Why the FDA can NOT make illegal E-Cigs (false concern), Usage Bans in Public are the REAL problem

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Berylanna

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The FDA can not ban E-Cigs as a category......and E-Cig devices are not substantially change........................................I am really offended by people saying that E-Cigs have changed SUBSTANTIALLY since introduction, its a heated coil, vaporizing liquid, unfiltered. Its the same for carts, clearos, drippers. They can not ban them, or claim each is significantly different........and they can not ban the raw hardware of APVs.

The FDA has gathered payments for "substantial equivalence" changes to regular cigarettes and had until recently gone more then 3 years without approving ANY including changes in label color on the pack, slight changes in the color of the filter paper, size of the dots etc. They still have approved hardly any.

You are using Webster's definition of "substantial", we are using the FDA's definition. Needless to say I prefer Webster but hey......
 

pjmarkert

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You could be right. I know plenty of small backyard plots that still use it, and of course the neonicotinoids are extremely popular in agribiz (and are lousy for bee populations, but that's another story).

As an avid gardener, I consider nicotine insecticide too wide-spectrum to use. I don't want to wipe out the helpful insects just to get rid of a few bad ones, so I tend to target or, when absolutely necessary, use a pyrethrin.


This would only ban labeling nicotine as a pesticide.
 

Jman8

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I agree and or appreciate most said in the stuff that I snipped out. I also agree of the most reasonable concerns about what the FDA could do, the single largest would be any attempt to restrict flavors. I do see parallels to mixed drinks, people can mix drinks that taste like candy too, but they are not for children obviosuly. The ban on flavors right now is related to cigerettes only. Flavored cigars are still being sold, and they have not attempted to regulate them out as of yet. (I mean with action, not just bluster and talk)...................So lets go with a worse case scenerio, they try to ban all flavors. The work around would be that base nicotine vaping solutions would be sold, and counter parts would sell mixing flavors, for bottle sizes. The profits of mixes would be smaller and would be an impact on vendors, but it would be a full work around. Since a full work around is available, I don't think the FDA would try to do it. We have to wait to see what the FDA will do.....

I agree there is a workaround, and agree that it leaves room for hope on what is, IMO, the biggest issue.

I still think FDA may go for it as there are umpteen anti-vaping articles that all cite flavors as issue (propaganda that alleges it entices children). I think at very least FDA will address it in some fashion via requirement for labeling, and note that says added flavors make liquid questionable on safety or something in that vein.

I do wonder if flavors were say 'banned' and vaping community went route of 'no big deal, we can do a workaround' thus not really challenging it, if it could plausibly lead local governments to banning usage of flavors. Like say eCigs are generally legal, but if caught with device that has a flavor other than those approved by FDA, it would be grounds for a fine.

At any rate, I think flavors is such a huge huge issue that if it did come up, it would be fought on so many levels that workaround would only be temporary measure while challenges sort things out. Other than outright ban of eCigs (which you and I agree won't occur), I think nothing will rally the vast majority of vapers, likely most vendors and even a whole bunch of non-vapers (seeing the issue for what it is) than the flavors issue. Every other issue, I think, is something that vapers / vaping community could be a bit divided on. I wish it were otherwise, especially as it relates to usage bans / being able to vape openly in public places.
 

tombaker

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The article in question says there are hundreds of products on the shelves that are waiting for approvals. They are being sold. The categories of changes for labels and marketing is what the FDA can do with the new FSPTCA. The things which you are concerned about, the different packages, will be found to be substanial equivilance....even if you are so worried about the approval process (and hundreds waiting but on the shelves). You and others are taking the slow FDA, as a menacing FDA. Do you think the FDA is going to spend its resources on E-Cigs vs Tiny Cigars?​
The FDA has gathered payments for "substantial equivalence" changes to regular cigarettes and had until recently gone more then 3 years without approving ANY including changes in label color on the pack, slight changes in the color of the filter paper, size of the dots etc. They still have approved hardly any. You are using Webster's definition of "substantial", we are using the FDA's definition. Needless to say I prefer Webster but hey......
 

