FDA FDA Released New Interpretation of Compliance Policy Guidance PDF

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zoiDman

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I'm not pulling myself back into this ridiculous discussion, I just want to ask one question. And it's not really directed at you Rossum, but ties into your point.

What enforcement action would they take against a person "manufacturing" products for personal use, and what violation would they be accused of?

For a 1st Offense, I think they Detain you in a Federal Holding area and make you listen to 90 Continuous Hours of Stan Glantz seminars.
 
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Rossum

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Huh? You're gonna need to elaborate a lil. :)

Canada isn't under the TCA, other countries are not required to follow our laws.
Nope. They have their own laws that make it illegal. Yet somehow, people manage to get it. Just like people in the US manage to get all manner of substances that are illegal here. Nature abhors a vacuum. If there's a demand, there will be a supply, the only real questions are the price (which is determined by the amount of risk involved in providing the supply) and the quality.
 
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Shekinahsgroom

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Nope. They have their own laws that make it illegal. Yet somehow, people manage to get it. Just like people in the US manage to get all manner of substances that are illegal here. Nature abhors a vacuum. If there's a demand, there will be a supply, the only real questions are the price (which is determined by the amount of risk involved in providing the supply) and the quality.

That is true and the price would speak volumes.

Could it happen, well sure....but it wouldn't be to the extent that it would be right now (not having to register).

If juice prices soar, which they probably will considering it's $1M+ for each new PMTA flavor, a black market would most definitely be a reality if DIY'ers don't have to register. I'm not disputing this and made it one of my key points for the possibility of DIY registration.

But once or if they do at some point, that would radically alter a black market and prices might go even higher than retail juice. But it would be much more difficult to obtain locally since everyone that's using local nic would have a registration number.

(Now we're talking Breaking Bad)

Those that don't...well, hope you like your bathtub gin for the same price or more? ;) Cuz going blind would the least of your worries, ya might wind up dead from an untested nicotine overdose!

"We got a fresh batch for ya, right off the cooker! Knock out an elephant, we like to call it Nicotanyl."
 
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zoiDman

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Not necessarily, it's another gray-area that they're not answering.
Distribution can simply be defined as someone else obtaining your stuff, whether you're aware if it or not.



What protections?
Show me the regs that are protecting you.
Show me the law that says DIY is exempt.



That's correct, but I don't understand your point?

Ya know what... Were kinda in a Loop here.

Your Interpretation of the FSTPCA is that it can be Extended to Individuals who are using a tobacco Product for Personal Use. And mine is that it Can't.

It Doesn't Really Matter what the previous FDA thinks/thought they can do. Or what the FDA chooses to Tell or Not Tell a Non-Stakeholder. What Matters is what the Court(s) say the FDA can/can not do.

Just like they did in the Food and Drug Administration v. Brown & Williamson Tobacco Corp., et al.

And just like they did in Sottera Inc. v. U.S. Food and Drug Administration.

So I guess we will have to leave this Informative "Debate" as Undecided.
 

Myrany

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Where are they gonna get their nicotine from if they can't smuggled it in?

Moot point, no black market if you cannot obtain nicotine suitable for vaping.
Nice try but the folks who would smuggle it would likely source it overseas, and bring it through themselves. It can be obtained. Remember these are people who don't give a crap about he law. Such is the nature of a black market.
 
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Shekinahsgroom

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Ya know what... Were kinda in a Loop here.

Your Interpretation of the FSTPCA is that it can be Extended to Individuals who are using a Tobacco Product for Personal Use.

Personal use has absolutely ZERO to do with registering, and your reference isn't my viewpoint.
You can use it however you want, you just can't distribute it or allow someone else to obtain it.
The FDA isn't going to sanction DIY'ers for personal use, it'll never happen...even if registration is required.
Personal use is NOT the issue, it's distribution.
They're not willing to answer specific questions pertaining to possible future registration and/or current distribution issues (misplaced, thrown-away, given away, stolen, whatever).
Nobody knows who the FDA is gonna crucify for DIY unauthorized distribution, can't get any answers from them.
But if you were registered, the responsibility would be just as clear as it is for establishments. The tobacco manufacturer would be responsible for unauthorized distribution.

It Doesn't Really Matter what the previous FDA thinks/thought they can do. Or what the FDA chooses to Tell or Not Tell a Non-Stakeholder. What Matters is what the Court(s) say the FDA can/can not do.

Just like they did in the Food and Drug Administration v. Brown & Williamson Tobacco Corp., et al.

And just like they did in Sottera Inc. v. U.S. Food and Drug Administration.

So I guess we will have to leave this Informative "Debate" as Undecided.

For the time being, and until the courts say otherwise, the laws stand how they're written.
 
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zoiDman

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Personal use has absolutely ZERO to do with registering.
You can use it however you want, you just can't distribute it or allow someone else to obtain it.
The FDA isn't going to sanction DIY'ers for personal use, it'll never happen...even if registration is required.
Personal use is NOT the issue, it's distribution.
They're not willing to answer specific questions pertaining to possible future registration and/or current distribution issues (misplaced, thrown-away, given away, stolen, whatever).
Nobody knows who the FDA is gonna crucify for DIY unauthorized distribution, can't get any answers from them.



For the time being, and until the courts say otherwise, the laws stand how they're written.

OK.

:)
 

Rossum

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Shekinahsgroom

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Here is an excerpt from an Interesting Article...

The FDA’s Deeming Rule was designed to extend the agency’s regulatory authority over a variety of tobacco products, which greatly impacts the vape industry. However, the recent clarification from FDA attorneys appears to confirm that the Deeming Rule does not extend to e-liquids that are either nicotine-free, or not made or derived from tobacco, when marketed and sold appropriately

FDA Makes Statements on Synthetic Nicotine - Convenience Store Decisions

If there is even a Question as to whether or Not the FDA has Legal Authority over TFN Nicotine, how much farther will the FDA have to Overreach to include Pure PG and or Pure VG sold as such?

Looks like Nicopure lost their battle (Aug 2016):

http://www.clivebates.com/documents/FDAresponse.pdf

[PROPOSED] ORDER Upon consideration of Defendants’ cross-motion for summary judgment, it is hereby ORDERED that the motion is GRANTED; and it is FURTHER ORDERED that Plaintiffs’ motions for summary judgment are DENIED; and it is FURTHER ORDERED that judgment is entered in favor of Defendants, and against Plaintiffs, on all claims raised in the complaints.
 
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Shekinahsgroom

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My friend... I think this lake has been all fished out.

Didn't know, haven't been following the law suites.

Zoi's post was the first that I'd seen anything about a recent challenge, but I wasn't aware they were already in litigation and arbitrarily lost.

Anybody know of other suites that have lost as well?

Line up the dominoes, they'll probably all lose....
 
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