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

[Sundodger]

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.

Some had flavors but more importantly they had colors when flavored. I used them between construction jobs for making pretty little origami figures. See those papers had different uses for different people. Not the intent of what the FDA saw. They took away my lively hood when I was laid off. No I do not trust them to do the right thing.

 

[kristin]

Tom, you misunderstand what pre-market approval means. E-cigs, while not ILLEGAL, are not legally recognized by the FDA as tobacco or nicotine products. The FDA has caused many such products to be removed from the market in the past. Consider nicotine water and pops, that were being sold and now aren't. Just because something is currently not illegal (which is not the same as legal), it doesn't mean that the FDA cannot apply new regulations to it. The FDA does not care that a product has been on the market already for 6 years or 20 years. (Unless it was commercially marketed before February 2007 in IT'S EXACT FORM and the FDA approves it as "grandfathered.") It can still say, "Under FSPTCA, the FDA has decided that these products must now get pre-market approval from the FDA before they can be legally sold to the public. Any company with this product currently on the market, that does not already have FDA pre-market approval, must immediately stop selling that product until it gets such approval." Is that a "ban?" No. Would it still effectively stop the legal sale of e-cigarette nicotine liquids in the US for several years - until some company manages to get FDA approval? Yes.

I'm sorry, but you clearly have absolutely no idea what has been going on with the FDA's regulation of tobacco, what is required to have pre-market approval, how nitpicky the FDA has been over the most tiny changes (can you tell us the differences in the health risks of inhaling strawberry e-liquid made from Lorann flavorings vs. watermelon from Flavor Art?), nor do you seem to understand the scope of the FDA's power to deem regulations on e-cigarettes once it legally recognizes them as unapproved new tobacco products. The point is, regardless of how long they have been sold in the US, the FDA still will regard every product as unapproved NEW products and can require companies to stop selling them until they go through whatever approval process the FDA creates. (The same is true for other new tobacco products that have been on the market for several years without regulation, such as tobacco lozenges, strips and sticks.)

I agree the FDA will have no power over devices unless the device is sold containing nicotine liquid. However, the FDA will have all nicotine liquids under its power and devices are pretty pointless if no one can legally sell the nicotine liquid.

You are the one who is legally wrong on so many points, not CASAA and numerous THR experts - all who are familiar with the FSPTCA, have been meeting with the FDA advisory panels, were involved in the Sottera vs. FDA lawsuit and have been following and analyzing this situation for over 4 years now.

Regarding the other part of your thread title - state and local bans - most are waiting to see what the FDA does before passing their own laws and taxes. Once the FDA officially deems e-liquid and devices sold containing e-liquid to be tobacco products and if it fails to distinguish the product as low risk and not a threat to public health (as we suspect will happen), those States and localities holding off for now will see an open door to bans and sin taxes. So, what the FDA does has HUGE implications for the state and local actions. (State and local actions against which CASAA has largely been leading the fight and creating many tools for others to do the same - something you don't seem to want to acknowledge.)

 

[Sundodger]

Tom, are you a lobbyist, pro or con to this subject? If you are I'll remind you of this:

Section 6 of the Lobbying Disclosure Act (LDA), 2 U.S.C. § 1605, provides that: The Secretary of the Senate and the Clerk of the House of Representatives shall "provide guidance and assistance on the registration and reporting requirements of this Act and develop common standards, rules and procedures for compliance with this Act"

That Act says no matter where or what you are doing, if it involves what your are a lobbyist for you have to identify yourself as a lobbyist to those involved.

In other words, even on an internet forum you are required to inform us that you are a lobbyist if you are posting information about the subject that you lobby for.

In a previous post you said you were concerned only with what was going on in the U.S. so this would apply.

 

[kristin]

Section 201(rr) of the FD&C Act defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” (21 U.S.C. 321(rr)). Section 910 of the FD&C Act sets out premarket requirements for new tobacco products (21 U.S.C. 387j). The term “new tobacco product” is defined as “(1) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007” (section 910(a)(1) of the FD&C Act, 21 U.S.C. 387j(a)(1)). Establishing that a Tobacco Product was Commercially Marketed in the United States as of Feb 15, 2007

This means a product is considered "new" unless it was actively being sold in its same exact form before February 15, 2007. ANY modification creates a "new" product. So, if a company was selling tobacco-flavored, 6 mg, 12 mg and 18 mg liquid on February 14, 2007, those products would be grandfathered. If it started selling 24 mg watermelon flavor on February 16, 2007 that product would not be grandfathered. The company would have to stop selling that product and submit an application for FDA approval to start selling it again. If another company was also selling tobacco-flavored 6 mg, 12 mg and 18 mg liquids but didn't start marketing them until March 2007, it would still be considered "new" but could apply to the FDA as being substantially equivalent to the stuff sold by company #1 that was grandfathered. However, the FDA could still require company #2 to prove its tobacco flavoring from FlavorArt (instead of company #1's Lorann tobacco flavor) and using a 60/40 PG/VG ratio (instead of company #1's 80/20 ratio) is also substantially equivalent. The FDA may require the company to submit lab tests and population-level studies to prove this. If you are familiar with what the FDA requires to prove a product to be a lower-risk product, you know that the FDA requiring outrageously impossible evidence is already happening and not unusual. The FDA is already creating huge barriers for approval for many products, so this is not FUD.

