message.

I'm not making any of this up. These are real facts and figures from real sources that any literate person with Internet access, and a calculator can put together.

Do your own research if you do not believe me... then call your representative and ask them to save the lives of more than 13000000 Americans - young and old - from a slow, painful, and apparently needless death. Tell them that they can do so by supporting HR2058 and the Cole-Bishop amendment.

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bigdancehawk

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Speaking of the record, I could have sworn that there was a period of public comment and I could have sworn that many thousands of vapers and businesses commented with everything from personal experience to scientific fact. The FDA truly ignored it, but it *is* part of the regulatory record, is it not?
Yes, absolutely.
 

snork

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Yes, absolutely.
Where I was going with that was: Do you think the final regulations so ignored that part of the record (for instance how nobody is to claim that vaping can be a smoking cessation aid because of lack of evidence, when I, perhaps you and thousands of others testified as to the evidence) that the record is proof of the arbitrary nature of their decisions?
 
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grandmato5

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I have a question, if anyone has any thoughts. So, starting yesterday there are different rules for what retailers and manufacturers can do. A manufacturer can put together items that come in a kit, a retailer cannot. However, businesses don't have to register as a retailer or a manufacturer until December. So... who knows if a store is a retailer or a manufacturer between now and December?

:lol: Had that conversation today with a vape shop owner.

Seems like the most likely answer would be that no one is going to be going around checking on what they are doing compared to their filing status (or lack of filing status) until after 12/31/16. BUT the FDA wouldn't want to actually put that in writing because that would only encourage those not planning on filing as manufacturers to continue doing the things up to 12/31/16 that will make them manufacturers after that date.

Opps came back to edit: There is no official way to tell. :)
 

bigdancehawk

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Where I was going with that was: Do you think the final regulations so ignored that part of the record (for instance how nobody is to claim that vaping can be a smoking cessation aid because of lack of evidence, when I, perhaps you and thousands of others testified as to the evidence) that the record is proof of the arbitrary nature of their decisions?
In addition to all the comments you're referring to, I believe CASAA submitted about 10,000 personal testimonials. So yes, I'd think that the FDA would at least have to explain why that's insufficient to allow them to conclude that vaping aids in cessation and, if not, what more information they'd need and why they went ahead and adopted the regulations without getting it. One or two of the briefs talk about cessation, but don't reference this evidence which is actually in the record.
 
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bigdancehawk

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SeniorBoy

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AND speaking of CASAA please note the following from the amici curiae brief:

"Pursuant to FRAP 29(c), the Amici state that Clive Bates is the sole author of this Brief; no money or other
consideration was received by him or by any member of his group from a party or its counsel to fund the preparation or submission of this Brief; the drafting of this Brief was not funded by any third person or entity, although CASAA's attorney, at CASAA’s expense, conformed the Brief to the requirements of this Court and filed it on the Project’s behalf."

tada #2!

:)
 

englishmick

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Speaking of the record, I could have sworn that there was a period of public comment and I could have sworn that many thousands of vapers and businesses commented with everything from personal experience to scientific fact. The FDA truly ignored it, but it *is* part of the regulatory record, is it not?

I seem to recall Bill Godshall sending in a massive batch of documentation for that very reason. So it would be available and admissible for future lawsuits.
 

Robino1

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There was a period of public comment. The FDA didn't take into consideration the thousands of people that have claimed that vaping helped them quit smoking. They, in their infinite wisdom, declared us anecdotal. :grr: We are not considered 'scientific' enough.
 

Eskie

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There was a period of public comment. The FDA didn't take into consideration the thousands of people that have claimed that vaping helped them quit smoking. They, in their infinite wisdom, declared us anecdotal. :grr: We are not considered 'scientific' enough.

Actually, they're right. It is anecdotal. However, the association should be strong enough for a reasonable person with knowledge of tobacco cessation treatments to recognize that a proper study should be conducted, and in the absence of a clear danger in use, should be allowed on the market until such time as it is either validated or not.
 

kbeam418

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Clinton or Trump but preferably both should support vaping and vaping community.
Don't know how many people vape in US but it has to be a substantial pool of voters that is hungry for support and is active on social media and blogs like this.
It would be a nice kick to any campaign.

Well I know Trump says the FDA is too powerful, not sure about Clinton. I would say maybe %5 of the US population vapes, if that. So it wouldn't really help too much, plus is there is bigger issues than nicotine right now.
 
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Spacewaffle

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Well I know Trump says the FDA is too powerful, not sure about Clinton. I would say maybe %5 of the US population vapes, if that. So it wouldn't really help too much, plus is there is bigger issues than nicotine right now.
True on more serious issues for sure.
Though only something like 50% of us population votes if I remember correctly. I wouldn't dismiss 5% of that. Especially that it's a very passionate community in my opinion. Considering Bush Jr won by like 400 some votes and Gore lost. 5% is a huge constituency. I think African American population for example is like 13.2% of total US population. Hispanics are 17% So if you are right on 5% being vapers that's huge even if half vote for you.
Not to mention what this amount would mean for local elections.
Im just saying if im a politician I'm looking at this. Good cause to get behind and win votes and get donations too and all I got to do is tell FDA to get back a bit.... not lije i have to defeat ISIS or get man to mars. pft it's a no brainer. Goes to show how out of touch all today's politicians are.
 

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