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

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tombaker

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There seems to be a lot of miss-direction of concern going on with E-Cigs and the FDA. Bottomline is the FDA is not going to be able to ban Nicotine, its already lost the battle in court, and the only thing that the FDA is going to be able to do is change the way that E-Cigs are marketed. Marketing will be changed, and it become a big who cares.

The real problem is with Cities like New York creating regulations on how E-Cigs can be used in public. Bans on usage are the laws that will be hard to fight, and hard to overturn, because they will go into effect before they can be overturned.

There will be no laws that Ban E-Cigerettes as a lawful device. I explain below. The FDA already lost, already has definitions that exempt E-Cigs. The FDA can and will change how E-Cigs are marketed, but that is meaningless. The FDA stops lots of Snake Oil claims....don't make the claim, problem solved.

The real risk is what New York just did….that is the area to fight, worry not about the FDA.
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1. There is a difference of vaping and selling electronic cigarettes. The FDA is concerned about how drugs are presented to the populous, as they should. There is no reason to Market E-Cigs as a smoking cessation device. It crosses lines for zero benefit. It is obvious enough of a relationship where they don't need to make marketing claims. The key is marketing claims.


2. The ruling has already been upheld that E-Cig devices. READ IT "This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices, Unfortunately it's tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."
3. Stop telling people that Vaping and/or E-Cigs are "smokeless" Why? Because "Smokeless" in the world of Tabacco is a legal term. A legal term that DOES not apply to E-Cigs. Smokeless is a definition that should not be applied to E-Cigs


4. The Government defines Nicotine as a Tobacco Free product already. And includes E-Cigarettes in this category. SEE What I found here. http://www.womenshealth.gov/smoking-...cotineProducts


5. Its going to be a stretch to put nicotine into the Tobacco classification, because that would be a move away from the current standard. But if it goes that way, remember the language of the law in question says "The law also imposes certain limits on FDA authority. The agency cannot ban conventional tobacco products, such as cigarettes and smokeless tobacco, or require the total elimination of nicotine in tobacco products." The end effect is that E-Liquid should be pretty safe from being as you so woefully fear as being twaken away.
7. Don't forgot to read, what 910 can do...and why.
Denial of application

The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—

(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;

(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;

(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or

(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.

Notice all the language about the Marketing....well that is what the FDA can do, restrict that, and then they can stop terrible manufacturing methods. The regulations IF they come, are going to hit the big guys, the national brands, People brewing up e-juice on their kitchen table, will still be able to slap a label on it and go.

You can be in fear, and worry, the Sky is falling according to one Chicken Little, and we must muster everyone together to fix it.....
or you can use the real information. Vaping is not Smokeless Tobacco, A Carto/Clearo/Tank + Battery can not be ruled and regulated as a drug device. FDA has No Authority over Electronic Cigarettes as a Drug Device So the E-Cig is not going anywhere, the hardware side. Nicotine is not Tobacco, as already acknowledged by the Government, see the link I found above. So E-liquid falls under all the categories of legal Nicotine. BUT if not that, its ruled some other way in the future. The Tobacco Law in question won't allow the product to be banned. And the items where it can be controlled are listed out.

Be thankful that there are enough big E-cig companies out there to hire the lawyers to argue for things mostly already decided.

A filled carto with nicotince MAY get some regulations about Marketing it, but Vaping is not under threat of any significance, other than public usage laws....but that is an entirely different topic.
 

Randy C

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Thanks for your thoughts! Unfortunately, greed, self interest, and politics often drive laws that defy logic.

I think one of the largest risks would be a ban on internet sales of nicotine. This one keeps me up at night. It's doubtful we'll see an all out ban on nicotine, but they could very well regulate the way we buy it.

An Internet ban on nicotine would drastically change the landscape of vaping as we know it today. Big tobacco would certainly be the winners in this scenario, since they already have the necessary supply chain needed to supply American vapers in the event an Internet ban were to happen. For me, this would be a worst case scenario... no more buying from my favorite vendors, since none of them are within driving distance.
 
I don't see how they could restrict nicotine sales to BT, it's already used in labs, has pharmaceutical uses (it's under testing for various diseases and so far shows some promise), and the agricultural industry uses it as an insecticide.