tombaker

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Well the good news is we have BLU out there who is going to fight with Johnson Creek against flavor bans. The law on the books right now only applies Flavor bans to Cigarettes.....NOT to Tabacco product.................... These are the details that CASAA and others seem to totally ignore. The FDA has a problem with Flavored Cigars right now............. They are tiny Flavored cigars which work around cigarette taxes, and are very popular in the schools. Those have all the real health risks. The FDA will focus its energy where it gets the most bang for the buck. They actually have to do work on real drugs too........................................................................ ------> The Law on Flavors applies only to Cigarettes, not cigars, not E-Cigs.
I agree there is a workaround, and agree that it leaves room for hope on what is, IMO, the biggest issue. I still think FDA may go for it as there are umpteen anti-vaping articles that all cite flavors as issue (propaganda that alleges it entices children). I think at very least FDA will address it in some fashion via requirement for labeling, and note that says added flavors make liquid questionable on safety or something in that vein. I do wonder if flavors were say 'banned' and vaping community went route of 'no big deal, we can do a workaround' thus not really challenging it, if it could plausibly lead local governments to banning usage of flavors. Like say eCigs are generally legal, but if caught with device that has a flavor other than those approved by FDA, it would be grounds for a fine. At any rate, I think flavors is such a huge huge issue that if it did come up, it would be fought on so many levels that workaround would only be temporary measure while challenges sort things out. Other than outright ban of eCigs (which you and I agree won't occur), I think nothing will rally the vast majority of vapers, likely most vendors and even a whole bunch of non-vapers (seeing the issue for what it is) than the flavors issue. Every other issue, I think, is something that vapers / vaping community could be a bit divided on. I wish it were otherwise, especially as it relates to usage bans / being able to vape openly in public places.
 

Sundodger

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Well the good news is we have BLU out there who is going to fight with Johnson Creek against flavor bans. The law on the books right now only applies Flavor bans to Cigarettes.....NOT to Tabacco product.................... These are the details that CASAA and others seem to totally ignore. The FDA has a problem with Flavored Cigars right now............. They are tiny Flavored cigars which work around cigarette taxes, and are very popular in the schools. Those have all the real health risks. The FDA will focus its energy where it gets the most bang for the buck. They actually have to do work on real drugs too........................................................................ ------> The Law on Flavors applies only to Cigarettes, not cigars, not E-Cigs.

That's good NEWS? Blu=BT ya know. OK, now I get it. UFO's are real and that government entity call the Air Force doesn't exist. Cool.
 

DC2

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Last edited:

tombaker

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We do not know what regulations FDA will settle upon; that is true. You are still heavily overstating the limitations built into law, though. More on this after the following quotes:

------> The FDA is a group of Scientists and Doctors, and there are Bureaucrats in their, along with partisans. The FDA is not looking to screw around with people. The attacks on Smokers of Analogs, have been city councils and States, and Mayors like Bloomberg. Besides treating Smokers like leapers, the politicians tax the heck out of it. Not the FDA.

The FDA did need to take a look at E-Juice when it did, it found out that a minority of producers were putting crap into the Juice, an the public in general thinks of Chinese Juice as not worth the risk, a boom for USA producers to this day. But they went to far, and the Judge smashed back at them.

When I have said the Tobacco Act in all past posts, I am refering to the 2009 FSPTCA Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This is the mechanism that the FDA will do, or at this rate Punt the ball, for all things E-Cigs. The FDA has said they agree to this, and the will not challenge the Major court case they lost. Those are done deals.

CASAA and others are in a frenic frenzy about all of the gross and horrendous things the FDA can do under FSPTCA. Much of what is being offered out, is not based in the law. The FSPTCA has specific limitations. And the Defacto Ban fear is based on wild conjecture, wait, its being offered out as facts of what the FDA is doing, and about to do.

Mean while the FDA has done none of this, and missed deadline after deadline. And besides reading local papers with wrong information on E-Cigs, the FDA is working with Doctors, and some of those Doctors are on the boards of the big E-Cig companies like BLU and V2. Most doctors agree that E-Cigs are greatly more safe than analogs. If you think the FDA is not listening to those Doctors and PhDs you are just wrong. It is wrong to consider the FDA as a menace. Most of the FSPTCA as it implies by the word Family, is aimed at Children, Marketing to Children, and making claims about smokeless Tobacco. Most importantly where the FUD from the CASAA misses the mark is its offering as Fact that the FDA can ban E-Cigs. This is purely false, as the FSPTCA explicitly state they can not. To have E-Cigs controlled by the FSPTCA, the FDA has now accepted as their premise that E-Cigs are a Tabacco product, and have formally given up on attempting to control them as any other means, unless they are being offered up as a Cessation device. All E-Cig OEM, and distributors better not claim or market them as such.

The inspections of facility that is being called out in the FSPTCA is for an inspection every 2 years. But the claims by some, is they are going to go nuts. FUD.

