FDA FDA Released New Interpretation of Compliance Policy Guidance PDF

[zoiDman]

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?

Here is an excerpt from an Interesting Article...

The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. However, the recent clarification from FDA attorneys appears to confirm that the Deeming Rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately

FDA Makes Statements on Synthetic Nicotine - Convenience Store Decisions

If there is even a Question as to whether or Not the FDA has Legal Authority over TFN Nicotine, how much farther will the FDA have to Overreach to include Pure PG and or Pure VG sold as such?

 

[Shekinahsgroom]

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?

I guess that you missed reading my entire opening statement as well as 2 pages of posts?
They neither deny it nor are acknowledging their intent, they're only willing to say that they're not enforcing DIY under the registration requirement written into the law...atm.

 

[Shekinahsgroom]

Here is an excerpt from an Interesting Article...

The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. However, the recent clarification from FDA attorneys appears to confirm that the Deeming Rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately

FDA Makes Statements on Synthetic Nicotine - Convenience Store Decisions

If there is even a Question as to whether or Not the FDA has Legal Authority over TFN Nicotine, how much farther will the FDA have to Overreach to include Pure PG and or Pure VG sold as such?

I appreciate your input zoi, but now were back to the eggplant scenario which has already been covered.

What good is pure nic, not derived from tobacco or synthetic, if you can't mix it?

Once you mix it with a TCA regulated product (PG/VG/flavors), the product is now under the control of the TCA as well as the person that mixed the new tobacco product.

And a key clause in that very same article emphasizing registration:

"In addition to this recent statement, the FDA has also extended the deadline for the registration and product listing requirements of the Deeming Rule, stating: “U.S. manufacturers of newly-regulated tobacco products who first manufactured those products prior to Aug. 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the Aug. 8 effective date of the deeming rule must register and list immediately with the FDA.”

DIY is a tobacco manufacturer (registration required under the law), you're just not an establishment until you distribute product (i.e. misplaced, given away, thrown-away, stolen, sold, whatever...)

After June 30, 2017...their attitude could change and DIY'ers could be forced to register as a tobacco manufacturer, even if you're not an establishment.

 

[Rossum]

They neither deny it nor are acknowledging their intent, they're only willing to say that they're not enforcing DIY under the registration requirement written into the law...atm.

Some things are effectively impossible to enforce.

 

[Shekinahsgroom]

Some things are effectively impossible to enforce.

Let's all hope that you're right, Rossum.

I'm not so sure that they cannot, especially considering their refusal to answer questions pertaining to the possibility in the future. Just this point, all by itself, is cause for concern.

The fact that DIY is written into the law under tobacco manufacturer means that they can control it. How effective it would be remains to be seen.

Wouldn't be difficult at all imo, especially if you had to provide a registration number along with your ID before being allowed to buy products through vape shops, distributors or anyone else handling TCA products.

Gear would be easy and probably not enforceable (assuming you're not caught red-handed), but juice could be. Without juice, your gear is useless unless of course you vape 0 nic and you don't mind buying tractor shop PG or soapy-tasting VG at your local pharmacy?

(Never understood why anyone would bother vaping 0 nic, why not just quit altogether? )

 

[Rossum]

Let's all hope that you're right, Rossum.
[...]
Without juice, your gear is useless unless of course you vape 0 nic?

No, I go through about 75mg of nicotine a day, and like pretty much everyone else who does DIY, I've stacked enough in the freezer to last a very long time.

However, that isn't because I think I won't be able to get nic in the future, or that I might have to register as a tobacco products manufacturer in order to do so. I'm confident that if I were sufficiently motivated, I could get nic no matter what the laws or regulations say about it. How effective was Prohibition or the War on (some) Drugs? Stacking is simply a risk-minimizing strategy. For the past few years, there has been a free and competitive market for high quality nic, meaning the prices have have not been far removed from the cost of production. There's no doubt in my mind that the government could distort the market causing the "street price" to increase by an order of magnitude or two.

 

[zoiDman]

I guess that you missed reading my entire opening statement as well as 2 pages of posts?
They neither deny it nor are acknowledging their intent, they're only willing to say that they're not enforcing DIY under the registration requirement written into the law...atm.

Not talking about running your Conjectures by the FDA. I asked have you Talked to a Lawyer about all this?

The FDA has a Lot of Power. And can Interpret the Authority granted to them thru Congressional Legislation in many ways. But I think you will find that their Powers (either Legal or Self-Established Overreached) are Very Limited when it comes to what an Individual Can/Can Not Do if the Individual is Not Engaging in Commerce or Distribution.

 

[Shekinahsgroom]

No, I go through about 75mg of nicotine a day, and like pretty much everyone else who does DIY, I've stacked enough in the freezer to last a very long time.

However, that isn't because I think I won't be able to get nic in the future, or that I might have to register as a tobacco products manufacturer in order to do so. I'm confident that if I were sufficiently motivated, I could get nic no matter what the laws or regulations say about it. How effective was Prohibition or the War on (some) Drugs? Stacking is simply a risk-minimizing strategy. For the past few years, there has been a free and competitive market for high quality nic, meaning the prices have have not been far removed from the cost of production. There's no doubt in my mind that the government could distort the market causing the "street price" to increase by an order of magnitude or two.

Geebus, 75mg??

I've cut waaay back since I first started, first at 18mg (07), then 25mg (08), then 35mg (09).
Quit on 35mg in 2009, but I've been down to 15mg for the past couple of years.
But I only vape about 2-3mls/day now.
Tried quitting completely a few times, went a week and didn't really notice not having it.
But it's nice having it under stress, it just works.