The simple fact is that many uses are far out of the FDA's range, and they have no jurisdiction there.
 
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DC2

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...and the agricultural industry uses it as an insecticide.
I'm not sure that's true anymore...

And when I look to find out who is using nicotine as a pesticide in the United States this is all I can find...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

This document presents the Environmental Protection Agency’s (EPA’s or the Agency’s) decision regarding the reregistration eligibility of the registered uses of the active ingredient nicotine. The Agency conducted human health and environmental fate and effects risk assessments for nicotine non-food uses. The registrant of the sole remaining nicotine pesticide product requested the cancellation of its registration on February 25, 2008, to be effective on December 31, 2013, with existing stocks permitted to be sold by dealers and distributors for one additional year. The Agency has accepted this request in concept, and it is subject to notice and public comment. If public comment provides no information that causes the Agency to reconsider, the Agency may accept the cancellation request.

The assessment of risks for the pesticidal use of nicotine is unique in that much of the supporting data is drawn from the open literature, as opposed to studies conducted according to Agency guidelines, and the data that are available are not entirely wellmatched to anticipated routes of exposure and use patterns for the nicotine pesticide. The lack of more relevant data adds considerable uncertainty to the risk assessment and would necessitate that the Agency call-in data from a range of guideline studies. Ultimately, the process the Agency undertook to assess risks and formulate reregistration eligibility decisions was overtaken by the registrant’s request for cancellation. The Agency is finalizing this reregistration eligibility decision as a record of the database and methodologies that were used to assess nicotine and the Agency’s preliminary conclusions about the risks associated with its use.

The sole remaining nicotine registration, for which cancellation has been requested, is a Restricted Use Pesticide used on greenhouse ornamentals, including poinsettias, bedding plants, and chrysanthemums to control whiteflies, aphids, and thrips. Nicotine has been known for its pesticidal properties for centuries, and came into common use in the U.S. about sixty years ago. Production and usage are now quite limited.

Using the limited available data, EPA has assessed the human health risks for the remaining nicotine registration and has concluded that risks for workers both during and after application, and for consumers of plants from treated greenhouses and members of the public who might be exposed to nicotine residues in treated greenhouses, are potentially of concern. Nicotine is not used on any food and feed crops so dietary risks have not been assessed. Because nicotine is used in greenhouses only, drinking water and ecological risks were not assessed for this use pattern, although the Agency did assess the ecological risks associated with another nicotine product used outdoors to repel vertebrate pests of ornamentals which has since been cancelled. The ecological risk assessment and an assessment of episodic ingestion of the nicotine repellant product are posted to the nicotine docket, as are the technical documents supporting the human health risk assessment for the nicotine greenhouse use.
 
I'm not sure that's true anymore...

And when I look to find out who is using nicotine as a pesticide in the United States this is all I can find...
http://www.epa.gov/oppsrrd1/REDs/nicotine_red.pdf

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.
 

permafrying

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You know I appreciate all the time and knowledge you put into this post. But I don't think you really understand how politics and law making works. Prior court decisions and the inner workings of the legal system don't mean a whole lot. On paper it all looks great for us but when you turn to a highly corrupt system never say something can't happen. Now whatever happens might be highly illegal or completely manipulated in a long time game but that doesn't mean anything in politics really that's what it's all about

Sent from my DROID RAZR HD using Tapatalk 2
 
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_Lee

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Blind faith and naivety that the elected officials will uphold the existing laws while keeping the best interest of their constituents is dangerous. I'm not a conspiracy theorist or a separatist, but never say the gubment cannot do something. The veils over our illusion of freedom is becoming thinner every time something is passed, or so it feels. Never put anything past greed and lust for power; even under the guise of "public safety".

The Domino Effect requires more than one domino to work.
 

Berylanna

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What everyone forgets people we do have smart very competent lawyers on our side.
Just for the sake of just cause

Ummm, who is funding them? The well-funded ones work for Big Ecigs, and they are happy to let the FDA hand them a monopoly. At least they're on our side when it comes to vaping in parks, but that might not be enough.

I'm hoping the original OP is close-enough to correct so that a 2-year supply will be enough to get me through court battles and I won't need to stockpile for a lifetime. But I cannot promise.