Here is one example of what is being profered out as just the FACTS.....A post is titled "FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs" This is a horribly wrong statement, its misleading, and its nothing more than an amatuerish analysis of law and the regulatory process. It has been deemed by the FDA, as supported by the court, that the FDA can use the FSPTCA on E-Cigs. The regulations are not written, and its not reasonable to suggest and yell FIRE, that this means all E-Cigs will be banned.

Want to read it its 3 pages. http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf Notices is bound in the directory of marketing and Advertising, that under labeling in the URL? Substantially Equivalent will be judge on 1. If it was for sale before Feb 15 2007, not the actual item, but one like it, by anyone.
2. If it is a different design, LIKE a filter, or other mechanical changes which result in a substantially different product.
3. If its a new Tobacco type.
4. New chemicals used in processing or in the item.
5. New BURN propeties. Specifially combustion.
6. New nicotine doping of the tobacco for high release cigerettes.
7. Flavoring of chewing tobacco
On all of these the E-Cig passes as not substainly different. This is under the law, and so much different than CASAA assessment. The E-Cig with Flavors was on the Market before 2007, it has not substantially changed. Sorry folks a clearomizer is no different than a cart, in function. Its basically the same....electric coil, against fluid, user created vacumm, = Vapor. The end.

So boil it down. Some people may want to write up a basic application, fill out the forms, and it will wait a long time, and eventually the FDA will ruberstamp it. Because once the first one flys, they all Fly. Get i? If BLU gets through, the door is open. Period.

So when Godshall writing a post subject line, or anyone else proclaims that he has proof that the FDA is gonna deem a ban on all E-Cigs its really wrong, and needless causing a panic. Again please understand that the LAW itself, which is all the FDA can use, says the can not do what Godshall posted. They can not ban a specific tobacco product....really....hello?....seriously they can not do it....stop saying it.....hello? So the subject is wrong. "FDA issues Brief Summary of “Not Substantially Equivalent” Determinations that delineates why deeming reg would ban all e-cigs " its just wrong. You think BLU is in a panic? You think they are betting millions of dollars on what Godshall posts as "fact".

There it is.....I will respond to the rest in another post. But when I say the CASAA is spreading FUD, where the laws and the products do not fall into this risk they present, I mean it. Group Think is what it is, it happens all the time.
 

DC2

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I don't see how you can read this and come to the conclusions you are coming to...
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM366584.pdf

Brief Summary of “Not Substantially Equivalent” Determinations

FDA may find a new tobacco product to be NSE either because there is inadequate
information submitted, or because FDA finds that the new product has different
characteristics and information demonstrates that it raises different questions of public
health.

Tobacco products have been found to be not substantially equivalent to specific
predicate products due to factors such as inadequate evidence that the proposed
predicate products were valid predicates and lack of complete information on the
characteristics of the new products and the predicate products. After considering all the
evidence, the agency determined that there were differences in characteristics between
the new products and the predicate products, and there was not an adequate showing
that the new products do not raise different questions of public health requiring a
premarket tobacco product application.

The types of deficiencies FDA found in one or more of these are summarized below.

• Predicate

Insufficient information for FDA to determine whether or not the tobacco product
that was referenced as a predicate was predicate-eligible. Specifically, adequate
evidence was not provided to demonstrate that the predicate product was
commercially marketed in the United States as of February 15, 2007.

• Design Features

Inadequate information on design features such as ventilation and filter
efficiency. This information is needed to understand if any changes in these
characteristics are present and, if they are, whether the new product raises
different questions of public health.

• Tobacco Type

Inadequate information on the type of tobacco used in the cigarette. This is a
significant deficiency because the type of tobacco can alter the levels of harmful
and potentially harmful constituents. This information is needed to understand if
any changes in these characteristics are present and, if they are, whether the
new product raises different questions of public health.

• Added Toxicants

Where information was provided about the levels of specific ingredients showing
they were present at higher levels than in the predicate product, there was not
adequate evidence that the changes did not result in the new product not raising
different questions of public health. Moreover, some of these ingredients have
been shown scientifically to cause both toxicological and dependence concerns.
For example, some of these ingredients are listed in the Hazardous Substances
Data Bank and have known toxicities.

• Harmful and Potentially Harmful Constituents

Inadequate information regarding “Harmful and Potentially Harmful Constituents”
(HPHCs) in new and/or predicate tobacco products and tobacco smoke. Lacking
this information, FDA was not able to determine whether the new product raised
different questions of public health.

