Deeming Regulations have been released!!!!

[crxess]

"We are concerned about the potential foraddictionand abuse of these products. We don't want the public to perceive them as a safer alternative to cigarettes. - Rita Chapelle, FDA spokeswoman "

Now, Look at the first link I found looking for her:
FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban
and the comments she made........

Causes rita cares about:

• Arts and Culture
• Children - When convenient as a tool for Government Propaganda
  
• Civil Rights and Social Action - My Rights are being Violated
• Disaster and Humanitarian Relief
• Economic Empowerment
• Education - So long as it is not about Truth
  
• Environment - ...., ...., ....
  
• Health - Unless you are a Smoker or Vaper
  
• Human Rights - Except to Choose a Lower Health Risk alternative
• Politics
• Poverty Alleviation - Gotta Get those Taxes
  
• Science and Technology - Totally in Denial

 

[Lessifer]

Well yeah it was foresight on your part i suppose, but " i told you so ", doesn't solve anything at this point. I don't really blame the industry ( and every one else who commented on the proposed deemings ) for trying. They thought they had a chance.

I don't really blame them either, just frustrated because it feels like we've lost time. Congressional action could take years. Imagine if we had picked a Congressman back in 2014 and started working the legislative angle then. Enough looking back though, we need to focus on what can be done now.

 

[The Ocelot]

I've skimmed it, and yeah, I saw that part about their estimates of applications. Even if we went with their most generous estimates of 80 applications, and the 90%(HAHAHAHA) approval rate estimated from drug approval rates(instead of the 0.00001% approval rate to date for tobacco products), that would leave us with 72 products to choose from. An entire industry of tens of thousands of products, reduced to what could fit on a 4'x4' display behind the counter. That is exactly what they want.

Also, of course they don't see vaping as an acceptable way to quit, because to them it's not quitting, it's transferring use from one tobacco product to another. There are no safe tobacco products.

This part is still my favorite:

"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."

FDA response:

"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 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."

I don't see how "logo counts from trade association websites and FDA listening sessions" are concrete data sources.

 

[HazyShades]

Well yeah it was foresight on your part i suppose, but " i told you so ", doesn't solve anything at this point. I don't really blame the industry ( and every one else who commented on the proposed deemings ) for trying. They thought they had a chance.

I hope nobody feels like we failed or wasted our time.
Doing nothing would have been a waste but in trying everybody learned and is learning a great lesson. Many good lessons. I was reading above where Les said he expected fair treatment from the FDA and I'm sorry Les but I chuckled at your seeming naivete.

A few days ago I was having a conversation with a conservative vaper lady
who is ready to go march in Washington DC even though she's never been politically inclined or been willing to get tear gassed for a cause before this.

Can we summarize the lessons we've learned?
Don't trust the government.
Money talks. We can only rely on one another.

I think we should assimilate what we've learned
and dismiss the defeatist attitude I'm perceiving...
this fight is far from over boys and girls.
It involves much more than vaping and it's only just begun.

Regards,
Hazy

 

[crxess]

This part is still my favorite:

"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."

FDA response:

"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 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."

I don't see how "logo counts from trade association websites and FDA listening sessions" are concrete data sources.

They are allowed to Guestimate in the absence of True data(at their discretion)

Like ignoring a 2008 Study:

Late in 2008, a study done by Health New Zealand, and funded by Ruyan was published, revealing testing that showed there were no questionable chemicals present at toxic levels. The study also showed e-cigarettes to be anywhere between 100 to 1000 times less hazardous to the health than conventional cigarettes. (http://www.healthnz.co.nz/ecigarette.htm)

History of the Electronic Cigarette

 

[The Ocelot]

Now, Look at the first link I found looking for her:
FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban
and the comments she made........

Causes rita cares about:

• Arts and Culture
• Children - When convenient as a tool for Government Propaganda
  
• Civil Rights and Social Action - My Rights are being Violated
• Disaster and Humanitarian Relief
• Economic Empowerment
• Education - So long as it is not about Truth
  
• Environment - ...., ...., ....
  
