Class Action Exploding Devices

[Lessifer]

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.....



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



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.

When I have more time I will map for you, definition to definition, but not right now. Even though, as I posted early on, it's in the title of the law:
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

However, again, in regards to this thread and what was being discussed prior to this side discussion, what is the point? If, as you say, DIY is manufacturing, do you believe people will stop doing it?

This thread is about devices, so let's discuss that. Bill's point was that the FDA has made product improvement, for existing and new products, nigh impossible. Nothing will get approved.

This drives people to find devices that will last(mechs) or possibly build their own mods. People don't even need to buy specific supplies for this. So, even if you're right, that the FDA considers building your own mod for personal use to be manufacturing, as you pointed how, how would they know? They will not be able to stop people doing DIY, whether they consider it manufacturing or not.

And, what does any of that have to do with class action lawsuits?

 

[Verb]

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

Me. I'm the one who determines if I plan to or execute the distribution of my property.

 

[Ca Ike]

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.

Actually Less proved you wrong.

First your source for definitions is flawed as that site does not define US laws.

Second you know nothing about US business law and that is obvious based on your choice of source for legal definitions.

Third. Your mixing up the basic definitions of manufacturer as it applies to the US.

What you say in your arguments lead me to ask where you are from because the core rules for your basis do not apply to US law. They do however apply to Russian law which does regulate DIY.

 

[Shekinahsgroom]

When I have more time I will map for you, definition to definition, but not right now. Even though, as I posted early on, it's in the title of the law.

The title doesn't answer my question Less, since it doesn't stipulate that in order to be considered a tobacco manufacturer you must be distributing product.

The law is written contrary to your belief:

• 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).”

And, since you proved already, that anyone that's manufacturing product is considered to be an establishment, then registration is required regardless of intent. That's to be determined upon registration.

The two sides of the argument pend on whether or not the law stipulates that distribution is a requirement to be a tobacco manufacturer. If that stipulation cannot be found within the terms of the law, then you have no argument. The title line means little since it cannot be found in the law itself, or at least I haven't found anything and I'm sure that nobody else has either.

 

[Shekinahsgroom]

Me. I'm the one who determines if I plan to or execute the distribution of my property.

"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."

Distribution is determined AFTER you register as a tobacco manufacturer. A DIY'er would be a tobacco manufacturer for personal use only (not a business).

Right back to the same point, show me the law that stipulates to support your belief that you make that determination without FDA approval.

There's nothing within the terms of the law that says DIY is exempt from having to register as a tobacco manufacturer. The law only defines what's considered to be a tobacco manufacturer....which would include DIY.

All DIY non-regulation theories come back to distribution. So unless this stipulation can be found within the terms of the law, the non-regulation theory collapses and DIY could be regulated by requiring tobacco manufacturers to register prior to your 'establishment' intent being determined by the FDA.

 

[Shekinahsgroom]

And, what does any of that have to do with class action lawsuits?

That's a good question.

Maybe you should ask the person that actually derailed the thread by proposing the argument in the first place?

Page 7: Bill Godshall

 

[Ca Ike]

Here you go shek. Part 807 sub A sec C of the FDA code of regulations which governs all regulations.

CFR - Code of Federal Regulations Title 21

(c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

Your entire argument is BS. Like I said, educate yourself on US codes and laws. Until you fall under section 2 "commercial distribution" you can not be considered an establishment , licensed business or r not.

 

[Shekinahsgroom]

Here you go shek. Part 807 sub A sec C of the FDA code of regulations which governs all regulations.

Not quite, "medical devices"....doesn't apply to vaping or tobacco products.

This was covered LONG before you even signed up here, I watched it happen in 2008 when the FDA seized shipments (old news):

Judge: e-cigarettes not subject to FDA oversight as drug delivery device - amednews.com

It was this ruling that stifled the FDA from the beginning when they tried to classify e-cigs as medical devices. But that didn't fly with federal law and the FDA was in serious trouble then because they over-stepped their authority and were sued by Njoy and I think it was Smoking Anywhere...or something.

Nothing in medical devices applies to tobacco products, even if some of the laws appear similar, but nice try though....

If you want to actually look for the law that pertains to the actual discussion, which governs tobacco products, you'll have to use the links that have already been provided that governs the TCA.

But you seemed to be missing the point entirely and either haven't caught up in the thread yet or you're just CLUELESS as to the foundation of the non-regulated DIY argument?

(c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

And just for the record, this isn't being disputed.
Matter of fact, it's the exact thing that Less proved for me...

(Thanks again, Less)

And you seem to think that I'm the idiot?

LOL, that's hilarious...

Your entire argument is BS. Like I said, educate yourself on US codes and laws.

Oh yeah, you sure showed me didn't ya?

Gawd...better than Reddit!

 

[Ca Ike]

Not quite, "medical devices"....doesn't apply to vaping or tobacco products.

This was covered LONG before you even signed up here, I watched it happen in 2008 when the FDA seized shipments (old news):

Judge: e-cigarettes not subject to FDA oversight as drug delivery device - amednews.com

It was this ruling that stifled the FDA from the beginning when they tried to classify e-cigs as medical devices. But that didn't fly with federal law and the FDA was in serious trouble then because they over-stepped their authority and were sued by Njoy and I think it was Smoking Anywhere...or something.

