Class Action Exploding Devices

[Shekinahsgroom]

In your example, intent doesn't matter. If you never distribute, there's nothing to regulate, it's all personal use.

Right, according to your definition of the law.
But now, if I ask the same question for the FDA...what are they going to say about it?
This is the point I'm trying to make, there are far too many unanswered questions where DIY could literally destroy the TCA at it's root, assuming that DIY isn't regulated.

Any business could circumvent the law from it's start simply by stating that they started out DIY...and later decided to open their own business. The FDA wouldn't be able to prove intent, even if a business operator fully intended on selling everything from the beginning but failed miserably.

While it may seem like a weak argument, it's a valid point that could significantly undermine the TCA at it's root...especially for a home-based business.

That one example destroys this reg because it's stating that you have to register as a manufacturer BEFORE you actually make anything.

"every person who owns or operates any domestic establishments engaged in the manufacture,preparation, compounding, or processing of a regulated tobacco product"

There's nothing here that stipulates sales or distribution; it's strictly manufacturing prior to sales, distribution, etc...

And so the next question, what happens to your inventory since you didn't register before making it while the law was on the books, after 8/8/16?

I'm guessing that they'd make you trash it, but how exactly? Can't throw it or give it away (distribution), can't export it.

 

[Shekinahsgroom]

Theft, disposal, whatever, is not distribution.

Added to my original post..

If DIY isn't regulated, anybody could make up whatever they wanted on how they obtained it, even if it was given to you by someone else. Since the FDA has no record of the product (or who made it) then they cannot trace it back to it's source and they cannot prove a thing.

So not only is manufacturing uncontrollable, so is distribution.

No record, no proof.

This is where everything falls back onto registering as a manufacturer prior to mixing or building anything.
If DIY isn't controlled it could completely destroy the TCA at it's foundation since there's no record or the persons who made the product, what's in the product, how it was obtained, etc...

You could even sell it as long as you never produced a receipt...(black market)

 

[Lessifer]

Added to my original post..

If DIY isn't regulated, anybody could make up whatever they wanted on how they obtained it, even if it was given to you by someone else. Since the FDA has no record of the product (or who made it) then they cannot trace it back to it's source and they cannot prove a thing.

So not only is manufacturing uncontrollable, so is distribution.

No record, no proof.

This is where everything falls back onto registering as a manufacturer prior to mixing or building anything.
If DIY isn't controlled it could completely destroy the TCA at it's foundation since there's no record or the persons who made the product, what's in the product, how it was obtained, etc...

You could even sell it as long as you never produced a receipt...(black market)

Yes Shek, people can break laws, ignore regulations. Laws and regulations, as concepts, are based on the idea that the majority of society will abide by them.

So, yes, there will likely be black market products, in fact, it's almost guaranteed. However, the majority of Americans will only buy approved products available from licensed retailers.

 

[Shekinahsgroom]

Yes Shek, people can break laws, ignore regulations. Laws and regulations, as concepts, are based on the idea that the majority of society will abide by them.

Just as long a the majority of society full understands those laws; hence why we're having this discussion in the first place.

Seems to me that the laws are not clear.....yet.

 

[Shekinahsgroom]

If you never distribute, there's nothing to regulate, it's all personal use.

"Tobacco Products
Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year."

I don't see anything in this clause that references distribution, do you?
So where's the separation of DIY intent? There isn't one and why I believe that it is (or could be) regulated.

The next clause does though, but it's separate from the first and shown as "registrants must also" and "for commercial distribution" which implies that one must register first before cataloging anything. That would then lead to you have to register first as a manufacturer, even for DIY (not intended for sale or distribution).

"All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling."

 

[Lessifer]

"Tobacco Products
Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year."

I don't see anything in this clause that references distribution, do you?
So where's the separation of DIY intent? There isn't one and why I believe that it is (or could be) regulated.

The next clause does though, but it's separate from the first and shown as "registrants must also" and "for commercial distribution" which implies that one must register first before cataloging anything. That would then lead to you have to register first as a manufacturer, even for DIY (not intended for sale or distribution).

"All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling."

I've explained that an establishment is a business, a business is an entity that sells or otherwise distributes products. You can't take one definition, you have to take them all as a whole.

However, I'm tired. What point are you even trying to make with all of this? There won't be class action suits against people who DIY. There aren't even enough incidents for specific products to qualify as a "class."

 

[Shekinahsgroom]

I've explained that an establishment is a business, a business is an entity that sells or otherwise distributes products. You can't take one definition, you have to take them all as a whole.

Then you first have to make sure that you're using the correct terminology that stated in the law before you can define it.

