FDA Response to my inquiry from Nicotine Supplier

[UnclePsyko]

Once I lost a pack of tube steaks in it for about five years: they were fine after I thawed them.

Cube steaks, right? Please tell me you meant Cube Steaks...
Seriously though, I have a chest freezer that was "leased" from Schwan's years ago. When we cancelled service, they told us to just keep the freezer!
They didn't want the hassle of picking it up.
Ours is food only though, we have two upright fridges out in the shed dedicated to our beer collection and the nic goes in the freezers.
The chest freezer would be a good investment for storing your stock for the long haul.

 

[Hitmetwice]

So now the FDA is causing excessive power consumption
(everyone buying new freezers)
global warming and a larger hole in the ozone layer due to leaking refrigerant. GREAT! Nice ability to keep your citizens safe USA.
Not to mention all the old nic that'll be dumped down the drain into the water supply in the coming years. But YEAH, nice work if you can "get it".
Lets sue 'em. friggin' no mind turdballs. Cheers.

 

[sofarsogood]

Seems one of the lab reps has become my e-pal. Been giving me updates on how the hoarders and preppers are running them out.

Reminds me of blizzard warnings here. First, the milk is gone... then the bread. (But the liquor stores are always my first stop so maybe I'm just late).

What does your contact say about how his nic is selling right now? There are vapers besides me at work. The only thing they know about FDA regulations is what I tell them. I menitioned storing nic. They aren't ready to think about that.

 

[KODIAK (TM)]

What does your contact say about how his nic is selling right now? There are vapers besides me at work. The only thing they know about FDA regulations is what I tell them. I menitioned storing nic. They aren't ready to think about that.

Nicotine is in plenty supply right now. But running out of flavors. My guess is most likely due to the herds of people trying to learn DIY overnight.

 

[sofarsogood]

Nicotine is in plenty supply right now. But running out of flavors. My guess is most likely due to the herds of people trying to learn DIY overnight.

It's interesting to hear about this. Thanks for the report. I put nic in the freezer last year just to keep me calm. My flavoring solution is a very small percent of one flavor and no effort to be chef vape. The DIY section should be on the main list and not buried and the excessive flavoring practices should be countered with easier alternative approaches.

 

[SeniorBoy]

OP: Thanks so much for the posts. I'm certainly willing to give NIC base vendors who sell a "finished product" more time to wrap their heads around the Deeming. However, I have a different view in some ways based on my reading of the Draft Guidance on PMTA

I just covered this in my blog post but let me pull a few direct quotes from the Draft Guidance PMTA. Bolded be me:

E. e-liquids 187
188
For the purposes of this guidance document, liquid nicotine and nicotine-containing e-liquids 189 (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients) are generally 190 referred to as e-liquids. Liquids that do not contain nicotine or other material made or derived 191 from tobacco, but that are intended or reasonably expected to be used with or for the human 192 consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s 193 tobacco control authorities.

F. Finished Tobacco Product 196
197
The term finished tobacco product refers to a tobacco product, including all components and 198 parts, sealed in final packaging intended for consumer use.

Bridging 1908
1909
Ideally, a PMTA will include studies conducted using the new tobacco product; however, 1910 bridging of data from one product to another may be feasible for a subset of products or for 1911 certain types of studies.

Summary by yours truly who is not an attorney: If a vendor sells a NIC base in the context of a "finished product" they will need to get PMTAs at the appropriate time. And that's per skew so a given NIC base strength + various solvent options could result in numerous PMTAs for a given strength. I’ve seen responses that include assertions that a given vendor is already licensed to sell NIC base by a given states “Tobacco Manufacterer” laws. Since Federal law usurps state law I'm reasonably sure this won't hold water with the FDA. Bridging is interesting and could provide a pathway to reduce the huge costs and dozens of PMTAs but I'm not optimistic. Finally, please consult the complete FDA Deeming Regulation Compliance Calendar prepared by VTA (Vapor Technology Association).

Stock up! Stay Strong! Fight!

 

[KODIAK (TM)]

SeniorBoy, I share your lack of "optimism" regarding base nicotine sales and future legality thereof. These deeming regs are the equivalent of banning ammo for gun owners.

And I have zero expectations that the FDA will accept any PMTA's. This is their pathway to obliterating the industry. Just like it was in 2010, it's sad that our hopes will pretty much lie in the hands of one lone Federal judge.
(No, I have no faith in Cole-Bishop or HR2058 at this point in time).

 

[mostlyclassics]

Cube steaks, right? Please tell me you meant Cube Steaks...

Nope, I meant "tube steaks." As in "hot dogs," as in "frankfurters."

Every so often, we make a trip north of the Cheddar Curtain to Wisconsin, where you can get honest-to-goodness German-recipe, skin-on tube steaks, which are nearly impossible to find in Chicagoland. We buy multiple packages of them and throw them in the freezer for later delectation. Ironically, that kind of tube steak makes the best Chicago-style hot dog.

Once, I found a package of Johnsonville-brand tube steaks buried towards the bottom of the freezer, just above the bottles of nic. The expiration date on the package told me that they were at least five years old.

There is a really good hot dog you can get in Chicagoland. Bobak's, a local sausage company, makes a gigantic, quarter-pound skinless veal hot dog. Needless to say, we've renamed these "Anthonys," after disgraced congressman Anthony Wiener.

Back to the topic I so rudely interrupted . . .

 

[UnclePsyko]

Nope, I meant "tube steaks." As in "hot dogs," as in "frankfurters."

Ah... got it. Sorry, it's a regional dialect thing.
I've never heard of hot dogs referred to that way, here in my neck of the woods, that means something TOTALLY different.

Back to the topic I so rudely interrupted . . .

Nope, continue... apparently I was the one who "Rudely Interrupted".
I meant no harm @mostlyclassics.

 

[mostlyclassics]

Hee hee, UnclePsyko! Actually, I first interrupted the discussion by mentioning my drop-in freezer, then telling a little story about it.

I take it, that in your neck of the woods, "tube steak" means what Anthony Wiener was taking selfies of?

 

[Bovinia]

Wondering out loud...was nic in pg/vg already on the market in 2007? If so, wouldn't it meet the substantial equivalent rule?

 

[mostlyclassics]

Maybe, Bovinia. But without the nicotine, then PG and VG are useless to most vapers. Besides, the PG and VG companies would have to apply to the FDA, at who knows what cost, to get SE status.

 

[Bovinia]

I meant nic already mixed in pg or vg. Yes they would have to apply with the FDA, but could possibly meet the equivalency rule.

 

[mostlyclassics]

Bovinia, someone on another thread did an internet search via "wayback." No one offered for retail sale liquid containing nicotine in any concentration in 2007. Sadly, the FDA did its homework with regard to this particular loophole.

 

[Bovinia]

I expected that would be the case, I haven't had much time for research the past couple of weeks. Thank you for your response, Mostlyclassics.