 

[Jay-dub]

This place... when challenged it so often devolves into accusations of subterfuge. An organization and culture so hell bent on attacking that which can promote it's own growth (free thought). I can make a thread of threads linking to how many times a challenging line of questions only raises the ire of the old hounds. There's an underlying current of religious fervor. Kind of why I'm uncomfortable calling people ANTz. I'm a member of a culture that denounces a group for being zealots while they repeatedly show me their willingness to be zealots. I hope for improvement.

To be fair I should say that I realize this community is also influenced by culture at large. We have 24hr news-cycles on networks who are really trying to sell ad space so everything is sensationalized. That's had an effect on all media. We notice when things go wrong but not so much when things go as they should. We notice when people do wrong but not so much when they do as they should or do right unless it's dramatic enough for airwaves. The primary process in most states is relegated to the extremists to decide who the general public will vote for so there's reasonable distrust of our leadership. But I highly doubt this community, or CASAA for that matter, could deny the presence (small or great) of alarmists.

 

[Sundodger]

This place... when challenged it so often devolves into accusations of subterfuge. An organization and culture so hell bent on attacking that which can promote it's own growth (free thought). I can make a thread of threads linking to how many times a challenging line of questions only raises the ire of the old hounds.

While I'd agree in some other threads there has been questioning. The OP's statements where outright allegations and attacks against CASAA and Bill. Had he came here and QUESTIONED what they were doing instead of attacking from the start he might have more credibility in his stance.

And yes, after 57 free rides around the Sun I guess I'm an "old hound" and proud of it. My stance on things today are much different than they were 10, 20, even 30 years ago, we all learn with experience, well, at least some of us do.

 

[kristin]

This place... when challenged it so often devolves into accusations of subterfuge. An organization and culture so hell bent on attacking that which can promote it's own growth (free thought). I can make a thread of threads linking to how many times a challenging line of questions only raises the ire of the old hounds. There's an underlying current of religious fervor. Kind of why I'm uncomfortable calling people ANTz. I'm a member of a culture that denounces a group for being zealots while they repeatedly show me their willingness to be zealots. I hope for improvement.

ECF isn't an "organization." Its a discussion forum. If you are saying that CASAA (as an organization or through statements made by official spokespersons) endorses or participates in making such accusations, I would have to disagree with you. I cringe with you when I see such accusations, but I cannot dismiss the possibility. We have seen the instruction manuals given to antis that specifically encourage and endorse joining smoking groups and forums to create division and doubt - or as Tom calls it, FUD. (Although I do believe it is ignorance and misunderstanding 99.9% of the time rather than subterfuge, so I dislike the accusasions being made publicly.)

An ANTZ is what it is. Unfortunately, I do see the term very often misused to mean anyone who is an "anti" and that is not what it means. Being anti-smoking but not anti-smoker or anti-nicotine does not make one an ANTZ. Bill Godshall and Dr. Michael Siegel, both champions of vaping, are "antis" in their own way but are certainly not ANTZ. (Bill supports smoking bans and other tobacco control policies, which some consider anti-smoker, and Dr. Siegel is anti-tobacco). There are many anti-tobacco and anti-smoker (some even anti-nicotine) vapers but they aren't ANTZ, either. To be an ANTZ, one must be anti-nicotine AND anti-tobacco in all forms and beyond reason. "Antis" can have their minds changed and may listen to reason. I created the acronym to distinguish the "antis" from the ANTZ.

Stanton Glantz, Ellen Hahn, Prut Talbot, Linda Rosenthal - they are all willing to lie and cheat to further their anti-tobacco, anti-nicotine, anti-smoker/Vaper agenda and don't care how many die as a result. THOSE are ANTZ. There is a huge difference between their zealotry and the passionate supporters of e-cigarettes, some of whom may sometimes be overzealous in their fight. Zealotry that causes pain and suffering to those you claim to protect and sometimes being defensively overzealous about something you believe is saving your life are hardly comparable?

 

[Jman8]

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.

IMO, all that we discuss stems from this. Whenever I review the history, especially in the legal document that is result of Soterra judgment it comes down to a) defendants gaining victory over FDA through b) having eCigs designated as a tobacco product and not a drug-delivery device.

And it seems to me, though I don't know for sure, that vapers at that time were pleased as punch to have won a very significant legal challenge on right to use these devices. That they accepted the ruling and were okay with idea that going forward these would be deemed tobacco products.

Flash forward to 2010 and for sure in 2013, and most every vaper thinks it stinks that eCigs are deemed to be tobacco products. Not realizing, in at least some cases, that if it weren't deemed that, it would've been deemed something that you only could get via prescription or over the counter (possibly) in a pharmacy.

IMO, if it weren't FDA, it would've been another of the bureaucratic alphabet soup entities that would be seeking to get a handle, full regulation and ultimately government grips / taxation on eCigs. Create a whole new classification entirely for eCigs all that may be desired. That isn't going to stop antis and others from wanting to regulate and tax eCigs.

So reality, right now and for the foreseeable future, is eCigs are a tobacco product. And that classification arose from a victory that went the way of early pioneers in the eCig industry, well before most reading this even heard of the word vaping.

