FDA TVECA post table of contents for Deeming Final Rule

[snork]

I expect you're right that it would be extremely difficult to differentiate between different plant derived nicotines if they were sufficiently purified, but I also expect that synthetic nic would be relatively easy due to the presence of R-isomers. Plants have an an uncanny ability to produce just the L-isomer, whereas it's my understanding that synthetic methods produce both isomers in equal amounts and they're very difficult (read expensive) to separate. See also:
https://www.e-cigarette-forum.com/forum/threads/l-and-d-nicotine.92643/

The differentiation between tobacco derived, other natural source derived and synthetic nicotine means nothing to entities so draconian or ignorant they can't differentiate smoke from vapor. It's an ......, good enough.

 

[Rossum]

I think it's irrelevant because any vape product that uses nicotine from a source other than tobacco loses the protection tobacco-derived products got under Sottera, i.e. the FDA can just outright ban such products as unapproved drugs or drug delivery devices.

 

[snork]

I think it's irrelevant because any vape product that uses nicotine from a source other than tobacco loses the protection tobacco-derived products got under Sottera, i.e. the FDA can just outright ban such products as unapproved drugs or drug delivery devices.

Good grief, hadn't even thought of that.

 

[inspects]

Thanks for this link

I read through some it and they are even calling "software" and programming as part of tobacco products.
So the FDA can regulate the Software industry too? WTH?
Didn't know I could consume programs.
Better confiscate all computers,androids and i-phones made after 2007 that do not have a pre market approval (PMT)!

There is a re occurring theme. "tobacco derived" products. Products used to inhale "tobacco products" are called ENDS.
ENDS = Electronic Nicotine Delivery Device.
ENDS is essentially any tobacco vape related product.

FDA wants PMT for all ENDS devices from effective date of Ruling.
There is one bright spot.
Raw tobacco nicotine products used for manufacture will not have to have PMT
So nicotine will still be available.

Which brings to mind, What about other states that have devices used for inhaling {other stuff}?

Obviously another market type will emerge that isn't tobacco related.
But truly Vaping isn't Tobacco related.
I'll just vape my tomato juice from now on.

All this will do is force us to buy devices used for medical {Other stuff} use and if we do not live in one of those states, Us nicotine users will have to move there to get the equipment.
So we all better get on the band wagon and be pro {Other stuff} legalization Federally on a state wide level.

ENDS ends all!

So [HASHTAG]#EndENDS[/HASHTAG]

Which is my concern, synthetic nicotine is NOT a tobacco product. Whether or not it's deadly to vape is unbeknownst to me. I do intend to find out.

 

[zoiDman]

Which is my concern, synthetic nicotine is NOT a tobacco product. Whether or not it's deadly to vape is unbeknownst to me. I do intend to find out.

I have heard Mr. Zeller state numerous times that the FDA has No Authority to Regulate Nicotine that is Not Derived from Tobacco Plants as a Tobacco Product.

But as Rossum mentioned earlier, there is the whole "Nicotine as a Drug" thing.

 

[StormFinch]

I have heard Mr. Zeller state numerous times that the FDA has No Authority over Nicotine that is Not Derived from Tobacco Plants.

Not that it would stop them from gaining the authority real quick and in a hurry. As far as they're concerned, anything that goes into an individual's body and isn't regulated by someone else is fair game.

Unless things changed, when I read up on synthetic nic back a few years ago, they had only managed to produce it at pesticide grade purity.

 

[zoiDman]

Not that it would stop them from gaining the authority real quick and in a hurry. As far as they're concerned, anything that goes into an individual's body and isn't regulated by someone else is fair game.

Unless things changed, when I read up on synthetic nic back a few years ago, they had only managed to produce it at pesticide grade purity.

I believe that Non Tobacco derived Nicotine can be made to Pharmacy Standards. But the Cost is Off the Charts.

 

[Katya]

I think it's irrelevant because any vape product that uses nicotine from a source other than tobacco loses the protection tobacco-derived products got under Sottera, i.e. the FDA can just outright ban such products as unapproved drugs or drug delivery devices.

FWIW:

Synthetic nicotine certainly does exist, and is already being marketed for vaping. The oil comparison doesn't work as nicotine is so cheap that even if it were 20x as expensive it could still be absorbed comfortably in the margins.

Synthetic nicotine may or may not be regulated as a drug, or it may fall under supplements laws - likely this depends on the marketing. The FDA has made it very clear that they are going to treat "indirect" medical claims as being evidence of "intended medical use" - so this will all play out in court.

