FDA update

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BuzzKill

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Regulation of E-Cigarettes and Other Tobacco Products

They have folded on making Ecigs a Drug devic eand will go with tobacco BUT they will come after us IMO !
I have looked at this very closely , IMO the device ( like a Buzz etc. ) will be fine to sell we may have to change the name from time to time BUT it will be available without FDA regs.

The juice on the other hand is another issue all together !@!!!



Read up everybody.
 

Ruppy

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Its a double edged sword

on the plus side..... They will NOT be banned in the US.
they will be marked as reduced harm it appears, from the FDA memo on their site. This is good as it puts it into a MUCH lower tax bracket.

Juice will be placed into the regulated category. Vendors will have to put a FULL list of ingredients on them. THey will have to register with the FDA. There are also a few other stipulations regarding marketing.

Mike is fully right that PVs themself will NOT fall under the regulation. Nor will cartos or any other hardware provided they do not contain nicotine juice.

Bare in mind it will take a LONG time for this to go into effect. Could be more than a year for them to get it in place. This is provided that no one files suit that it is not a tobacco product lol. Then it could be tied up for two or more years.

THis is a very informative post
http://www.e-cigarette-forum.com/fo...2-fda-regulate-e-cig-tobacco.html#post3084083
 
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GMoney

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Its a double edged sword

on the plus side..... They will NOT be banned in the US.
they will be marked as reduced harm it appears, from the FDA memo on their site. This is good as it puts it into a MUCH lower tax bracket.

Juice will be placed into the regulated category. Vendors will have to put a FULL list of ingredients on them. THey will have to register with the FDA. There are also a few other stipulations regarding marketing.

Mike is fully right that PVs themself will NOT fall under the regulation. Nor will cartos or any other hardware provided they do not contain nicotine juice.

Bare in mind it will take a LONG time for this to go into effect. Could be more than a year for them to get it in place. This is provided that no one files suit that it is not a tobacco product lol. Then it could be tied up for two or more years.

THis is a very informative post
http://www.e-cigarette-forum.com/fo...2-fda-regulate-e-cig-tobacco.html#post3084083

they will be marked as reduced harm it appears,

Unless I read the wrong memo, I have to disagree with you there. It merely states that a tobacco product would need to pass "review" to be labeled as "reduced harm".
 

5cardstud

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Well I hate regulation but at least this stops any ban and it should stop all the seizures at the border. I agree it will take some time unless they have been working on it in case this happened. But I can't imaging the government doing any work it didn't have to do. I know the Pharmaceutics Co. aren't going to like this.
 

Ruppy

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Unless I read the wrong memo, I have to disagree with you there. It merely states that a tobacco product would need to pass "review" to be labeled as "reduced harm".

Ill have to find the article but ecigs only fit into reduced harm. Theres a article about that too Ill try to find it later today. The review is just the formal process for it.

That said the battle is far from over. Anyone that thinks the FDA doesnt have more tricks up their sleeve is a fool. One battle is won. The banning has been stopped. However no the battle for regulation and taxation begins.
 
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PoliticallyIncorrect

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The encouraging/troubling paragraph in the FDA's public announcement is this:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

I don't have a problem with ingredient listing—or, for that matter, good manufacturing practices (although the phrase good manufacturing practice requirements gives me pause; just what sort of flaming hoops would juice makers be required to leap through?)

Shortening the leash on adulteration and misbranding doesn't bother me either; we can all survive just fine without certain sleazeballs in our midst that spike their juices with erectile dysfunction drugs, or sell bottles of 100% nicotine.

Where the language is vague and the meaning potentially catastrophic is in terms such as general controls, registration, user fees and premarket review.

At best, that probably adds up to sudden death to small, mom & pop juice makers—the sort for whom a good vape is a labor of love first, a business second (think pre-CBS Fender guitars).

At worst, all those general terms could prove to be sticks used to beat the vaping community into submission; they might not kill us, just make us wish we were dead.
 

