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

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laurel099

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Anyone know about this yet?? Scary stuff to consider :(

76 FR 55835 - Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products

76 FR 55835 - Non-Face-to-Face Sale and Distribution of tobacco Products and Advertising, Promotion, and Marketing of tobacco Products


Summary: The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. FDA is taking this action as part of its implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is requesting comments, data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients.
 

calico21

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Crap, crap crap!!!!!!How do we store Nic mixes again? Pre-mixed juice? Could they just have an age verification system like certain unmentionable web sites do? Shouldn't my dang credit card be enough! How about all those jobs we're supposed to be creating? I'm so sick of government PERIOD! There is no brick and mortar shop around here that carries VG juices.( Anyone wanna start one, I have management experience.) I may be done ranting not sure yet?!?
 

VpnDrgn

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This bares out what I said in another thread, here, about new research that cites E-cigs as a viable NRT.

People seem to forget that we DON'T want E-cigs seen as a stop smoking aid, because that allows the FDA
to claim it is a drug and can regulate it under much more strict ( and expensive ) procedures.
Not to mention lengthy clinical drug trials, unless you're "Big Pharma" and know how to push through
trials on the fast track with the help of your good buddies at the FDA. :facepalm:

For now, the FDA can only regulate as a tobacco product, so they are going after our main distribution point.
I think it behooves our vendors to make sure that all "point of sales" have proper age verification in place,
and all advertising has age restriction notification. ( IMO this should include banners )
 

KTaylor

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The owner of my local brick and mortar told me about this last week. He said it came about in large because they have had a few instances where juveniles under the age of 18 used their debit/check cards and ordered juice and hardware from online vendors. We spoke in great length about it (over an hour). I only hope that it will not be a knee jerk type reaction in the forming of regulations. We all know that clicking on the "I'm over 18" thing is a joke. It's sad that the use of a credit card in the past meant that you WERE of legal age, but now days kids have check cards that work like credit cards. This will definately be a pain for all of the great vendors out there that have worked hard to run an honest business, provide jobs and convenience to the consumer. I think something as simple as a photo ID verification system could be put in place to fix the issue, but we all know that the FDA and BT are going to make things difficult.
 

VpnDrgn

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When I got my first bank account, I had to sign paperwork because I was a minor. Don't they still do that?
It seems the bank should be able to incorporate the age in with the ID verification for online transactions.

Seems like this would help with preventing kids from getting other questionable materials online.
Of course, our gov't would never institute a procedure that would be that efficient.

And why should my liberties be restricted because parents can't monitor their own children?!!

Uh Oh.. I feel a rant coming on... :facepalm:
 

KTaylor

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And why should my liberties be restricted because parents can't monitor their own children?!!

Uh Oh.. I feel a rant coming on...

LOL!!! VpnDrgn, I actually deleted the same statement before I hit post. I agree 10000000%. The problem is that mommy and daddy can get an extra card for the kid on their acct and of course there's no monitoring of what little johnny is buying on the internet. I'm with you on the whole ID verification thing. It should have been in place a long time ago, it can't be that hard to implement.
 

laurel099

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Yeah don't get me started on parents that don't monitor their children :(

I will say that I have bought wine online and when it was delivered the delivery person had to verify I was over 21...had to sign for package. Someone else mentioned the same thing happens when they order Snus. It makes delivery cost a bit more but... does verify age.

I worry about how many mom/pop online shops would be put out of business if they restrict internet sales. Also, they look to change rules for advertising/mkt'ing for the products.. hell that could even change the way vendors are allowed to advertise online - might be really bad for ECF too.

:( Whole thing STINKS! Last time I checked - tobacco products - yup - are still freaking legal :(
 

x-smok3

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I have ordered my first DIY nic liguid for just this kind of thing. I don't plan on getting into DIY unless I have to but I want to be prepared for the worst case. RTS prices are very reasonable and from the DIY forum they have quality liquid so I figure it is best to be prepared.
I may be wrong about this but I suspect within 6 months we will either be severely limited or completely out of luck in getting E-liquids with nic and possibly any tobacco flavoring as well.
 

John Phoenix

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This bares out what I said in another thread, here, about new research that cites E-cigs as a viable NRT.

[ People seem to forget that we DON'T want E-cigs seen as a stop smoking aid, because that allows the FDA
to claim it is a drug and can regulate it under much more strict ( and expensive ) procedures. ]

I disagree with the statement I have placed in brackets.

Hell YES I want it widely publicized that E-cigs are a great stop smoking aid. I not only want this I feel it should be a main attraction for e-cigs with never a doubt right next to " It can be a great smoking alternative."

If a Billion users stood up and proudly proclaimed how great the e-cig is as a stop smoking aid it would make no difference to the laws on the books and legally, it could not, once you understand why the law is there and who it protects.

Only for legal reasons the e-cig cannot be sold or advertised as a stop smoking product by manufacturers and sellers. The using public has no such restrictions and should Not have.

This law's roots goes back years to the 80's when with the FDA's help they made a "law" that says in effect " Only a FDA approved Drug can cure disease and or be administered with an FDA approved delivery method"

If you claim that e-cigs are "safer" than regular cigs or that they are a drug delivery device you then are making a health claim that steps on this laws toes. Cannot have that for legal reasons, but that does not make it any less true.

The Fact that e-cigs ARE " drug delivery devices " and the Fact that they ARE " safer than cigarettes " was really Never in dispute - It is silly to dispute this in court when the majority of evidence is overwhelming in favor of these issues. Example, Cigarettes themselves Are drug delivery devices yet, they are sold publicly because they make no health claims.