TLDR: SynNic is here; it's not covered by Deeming; it's going to create an interesting dynamic.

 

[inspects]

FWIW:

Thanks Kayta, SmokeyJoe.......

 

[Alexander Mundy]

Well, Nicotiana gossei leaves contain up to 1.1% nicotine compared to Nicotiana tabacum containing 2% to 8% so it would certainly be feasible to derive Nicotine from. With selective breeding it could probably rival tabacum. Problem is they would certainly redefine tobacco to include it if someone commercially produced it.

 

[inspects]

Well, Nicotiana gossei leaves contain up to 1.1% nicotine compared to Nicotiana tabacum containing 2% to 8% so it would certainly be feasible to derive Nicotine from. With selective breeding it could probably rival tabacum. Problem is they would certainly redefine tobacco to include it if someone commercially produced it.

They may as well redefine watermelons too, while they're at it......

 

[Alexander Mundy]

I think it's irrelevant because any vape product that uses nicotine from a source other than tobacco loses the protection tobacco-derived products got under Sottera, i.e. the FDA can just outright ban such products as unapproved drugs or drug delivery devices.

I'm not so sure of that. The Judge said they couldn't shut it down as a drug because they were not making health claims. He also said they could control it as tobacco if they deemed it. I do not believe he said because it is tobacco it isn't a drug. I think the 2 lines of thought are independent and not a cause and effect.

 

[kkay59]

http://thehill.com/regulation/258465-e-cig-firms-steel-for-legal-battle
E-cig firms steel for legal battle
I found this just now. It is worth your time to read.

 

[Racehorse]

Glad to hear about some legal maneuvers. Hope they can get some people who have worked in this kind of space (shark infested) and at this level....

Because this idea of sending in little personal stories to entities (who don't care about you) hasn't accomplished anything.

Emotionality and emotional anecdotal story-telling is the realm of counsellors and social workers.

It falls on deaf ears when delivered to players and investors competing in the space of high profit (high stakes) emerging technologies.

We are talking about players who are wanting to step into the $85 billion market space that has been occupied by traditional cigarettes.

It is rather foolish to think they would care about anyone's nicotine cravings, health, or future in the face of that.

 

[Nuggit]

I'm afraid that the "room for change" won't work in our favor.
This is big business and big government we are talking about, we've all seen this small group run rip shod over the masses before, hope I'm wrong.

 

[Kent C]

This 'deemonzing' comes from the gov't - the true sharks. The ones who have a monopoly on teeth/force. It is they who create big business by handing out favors and taking contributions. Without the favors - there's no big anything, unless they can actually earn it in a free market and then only that lasts until the next 'new idea' or a substitute product/service like Uber for example.

 

[Nuggit]

Exactly right!
All the power and all the teeth. Unfortunately to a much greater degree than we the people should be comfortable with, big GOV, and big business have us by the hoo-hoo. I can emphasize much better the boat our founding fathers were in than I could when I was in shool learning. Lol
I'm sure that there are many things that would be unconstitutional if we could pursue the issue.
Like you said, they have the monopoly on teeth.

 

[Katya]

This 'deemonzing' comes from the gov't - the true sharks. The ones who have a monopoly on teeth/force. It is they who create big business by handing out favors and taking contributions. Without the favors - there's no big anything, unless they can actually earn it in a free market and then only that lasts until the next 'new idea' or a substitute product/service like Uber for example.

Uber? Needs to be regulated! And fined. Or get the heck out of its home state.

http://www.latimes.com/business/la-fi-uber-suspended-20150715-story.html

 

[IanDVaypes]

Let's be honest, a lot of blame can go towards ignorant vapers. Blowing huge clouds that makes it look like there's going to be a thunderstorm indoors is quite intimidating to non vapers/smokers. Blowing huge clouds in general does not look healthier than smoking. Regardless of the health benefits with switching to vaping, it "LOOKS" scary to one's health and the health of the surrounding victims. Because of these arrogant idiots, people want them to vape in the same place as the smokers. In a lot of cases, that would mean off of the physical property. Just thank the ignorant cloud chasers who just can't wait till they get to an appropriate place to cause thunderstorms.

 

[IanDVaypes]

Just think about it. The majority of the population (registered voters) doesn't vape or smoke. I can understand that they don't want to be around that stuff. They need to be taught about the real facts but it's not easy with those arrogant ... holes.