• Change in Burn Properties

Inadequate information regarding changes in additives that could change the
burning properties of a cigarette. Lacking adequate evidence, FDA was not able
to determine whether the new product raised different questions of public health.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Increase in Free Nicotine

Inadequate information regarding the effect of increased free nicotine
(unprotonated nicotine) in smokeless tobacco products on initiation and
cessation. An increase in free nicotine may lead to a higher rate and amount of
nicotine absorbed in the body. An increase in free nicotine may cause the new
product to raise different questions of public health because initiation may
increase and/or cessation may decrease.

• New Characterizing Flavor

Inadequate information regarding the effect of a new characterizing flavor in
smokeless tobacco products on product initiation and cessation. Addition of a
new characterizing flavor may cause the new product to raise different questions
of public health because initiation may increase and/or cessation may decrease.

• Differences in Tobacco Blend

There were significant differences in the tobacco blends between the predicate
and new tobacco products. Tobacco blend differences can result in different
levels of harmful and potentially harmful constituents.

• Health Information Summary

Submitted health information summary does not comply with section 910(a)(4) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Therefore, a marketing
order cannot be issued for the new tobacco product.
 

tombaker

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---------> Sorry the theory that an EGO battery, or a dual coil clearomizer is different than a small battery, and a poly filled cartomizer is just wrong. Its a convenient theory I suppose, but it ignore that the hardware itself, no juice, can be sold, all day long, and nobody can stop raw hardware of APV. So hint away but you are asking people to be fearful on the premise that the FDA can go after a Provari....do you hear how that sound when I say it back now. A battery is not going to be banned by the FDA.

Okay Okay I will buy into it for a second. I will make a Ego style flashlight bulb, that screws onto a Provari, tada, its a flashlight with interchangeable bulbs.....do you honestly think they can stop a Provari. This is the foundation of the FUD. Up to arms folks, they are coming after our batteries!!!!!!!

Okay so you think I am foolish? Listen to what you just said----------> "At best, we could be stuck with the very primitive models...."

AT BEST, this is of the universe of possible outcomes, what you are saying is the BEST that could happen. Dang the silliness of it is manifest.


All I can add to what Kristin, Fulgurant, and DC2 have already said is this.

Read the Family Smoking Prevention and Tobacco Control Act (aka Tobacco Control Act) in its entirety before you proclaim what the FDA can and cannot do. https://www.govtrack.us/congress/bills/111/hr1256/text

Do a search for "2007" and you will learn why Bill Godshall believes that a regulation that deems e-cigarettes to be a tobacco product could eliminate many of the more advanced products from the market. [Here's a little hint. Back in 2007 there was no such thing as an eGo, a Provari, a Chuck, or even a Joye 510. At best, we could be stuck with the very primitive models that didn't deliver nicotine very effectively. At worst, the FDA can say that there were NO models being sold in 2007, which would be a de facto ban.]

Of course that could only happen if the FDA decided to apply every last paragraph of the Tobacco Control Act to e-cigarettes. Remember that the Tobacco Control Act was designed with an objective of preventing any new combustible cigarettes from coming on to the market and of lowering the amount of nicotine in the existing products to make them "less addictive" (i.e., less appealing to consumers.)

----> Sorry that is factually wrong, if you read it, that is not the intent, and it specificly prohibits it. It angled at preventing kids from starting smoking, preventing marketing to Families (read as Kids), limiting tricks used to dope up the nicotine. Frankly what you just said is a wild conspiracy theory, unfounded in the letter of the law, a law which specifically says they can not ban Tobacco products. A judge will not allow the FDA to go outside of the law, which is why your characterization of it, does not provide the dangers that are being presented.....as fact, best case Facts.

Now, consider the text of the deeming regulation. The text is here View Rule

A little background. When a federal agency wants to issue a regulation, it has to fill out a form that asks the agency to justify the need for the regulation. The form is submitted to the Office of Management and Budget. It might be easier for you to look at this extraction. All the black text is boiler plate text from the form itself--it's actually directions on what should be entered in this area of the form. The only text written by the FDA is what's shown in red. http://www.e-cigarette-forum.com/fo...formation-december-agenda-2.html#post11417686

In other words, these products will need to go through everything we make cigarettes go through, so we can be consistent. And it is really, really needed because people are gravitating away from those old products to these new ones. (There's an implication that the old and the new are equally hazardous--else why would the same controls be necessary for both?)

No, not in other words at all. Your other words are just selective attempts and reading between the lines....and guess what, the courts rule on the letter of the law, not the white space that people seem to express great clarivoiance on. The citations above are saying that the FDA deems E-Cigs to be within their domain, and will with all the other items, use the FSPTCA. They already said this when they responded to the previous court case....They said the would not challenge it, and instead use the FSPTCA for anything E-Cig. You still miss the fact they can not ban Tobacco products.....instead you point to opinions using a guess, and that guess is presented as some sort of impending BAN ON E-CIGS. Its a gather snowball of garbage in garbage out. Again, the hardware of APV can not be prohibited. And the FSPTCA can not ban E-Cigs. Sorry....wait....I mean Hooray.