• Health - Unless you are a Smoker or Vaper
  
• Human Rights - Except to Choose a Lower Health Risk alternative
• Politics
• Poverty Alleviation - Gotta Get those Taxes
  
• Science and Technology - Totally in Denial

Economic Empowerment Unless it comes from the vaping industry.

 

[The Ocelot]

I haven't read this one yet.

Guidance for Industry: Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM416498.pdf

Here's another one: Grandfathered Tobacco Products

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM420769.pdf

 

[lauragal]

I don't see how a PMTA could be obtained? It can't be Done. It's a Ban thru Regulation. And of Course, the FDA knows this. Because they wrote it.

And where is the Friggin Public Health in all this? Just Scrap the Whole Concept of Harm Reduction.

Can you imagine if every single vendor/manufacturer of mods, batts, atty's, flavors, i.e. everything single component of vaping filed for a PMTA? I think the U.S. would finally be out of debt. lol

 

[crxess]

FDA KMA

 

[Lessifer]

I hope nobody feels like we failed or wasted our time.
Doing nothing would have been a waste but in trying everybody learned and is learning a great lesson. Many good lessons. I was reading above where Les said he expected fair treatment from the FDA and I'm sorry Les but I chuckled at your seeming naivete.

A few days ago I was having a conversation with a conservative vaper lady
who is ready to go march in Washington DC even though she's never been politically inclined or been willing to get tear gassed for a cause before this.

Can we summarize the lessons we've learned?
Don't trust the government.
Money talks. We can only rely on one another.

I think we should assimilate what we've learned
and dismiss the defeatist attitude I'm perceiving...
this fight is far from over boys and girls.
It involves much more than vaping and it's only just begun.

Regards,
Hazy

I think you misread something, I've never expected fair treatment from the FDA.

 

[Kent C]

Well, everything I've ever seen refers to it being Substantially Equivalent to a predicate product. I've wondered about it before, and no one seemed to have an answer.

ETA: statutorily?

The passage that crxess quoted is in (at least two places in the doc) - pg38 and 39. Pg 38:

"The commenter’s estimate of the number of electronic cigarette (ENDS) products remaining on the market is difficult to evaluate from the information provided. In our analysis of the proposed rule, we forecasted that all ENDS products would require PMTAs, and that the number of submissions would be far fewer than 633. (Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.) However, we now forecast that some ENDS delivery systems may be able to use the SE pathway and that both e-liquids and delivery systems may be able to use the exemptions pathway after the initial round of marketing authorizations. Given this and the growth we have seen in the ENDS market, we now forecast that a larger number of requests for marketing authorization will be submitted for e-liquids and ENDS delivery systems, as described in Section III.C.3.b.2 of the final RIA."

Pg 39:

" Innovation by small and medium-sized businesses will halt, and the industry will become increasingly concentrated. Premarket costs would cause product exit as well as factory closures. [Response]: We acknowledge that premarket requirements have associated costs, but we disagree that they will be a de facto ban on specific types of products. The ENDS market has grown into an estimated 3.5 billion dollar market, according to one market source (Herzog et al., 2015). While we expect to see product consolidation and exit in this emerging market, we fully expect the market to be able to support new product applications. Our best forecast in the PRIA was that all manufacturers of ENDS products would seek marketing authorization through the PMTA pathway. However, we now forecast that some ENDS delivery systems may be able to use the SE pathway and that both e-liquids and delivery systems may be able to use the exemptions pathway after the initial round of marketing authorizations. Regardless of the pathway through which ENDS products receive premarket authorization, we do not expect ENDS products to disappear from the marketplace; we expect manufacturers to be successful in obtaining premarket authorization for their ENDS products"

 

[crxess]

 

[HazyShades]

I think you misread something, I've never expected fair treatment from the FDA.

Nah, I'm paying attention though I think we all need some shuteye.
Here:

See where you say you "seem to have wasted quite a bit of time expecting fair treatment from the FDA"? Did I misread that? If you never expected fair treatment then why did you waste your time expecting fair treatment? It's all good.
I stopped expecting fair, ethical, honest treatment from the feds or anybody else in gub'min years ago.
But I understand both expecting it
and wanting to think you never did when you don't get what you expect or hope for.
It's very frustrating..but you haven't wasted any time. You've grown

Regards,
Hazy

 

[crxess]

You will Never hear Claims like this again:



Good night all

 

[The Ocelot]

FDA KMA

Gawd you kids and your urban slang, making me Google your posts.