As for nicotine being used outside of the FDA's purview, look at Health Canada, who is having things seized that are outside their purview. And as for other current uses of nicotine, note that we now have to register to buy the original-forumulation sudafed. Things can change. They can change either way.

I say any victories we have so far came from fighting, and NOT from complacently assuming someone else will take care of it for us.

(The good lawyers I trust to be on our side have to eat. WE are CASAA, there are no paid CASAA members. Everybody has to take some of their limited vacation days to do ANYTHING for us.)
 
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randyith

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Ummm, who is funding them? The well-funded ones work for Big Ecigs, and they are happy to let the FDA hand them a monopoly. At least they're on our side when it comes to vaping in parks, but that might not be enough.

I'm hoping the original OP is close-enough to correct so that a 2-year supply will be enough to get me through court battles and I won't need to stockpile for a lifetime. But I cannot promise.

As for nicotine being used outside of the FDA's purview, look at Health Canada, who is having things seized that are outside their purview. And as for other current uses of nicotine, note that we now have to register to buy the original-forumulation sudafed. Things can change. They can change either way.

I say any victories we have so far came from fighting, and NOT from complacently assuming someone else will take care of it for us.

(The good lawyers I trust to be on our side have to eat. WE are CASAA, there are no paid CASAA members. Everybody has to take some of their limited vacation days to do ANYTHING for us.)

The good lawyers are funded by large e-cig companies like e-smoke and blue. Even we have 3 separate lawyers on retainer.
 

Jay-dub

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I like this thread. At least, the points made in the OP. It's a refreshing read that stands out among a lot of posts. There's a devloping victim mentality around here that surely adds to the defensiveness and posturing I see a lot. People actually lash out against good/calming news. LOL! We're all victims of fascist policies! If you disagree you're wrong so shut up! I get tired of worrying about what might happen.
 

2coils

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I understand there are opinions on both sides of the fence as to what might happen with our e-cigs. I too, am exhausted thinking about it. Remember, very few e-cig vendors etc... have the money or are going to want to part with the money for an expensive battle in court. The only significant representation is funded by BT. As Berrylana mentioned, BT is going to fight for BT, not for our refillable liquids etc...

It would me more than foolish to sit back and do nothing as a consumer and a citizen. Take a look at what is going on in the rest of the world before making a decision to remain complacent. Even if one thinks e-cigs are going to be fine, please do your part anyway, just in case that thought process is wrong, as I believe it may be!
 

Berylanna

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The good lawyers are funded by large e-cig companies like e-smoke and blue. Even we have 3 separate lawyers on retainer.

Cool! I had not heard of any PAID lawyers fighting for eliquid refillability! Nice to know!

One point about the OP's concerns about "use in public" bans: I think fighting these use bans is critical to public education, which in turn is the key to ANY part of the fight. I think this influences the FDA. That is where most of my effort has gone.

But the reverse is also true. If the FDA tries something harsh, even if they lose in court, there will be cities and states who get it TOTALLY BACKWARDS and interpret any FDA court loss as a win for smoking. So we need to fight on both fronts.

Fortunately, we've been there and done that, so we can do it again.
 
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Randy C

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a ban on eCigs is not what I am worried about ... I am concerned they will award the distribution of nicotine exclusively to BT.

Well... the FDA can't legally do this. They aren't in a position to "award" anything.

But, think about about a potential Internet ban- which is within FDA's authority to do.... If Internet Sales are banned, we'll be forced to go to local B&M's or gas stations for eliquid. With that said, where will these folks get their juice from? Who has a supply chain large enough and organized enough to supply them? Why.... big tobacco of course.

The FDA has limited authority, however they're a crafty crowd. They'll go to any length to accomplish their goals.
 

WillyZee

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Well... the FDA can't legally do this. They aren't in a position to "award" anything.

But, think about about a potential Internet ban- which is within FDA's authority to do.... If Internet Sales are banned, we'll be forced to go to local B&M's or gas stations for eliquid. With that said, where will these folks get their juice from? Who has a supply chain large enough and organized enough to supply them? Why.... big tobacco of course.

The FDA has limited authority, however they're a crafty crowd. They'll go to any length to accomplish their goals.

Hi Randy C ... basically, this is similar to what I mean ... nicotine being very hard for everyone to obtain except BT ... and the suppliers we know now, only permitted to sell to BT :blink:
 
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