Ruppy

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The encouraging/troubling paragraph in the FDA's public announcement is this:

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

I don't have a problem with ingredient listing—or, for that matter, good manufacturing practices (although the phrase good manufacturing practice requirements gives me pause; just what sort of flaming hoops would juice makers be required to leap through?)

Shortening the leash on adulteration and misbranding doesn't bother me either; we can all survive just fine without certain sleazeballs in our midst that spike their juices with erectile dysfunction drugs, or sell bottles of 100% nicotine.

Where the language is vague and the meaning potentially catastrophic is in terms such as general controls, registration, user fees and premarket review.

At best, that probably adds up to sudden death to small, mom & pop juice makers—the sort for whom a good vape is a labor of love first, a business second (think pre-CBS Fender guitars).

At worst, all those general terms could prove to be sticks used to beat the vaping community into submission; they might not kill us, just make us wish we were dead.

Somewhere on the FDA site is a list of the good manufacturing requirements PI. This is definitely a point that will bring some problems. Manufacturers will be required to show evidence that they have a legitimate preparation area with appropriate facilities. This dosent mean that people cannot do it out of their home it just means you cant use your kitchen table. A specific area with non porous surfaces must be established. It reads very similar to the requirements for a food preparation area.

Take a trip over to Johnson Creeks site and read a little about what they did to register with the FDA. Vapor4life is in the process of doing it now as well.

I hope noone misunderstands me. There are still big problems to overcome. However this step means we will be able to legally vape. Everyone needs to get involved to ensure we get to do it on our terms. This is not a victory really but more of a step in the right direction.

Its not going to be the fact that the little companies CANT do it, its going to be a question of if they WANT to do it. It will take time, investment, and patience.
 

Poppa D

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Hopefully when its all said and done the industry will evolve into a better product.
As things are now its a lot like white lightning, that's always just been the accepted norm.
I personally hope its all for the better.
In the future I'll be able to go get a bottle of BWB when ever I want it, cash and carry.
 

Ruppy

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Well said Ruppy , I did NOT sell Juice for a long time because of the liability potential , the juice I have is from another MFG in the USA who from what I am told has set up a FDA type lab.
Yep thats the key right there Mike. You dont make the Juice. As long as your supplier registers thats all that matters. Im sure that they will be required to send you a certificate for your file and thats it. You might eventually have to add a tax to the price. Beyond that business as usual.
We all new this day would come , now it has ! we will just have to wait and see what takes place , st least we do know that they will not be BANNED ! and that is the main thing IMO .
Absolutely. Now is everyones chance to fight for what we want. A handful of vapers cant win, CASAA cant win, National vapers cant win. ALL of us together can absolutely make the politicians and the FDA listen. There are enough vapers now that united we can absolutely wield some power. People can complain all day long about the government but in the end WE are the only ones that can reshape it.


Hopefully when its all said and done the industry will evolve into a better product.
As things are now its a lot like white lightning, that's always just been the accepted norm.
I personally hope its all for the better.
In the future I'll be able to go get a bottle of BWB when ever I want it, cash and carry.
There is definitely the potential for this to turn out as a positive for consumers in the end. It will take involvment. I definitely see ALOT more Brick and Mortar shops opening.
 

5cardstud

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Well if anyone didn't think the government was going to latch onto this cash cow (no offense Bovinia) they are very naive. That's were our government is at it's best. The more you have the more they take.
They'll be selling ecigs and juice in every store around. K Mart, Target, Walley World etc..
 
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BuzzKill

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Well if anyone didn't think the government was going to latch onto this cash cow (no offense Bovinia) they are very naive. That's were our government is at it's best. The more you have the more they take.
They'll be selling ecigs and juice in every store around. K Mart, Target, Walley World etc..

This will definitely open up that market 5CS , if stores were holding off for the FDA the time is now .
 
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