Class Action Exploding Devices

[Shekinahsgroom]

And the plot thickens...

http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm234625.htm

"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.

Legal definition of domestic establishment:
http://legal-dictionary.thefreedictionary.com/domestic+establishment
(2 reference links; family & household)

And here's the secondary part of the same clause:

"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."

2 separate and distinct requirements; one for manufacture and one for commercial distribution. No where does it say that a domestic manufacturer is exempt from having to register if commercial distribution is not intended.

That would mean, based on what I'm seeing, that DIY is regulated and you'd have to register as a manufacturer even if you didn't intend to distribute.

 

[Shekinahsgroom]

Double post, ECF must be updating the server?

 

[Shekinahsgroom]

Double post, ECF must be updating the server?

 

[skoony]

Key point; Distribution.

If you DIY, it's your responsibility as a manufacturer to make sure that anything that you make is only used by you. If you fail to take the necessary steps to protect anyone around you from being harmed by your manufactured products, then the responsibility falls onto you if/when the FDA or any other agency comes after you for violations of the Act.

In the event something that you made harms someone, you have distributed (whether accidental or negligence) your product unlawfully.

If you willfully give something away, that's also distribution.

Like my last statement with Less, Co-Ops are permanently gone now because a host would have to register as a distributor. This topic was widely debated for months after the loophole was closed. But in the end, it was determined and agreed to (by most) that even DIY can be a distributor if someone other than you gets a hold of whatever you made. So if you're not registered in such an event...you're !

I didn't say they would or could, but they can and might come after you if you distribute items that you manufactured which harm someone or if you're giving stuff away en-mass, acting as a Co-Op host or something else similar; make you register.

Not to mention being sued by whomever you harm, you'll almost certainly lose your case since the FDA law is in place and classifies DIY as a manufacturer.

Let's refresh, shall we?
This is where the topic began.



I think that it's abundantly clear now that my original statement is in fact true, so as far as I'm aware...you're arguing about self-only DIY, correct?

If that's your point, then our discussion is not an argument...you're just agreeing with me.

The FDA has no jurisdiction for DIY,period if not for sale and or you do not distribute what
you make. This is un-disputable.
The RYO section you refer to has nothing to do with someone rolling their own
cigarettes themselves. It covers the papers and filters you buy. You can make
those yourself also if you know how. It was also intended to regulate shops
who provided rolling as a service and specifically to eliminate the rolling machines
found in shops that people could use for a fee.
Regards
Mike

 

[MacTechVpr]

The FDA has no jurisdiction for DIY,period if not for sale and or you do not distribute what
you make. This is un-disputable.
The RYO section you refer to has nothing to do with someone rolling their own
cigarettes themselves. It covers the papers and filters you buy. You can make
those yourself also if you know how. It was also intended to regulate shops
who provided rolling as a service and specifically to eliminate the rolling machines
found in shops that people could use for a fee.
Regards
Mike

Skoon don't mire us in this sticky wicket of intent and purpose. We're all confused enough as it is by the FDA's kitchen sink wish list fantasy.

But while we're at it, where do I find 349 legal employees so I can register?

Good luck.

 

[Shekinahsgroom]

The FDA has no jurisdiction for DIY,period if not for sale and or you do not distribute what you make. This is un-disputable.

Read my post just above yours, DIY is regulated.

The FDA is forcing all manufacturers to register, so they can come after you if you don't register.

But like Less' argument, "Who's gonna know?" if you're DIY'ing for yourself?

And the answer is nobody, unless you're caught. But if you're caught, you're in serious legal trouble both with the FDA and anyone else involved since you're not a registered manufacturer.

So there ya have it peeps, the long "argument" is over, unregistered DIY is considered to be illegal by the FDA.

 

[Lessifer]

Read my post just above yours, DIY is regulated.

The FDA is forcing all manufacturers to register, so they can come after you if you don't register.

But like Less' argument, "Who's gonna know?" if you're DIY'ing for yourself?

And the answer is nobody, unless you're caught. But if you're caught, you're in serious legal trouble both with the FDA and anyone else involved since you're not a registered manufacturer.

So there ya have it peeps, the long "argument" is just like my opening statement for the topic expressed.