Nothing in medical devices applies to tobacco products, even if some of the laws appear similar, but nice try though....

If you want to actually look for the law that pertains to the actual discussion, which governs tobacco products, you'll have to use the links that have already been provided that governs the TCA.

But you seemed to be missing the point entirely and either haven't caught up in the thread yet or you're just clueless as to the foundation of the non-regulated DIY argument?



And just for the record, this isn't being disputed.
Matter of fact, it's the exact thing that Less proved for me...

(Thanks again, Less)

And you seem to think that I'm the idiot?

LOL, that's hilarious...



Oh yeah, you sure showed me didn't ya?

Gawd...better than Reddit!

Way to cherry pick facts and ignore ones that don't fit your view. This is pulled from the code of regulations that applies to ALL regulations. Whatever, you refuse to listen even to those that are experts in the fight and just continue your same drivel. Your nothing but a classic troll now. I'm done with ya.


Sent from my iPad using Tapatalk

 

[Shekinahsgroom]

Let's see now, where were we?

Oh yeah....

Shek 1
Lessifer 1 (Proving my point)
Bill [wrong; disqualified]
Ca lke [wrong; disqualified]

Can't wait to see what's next....

 

[Shekinahsgroom]

Way to cherry pick facts and ignore ones that don't fit your view. This is pulled from the code of regulations that applies to ALL regulations. Whatever, you refuse to listen even to those that are experts in the fight and just continue your same drivel. Your nothing but a classic troll now. I'm done with ya.

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

Look just below the header, it shows where you found it.
FDA home; medical devices; databases.


Babye...stop by when you get your facts together, Mr. Expert!

 

[Verb]

"
Distribution is determined AFTER you register as a tobacco manufacturer. A DIY'er would be a tobacco manufacturer for personal use only (not a business).

No! Distribution is determined after you distribute product.

 

[Shekinahsgroom]

No! Distribution is determined after you distribute product.

Now that doesn't make any sense at all, but I'll let you think about that more closely.

I'll repeat...

All DIY non-regulation theories come back to distribution. So unless this stipulation can be found within the terms of the law, the non-regulation theory collapses and DIY could be regulated by requiring tobacco manufacturers to register prior to your 'establishment' intent being determined by the FDA.

Find the law that's missing from the equation, Verb...and this whole argument goes away.

 

[Verb]

I'll repeat...

All DIY non-regulation theories come back to distribution. So unless this stipulation can be found within the terms of the law, the non-regulation theory collapses and DIY could be regulated by requiring tobacco manufacturers to register prior to your 'establishment' intent being determined by the FDA.

Find the law, Verb...

It's the opposite in a free society. It is permitted, unless it can be shown that unregulated manufature is restricted. There is currently no regulation governing tobacco products that are not distributed.

 

[Shekinahsgroom]

It's the opposite in a free society. It is permitted, unless it can be shown that unregulated manufaturer is restricted. There is currently no regulation governing tobacco products that are not distributed.

"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."

• 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).”

Then show me the law that supports your point of view and contradicts these laws above. Cuz there's no such thing as an unregulated tobacco manufacturer in the text of the law. If you manufacture a tobacco product, you HAVE TO register.

You can argue your point to death, everything comes back to distribution. So...until the "missing link" can be shown in the letter of the law, you have no argument.

Less knows this and fully understands now....cuz he tried to prove the DIY non-regulation theory by posting the title of the law. The but title means little since it cannot be supported by the actual text of the law.

EVERYTHING tilts on this 1 point, the missing link, which can ONLY be found in the text of the law. But guess what, it ain't there. Or at least I can't find it, maybe someone else wants to look for it? Huge headache going through all of the regs...

 

[Shekinahsgroom]

Everything in a nutshell right here; my response above to Less:

"And, since you proved already, that anyone that's manufacturing product is considered to be an establishment, then registration is required regardless of intent. That's to be determined upon registration.

The two sides of the argument pend on whether or not the law stipulates that distribution is a requirement to be a tobacco manufacturer. If that stipulation cannot be found within the terms of the law, then you have no argument. The title line means little since it cannot be found in the law itself, or at least I haven't found anything and I'm sure that nobody else has either."

This is the title of the law...

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

Less is going to try to prove (later today) the definitions of the title. But if he cannot find the law that stipulates that distribution is a requirement to be a tobacco manufacturer, then the entire non-regulated theory gets flushed down the toilet. DIY is then considered to be a tobacco manufacturer, which would require registration of your establishment before anything can even be made. Distribution intent could only then be determined by the FDA. In this case, a DIY'er would register as a tobacco manufacturer for personal use. That would make your 'establishment' exempt since it's not a business and you do not intend to distribute your products. But that can only be determined after you register and get permission from the FDA to make your stuff for your own personal use.

Understand now?

 

[Verb]

Drink Brawndo, got it!

 

[Shekinahsgroom]

Drink Brawndo, got it!

Drink water, it's better for you.

 

[Verb]

Self-regulation beyond the scope of the stated requirement is a favored tool of our taskmasters.

Recall the eternal battle of liquid water and solid rock. Be the water.

 

[MacTechVpr]

…Be the water.

I like that. Good luck.