FDA FDA deeming regulation proposals

[twgbonehead]

They're vague about the diffo between "components and parts" vs "accessories." But keep in mind that the statute lets them regulate both. They could issue another proposed rule later, and ban EGO carrying cases and Provari tee shirts. That's not as funny as it may seem: you can't get "Marlboro" gear anymore.

Anyway since the statute lets them regulate both, they can draw the line anywhere they please. Zeller has said that "components or parts" are "intended or anticipated for use w/ a covered tobacco product." Does that refer to Provari tee shirts? Probably not. Does it include all the equipment that we currently use, including drip tips? Yes, it could. Of course they are not going to regulate 186xx batteries, that's just silly and impractical because they have so many other uses. Ditto PG, VG, water-soluble flavorings.

It's the stuff that's essential to and unique to vaping that they can (and most of us think will) go after.

Roger,

I guess one important difference is that "components and parts" WILL need to go through the certification process, whereas accessories will not under the current plan. So, while ProVari T-shirts are not safe forever, they would seem to be safe for now. Whereas EVOD heads are definitely in danger.

I can get tons of Marlboro gear from my basement. I'm not proud of that fact.

 

[Jman8]

Jman8

Why do I get the feeling you are consulting with others to see how you can tangle this bet to keep me quiet?
I am starting to wonder about you.

I am not consulting with anyone on this bet. You are welcome to come to my physical location, observe me for as long as you desire, and watch as I type daily on ECF.

This idea of me as a shill of some sorts or having any sort of amicable relationship with shills is fascinating. When all else fails in getting across our message of despair, let's go after the people that disagree with this?

Who on this site advocates for vaping everywhere? Today, I was sitting in appointment to discuss health insurance, from a provider. Vaped during that appointment. Am still batting 1.000 in my vape everywhere universe. I still think it is 'most reasonable' position to have at this time. While not having much to do with FDA proposals, it has a lot to do with what we are currently up against.

And if you keep saying no one will take you up on this bet, I will not remain silent.

And I am glad. Though I do seek clarification, partially for your benefit. I'd rather make a fair bet that is understood clearly by both parties going in, then just win the bet (easily) cause you didn't realize, until later on, that you agreed to something else.

 

[twgbonehead]

This is true, but you really must see it from a Realistic stance. A Toilet Paper or Paper Towel roll "CAN" be used to smoke tobacco, anything on this planet CAN be used to make an ecig. They cannot possibly regulate everything on the planet. It is simply impossible for them to gain full control over this industry. It Cannot Be done realistically.

Yes, but there are people saying "If you order a ProVari (or a Reo, or a Mech Mod, I don't mean to pick on the Provarinatti) and order a flashlight head as well, they can't touch you".

It's not true. They can take vendors to court, and have customs seize stuff that's coming in.

They might not be right, but the vendors then have to pony up a bunch of money to defend themselves. Remember, the FDA doesn't have to stop ALL shipments, it just has to stop enough to intimidate the vendors.

Look at the situation in Canada, where even though nic liquid is NOT illegal, shipments still get seized, due to intentional mis-interpretation of the laws.

 

[DC2]

I am not consulting with anyone on this bet. You are welcome to come to my physical location, observe me for as long as you desire, and watch as I type daily on ECF.

Well, Wisconsin is one of the few states I have not been to yet.
I might take you up on that.

And I am glad. Though I do seek clarification, partially for your benefit. I'd rather make a fair bet that is understood clearly by both parties going in, then just win the bet (easily) cause you didn't realize, until later on, that you agreed to something else.

Okay, then see my other post above in order to approach clarification.

I don't mind losing the money, but if you're going to keep saying that no one will take you up on the bet then I will be seeking that bet.
It's a bet I don't mind losing, which is why I can't imagine anyone else taking you up on it.

But I will.

 

[Sirius]

There is something that I do not quite understand about the legality of the FDA holding out its hand and demanding that business owners put millions upon millions into its outstretched hand or go out of business.

Say, there is this shop operating on some street, this mom and pop store.
The store is going well, and mom and pop can live on the proceeds.
One day, a couple of .. let's say "guys" .. see this shop, and they walk into the shop and say:
"Hey, you, shop owner! You got this shop going here. And you are making money. And we are not getting any of that money.
This will stop right now! Starting today, you will give us a big portion of your earnings.
If you do, we will let you stay in business. And we will "protect" your shop.
But if you do not, then we will smash all your merchandise and we will burn your shop to the ground!"

Hm.. if private people act this way, it is called extortion.
But if a government agency acts this way, demanding big amounts of money for nothing, it is called "regulation"?

Something is very, very wrong.

Anja -- They are known as Government Bullies sweetheart..No less than legalized Mafia. They do it because they can. See IRS, NSA, FBI, FDA, CDC,and CIA.

