Class Action Exploding Devices

[MacTechVpr]

Any entity with the perverse hutzpah to glean jurisdictional authority to deem a battery tobacco could very well use what language they will to deem you a non-compliant producer. When language, practice and precedent mean nothing but what they say it is, who is to say otherwise?

See no lawful authority in the FDA to regulate nicotine (an organic molecule) as tobacco. How the back-door pretext of sale to minors got us here needs to be acknowledged and its compromising unfounded expression revoked, stamped out. Until then, come what may otherwise, that poison which really threatens to kills us still runs through our veins.

As long as they may hide behind the children their corrupt agenda wins. The sanctimonious deferral of authority to agency must be ended and such law eradicated. We will otherwise never prove the negative upon which such relies.

Good luck.

 

[Bill Godshall]

I'm surprised with you Bill, I would have thought a person of your vaping presence would have had your facts straight before posting mis-information and calling someone wrong before knowing if your information is even correct?

Since 2009, the FDA has taken >500,000 compliance/enforcement actions for the TCA (which included RYO), and every single one of those enforcement actions was taken against a tobacco retailer (>495,000) or a tobacco manufacturer (>5,000).

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).

 

[Shekinahsgroom]

Since 2009, the FDA has taken >500,000 compliance/enforcement actions for the TCA (which included RYO), and every single one of those enforcement actions was taken against a tobacco retailer (>495,000) or a tobacco manufacturer (>5,000).

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).

I'm sorry, I'm missing your point Bill.

Was that an apology?

 

[DC2]

See no lawful authority in the FDA to regulate nicotine (an organic molecule) as tobacco. How the back-door pretext of sale to minors got us here needs to be acknowledged and its compromising unfounded expression revoked, stamped out.

In order to do that, we need to figure out who supports this crap.
Who supports, or even encourages, our government in these efforts to constrain liberty?

If you've got a precious snowflake, you certainly need to protect it.
Precious snowflakes melt unless they are protected.

 

[Shekinahsgroom]

@Lessifer is right. One is only a manufacturer if one sells or distributes what they make.

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 !

 

[Lessifer]

Nevermind the fundamental misunderstanding of the concepts here...

The FDA will not stop people from building their own mods, they can't.

Their rule that disincentives making product improvements on existing products also works to ensure that new products will not be brought to market. Except possibly proprietary closed systems.

 

[MacTechVpr]

In order to do that, we need to figure out who supports this crap.
Who supports, or even encourages, our government in these efforts to constrain liberty?

If you've got a precious snowflake, you certainly need to protect it.
Precious snowflakes melt unless they are protected.

Eliminating bad provisions of law is far more effective than EO's. Lasts longer, more meaningful. When they go so does the deadwood.

I hate to have to do things twice.

Good luck.

 

[Shekinahsgroom]

The FDA will not stop people from building their own mods, they can't.

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.

 

[Lessifer]

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.

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.

Yes, any form of distributing, for profit or not, is under FDA jurisdiction. That's not what was being argued.

The deeming regs discourage safety developments because existing products AND new products would both have to have an approved PMTA to be released, effectively freezing the industry where it is. The prospect of vaping becoming unavailable leads people to DIY both liquid and mods, for their own use.

The FDA isn't making things safer. Their version of making things safer is limiting what's available to a very small class of products, if any.

 

[Shekinahsgroom]

Yes, any form of distributing, for profit or not, is under FDA jurisdiction. That's not what was being argued.

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

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

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.

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).

 

[Shekinahsgroom]

I do understand Less, but you're missing what I'm saying.

Trust me, it's been debated to death already....

Okay Less, what next on the debate floor?

Shek 1
Lessifer 0
Bill [disqualified]

 

[Lessifer]

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.

You're still not understanding your own point, or what's being argued. DIY, the act of making your own mod or liquid, is not manufacturing that is under the jurisdiction of the FDA. It does not become distribution until you give that to someone else, for money or not. Making it yourself and using it yourself does not make you a manufacturer, as far as the regulations are concerned, because the regulations govern sales and distribution. The supplies used to DIY fall under the regulations, because they are sold and distributed.

 

[Joergl100]

The title of this thread should be changed...sorry...