As such, I continue to believe that the tobacco act is what we are up against, and not distinguishing hopelessly that our product isn't at all like their product. When every article ever written, vast majority of posts on eCig forums, and general perception is that it is at least a little like that other evil product that BT mass produces.

Win (small) victories on the entire tobacco act, and you likely win huge victories on the eCig front. Especially if hyper aware of both issues. But continue to allow or even encourage BT to be thrown under the bus, and I see that as inadvertently willing (actually willing) to throw eCigs under the same bus, or another one that will roll up right behind that bus and be far more confident / powerful than the current bus.

 

[Fulgurant]

Regarding the other part of your thread title - state and local bans - most are waiting to see what the FDA does before passing their own laws and taxes. Once the FDA officially deems e-liquid and devices sold containing e-liquid to be tobacco products and if it fails to distinguish the product as low risk and not a threat to public health (as we suspect will happen), those States and localities holding off for now will see an open door to bans and sin taxes. So, what the FDA does has HUGE implications for the state and local actions. (State and local actions against which CASAA has largely been leading the fight and creating many tools for others to do the same - something you don't seem to want to acknowledge.)

Yep. Half of the mealy-mouthed justifications you hear for local bans feature the statement, "E-cigarettes don't have FDA approval." To ignore the link between the putative authority on all things safe and wholesome (FDA) and the pandering irrationality of self-important local officials is, itself, irrational.

Tom doesn't have a legal argument, and he never did. Every time he's pressed on the matter of the FDA's powers, he reverts to an argument that FDA will not fully use those powers. That's not reason; that's faith. He's welcome to his beliefs; under different circumstances I might even be encouraged by his optimism -- but as it stands, I'm forced to write him off as yet another contrarian internet know-it-all who really knows squat.

 

[Fulgurant]

IMO, all that we discuss stems from this. Whenever I review the history, especially in the legal document that is result of Soterra judgment it comes down to a) defendants gaining victory over FDA through b) having eCigs designated as a tobacco product and not a drug-delivery device.

And it seems to me, though I don't know for sure, that vapers at that time were pleased as punch to have won a very significant legal challenge on right to use these devices. That they accepted the ruling and were okay with idea that going forward these would be deemed tobacco products.

Flash forward to 2010 and for sure in 2013, and most every vaper thinks it stinks that eCigs are deemed to be tobacco products. Not realizing, in at least some cases, that if it weren't deemed that, it would've been deemed something that you only could get via prescription or over the counter (possibly) in a pharmacy.

IMO, if it weren't FDA, it would've been another of the bureaucratic alphabet soup entities that would be seeking to get a handle, full regulation and ultimately government grips / taxation on eCigs. Create a whole new classification entirely for eCigs all that may be desired. That isn't going to stop antis and others from wanting to regulate and tax eCigs.

So reality, right now and for the foreseeable future, is eCigs are a tobacco product. And that classification arose from a victory that went the way of early pioneers in the eCig industry, well before most reading this even heard of the word vaping.

As such, I continue to believe that the tobacco act is what we are up against, and not distinguishing hopelessly that our product isn't at all like their product. When every article ever written, vast majority of posts on eCig forums, and general perception is that it is at least a little like that other evil product that BT mass produces.

Win (small) victories on the entire tobacco act, and you likely win huge victories on the eCig front. Especially if hyper aware of both issues. But continue to allow or even encourage BT to be thrown under the bus, and I see that as inadvertently willing (actually willing) to throw eCigs under the same bus, or another one that will roll up right behind that bus and be far more confident / powerful than the current bus.

Ayup. Relevant: E-cigarettes are a tobacco product, so please stop wasting time arguing otherwise | Anti-THR Lies and related topics

 

[kristin]

Amen, Jman!

 

[Jman8]

This means a product is considered "new" unless it was actively being sold in its same exact form before February 15, 2007. ANY modification creates a "new" product. So, if a company was selling tobacco-flavored, 6 mg, 12 mg and 18 mg liquid on February 14, 2007, those products would be grandfathered. If it started selling 24 mg watermelon flavor on February 16, 2007 that product would not be grandfathered. The company would have to stop selling that product and submit an application for FDA approval to start selling it again. If another company was also selling tobacco-flavored 6 mg, 12 mg and 18 mg liquids but didn't start marketing them until March 2007, it would still be considered "new" but could apply to the FDA as being substantially equivalent to the stuff sold by company #1 that was grandfathered. However, the FDA could still require company #2 to prove its tobacco flavoring from FlavorArt (instead of company #1's Lorann tobacco flavor) and using a 60/40 PG/VG ratio (instead of company #1's 80/20 ratio) is also substantially equivalent. The FDA may require the company to submit lab tests and population-level studies to prove this. If you are familiar with what the FDA requires to prove a product to be a lower-risk product, you know that the FDA requiring outrageously impossible evidence is already happening and not unusual. The FDA is already creating huge barriers for approval for many products, so this is not FUD.

Mostly responding to the bolded part, but I often wonder if FDA (or any organization that isn't fully pro-vaping) realizes that this would undoubtedly create a black market, and a rather significant one. I think they do realize it, and as I'm not prone to go conspiracy route, I think it would be sloughed off as 'we won a little victory' and treated as good enough for next few months, hopefully a couple years.

