FDA FDA Released New Interpretation of Compliance Policy Guidance PDF

[mikepetro]

Regardless of regulations and interpretations that currently exist, I believe the FDAs ultimate goal is to completely control/regulate the ecig market. devices can be made from off the shelf parts, they cant really stop that, curtail maybe but not stop. Just look at any college town and you find plenty of pipes clearly intended for uses other than advertised.

The ONE thing that can control this market is access to nicotine. The average person cannot extract their own. If I were a betting man, I would bet that the FDA will sooner or later control the flow of nicotine itself, at all levels, thereby giving them control of the whole market. Nicotine is the bottleneck to everything we do.....

 

[Lessifer]

How is it being regulated other than as a pharmaceutical or in use in a ENDS product made for
sale or distribution? My analogy being anyone can get tobacco seeds and grow tobacco.
Any one can carve their own tobacco pipe.Any one can buy of the shelf components and
make their own vaping device. Isn't nicotine just another component in and of itself?
I can see requiring one to aver to not use the product for sale or distribution. You may be
right in assuming the FDA will assert it's authority over nicotine. I have always
said if a lot of people turn to DIY to the point of affecting the retail market it probably will
become an issue. Remember the FDA in its infinite wisdom has said raw tobacco leaf
is not a regulated tobacco product. At the same time they say nicotine as a component
of a ENDS product made for sale or distribution (by their own definition) is a tobacco
product and thus under regulatory restriction. This implies DIY which is not for sale or
distribution is not a regulated product. RYO is a issue because most if not all that RYO
buy there materials at the retail level specifically sold as RYO. There is nothing that says one can't go to the source.

I of course am assuming that making your own e-liquid is the equivalent of growing and
curing your own tobacco. Hard liquor is illegal to make in Minnesota (I assume in most if not all states)
but,there doesn't seem to be much regulating going on here.
Moonshine Still Kits|Complete Still Kits
Regards
Mikw

I meant it is being regulated as a tobacco product component. Liquid nicotine isn't a direct correlation to a tobacco plant, as liquid nicotine is a manufactured product. It would be more like loose leaf cured tobacco, which is regulated when sold to consumers.

 

[Shekinahsgroom]

If I were a betting man, I would bet that the FDA will sooner or later control the flow of nicotine itself, at all levels, thereby giving them control of the whole market. Nicotine is the bottleneck to everything we do.....

Is that why you placed the maximum bet on that liter of pure nic?

You're a braver man that most, Hazmat suit and all!

 

[mikepetro]

Is that why you placed the maximum bet on that liter of pure nic?

You're a braver man that most, Hazmat suit and all!

I did my homework first...
Yep, I placed my bet, and the neat thing is no matter how all this shakes out, I wont lose.

 

[skoony]

I meant it is being regulated as a tobacco product component. Liquid nicotine isn't a direct correlation to a tobacco plant, as liquid nicotine is a manufactured product. It would be more like loose leaf cured tobacco, which is regulated when sold to consumers.

I'll bet you a donut BT buys it as a raw material. On the other hand if sold in lower ready
to use doses mixed with various ratios of PG/VG that just needs flavoring if it is wanted
it would be a accessory and or component. At 100 mg per ml more or less it is not suitable
for use in ENDS products. PG/VG and flavorings are all processed materials I assume would
be considered raw material. Dow chemical doesn't need FDA approval to sell PG to anyone.
Regards
mike

 

[Shekinahsgroom]

....the neat thing is no matter how all this shakes out, I wont lose.

Depends on how long your nic will remain ....active?

Since nobody really knows how long nic will last in deep freeze, I seriously doubt that it'll last 40 years.

Even though that's probably close to how long you planned to use it?

 

[Verb]

Depends on how long your nic will remain ....active?

Since nobody really knows how long nic will last in deep freeze, I seriously doubt that it'll last 40 years.

Even though that's probably close to how long you planned to use it?

I'm pretty sure he's not talking about a stockpile. But, gaining the knowledge and skills required to take care of himself.

Edit: wording

 

[mikepetro]

Depends on how long your nic will remain ....active?