 

[Devonmoonshire]

Yes, but there are people saying "If you order a ProVari (or a Reo, or a Mech Mod, I don't mean to pick on the Provarinatti) and order a flashlight head as well, they can't touch you".

It's not true. They can take vendors to court, and have customs seize stuff that's coming in.

They might not be right, but the vendors then have to pony up a bunch of money to defend themselves. Remember, the FDA doesn't have to stop ALL shipments, it just has to stop enough to intimidate the vendors.

Look at the situation in Canada, where even though nic liquid is NOT illegal, shipments still get seized, due to intentional mis-interpretation of the laws.

Yeah that is very true. So they change their company name from say Provape to Prolight or some derivative thereof. They are no Longer selling vaping gear, they are selling actual flashlights. The fact that the end user takes the bulb housing off of said flashlight and places an atomizer on top instead is strickly out of the companies hands.

You are correct, Nicotine content is going to be the largest hurdle to overcome. That is going to make it unappealing to most people, if it doesn't contain nicotine then what's the point? Well I can and have gone zero nic on many occasions and done just fine, I like my nicotine for sure, but I know that I personally can live without it as for me it is more of a physiological habit than a chemical dependency anymore.

Personally I think someone in the Government should grow a pair and put their foot down and tell the FDA to go back to the drawing board because they are stomping all over the entire definition of what it means to be an American with these unfair and discriminatory regulations they are proposing.

 

[Sirius]

Yeah that is very true. So they change their company name from say Provape to Prolight or some derivative thereof. They are no Longer selling vaping gear, they are selling actual flashlights. The fact that the end user takes the bulb housing off of said flashlight and places an atomizer on top instead is strickly out of the companies hands.

You are correct, Nicotine content is going to be the largest hurdle to overcome. That is going to make it unappealing to most people, if it doesn't contain nicotine then what's the point? Well I can and have gone zero nic on many occasions and done just fine, I like my nicotine for sure, but I know that I personally can live without it as for me it is more of a physiological habit than a chemical dependency anymore.

Personally I think someone in the Government should grow a pair and put their foot down and tell the FDA to go back to the drawing board because they are stomping all over the entire definition of what it means to be an American with these unfair and discriminatory regulations they are proposing.

Not if it's Devans 100% Natural Bug Repellant ( contains 6mg nicotine) Guaranteed to fog mosquitoes off of your lips.

 

[DC2]

Not if it's Devans 100% Natural Bug Repellant ( contains 6mg nicotine) Guaranteed to fog mosquitoes off of your lips.

Unfortunately, vaping seems to attract the mosquitoes rather than repelling them...
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/306815-side-effect-vaping.html
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/434954-mosquito-attraction.html

 

[Jman8]

I'm not understanding how a black market is a good outcome.

It is not an inherently good outcome, though it could be good from a number of perspectives. Regulators would likely disagree, vehemently.

If the only place to get vaping products is the black market, then the FDA successfully regulated it out of existence.

That doesn't make sense. All things currently on the black market are not "out of existence." It is true that they may not be distributed thru a legally authorized market, but then again, they could be. There is a black market currently for smokes, for prescription drugs, and other things that are sold legally. But because they are marked up mostly to entirely to satisfy government regulations, then another underground market has been established.

Clones that exist today are essentially an underground market product. I'm not sure who in the U.S. would call that a legal product.

I think it is easy to buy into notion that "black market" equals dark, nefarious, and possibly very dangerous to be involved with. IMO, that depends greatly on the product. Perhaps underground market, a synonym, would make that connotation different. If I DIY some juice, and am good at it both in terms of quality and taste, and you in turn wish to have some, then I may seek some sort of compensation so I can produce enough to satisfy both you and me. Once you have given me money, you are possibly engaged in an underground market. If I have arrangement that I have with you with 100 other people, that underground market is bigger.

The more buyers I can obtain, the better my business would be, and the less likely it is that the product will be out of existence. If demand goes down to zero, it wouldn't matter how much supply is around. If I have 10 million buyers, for 50 years, not only am I going to be very wealthy, but depending on how things go with my buyers, I will establish a viable scenario where the government will be seen as engaging in deception and poor regulation management, not due to concern for public safety, but for reasons that will look a lot like government overreach.

I'm really concerned about this whole thing. I'm not going to go looking for illegal dealers

Some so called illegal dealers could be the 'best people around.' If eCigs truly save lives, like we all say they do, then one who is selling/distributing in an underground market will be akin to service provider, from a certain perspective. From the ANTZ side of the equation, they will be known as dirty, seedy, harmful dealers.

Who are targeting America's youth.

 

[Jman8]

There is no time period.

My bet would be the NO small business will ever be able to produce their own flavored e-liquids and have them approved by the FDA.
Ever means ever.


As far as what is a small business, well that's a sticking point isn't it.
I think that what that means is pretty clear to those that know what's going on here.