I think many vapers, and for sure a whole bunch of potential vapers would be 'hurt' by making it a black market rather than an open, free market that is reasonably regulated. And as long as that is ignored, this is what the black market will be showing by its mere existence. The demand won't stop, and thus supply is very very unlikely to stop. Reasonable regulations would satisfy most big players even while all players will still find little things to gripe about, forever and ever.

Yet, I do think black market would be a victory of another sort, even while it will, by its nature, constantly show up as a dark shadowy victory.

I honestly think FDA and the larger organizations that aren't preaching anti-vaping messages (even while they may dabble in that) are not interested in cutting off supply based on their awareness of demand (from many other markets, and thus experience). I do think they are highly interested in regulations. And to some degree, based on creating a sensible (well sensible to them) framework for heavy taxation by other governmental personnel.

I do think if we are on this side of pro-vaping and we are interested in what FDA *could* do, then black market strategies going forward ought to not be ignored. I almost think by being public about that sort of strategy *could* send a couple of messages to a whole bunch of people, not the least of which is one to FDA/regulators that says we are prepared for what is plausibly your worst case scenario. And is even more reason why we fully desire to work WITH you on reasonable regulations.

I think we get concerned about who the industry will be handed over to if any regulations are put forth. Reasonable ones would allow small businesses (teeny tiny vendors) to exist without creating enormous barriers for entrance into the market. At same time, barriers and regulations are nearly synonymous with every other market I'm familiar with. And so, inevitably some business with greater capital going in, is going to benefit regardless of how the market is set up or regulated. Our collective fear of handing things over to BT, IMO, needs to be put into perspective of what *could* happen if BT is deemed absolutely the worst people to get into bed with. This would tell me that some vapers are perfectly okay getting into bed with shadowy, dark entities who are all to happy to operate in a black market and make record profits off of an increasing demand from vapers.

 

[tombaker]

Tom, are you a lobbyist, pro or con to this subject? If you are I'll remind you of this:

Section 6 of the Lobbying Disclosure Act (LDA), 2 U.S.C. § 1605, provides that: The Secretary of the Senate and the Clerk of the House of Representatives shall "provide guidance and assistance on the registration and reporting requirements of this Act and develop common standards, rules and procedures for compliance with this Act"

That Act says no matter where or what you are doing, if it involves what your are a lobbyist for you have to identify yourself as a lobbyist to those involved.

In other words, even on an internet forum you are required to inform us that you are a lobbyist if you are posting information about the subject that you lobby for.

In a previous post you said you were concerned only with what was going on in the U.S. so this would apply.

Baaahahahaaahhaaaaaaaa you can not be serious.....wait, you are.......LOL ROLF, I can not breathe, wait wait, LOLOLOLOLOLOLOL hep me hep me LOLOLOLOL.

Edit: Still ROLF, but then I realize you think you are serious, my oh my, so I gotta tell you, so as to preclude a "so are you" thread muddying reply....ROLF

Sooooooo I can tell you that, I am not now, nor ever been a member of the Communist party, opps wrong script, wait wait, let me get it straight for you....

I am not paid, nor a member of any government agency, nor am I associated in any manner (and also not using any "depending on what "is" is ) with any E-Cig company, hardware vendor, or Big Tabasco or Juice supplier, and I am not a lobbyist by legal or other definition, and not associated with any 501c. I also remain within the bounds of the Canons of Legal Ethics, and will not be providing you a CRV. I will not respond to any further where or who is Waldo inquiries.

I may or may not be Spartacus but will respond to that name if so asked.

 

[tombaker]

Kristin, as I have said multiple times, I appreciate your responses, value them, but I need to continue to correct the the wrong conclusions based on on faulty legal analysis, and the needless FUD they create. my comments in Bold

Tom, you misunderstand what pre-market approval means. E-cigs, while not ILLEGAL, are not legally recognized by the FDA as tobacco or nicotine products. The FDA has caused many such products to be removed from the market in the past. Consider nicotine water and pops, that were being sold and now aren't. "Nicotine Water." Based on several factors, including statements contained in the labeling of the product, and other evidence of intended use, FDA has determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement. They were marketing it as a drug, they got removed. The Sottera decision and the FDA formally saying they will not challenge that decision makes the Nicotine Water arguments completely moot for E-Cigs going forward.

Just because something is currently not illegal (which is not the same as legal), (Actually it does mean that, but I don't want to debate that)it doesn't mean that the FDA cannot apply new regulations to it. The FDA does not care that a product has been on the market already for 6 years or 20 years. (Unless it was commercially marketed before February 2007 in IT'S EXACT FORM (you have again ignored substainally equivilent, which all E-Cigs are to each other. But you are wrong on the assertion of EXACT FORM also) and the FDA approves it as "grandfathered.") It can still say, "Under FSPTCA, the FDA has decided that these products must now get pre-market approval from the FDA before they can be legally sold to the public. Any company with this product currently on the market, that does not already have FDA pre-market approval, must immediately stop selling that product until it gets such approval." (this is where you immediately spin outside of what can and can not be done. The ruling is that E-Cigs are not a medical device, and the FDA says it will treat them as a Tobacco product, they can not prohibit a Tabacco product, by the Law they operate on.) Is that a "ban?" No. Would it still effectively stop the legal sale of e-cigarette nicotine liquids in the US for several years - until some company manages to get FDA approval? Yes. No! This scenario is FUD without legal foundation. The problem is you are saying they can do something, where they can not actually do it. And that means a Judge would immediately stop them, if they tried.