Law Dictionary

domestic establishment

Nothing there that says anything about a business, it's just a homestead.

However, I'm tired. What point are you even trying to make with all of this?

Your argument is solely backed by distribution and nothing else.
But the way the law is written, your argument may not be correct.

Nobody can prove that DIY isn't regulated since it's not clearly defined in the TCA. It's very possible that it could be but nobody knows for sure either way.

 

[Lessifer]

Then you first have to make sure that you're using the correct terminology that stated in the law before you can define it.

Law Dictionary

domestic establishment

Nothing there that says anything about a business, it's just a homestead.



That nobody can prove that DIY isn't regulated since it's not clearly defined in the TCA. It's very possible that it could be but nobody knows for sure either way.

OMFG you have to use the definitions in the rule that you're looking at, which is why I linked to this:http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf
which defines both domestic establishment, and establishment:
Domestic establishment: The term domestic establishment means an establishment in any State or Territory or possession of the United States. •
Establishment: The term establishment means a place of business under one ownership at one general physical location. A single building may house more than one distinct establishment if the establishments are under separate ownership

 

[Shekinahsgroom]

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM191940.pdf

• Domestic establishment: The term domestic establishment means an establishment in any State or Territory or possession of the United States.

Correct, but that doesn't say anything about it being a business...does it? Could be anything, including a homestead.

(Refer back to homestead business that doesn't register and never sells a thing that you say is DIY. You're contradicting your own argument by making every establishment a business which according to the law...you'd have to register as a tobacco manufacturer before making anything. You just proved my point Less.)

• Establishment: The term establishment means a place of business under one ownership at one general physical location. A single building may house more than one distinct establishment if the establishments are under separate ownership.

(See above reference for an establishment.)

• Manufacturing: The term manufacturing means the manufacture, preparation, compounding, or processing of a tobacco product, including repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package (section 905(a)(1) of the FD&C Act). This term includes the activities of reconstituting and blending tobacco leaf; testing for quality control and product release; and applying any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist. This term excludes the activities of de-stemming, drying, or packing tobacco leaf; mechanically removing foreign material from tobacco leaves; and humidifying tobacco leaf with nothing other than potable water in the form of steam or mist.

• Tobacco product: The term tobacco product is defined in section 201(rr) of the FD&C Act, which states in relevant part: (1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

I'm missing the part where it states your distribution requirement to be considered a tobacco manufacturer?

Maybe you could point that out for me?

Does everybody understand what I'm saying now?

It means that if you make any kind of a tobacco product, you're considered to be a business establishment regardless of your intent whether it be for personal use or sales, your intent is determined when you register and your products cataloged for sale or personal use.

I've explained that an establishment is a business, a business is an entity that sells or otherwise distributes products. You can't take one definition, you have to take them all as a whole.

This is exactly why DIY could be regulated and Less just proved my point as to why, because he grouped everything into a business establishment (including your homestead) according to how the law is written and worded. Your intent is determined by the FDA.

Thanks for proving my point Less...

 

[Lessifer]

personal use is not business...

I'm not going to get you to understand. Wait for a response from the FDA. Or try to apply as a manufacturer of liquid for personal use. I don't care anymore.

So, what's the point of all this, what does it have to do with class action suits, or making things safer? If, by your estimation, anyone who assembles a mod, or mixes or otherwise repackages a liquid is a manufacturer, but the FDA won't know that unless they register, what is your point?

Let's just say I agree with you. We're all manufacturers. What now? Where are you going with this?

 

[KODIAK (TM)]

OMFG...

This pretty much sums it up for yours truly.

 

[Shekinahsgroom]

personal use is not business...

I agree, but according to how the law is written you'd still have to register as a tobacco manufacturer before that could be determined by the FDA.

I'm not going to get you to understand. Wait for a response from the FDA. Or try to apply as a manufacturer of liquid for personal use. I don't care anymore.

That's not true and you know it Less. You care deeply otherwise you wouldn't be in here.
I do understand your point of view, that isn't the problem. It's my point of view that people don't seem to understand. But now that you've cleared it up a bit for me, I think that more people will begin to see the light.

So, what's the point of all this, what does it have to do with class action suits, or making things safer? If, by your estimation, anyone who assembles a mod, or mixes or otherwise repackages a liquid is a manufacturer, but the FDA won't know that unless they register, what is your point?

I would like to see a written statement directly from the FDA that specifically states that DIY is exempt. But they'll obviously have to change the way the law is written right now...and you clearly proved it as to why.

Let's just say I agree with you. We're all manufacturers. What now? Where are you going with this?