Since nobody really knows how long nic will last in deep freeze, I seriously doubt that it'll last 40 years.

Even though that's probably close to how long you planned to use it?

Like I said Shek, I did my homework.

Sent from phone.

 

[TheotherSteveS]

I meant it is being regulated as a tobacco product component. Liquid nicotine isn't a direct correlation to a tobacco plant, as liquid nicotine is a manufactured product. It would be more like loose leaf cured tobacco, which is regulated when sold to consumers.

pretty much all of the nic used in juices is extracted from tobacco as far as i know although some might be extracted from other plants like tomatoes. Totally synthetic nicotine is available but i dont think juice manufacturers use it and the nic base we buy is also tobacco derived I think!! Happy to be corrected if i'm off base..

 

[Lessifer]

pretty much all of the nic used in juices is extracted from tobacco as far as i know although some might be extracted from other plants like tomatoes. Totally synthetic nicotine is available but i dont think juice manufacturers use it and the nic base we buy is also tobacco derived I think!! Happy to be corrected if i'm off base..

Most of the nic we use is tobacco derived, there is I believe one company using synthetic, and no one that I know of using nicotine derived from other plants. My statement was referring to the fact that Nicotine is not necessarily a raw material like a tobacco plant would be, it is a processed commodity like cured tobacco is.

 

[TheotherSteveS]

Most of the nic we use is tobacco derived, there is I believe one company using synthetic, and no one that I know of using nicotine derived from other plants. My statement was referring to the fact that Nicotine is not necessarily a raw material like a tobacco plant would be, it is a processed commodity like cured tobacco is.

All clear!! The problem remains that it is a tobacco product, however we would like to look at it and I'm sure that has not escaped the attention of the FDA and other 'regulatory' bodies elsewhere in the world

 

[skoony]

Most of the nic we use is tobacco derived, there is I believe one company using synthetic, and no one that I know of using nicotine derived from other plants. My statement was referring to the fact that Nicotine is not necessarily a raw material like a tobacco plant would be, it is a processed commodity like cured tobacco is.

The metal used to make our devices is a processed commodity. It is not regulated until
it is sold or distributed as a vaping device.

I do not believe tobacco leaf cured or not is regulated as a finished tobacco product.
Many growers if not all prepare their crops for sale. This involves properly drying the
leaf at minimum. Pure concentrated nicotine is not a finished ready to use retail commodity.
Nicotine is a derivative of tobacco leaf. In essence a modified form of tobacco leaf.
If tobacco leaf is a raw material than the nicotine in it or out of it is a raw material.
Federal and State tobacco taxes are not collected until sold by the manufacturer
as finished tobacco products ready for the consumer to purchase.
Some States are trying to collect the taxes they impose retroactively on products
sold before the tax was assessed. This is because buy the time a tobacco product
reaches a retail establishment the taxes have already been paid. In Minnesota
the liquor and tobacco taxes are collected by authorized wholesalers.Our local
tobacco/liquor store does not write a separate check for these taxes as with
regular sales taxes.

The separation of what constitutes a raw material as opposed to a finished product
is not for health,safety or welfare. It is for being able to establish a process for the
collection of the additional taxes that are or will be imposed.
Regards
Mike

 

[mikepetro]

Some States are trying to collect the taxes they impose retroactively on products
sold before the tax was assessed.

This is just wrong on so many levels. (not you, the retroactive thing)

 

[Lessifer]

The metal used to make our devices is a processed commodity. It is not regulated until
it is sold or distributed as a vaping device.

I do not believe tobacco leaf cured or not is regulated as a finished tobacco product.
Many growers if not all prepare their crops for sale. This involves properly drying the
leaf at minimum. Pure concentrated nicotine is not a finished ready to use retail commodity.
Nicotine is a derivative of tobacco leaf. In essence a modified form of tobacco leaf.
If tobacco leaf is a raw material than the nicotine in it or out of it is a raw material.
Federal and State tobacco taxes are not collected until sold by the manufacturer
as finished tobacco products ready for the consumer to purchase.
Some States are trying to collect the taxes they impose retroactively on products
sold before the tax was assessed. This is because buy the time a tobacco product
reaches a retail establishment the taxes have already been paid. In Minnesota
the liquor and tobacco taxes are collected by authorized wholesalers.Our local
tobacco/liquor store does not write a separate check for these taxes as with
regular sales taxes.

