FDA FDA Released New Interpretation of Compliance Policy Guidance PDF

[Shekinahsgroom]

Regulated how, by what agency? What exactly are the restrictions?

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Liquid nicotine is a product made from tobacco, it's regulated by the FDA under the TCA.

The only instance where it wouldn't be regulated is the point that skoony tried to make.

If you grew your own tobacco (not regulated) and you extracted your own nicotine from that tobacco (not regulated), you could use it for DIY and the TCA would have no control over you.

However, once you mix liquid nicotine with a regulated product that you'd have to purchase (PG/VG/etc), you're now considered to be a tobacco product manufacturer and the FDA could make you register as such....even if it's for personal use.

The only way around the TCA is if you never have to buy any of the ingredients, but unless you're a lab specialist that knows how to make liquid nic, PG or VG...you're stuck.

It's for these very reasons that this topic comes into play:

E-Cigs Are Going Tobacco-Free With Synthetic Nicotine

While I seriously doubt this would ever happen, the very same could be said for extracting nicotine from a different source, like eggplant. But you're still stuck cuz you'd have to mix it with a carrier in order to vape it.

 

[zoiDman]

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However, once you mix liquid nicotine with a regulated product that you'd have to purchase (PG/VG/etc), you're now considered to be a tobacco product manufacturer and the FDA could make you register as such....even if it's for personal use.

...

An Interesting concept.

But it is Lacking for the Purpose of Engaging in Commerce. Or the Intent to Distribute.

 

[Shekinahsgroom]

I believe you're confusing extraction of flavor. Nicotine levels are insignificant. The only vaping-specific extraction of nicotine I've heard of is for Whole Tobacco Alkaloids, used by perhaps .001% of vapers.

No I'm talking about isolating nicotine from tobacco.

 

[zoiDman]

...

However, once you mix liquid nicotine with a regulated product that you'd have to purchase (PG/VG/etc), you're now considered to be a tobacco product manufacturer and the FDA could make you register as such....even if it's for personal use.

...

BTW - When you get a chance, maybe you could Post the Regulations you referred to for PG or VG.

 

[Rossum]

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Liquid nicotine is a product made from Tobacco, it's regulated by the FDA under the TCA.

Oh, I don't disagree that it's "regulated" under the Deeming, but the original context was your contention that:

Pure nicotine was regulated long before vaping was even a word

 

[Shekinahsgroom]

An Interesting concept.

But it is Lacking for the Purpose of Engaging in Commerce. Or the Intent to Distribute.

Distribution is regulated for taxes and fees, but you're a tobacco manufacturer the moment you mix it.

This is why I keep referring back to this:

"The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer."

Importing, distribution, marketing and sales are not a requirement to be a tobacco manufacturer.

The law separates the two, which is how the FDA could make DIY'ers register as a tobacco manufacturer, even if you only intend on using it for personal use. It's this very clause that could destroy a black market scenario.

Black market could mean anything that's distributed, but not necessarily for sale. You could give it away and it would still be considered contraband because you willfully distributed it. This is exactly where other problems can form where distribution is a gray-area (misplaced, thrown away, stolen, whatever). Since you made it and someone else obtained it, whether by your knowledge or not, you could be held accountable.

But requiring registration, even for DIY, would carry direct responsibility under the terms of the law.
But who the hell is gonna agree to that?
Would you?

ATM, registration is not being enforced....but that doesn't mean that it might not be in the future.

 

[Shekinahsgroom]

BTW - When you get a chance, maybe you could Post the Regulations you referred to for PG or VG.

While I'm at it, should I also find Kanthal, Nichrome wire, batteries, 0% nic-juice and anything else that's deemed a tobacco product?

It's in there, that's why so many people are suing the FDA.

 

[Rossum]

But who the hell is gonna agree to that?
Would you?

And therein lies they rub. Hardly anyone would comply. Do you suppose the FDA doesn't realize this? And if they do realize it, why would they requiring something that they have no prayer of being able to enforce? That would just make them look silly.

 

[Shekinahsgroom]

Oh, I don't disagree that it's "regulated" under the Deeming, but the original context was your contention that:

Make it easy on yourself, call up John MacLeod (owner) at Wizard Labs and ask him. I don't know what the exact restrictions were prior to the TCA and I certainly have no desire to look for them, just easier to ask John.

Wiz got his start at Vapatron, I knew him back when he was just a small lab back in 2011.

Last contact that I had with him though was in 2014 for a Co-Op that I hosted. But he'll answer you directly if you send him an e-mail, or at least tell staff to answer.

 

[zoiDman]

Distribution is regulated for taxes and fees, but you're a tobacco manufacturer the moment you mix it.

This is why I keep referring back to this:

"The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer."

Importing, distribution, marketing and sales are not a requirement to be a tobacco manufacturer.

...

It was Really a Two Part Post. Saying that it is Ultra vires for the FDA to attempt to Regulate an Individual who does Not Engaging in Commerce or Distribution.

 

[Shekinahsgroom]

And therein lies they rub. Hardly anyone would comply. Do you suppose the FDA doesn't realize this? And if they do realize it, why would they requiring something that they have no prayer of being able to enforce? That would just make them look silly.

I think that they're planning to ruin vaping as a whole, call it a conspiracy theory.