All E-Cigs are substantially the same as each other, electric coil, heating fluid to Vapor, no filters. There is no legal basis to say otherwise. The FDA has not removed many products that fall into the same category you suggest. The remain being sold. If any E-Cig is legal, they are all legal. Everything now, is truly equivalent to anything be sold in 2007.

---Now let me help you on the 2007 date, from a legal side. It is also important to understand that February 15, 2007 was selected as the original Grandfather Date because that was the date that the bill eventually became the Tobacco Control Act was first introduced into Congress, 23 thereby putting the tobacco industry ( i.e. , manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco) on official notice that it was going to be regulated by FDA.

At the time, Congress had not contemplated including e-cigarettes (which were just being introduced into the U.S. market) or other non-traditional tobacco products in the legislation. For this reason, it simply would not make sense for the Deeming Regulation to mandate February 15, 2007 as the grandfather date for e-cigarettes. Rather, using the same logic of “First Notice,” there are two much more likely potential grandfather dates for e-cigarettes and other deemed tobacco products. he first would be the date that the NPRM for the Deeming Regulation is actually published in the Federal Register ( i.e. , December 2013 or later).

The second potential grand father date would be April 25, 2011 – the date the Agency published its letter to stakeholders indicating that it intended to capture e-cigarettes through the Deeming Regulation.


I agree the FDA will have no power over devices unless the device is sold containing nicotine liquid. However, the FDA will have all nicotine liquids under its power and devices are pretty pointless if no one can legally sell the nicotine liquid.
We probably agree nicotine liquid is what is being recognized as the Tobacco product, The mechanism of Vaping is the same, always. As every liquid is composed of the famous 4 ingredients, if one liquid is legal, the are all legal. The FSPTCA says specifically the can not ban classes of Tobacco products. Because of the wrong legal views being presented as fact, an entirely wrong scenerio is being offered out as being possible. Simply said, much of what you are asking to be a concern, can not happen. Heck the law went into effect in 2009, 4 years of this should give some pause, because the doom is not happening.

And PLEASE recognize that in 2007, lead was coming in children's Toys, thousands of Dogs were killed from imported dog food with Melamine inside of it, from China. 2007 pet food recalls - Wikipedia, the free encyclopedia The FDA looking at the contents of E-Juices was needed, someone had to test. Heck the Dog food was mostly good ingredients, nobody was testing. The end result was some bad actors were stopped, and the USA liquid market was created, and almost granted monopoly status. So they did, and their attempt to take those test further was entirely slapped down by the Courts, a loss that makes all these doomsday scenerios much less likely, and often impossible.

You are the one who is legally wrong on so many points, not CASAA and numerous THR experts - all who are familiar with the FSPTCA, have been meeting with the FDA advisory panels, were involved in the Sottera vs. FDA lawsuit and have been following and analyzing this situation for over 4 years now.
Look, this is the simplistic blanket FUD, I am talking about. I am wrong on what? I list off exactly what I know you are wrong on. I cite. I link. Now you toss out the CASAA are inflalible stuff. Okay sure. NOT. Been 4 years of it....so far, not right. The entire premise is that the FDA wants take a much safer, by everyone standards, product off, and push people back to Tobacco. That dog don't hunt. Or that the FDA is gonna tax people to death, when the FDA does not have that ability at all. I have pointed out so many specific places that entire card house is built upon....I have summarized them, I address each of the ones claimed to exist

Regarding the other part of your thread title - state and local bans - most are waiting to see what the FDA does before passing their own laws and taxes. Just wrong, localities are moving ahead right now, did you not notices that tiny locality the other week, NEW YORK. The bans are NOW. But worse is you just make up, that they are waiting for the FDA, just picked it out of thin air. Nobody has surveyed these theoretical regulator zealots, and then the respond, OHH we are waiting for the FDA. An if an isolated one said as much, its only because the politican is doing nothing, and clueless to the Entire world, plenty of those politicians. The BANS ARE HAPPENING NOW, that is the fight to work, not these windmills of Group think.

Once the FDA officially deems e-liquid and devices sold containing e-liquid to be tobacco products and if it fails to distinguish the product as low risk and not a threat to public health (as we suspect will happen), There you go again. You are saying that E-Cigs are not safe, and the FDA will see it that way. You Suspect? Gosh really, now you are buying into some sort of study that is the basis of this not safe thing? AND AGAIN the LAW, that little thing, says they specifically can not do what your are saying YOU SUSPECT they will. Its just a foundation of group think, with a lovely and spectaluarly evil end theory, all based on things which are not legal. BTW, lawyers can generate fees, or give pro bono out of their training expertise, but they can not void laws, and Sottera should give you some confidence you can not do and end run around the specific language of the law.

those States and localities holding off for now will see an open door to bans and sin taxes. (this is the here it comes again theory, as if people don't know smokers who have switched to E-Cigs, as if Politicians want to get voted out for treading on the) So, what the FDA does has HUGE implications for the state and local actions. (State and local actions against which CASAA has largely been leading the fight and creating many tools for others to do the same - something you don't seem to want to acknowledge.)

