Your forgot crab juice. If you do not know what that is google the Phil Busardo video of him tasting it. His face is epically memorable.
Deeming Regulations have been released!!!!
- Thread starter Oliver
- Start date
- th_trl_thread_readers 0
Why are you trying to hook a new generation of asian nicotine addicts?
p.s. It's okay, I'm asian.
p.p.s. wired already knew that, this was for anyone else who might get offended.
Correct - Adjusted before Deeming - Possible issue of Legal Definition of reasonably justified - to be revisited no doubt in additional Future additional/Modified regulation
I'm not sure I'm clear on when the OMB made the change. Was it after the release date? Now that I re-thought it I believe it was well before.
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...
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
Guys please if we fight amongst ourselves then the FDA and Antz have already won.
Take a step back and let it go.
Take a step back and let it go.
Ok, I watched some more people trying the crab juice. I'm not sure how I missed this before, but I can say that that stuff is the only reasonable excuse for the FDA having control over flavors.
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
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue
Last edited:
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
I like this snippet. It's exactly what I posted in another thread. The answer to the inquiry will bring to light potential specific flaws in the regs for litigation.
"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."
It fits very much into the same self-righteous attitude that I believe they had with Judge Leon that got him miffed. I'm hoping that they just can't help themselves and continue to PO everyone who questions them on the deeming regs with that attitude of being beyond legislative or judicial review.
I appreciate you trying to make me feel better. I do. I'm not sad because I wasted my time though, that's my point. I'm angry because we as a community wasted our time on a fight we never had a chance of winning. I don't blame the advocacy groups, they truly believed that reason would win out. That doesn't change the fact that we lost YEARS. I have supported the advocacy groups, but at the same time I have been doing what I can(which isn't much) to promote the idea that vapor products do not belong under tobacco regulations, not just because they contain no tobacco, but because the regulations themselves are designed to inhibit growth and ingenuity.
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 relevant 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 estimates give 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 the same options to stop using combustible tobacco as I did.
Thank you in advance for having common sense.
Sincerely,
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 relevant 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 estimates give 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 the same options to stop using combustible tobacco as I did.
Thank you in advance for having common sense.
Sincerely,
Last edited:
thank you for posting the link. I too have been searching for some follow up from yesterday's deadline. I hope by "louder" the committee brings to the fore front the study done by the RCP and PHE which run absolutely counter to the position this regulation has taken. I hope to hear more formal responses from Sen Johnson and his committee.
It may well work out for the best..when they dis enough gub'min bureaucrats
they'll all turn on themselves and any good bureaucrats will finally realize
what's going down..which I reiterate involves much more than vaping
Similar threads
- Locked