I find it alarming that the FDA apparently sees our movement away from cancer sticks to the "proposed deemed products" as a problem that it is particularly necessary for the FDA to address in order to stop the tobacco epidemic.

Look I think your fear and alarm are not reality based....the FSPTCA is directly aimed at youth....it says it over and over.....its not a case of first they stop children, next the come for us! Nobody under 18 should be using E-Cigs. Every Vendor agrees. The FSPTCA is not going to come down and pull E-Cigs out of teenagers hands, it can't but it want to stop selling to kids, like was done perviously by Tobacco. See it here, fear it not so much Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

Basically, the deeming regulation as worded here gives the FDA a blank check to apply any of the powers that are mentioned in the Tobacco Control Act to the new products. Why bring up such things as "appeal to youth and young adults" if the FDA was not seriously considering stretching the applicability of Section 907 (A)(1)(a) to the newly deemed products? Nothing in the Tobacco Control Act would prevent the FDA from setting a top nicotine concentration in cartridges so low that only a tiny fraction of smokers would find them an acceptable substitute for combustible cigarettes.

Your fears are not founded in the law, the definition of Deeming Regulation, and by the simple fact that Doctors in the FDA are not stupid, they want real Cigarettes out of the hands of kids, because the FDA now includes E-Cigs in the large group of products DOESN"T mean everything will be treated the same.....there is nothing even suggesting the persecution being offered as fact.
 

Jman8

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The FDA is a group of Scientists and Doctors, and there are Bureaucrats in their, along with partisans. The FDA is not looking to screw around with people. The attacks on Smokers of Analogs, have been city councils and States, and Mayors like Bloomberg. Besides treating Smokers like leapers, the politicians tax the heck out of it. Not the FDA.

Again, bold emphasis mine after unbolding all that you wrote.

I think you possibly lost your target audience with that bolded part. Akin to me going to another site, let's say the Tea Party forum, and claiming "Obama is not looking to screw around with people." And then following that up with a 1000 word essay in an attempt to support my position that 'they' are all overreacting.

Everyone has their unique take on the FDA and eCig issue, and mine is that the FDA could show up as friend of eCigs whereby we are living in a world that amounts to eCigs being FDA approved. I'm thinking almost all vapers that care about politics of eCigs would celebrate this, and think it is a wonderful thing that they finally came around.

Yet, because of FSPTCA and what that allows for (complete manipulation of tobacco industry), it is challenging to see how FDA isn't screwing around with people. I think there is portion of vapers/vaping community that takes no issue with screwing with traditional cigarettes and sees it only as item of, don't mess with eCigs. Screw BT, but don't mess with my eCig dag nabbit. IMO, those people are misguided and is huge part of reason why we are where we, the vaping community, are today. Win on the tobacco control issue, and you win on the eCig issue. Throw one item (easily the biggest item) under the bus, and prepare for the antis to eventually do the same to all the little items. People need their boogeyman and once BT is seen as slain, then BV (big vapor) will be next on the chopping block.

The FDA did need to take a look at E-Juice when it did, it found out that a minority of producers were putting crap into the Juice, an the public in general thinks of Chinese Juice as not worth the risk, a boom for USA producers to this day. But they went to far, and the Judge smashed back at them.

Hence, you acknowledge they have ability to screw with people, and with eCig industry.

When I have said the Tobacco Act in all past posts, I am refering to the 2009 FSPTCA Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This is the mechanism that the FDA will do, or at this rate Punt the ball, for all things E-Cigs. The FDA has said they agree to this, and the will not challenge the Major court case they lost. Those are done deals.

Correct, and I honestly believe that every vaper who sees you as making a molehill out of a mountain wishes you were 100% correct in your logic. Yet, new deals and new attitudes toward eCigs are being formed all the time. New scientific studies coming out and new organizations forming just based entirely on eCig industry. Both for and against that industry. So, here at end of 2013, the 2009 Act is perhaps most relevant. Yet, it is entirely plausible a new Act will come about some point in the future and be looked at the same way we all look at tobacco legislation from the 1950's (read as outdated). And because the world / information exchange works exponentially faster than it did just 15 years ago, I don't think it'll be another 50 years when the new Act is written. More like 3 to 10 years. In the meantime, those who could pass policies anywhere in the US are bound by FSPTCA, and are taking their lead, or sense of authority from whatever that act says both implicitly and explicitly.

