Deeming Regulations have been released!!!!
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I don't think that's entirely true. I believe they can further restrict products that were grandfathered in if they decide to go after something in particular. For instance, I believe they could decide that all cigarettes should have a lower nicotine content, they can then force the cigarette companies to alter their products or remove them.BINGO!
Nothing New is absolutely protected if it can (under Zeller) Relate back to 2007 - Key word - NEW.
Nothing Old(pre- Feb. 15, 2007) Can be Banned or even ordered limited in sales volume, or further restricted by the FDC - i.e. is protected.
While the FDA can create aStorm over New innovation, the Very most the FDA can do to Grandfathered tobacco is:
1) continued incremental Tax Increases(have to protect Fed./State Revenues)
2) Spend Millions on Anti-tobacco use campaigns.
3) Waste Millions on Tobacco Research Backing Ad Campaigns covering already Established Scientific proof of the Dangers of Smoking.
I wonder just how astronomical the Total output of $$$ US Dollars $$$ is on informing an already informed public rather than Cracking down on Child Smoking/Possession Violations through the Wallets and livelihood of Complicit Adults.
With Health groups included I would venture to Guess - Billions?
We have a much more economical solution
I'm not 100% positive on that though.
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) specifically prevents the FDA from banning cigarettes or reducing their nicotine content to zero. This is the same act that provided them the authority to deem other tobacco products to be under their regulatory control.While the FDA can create a
1) continued incremental Tax Increases(have to protect Fed./State Revenues)
2) Spend Millions on Anti-Tobacco use campaigns.
3) Waste Millions on Tobacco Research Backing Ad Campaigns covering already Established Scientific proof of the Dangers of Smoking.
The FSPTCA was written prior to anyone knowing or caring about electronic cigarettes. The idea that they can not ban cigarettes was put there by Congress because doing so would have serious negative economic impact. Our country was practically FOUNDED on tobacco, and our economy is still quite tied up in the sale of tobacco. Only now, it's more about the taxes than anything else.
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Can't ban or reduce to 0, but I do believe they can still mess with the existing products.
I was just reading an article that stated anti smoking ads actually increased smoking by teens so now that anti vaping policies are set has the FDA studied the increase in vaping due to not grandfathering any legal vape products ? Are they setting themselves up for increased use?? I know FDA says they are not banning vaping but not allowing any vape products pre Feb 2007 does just that, a complete ban with no promise to approve.
I would have to believe they can mess with existing product if they choose to, part of "control" as times and information changes?
So some of you think that the FDA can require the cigarette companies revise existing (grandfathered) products?
If so, wouldn't that then require those companies to file SE or PMTA apps for the revised products?
If so, wouldn't that then require those companies to file SE or PMTA apps for the revised products?
That's a really, really good question.If so, wouldn't that then require those companies to file SE or PMTA apps for the revised products?
They left the door open to go after menthol at some point.
In the Deeming regs and the RIA it defines "flavors" as other than tobacco flavored. Since e-liquid doesn't taste like combustable tobacco, what flavor are they referring to?
Honestly, the idea of them going after flavors if fraught with problems.
What exactly defines a tobacco flavor?
I have to wonder if Tribeca can survive such an arbitrary decision.
But I do believe that Unicorn Milk won't make the cut.
I'm going with no.........................or they would, long ago, have done so.(Assuming Nicotine is what Hooks Kids on Smoking)
I tend to favor, the Hook is in the Delivery method.
Well now, that sounds like Bass-ackwards thinking on the part of Government, now doesn't it.
We now have more information that Vaping is safer than Smoking so it will Be summarily Extinguished.
Even though it doesn't completely answer the questions in Sen. Ron Johnson's letter, I have a feeling the FDA is going to submit their Final Regulatory Impact Analysis (RIA) as part of their response. It is the most complex, confusing and contradictory report I have read so far. 156 pages of WTH?
I was pulling quotes from it last night and it's clear BT is the intended beneficiary. I'm going to write another letter to Johnson's committee, but there so much I want to say that it's hard to edit.
I may be cherry picking, but so is the FDA. However, unlike them, I have no financial interest in the matter. I just want access to the products that 4 years ago helped me to quit a 40-year smoking habit when nothing else worked. And I want current smokers to have the same options.
“We have…quantified the baseline number of ENDS products in terms of e-liquids and delivery systems. These counts contain some components and parts that are not made or derived from tobacco, including e-liquids not containing nicotine (if they are intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not constitute a tobacco product accessory) and delivery systems not containing a tobacco- derived component. The costs for other components and parts are not quantified due to lack of data.”
“…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. The medium-cost case also involves a closed-system product line involving a smaller number of products and greater burden to conduct original research on their health effects and risk attributes. The total cost is somewhat higher at $440,725. Finally, 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 this 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 clear 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?
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.
“As described in previous responses and the FRIA, we have updated our estimate of the number of ENDS products currently on the market. 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.”
“We also note that the burgeoning market for ENDS is still in a state of flux. Considerable product consolidation might be expected to occur under the baseline due to industry life-cycle consolidation in coming years, as successful products gain rising market shares and less successful ones are driven out, and as larger firms or manufacturers of traditional tobacco products enter this market and perhaps absorb smaller manufacturers and products.”
