Deeming Regulations have been released!!!!

[Hulamoon]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

Excellent post. Great to see there are several decent avenues to go down on this road. Thanks

 

[HazyShades]

I thought he was being mean to me on another thread and then I looked through his other postings to me and realized he really is just trying to help. Hazy is all good. And I listened to the whole song he posted very relaxing. Now

You have to tell me where it was that you thought I was being mean to you.
I'm sure I wasn't. You'd know for sure if I was being mean
but I'm generally a very gentle giant...which is an attribute I'm beginning to reconsider...

But thank you so much for your above words. Really appreciative
that you'd see me through the fog.

Regards,
Hazy

 

[Pamawoman]

You have to tell me where it was that you thought I was being mean to you.
I'm sure I wasn't. You'd know for sure if I was being mean
but I'm generally a very gentle giant...which is an attribute I'm beginning to reconsider...

But thank you so much for your above words. Really appreciative
that you'd see me through the fog.

Regards,
Hazy

You called me an independent woman or something, like I was a wussy little girl. Well that is how I took it at first glance. Then I went back and realized it was not like that at all. Like someone said we are all on edge. I know I am. I have to up my nic. LOL

 

[Lessifer]

He's Lessifer.
My middle name is Lucien which is a derivative of Lucifer.

Nah, I wasn't attacking anybody. I believe we're all on the same side.
I was offering sympathy and encouragement.
I realize many of us are especially sensitive and angry which is why I'm taking
all reactions with a grain of salt and laughing..Life is too short to
run around being angry with our friends or sad...especially when we all knew this crap was gonna go down eventually.

Vape on. Peace.
Regards,
Hazy Ω

I didn't take any offense at your post, just tried to point out that you used the wrong pronoun. I'm not upset about my wasted time, I'm upset about OUR wasted time.

 

[HazyShades]

I didn't take any offense at your post, just tried to point out that you used the wrong pronoun. I'm not upset about my wasted time, I'm upset about OUR wasted time.

I know I know, just let it go b4 somebody else comes along and misinterprets me..or you.

All those tests in school say my command of the English language is 99.2 %
better than the rest of the US
but occasionally that .8 percent
apparently helps me and my VERBS like "expecting" and NOUNS like "expectation" be misinterpreted...
Guess having been editor of my college newspaper didn't help...

Peace.
Regards
Hazy

 

[Katya]

I'm upset about OUR wasted time.

We haven't been wasting time, Les. We've been building our case against the FDA. Brick by brick, hearing after hearing, petition after petition, study after study. Nobody expected the FDA to just see the light and embrace vaping. But "we" now have a mountain of evidence against them and all that evidence will be used in court. If you don't believe me, listen carefully to what Azim told Dimitri about suing the FDA. Very enlightening.

 

[Pamawoman]

I am watching frozen AGAIN with my 6 year old. I am def going to up my nic. LOL

 

[The Ocelot]

Great letter, O! Would you mind reposting it in our new stickied thread for advocacy letters? The idea is to gather letters written by us, vapers, in one place--for inspiration and help to others who want to write their representatives. No chitchat--just the letters.

FORM LETTERS - For Congress, State, Commissioners

If any of you good people have written a letter you want to share with us, please, please post it there, too. Thanks.

I just posted 3 of mine.

 

[Katya]

I just posted 3 of mine.

Thanks, doll!

Anyone else? We need those letters, folks! There's going to be a lot of letter writing in the near future. Post them, share them, read them, write them. Have them ready when the calls to action are issued.

Good luck and keep the faith!

 

[Lessifer]

We haven't been wasting time, Les. We've been building our case against the FDA. Brick by brick, hearing after hearing, petition after petition, study after study. Nobody expected the FDA to just see the light and embrace vaping. But "we" now have a mountain of evidence against them and all that evidence will be used in court. If you don't believe me, listen carefully to what Azim told Dimitri about suing the FDA. Very enlightening.

Oh, I know, you're right. Not a waste of time. That was the wrong word.

Oh well, move forward.

 

[The Ocelot]

It looked to me like you were attacking Lessfire, Lucifer, or whatever his name is and it ticked me off. I've sent his video to family and friends to explain the deal with the regs.
I think we are all a little edgy right now (well, most of us). I'm going to go listen to some Grateful Dead on some old chrome cassette tape after catching up on ECF.
Vaping J.C. Domestic 1.8% in a Kabuki on a P3, 9.2 watts because I just woke up. Was vaping 9.8 watts before sleep.

P3, Kabuki, drip tip (even the one that comes with the Kabuki is a separate component), juice, replaceable battery (if purchased from a company that indicates it might be used in a vaping product) = 5 separate components. By the FDA's vague definition, that would be an "open system." It is suggested, although completely unclear, that each component might require a separate PMTA. Projected estimate to bring what you are currently vaping to market: 13 million dollars.

 

[The Ocelot]

I am watching frozen AGAIN with my 6 year old. I am def going to up my nic. LOL

@StormFinch mentioned 100s of pages back that I like to take phrases and translate them through several different languages to see what eventually emerges while finally translated back to English. I have discovered a woman who likes to do the same thing.

*Entertainment break*

 

[crxess]

Nailed Md Democratic Representative Delaney on Facebook. Will he respond?

"
My apologies for not supporting your Email Causes. However your canned Party Responses to my Emails on Concerns are an embarrassment to any thought of supporting any Representative Of the People.... On open Forum, Have you or your Assistants at any time attempted to Read up on the significant Reduction of Health Harm to Person and Public from those Choosing to Switch from Smoking Tobacco to Using a 95% Risk Reducing Vapor Product?... As a Resident of Maryland and a Voter who supports Honest, working For the people, Candidates - I ask you to consider Supporting the Bipartisan Cole-Bishop Bill and Possibly saving 1 Billion Lives this century."

