FDA TVECA post table of contents for Deeming Final Rule

[zoiDman]

This is a means to regulate a product...

In a way, Anything that is done is a way to Regulate a Product.

If I Don't want Non-Smokers to start Smoking, but I Can't ban Cigarettes from being sold, would Banning Marketing/Advertising of Cigarettes be a Step in the Direction I want to go?

 

[pennysmalls]

Probably so, except for nic base. It's been a while since I read the Indiana law, but my recollection is that it's quite easy to see a prohibition on nic base, especially since it can be used for vaping as is without adding anything else.

You may be right. I do remember many of us being upset about the vagueness of the language but at the same time one would think because nic is so essential Indiana would have gone for the jugular and specifically and unequivocally made that part clear. It's strange to me they didn't. That has me wondering if they didn't because of where that could lead.

 

[Rossum]

Exactly how hard is it to open a package and place the glass bottles in your freezer? Please!

Prepare for the slaughter by Steve

I will personally attest that this is Not Difficult at all. If you order 120ml bottles, they usually come in an inner pack of two to a tightly sealed bubble-padded envelope. I grab a Sharpie, wrote "NICOTINE" and the date on it, and in the freezer they go.

You wanna know what the hardest part is? Finding room in the freezer. My wife tends to keep it FULL of non-essential stuff like food!

 

[DC2]

And that leads me to wondering is the FDA/ federal government immune to lawsuits?

It's a little bit complicated, but for the most part yes, they are immune to lawsuits...
Google results for FDA sovereign immunity

 

[Rossum]

90% of current vapers and smokers will obey the law whatever it is.

I think the percentage who will obey the rules depends a great deal on just how reasonable or unreasonable those rules are. Pretend for a moment that a new law passed next week that imposed an outright prohibition on all tobacco/nicotine products. Do you really believe 90% would comply?

 

[skoony]

You may be right. I do remember many of us being upset about the vagueness of the language but at the same time one would think because nic is so essential Indiana would have gone for the jugular and specifically and unequivocally made that part clear. It's strange to me they didn't. That has me wondering if they didn't because of where that could lead.

I would guess the reason nicotine wasn't specifically mentioned is to
Cover any and all present and future ingredients and substitutes.
Regards
Mike

 

[Kent C]

Intended use is their game plan, even though Judge Leon already shot them down.
So they just decided to write "intended use" right into the deeming regs.

Agree. And for those who didn't see the conversation among Zoidman, you and me (and others) - it's worth a look, because it's the FDA addressing ecigs and the case law they're looking at:


Big news coming out of FDA

Big news coming out of FDA

Big news coming out of FDA

Judge Leon shot it down under the context he was judging but that doesn't mean it would be shot down in another context - deeming. "Intended use" could be quite broad as to how it is determined - even as the one case points out:

“any . . . relevant source,” including but not limited to the product’s labeling, promotional claims, and advertising"

"To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold."

 

[sofarsogood]

The possibility of outlawing mixing for personal use, even from pre existing supplies, is chilling. The vape shops and larger commercial e liquid suppliers aren't sweating because they will cut themselves a deal that we will pay for.

The shops and commerical e liquid makers would be ecstatic if DIY were outlawed and we could only obtain their products at their prices. They don't care about taxes since we pay those, not them. Prepare to be sold down the river. If you are getting a creepy feeling at your local vape shops lately, like I am, may be you are the chump, not them.

 

[Rossum]

The possibility of outlawing mixing for personal use, even from pre existing supplies, is chilling. The vape shops and larger commercial e liquid suppliers aren't sweating because they will cut themselves a deal that we will pay for.

The shops and commerical e liquid makers would be ecstatic if DIY were outlawed and we could only obtain their products at their prices. They don't care about taxes since we pay those, not them. Prepare to be sold down the river. If you are getting a creepy feeling at your local vape shops lately, like I am, may be you are the chump, not them.

Perhaps they THOUGHT they were cutting themselves a deal, but if the leaked Guidance is what's really coming, well, I'll still be mixing long after 99.9% of them are gone.

 

[LessSaidTheBetter]

Ok I may be a little late to the discussion and this could have already been discussed but my cat knows someone that used to be into research chems getting bags of questionable powder shipped across the world in the mail. How does the fda plan on stopping gear, nic base, and eliquid from Chinese companies being shipped into the us. Based on my cats friends previous experience worst case scenario is that the package is seized at customs but any company that knows the nature of that industry sends free replacement when that happens.

