Deeming Regulations have been released!!!!

[Rossum]

When I can make my own, or trade with/buy from a neighbor...
How long can such a "regulated" market sustain itself?

You can grow your own smoking/chewing tobacco too, and some people actually do that, yet there's a pretty big regulated market for such products.

This is disruptive technology at it's finest.
And it's going to disrupt things big time for a long time.

It's disruptive for those of us who've already gotten to know it in its free, unregulated condition. But five years from now, when a smoker is thinking about switching, do you think he'll turn to the informal market that we will certainly maintain, or do you think he'll go for FDA-Approved vapor products (assuming the FDA actually approves some)?

My guess is THEY will establish and maintain a stranglehold for as long as possible. And that's going to start and end with free-roaming nicotine.

I don't doubt they will make some attempt at some point. The question is when, and how effective they'll be.

 

[DC2]

Arguing over raw or pg/vg mixed nic is moot. It is grandfathered in under the FSPTCA. It is not regulated as a drug either but as an herbal supliment which is why BP doesn't need FDA approval for their stuff and you don't need a prescription. BP made that case ages ago for gum and patches and their inhaler so it can be sold over the counter without age limits or pmta/pmdr.

It's been around since at least the 60's in the form of lobelia or other tobacco herb extracts. Earlier than that if you look at some of the witch doctor brews from the 1800's only then it was mostly called Indian or red man tobacco unless it came from Europe.

I'm sorry dude, but this is completely wrong.
And I have to point that out, because it is really important.

Big Pharma nicotine products have a pass because they are drugs.
And drugs are not covered by the FSPTCA, and are subject to a different set of regulations.

I don't know, maybe I was misunderstanding you?
I haven't known your posts to be as off-base as that one seemed to be.

 

[Alexander Mundy]

Nicotine itself has USA suppliers with FDA approved Nicotine and no requirement for the buyer. Now whether it stays that way or not is anyone's guess.

 

[DC2]

You can grow your own smoking/chewing tobacco too, and some people actually do that, yet there's a pretty big regulated market for such products.

The time and effort needed to produce your own is extensive compared to the regulated cost.
But DIY e-liquids take very little time or effort, and cost nearly nothing.

Free-roaming nicotine makes or breaks the entire vaping world.
Cost will be a very significant factor, but only if availability continues to exist.

 

[DC2]

Nicotine itself has USA suppliers with FDA approved Nicotine and no requirement for the buyer. Now whether it stays that way or not is anyone's guess.

What do you mean by "nicotine itself" would be my question.
Because I don't think any such product is grandfathered under the current deeming.

 

[Alexander Mundy]

The purity we can't discuss except in passing has been for sale with FDA approval numbers for a long time so I'll leave it at that.

 

[Lessifer]

A thought just crossed my mind. Isn't nicotine already grandfathered in? Surely it was marketed prior to the date. Even as lab material some had to be used to study nicotine as derived from tobacco
for medicinal purposes. China was certainly selling e-juice to the states then. Would nicotine
in a completed tobacco product (cigalike cartridge) count?
Regards
Mike

Categories of products cannot be grandfathered in, only specific products. So, if someone had a nicotine product that they sold in the US before february 2007, then THAT PARTICULAR product would be grandfathered in, as long as your product of today is EXACTLY the same. Otherwise, no, it's a new product.

 

[Ca Ike]

I'm sorry dude, but this is completely wrong.
And I have to point that out, because it is really important.

Big Pharma nicotine products have a pass because they are drugs.
And drugs are not covered by the FSPTCA, and are subject to a different set of regulations.

I don't know, maybe I was misunderstanding you?
I haven't known your posts to be as off-base as that one seemed to be.

Yea I worded it a bit badly didn't I. Nicotine as a tobacco product is grandfathered since it's been around in an extract form for at least 50 years. However, it has been an herbal extract longer than it has been a BP/BT product.

I have to hunt down the specifics again but BP didn't do the usual drug path for NRT. The FDA did treat it as a medicine for a while, but BP argued that it was a a nicotine supplement and not a drug. That's how they got past all the usual drug regulations and trials. Except for chantix and the like. NRT is not an FDA approved drug, but an FDA approved therapy because it does do what they claim, somewhat and that's a different class than drugs. They are also considered GRAS allowing for the unrestricted sale they have now.

It's ironic that the very argument BP used for patches, gum and their inhaler ( nicotine not being a drug) is what is being used against vaping now. It has been argued that tobacco is an herb and nicotine an herbal extract.

 

[Rossum]

Yea I worded it a bit badly didn't I. Nicotine as a tobacco product is grandfathered since it's been around in an extract form for at least 50 years. However, it has been an herbal extract longer than it has been a BP/BT product.