(See above purpose)

We're you being literal or just patronizing me?

 

[Verb]

Being an unregulated manufacturer of products for yourself is legal and encouraged by some. Nothing wrong with that. If your state has shared property laws, there's no distribution between spouses.

Depending on your state laws it may be completely legal for a minor to DIY and use their creation, vape or leaf tobacco.

To be a regulated manufactuerer you need to own or operate a domestic establishment.

 

[Shekinahsgroom]

To be a regulated manufactuerer you need to own or operate a domestic establishment.

Correct, but you'd have to register as a tobacco manufacturer first in order for the FDA to make that determination.

Goes back to manufacturing, which then leads back to the primary argument of having to register.

You cannot self-regulate, you first need permission from the FDA to manufacture anything...at least according to how the laws are written.

Everything in the law points directly having to register, including DIY. Less proved that by classifying everything into a business if you're making your own stuff.

 

[Verb]

Correct, but you'd have to register as a tobacco manufacturer first in order for the FDA to make that determination.

Goes back to manufacturing.

(Going in circles now)

Not if you don't distribute.

 

[Verb]

It means that if you make any kind of a tobacco product, you're considered to be a business establishment regardless of your intent whether it be for personal use or sales, your intent is determined when you register and your products cataloged for sale or personal use.

This is where the disconnect in the dialog is occurring. It does not state that in any way.

 

[Shekinahsgroom]

Not if you don't distribute.

Who's going to determine that if you don't register?

 

[Shekinahsgroom]

This is where the disconnect in the dialog is occurring. It does not state that in any way.

It does, Less just proved it.
If you make anything that's defined as a tobacco product, you're immediately considered to be an establishment (business). Now, in order to make a determination of intent for personal use, you'd have to register as a tobacco manufacturer for personal use.

 

[Lessifer]

It does, Less just proved it.
If you make anything that's defined as a tobacco product, you're immediately considered to be an establishment (business). Now, in order to make a determination of intent for personal use, you'd have to register as a tobacco manufacturer for personal use.

No, that's not what I proved at all. A business: <a href="business">business</a>
If there will be no sale or distribution, you are not a business, which means your residence, or wherever you mix is not an establishment, meaning it's not a domestic establishment. You don't have to register our intent to not sell or distribute anything. That would be absurd.

I agree, but according to how the law is written you'd still have to register as a tobacco manufacturer before that could be determined by the FDA.



That's not true and you know it Less. You care deeply otherwise you wouldn't be in here.
I do understand your point of view, that isn't the problem. It's my point of view that people don't seem to understand. But now that you've cleared it up a bit for me, I think that more people will begin to see the light.



I would like to see a written statement directly from the FDA that specifically states that DIY is exempt. But they'll obviously have to change the way the law is written right now...and you clearly proved it as to why.



(See above purpose)

We're you being literal or just patronizing me?

I suppose you could call it patronizing. I don't want to argue the point anymore because it's not leading anywhere.

My question was, when you first brought up this notion that anyone who mixes, assembles, or basically does anything with a vaporizer or liquid is a manufacturer, what was the point?

This was a very early topic of discussion, but soon after the FDA caught wind of the "loophole", they covered it.

DIY is considered to be a manufacturer; falls under roll-your-own.

So if anybody is caught making their own mods/juice, you're gonna be in a serious -storm of legal trouble!

But the only way that I can see someone getting caught is if their device or juice harms an innocent person (someone other than you).



And I'm pretty sure that this only covers items presently on the market. It doesn't include new submissions for approval.

There's no doubt that this was done intentionally to weed out any unsafe products from the market entirely....(babye mechs).

 

[Shekinahsgroom]

No, that's not what I proved at all. A business: <a href="business">business</a>
If there will be no sale or distribution, you are not a business, which means your residence, or wherever you mix is not an establishment, meaning it's not a domestic establishment. You don't have to register our intent to not sell or distribute anything. That would be absurd.

Then answer the question that you avoided instead of trying to dodge it with patronizing comments.

Show me the law that says distribution is required to be considered a tobacco manufacturer?

If you can't, then your entire argument collapses.....

I suppose you could call it patronizing. I don't want to argue the point anymore because it's not leading anywhere.

Correct, your argument died right there because you can no longer support it since you contradicted your own statement.

My question was, when you first brought up this notion that anyone who mixes, assembles, or basically does anything with a vaporizer or liquid is a manufacturer, what was the point?

That DIY is regulated, falls under roll-your-own.

And Bill's response, after I posted the facts, was also dodging...stating that he wasn't aware of the FDA going after anyone. That's a soft way of admitting that he misspoke and didn't see the law.