FDA Seeks: Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products

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Uncle Willie

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I agree 100%. I have stated many times before, if the vendors don't work together to establish uniform protocols,
and present a uniform front to show the FDA that the industry is safe, the gov't will allow the FDA to step in.
And, I am sure BP and BT will be working behind the scenes to make sure those regulations are very strict.

Exactly .. and Uncle Sam does not have to give the FDA permission .. they can easily work within what they have as shown by the topic of this thread ..
 

calico21

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- Clinical drug trials, very expensive and could take years
- can make ejuice available by prescription only, like nicotine inhalers and other NRT's
- require ejuice to be mixed in a lab grade environment with all kinds of inspections and documented regulations
- ejuice can only be mixed by "certified" technicians, or worse, certified pharmaceutical lab techs
- all kinds of inspections for mnf of hardware and monitored documentation for compliance with regulations and quality control
- a lot of vendors use some kind of adhesive compound to stabilize components in a mod, how expensive do you think it would
be if these adhesives had to be tested for harmful emissions?! Or, if the employees had to wear the proper PPE ( personal protection equipment )
for protection against fumes from solder.
How is all this bad .. ??

COST OF COURSE!!!!
 

calico21

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I just paid $80 for a skin cream that isn't available in a generic form yet.The tube only contains 5 grams, imagine that in a juice bottle and it's not alot! So lets imagine BP gets approval and pattens their juice how do you feel about paying $80 for a 6ml bottle of juice. I'm for keeping the GOV and BP out at whatever it takes.
 

Uncle Willie

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I just paid $80 for a skin cream that isn't available in a generic form yet.The tube only contains 5 grams, imagine that in a juice bottle and it's not alot! So lets imagine BP gets approval and pattens their juice how do you feel about paying $80 for a 6ml bottle of juice. I'm for keeping the GOV and BP out at whatever it takes.

The point is no one will keep them out .. they are already in .. the e-cig is definitely on the radar .. the cat is out of the bag .. what we are saying is the industry is doing nothing to self regulate ..
 

John Phoenix

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I'll say it again, people don't understand the consequences if ecigs are recognized as a stop smoking device or a NRT ( nicotine replacement therapy ).

Are ecigs good for helping people to stop smoking? Absolutely !! But, claiming this allows the FDA to label ejuice and the hardware for delivery
as "Drugs". This allows them to develop all kinds of regulations and procedures for production and sales.


It may be cynical to point out that the only way we can defend ecigs is to twist our words to get the message across,
but hell, how do you think Big Tobacco has been able to keep cigarettes legal?

I don't agree. The whole world can openly recognize the e-cig as a stop smoking aid, NRT, drug delivery method - it doesn't matter..there will be and can be No consequences from this. Why do you assume that this will cause the FDA and others to try to regulate them under laws designed for those things? It ONLY matters if they are being manufactured and sold as such.

I understand how and why they made the law so I have absolutely no fear that they can change the laws based on this. Again, your mixing apples and oranges, you just cannot see it that's the bottom line. It is fear not knowledge that is causing you to feel the way you do.

Big tobacco is selling a product.. they are a seller and manufacturer of the product. they get away with selling them the very way I suggested above, they are making no health claims nor advertising them as a drug delivery device. I do not suggest sellers or manufacturers of E-cigs break the law and claim these things, but no harm whatsoever can come from users making such claims - that is not illegal and does not come into conflict with the ideas of the FDA.

They could never seek to regulate e-cigs as drugs simply because users openly admit ( which is the truth) that the e-cig delivers nicotine, a drug. i don't care how many users shout it from the rooftops. Regulation only comes into play at the selling and manufacturing level. As long as sellers and manufacturers do not make such claims, there is no problem. I think people can see fearful users shying away from this truth and think we are trying to hide something.. that would be worse. I am all for honesty across the board. We don't need to twist the truth to keep legislation on our side as long as the laws are obeyed.

On a e-cig sellers forum, it doesn't matter either. A user can say whatever he wants on the sellers forum. As long as it's understood it is the users opinion and not the official view of the seller, there is no problem. If the owners and moderators of that forum are fearful of such views, they can remove the thread.

As long as we obey the laws everything is fine. If we let the powers that be stop us from stating our views and become fearful, then they have already won.
 