Political vapers are arguing / debating and making calls to action based on what it says implicitly. And that language does, implicitly, screw with people and their behaviors.

the Defacto Ban fear is based on wild conjecture, wait, its being offered out as facts of what the FDA is doing, and about to do.

Based on conjecture? Yes. Wild is your unique take on it. But not yours alone. Some of the time, I agree with your view on this, but other times, I do not. When I do not, I am constantly hoping cooler heads will prevail. Yet, some to most of those same heads seem to have no issue manipulating the heck out of BT and screwing with them. That saddens me, as I feel it is misguided.

Most importantly where the FUD from the CASAA misses the mark is its offering as Fact that the FDA can ban E-Cigs. This is purely false, as the FSPTCA explicitly state they can not. To have E-Cigs controlled by the FSPTCA, the FDA has now accepted as their premise that E-Cigs are a Tabacco product, and have formally given up on attempting to control them as any other means, unless they are being offered up as a Cessation device. All E-Cig OEM, and distributors better not claim or market them as such.

And here we agree.

Yet, the counter argument is that FDA will change whatever this golden era is, into whatever is the BT industry today (or tomorrow). Seen optimistically, that means profit can still be made, product is still sold, and people are still discovering / enjoying the wonders of vaping. Seen pessimistically, it means flavors are gone, legal devices are limited, no more online purchases, and usage bans are in full force. I would add, from my own unique take, that it also means shaming eCig users is seen by vast majority as perfectly okay, for shaming (as the story goes) will help your addicted friend/relative see the light and question their dangerous, dirty habit. If we look at how shameful smoking has become, I do believe we aren't too far away from witnessing to similar shaming among vapers, possibly even from fellow vapers (as I can find that right here on ECF).

Here is one example of what is being profered out as just the FACTS.....A post is titled "FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs" This is a horribly wrong statement, its misleading, and its nothing more than an amatuerish analysis of law and the regulatory process. It has been deemed by the FDA, as supported by the court, that the FDA can use the FSPTCA on E-Cigs. The regulations are not written, and its not reasonable to suggest and yell FIRE, that this means all E-Cigs will be banned.

Again, we agree.

There it is.....I will respond to the rest in another post. But when I say the CASAA is spreading FUD, where the laws and the products do not fall into this risk they present, I mean it. Group Think is what it is, it happens all the time.

But is happening on all sides of the issue from arguably all organizations, including FDA, as witnessed by their approach to tackling the BT perceived problem.

What I think would be interesting is if you were put in charge of CASAA and how would you choose to govern the organization. Perhaps not solely in charge, but say as member of the Board. After sharing your diatribe (some of which I definitely agree with) and getting that rant on the table, how would you move an organization such as CASAA forward? And if you'd really rather not answer that because it is CASAA, then pick another group or make up one that deals with the real issue you cited of usage bans. And I truly mean this when I say this, good luck! I'd love to see language you use and words you put together that helps give hope to the vaping community, for how we can win on that rather significant issue. Especially taking into account the idea that there are anti-vapers roaming this planet.
 

Apptiger

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Interesting thread. I love a good debate. Don't have time to read it all closely right now but when did the lawmakers and regulators in DC ever pay attention to all the rules, laws and the constitution? Not to get political but Washington in general has been ignoring it for years and it is getting worse, faster.
Having said that the biggest thing to watch is the money. Government taxes things into oblivion and then has to move somewhere else for more tax money. So far that hasn't worked for tobacco taxes. In 2002 the taxes collected on tob was just over 9 billion in 2011 it was over 17.2 billion. More and more and more. Less people using tob but the money still increasing, hmmm.
Thinking it will break soon and they are afraid vaping will be a part of breaking it.
They want to tax it and control it like a tob so they can keep the money flowing. I expect no ban but far more regulation so they can control it, and tax the snot out of it.
 

Sundodger

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Sep 22, 2013
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---------> Sorry the theory that an EGO battery, or a dual coil clearomizer is different than a small battery, and a poly filled cartomizer is just wrong. Its a convenient theory I suppose, but it ignore that the hardware itself, no juice, can be sold, all day long, and nobody can stop raw hardware of APV. So hint away but you are asking people to be fearful on the premise that the FDA can go after a Provari....do you hear how that sound when I say it back now. A battery is not going to be banned by the FDA.

Tell that to some of the rolling paper manufacturers, they had to pull products off the market and are now limited as to what they can sell without the blessings from on high.

