New FDA regulations and effect on DIY?

[ENAUD]

They will pry my vape from my cold dead fingers!
That is from this Great Grandfather.

I consider it a worthy fight myself, and truly believe that though I may not win, I would be in the right to fight for the defense of my choice.

 

[jambi]

Just got an email from a neighbor who works part time at a vape shop locally. Guy who owns it has about 4 in different towns. I'd asked the neighbor what the owner has said, about how the new FDA garbage will affect his shop and/or others. Here's his response:

"Found out today that _____ already has a tobacco manufacturer's license, so they're in the clear and won't have to put up with the BS about getting one after this big announcement. Those that don't have it will be hit the hardest. He's still waiting to hear if the flavoring makers will be able to only sell to license holders, or still to anyone, like you who makes your own."

So I guess there are some vape shops who know they'll definitely be OK already, as far as the FDA is concerned. At least people will still have places to get eliquids, though who knows what prices those places will charge then.

Yeah, I got the same answer from my local vape shop as well. However, they were also pretty clear about "We can't sell it if we can't get it." Translation...it's on Cuttwood, Cosmic Fog, etc. to jump through whatever hoops they need to to keep their products on the shelves. For the moment, this may be simply a matter of getting licensed, if they aren't already. I can't imagine how the larger juice companies wouldn't have seen this coming and gotten their license, but what do I know?

Many of these juice makers (ie: Cuttwood) are already based in California, which just implemented its own regulations (vape is now tobacco), so things are going to move faster here than they will at the national level. So, watch California for a larger prediction. At any rate, simply getting licensed as a tobacco manufacturer/distributor is a far cry from (easier than) getting FDA approval for your eliquid line.

I think what's going to kill vape shops over the long haul will be a lack of product, not licensing. I suspect a lot of them will take on tobacco products/paraphernalia, and *other items to stay in business as tobacconist/head shop/vape shop hybrids.

 

[frizzy_tyger]

I don't know. I think that would certainly make an interesting test case for the court system, as would the unrepentant introduction of a new device.

Another thing that would be interesting to test in court is: How can does the FDA regard mods & atties as "tobacco products" but as far as I can tell, they are ignoring pipes that are typically used for smoking pipe tobacco? Conceptually, the are pretty much identical.


No, of course not, provided your nicotine or other "tobacco product" has been blessed by the FDA.

The FDA regulating pipes for tobacco didn't stick out as being regulated to me. But hookahs, plastic sleeves for ciggars, and tins for pipe tobacco did, so I'm assuming pipes are going to be as well even though it didn't jump out at me. Though most of those will be fine because they have the advantage over us, of having many products available before 2007.

 

[dannyv45]

I see panic starting to set in but you all do have time if you start now. The key is to start stock piling early a little at a time and start research on how to make your own juice. Get started now so you'll be past the learning, mistakes and wasted supplies stage before this all comes into effect.

Let me get you all started with some research. There's lots of folks here to help you through this.

My blogs will give insight into all aspects of DYI, from steeping to what supplies to have on hand to a basic walk through mixing your first E-juice.

E-Cigarette Forum - dannyv45 - Blogs

Then read hoosier's blogs. These blogs concentrate on fine tuning your mix and give insight on additives.

E-Cigarette Forum - Hoosier - Blogs

Then read Boletus's blog's. These blogs concentrate on formulation of nicotine bases regarding proper calculations methods for figuring Nicotine concentration as well as safety.

E-Cigarette Forum - Boletus - Blogs

Then read Ginger's book "E-Cigarettes 102: DIY E-Liquid". It is a book which I've contributed to that delivers an in depth easy to follow guide in the art of DYI.

E-Cigarettes 102: DIY E-Liquid

I recommend viewing VPLive Vape Team Episode #82: DIY Safety and bookmark it for future reference. It explains safety in all aspects of DYI.

VPLive Vape Team Episode #82: DIY Safety

then read the stickies at the top of the page.

this will explain a lot of the how's and why's. Keep a level head and you'll all get through this and be in good shape for the future.

 

[Andromendous]

I've sent a few messages to different business to see their thoughts on the situation. This is part of what one said back to me, "The best thing you can do is join the "We Are CASAA" FaceBook page and learn there what you can do to help. Specifically we need EVERYONE to send emails/letters/phone calls in support of HR2058"

 

[Frocket]

I've sent a few messages to different business to see their thoughts on the situation. This is part of what one said back to me, "The best thing you can do is join the "We Are CASAA" FaceBook page and learn there what you can do to help. Specifically we need EVERYONE to send emails/letters/phone calls in support of HR2058"

I've sent my thoughts on it. I hold out hope, though. A lot can change in 2 years, and there may also be ways to work around the regulations.

Until more is known, however, I know that I have some time to prepare. By the time 2 years is over, I'll hopefully have enough stocks/spares to deal. Optimism is great, but it doesn't hurt to prepare for contingencies.