So what the smart e-cig lawyers did was work within already established law to get the judge to rule in their favor. They used knowledge of the above law to cause the case against them to backfire. This got the e-cig companies on trial off the hook only with the stipulation they don't make any health claims or sell them as drug delivery devices where they must only be regulated by the FDA.

Like cigarettes, it took the issue out of the FDA's hands. E-cigs being safer than cigarettes or drug delivery devices was never in and of itself, on trial. So the public can claim these things all they want till the cows come home and rightfully so because people NEED e-cigs to be stop smoking aids. I know it's what has drawn myself and many others to use an e-cig and thank the heavens.

A user making these claims are 100% within their right to do so and they will not, cannot change the law based on this because they would then be trying to compare apples and oranges.. two distinct different issues from the issues of the trial and it's decision.

I could have a big road side banner seen for miles that says, " E-cigs - The Best way to Quit Smoking Cigarettes! E-cigs are Safer than cigarettes and Deliver Nicotine without harmful Smoke. E-cigs can help Save your Life Today! " and as long as I'm not selling them, it's all good and legal.
 
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Hiryu

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Is there any way vendors, companies, organizations and distributors can send a class action suit against the FDA? I mean, all the research and numbers contradict everything the FDA and assorted politicians say about e-cigs, and the lies simply cannot hold up under scrutiny.

Otherwise, the FDA will just keep on going until every American e-cig related job is destroyed and we are forced to either go back to smoking or get supplies from China - until they also ban them at customs, of course.
 

Uncle Willie

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Is there any way vendors, companies, organizations and distributors can send a class action suit against the FDA? I mean, all the research and numbers contradict everything the FDA and assorted politicians say about e-cigs, and the lies simply cannot hold up under scrutiny.

Otherwise, the FDA will just keep on going until every American e-cig related job is destroyed and we are forced to either go back to smoking or get supplies from China - until they also ban them at customs, of course.

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 ..
 

VpnDrgn

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If a Billion users stood up and proudly proclaimed how great the e-cig is as a stop smoking aid it would make no difference to the laws on the books and legally, it could not, once you understand why the law is there and who it protects.

Only for legal reasons the e-cig cannot be sold or advertised as a stop smoking product by manufacturers and sellers. The using public has no such restrictions and should Not have.

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.

- 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.

I saw a video on here that Leaford posted, showing the mnf facilities in China. Everything was lab grade equipment with people wearing
smocks, head covers, and footies. The production areas were kept spotless with controlled air locks like you would see in a clean
room for mnf computer chips or disease control. I'm sure China can produce products for such a cheap price because they already
had these facilities for mnf other products, they just had to re-purpose the production lines. The same way Big Pharma and Tobacco
already have the facilities for producing drugs and processing tobacco. It would cost them pennies compared to the expense
of setting up the necessary facilities to meet FDA regulations from scratch.

Do you see any current vendors being able to meet stringent FDA controls with their current facilities?!

While I would love to join you on that mountain top to proclaim to the world that I stopped smoking with the use of ecigs, and
encourage all smokers to leave behind evil tobacco. I am pragmatic enough to realize that this would play into the hands of the FDA.

We want the courts to keep agreeing with us that ecigs are a smoking alternative and should be regulated as tobacco, not drugs.
This allows for much looser regulations, and it behooves us to make sure that we don't provide any other ammunition for the FDA
by making sure that we control the purchase of ecigs. After all, "harming the kids" is the FDA's, and other detractors, biggest bullet
in targeting ejuice and ecigs in general.

Just to give you an example; if you post on a vendor website, "E-cigs are safer than smoking and help to stop smoking.", then the FDA can
claim that we are making false and misleading claims because there has been no clinical trials to verify these statements as facts.
If however, a vendor post the statement "E-juice does not contain many of the harmful chemicals that smoking tobacco produces,
and many users have stated that they were able to use ejuice as a smoking alternative.", then we are making claims that can
be defended and verified.

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?
 

Uncle Willie

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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 .. ??
 

VpnDrgn

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Well, clinical trials could take ejuice off the market for years.
If ejuice were to be made available only by prescription, as a smoking cessation drug,
how long do you think the doctors would let you keep using it after you stopped smoking?
Everything else would just pump up the price, a lot.
And, would put 99% of the industry, as it stands now, out of business.

The end product might be made a lot more safer, but how many people would be able to afford access?!

I believe there should be some regulations, but only in the way of reasonable precautions.
Some monitored procedures to guarantee uniform quality control, verified nicotine levels, and acceptable
sanitary practices, would increase the price some but not make it exorbitant or put it out of reach for
existing vendors.

I mean, hell, I don't want to buy juices from Bubba, that were slopped together in the garage.
But, reasonable regulations should avoid the necessity for laboratory grade mixing facilities.
 

Uncle Willie

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Well, clinical trials could take ejuice off the market for years.
If ejuice were to be made available only by prescription, as a smoking cessation drug,
how long do you think the doctors would let you keep using it after you stopped smoking?
Everything else would just pump up the price, a lot.
And, would put 99% of the industry, as it stands now, out of business.

The end product might be made a lot more safer, but how many people would be able to afford access?!

I believe there should be some regulations, but only in the way of reasonable precautions.
Some monitored procedures to guarantee uniform quality control, verified nicotine levels, and acceptable
sanitary practices, would increase the price some but not make it exorbitant or put it out of reach for
existing vendors.

I mean, hell, I don't want to buy juices from Bubba, that were slopped together in the garage.
But, reasonable regulations should avoid the necessity for laboratory grade mixing facilities.

I agree with your comments .. however, the only way our industry will ever see consistency, safety and quality is thru some form of intervention as it appears no one is attempting any movement in that direction privately .. and that's sad, IMO and will be the downfall .. essentially due to the vendors / distributors and makers lax and uncaring direction ..
 

VpnDrgn

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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.
 
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