DIY...if you're caught = serious -storm of legal trouble!

Your argument is if you're caught distributing your DIY then you're a manufacturer. Yes, if you distribute, you are a manufacturer. That wasn't the question though. DIY for personal use, that is not distributed, is not regulated by the FDA. If you distribute your DIY, then you are a manufacturer.

I'm 99% positive that your assertion that unwillingly and unknowingly "distributing," like having your DIY stolen, would qualify you as a manufacturer, is complete BS, but I'm not a lawyer.

 

[Shekinahsgroom]

Your argument is if you're caught distributing your DIY then you're a manufacturer. Yes, if you distribute, you are a manufacturer. That wasn't the question though. DIY for personal use, that is not distributed, is not regulated by the FDA. If you distribute your DIY, then you are a manufacturer.

I'm 99% positive that your assertion that unwillingly and unknowingly "distributing," like having your DIY stolen, would qualify you as a manufacturer, is complete BS, but I'm not a lawyer.

Registration and Listing

DIY is regulated Less and you have no argument.

You're a manufacturer the moment you DIY anything.

Your "argument" is nothing less than saying...."I'm not a thief until I'm caught".

No, you're a thief the moment you steal something.

 

[Lessifer]

Registration and Listing

DIY is regulated Less and you have no argument.

You're a manufacturer the moment you DIY anything.

Your "argument" is nothing less than saying...."I'm not a thief until I'm caught".

No, you're a thief the moment you steal something.

For the fourth, or fifth time, the regulations only apply to those who sell or distribute products in the US. This is also the reason why you wouldn't have to follow any of the rules if you manufactured product strictly for sale outside of the US.

If you DIY, but you do not sell or otherwise distribute your product, none of the regulations apply to you. They would however apply to those you buy supplies from.

 

[Shekinahsgroom]

For the fourth, or fifth time, the regulations only apply to those who sell or distribute products in the US. This is also the reason why you wouldn't have to follow any of the rules if you manufactured product strictly for sale outside of the US.

If you DIY, but you do not sell or otherwise distribute your product, none of the regulations apply to you. They would however apply to those you buy supplies from.

Fraid not..

"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."

DIY = manufacturer who must register any products being made.

If you don't register as a manufacturer, you're building/mixing stuff illegally.

 

[Shekinahsgroom]

Tobacco Control Act

"To protect the public and create a healthier future for all Americans, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products."

You're a manufacturer the moment you build or mix anything; see thief example above.

 

[Shekinahsgroom]

Let's try another perspective Less.

If someone wanted to open a shop out of their home with the intent to sell their products, they'd have to register with the FDA.

But let's say that they don't register and start building/mixing products....but never sell a thing.

You're trying to prove that everything that this guy made is perfectly legal....since they weren't sold to anyone. And because they weren't sold to anyone, then there's no need to register.

So said failed business operator closes up shop and throws away all of his juice.

Then someone gets a hold of the juice that this guy made and poisons themselves.

Who is the FDA going to come after since the product wasn't registered and there are no warning labels on the products?

They'll make every attempt to find the manufacturer and if they find him/her....they're !

It's no different than DIY, your intention not to sell anything doesn't mean a thing. You're manufacturing products without the FDA's permission and you haven't registered as a manufacturer. Everything that you make is considered to be illegal and unregistered contraband.

Your whole argument is based on distribution; "Who's gonna know if I manufacture stuff that will only be used by me?" = "I'm not a thief until I'm caught".

DIY is still illegal if you're not registered, even if you're never caught.

Your intent means squat.

 

[Lessifer]

The FDA only has authority of the sale(marketing) and distribution, and manufacturing as it pertains to sale and distribution.

If someone died because they found something you threw out, it wouldn't be the FDA that came after you. You might get charged with improper disposal of hazardous materials, but it wouldn't be the FDA.

Trying to comprehend your reality is making my head hurt.

 

[Shekinahsgroom]

The FDA only has authority of the sale(marketing) and distribution, and manufacturing as it pertains to sale and distribution.

If someone died because they found something you threw out, it wouldn't be the FDA that came after you. You might get charged with improper disposal of hazardous materials, but it wouldn't be the FDA.

Trying to comprehend your reality is making my head hurt.