 

[crxess]

I just sent another email to the Homeland Security and Governmental Affairs Committee.

Dear Senators,

Yesterday you should have received a response from the FDA to Sen. Ron Johnson’s letter regarding the burdensome e-cigarette regulations. I urge you to review the material very carefully. I suspect much of the response will be based on Final Regulatory Impact Analysis (Docket No. FDA-2014-N-0189).

I am a member of the Electronic Cigarette Forum, a web forum with over 244,000 members. Many of us have been analyzing the Final RIA line-by-line (as we have, and continue to do, with any other documents we find) and, honestly, the report is more complex, confusing and contradictory than the Final Deeming regulations.

Here is a short list (I realize it’s actually long, but there are a lot of troubling statements in the document):

1) It is clear the FDA has little information on how many businesses the regulations impact. They seem pretty arrogant about it as well.

"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 more concrete data sources than industry estimates. All they have identified are manufacturers with logos who are members of trade associations.

2) The word “consolidation” appears 37 times in the report. According to my interpretation, it suggests Big Tobacco companies that can afford to comply with the regulations will buy-out smaller companies they forecast to be profitable. As for the rest, all they have to do is wait for the competition to exit the market.

The word “exit” appears 147 times.

“…consolidation and exit would be expected to occur under the baseline as successful firms represent an increasing share of market sales, market leaders perhaps absorb smaller firms and products, and smaller firms merge into larger entities or exit from the market). We expect a much larger share of ENDS products to exit rather than submit a premarket application.”

“We continue to assume a substantial amount of product consolidation and exit will occur as a result of regulation, as described in the final RIA.”

“[The] FDA acknowledged in the PRIA that premarket submission requirements could lead to significant product exit and reduced entry.”

“To the extent that smaller firms or firms in particular segments of the industry have relatively low sales volume per product, they will be disproportionately burdened…”

“…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…”

“We also assume 54 percent of delivery systems and somewhere between 50 and 87.5 percent of e-liquids will not submit a marketing application and will exit the market after the initial compliance period for the submission and FDA receipt of PMTAs ends. The e-liquid share is particularly difficult to predict in view of uncertainties about the number of distinct products currently available on the market.”

3) The high estimate of smaller companies exiting the market isn't surprising when one considers:

“…at the low end of the average cost spectrum would be product lines of cartridge- or disposable e-cigarettes which have an identical underlying delivery system, flavor variants likely to share basic ingredients, and similar ingredients and constituents for which existing information can be used to support a PMTA. This case is assumed to have total costs of $285,656.”

“…at the high average cost end is a single open-system device requiring considerable original research and testing amounting to $2.6 million.”

It is clear these estimate gives an unfair advantage to the makers of cartridge or disposable e-cigarettes, which are what Big Tobacco companies currently have on the market.

I also have yet to find a specific definition of a “single open-system device.” Does that refer to the battery tube/box? The tank? The drip tip? The device I am using this very moment is made up of components from 5 separate companies. Does that really mean it would take 13 million dollars to bring the same configuration to market?

By using what I think is an “open system,” I was able to quit cigarettes 4 years ago after smoking for 40 years. I’m very worried about this situation as a consumer, a supporter of small businesses, and as person who wants other smokers to have options to stop using combustible tobacco.

Thank you in advance for having common sense.

Sincerely,

I think I'm in love

Awesome Work..........absolutely awesome!

But you left out the admitted True PMTA estimate over the next 2 years and the number expected there after.

(Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.

Page 38
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

 

[The Ocelot]

I think I'm in love

Awesome Work..........absolutely awesome!

But you left out the admitted True PMTA estimate over the next 2 years and the number expected there after.


Page 38
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

True, but I had enough trouble trying to edit it down from my first three drafts.

 

[crxess]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

Early confirmation should Not be expected. If the FDA does respond it will be with a Huge Pile of Dribble the Senator will have to wade through and weigh before any confirmation of response might be expected.

 

[Pamawoman]

@StormFinch mentioned 100s of pages back that I like to take phrases and translate them through several different languages to see what eventually emerges while finally translated back to English. I have discovered a woman who likes to do the same thing.

*Entertainment break*

That was so cool. Me and my husband were cracking up. GIVE UP! Me and my daughter had to learn that ENTIRE song for her speech therapy. Drove me nuts. LOL

 

[Pamawoman]

Nailed Md Democratic Representative Delaney on Facebook. Will he respond?

"
My apologies for not supporting your Email Causes. However your canned Party Responses to my Emails on Concerns are an embarrassment to any thought of supporting any Representative Of the People.... On open Forum, Have you or your Assistants at any time attempted to Read up on the significant Reduction of Health Harm to Person and Public from those Choosing to Switch from Smoking Tobacco to Using a 95% Risk Reducing Vapor Product?... As a Resident of Maryland and a Voter who supports Honest, working For the people, Candidates - I ask you to consider Supporting the Bipartisan Cole-Bishop Bill and Possibly saving 1 Billion Lives this century."

Stealing and sending to ALL my government non reps.

 

[The Ocelot]

I found another place to send emails to:

CTP Ombudsman

 

[coldgin96]

P3, Kabuki, drip tip (even the one that comes with the Kabuki is a separate component), juice, replaceable battery (if purchased from a company that indicates it might be used in a vaping product) = 5 separate components. By the FDA's vague definition, that would be an "open system." It is suggested, although completely unclear, that each component might require a separate PMTA. Projected estimate to bring what you are currently vaping to market: 13 million dollars.

Yeah, and I forgot to add I am using a HH coil... lol