But just to make it crystal clear, you tell me what you think it means for the purposes of the bet.


EDIT: And yeah, if you're going to go with ECBlends then I would count them as a small business
EDIT: In other words, they would never get any flavor approved

Just one last bit of clarification.

"approved" equals "compliant" - yes?

Your side of the bet is saying that once FDA rules are in effect, and any business can submit a "market application" to FDA for compliance of their product under TCA, that zero will be approved when it comes to flavored e-liquids that they produced.

Just to clarify, for you benefit, this means e-liquids with nicotine, yes?

And if ECB is game for the bet, and assuming we are on same page for other items above, then yes, I accept your wager.

 

[Jman8]

I don't mind losing the money, but if you're going to keep saying that no one will take you up on the bet then I will be seeking that bet.
It's a bet I don't mind losing, which is why I can't imagine anyone else taking you up on it.

But I will.

What I see as inherently unfair to you, is that I get forever to have just one flavor go thru, and you would be forced to pay the moment that a flavor does go thru, in say 2015. Perhaps, we could say by 2020, to help your side of the wager?

I think your recourse could be that it wasn't a small enough business, but if ECB is fair game, then really there aren't a whole lot of companies other than BT, and maybe 4 others that are excluded. I'd be very up for you creating a list, before bet goes into play, which excludes companies that you say are for sure not small business.

 

[Sirius]

Unfortunately, vaping seems to attract the mosquitoes rather than repelling them...
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/306815-side-effect-vaping.html
http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/434954-mosquito-attraction.html

Well since the FDA is stupid enough to call vaping smoking and juice tobacco I just figured......lol

 

[neutrontech]

It is not an inherently good outcome, though it could be good from a number of perspectives. Regulators would likely disagree, vehemently.



That doesn't make sense. All things currently on the black market are not "out of existence." It is true that they may not be distributed thru a legally authorized market, but then again, they could be. There is a black market currently for smokes, for prescription drugs, and other things that are sold legally. But because they are marked up mostly to entirely to satisfy government regulations, then another underground market has been established.

Clones that exist today are essentially an underground market product. I'm not sure who in the U.S. would call that a legal product.

I think it is easy to buy into notion that "black market" equals dark, nefarious, and possibly very dangerous to be involved with. IMO, that depends greatly on the product. Perhaps underground market, a synonym, would make that connotation different. If I DIY some juice, and am good at it both in terms of quality and taste, and you in turn wish to have some, then I may seek some sort of compensation so I can produce enough to satisfy both you and me. Once you have given me money, you are possibly engaged in an underground market. If I have arrangement that I have with you with 100 other people, that underground market is bigger.

The more buyers I can obtain, the better my business would be, and the less likely it is that the product will be out of existence. If demand goes down to zero, it wouldn't matter how much supply is around. If I have 10 million buyers, for 50 years, not only am I going to be very wealthy, but depending on how things go with my buyers, I will establish a viable scenario where the government will be seen as engaging in deception and poor regulation management, not due to concern for public safety, but for reasons that will look a lot like government overreach.



Some so called illegal dealers could be the 'best people around.' If eCigs truly save lives, like we all say they do, then one who is selling/distributing in an underground market will be akin to service provider, from a certain perspective. From the ANTZ side of the equation, they will be known as dirty, seedy, harmful dealers.

Who are targeting America's youth.

I never said dealers would be bad people. It is irrelevant who is selling. However I would be breaking the law purchasing from them. I'd rather not have to hide my vaping or be afraid of being pulled over after a sale. I'm not going on the Silk Road to buy nicotine, just like im not going on there to buy any other drug. I wouldn't buy from you or anyone else, if it were illegal. That means the FDA successfully got me to stop vaping, hence they win.

Off topic, but I live in the US and I consider clones to be a legal product, as long as they are forthcoming with the fact it is a clone and the original maker hasn't objected.

Sent from my SCH-I605 using Tapatalk

 

[DC2]

Just one last bit of clarification.

"approved" equals "compliant" - yes?

I'm not sure what "compliant" means, but I am talking about being allowed to be marketed and sold by the FDA.
Which from what I understand means passing the Premarket Tobacco Approval.

Your side of the bet is saying that once FDA rules are in effect, and any business can submit a "market application" to FDA for compliance of their product under TCA, that zero will be approved when it comes to flavored e-liquids that they produced.

No, I'm saying that no small businesses will will be approved.

Because none of them will spend the money to submit the application.
Or they will submit it in such a manner that it will be rejected or returned for further effort.

My bottom line is that under no circumstances, for whatever the reason, will any such e-liquids from small vendors EVER be approved.
Or "be allowed to be marketed and sold" if you prefer that wording.

Just to clarify, for you benefit, this means e-liquids with nicotine, yes?

Yes.

And if ECB is game for the bet, and assuming we are on same page for other items above, then yes, I accept your wager.