Please, pay attention to history and learn from it. If you (we) don't, we will repeat the same mistakes.
 

kristin

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Well the good news is we have BLU out there who is going to fight with Johnson Creek against flavor bans. The law on the books right now only applies Flavor bans to Cigarettes.....NOT to Tabacco product.................... These are the details that CASAA and others seem to totally ignore. The FDA has a problem with Flavored Cigars right now............. They are tiny Flavored cigars which work around cigarette taxes, and are very popular in the schools. Those have all the real health risks. The FDA will focus its energy where it gets the most bang for the buck. They actually have to do work on real drugs too........................................................................ ------> The Law on Flavors applies only to Cigarettes, not cigars, not E-Cigs.

You keep quoting the current regulations and completely ignore the fact that the FDA has power under FSPTCA to create NEW regulations as it sees fit on NEW tobacco products. The FDA is defining e-cigarettes as new tobacco products. It will not be limited to regulating e-cigarettes under regulations for cigarettes or other established tobacco products.

The FDA considers changing the color of the stripe on the wrapper of a cigarette something that needs FDA approval and scientific evidence from the tobacco company that the color change will not pose increased risk to the public. Considering this fact, all of the changes to e-cigarettes since 2007 would be HUGE. Do you know what was actually ON THE MARKET IN THE U.S. as far as e-cigarettes in 2007? When I started vaping in 2009, it was still mostly 3-piece devices with pre-filled cartridges, very limited flavors and "high" nicotine was 24 mg.

But regardless of whether or not the FDA decides to use the substantial equivalence part of the law, the FDA can still create a whole set of requirements for selling e-cigarette liquid under its power of deeming regulation and that includes limiting what flavors it wants to legally allow. The flavor law regarding cigarettes has nothing to do with what the FDA can deem for e-cigarettes. FSPTCA allows the FDA to make up new regulations for e-cigarettes. I don't know how much clearer I can make that.

Why do we believe that the FDA won't base these regulations on fair policies and scientific fact? Consider the history of the FDA regarding e-cigarettes:
  • The FDA started confiscating e-cigarettes through US Customs and declared e-cigarettes couldn't be sold in the U.S. because they were unapproved drugs.
  • When the FDA was sued by two companies, it tested the products JUST from those two companies and then issued a misleading and scare-mongering statement that it found "carcinogens" and a chemical found in "toxic anti-freeze." It neglected to mention that the levels found were thought to be harmless. The agency clearly sought to sway public opinion to support the FDA's position that e-cigarettes needed to be removed from the market until they got FDA approval.
  • Even after the FDA's deception was exposed, it refused to remove the slanderous claims from its web site.
  • The FDA sought "advice" regarding e-cigarettes only from known anti-tobacco and anti-e-cigarette "experts."
  • The FDA accepted that it couldn't ban e-cigarettes as unapproved drugs, because of the court ruling, but clearly saw it could still regulate them under FSPTCA as new tobacco products. Because the FDA can basically write its own rules and regulations for these new tobacco products under FSPTCA, it can require all e-cigarette products to be approved as new tobacco products under its still-to-be-established standards and effectively prohibit all e-cigarette liquids from being sold in the US until they gain FDA pre-market approval as new tobacco products.
  • The FDA has shown NO signs that it suddenly sees e-cigarettes as a good product or any different than any other tobacco product. So, there is no reason to believe that it will treat e-cigarette liquid with a lighter touch than it does other tobacco products. All signs point to an agency that wants to see all e-cigarettes off the market until they have been given market approval by the FDA under the FDAs new regulations for e-cigarettes.

Yes, the FDA may choose rational thinking and scientific evidence on which to base its e-cigarette regulations, but so far it has not given us ANY reason to believe that the agency doesn't still want all e-cigarettes off the market until they get FDA approval. And regardless of substantial equivalency or current regulations pertaining to non e-cigarette products, the FDA will absolutely try to require pre-market approval for e-cigarettes - as it is currently requiring of ALL new tobacco products, no matter how small the changes - and very few products on the market today will be able to be "grandfathered" in and stay on the market. All we can fight for is that gaining pre-market approval isn't made so difficult that 99% of the products currently on the market cannot afford or achieve the pre-market approval.
 
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tombaker

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Oct 21, 2013
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Tell that to some of the rolling paper manufacturers, they had to pull products off the market and are now limited as to what they can sell without the blessings from on high.
I believe you are talking about flavored rolling papers. Which is listed as "roll your own" cigarettes....where cigarettes specifically are listed as having flavors prohibited. The law specifically went after these. Within the letter of the law.