The separation of what constitutes a raw material as opposed to a finished product
is not for health,safety or welfare. It is for being able to establish a process for the
collection of the additional taxes that are or will be imposed.
Regards
Mike

The FDA is pretty clear on how they intend to enforce this:

"However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product."

If it's sold to another manufacturer to be used to make a finished product, it's not subject to regulation. If it's sold directly to the consumer, it is a finished product, and is subject to regulation.

So, the same liquid nicotine, sold to an e-liquid manufacturer, doesn't require a PMTA, but if it is sold directly to the consumer, it does.

 

[skoony]

This is just wrong on so many levels. (not you, the retroactive thing)

Of course it's retro active. Do you know how tobacco and alcohol taxes are collected?
Buy the time their ready for retail sale the taxes have already been paid at the wholesale
level. When a retail establishment buys the product the taxes have been rolled into the wholesale
cost. Retailers do not write a separate check for the taxes. At least not in Minnesota.
General sales taxes are collected at the retail level and are itemized on your receipt.

So, the same liquid nicotine, sold to an e-liquid manufacturer, doesn't require a PMTA, but if it is sold directly to the consumer, it does.

Do you mean 100 mg per ml or more? If this is true than cotton is a tobacco product.

In contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product."

If you are not manufacturing a product for distribution or sale your neither a manufacturer or a consumer
of a finished tobacco product. In my state as in most I assume you can make your own fire arm for personal use. In this case you are purchasing the same raw materials a gun manufacturer would
buy. Steel is considered a raw product and it was processed from ore. I do agree though that if
push comes to shove the FDA will do what it pleases. I am not sure,does the Nicopure lawsuit
cover this aspect?
Mike

 

[mikepetro]

Of course it's retro active. Do you know how tobacco and alcohol taxes are collected?
Buy the time their ready for retail sale the taxes have already been paid at the wholesale
level. When a retail establishment buys the product the taxes have been rolled into the wholesale
cost. Retailers do not write a separate check for the taxes. At least not in Minnesota.
General sales taxes are collected at the retail level and are itemized on your receipt.

I was mainly thinking about places like PA where levy a new tax, and then say you owe that tax on all of your existing inventory.

 

[Myrany]

I was mainly thinking about places like PA where levy a new tax, and then say you owe that tax on all of your existing inventory.

And you owe that tax weather you are a business or not. As I understand it even private citizens who bought vape gear before the tax existed owe tax on that gear.

 

[Lessifer]

Do you mean 100 mg per ml or more? If this is true than cotton is a tobacco product.

The FDA does not make any mention of a distinction based on concentration, so I don't either. Also, yes, according to the regulations cotton is a tobacco product component if it is sold by a vape retailer for the purpose of being used in a vaporizer(tobacco product).

If you are not manufacturing a product for distribution or sale your neither a manufacturer or a consumer
of a finished tobacco product. In my state as in most I assume you can make your own fire arm for personal use. In this case you are purchasing the same raw materials a gun manufacturer would
buy. Steel is considered a raw product and it was processed from ore. I do agree though that if
push comes to shove the FDA will do what it pleases. I am not sure,does the Nicopure lawsuit
cover this aspect?
Mike

Firearms have their own separate regulations. According to the regulations regarding tobacco, if you purchase a finished tobacco product, you are a consumer, if you sell your product to consumers, it is a finished tobacco product. Yes, it's circular.

 

[Verb]

And you owe that tax weather you are a business or not. As I understand it even private citizens who bought vape gear before the tax existed owe tax on that gear.

Nope. Just new inventory owned by a retailer.

 

[Myrany]

Nope. Just new inventory owned by a retailer.

ok thought it went the other way. Will let a friend in PA know he can stop looking for his old receipts now. Thanks for the correction.