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Uncle Willie

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I don't agree. The whole world can openly recognize the e-cig as a stop smoking aid, NRT, drug delivery method - it doesn't matter.. why do you assume that this will cause the FDA and others to try to regulate them under laws designed for those things? It ONLY matters if they are being manufactured and sold as such.

I understand how and why they made the law so I have absolutely no fear that they can change the laws based on this. Again, your mixing apples and oranges, you just cannot see it. It is fear not knowledge that is causing you to feel the way you do.

Big tobacco is selling a product.. they are a seller and manufacturer of the product. they get away with selling them the very way I suggested above, they are making no health claims nor advertising them as a drug delivery device. I do not suggest sellers of manufacturers of E-cigs break the law and claim these things, but no harm whatsoever can come from users making such claims - that is not illegal and does not come into conflict with the ideas of the FDA.

They could never seek to regulate e-cigs as drugs simply because users openly admit ( which is the truth) that the e-cig delivers nicotine, a drug. Regulation only comes into play at the selling and manufacturing level. As long as sellers and manufacturers do not make such claims, there is no problem. I think people can see fearful users shying away from this truth and think we are trying to hide something.. that would be worse. I am all for honesty across the board. We don't need to twist the truth to keep legislation on our side as long as the laws are obeyed.

Sorry, but I disagree .. tobacco use is what made the USA .. it is an ingrained part of our society .. since the Revolutionary War .. and that's why it's still around .. if the analog cigarette were invented tomorrow, it would be banned .. and, BT does make health claims .. on each and every pack sold .. it's just negative health claims ..

The vendors don't need to make good health claims .. many have links to this site and others .. the users and potential users can read all the good health claims they want right here .. and no one should have any doubt that this site is monitored ..
 

VpnDrgn

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We have strayed a bit from the OT, but I'll try to make my point one more time.

Phoenix, you need to do a little more reading about the history of our problems with the FDA.

Last year Judge Leon ruled that ecigs should be regulated under standards for tobacco and not drugs.
Why did he need to make this particular ruling? Because the FDA was actively seizing shipments from
China and were in the process of sending out cease and desist letters to some of the more commercialized
website vendors ( like Johnson Creek ). He agreed that ecigs were a smoking alternative and not a drug
used as a NRT, therefore, the FDA had no jurisdiction and was illegally seizing shipments.

What was the FDA's main defense? That vendors where claiming health and smoking cessation properties
on their websites and in advertising. ( health being stated as under the purview of drugs ) They were using
this angle because there were not enough unbiased studies to use in their argument. Now their are
studies coming out that may reinforce the perception of ecigs as a drug.

As a smoking alternative, ecigs could be classified as a tobacco product. But, if you claim it can be used
to stop smoking then it becomes a drug as far the FDA is concerned. That's why all the vendors stopped
advertising that it helped stop smoking and re-focused on the benefits as an alternative.

You keep coming back to your statement that we can say anything we want as end users, and you are right.
But, the point of my first post was that new studies were acknowledging ecigs as a NRT. If this happens,
the FDA can re-open their argument that ecigs are a drug and Judge Leon's ruling may be overturned.
Couple this with the FDA's new attack on our vendors websites for failing to prevent underage sales,
( even though, I think, technically their is no age restriction because ecigs haven't been regulated yet )
and they are that much closer in getting the courts to allow their jurisdiction in regulating this product.

Most websites have customer reviews and comments stating ecigs helped them quit. Their are 10's of
thousands of members on this forum alone, not counting how many users their are on other forums.
Their are countless thousands of other sites with stories about ecigs and user comments defending them.

But, the FDA has stated many times that these are "anecdotal" evidence at best, and are therefore
inadmissible in any argument for or against ecigs.
 

GregH

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Good luck with that .. in our splintered industry, there are no standards, many are in it for a quick fad money grab and there is not much in the way of organization ..

I completely agree. It is way past time for the vendors to step up and join lead this fight as an industry. (Not counting NJoy and SE, without whom we would already be underground as a black market.) Most days, it seems that it's the consumers who are waging this fight alone, specifically members of CASAA and other individuals who have no financial stake in it. With some exceptions, it's the consumers who are making the calls, writing the letters, leaving the comments, and attending the hearings. Where are the vendors? I hate to say it, but it often looks like a great number of them are simply riding the wave as long as it'll carry them.