What part of this don't you understand, Less?

"To protect the public and create a healthier future for all Americans, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products."

Whatever it is that you're thinking, look at the reverse:

The Tobacco Control Act does not:
The law makes clear that FDA's role is to regulate and protect the public health, but it places a few restrictions on FDA's powers. FDA cannot:

• Require prescriptions to purchase tobacco products.
• Require the reduction of nicotine yields to zero.
• Ban face-to-face sales in a particular category of retail outlets.
• Ban certain classes of tobacco products.

There's nothing in the law that says they do not regulate manufacturers of products intended for personal use.
If you manufacture products, for DIY or sales, you have to register and/or get a PMTA.

If you don't, everything that you make is illegal.

This is WHY Bill posted this follow-up comment:

I'm not aware of any FDA enforcement action ever taken against any consumer who engages in DIY (for any food, drug, cosmetic, or tobacco product) as long as none of the DIY products are put on the market (i.e. sold or offered for sale).

Just because he's not aware of the FDA taking legal action on a DIY'er doesn't mean that DIY products are exempt from the law.

You're both talking semantics about which agency is gonna come after you. It doesn't matter because the law is clearly written that the FDA has the authority to regulate ALL manufacturing of tobacco products....

Is the FDA gonna single-out DIY'ers? Probably not, but that doesn't mean that they can't take action. The law says that they can come after you if you do not register as a manufacturer.

 

[Lessifer]

You have to understand the purpose of the rule, which is in the title of the actual rule, not the web page:
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


After the effective date, no person may manufacture for sale or distribution within the United States any such product the package of which does not comply with this rule;

 

[KODIAK (TM)]

"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."

DIY = manufacturer who must register any products being made.

If you don't register as a manufacturer, you're building/mixing stuff illegally.

I can say with 100% confidence that you are the only person on the planet who is interpreting the TCA this way. You're splitting hairs over the word, "manufacturer" and taking it way out of context. Well outside the intent of the regulations.

And to Less: Give it up.

 

[Shekinahsgroom]

When you guys find the clause that says "Manufacturing of tobacco products for personal use is not regulated by the FDA or the Tobacco Control Act"....then I'll concede to your argument(s).

But until you find something to that effect, you have no argument.

Cuz if DIY isn't regulated, then anyone (including underage kids) could legally make their own stuff for personal use.

 

[Lessifer]

When you guys find the clause that says "Manufacturing of tobacco products for personal use is not regulated by the FDA or the Tobacco Control Act"....then I'll concede to your argument(s).

But until you find something to that effect, you have no argument.

Cuz if DIY isn't regulated, then anyone (including underage kids) could legally make their own stuff for personal use.

They can, they just won't be able to purchase the supplies for DIY, which is the closure of the "loophole."

Bulk nic is regulated, devices are regulated.

A teen can buy vg/pg/flavors and mix to their heart's content, as long as they don't share it with anyone else.

 

[Shekinahsgroom]

They can, they just won't be able to purchase the supplies for DIY, which is the closure of the "loophole."

Bulk nic is regulated, devices are regulated.

A teen can buy vg/pg/flavors and mix to their heart's content, as long as they don't share it with anyone else.

Nothing to stop them from buying products overseas, like China.

Age requirement for a bank account is 16, that includes a debit card.

Countries outside of the USA are not required to follow our laws. That's why China laughs at our government when we "order" them to stop producing counterfeits.

So your argument, since DIY isn't regulated, now includes importing.

 

[Shekinahsgroom]

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM248241.pdf

Top of page 8

The term manufacturer includes any person, “including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette or smokeless tobacco product.” 15 For example, if you make cigarettes, you are a manufacturer under these regulations. Similarly, if you take finished cigarettes from Company A, remove the cigarettes from Company A’s cartons, and place them in packages with your company’s name (or any other name) on the package, you are a manufacturer because you repacked and relabeled the cigarettes, even though you did not make the finished cigarettes themselves.

Just this definition, all by itself, includes DIY. There's nothing in here that stipulates distribution and/or sales required to be classified as a manufacturer. It only stipulates labeling.

(Or any other name); Lessifer's Special Mix

Still searching for personal use stuff.