 

[Shekinahsgroom]

You're still not understanding your own point, or what's being argued. DIY, the act of making your own mod or liquid, is not manufacturing that is under the jurisdiction of the FDA.

At least not until you're caught, which would only happen if you harmed someone or were caught distributing.

At no point did I ever say that the FDA could come after you for mixing or making your own stuff for personal use, but that doesn't mean that DIY for personal use isn't classified as a manufacturer. You don't become a manufacturer when you're caught distributing. You're a manufacturer from the moment you DIY anything.

"If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any "tobacco product," then you are considered a tobacco product "manufacturer."

The definition is no different than someone building/mixing stuff for sale. Because if it were, then there would be no need for the loophole clause.

"Note: If you mix or prepare e-liquids, make or modify vaporizers, or mix loose tobacco, and you also sell these products, you will be regulated as both a retailer and a tobacco product manufacturer."

Modify/mix = manufacturer
Sales = retailer

It's exactly why the manufacturer clause can come back to bite you in the azz if you're sued. Cuz according to the definitions of the Act, you're a non-regulated (or non-retail) manufacturer. And you'd be held accountable (for damages/harm) just like any other manufacturer.

They can and might come after you for any kind of distribution which would include someone else getting their hands on whatever you made or if those materials harmed anyone.

If you don't believe me Less, find a lawyer on the forum that's versed in the FDA Act and bring him in here.

Okay Less, what next on the debate floor?

Shek 1
Lessifer 0
Bill [disqualified]

 

[Shekinahsgroom]

The title of this thread should be changed...sorry...

You must be new to the forum?

 

[KODIAK (TM)]

At no point did I ever say that the FDA could come after you for mixing or making your own stuff for personal use, but that doesn't mean that DIY for personal use isn't classified as a manufacturer.

As a DIY'er myself, I don't care what "label" they (or you) assign me. If the FDA comes after me for consuming my own "tobacco" creations derived from legal ingredients then my lawsuit will be the trial of the century.

You will all be invited.

 

[Shekinahsgroom]

As a DIY'er myself, I don't care what "label" they (or you) assign me. If the FDA comes after me for consuming my own "tobacco" creations derived from legal ingredients then my lawsuit will be the trial of the century.

You will all be invited.

If you try to sell it or you give it away to someone or if someone gets a hold of your stuff with or without your knowledge and it harms them or causes damage...then yes, they can come after you.

It's highly unlikely that they would, but the plaintiff's lawyer (your victim) would kill you in court because of the definitions of the Act because your tobacco product was not approved by the FDA.

 

[KODIAK (TM)]

If you try to sell it or you give it away to someone or if someone gets a hold of your stuff with or without your knowledge and it harms them or causes damage...then yes, they can come after you

That generic statment applies to any number of negligent acts. But I guarantee if I did not "willfully" distribute said stuff that caused the harm it would not fall under the purview of the FDA.

 

[Shekinahsgroom]

Less...

Look at it from this perspective.

When is a Property Owner Liable for a Trespasser's Injuries? - AllLaw.com

Let's say you build a mech from scratch and some jerk steals it from you, you're liable if it blows up and harms him or others because you're a non-regulated manufacturer. (FDA didn't give you permission to build it)

But if you were a registered product manufacturer and a thief stole something from the factory and it blew up and caused him harm, the manufacturer might not be responsible because he would have a PMTA approval.

(Manufacturing defects aside for law suites, this comparison is being used for the difference between unregulated and PMTA approved manufacturer.)

This is why the definitions are written to include the loophole clause.
It makes DIY'ers directly responsible for anything that they make since they haven't applied for (or been approved for) a PMTA. So in the event you're sued for damages, you literally have no defense....you're dead meat because you didn't get the FDA's permission to make said product.

 

[Shekinahsgroom]

That generic statment applies to any number of negligent acts. But I guarantee if I did not "willfully" distribute said stuff that caused the harm it would not fall under the purview of the FDA.

I'm afraid that it would my friend. Willful or not, if your product causes someone else harm or damages, you're responsible if you haven't applied for or approved for a PMTA (Pre-Market Tobacco Application).

Whether or not the FDA would come after you is not yet known since we don't have any examples yet. But technically speaking, distribution could mean anyone that's in possession of what you made whether intentional or not if you're a non-registered tobacco product manufacturer.