Deeming Regulations have been released!!!!

[The Ocelot]

I have to stop reading the RIA it is too upsetting.

"The baseline number of manufacturers and importers of ENDS products is uncertain. Some public comments referenced the Smoke-Free Alternatives Trade Association in stating that there are over 1,200 ENDS manufacturers.

"Many of these manufacturers, however, are believed to be smaller, informal participants in this market; in describing the current landscape in the ENDS industry, an industry survey respondent wrote, “Too many companies are making e-liquid in their kitchens/bathrooms,” (Herzog et al., 2014a). We do not have reliable counts on these informal producers but we expect that few if any of them will continue to manufacture after this final rule takes effect."

 

[crxess]

small businesses (referred to as "Entities")

Easy there, don't want people to realize they are talking about Actual Americans With actual Business and Actual Incomes that are Being Pushed to the Unemployment Line like Cattle to Slaughter.
Entities - Sounds so much more indistinct and like a Threat to AMERICA. ET-Go Home

We agree that product exit WILL occur, but much of this WILL occur WITHOUT a result of consolidation of similar products within ALL product lines Forcing exit by manufacturers, although we expect ALL vape shops that currently mix e-liquids will BE FORCED TO convert to a retail model once the initial compliance period for submission of PMTAs ends."

^^^Corrected For Truth in advertising ^^^

8-8-16
***Product Adulteration***
8-8-16 - Any Business Mixing E-liquids is a Product Manufacturer.

Are your Bottles FDA APPROVED? Caps and Bottles!
KNOW YOUR RESPONSIBILITIES under these onerous Regulations

Has the FDA left out ANY information that would Protect you from being immediately Shut Down?

!!!!! No Need Calling the FDA - 2 Calls asking the exact same Question may garner 2 Different Explanations<<<<<invalidating each other>>>>>
Even they do not know what they think they know

Hope for the Best, but Prepare for the worse
Those Prepared might survive the next 24 months.

 

[The Ocelot]

PAX Labs, makers of some of the most popular premium vaporizers on the market, announced that the company has succeed in acquiring a patent for the company’s E-Cigarette division. The company announced today it has received a U.S. patent for the nicotine salt e-liquid formulation found in its landmark e-cigarette, JUUL.

Unlike other products in the e-liquid space, JUUL uses nicotine salts found in leaf tobacco, rather than free-base nicotine, as its core ingredient. JUUL’s special chemical process and easy-to-use micro-tank vaporizer deliver the right nicotine strength and vapor quality to provide a “uniquely pleasing and consistent experience” for adult smokers according to the company. In the announcement the company also stated, “This patent exemplifies innovation that is occurring in independent vapor technology companies.”

PAX secures patent for "Nicotine Salt E-Cigarette" | The Slanted

 

[tidegirl]

But do they have FDA approval? Patents don't come from the FDA/

 

[The Ocelot]

Another ignored study.

Contexts of cigarette and e-cigarette use among dual users: a qualitative study
Pallav PokhrelEmail author, Thaddeus A. Herzog, Nicholas Muranaka, Sakshi Regmi and COPYRIGHTDMCA Fagan
Published September 4, 2015

Long/lots of charts - but very interesting, especially the Discussions and Conclusions

A few highlights:

Discussions
"Based on the current findings, it appears that cigarette smokers switching over to e-cigarettes may continue to use cigarettes when facing strong craving or the need for strong stimulation, until they find an e-cigarette device that satisfies such needs. Dual users seem to prefer cigarettes over e-cigarettes in situations where the need for the physiological effects of nicotine is paramount. Cigarettes are known to deliver nicotine more efficiently into the human body than e-cigarettes."

Conclusions:
It is possible that effective application of e-cigarettes in smoking cessation and/or harm reduction may partly depend on improved technology on e-cigarettes’ part in delivering nicotine efficiently. However, more importantly, promotion of e-cigarette use in smoking cessation or harm reduction may need to be coupled with counseling focused on training smokers on how to manage e-cigarette devices and behaviors and situations associated with tobacco smoking.

ETA: Link BMC Public Health

ETA: WTH?

Acknowledgements
This study was supported by Food & Drug Administration/National Institute of Health (NIH/FDA) Tobacco Regulatory Science Program in the form of research grant [P30 3P30CA071789-15S3-Project 2] awarded to Pallav Pokhrel.

 

[nicnik]

PAX Labs, makers of some of the most popular premium vaporizers on the market, announced that the company has succeed in acquiring a patent for the company’s E-Cigarette division. The company announced today it has received a U.S. patent for the nicotine salt e-liquid formulation found in its landmark e-cigarette, JUUL.

Unlike other products in the e-liquid space, JUUL uses nicotine salts found in leaf tobacco, rather than free-base nicotine, as its core ingredient. JUUL’s special chemical process and easy-to-use micro-tank vaporizer deliver the right nicotine strength and vapor quality to provide a “uniquely pleasing and consistent experience” for adult smokers according to the company. In the announcement the company also stated, “This patent exemplifies innovation that is occurring in independent vapor technology companies.”

PAX secures patent for "Nicotine Salt E-Cigarette" | The Slanted

I really doubt their patent will hold up under a good challenge. They're not the first to use acidic substances to lower ph of nicotine, for faster absorption upon inhalation.

 

[The Ocelot]

But do they have FDA approval? Patents don't come from the FDA/

I don't see how they could, since they use 'nicotine salts found in leaf tobacco" and leaf tobacco is covered in the FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT. However, the patent might be used to muddy the water if nicotine salts could someday be derived from other sources.