Okay, how much and who do you want to hold the money?

I think your recourse could be that it wasn't a small enough business, but if ECB is fair game, then really there aren't a whole lot of companies other than BT, and maybe 4 others that are excluded. I'd be very up for you creating a list, before bet goes into play, which excludes companies that you say are for sure not small business.

That's nice of you, and I wouldn't mind you doing that.
But I don't need it to make the bet.

 

[Myk]

Personally I think someone in the Government should grow a pair and put their foot down and tell the FDA to go back to the drawing board because they are stomping all over the entire definition of what it means to be an American with these unfair and discriminatory regulations they are proposing.

Even worse. The FDA is stomping all over the intent of the law and trying to hold tobacco at a certain time in history and not allowing any progression.

Not allowing a new flavor of chewing tobacco doesn't do anything to "cure" tobacco addiction. Not allowing harm reduction products does the opposite and continues the old school addiction.

 

[Devonmoonshire]

Even worse. The FDA is stomping all over the intent of the law and trying to hold tobacco at a certain time in history and not allowing any progression.

Not allowing a new flavor of chewing tobacco doesn't do anything to "cure" tobacco addiction. Not allowing harm reduction products does the opposite and continues the old school addiction.

I think more than trying to halt progression, they are simply leveraging their authority to stall it until they can gather their wits about them and make it into something THEY and THEY alone can profit from.

That is the long and short of it. They are greedy and they are losing money therefore they abuse their authority to squash the competition.

Under the guise of "Save The Children" and "Protect Public Health" which are two things they have no care in the world about which is obvious by the lethal drugs they push through all the time.

 

[Roger_Lafayette]

Even worse. The FDA is stomping all over the intent of the law and trying to hold tobacco at a certain time in history and not allowing any progression.

Not allowing a new flavor of chewing tobacco doesn't do anything to "cure" tobacco addiction. Not allowing harm reduction products does the opposite and continues the old school addiction.

No one really knows what Congress intended regarding vaping, when the FSPTCA was passed back in '09. (At least I don't think so ... maybe there's some stuff in the Congressional Record about it.)

Congress certainly knew or could've easily discovered that smokeless tobacco was incredibly effective at THR. Snus has been around forever, and Congress has had numerous opportunities (under both parties) to order the FDA to embrace it as harm reduction.

I'm no defender of the FDA, but let's not let the US legislative and exective branches off the hook (or either party, for that matter).

They're the real enablers of the FDA.

And ultimaely - if we, the American people - had been informed and taken action, millions of smokers' lives would've been saved (provided we accept the statistics about the death toll from cigarette smoking).

 

[DC2]

I think your recourse could be that it wasn't a small enough business, but if ECB is fair game, then really there aren't a whole lot of companies other than BT, and maybe 4 others that are excluded. I'd be very up for you creating a list, before bet goes into play, which excludes companies that you say are for sure not small business.

That's nice of you, and I wouldn't mind you doing that.
But I don't need it to make the bet.

Sorry, I misread that, I thought you were offering to make such a list.

Here is my list then...
--Phillip Morris/Altria
--RJ Reynolds
--British American Tobacco
--Lorillard/Blu
--NJoy
--Logic
--Mystic
--V2

I hope I didn't miss any, as it could cost me a pretty penny.

So let's do it this way then...
The list includes anyone making under $1M in revenue per year.

But the real idea is that it will only be cigalike vendors with tobacco and menthol flavors.

 

[Stosh]

No one really knows what Congress intended regarding vaping, when the FSPTCA was passed back in '09. (At least I don't think so ... maybe there's some stuff in the Congressional Record about it.)

Congress certainly knew or could've easily discovered that smokeless tobacco was incredibly effective at THR. Snus has been around forever, and Congress has had numerous opportunities (under both parties) to order the FDA to embrace it as harm reduction.

I'm no defender of the FDA, but let's not let the US legislative and exective branches off the hook (or either party, for that matter).

They're the real enablers of the FDA.

And ultimaely - if we, the American people - had been informed and taken action, millions of smokers' lives would've been saved (provided we accept the statistics about the death toll from cigarette smoking).

Regarding Swedish snus, there are decades of studies, yet the FDA and the government has dismissed the science. Hopefully we are not following the same path as snus users have had to endure.

Here's some science and then some very scary reading about what can be done to an industry....

The Swedish experience

Research on snus

Systematic review of the relation between smokeless tobacco and cancer of the pancreas in Europe and North America.

http://www.e-cigarette-forum.com/forum/smokeless-tobacco/55977-pact-act-concerns.html

 

[aikanae1]

I think when the Master Settlement Act was signed, back in the '90's that Gohshall was quoted saying something about the act "created an unholy alliance between tobacco companies and government". Not only was he right, but I think he nailed it that it's bigger than any administration.