Deeming Regulations have been released!!!!

ZeroedIn

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Here is a piece of that conversation with the Ron Johnson staffer...

"I asked him what the Committee’s specific powers were to enforce changes on the FDA’s ruling. A direct answer to this question is too complicated for a simple phone call, most likely over-complicated because of the two centuries of precedence fueled by political maneuvering. But the general summary I can give from our conversation is direct action by the Committee will likely not be necessary.

The Committee seeks first to expose information for the public. This information then becomes available to private interests who can and are filing lawsuits to stop the FDA. The Committee’s expectation is these lawsuits will be successful and they see their role as helping to bring relevant information to light to make these lawsuits easier to pursue."


I stated earlier when this questionnaire was first mentioned on this thread not to get overly excited about it. I said this because I saw many people jumping on this as if it was the magic arrow that would deflate the Deeming regulations. This staffer's response proves this is NOT a magic arrow as I stated. I was also accused of being somewhat of a "Gloomy Gus" for suggesting this would not be a magic arrow. I'm sorry, but I want to deal in reality. These questionnaires are standard procedure and rarely (if ever) force change in and of themselves. I hate to see anyone get all pumped up about something only to be let down when it does not produce the results they had hoped for. If this makes me a "Gloomy Gus" then so be it. At least what I say has credibility.

That said (and I said it before as well), this does NOT mean Senator Johnson's questionnaire is a waste of time or useless. It does have some merit as outlined by his staffer in his quote above. It does add to our quiver that can be used to make our argument. Just a small piece, but a piece nonetheless. For this, we should be thankful for Senator Johnson's efforts. But let's be sure we keep this action by Senator Johnson (and other actions) in their proper proportions so as to keep us continually focused on all things big and small and the attention each deserves. More than Senator Johnson's questionnaire, his activism beyond this questionnaire will likely be more impactful. It is nice to have advocates in the legislature and Senator Johnson appears to be taking a lead.

Not a Gloomy Gus, but maybe a Bronze Bummer...

I see the Facilitating Death Administration's refusal to answer the Committee as a reckless and wanton disregard of Congressional oversight. This will certainly be used as an arrow in the quiver for current and forthcoming legal actions against the agency. Yes, it is not the be all to end all, but it is, based on the staffer's reply, IMHO, a positive outcome.
 

Bronze

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I see the Facilitating Death Administration's refusal to answer the Committee as a reckless and wanton disregard of Congressional oversight. This will certainly be used as an arrow in the quiver for current and forthcoming legal actions against the agency. Yes, it is not the be all to end all, but it is, based on the staffer's reply, IMHO, a positive outcome.
Agree, and this is what I said. My only point is let's make sure we understand it is one arrow and it is not magical. It's just one standard issue arrow. One that I would fight like hell to keep knowing we need all the arrows we can get. For this, I am appreciative.

BTW, reckless and wanton disregard of Congressional oversight is standard operating procedure in Washington. Ask yourself, how often do we see contempt charges levied? We're lucky if we even see a censure handed out. We have a current presidential candidate who, if anyone else, would be sitting in the slammer baking cookies for her fellow inmates.
 

ZeroedIn

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Agree, and this is what I said. My only point is let's make sure we understand it is one arrow and it is not magical. It's just one standard issue arrow. One that I would fight like hell to keep knowing we need all the arrows we can get. For this, I am appreciative.

BTW, reckless and wanton disregard of Congressional oversight is standard operating procedure in Washington. Ask yourself, how often do we see contempt charges levied? We're lucky if we even see a censure handed out. We have a current presidential candidate who, if anyone else, would be sitting in the slammer baking cookies for her fellow inmates.
Yeah. We're in it up to our necks, aren't we; and on many more levels than just vaping.
 

coldgin96

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I'm splitting hairs? Man that's a real stretch.
Tell you what, maybe the reason he didn't get fair treatment
IS because he didn't expect fair treatment.

I'll give you that I didn't quote him correctly
INSTEAD I POSTED A SCREENSHOT of what Lessifer said
ok, I left out the word "expected"
so in fact I did not quote Lessifer correctly and the one word "expected"
suddenly turned into "PUTTING WORDS IN PEOPLE'S MOUTHS"
(who is putting words in people's mouth's again?..If I put ONE word in his mouth
WHERE DID THEY BECOME PLURAL?)
yea my fault Indeed... :lol:

IT SEEMS to me that it is y'all who are splitting hairs
then again it may be some people do things for the heck of it
never EXPECTING that what they do will bear fruition
so then when it doesn't bear fruition
they get angry. (but only at themselves ..) and sad (with everybody)
What is making me LAUGH now is that
there I went and tried to offer some sympathy and encouragement to Lessifer
and as a reaction I get grief.

If you ask me it is you who might go have a vape
'cause I've been vaping all along
:tumble:
 

HazyShades

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I think Hazy is like my cousin. Who I adore and think is one of the funniest people I Have ever met. Just a stink stick. Don't go for the bait. His hearts in the right place. Love, Sarge. LOL
LOL...It's a Florida thang, Sarge.
Mind if I add you to my friend's list? I need all I can get sitting here
by my lonesome watching the world go by...


at least I'm laughing
Regards,
Hazy
 

Qew

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I believe they're still working out how to describe the only allowed flavors of "white rice, plain boiled potato, plain grits, sunshine, and ashtray."

This is the FDA we're talking about. It's more likely to be some (FDA approved) GMO corn, soy or wheat. If you want a fruit flavor, how about strawberry/salmon juice? No label necessary!

:censored::censored::censored:
 

coldgin96

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I'm not fighting..I was trying to offer encouragement and sympathy
but is seems many of us are extremely sensitive...

But really, Myrany. I get the feeling the FDA and Antz have already won.
You're probably correct that fighting among ourselves
could well be the reason they won (so far, 'cause I'm not crying in my soup and haven't given up) and fighting among ourselves and splitting hairs
is one reason I like to stay away from these "political" threads.

Regards,
Hazy
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.
 

Pamawoman

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LOL...It's a Florida thang, Sarge.
Mind if I add you to my friend's list? I need all I can get sitting here
by my lonesome watching the world go by...


at least I'm laughing
Regards,
Hazy

I just wish I could get him to vape and quit smoking. He's a trucker based in Indiana and unfortunately he believes all the crap the ANTZ have been spreading in Indy. Maybe someday.
 

Myrany

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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.
This whole deeming thing has got me so wound up I broke out the LPs and have been listening to some Jazz. Mingus anyone?
 

HazyShades

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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.
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
 

Pamawoman

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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.
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
 

HazyShades

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I just wish I could get him to vape and quit smoking. He's a trucker based in Indiana and unfortunately he believes all the crap the ANTZ have been spreading in Indy. Maybe someday.
Keep working on it, you'll convince him and after he does it a while
he'll finish convincing himself.
I do suggest that you use honey...Sarge :rolleyes:
Regards,
Hazy

PS. I've added you to my friends list..Hope you don't mind
 
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Katya

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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,

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.
 

Pamawoman

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Keep working on it, you'll convince him and after he does it a while
he'll finish convincing himself.
I do suggest that you use honey...Sarge :rolleyes:
Regards,
Hazy

PS. I've added you to my friends list..Hope you don't mind
I might need a stick instead of a carrot with him. Or his wifey. LOL. I don't mind if you added me. CHEERS!
 
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