Take out commercial sales first, by increasing juice price to absurdity.
DIY would likely take over the market, eliminating retail stores juice sales which could in turn cause retail store closures. Get retail sales out of the way first, much easier to control distribution.
All that would be left is major distributors of liquid nic, PG/VG and flavoring.
Then spring DIY registration as a requirement, something along the lines of having to provide an FDA registration number (along with your I.D.) before you're able to purchase DIY supplies.
This would murder DIY sales, cuz who the hell would agree to be registered under the laws? I wouldn't do it, too much responsibility. Others might and might get along just fine, hard telling.
But if they implement it now, a black market could form in preparation.
Waiting and hiding their intentions would make the general DIY population feel safe and wouldn't be cause for any alarm.
I dunno, it's all speculation, but it wouldn't surprise me in the least if they're planning something along these lines. It would make more sense why they're not answering specific questions about DIY and completely avoiding it.

 

[zoiDman]

While I'm at it, should I also find Kanthal, Nichrome wire, batteries, 0% nic-juice and anything else that's deemed a tobacco product?

It's in there, that's why so many people are suing the FDA.

No. Just the Regulations you implied to PG and VG are fine.

 

[Shekinahsgroom]

No. Just the Regulations you implied to PG and VG are fine.

Here ya go man, enjoy :

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

 

[zoiDman]

Here ya go man, enjoy :

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

Don't see anything about an Individual using PG or VG for Personal Use.

Got anything Specific?

BTW - Just posting a FDA Main Page isn't doing much to Inform or Enhance someone's Knowledge. And below that, doesn't go very far to Support a Claim someone makes about FDA Regulations.

Just Say'n.

 

[Shekinahsgroom]

Just Say'n.

You can start reading on your own, I'm not gonna do it for ya.
I'm not saying that to be rude, I'm just being honest.

FDA Says Nicotine-Free E-Liquids Are Tobacco Products in 'Certain Circumstances'

Federal Register :: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

You're not going to find anything for DIY because it isn't in the regs....that's the whole point man.

The only thing that IS in there is what makes anyone a tobacco manufacturer, that would include DIY unless you're growing your own tobacco and extracting your own nicotine from it, making your own PG from scratch or anything else.

If you have to purchase any of the TCA regulated ingredients, anything that you make from those ingredients is regulated. The regulation on DIY would be registration as a tobacco manufacturer...which isn't being enforced atm.

 

[puffon]

If I buy PG for my cows, at Tractor Supply or VG at Bulk Apothecary, for making soap I'm not a tobacco manufacturer.
If I buy them from Joe's vape shop, they are tobacco products.
That's the way I understood it?

 

[Myrany]

If I buy PG for my cows, at Tractor Supply or VG at Bulk Apothecary, for making soap I'm not a tobacco manufacturer.
If I buy them from Joe's vape shop, they are tobacco products.
That's the way I understood it?

Same for batteries. Purchase from a vape shop they are regulated purchased from a flashlight shop they are not.

 

[Rossum]

If I buy PG for my cows, at Tractor Supply or VG at Bulk Apothecary, for making soap I'm not a tobacco manufacturer.
If I buy them from Joe's vape shop, they are tobacco products.
That's the way I understood it?

Someone will now say, "It's how you intend to use them" that determines whether they are or aren't tobacco products. Technically, they might be right, but that doesn't make it at all enforceable.

 

[Shekinahsgroom]

Same for batteries. Purchase from a vape shop they are regulated purchased from a flashlight shop they are not.

If I buy PG for my cows, at Tractor Supply or VG at Bulk Apothecary, for making soap I'm not a tobacco manufacturer.
If I buy them from Joe's vape shop, they are tobacco products.
That's the way I understood it?

Right up to the point that you make a regulated product from those 'ingredients'.
Where you obtain the parts is irrelevant, you'll still be able to use them for DIY....unless the FDA starts enforcing registration for DIY'ers. If that happens, then the only thing that a non-registered DIY'er would have to worry about is keeping your 'products' out of the hands of anyone but you.

The whole point peeps is DIY could be regulated at some point by requiring DIY manufacturers to register. If that happens, everything is going to fall apart and DIY will all but disappear. Nobody in their right mind is going to risk their freedom in order to vape or build their own gear, cuz the moment someone other than you gets a hold of anything that you make and they're caught....you're dead meat!

You may as well be running drug-lab cuz that's what kind of trouble you'd be facing....in theory.

This is why I posted this thread, I'm royally ...... that the FDA is hiding facts regarding their intentions. They are absolutely hiding those intentions and refusing to answer direct questions about DIY being classified as a tobacco manufacturer; requiring registration.

The ONLY thing that they're willing to say (according to others) is that registration is not being enforced (for DIY) atm. Nothing of the sort was said to me in their replies, they avoided every question and didn't answer a thing!

 

[zoiDman]

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You're not going to find anything for DIY because it isn't in the regs....that's the whole point man.

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Maybe I'm not going to Find Anything because there Isn't Anything?

Kinda an Occam's Razor?

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The whole point peeps is DIY could be regulated at some point by requiring DIY manufacturers to register. If that happens, everything is going to fall apart and DIY will all but disappear. Nobody in their right mind is going to risk their freedom in order to vape or build their own gear, cuz the moment someone other than you gets a hold of anything that you make and they're caught....you're dead meat!

You may as well be running drug-lab cuz that's what kind of trouble you'd be facing....in theory.

...

Could be... at some point... If that happens... in theory...

We can Could be, at some point, if that happens, in theory ourselves to Death. So I guess anything goes.

If you want to think that the FDA is going to Enforce Regulations on Individuals who practice "For Personal Use", that's Cool.

Just not Seeing it. Sorry.

Seriously. Have you run this whole "The FDA is going to go after People doing DIY in their Homes for Personal Use" thing by a Lawyer who has some Expertise in Regulatory Law?