CASAA is wrong on the legal matters with FDA. I have shown that, happy to continue. Bans by localities are where the action is. I have read Successful CASAA Campaigns, I am Okay with that. Is everyone who does anything with their own cities a CASAA member, no, but those 5 examples they pushed off the decsions. Would it been the same outcome with nobody from CASAA, probably if you want that view. Do I think that local e-cigarette merchants, and locals do all the heavy lifting, absolutely. Does CASAA send out blast emails of local events, if they hear about them, yeah.

I am not available to validate CASAA, I need not acknowledge anything, you group is one of many forces. I have to say that attacking companies like BLU and V2 for being big or owned by a Tobacco company, is a bad thing for ALL vapers. If BLU is in, every mom and pop shop is in, if V2 is selling E-Liquids, Everyone is going to be able.

It is wrong and bad for Vapers of all varieties to be against the muscle of V2 and BLU. The hardware of APV is so outside of FDA control, I can believe that folks are still suggesting they can take away a Provari

Again on the legal side, all E-Liquid is the same 4 ingredients (okay most every, and whatever else is questionable if included)...so if any E-Liquid is available, all by definition are substantially Equivalent under the law.....so what is the theory that they can all be banned. Legally you don't have the support, of what you claim is the Doom to come. Your response would be most welcome

 

[Orb Skewer]

Are you or are you not an AUNT Tom, come on, out with it !

 

[tombaker]

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.

^
http://www.e-cigarette-forum.com/fo...ing-substantial-equivalence-requirements.html

I find this thread to be very contradictory the CASAA alarms-a-blarring approach, perhaps you can consider it, before saying the holy grail of E-Cig regulation is coming from the FDA.

The Bans on usage from cities, is where the problems are at, the chances of them extending in homes is nearly nill, because vaping is as toxic as burning candle in the home. I would also suggest that nobody should have a big heartache about banning e-Cigs near 100 feet of schools, its a fight that CASAA or anyone will ever win. Don't fight what you can never get a win on. The fact remains, stopping kids from starting Tobacco products is going to win, Every time. I would suggest you not try to stop everything as far as bans.

Forgetting schools, I definitely support addressing rule that make E-Cigs the same as Smoking rules already on the books....The is the quickest and most dangerous Ban for E-Cigs is dumping into this existing laws.

Focus on what is real.

 

[kristin]

Kristin, as I have said multiple times, I appreciate your responses, value them, but I need to continue to correct the the wrong conclusions based on on faulty legal analysis, and the needless FUD they create. my comments in Bold

I list off exactly what I know you are wrong on. I cite. I link. ...I have pointed out so many specific places that entire card house is built upon....I have summarized them, I address each of the ones claimed to exist

Excuse me, but you have been given links and explanations, not just "CASAA is right." You either ignore them or give your OPINION that our analysis is wrong, without giving any reason for us to believe your analysis (ie opinion) is the right one.

Nicotine Water." Based on several factors, including statements contained in the labeling of the product, and other evidence of intended use, FDA has determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement. They were marketing it as a drug, they got removed. The Sottera decision and the FDA formally saying they will not challenge that decision makes the Nicotine Water arguments completely moot for E-Cigs going forward.

The issue with nicotine water - in addition to nicotine lip balm and pops - is that the companies could have stopped making therapeutic claims and done as e-cigarette companies did, claiming that the products were meant as an alternative to smoking rather than a treatment. One company (NicoWater) argued that it was selling the water as a dietary supplement, not as a smoking cessation product. So, the FDA's authority over the product was in question, the same as with e-cigarettes. Such a product was not illegal and by your definition, was legal. There is and never was a ban on nicotine water. You had implied that the FDA cannot stop a company from selling a legal product that has already been on the market, yet it did by falsely arguing it was an illegal drug. The only difference between NicoWater and e-cigarettes is that the FDA lost the argument against e-cigarettes.

Just because something is currently not illegal (which is not the same as legal), (Actually it does mean that, but I don't want to debate that)

No, it doesn't. Something being "not illegal" vs. "legally recognized" (which is what I meant by "legal") are two different things. The FDA does not currently recognize e-liquid as a tobacco product. (That is what it will be deeming.) Therefore, it is not considered, by legal definition, to be a tobacco product by the FDA. The same goes for e-cigarettes on the state level. Most states do not legally define e-liquid as a tobacco product, therefore, it does not get taxed the same as legally defined tobacco products. E-liquid is not illegal, but it is not yet legally defined as a tobacco product and therefore, it does not receive the same protections under FSPTCA as products that are legally recognized. Once it is legally defined as a tobacco product, then it will fall under FSPTCA regulations and protections.

(Unless it was commercially marketed before February 2007 in IT'S EXACT FORM (you have again ignored substainally equivilent, which all E-Cigs are to each other. But you are wrong on the assertion of EXACT FORM also)

This is your OPINION.

The FDA's draft guidance for demonstrating "substantial equivalency" states:
"FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products."

What evidence do you have that the FDA will consider 12 mg tobacco-flavors to be substantially equivalent to cinnamon-flavored 36 mg liquid? Do the ingredients in the "tobacco" flavors that are grandfathered and cinnamon or other blends of flavors that aren't have the same health risks?

The draft guidance also states:
"The manufacturer must obtain appropriate market authorization for any changes to a tobacco product, including modifications to components. For example, if a finished cigarette manufacturer’s filter supplier changed the conformation of its filters, or changed the ingredients in its filters, the finished cigarette manufacturer would be responsible for including this change as part of its submission of its new product application."