 

[Shekinahsgroom]

Not talking about running your Conjectures by the FDA. I asked have you Talked to a Lawyer about all this?

The FDA has a Lot of Power. And can Interpret the Authority granted to them thru Congressional Legislation in many ways. But I think you will find that their Powers (either Legal or Self-Established Overreached) are Very Limited when it comes to what an Individual Can/Can Not Do if the Individual is Not Engaging in Commerce or Distribution.

Tried contacting this guy at the same time I contacted the FDA's compliance office:

Compliance with Premarket Tobacco Product Applications (PMTA) Requirements - Brown & Charbonneau, LLP

I never got a response.

____

And I think that you might be confusing the separation of laws?
If you mix anything that's regulated, you're a tobacco manufacturer...which registration is required.
There's no stipulation within the text of the law that says distribution is a requirement to be a tobacco manufacturer. I and countless others have looked, it's not in the text.

The law means what it says, "The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product."

The regulation would fall on DIY as having to register as a tobacco manufacturer and could only be used to prevent you from unauthorized distribution (since you're not an establishment).
This could be done simply by issuing registration numbers that would have to be presented along with your I.D. before any purchases could be made.

Having to register would effectively kill a black market, but it would also place a huge burden of culpability on the DIY'er in the event someone else gets their hands on your stuff (unauthorized distribution), especially if it's a minor!

It would be worse for a DIY'er than it would be for a normal user that buys their stuff from a vape shop. No registration required if you only bought pre-made juice and pre-made gear.

 

[Rossum]

Geebus, 75mg??

Yes, 75 mg per day. 5 ml/day * 15 mg/ml = 75 mg/day. Not 75 mg/ml.

 

[Myrany]

Having to register would effective kill a black market

Now that is an absurd comment.

Those that function in a black market scenario do not give a hoot about the applicable laws and would NOT register. They would simply smuggle Nicotine liquid into the country. Having to register would do NOTHING to kill a black market it would in fact expand the black market.

As for this comment

Geebus, 75mg??

Who cares how much or how little nic someone uses. Isn't the point to keep from smoking? It is not our place to judge someone else's nic use.

Also he is talking about total MG vaped not the strength of the liquid. Your stated

I've been down to 15mg for the past couple of years.
But I only vape about 2-3mls/day now.

would be 30-45 mg a day

 

[Shekinahsgroom]

Yes, 75 mg per day. 5 ml/day * 15 mg/ml = 75 mg/day. Not 75 mg/ml.

Ah, okay...

 

[zoiDman]

...

And I think that you might be confusing the separation of laws?

...

The Reason I keep Including "Distribution" is if I Distribute (in anyway) an e-Liquid, I just Forfeited my Bases of "Personal Use". And the Recreational Use of Tobacco protection(s) afforded to an Individual could be viewed as No Longer applying.

And those Protections would include my Ability to Mix my own e-Liquids for Personal Use without becoming an Manufacture.

Just like if I make a Mod or an RDA in my Garage for Personal Use. Not Problems there. The FDA might not like it, but they can EAD. But the Moment I Sell one or even Give One to a friend (Distribute), I have now Crossed over into something that the FDA could have Regulatory Authority over.

 

[Lessifer]

Some things are effectively impossible to enforce.

I'm not pulling myself back into this ridiculous discussion, I just want to ask one question. And it's not really directed at you Rossum, but ties into your point.

What enforcement action would they take against a person "manufacturing" products for personal use, and what violation would they be accused of?

 

[Shekinahsgroom]

They would simply smuggle Nicotine liquid into the country.

Yea...good luck with that.

 

[Myrany]

Yea...good luck with that.

Ok enough with implying I would do this. You are diverting from the point.

Someone that has no problem with being a black market supplier already has made the decision to break the law. Why would such an individual register? There is no percentage in drawing the attention to themselves. Bad for their business. They know they are breaking the law. They are not going to put a flashing neon sign on themselves screaming "Arrest me please." It is absurd.

 

[Shekinahsgroom]

The Reason I keep Including "Distribution" is if I Distribute (in anyway) an e-Liquid, I just Forfeited my Bases of "Personal Use". And the Recreational Use of Tobacco protection(s) afforded to an Individual could be viewed as No Longer applying.

Not necessarily, it's another gray-area that they're not answering.
Distribution can simply be defined as someone else obtaining your stuff, whether you're aware if it or not.
An example would be a parent that DIY's and their underage kid gets a hold of some of Dad's stash.
Who's in trouble?

And those Protections would include my Ability to Mix my own e-Liquids for Personal Use without becoming an Manufacture.

What protections?
Show me the regs that are protecting you.
Show me the law that says DIY is exempt.

Just like if I make a Mod or an RDA in my Garage for Personal Use. Not Problems there. The FDA might not like it, but they can EAD. But the Moment I Sell one or even Give One to a friend (Distribute), I have now Crossed over into something that the FDA could have Regulatory Authority over.

That's correct, but I don't understand your point?

 

[Rossum]

Yea...good luck with that.

Canadians manage to do it.

 

[Myrany]

Canadians manage to do it.

As do many Australians.

 

[Shekinahsgroom]

Ok enough with implying I would do this. You are diverting from the point.

Someone that has no problem with being a black market supplier already has made the decision to break the law. Why would such an individual register? There is no percentage in drawing the attention to themselves. Bad for their business. They know they are breaking the law. They are not going to put a flashing neon sign on themselves screaming "Arrest me please." It is absurd.

Where are they gonna get their nicotine from if they can't smuggled it in?

Moot point, no black market if you cannot obtain nicotine suitable for vaping.