# Not good news



## Alex (25/3/15)

_I didn't really want to post this here, but I have to share the bad news too._

submitted 6 hours ago * by DEATH_INC
http://www.fda.gov/TobaccoProducts/...baccoProductReviewandEvaluation/ucm304506.htm

http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm

From Bill Godshall -

*"FDA delineates how “Deeming Regulation” protects cigarettes and threatens lives of vapers and smokers by banning >99.9% of vapor products, giving e-cig industry to Big Tobacco [as Premarket Tobacco Applications for vapor products would cost >$10 million/SKU, and FDA won’t accept applications for open system products (aka e-liquids and PVs)]."*

the big FU to the vaping industry is in the Substantial Equivalence section that dictates -

*New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:*

*It was commercially marketed after February 15, 2007 but before March 22, 2011; and A Substantial Equivalence Report was submitted by March 22, 2011*

We are screwed ladies and gentlemen. Stock up on Nicotine base and learn to DIY with e-liquid. Stock up on RDA's/RTA's while you can. Learn how to solder to make mosfet boxes if need be. I have two liters of 100MG Nicotine in the freezer just in case, should last a while.

Keep fighting, but just be wary that whatever they propose is due by a *June 2015 deadline* and it wont benefit us. Plan ahead accordingly.

source: http://www.reddit.com/r/electronic_..._delineates_how_deeming_regulation_would_ban/

Reactions: Like 2 | Informative 3


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## Jakey (25/3/15)

I dont know what to rate this post, if this is the case, absolute bull.

Reactions: Like 1


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## Alex (25/3/15)

* Why do ecigarette bans and restrictions exist?*
Simple: to protect the smoking economy. Although there are almost too many to list, the principal beneficiaries are existing industries, government revenues and NGOs dependent on funding by industry. Legislation is designed principally to protect existing industries, but cannot be obtained directly by them; so they use front groups instead: pressure groups funded by industry who appear to be independent 'pro-health' lobbyists, but are funded by commercial interests. Because continuation of smoking has multiple benefits for government, they are implicitly involved in protecting it.

These are some of the important factors:


Governments in countries such as the UK are 90% stakeholders in cigarette sales - cigarettes are, in effect, bought from the government
You buy 18 out of the 20 cigarettes in a pack directly from the government, not the tobacco industry
Smoking is vigorously protected, because government cannot afford to lose the huge revenues or infuriate 25% of voters by banning smoking
The amount the UK government makes from smoking is at least double the cost of EU membership (which was £8.9bn for 2010/11 according to the UK Treasury) - after all costs are paid
Government is also under pressure from the multiple giant industries who strongly benefit from smoking
The cigarette industry's financial strength ensures that competitors do not succeed
The disease caused by smoking is just as profitable as the cigarette sales in the first place. In the UK, the pharmaceutical industry earns the same from smoking as the tobacco industry does and in fact it may even earn more
Most tobacco industry players can mitigate the expected losses caused by the drop in cigarette sales due to THR, but the pharmaceutical industry cannot - it depends on the resulting disease for a significant proportion of its overall income (at least 10% and possibly as much as double that)
The pharmaceutical industry will lose billions as THR advances, due to the concomitant fall in disease; because it has significant influence within government it is in practice the most powerful opponent of THR
The pharmaceutical industry has absolute control of a government department (and this probably holds true in every country due to the enormous wealth of the industry), who will always ensure that its interests are protected and promoted above all others - and this most certainly includes public health
The ideologists in the tobacco control industry provide the workforce for the commercial players who need bans and restrictions on THR in order to protect cigarette sales and the profitable disease they cause; the agendas of the two groups overlap sufficiently that the relationship is symbiotic: tobacco control does the work, industry pays the bills
The tobacco control industry's agenda is to remove all access to cigarettes, tobacco and nicotine, and to destroy the tobacco industry; the pharmaceutical industry funds them extensively as blocking access to THR products is a core part of the TCI agenda and benefits pharma tremendously (since THR is now the only thing that threatens the hugely profitable smoking disease income channels); and because they know that the TCI cannot possibly succeed in significantly reducing smoking, never mind removing it, due to the 20% Prevalence Rule
Pharma knows the TCI are in effect useless after the 20% barrier, and funds them to protect smoking by blocking THR, which is the only threat to disease levels and therefore pharma income
Therefore the pharmaceutical industry's vast income from smoking is safe: access to THR products is blocked, smoking is protected, and disease levels remain high; and the best feature of all is that _the legislation to protect smoking by preventing access to THR products appears to have been obtained by 'public health' groups_.
Pharma's hands are clean; and government is happy because the money machine rolls on.

_The most important of all issues_ to the pharmaceutical industry is to defend the unspoken principle that it alone decides health policy. It has an iron grip on health policy, services and provision, and this must be defended at all costs since it is the key to profitability.