 

[HazyShades]

Can you imagine if every single vendor/manufacturer of mods, batts, atty's, flavors, i.e. everything single component of vaping filed for a PMTA? I think the U.S. would finally be out of debt. lol

As large as the US debt keeps getting probably not.
But can you imagine how long it would take the feds to process
all those PMTAs, especially at the typical bureaucrat pace?

Regards,
Hazy

 

[coldgin96]

It's not, as of the regs that are written today, but it could be made illegal to buy as an individual, with just a snap of the fingers, on any day after 8 August.

All it would take is grumblings from the FDA that they intend to do something about it, and the nic suppliers could sell out overnight.

Do yourself a favor and order some now.

EcigExpress has it for $45 per liter. If you order two, you're over the $60 free-shipping threshold, and the orders I've placed with them have all arrived in two USPS days.

Order glass bottles at the same time, because you don't want to long-term store it in the plastic it ships in. Kurt has an excellent instructional sticky over in the DIY forum with a link to bottles that are perfect. Enough bottles to store 2L will run you about $30, after shipping.

Order what you can afford today. There is no way the FDA is going to leave liquid nic alone for very long.

For all the nebulousity of their claims to jurisdictional power over other parts of the ecig, liquid nic is the one they have the most legitimate claim over, and it is the one critical link. They have to know that.

Thanks. Found it! Yeah, I copied the link to that bottle site and I'm keeping a link to his post. It's the reason I'm getting 100% VG nic juice and adding PG later

 

[coldgin96]

Nah, I'm paying attention though I think we all need some shuteye.
Here:
View attachment 560985

See where you say you "seem to have wasted quite a bit of time expecting fair treatment from the FDA"? Did I misread that? If you never expected fair treatment then why did you waste your time expecting fair treatment? It's all good.
I stopped expecting fair, ethical, honest treatment from the feds or anybody else in gub'min years ago.
But I understand both expecting it
and wanting to think you never did when you don't get what you expect or hope for.
It's very frustrating..but you haven't wasted any time. You've grown

Regards,
Hazy

Whoa, dude, you need a vape. You're splitting hairs and putting words in people mouths. Just because he said we tried to get fair treatment, doesn't mean he expected it. You didn't even quote him correctly! So, yeah, I'd say you misread it.

 

[GunMonkeyINTL]

...Enough looking back though, we need to focus on what can be done now.

I agree with your entire line of reasoning, that we needed to distance ourselves from tobacco earlier on in this debate, and also (I believe it was your point) about even distancing nicotine from tobacco and the whole issue with supporting age restrictions.

I also agree that we need to start looking forward (again) from our new position of peril - but I think we're failing again. I think, at this point, we need voices, as many voices as we can get, speaking of outrage and hypocrisy. We need so many voices, if we hope to get anything done, that we NEED non-vapers to be screaming as loud as those of us with a personal stake...but we're failing to even get the actual vapers to take notice. And, it's our fault.

The experience I had at one of my local B&Ms yesterday was almost the exact same I've had three times now. (Sorry in advance for the long story, but you've all probably figured out by now that that is how my brain works.)

It wasn't a shop that I frequent, because their prices are a little crazy, but the current step in my carefully crafted stockpile plan is to get several mech mods, and I've been hitting all the shops to see what they had.

While I was checking out the mechs, another customer walks in with a broken regulated box and starts talking to the shop keeper about a new one. The owner showed him some options and said the best one he had was a Subbox kit ($95!!?!?), which is what I had walked in with, so the owner asked me how I liked mine, hoping for a positive review that would help him.

I told him I thought it was a good upgrade to his broken box (not wanting to get into fixing the broken one, or the ridiculous price they had on the Subbox, out of respect for the shop), and the other customer asked if he'd need one of the battery tubes I was looking at, too; "is that like an extension or something?"

