Deeming Regulations have been released!!!!

[Brewdawg1181]

Might?

Is Nicotine Base a Product that contains Nicotine that was Derived from tobacco that can be Reasonably Assumed to be used for Human Consumption with an e-Cigarette?

I'm Not a Lawyer. But there just Doesn't seem to be much Wiggle Room there.

LOL

I know all the Focus lately has been on what the FDA is going to do with Flavored e-liquids. But have people Really been Thinking that the FDA was just going to Look-the-Other-Way when it came to Nicotine Base?

Not what I said or meant. Please (re?)read the last sentence of my post. I'm not so dense that I don't think nic will be banned or restricted one way or another.

My question was whether Deeming specifically includes it, or whether it'll require separate legislation or clarifying statement, which are often used when regulation, rather than legislation is the tool being used.

 

[zoiDman]

I believe when the PMTA was first released raw nic was excluded because it wasn't a finished product, and didn't need PMTA approval.
Of course they seem to be changing requirements as they go along.

BTW - I Edited my post about PMTA/Nicotine Base to include the word Individual.

I should have been More Clear. But I had that Charade of a "Hearing" on C-SPAN playing in the background while I posted it. And it was Hard to be Concise while all that Emotional Hype and FUD was being Spewed.

 

[Baditude]

Worshipping the P.E.N.I.S. isn't publicly acceptable.
(Old joke for ahem, newcomers. lol)

For the newcomers: Personal Electronic Nicotine Inhalant System

 

[zoiDman]

I guess we will have submit paperwork that we are tobacco manufactures....
Just never sell anything...

You mean You haven't filled yours Already?

 

[zoiDman]

Not what I said or meant. I'm not so dense that I don't think nic will be banned or restricted one way or another.

My question was whether Deeming specifically includes it, or whether it'll require separate legislation or clarifying statement, which are often used when regulation, rather than legislation is the tool being used.

If you are talking in the Context of Nicotine Base being sold to an Individual, then Nicotine Base would be a "Covered Tobacco Product".

 

[sofarsogood]

If you Don't have a PMTA on file with the FDA at the time of the FDA's Drop Dead Date, why would you Legally be able to sell Nicotine Base?

May be nic suppliers in the US will turn in PMTA's. May be that won't be necessary for a product that may have been for sale long before ecigs (the FDA can't ban PG and VG). The FDA may have already decided this. There is a difference between wholesale shipments and consumer packages. There are likely consumer products legal to sell in some nations but not in America but are being sent in consumer packaging never the less. Does Customs successfully intercept those items? Do they try? Will Customs try to intercept Fastech packages? The current state level flavor ban is toothless for consumers. They'll go mail order and thousands of businesses and lives will be ruined for no worthwhile purpose. Will the FDA rules in May mean domestic nic and offshore hardware are no longer available?

 

[zoiDman]

May be nic suppliers in the US will turn in PMTA's. May be that won't be necessary for a product that may have been for sale long before ecigs (the FDA can't ban PG and VG). The FDA may have already decided this. There is a difference between wholesale shipments and consumer packages. There are likely consumer products legal to sell in some nations but not in America but are being sent in consumer packaging never the less. Does Customs successfully intercept those items? Do they try? Will Customs try to intercept Fastech packages? The current state level flavor ban is toothless for consumers. They'll go mail order and thousands of businesses and lives will be ruined for no worthwhile purpose. Will the FDA rules in May mean domestic nic and offshore hardware are no longer available?

I Can't really Say how effective it Will or Won't be to try to obtain Overseas Nicotine Base after the FDA Drop Dead Line.

It will be Problematic though. Because at some point, a concentration of Nicotine is going to be considered a Hazardous Cargo.

But all that Said. The FDA knows that it can Not 100% stop anything/everything coming into the USA.

But if an Individual Can't legally buy Nicotine Base from a US Source, and seeing that the Vast Majority of US Vaper's Don't do DIY, I would say that the FDA would consider their Regulations to be Effective.

 

[zoiDman]

May be nic suppliers in the US will turn in PMTA's. May be that won't be necessary for a product that may have been for sale long before ecigs (the FDA can't ban PG and VG). The FDA may have already decided this. There is a difference between wholesale shipments and consumer packages. There are likely consumer products legal to sell in some nations but not in America but are being sent in consumer packaging never the less. Does Customs successfully intercept those items? Do they try? Will Customs try to intercept Fastech packages? The current state level flavor ban is toothless for consumers. They'll go mail order and thousands of businesses and lives will be ruined for no worthwhile purpose. Will the FDA rules in May mean domestic nic and offshore hardware are no longer available?

BTW - How would you go about Paying for Overseas Nicotine Base after the FDA Drop Dead Date?

Bitcoin?

 

[sofarsogood]

I found this PDF about nicotine generically.
https://www.google.com/url?sa=t&sou...FjANegQIEhAB&usg=AOvVaw3D498Kn2kTBS-g-PQeLh9y
Apparently a lot of nicotine is refined far beyond the ecig market and has for a long time. How these are the same or different I don't know. I wonder if nic equivelent to what the ecig nic companies are offering is out there.