People who claim they are legislating to protect public health are sentencing millions to death _for the sole purpose of protecting existing industries_. The use of EVs (electronic vapourisers or 'e-cigarettes') is likely to prove 1,000 times safer than smoking - it cannot possibly be less than 100 times safer and may even be 10,000 times safer. Read the statements here from Profs. Britton, Phillips, Rodu and West, and decide for yourself; there are dozens more in the same vein from many other professors of public health, clinical research, and law, and from other independent expert public health advocates such as Clive Bates.

http://www.ecigarette-politics.com/

Reactions: Like 1 | Informative 1


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## johan (25/3/15)

How can an already hated smoking community, suddenly be so protected, geez?

Reactions: Like 2


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## kimbo (25/3/15)

If i was a government i would start dropping my cigarette stock and buy some in ecigs, look at the future not hold on to the past. It is a proven fact that ecigs will take over from cigarettes the governments must just open their eyes and see.

Edit: This is a golden opportunity for a political party to use

Reactions: Like 1 | Agree 2


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## JakesSA (25/3/15)

Maybe e-liquids and possibly mods will fall under the "*Substantial Equivalence" *exclusion:

*"Substantial Equivalence*
_Substantial equivalence is a second pathway manufacturers can use to market a new tobacco product in certain circumstances.

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:
_

_It was commercially marketed after February 15, 2007 but before March 22, 2011; and_
_A Substantial Equivalence Report was submitted by March 22, 2011,_
_then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to a valid predicate product. 

Marketing orders for substantially equivalent tobacco products can be issued for new products that have the same characteristics as valid predicate tobacco products, or have different characteristics but the new products do not raise different questions of public health"
_

Do a search on google for electronic cigarettes and restrict the date range to 2010.

The Ali'i bottom feed box mod was available back then (check the date on the video *26 Oct 2010*)

Reactions: Like 2


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## Alex (25/3/15)

JakesSA said:


> Maybe e-liquids and possibly mods will fall under the "*Substantial Equivalence" *exclusion:
> 
> *"Substantial Equivalence*
> _Substantial equivalence is a second pathway manufacturers can use to market a new tobacco product in certain circumstances.
> ...




Lets just hope he submitted a Substantial Equivalence Report before March 22 2011 then.

Reactions: Like 1


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## JakesSA (25/3/15)

It sort of reads that way, but on the explanation for substantial equivalence it is set out as: The "No" section indicating that a Substantial Equivalence Report has to be submitted. If the answer is "Yes" which I guess is unlikely you may continue marketing without any submission.

*"Could I Ever Sell My New Tobacco Product Without Receiving an Order from FDA?*
To answer this question, determine the following:


*Was your new tobacco product first commercially marketed between Feb. 15, 2007, and March 22, 2011?*
*Did you submit a Substantial Equivalence Report to FDA by March 22, 2011?*





*YES:* If you answered “yes” to both questions, you may market your tobacco product unless FDA issues an order that your product is not substantially equivalent. If FDA makes this determination, your product must be withdrawn from the market.




*NO:* If you answered “no” to either question, then your new tobacco product may not be marketed without an order from FDA based on either a Substantial Equivalence Report or a Premarket Tobacco Application "

However it reads, its not good news since submitting anything to government for approval will be a dicey business but there is grounds for them not to be able to decline outright.

Reactions: Thanks 1 | Informative 1


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## FireFly (25/3/15)

I should be on 0 Nic by then, but still Bull sh!t IMO
Bring on the Vaping underground! 
Could never be stopped...

Reactions: Agree 2


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## Renesh (25/3/15)

<start of rambling dumbness> 

My dumb question for the day...and apologies if its been answered already..
Whats the impact for SA vapers? 
Possible ban on importing Nic? Coz i battle to see SA banning importing e-cigs (as an electronic device)..or even better, banning importing mech mods (metal battery tube)... 

If Nic imports are banned... what would it take to create local Nic?

Either way, we are a bunch of really resourceful people and if its banned (in some manner), shouldn't take too long to find an alternate for what ever is banned...

</end of rambling dumbness>

Reactions: Like 1


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## Jakey (25/3/15)

Renesh said:


> <start of rambling dumbness>
> 
> My dumb question for the day...and apologies if its been answered already..
> Whats the impact for SA vapers?
> ...



these developers eh......


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## DoubleD (25/3/15)

I feel sick

Reactions: Can relate 1


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## Alex (25/3/15)

DoubleD said:


> I feel sick



The guys on reddit are going crazy
http://www.reddit.com/r/electronic_...a_this_is_how_imminent_these_regulations_are/

Reactions: Like 1


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## rogue zombie (25/3/15)

Thanks for keeping us in the loop @Alex, really!