I have to hunt down the specifics again but BP didn't do the usual drug path for NRT. The FDA did treat it as a medicine for a while, but BP argued that it was a a nicotine supplement and not a drug. That's how they got past all the usual drug regulations and trials. Except for chantix and the like. NRT is not an FDA approved drug, but an FDA approved therapy because it does do what they claim, somewhat and that's a different class than drugs. They are also considered GRAS allowing for the unrestricted sale they have now.

It's ironic that the very argument BP used for patches, gum and their inhaler ( nicotine not being a drug) is what is being used against vaping now. It has been argued that tobacco is an herb and nicotine an herbal extract.

Initially, NRT products such as patches & gum were available only by prescription. I'm quite confident about this because I vividly recall going to my family doctor to get scripts for both patches and gum at different times. Of course, neither really worked for me, but the point is, the fact that these were only available by prescription means the FDA certainly did treat them as a drug.

 

[Mazinny]

The switch from prescription to OTC started in 1996, for patches and gum.The nicotine lozenge was approved directly for OTC use however.

Less than 10 years ago, the nicotine patch was available by prescription only. However, since 1996, nicotine drug products for use as "stop smoking aids" have been available without a prescription. In February 1996, the Food and Drug Administration approved the "switch" of Nicorette gum to over-the-counter (OTC) status. In the summer of 1996, the FDA also approved the prescription-to-OTC switch of two transdermal nicotine patch products (Nicotrol in July 1996 and NicoDerm CQ in August 1996). Switches of other nicotine patch products followed (Prostep in December 1998 and Habitrol in November 1999). In October 2002, the FDA approved Commit, the first lozenge dosage form containing nicotine.

Now Available Without a Prescription

 

[Sugar_and_Spice]

The switch from prescription to OTC started in 1996, for patches and gum.The nicotine lozenge was approved directly for OTC use however.

Less than 10 years ago, the nicotine patch was available by prescription only. However, since 1996, nicotine drug products for use as "stop smoking aids" have been available without a prescription. In February 1996, the Food and Drug Administration approved the "switch" of Nicorette gum to over-the-counter (OTC) status. In the summer of 1996, the FDA also approved the prescription-to-OTC switch of two transdermal nicotine patch products (Nicotrol in July 1996 and NicoDerm CQ in August 1996). Switches of other nicotine patch products followed (Prostep in December 1998 and Habitrol in November 1999). In October 2002, the FDA approved Commit, the first lozenge dosage form containing nicotine.

Now Available Without a Prescription

Reading your link and knowing what lengths the FDA is trying to put the industry through is polar opposites. They want to help us(the consumer) in managing our own addictions, yet are making it near impossible for us to do just that with the deeming. Just goes to show that they are bouncing yo-yo's and swing which ever way the wind is blowing.

 

[Eskie]

Nicotine patches, gum, and lozenges may all be approved for over the counter sale, but that does not negate the fact they are still drugs, approved and regulated as such. Just because they changed from prescription only to over the counter does not invalidate that classification. As far as the FDA has been concerned any product that delivers nicotine for the purpose of smoking cessation is a drug.

 

[seminolewind]

Categories of products cannot be grandfathered in, only specific products. So, if someone had a nicotine product that they sold in the US before february 2007, then THAT PARTICULAR product would be grandfathered in, as long as your product of today is EXACTLY the same. Otherwise, no, it's a new product.

Well those first e-cigarettes prior to 2007 had to have something in them. I wonder what? In creating cigarettes, nicotine is removed from the tobacco, then added at the mg. stated.

It seems, as this mess of a case goes on, that it's a lot about nothing. Just like the rest of the government swamp system, they are crooked and have motives that do not improve people's health in any way shape or form. They are trying to deem ordinary products from the supermarket or Walmart as Tobacco derived. There is too much gray area in the grandfathering clause to actually force a regulation on non nicotine objects that sell commonly in stores. If the oldest e-cig sold was prior to 2007, that would mean that the liquid was also sold prior to 2007. You really can't enjoy an e-cig without the liquid. When they remove nicotine from tobacco and put it back at a certain mg., is the nicotine not put in some liquid substance during this part of manufacture?

Many of our vendors in the past 9 years have labeled, warned, listed ingredients, put child proof caps on and sealed with a plastic non-tamper wrapper all on their own out of respect for the public and just being the right thing to do. BG doesn't even mention that. BG thinks that they are dealing with a bunch of yahoos that don't have much of an education - just look at what they are trying to make us believe! They think by deeming that water runs up a hill makes it so and we'll just roll over and believe that they are the intelligent ones. BS! And this is not about tobacco at all. It's about nicotine and only nicotine. If they want to mess with nicotine and deeming and restricting, let them. But don't "make" us tobacco and mess with us as tobacco. It's just not true. The entire government system is corrupt. It's a shame there's not one honest person in the whole FDA who has actually studied everything involved.