Sent from my D6603 using Tapatalk

 

[mhertz]

As stated, the PMTA needs to be filed, to then get it approved and get a marketing authorization order, to be able to sell it. If having a comparable FDA license then you don't need it. I know e.g. nicobrand in UK which both makes nicotine and nicotine-dilutions in PG/VG in different strengths already has an MA and is FDA audited since 1995. The MA stands for marketing authorization, which is what the PMTA is licensing with, according to there docs...

The vendors I use for nicobrand nic is not doing dilutions themselves, but just buying nicobrands already made dilutions and selling them, so they don't "change the product", but rebottle from 50L batches.

Totally-wicked's US site also sells nicobrand nic diluted direct by nicobrand themselves.

I don't think it will be an issue buying nic-bases after the two years, but I just believe it will be much less cheap and in lower MGs(in EU atleast because of TPD), hence stocking up is the way to go...

 

[StormFinch]

Yep I don't think that Vape Shop owner understands what is coming at him.
Sounds like he makes and sells juice. He will have to have each juice permitted and even different nic levels or PG/VG ratios all require an approval.
Just having a tobacco license does nothing for the vape stuff except he is that one step ahead. But a hundred steps behind.

The way I understand the regs it will wipe out "house" made juice for sale.

And, let's not forget building coils for the customer, if there's anything to build the coils for. That automatically makes you a tobacco manufacturer, and requires another application.

And for whoever was talking about tobacco pipes, yes, they are listed in the new deeming.

 

[GammaRadiation]

I work in the dietary supplement and OTC industry. I deal with 21CFR a lot. Let me allow myself to calm some of the anxiety. DIY will not be affected to any extreme degree. The reason for this is all a company has to do is get an unflavored nicotine base approved for sale. DIY people may then purchase that high concentration base and dilute it with USP glycerin and PEG along with food grade flavors as they already do. Other regulations may tax nicotine in the future making the price jump substancially but that has little to do with the FDA regs.

Personally I hope the investigations show reduced harm in comparison to cigs allowing companies to market the devices as such and offering reason to not tax the same as tobacco. Of course, I am eager to have well designed studies tell us the facts regardless of outcome.

On the subject of hardware, voltage regulators and wire will never be regulated as they are utilized in many other unrelated industries. The fact of the matter is these devices are VERY simple and any amateur electrician can design and build one. Atomizers will be the only real target of regulation. We will have to see how that one plays out.

I think the regulations are an overreach but some regulation was necessary and we had to expect the FDA to push loke this because it involves harm reduction. I DO NOT want companies like phillip morris running this industry. I do want to know if the juice is harming me and what my level of risk is.

In the end, even if the FDA goes nuclear a black market will still exist. The US government has been trying to get cannabis off the market for the better part of a century...yet its easier for a middle schooler to get a nugget than a 40oz. They arent stupid, they know this, expect final market regulations to reach a happy medium. When the taxes come is when I'll reallt get up in arms.

 

[mhertz]

This was posted on the ELR forum 3 days ago by Nicotine_river:

To be very very honest - We are not stressing one bit. Nothing on our end is changing and I don't see this effecting the DIY based market once so ever. The bigger juice companies we distribute to definitely have a fight on their hands. There is way to many of us (Consumers, DIYers, Big Businesses) that will fight this month after month until they come up with better solutions. Think about it like this - You have Coors, Budweiser, Bud Light, and in this situation that would be Ruthless, Space Jam, Cosmic Fog. There are literally thousands of microbrew companies that exist beneath these giants and everyone gets to build there dream companies and play. Why should this industry be any different? People will fight this until the end and it will be a constant revolving battle. Nicotine River will adapt to every situation they throw at us and make it work. Don't stress - Fear is what they thrive on.

 

[GammaRadiation]

I do not like the craft brew analogy. Deregulation is what has allowed craft brew to grow so rapidly. Americans did not suddenly develop a taste for good beer...we were forced to drink pisswater because pisswater manufacturers ran the industry. Now sales of cheap macro batch beer are down and quality micro batch beer is pumping out money hand over fist and the only down side is the caloric value is higher.

 

[englishmick]

I work in the dietary supplement and OTC industry. I deal with 21CFR a lot. Let me allow myself to calm some of the anxiety. DIY will not be affected to any extreme degree. The reason for this is all a company has to do is get an unflavored nicotine base approved for sale. DIY people may then purchase that high concentration base and dilute it with USP glycerin and PEG along with food grade flavors as they already do. Other regulations may tax nicotine in the future making the price jump substancially but that has little to do with the FDA regs.

You're right, the FDA regs are just part of the story. The Indiana State regs come into effect in a couple of months, and there's a blanket ban on internet purchase of anything explicitly vape-related from outside the State. We aren't 100% sure because of the fuzzy language in the bill, but it looks like nic base is included in that. I don't think there are any nic manufacturers in the State. It's possible it will still be legal for FDA licensed shops in Indiana to buy nic base from out of State and resell it, but once the regs kick in and shops aren't able to make and sell their own juice there won't be any shops around anyway.