 

[Myrany]

Ok I may be a little late to the discussion and this could have already been discussed but my cat knows someone that used to be into research chems getting bags of questionable powder shipped across the world in the mail. How does the fda plan on stopping gear, nic base, and eliquid from Chinese companies being shipped into the us. Based on my cats friends previous experience worst case scenario is that the package is seized at customs but any company that knows the nature of that industry sends free replacement when that happens.

From what I have read on ECF the last time Vaping went through regulation woes the government did indeed do an excellent job of shutting down getting vaping supplies in that way. I wouldn't count on that working.

 

[LessSaidTheBetter]

From what I have read on ECF the last time Vaping went through regulation woes the government did indeed do an excellent job of shutting down getting vaping supplies in that way. I wouldn't count on that working.

For that to work customs would have to open and inspect every package coming into the us. That is not possible given the amount of mail that gets sent through international ports. If the dea can't stop drugs coming into the country how does the fda expect to be able to intercept all vape products?

 

[Myrany]

For that to work customs would have to open and inspect every package coming into the us. That is not possible given the amount of mail that gets sent through international ports. If the dea can't stop drugs coming into the country how does the fda expect to be able to intercept all vape products?

DO some searching. What happened during the vapocalypse that led up to the Sotera case is well documented here on ECF. Will they get everything? No probably not but they will get enough of it to make people think twice and if they attach high fines to trying to get it through even more will decide not to try.

 

[LessSaidTheBetter]

Considering China makes about 90% of the vape gear and that the US owes them billions of dollars I could see this turning intosomething way bigger than it needs to be if the FDA really wants to do what everyone fears is the worst case scenario.

 

[squee]

DO some searching. What happened during the vapocalypse that led up to the Sotera case is well documented here on ECF. Will they get everything? No probably not but they will get enough of it to make people think twice and if they attach high fines to trying to get it through even more will decide not to try.

What happened in that case was very large commercial shipments being stopped. Not hard to do. Individual orders via USPS - extremely difficult to stop. Unless they change the classification for import/customs (per that document linked a page or so back) and then make an expensive and time consuming effort to enforce it.

 

[LessSaidTheBetter]

Concessions will be made and taxes will be levied at the state level. That's what the whole thing is about. Am I worried about not being able to get mods, batteries, kanthal, cotton, everything involved up until the point of actually wetting a wick absolutely not. Liquid is another thing. Am I stocking up? A little bit.

 

[Kent C]

They don't care about taxes since we pay those, not them.

Imagine if that concept ever seeped into the brain of those who say 'tax the rich' (or tax businesses).

 

[zoiDman]

For that to work customs would have to open and inspect every package coming into the us. That is not possible given the amount of mail that gets sent through international ports. If the dea can't stop drugs coming into the country how does the fda expect to be able to intercept all vape products?

I don't think Anyone Believes that the US Government can 100% Stop anything that is sent via a Mail Carrier. But I'm sure that a 98% Success rate would be OK with the FDA.

You also have to Think a Little Deeper that just Packages going thru Customs.

Could the US Gov put pressure on CC Companies and or Paypal for doing "Illegal" Transactions of Non FDA Approved "Tobacco Products"?

 

[skoony]

For that to work customs would have to open and inspect every package coming into the us. That is not possible given the amount of mail that gets sent through international ports. If the dea can't stop drugs coming into the country how does the fda expect to be able to intercept all vape products?

If the FDA chooses to do so the whole thing gets shut down. If you understand how things are shipped between
country's you would know bar codes would flag every thing of interest.

Concessions will be made and taxes will be levied at the state level. That's what the whole thing is about. Am I worried about not being able to get mods, batteries, kanthal, cotton, everything involved up until the point of actually wetting a wick absolutely not. Liquid is another thing. Am I stocking up? A little bit.

Wise decision.
mike

 

[SeniorBoy]

Good evening Girls and Boys!

See lines 1428-1459 of the leaked TVECA document: “Guidance for Industry/Draft Guidance”

Let me make it easy:

And, if your thinking for a mila second or less /lol that you won't need to send your Mod to the FDA to support your PMTA application, I beg to differ. Imagine the testing someone will perform to insure your Mod complies.

Please enjoy your mechanicals while you can. /sar