 

[seminolewind]

Nicotine patches, gum, and lozenges may all be approved for over the counter sale, but that does not negate the fact they are still drugs, approved and regulated as such. Just because they changed from prescription only to over the counter does not invalidate that classification. As far as the FDA has been concerned any product that delivers nicotine for the purpose of smoking cessation is a drug.

Sure, but the delivery product is not a drug, and nicotine is legally sold over the counter.
In fact, why can we buy quantities of nicotine without regulation?

 

[Verb]

Double post for visibility.

Last week's replies to the judges questions are up.

Tobacco On Trial » Blog Archive » NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM to Respond to the Court’s October 26, 2016 by FDA, Nov 1, 2016

Tobacco On Trial » Blog Archive » NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM re Minute Order by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, et. al. Nov 1, 2016

Nicotine free eLiquid is not covered if you walk the tight rope. Free samples would be permitted since they are not covered. But, if you become successful, they will create the data set to show your product is expected to be mixed with nicotine and crush you. Absolutely no mention of their earlier stated reasoning: a hardware unit that may be used to vaporize a nicotine containing liquid is used to vaporize a nicotine free liquid; therefore, the nicotine free liquid that is used with the tobacco free tobacco product is now a tobacco product.

 

[Buckeyevapen]

Double post for visibility.

Last week's replies to the judges questions are up.

Tobacco On Trial » Blog Archive » NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM to Respond to the Court’s October 26, 2016 by FDA, Nov 1, 2016

Tobacco On Trial » Blog Archive » NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM re Minute Order by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, et. al. Nov 1, 2016

Nicotine free eLiquid is not covered if you walk the tight rope. Free samples would be permitted since they are not covered. But, if you become successful, they will create the data set to show your product is expected to be mixed with nicotine and crush you. Absolutely no mention of their earlier stated reasoning: a hardware unit that may be used to vaporize a nicotine containing liquid is used to vaporize a nicotine free liquid; therefore, the nicotine free liquid that is used with the tobacco free tobacco product is now a tobacco product.

Thank you for posting these Verb. So let me get this straight, the FDAs argument is if my 0mg e liquid sits in a bottle and I never use it it IS NOT a tobacco product BUT if I intend to put it into a tank and vape my 0mg e liquid it magically turns into tobacco!!???! Go home FDA your drunk. I vape, I vote.

 

[Verb]

Thank you for posting these Verb. So let me get this straight, the FDAs argument is if my 0mg e liquid sits in a bottle and I never use it it IS NOT a tobacco product BUT if I intend to put it into a tank and vape my 0mg e liquid it magically turns into tobacco!!???! Go home FDA your drunk. I vape, I vote.

That's an arugement the FDA previously stated publicly, but fails to mention here. It would be counter to their assertion of a case-by-case review process. Nicopure's side didn't bring it up in their brief either.

 

[Buckeyevapen]

That's an arugement the FDA previously stated publicly, but fails to mention here. It would be counter to their assertion of a case-by-case review process. Nicopure's side didn't bring it up in their brief either.

I guess I took the 2nd paragraph of their statement to mention it not specifically: if 0mg e liquid suddenly becomes a component or part of a tobacco product then it itself turns into a tobacco product. Also how is "case by case" the specific steps the judge asked for? Either the FDA waited until the night before to write their response or they believe this lawsuit to be beneath them and their "higher calling" and further believe that the judge's question is irrelevant. I've never been a judge but that would not get you in my good graces. Thanks again Verb for posting.

 

[bigdancehawk]

Thank you for posting these Verb. So let me get this straight, the FDAs argument is if my 0mg e liquid sits in a bottle and I never use it it IS NOT a tobacco product BUT if I intend to put it into a tank and vape my 0mg e liquid it magically turns into tobacco!!???! Go home FDA your drunk. I vape, I vote.

I think Nicopure missed a good argument. FDA says tanks are tobacco products because they're intended for use with liquid containing nicotine and that's mostly what they're used for. Therefore, all nicotine free liquids are subject to regulation as components or parts because they're going to be put in a tobacco product.

 

[Eskie]

Sure, but the delivery product is not a drug, and nicotine is legally sold over the counter.
In fact, why can we buy quantities of nicotine without regulation?

Fell through the cracks loophole type of situation. No reason for the FDA to even look at plain nicotine before vaping came along. It's part of the problem in the FDA even figuring out the proper way to regulate these things. They already found that NRT for smoking cessation is a drug. I believe they tried that route and were shot down in court, so all they had left to rely on was the TCA.