The customer had said that his broken box had only lasted a year, he was using an aspire tank with packaged coils, and that he wanted a new box that would work with his tank and his battery. It was pretty obvious he was a one-device, store-bought kind of guy, who got all/most of his info from the shop where he bought his coils and juice- the kind that will be most devastated by these new regs.

I explained that the "battery tube" was a separate mod, and that I was stockpiling extra gear in light of the upcoming regs/bans.

"What regs?"

So I did the "elevator-speech" version of what's happening that I've sort-of distilled after talking to so many casual-vaper and maybe-vaper friends/family/co-workers.

The customer was floored, but so was the shop owner. He stopped me and said "nothing's being banned, the government is just posturing..."

The guy was standing in front of one of the CASAA posters that says something like "This shop supports your right to vape...join CASAA", so I was a little confused that the owner, obviously affiliated with the advocacy groups in some manner or another, could understand the situation so poorly.

So, to try to help, I started to flesh out the points in the "elevator-speech" a little, and the shop owner stopped me again, getting a little agitated. He explained to me and the other customer the grandfather date, what the predicate product, if there really was one, would look like, the PMTA process, and even cited the Nicopure suit, and the injunction that was "sure to come".

...so the shop owner clearly was following the regs and the developments...

I countered that the litigation steps being taken might help, but there was no guarantee of victory, or even an injunction and...

He shut me down again. To the other customer, "Trust me. WE know what's going on. This thing is going to be tied up forever and nothing is going to happen."

I let it be, paid for what I'd picked out and left. His shop, his atmosphere, not my place to upset it.

But it bothered me.

This is the third time I'd had an experience similar to this one. Granted, the other two were not as hostile, but in both other cases, the shop owners wanted me and the other customers to rest easy and trust that "they" had it all under control.

They're the church, we're just the parishioners. Let the adults handle it.

I spent a good while thinking about it, and I suppose I can see some possible reasons why a retailer might want to downplay the concern, but it goes against everything I've learned about grass-roots advocacy.

In my industry, the retailers don't try to downplay the concern, they use it. When there is a new legislative attack, the gun shop owners will actually hang signs "get it while you still can", and run specials on products that are subject to new restrictions. They WANT every customer to know what the current threats are, when they walk in the door, whether they buy the thing or not, so that they will at least tell someone else after they leave.

My experience above is not unique, but is also not typical of my recent shopping experiences (I've visited A LOT of vape shops the last several months). I travel for work and visit as many local shops as I can find on each trip, and I've had a couple strong advocates (only a couple), a BUNCH of totally oblivious shops, and, then, three like the one I described above.

Why, in light of the fact that our life-saving "hobby" is facing a near-total ban, have I NEVER been asked, as soon as I walked in the door, if I was aware that my right to vape is being mortally threatened?

Never mind that it doesn't happen EVERY time, why haven't I heard it even once?

Is SFATA (I'm obviously not a member) sending out mailers to instruct retailers on the importance of informing their customers of what is happening? If not, why not?

Even if SFATA can't get their transmission in gear for a simple advisory like that, why are the retailers failing to see the importance of a well-informed customer base?

Most of my purchases have had a POS that asked for an email to send my receipt. Why hasnt SFATA asked their retailers for email lists, and handed them over to CASAA for daily call-to-action/donation-drive emails?

Why hasn't SFATA provided their retailers with ready-made email blasts for them to send out directly?

Why? Because of this industry's lack of maturity and focus that I've been ranting about for the last 400 pages.

Because, to the nexus point of your post and this one, with very few individual exceptions, this industry either doesn't want to, or just isn't capable of looking forward. They are, I'm afraid, going to continue fighting defensive battles that are already lost until they've defended their way right into losing the war.

 

[retired1]

Most of my purchases had has a POS that asked for an email to send my receipt. Why hasnt SFATA asked their retailers for email lists, and handed them over to CASAA for daily call-to-action/donation-drive emails?

Because the first company that hands over my email address to a third party will never, ever get my business again. I don't care what the reasons are, companies should not be handing over customer information like that.