“We agree that product exit is likely to occur, but much of this may occur as a result of consolidation of similar products within product lines instead of through exit by manufacturers, although we expect most vape shops that currently mix e-liquids will convert to a retail model once the initial compliance period for submission of PMTAs ends.”
“We do, however, expect there to be a substantial amount of product exit for certain product categories, such as ENDS.”
“…costs of market entry under the final rule are likely to be higher than they would be under the baseline, so we can expect the industry to become more concentrated more quickly than would be the case without the rule, as the substantial expense of seeking premarket authorization will represent an important new barrier to entry.”
“After the initial 24-month compliance period for the submission and FDA receipt of PMTAs expires, vape shops selling new newly deemed tobacco products, including e-liquid mixtures, for which neither they nor an upstream supplier has submitted an application for premarket review, will be subject to enforcement action. Therefore, we expect vape shops that mix e-liquids will overwhelmingly cease mixing. This does not necessarily imply closure of vape shops, but rather a change in business operations to pure retailing.”
I’m confused by the claim that “most vape shops that currently mix e-liquids will convert to a retail model.” If small manufacturers, such as ones that produce tanks, “open” device components, handmade drip tips, handmade wooden mod stands, vinyl protective mod covers and similar items that are now deemed tobacco products, can’t afford the cost of PMTAs (let alone trying to figure out they impact public health), what are the retail vape shops expected to sell?
This paragraph has me quite perplexed:
“We lack a baseline estimate of consumer valuation of tobacco product variety, making it impossible to estimate how consumers who continue to use tobacco products would value the potential loss of variety due to product exit under this final rule. Today we see very large numbers of products embodying minor variations. Even if considerable product consolidation were to occur, close substitutes would exist for discontinued products, which would limit the size of any ongoing impact on consumers who switch to a substitute product.”
They claim it’s impossible to estimate, but they do anyway.
And what is a “substitute product?” Does that mean giving up the “open” (which should really be “customizable”) system that has kept me cigarette free for 4 years, for a device produced by a Big Tobacco company?
“Close substitutes would exist for discontinued products,” reeks of GovSpeak for “the products you use are no longer on the market, but this device produces vapor, so it’s close enough.”
For more information on the Big Tobacco companies stake in the market I suggest reading this article from Forbes: Who Stands To Gain From The E-Cigarette Phenomenon? Who Stands To Gain From The E-Cigarette Phenomenon?
RIA:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
I was pulling quotes from it last night and it's clear BT is the intended beneficiary. I'm going to write another letter to Johnson's committee, but there so much I want to say that it's hard to edit.
I may be cherry picking, but so is the FDA. However, unlike them, I have no financial interest in the matter. I just want access to the products that 4 years ago helped me to quit a 40-year smoking habit when nothing else worked. And I want current smokers to have the same options.
“We have…quantified the baseline number of ENDS products in terms of e-liquids and delivery systems. These counts contain some components and parts that are not made or derived from tobacco, including e-liquids not containing nicotine (if they are intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not constitute a tobacco product accessory) and delivery systems not containing a tobacco- derived component. The costs for other components and parts are not quantified due to lack of data.”
“…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. The medium-cost case also involves a closed-system product line involving a smaller number of products and greater burden to conduct original research on their health effects and risk attributes. The total cost is somewhat higher at $440,725. Finally, 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 this 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 clear 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?
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.
“As described in previous responses and the FRIA, we have updated our estimate of the number of ENDS products currently on the market. 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.”
“We also note that the burgeoning market for ENDS is still in a state of flux. Considerable product consolidation might be expected to occur under the baseline due to industry life-cycle consolidation in coming years, as successful products gain rising market shares and less successful ones are driven out, and as larger firms or manufacturers of traditional tobacco products enter this market and perhaps absorb smaller manufacturers and products.”
“We agree that product exit is likely to occur, but much of this may occur as a result of consolidation of similar products within product lines instead of through exit by manufacturers, although we expect most vape shops that currently mix e-liquids will convert to a retail model once the initial compliance period for submission of PMTAs ends.”
“We do, however, expect there to be a substantial amount of product exit for certain product categories, such as ENDS.”
“…costs of market entry under the final rule are likely to be higher than they would be under the baseline, so we can expect the industry to become more concentrated more quickly than would be the case without the rule, as the substantial expense of seeking premarket authorization will represent an important new barrier to entry.”
“After the initial 24-month compliance period for the submission and FDA receipt of PMTAs expires, vape shops selling new newly deemed tobacco products, including e-liquid mixtures, for which neither they nor an upstream supplier has submitted an application for premarket review, will be subject to enforcement action. Therefore, we expect vape shops that mix e-liquids will overwhelmingly cease mixing. This does not necessarily imply closure of vape shops, but rather a change in business operations to pure retailing.”