Now, if a filter change could be considered a substantial change, how would a completely different flavoring or higher nicotine content in e-liquid not be considered a significant change??

Again from the draft guidance:
"New tobacco products first introduced or delivered for introduction into interstate commerce on or after March 22, 2011, and products introduced between February 15, 2007, and March 22, 2011, for which a 905(j) report was not submitted before March 23, 2011, may not be marketed without an order from FDA under either section 910(c)(1)(A)(i) or 910(a)(2)(A) of the Act."

This means any e-cigarettes marketed on or after 3/22/11 or introduced between 2/17/2007 and 3/22/11 that haven't submitted a 905(j) report (how many e-cig companies have submitted 905(j) reports? According to the FDA, none), then they MAY NOT BE MARKETED without an order (ie. permission) from the FDA. This means those companies must STOP SELLING those products until they get FDA approval to sell them again.

No. Would it still effectively stop the legal sale of e-cigarette nicotine liquids in the US for several years - until some company manages to get FDA approval? Yes. No! This scenario is FUD without legal foundation. The problem is you are saying they can do something, where they can not actually do it. And that means a Judge would immediately stop them, if they tried.

Based on the above draft guidance, the FDA clearly has legal authority to stop the sale of products introduced to the market after 2/11/07 that do not have pre-market authority and clearly, the companies must PROVE substantial equivalency to the FDA. They cannot just say, "Well, our product is basically the same as the stuff on the market before 2/11/07, so we are OK to sell it." No judge is going to stop the FDA from telling companies that have not received FDA-approval PER THE LAW that they have to stop selling the products. Once the FDA deems e-liquids to be new tobacco products, any products on the market not legally given permission by the FDA to market the product - whether by being acknowledged as a grandfathered product or by being given substantial equivalency - would then be ILLEGAL.

All E-Cigs are substantially the same as each other, electric coil, heating fluid to Vapor, no filters. There is no legal basis to say otherwise. The FDA has not removed many products that fall into the same category you suggest. The remain being sold.

That first sentence is your OPINION. It's the FDA that makes that determination and the legal basis for it to do that is the FSPTCA pre-market and other requirements that kick in once the FDA deems e-liquid to be a tobacco product. The FDA has not removed any e-liquid yet because it still hasn't deemed e-liquid to be a tobacco product!

From the draft guidance:
"will review the 905(j) report and supporting information consistent with the requirements of sections 905(j) and 910 of the Act, i.e., to determine whether the new tobacco product is substantially equivalent to the predicate tobacco product. In addition to determining that the product is substantially equivalent, FDA must also determine that the new tobacco product is in compliance with the requirements of the Act before issuing an order under section 910(a)(2)(A)(i)."

If any E-Cig is legal, they are all legal.

No, you are wrong. All products must be deemed legal on their own merit. The FSPTCA is clear on that fact. I don't know how you come to this conclusion, but it is 100% wrong. The rules for existing tobacco products (before 2/11/07) are different than the rules for products introduced after that date. Anything introduced after that date clearly require pre-market approval. So e-liquids that came after 2/11/07 must prove substantial equivalency to those that came before. They don't get automatically approved because of the pre-existing e-liquids. The law is clear on that.

Everything now, is truly equivalent to anything be sold in 2007.

Again, your opinion and while that may be true, the products introduced after 2007 still require pre-market approval and must prove that substantial equivalency to the FDA. There is no way you can know that the FDA will see different flavoring ingredients and different nicotine strengths as being "equivalent."

The entire premise is that the FDA wants take a much safer, by everyone standards, product off, and push people back to Tobacco. That dog don't hunt.

Again, your opinion. I've given you reason why we think our opinion on this is valid.

Or that the FDA is gonna tax people to death, when the FDA does not have that ability at all.

Neither I nor CASAA has ever said the FDA actions have anything to do with taxes. We know that the FDA doesn't create taxes. However, the FDA deeming e-liquid a tobacco product will give states and local governments an excuse to create taxes.

ust wrong, localities are moving ahead right now, did you not notices that tiny locality the other week, NEW YORK. The bans are NOW.... The BANS ARE HAPPENING NOW, that is the fight to work, not these windmills of Group think.

Seriously? We were fighting in New York! And LA, DC, Minnesota, Oregon, Illinois, etc. It's ridiculous for you to be schooling us about the bans that are "happening now."

But worse is you just make up, that they are waiting for the FDA, just picked it out of thin air. Nobody has surveyed these theoretical regulator zealots, and then the respond, OHH we are waiting for the FDA.

SMH. Several municipalities have backed off on bans and said they will wait until the FDA acts. Some 40+ state attorneys general wrote the FDA, pleading for it to act: "With the protection of our States’ citizens again in mind, the undersigned Attorneys General write to highlight the need for immediate regulatory oversight of e-cigarettes, an increasingly widespread, addictive product."

You are saying that E-Cigs are not safe, and the FDA will see it that way. You Suspect? Gosh really, now you are buying into some sort of study that is the basis of this not safe thing? AND AGAIN the LAW, that little thing, says they specifically can not do what your are saying YOU SUSPECT they will. Its just a foundation of group think, with a lovely and spectaluarly evil end theory, all based on things which are not legal. BTW, lawyers can generate fees, or give pro bono out of their training expertise, but they can not void laws, and Sottera should give you some confidence you can not do and end run around the specific language of the law.