Reactions: Thanks 1


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## Alex (26/3/15)

blitz206CLDMKR Whiteout 196 points 16 hours ago* 

I think the general public needs to realize that this battle is not one over safety, or just about big tobacco "swooping in" to the market. Look at it on a larger scale. Like it or not, eliminating the traditional tobacco industry would be damaging to the US economy. (Note: Don't consider this comment as being in support of regulation. Read the rest first.)

There's the obvious surface issue of a non locally- and federally-taxed product competing with one of the top tax earners in the country. We are talking about a product that the government heavily relies on for revenue. Increasing tax levels have not made a significant difference in consumer habit; either. Also a "surface" issue is the consideration that traditional cigarettes are statistically a habitual loop; you will probably be a consumer for the remainder of your life. A product designed to break this cycle isn't good news for a government that relies on the stability of the tobacco consumerism as a primary revenue generator. Couple this with the fact that it is significantly easier for a politician to suggest tax increases on taboos, you have a pretty good recipe for revenue generation.

*Dig deeper.* The health care industry generated $133 billion revenue as a direct result of smoking-related illness between 2009-2012. Electronic cigarettes jeopardize that revenue stream. The agriculture and logistics markets would invariably suffer, too.

*At the end of the day, smokers die earlier. This costs less for the government, as well.*

“Smokers actually save the government money, both by dying earlier and thus reduce social security payments, and, to a lesser extent, by dying of relatively cheap ailments like lung cancer, a fairly quick killer, rather than more expensive, lingering ailments.”

What is a government to do at this point? They are scrambling to mitigate revenue loss, generated directly by tobacco. The possibilities are to either:


Tax the vaping industry at the same rate as cigarettes are taxed. The con in their eyes: this still doesn't solve the issue of vaping being a smoking cessation product. There is a long history of tobacco taxation that won't be fought, and tobacco has a high "consumer retention rate".
So, the next 'logical' thing to do would be to:


Cripple the industry to protect tobacco-generated revenue and prevent any financial hardships that would follow suit.
The government has relied on tobacco taxation as a staple of its portfolio for more than 100 years, so it's pretty clear to see what's going on here in my opinion. Sure, you can try to make the blow easier by hiding behind the veil of health concerns, and perhaps some of the lesser political puppets will take the bait. In the end, though, it seems pretty evident that the situation is about a flawed taxation system. When an innovative product comes along that saves lives and generate tens of thousands of small businesses around the country but threatens pulling the financial rug out from under an already economically-weak government, their solution will be to stomp out the disruptors.

There will have to be a compromise of some nature, unfortunately. The government has been heavily reliant on taxing a taboo that we are ultimately eliminating. They will either seek to regain lost revenue by taxing the vaping industry, or look to crush the industry as a whole to maintain status quo.

My two cents.

*EDIT:* A lot of people have been tossing around solutions; here's what I think a feasible defense looks like. Considering the vaping industry is largely comprised of "small business", there is no single entity that has the cashflow to facilitate Washington lobbying. I think we can all agree that lobbying, coupled with a strong association and rock-solid scientific studies, is the quickest way to produce tangible results.

There are the likes of NJOY et al., but their agenda is different than the community agenda. A proposed discussion point is to have a single representative body carry out the hiring and management of top-tier industry lobbyists to give these guys hell for the next couple of years. Lobbying _could_ buy time while the industry strengthens, and we should see some larger corporations of sizable valuation rise up and aid in combatting harsh regulation. Secondarily, third party scientific testing will need to be performed on the behalf of the vape community, which is not a cheap endeavor either. Thirdly, campaigns need to be created to combat the smear campaigns and misinformation being run against the industry. This combo seems to be one of the only ways real progress will be made.

The issue of funding is a big one, of course. NJOY, for example, spent $340,000 last year in lobbying on the State. There will undoubtedly be the need for a good cash reserve in order to accomplish anything, and the industry is way too young to have corporate giants that will lead the pillage. I see this happening in a few different ways, ranked in order of efficacy:


*Community Donations.* If you want to fight, pony up. I'm sorry to tell you, but an email to your Congressman won't be bringing any kind of change. Money fights money.


*Fundraising Campaigns.* You see these with all major associations; the vaping industry should be no different. A proper campaign will double as a great mass-market awareness tool.


*B&M and Online Shop-Solicited Donation Requests.* Self explanatory, customer opt-in.


*A Weekly or Monthly day where a portion of nationwide purchases goes to the campaign.* A sliver of all purchases made on said day will go towards the cause. Consider this, ironically, a tax of sorts. The difference is, it will be a selective participation event and it will be paid for on the shop-end. State bodies use this method in other scenarios very successfully.

*No one else will fight for you; in life, in business, and in vaping.* Everyone has an agenda, and for a fight to be even remotely successful, this needs to be the adopted mentality. Money will continue to be the most effective way to fight money, as it historically has. The question is; how bad does the community want to preserve our industry?

http://www.reddit.com/r/electronic_...a_this_is_how_imminent_these_regulations_are/

Reactions: Winner 1


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