None of this is written within the law for E-Cigs for flavors, there was on Cigarettes and roll your owns of Analogs. As far as flavors you can be sure the big boys like V2cigs will have lawyers at the ready if they do try something. Most of what I am talking about is what can be done under the law. The law that went into effect in 2009. 4 years later nothing has been done or proposed to be done on flavors of juice.....they acted on what was within the law on papers...immediately.

Since the true and supportable medical data shows E-Cig safety, and it is going to define as a Tobacco Product by the FDA, the FDA has accepted that the law says they are a legal product, which can not be banned. I simply believe the FDA is going to be considering real science in their actions.

The problem as I state in the thread topic, is local cities and States, are going to be at the whims of local officals, and they can push out regulation on Usage that will have immediate effects. If it were not for so many assertions that the FDA is gonna ban E-Cigs, which is blatantly false, it would not even be a topic. The FDA can not control or ban, tanks or batteries, its not within the law, and the FDA already concedes that E-Cigs are a legal product.
 

tombaker

Moved On
Oct 21, 2013
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...........All we can fight for is that gaining pre-market approval isn't made so difficult that 99% of the products currently on the market cannot afford or achieve the pre-market approval.
Kristin, I earnestly appreciate you taking the time to reply. You are legally wrong on many items beyond the last line I quoted above.

Just in your last line, your legal misconceptions are typified. You want to get pre-market approval for products that are already on the market. You already agree that hundreds of the leaf-based tobacco products are being sold, as they wait for FDA approval of the filed forms. Being sold today. Now you want to suggest the E-Cigs would be different. Such needless Fear, Uncertainty and Doubt FUD, built from bad information then extrapolated to mind-numbing pontifications of Doom™.

All juices are going to be substantially the same as every on juice on the market. Fill out the form, list your 4 ingredients....and they are in fact exactly equivalent, you are good to go. The FDA knows that.....how on earth can you claim otherwise????? Fees will be done by market share. Some of these small shops will have fees based on 0.0025 % of the market. V2Cigs will be doing the heavy lifting on fees. ----->Its in the deeming reg proposals, nobody is reading. You realize there is absolutely no TAX provisions with the Family Smoking Prevention and Tobacco Control Act....NONE

I will respond in detail to your full text, when time permits.

May I ask you for the name of the CASAA contact point person within the FDA, you can send their name in a PM if you want. If CASAA does not have a contact person within the FDA, then that would be very telling on how so many of the items being proffered are so wrong by the law.

E-Cigs are a legal product, as of yet unregulated, and the law cannot ban them, and specifically prohibits them from being banned.
 

Berylanna

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Kristin, I earnestly appreciate you taking the time to reply. You are legally wrong on many items beyond the last line I quoted above.

May I ask you for the name of the CASAA contact point person within the FDA, you can send their name in a PM if you want. If CASAA does not have a contact person within the FDA, then that would be very telling on how so many of the items being proffered are so wrong by the law.

E-Cigs are a legal product, as of yet unregulated, and the law cannot ban them, and specifically prohibits them from being banned.

A contact within the FDA would be in no better position to comment definitively on the law, which is a SEPARATE issue from what the FDA could try to do, than the lawyers already in CASAA. Both sides have lawyers, lawyers disagree routinely....in front of judges, for heaven's sake!

Until the FDA makes PUBLIC statements different from Zeller's, we vapers and CASAA members are in the dark and will fight on both fronts. Has it occurred to some vapers that the delays from the FDA are deliberate in order to give RWJF et al time to get the cities and states to do the dirty work for BP and BT? Yes. Has it occurred to me that the reason that OMB appeared to be so bored with Bill Godshall's visit was that OMB has told the FDA they may not ban refillables? Yes, but that is not the same as a statement or regulation getting published. Has it occurred to vapers that the House and Senate could bow to BP and change the law to make things worse for us, or signal the FDA that pre-market approval would be allowed under existing law, since so many cigarette taxes are at stake? Yes.

Meanwhile, Bill Godshall and other CASAA members are also in the forefront of the fight in the states, counties and cities.

CASAA is not saying the FDA *will* *do* things damaging to us, they are saying the FDA *could* and has not said, publicly and officially, (or even publicly and unofficially!) that they will not. And, as is proper, the FDA is not saying privately either, in their "listening sessions."

If the title of your thread should have been "Insider says the FDA will play nice, worry about Cities/States!" then your argument about the correctness of your thread title might be valid. But even then your attacks on CASAA leaders would not be.
 
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