I’m confused by the claim that “most vape shops that currently mix e-liquids will convert to a retail model.” If small manufacturers, such as ones that produce tanks, “open” device components, handmade drip tips, handmade wooden mod stands, vinyl protective mod covers and similar items that are now deemed tobacco products, can’t afford the cost of PMTAs (let alone trying to figure out they impact public health), what are the retail vape shops expected to sell?
This paragraph has me quite perplexed:
“We lack a baseline estimate of consumer valuation of tobacco product variety, making it impossible to estimate how consumers who continue to use tobacco products would value the potential loss of variety due to product exit under this final rule. Today we see very large numbers of products embodying minor variations. Even if considerable product consolidation were to occur, close substitutes would exist for discontinued products, which would limit the size of any ongoing impact on consumers who switch to a substitute product.”
They claim it’s impossible to estimate, but they do anyway.
And what is a “substitute product?” Does that mean giving up the “open” (which should really be “customizable”) system that has kept me cigarette free for 4 years, for a device produced by a Big Tobacco company?
“Close substitutes would exist for discontinued products,” reeks of GovSpeak for “the products you use are no longer on the market, but this device produces vapor, so it’s close enough.”
For more information on the Big Tobacco companies stake in the market I suggest reading this article from Forbes: Who Stands To Gain From The E-Cigarette Phenomenon? Who Stands To Gain From The E-Cigarette Phenomenon?
RIA:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
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Perhaps the government can finally answer the classic newbie question, "What juice tastes like a Marlboro?"
I think that will fall under the FDA dairy products regulations
or maybe the endangered species act
I'm not so sure about that.
I apologize for a post that may require you to shine up your tin foil hat, but the dates involved seem a little too coincidental to me.
The FSPTCA was written and passed in 2009, with a retrograde-grandfather date of 2007. While its NET-effect appears to be a negative for BT, it had the provision for not allowing the FDA to outright ban their products, or force out the "addictive" properties. It is not uncommon for industries to actually support "compromise" legislation like this, and I would bet money that BT was actually in support of the FSPTCA.
In 2009, Blu was founded (yet independent from BT), also, the eGo and clearomizer were introduced. While these products certainly weren't on the public's tongue at that time, you know they were on BT's radar.
The success of the Ruyan, from 2003 on in China, a VERY significant market in BT's portfolio, could not have been missed by them. Ruyan eventually found its way to US shores in 2007- coincidentally just after the grandfather date.
I don't find it a stretch to believe that the FSPTCA was written, specifically when and how it was written, with the support of BT, with an eye on the e-cigarette.
While appearing as a NET-negative for BT, it shifted their regulation to an agency where they only had to buy dozens, rather than hundreds, of people to do their bidding, it guaranteed them immunity for the vast majority of their stable of products, and it opened a window for them to influence the regulators to so convieniently ban an entire industry of competiton.
And that window to ban the ecigarettes came with an easy alibi, in that the dates of Congress' legislation were to blame if the competitive industry went under, NOT the regulatory agency.
Mitch Zeller said, himself, (in that webinar last week) that the one of the asks during the deeming comments period was an explanation why they COULD change the grandfather date, and no one met the burden, so, now, they HAD TO follow the 2007 date.
I believe that it is not only possible, but highly likely, that the FSPTCA was written with an eye to the e-cigarette. It became a holstered weapon that BT could use one day, should its new competitor ever become a serious contender- which it did 3-4 years later.
The deeming is coming out now, 2-3 years after the e-cig boomed, because it took a couple years worth of steak dinners, lap dances, and happy endings for BT to convince its regulation-whores in the FDA to actually put their name to a rule that calls flashlight batteries and tampons "tobacco products".
Well, Camel Lights were grandfathered in, but at the same time they weren't allowed to call them "light" anymore, and I don't think they had to file an SE to change the name to Blue since the change was forced by the FDA. Not sure though.So some of you think that the FDA can require the cigarette companies revise existing (grandfathered) products?
If so, wouldn't that then require those companies to file SE or PMTA apps for the revised products?
So some of you think that the FDA can require the cigarette companies revise existing (grandfathered) products?
If so, wouldn't that then require those companies to file SE or PMTA apps for the revised products?
I believe that SE and PMTA are applicable to "New" Products.
So if say the FDA Banned the addition to Menthol in Cigarettes, Kool Menthal would Not Exist anymore.
And that e-Liquid that Joe's Vape shop is under some 2 Grace Period to file a PMTA for (wink, wink) would not be able to sell ANY e-Liquid that contained Menthol. Given that the Menthol e-Liquid was on the Market before Aug 8th that is.
Or if the FDA said that the Maximum mg/ml in a e-Liquid (either Liquid or Closed system Cartridge) that could be Shipped in the Mail is 12mg/ml. This wouldn't create New Products. Only Restrict some Existing Products that people were Preparing PMTA's (wink, wink) for.
Minor point, but it seems to me that handmade wooden mod stands and vinyl protective mod covers would be accessories to tobacco products even under the onerous definitions in the regs as currently published, and thus exempt from regulation.
I think it maybe a bit more complicated than that...
What is the Grandfather Date of the Tobacco Control Act & How Will it Impact the Vapor Industry? - SFATA | Smoke Free Alternatives Trade Association
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