So how about it vendors? Show us you're in it for the long term and aren't just looking to cash in. Get together and organize. Put whatever politics and petty grievances you might have with each other aside and talk. Come up with a set of guidelines and standards that all reputable vendors should follow. Put a legitimate face on vaping so we, the consumers, know you care as much as we do.
 

calico21

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In a side note the Homemade/handmade Soap community has managed to do this exact thing by self-regulating. I am a member of that community as well and as such, as long as I make no medical claims I don't even have to label the ingredients in my soap. Strange but true. As a conscientious provider of such products (even though it's only to family and friends) I still properly label all my soap. Is it too much to ask them(vendors)to come to an acceptable agreement as for health and safety standards. A standard by which nicotine level in the juice is regularly tested and verified. (You can do this easily according to DIY forum), and regulations as far as cleaning and sanitation procedures. If /when the time comes that a regulatory force puts some of these things into effect they will at least be a step closer already by saying look we already do this.
 

John Phoenix

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What was the FDA's main defense? That vendors where claiming health and smoking cessation properties
on their websites and in advertising. ( health being stated as under the purview of drugs ) They were using
this angle because there were not enough unbiased studies to use in their argument. Now their are
studies coming out that may reinforce the perception of ecigs as a drug.

As a smoking alternative, ecigs could be classified as a tobacco product. But, if you claim it can be used
to stop smoking then it becomes a drug as far the FDA is concerned. That's why all the vendors stopped
advertising that it helped stop smoking and re-focused on the benefits as an alternative.

You keep coming back to your statement that we can say anything we want as end users, and you are right.
But, the point of my first post was that new studies were acknowledging ecigs as a NRT. If this happens,
the FDA can re-open their argument that ecigs are a drug and Judge Leon's ruling may be overturned.
.


I understand what was done in the ruling and why, I'm saying I know how things got to that point.
I don't think end users perception of an e-cig as an NRT is going to sway the FDA to reopen the case or get the decision overturned at all. As long as the sellers keep adhering to the laws in place now. The fact that it does work so well as an NRT is just a happy side effect of it's use. There is mounting overwhelming proof of this but that in itself does not give the FDA a leg to stand on.

Coffee, tea, soft drinks and water are all used as healthy alternatives to drinking alcohol and encouraged for use to help stop drinking. By your definition coffee tea soft drinks and water should be considered drugs and are obtained via prescription. But that doesn't happen because we know that's silly. This is the same reason why e-cigs will never be regulated as drugs no matter how effective they are as an NRT. I can make the same type of example with dozens of products that replace more harmful drugs. The FDA is just sore that they don't get a part of the pie and have something else they can control, for the money hungry pharmaceutical industry.
 

rothenbj

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Greg, really well stated. I constantly wonder why some trade organization hasn't been formed to at least formulate some minimal standards and as a vendor voice on regulation to combat the ANTZ. The pressure from the FDA, state and local governments is only going to grow. We're like the un-invited party crashers at a huge corporate function.

We're still a minor annoyance to a massive money machine. However, from several thousand to what I believe is over a million US ex/reduced quantity smokers do to harm reduction products in just a few years, critical mass may be approaching quickly. Two massive corporate sectors, untold ?non-profit?"health" associations and government at all levels are threatened by this maverick industry.

Just look at the effort being expended to kill it with "we just don't knows" and "what about the childrens". What's the expression, "If you can't dazzle them with brilliance, baffle them with BS".
 

VpnDrgn

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I understand what was done in the ruling and why, I'm saying I know how things got to that point.
I don't think end users perception of an e-cig as an NRT is going to sway the FDA to reopen the case or get the decision overturned at all. As long as the sellers keep adhering to the laws in place now. The fact that it does work so well as an NRT is just a happy side effect of it's use. There is mounting overwhelming proof of this but that in itself does not give the FDA a leg to stand on.

I specifically stated that the FDA doesn't care what users are saying because they don't consider anecdotal evidence as valid.
They would however be able to use any comments from a study by a medical group that thinks ecigs may be a valid NRT.

Coffee, tea, soft drinks and water are all used as healthy alternatives to drinking alcohol and encouraged for use to help stop drinking. By your definition coffee tea soft drinks and water should be considered drugs and are obtained via prescription. But that doesn't happen because we know that's silly. This is the same reason why e-cigs will never be regulated as drugs no matter how effective they are as an NRT. I can make the same type of example with dozens of products that replace more harmful drugs. The FDA is just sore that they don't get a part of the pie and have something else they can control, for the money hungry pharmaceutical industry.