I'm confident they can't interfere in the sale of flavorings because most flavorings aren't bought by vapers. They just can't be marketed for vaping. But as far as I'm aware nobody else buys nicotine in VG/PG base on a retail basis. Do individuals still buy it to make organic pesticides?

Between the Feds and the States they can nibble away at everything. I'm sure a black market for juice will pop up soon enough. When that happens the States will have both a motive and a justification to clamp down on nic base sales.

 

[englishmick]

I don't worry too much about that aspect of it, it's still pretty early on in the game. My very real concern is how will liquid nic base be handled once the tax schedules are worked out. Will our stashes be grandfathered? Will handling, mixing, be somehow regulated to require a license? Will there be a tax stamp and if no proof can be shown of tax paid what will the potential penalties be? This is all brand new territory, what will be considered personal consumption quantities? I'm not even thinking that they will come bust down the doors looking for it. But if things proceed as they will, and tax legislation hits the books, I am sure some folks will have the bad luck for whatever reasons, to come afoul with these new laws. Some will pay the price at that time.

That's a whole other scary area. Should we all be saving juice bottles with the labels still on for carrying our DIY juice around in public.

Are those of us who plan on DIY'ing 5 years from now going to be limited to vaping discretely in our own homes, or taking a sneaky drag in the car when there are no cops around?

You could drive yourself crazy thinking about this stuff.

 

[GammaRadiation]

That's a whole other scary area. Should we all be saving juice bottles with the labels still on for carrying our DIY juice around in public.

Are those of us who plan on DIY'ing 5 years from now going to be limited to vaping discretely in our own homes, or taking a sneaky drag in the car when there are no cops around?

You could drive yourself crazy thinking about this stuff.

The FDA has no jurisdiction for intra state commerce and individual usage. A state could ban vapes outright, DoHaHS cannot.

 

[Alien Traveler]

...Let me allow myself to calm some of the anxiety. DIY will not be affected to any extreme degree. The reason for this is all a company has to do is get an unflavored nicotine base approved for sale. DIY people may then purchase that high concentration base...

It's easy for FDA. Make nicotine a controlled substance (deadly for children, damaging to adults, and so on). Prohibit sale at concentrations above, say, 12 mg and at quantities above 30 ml. Tax it 500%. Done.

 

[GammaRadiation]

Again, the FDA doesnt control taxes. The DoHaHS cannot schedule nicotine without also banning cigarettes which is clearly not their intention.

The doom reaction has not yet been justified. It is clear the FDA wants to force the industry to prove the efficacy it is claiming. If the FDA hadnt stepped in it was only a matter of time before the FTC did. Reduced harm claims are based on a handfull of relatively small studies with narrow hardware and juice parameters. In a few years I think we will all be happier with the market. Say what you will about the FDA, there is a reason US Food and Drugs are sought after internationally. Our standards of efficacy, safety, and enforcement are some of the best in the world...and the FDA is grossly underfunded.

 

[Frocket]

Hopefully nic base gets approved in a useful concentration. Though, I suppose it would still be doable at 20mg/ml or so - just not very convenient.

Sent from my D6603 using Tapatalk

 

[Vaslovik]

I got another liter of nic from Nude Nicotine today in 2 500 ml bottles. They went right into my freezer. I have to say, it arrived really fast. Those guys are good. If you are stockpiling you should consider them...

 

[LoveVanilla]

No guarantees but I have stored flavor for 2 1/2 - 3 years without issue. I keep a variety of what I vaped mixed on the desktop and then usually mix en mass every three to four months with 2-4 favorites occasionally mixed more often. Then keep ~10ml of each concentrate in the frig and larger balances in the freezer. I use locked ammo cases (with o-rings) for both nic and flavors. In the freezer I have 50ml, 100ml bottles, and ziplocks with multiple 10ml bottles. Flavors are from Hangsen, FA, TFA with a few miscellaneous.

The only degradation I have noted has been on 1 1/2+ year old mixed juice left on the desktop (i.e. largely ignored). Bottom line: I am seeing little to no issue storing flavors in the refrigerator or freezer. Enjoy!

 

[mhertz]

Sorry, I previously wrote that a nic-source with an MA would probably be OK to resell if unchanged, but it's not, but however reduces the PMTA cost significantly, e.g.:

Nicobrand's nicotine is approved by the US FDA (Master File MF 007884).
In FDA Guidance, "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems," FDA said, that it encourages you to use tobacco product master files (TPMFs) whenever possible. A TPMF created by a company that sells liquid nicotine to downstream e-liquid manufacturers can grant a right of reference to its master file for use in the manufacturers' applications, reducing the cost of your PMTA significantly.