 

[MsLoud]

 

[crxess]

May I?

Is there anything to work with from PAX?

 

[salemgold]

Leaving this here by special request.

 

[The Ocelot]

Referencing my prior post:

"Many of these manufacturers, however, are believed to be smaller, informal participants in this market; in describing the current landscape in the ENDS industry, an industry survey respondent wrote, “Too many companies are making e-liquid in their kitchens/bathrooms,” (Herzog et al., 2014a). We do not have reliable counts on these informal producers but we expect that few if any of them will continue to manufacture after this final rule takes effect."

ETA: Such BS! I was trying to find the source of the comment attributed to Herzog et al., 2014a Talk about cherry-picking and deception!

It came from a survey by WELLS FARGO SECURITIES, LLC Tobacco EQUITY RESEARCH DEPARTMENT (compiled by Bonnie Herzog, Senior Analyst, among others)

The comment about kitchens/bathrooms is has no identifiable source, it's just an anonymous response. Here's how it is presented on the list in context with the comment before and after it:

• “BLU, in particular, made a wise strategic move in the roll out of their Starter Kits. Unlike NJOY, who decided on a flawed, all-in strategy with disposables, BLU realized the E-Cig consumer is a young, but maturing consumer. The next natural progression was to incorporate kits into their full retail play. Market indicators suggest their consumers are migrating nicely towards it and its substantial retail ring.”
• 
  
• “Too many companies are making e-liquid in their kitchens/bathrooms. E-liquid companies don't understand batch testing, nitrosamines, etc.”
• 
  
• “We hear every day from our customers how much they feel healthier after they switched to e-cigs. We recently collected some data and found that about 15% of our customers quit smoking completely after they started using our products for few months. Many customers have switched from higher levels to 0mg strength nicotine and just enjoy vaping but with no nicotine at all. Most of our customers have shown great satisfaction after they switched to e-cigs.”

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

 

[YoursTruli]

Leaving this here by special request.

Everyone seriously needs to watch this

 

[Rossum]

I really doubt their patent will hold up under a good challenge. They're not the first to use acidic substances to lower ph of nicotine, for faster absorption upon inhalation.

Not long after Juul came out, I was intrigued enough to buy one and a fair number of their pods. My reaction to it (and their magic-sauce juice) was: "Meh".

 

[zoiDman]

Leaving this here by special request.

Thank you for Posting this again Salem.

BTW - For anyone who starts to listen to this Webinar and just Can't Finish it, please Skip to the 2nd to Last Question (1:07:43) about Age Verification for Online Sales before you go.

 

[tidegirl]

Another ignored study.

until they find an e-cigarette device that satisfies such needs.

Gee, that sounds so familiar. Where have I heard that before???...

Oh yeah. It was here. For the last five years. Maybe they should have listened to us in the first place.

 

[Train2]

I dunno...they don't honestly ANSWER anything...they just repeat the damned reg verbatim over and over. I watched some. I think I'd rather stick stuff under my fingernails than watch the whole thing.



Is zero nic juice going to be regulated?

"well....that depends. If we feel like it, and we want to say it's intended for or expected to be used with nic, then it's a component and could be regulated".

Is this mod a tobacco product?
"well, that depends...blah blah blah"

Is it me, or do their spokespeople seem like....well...a little like self-righteous ash-hats who probably also enjoy spending their free time explaining to people why they're going to go to hell?
OK that's a little harsh. They seem evil, or ELSE perhaps COMPLETELY IGNORANT, like they really have NO IDEA that these regs are completely and utterly IMPOSSIBLE to apply to the vaping market - those MILLIONS of people who have a hobby/habit that has replaced smoking. Could they believe this is reasonable? that e-cig manufacturers just have to fill out some forms and follow some labelling rules like, oh I don't know...like a food company would?


FDA = "ash-hats".
Yep, immature, but I'm OK with that.

Everyone seriously needs to watch this

 

[tidegirl]

Leaving this here by special request.

I can't watch the whole thing tonight since I need my beauty sleep, but so far this reminds me of a former boss. I would email a simple yes or no question. In response I would get 3 or 4 paragraphs of talking in circles, after which I still didn't know if the answer was yes or no.

 

[Vandal]

Could they believe this is reasonable? that e-cig manufacturers just have to fill out some forms and follow some labelling rules like, oh I don't know...like a food company would?

You know, from what reading I have done, I think that's exactly what many think, and I think that's the impression the FDA is trying to give the public.

 

[Kent C]

Leaving this here by special request.

Original thread which may interest others:

FDA Webinar

 

[Lessifer]

I have to stop reading the RIA it is too upsetting.

"The baseline number of manufacturers and importers of ENDS products is uncertain. Some public comments referenced the Smoke-Free Alternatives Trade Association in stating that there are over 1,200 ENDS manufacturers.

"Many of these manufacturers, however, are believed to be smaller, informal participants in this market; in describing the current landscape in the ENDS industry, an industry survey respondent wrote, “Too many companies are making e-liquid in their kitchens/bathrooms,” (Herzog et al., 2014a). We do not have reliable counts on these informal producers but we expect that few if any of them will continue to manufacture after this final rule takes effect."

The FDA wants to treat e-liquid "manufacturers," who are really e-liquid mixers, like moonshiners. In reality though, they're more like bartenders. Can you imagine if every bar in America had to be certified as an alcohol producer? Every margarita had to go through an application process and had to be certifiably identical to all previous margaritas made at that bar?

No, we don't do that. We make sure the ingredients are what they're supposed to be, and if it's legal to consume, you can combine it however you want. That's how it SHOULD be with e-liquid.