This is a specious argument at best, and yes, it is silly.

Your last sentence just proves the issue. BP and BT see ecigs as a threat to a multi billion dollar industry. They have influence with the FDA
and the FDA will use any info that it can get to skew perceptions to a negative view of ecigs. Any study by a medical group or any recognized
entity is just more ammo for them. Judge Leon called them on their last suit because they tried to present facts out of context and he didn't
fall for it. But, if they bring another suit with comments from a study that suggest ecigs are a valid NRT, they may be able to get ecigs
recognized as a drug. Their claim failed last time because they tried to spin facts to support their stand, but if they can present facts from a
third party to support them, they have a valid claim.

I guess it all boils down to this:
Vendors need to stand together and regulate themselves or the FDA will gladly step in and do it for them.
As users we need to be aware and talk to our representatives whenever local gov't tries to ban ecigs.

"And that's all I got to say about that" :vapor:
 

Uncle Willie

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I guess it all boils down to this:
Vendors need to stand together and regulate themselves or the FDA will gladly step in and do it for them.
As users we need to be aware and talk to our representatives whenever local gov't tries to ban ecigs.

Nail Hit on Head
 

Vocalek

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VpnDrgn:

I agree with your conclusion.

I guess it all boils down to this:

Vendors need to stand together and regulate themselves or the FDA will gladly step in and do it for them.
As users we need to be aware and talk to our representatives whenever local gov't tries to ban ecigs.

However the FDA would not need to "reopen" the case -- in fact it could not do so -- merely because there are medical studies that prove (some) e-cigarettes do help people quit smoking.

Judge Leon already handled a couple of alternative scenarios in his opinion document:

The "intended use" of a product is determined by "the objective intent of the persons legally responsible" for labeling the product. 21 C.F .R. § 201.128. Objective intent may be shown, for example, "by labeling claims, advertising matter, or oral or written statements" by the labeler.

14 The Tobacco Act certainly contemplates that tobacco products marketed for the therapeutic purpose of treating nicotine addiction might constitute a drug-device combination excluded from the Tobacco Act's definition of "tobacco product." The Act specifically provides that products "intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the Food and Drug Administration and is subject to the requirements of subchapter V of this chapter." 21 U.S.C. § 387k(c).

Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product-whether traditional or not-that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes. 13

This conclusion does not mean that tobacco products can never be classified as a drug or device in the absence of therapeutic claims. A case might arise, for instance, where a manufacturer markets its tobacco product as having a non-therapeutic effect on the structure or function of the body that is different from nicotine. In that circumstance, the product might properly be classified as a drug or device because it is not a tobacco product as "customarily marketed."
http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

So the take-home idea here is that everything hinges on the claims made by the vendor. If a manufacturer wanted to go through the drug approval process, they are free to do so, but cannot make therapeutic claims until they are approved for that purpose. Merely because a product can be used for therapeutic purposes does not make it a drug.
 

mooreted

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If they stop Internet sales of e-cigarettes, liquids and devices I guess I'll have to talk my local tobacco store into selling more than just Cig2o products. Wonder if I could get a bunch of vapors from town to help with that. Maybe vendors should start setting up more brink-and-mortar businesses. Seems like there will be a way to survive this as long as vendors don't claim e-cigarettes are smoking-cessation devices.
 
I'd start with a practice that my web host implements if you want shell access to the server you're leasing:

Require a scanned copy of the individual's Driver's License or State Identification card--one which matches the credit card name used for payments--prior to account creation.
 

mwa102464

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Riddle me this vapors,,,, The FDA cant, doesn't, won't stop all these illegal drugs such as ...... and steroids from coming into this country via China and all over the world, so why are they even looking at ecigs to begin with first ? shouldn't they be more worried about all these other sometimes deadly Pharma products that come in by the millions daily to this country ? They do absolutely nothing about this, the spam and bulk emails sent out by these companies selling these drugs are sent by the millions daily and they can be had with the click of a few buttons, yet they are concentrating on ecigs ? something really stinks here in my opinion !

I agree also with self regulation, maybe Cassa should consider creating there own board to self regulate & control vendors and set there own standards, then the FDA would have one place to go to, it may be a viable option and a good one at that.
 
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