I was not saying e-cigarettes are not safe. But what you and I consider safe the FDA sees in a whole different way. The law does NOT specifically state that the FDA cannot create regulations for e-cigarettes. In Sottera vs. FDA, the opinion was specifically that the FDA can regulate e-cigarettes as tobacco products and FSPTCA gives the power to the FDA to create standards and rules for selling e-cigarettes:
"The Family Smoking Prevention and Tobacco Control Act, commonly referred to as the Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health."
Tobacco Control Act

"Gives FDA authority over, among other things:

Registration and inspection of tobacco companies – Sec. 905 of the FDCA
Requires owners and operators of tobacco companies to register annually and be subject to inspection every 2 years by FDA.
Standards for tobacco products – Sec. 907 of the FDCA
Allows FDA to require standards for tobacco products (for example, tar and nicotine levels) as appropriate to protect public health.
Bans cigarettes with characterizing flavors (except menthol and tobacco).
“Premarket Review” of new tobacco products – Sec 910 and 905 of the FDCA
Requires manufacturers who wish to market a new tobacco product to obtain a marketing order from FDA prior to marketing that new product.
“Modified risk” products – Sec. 911 of the FDCA
Requires manufacturers who wish to market a tobacco product with a claim of reduced harm to obtain a marketing order from FDA.
Enforcement action plan for advertising and promotion restrictions – Sec 105
FDA published a document entitled “Enforcement Action Plan for Promotion and Advertising Restrictions.”
The action plan details FDA’s current thinking on how it intends to enforce certain requirements under the Tobacco Control Act.


The Tobacco Control Act also requires:
Tobacco industry must disclose research on the health, toxicological, behavioral, or physiologic effects of tobacco use. – Sec 904 of the FDCA
Tobacco industry must disclose information on ingredients and constituents in tobacco products; and must notify FDA of any changes. – Sec 904 of the FDCA
Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer fact Sheet

The FSPTCA gives the FDA the legal power to do EXACTLY what we suspect. I've already given you the reasons (in a previous post) why we suspect the FDA will use this authority to get e-cigarettes off the market. The FSPTCA prohibits an outright ban, but it does NOT prohibit the FDA from making other rules and standards for e-cigarettes that could decimate the industry.

those States and localities holding off for now will see an open door to bans and sin taxes. (this is the here it comes again theory, as if people don't know smokers who have switched to E-Cigs, as if Politicians want to get voted out for treading on the)

It's not a theory. We are seeing it happen already even without the FDA deeming them tobacco products and it will only get worse once the FDA deems them tobacco products. In Oklahoma, they are passing bans for MSA payments. In Minnesota, e-cigarettes are already being taxed like tobacco. In Wisconsin, there is a proposed act to start treating and taxing them like cigarettes.

The general public doesn't support smokers' rights and they are being convinced by the public health groups that e-cigarettes are no different than smoking OR that e-cigarettes will addict kids and lead them to smoking. Smokers make up only 20% of the US adult population and vapers are a tiny fraction of that. The politicians see non-smokers as their strongest constituency and want to make them happy. The public sees tobacco taxes as "win-win" and there is no reason to believe they won't view e-liquid taxes the same way. The tactic is already working and a "blessing" by the FDA (ie. "Yes, these are tobacco products and we have no evidence that they are safe LONG TERM") will only open the floodgates.

I have to say that attacking companies like BLU and V2 for being big or owned by a Tobacco company, is a bad thing for ALL vapers.

Neither CASAA nor I have attacked e-cig companies owned by tobacco companies. CASAA endorses the use of certain smoke-free tobacco products as a part of tobacco harm reduction policies, so CASAA certainly doesn't try to demonize the tobacco industry; because we understand and try to educate the public that there are tobacco products that smokers could switch to that are just as safe as e-cigarettes.

 

[kristin]

I find this thread to be very contradictory the CASAA alarms-a-blarring approach, perhaps you can consider it, before saying the holy grail of E-Cig regulation is coming from the FDA.

The Bans on usage from cities, is where the problems are at, the chances of them extending in homes is nearly nill, because vaping is as toxic as burning candle in the home.

Focus on what is real.

In some places, governments have already banned e-cigarette use in peoples' homes. So, it is very real. (Not that it's enforceable, but the laws are on the books.)

 

[Berylanna]

I think you'll find that no vaping in RENTED homes will be quite enforceable wherever there is rent control, poverty, or urban renewal.

 

[kristin]

I think you'll find that no vaping in RENTED homes will be quite enforceable wherever there is rent control, poverty, or urban renewal.

I meant it's kind of difficult to prove someone is vaping in their home. If they cannot show any evidence that the person has been vaping (ie. unlike smoking there is no odor drifting into the hall or other units, no odor left on furniture/walls/carpet, no butts or ash left behind) how can they enforce it? They can ban it, but they'd have a hard time keeping people from still doing it, because they'll have no proof it's being done - unless they barge into the home unannounced and catch people in the act and that isn't legal in most places.

For example, I vape all of the time in non-smoking hotel rooms. How are they going to prove I was breaking any rules?