 

[mikepetro]

If you Don't have a PMTA on file with the FDA at the time of the FDA's Drop Dead Date, why would you Legally be able to sell Nicotine Base to an Individual?

I agree.
Do you really think a Nic concentrate would get approved via a PMTA?
Maybe for registered manufacturers, but I doubt it would fly for public sale.

 

[mikepetro]

I believe when the PMTA was first released raw nic was excluded because it wasn't a finished product, and didn't need PMTA approval.
Of course they seem to be changing requirements as they go along.

However, I can easily see "unfinished concentrated nic" being restricted to registered manufacturers. Nothing in the regs stops it.

 

[mikepetro]

Then black market operators will have virtually no legal issues whatsoever. They'll have tons of items in stock. They may get caught for selling, then again, I bet most don't.

True, it will be easy, especially if they stocked up now.

It comes back to that "trust" thing. People trusted those Dank cartos and look what happened.

 

[zoiDman]

I agree.
Do you really think a Nic concentrate would get approved via a PMTA?
Maybe for registered manufacturers, but I doubt it would fly for public sale.

From a Science/Health based standpoint, Unflavored e-Liquids under say 18mg/ml or maybe 24mg/ml would be the Easiest to PMTA. Because the Bulk of the Science and Study Data is going to be Focused of Health Risks/Issues involving Flavoring. And Flavoring(s) combinations.

Approval of e-Liquids over say 18 or 24mg/ml? I don't think they have much of a Chance.

And I see Zero, and I mean ZERO, chance of a Bottled e-Liquid or Nicotine Base even being considered for Individual use.

 

[mikepetro]

That's actually what I was about to ask. @mikepetro , being one of the few who have actually read it:
What's your take on what requires a PMTA and what doesn't, particularly as it relates to diy? I'm assuming it can't really cover products like PG and VG, and most flavorings that have other uses. But it seems that they might pull nic base into this, unless there's pretty wide use of it for other legitimate purposes? Are there other real uses for the type nic base we buy? Or will nic require legislation, or some sort of clarification statement to include it?

Nothing specifically addresses DIY.

Nic base (regardless of strength) is considered a tobacco product. If it is marketed\sold to the public then a PMTA will probably be required.

"As defined in section 910(a)(1) of the FD&C Act, “new tobacco product” means: (1) any
tobacco product (including those products in test markets) that was not commercially marketed
in the United States as of February 15, 2007; or (2) any modification (including a change in
design, any component, any part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product
where the modified product was commercially marketed in the United States after February 15,
2007."

 

[ENAUD]

I guess we will have submit paperwork that we are tobacco manufactures....
Just never sell anything...

Funny thought, but then you would be open to FDA inspections at their leisure...

 

[mikepetro]

I found this PDF about nicotine generically.
https://www.google.com/url?sa=t&sou...FjANegQIEhAB&usg=AOvVaw3D498Kn2kTBS-g-PQeLh9y
Apparently a lot of nicotine is refined far beyond the ecig market and has for a long time. How these are the same or different I don't know. I wonder if nic equivelent to what the ecig nic companies are offering is out there.

Dated 1951, since then it has stopped being used as a pesticide in the USA.

 

[ENAUD]

But have people Really been Thinking that the FDA was just going to Look-the-Other-Way when it came to Nicotine Base?

Best case scenario, we DIY'ers are too small a number for their concern in the early stages, they are going to have their hands full with market enforcement. I don't for one second believe that they will allow continued sales of 100 mg/ml long term though.

Scary thought, they urge congress and senate to pass legislation "deeming" hight test nic as a drug.

 

[zoiDman]

Best case scenario, we DIY'ers are too small a number for their concern in the early stages, they are going to have their hands full with market enforcement. ...

I Wouldn't count on it.

Because just like Many People here have mentioned, a Ban on Flavors is going to Promote Teens to start doing DIY. The FDA is Smart Enough to know that Also.

So if you Can't control what Millions of People do, control what they Do It with.

And that is Something the FDA can Very Easily Do.

 

[Brewdawg1181]

Nothing specifically addresses DIY.

Nic base (regardless of strength) is considered a tobacco product. If it is marketed\sold to the public then a PMTA will probably be required.

"As defined in section 910(a)(1) of the FD&C Act, “new tobacco product” means: (1) any
tobacco product (including those products in test markets) that was not commercially marketed
in the United States as of February 15, 2007; or (2) any modification (including a change in
design, any component, any part, or any constituent, including a smoke constituent, or in the
content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product
where the modified product was commercially marketed in the United States after February 15,
2007."

Okay, thanks - that's exactly what I was looking for. Needle in a haystack, finding their definition of Tobacco Product. I found this one, and it made me think some might begin offering synthetic (not derived from tobacco) nicotine, until they clamped down on it. But the definition you gave precludes that.

And I was wondering about other uses of nic, and if there were a substantial market, whether diy'ers would be able to do workarounds access them for a while somehow. But it seems there are no other current uses I can find - that US quit using it as a pesticide in 2014, and EU banned it 10 years ago. Probably still used in China and other countries, though. But if virtually all nic is made for human consumption, that's gonna make it tougher for anyone to get.

Sucks for any that aren't stockpiling.

 

[Baditude]

Thoughts? This is what's going on in Michigan.