FDA Big news coming out of FDA

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f1vefour

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Agreed.

Assuming that there would be any market left after all the makers small and large shut down.

Here's still hoping us DIY'ers will still be able to get nicotine at a reasonable price.

Definitely, when FDA regulations set in DIY will be where it's at. I need to source a couple liters of 1K/mg nic and a lockable freezer for myself. That would last me into the foreseeable future.
 

JMarca

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Yup, nic is THE crucial element. Everything else - a bit of ingenuity, a small lathe and a few tools to fashion portable air moisteners shouldn't be too much of a problem. Flavours, PG, VG ... way too many uses for that stuff to keep it away from our grubby hands :)

And there's hope even for the nic... in anticipation of a possible vapegeddon, I did look up some chemisty forums. Seems DIY extraction from raw tobacco can be doable without turning the neighborhood into a smoldering crater. Although it's degree of toxicity has come under a lot of scrutiny recently, it's serious stuff. Hence I am not going to post any links.

Nicotine is widely available and has been for many many years before vaping came along, believe it or not it has other uses other than what we use it for. Unless they start shutting down farms and pesticide plants Nicotine will be available for purchase online no matter what happens with the FDA. Juice vendors might not be so lucky but I believe the DIY will go on strong. Flavors are inherently used for consumption not inhalation so Capella, TFA, etc... have nothing to worry about and PG/VG have other uses as well.

That said it might suck to be a juice maker these days but it by no means will just go away. Besides the FDA's ultimate goal isn't to stop vaping it's to make a major profit on it by taxing it to oblivion, the government isn't stupid.
 

CorTEH

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Like a drug addict is addicted to drugs, the USA is addicted to tobaccos tax money, and if that starts to go away, they HAVE to supplement the loss
somewhere, and vaping is the easiest target. We literally cant do anything, they will push and push until they get what they want. Its sad that it takes riots
in the streets with thousands of people before our voices get heard.
 
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DC2

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It seemed like they were trying to widen the net on what constitutes a cessation claim. So it wouldn't be necessary that the manufacturer or seller made those claims, they could look beyond that. If it was widely considered to be a way of quitting smoking, and people talked about it that way, that would be enough. The fact that they took the time to publish that language suggests that they see it as a possible future tactic.
This was already decided in the NJoy vs FDA case...
AKA the Smoking Everywhere vs FDA case...

The FDA tried to argue that testimonials from vapers claiming that they quit smoking were on vendor websites.
Judge Leon ruled that the FDA can go pack sand with that argument.

But I agree, it does sound like the FDA is trying to go there again.
In spite of being told to shut the hell up.
 

Wow1420

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Nicotine is widely available and has been for many many years before vaping came along, believe it or not it has other uses other than what we use it for. Unless they start shutting down farms and pesticide plants Nicotine will be available for purchase online no matter what happens with the FDA. Juice vendors might not be so lucky but I believe the DIY will go on strong. Flavors are inherently used for consumption not inhalation so Capella, TFA, etc... have nothing to worry about and PG/VG have other uses as well.

That said it might suck to be a juice maker these days but it by no means will just go away. Besides the FDA's ultimate goal isn't to stop vaping it's to make a major profit on it by taxing it to oblivion, the government isn't stupid.

1. I don't think I want to vape pesticide grade nicotine.

2. What I've read is that nicotine has been taken off the market as a pesticide anyway.
 

DC2

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Nicotine is widely available and has been for many many years before vaping came along, believe it or not it has other uses other than what we use it for. Unless they start shutting down farms and pesticide plants Nicotine will be available for purchase online no matter what happens with the FDA.
Based on my research it doesn't look like there are any nicotine-based pesticides at this time...
Nicotine | Pesticides | US EPA
Reregistration Eligibility Decision for Nicotine
The registrant of the sole remaining
nicotine pesticide product requested the cancellation of its registration on February 25,
2008, to be effective on December 31, 2013, with existing stocks permitted to be sold by
dealers and distributors for one additional year.

Also, the PDF document goes into some detail as to what it would take to get a nicotine pesticide approved.
 

zoiDman

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This was already decided in the NJoy vs FDA case...
AKA the Smoking Everywhere vs FDA case...

The FDA tried to argue that testimonials from vapers claiming that they quit smoking were on vendor websites.
Judge Leon ruled that the FDA can go pack sand with that argument.

But I agree, it does sound like the FDA is trying to go there again.
In spite of being told to shut the hell up.

I would be More Concerned about Hardware being considered a "Tobacco Product" than e-Liquids being considered a Drug.

Because not making any Safety or Quitting Smoking claims about an e-Liquids does not seem that hard.

But the Inclusion of Hardware into the Realm of Tobacco Products based of the wording of this FDA Clarification is Very Troubling.
 

zoiDman

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Nicotine is widely available and has been for many many years before vaping came along, believe it or not it has other uses other than what we use it for. Unless they start shutting down farms and pesticide plants Nicotine will be available for purchase online no matter what happens with the FDA. ...

Why would it Matter what the Stated use for Raw Nicotine is?

If under this FDA Clarification the FDA could make there own Determination of what the Intended Use is based on Historical evidence?
 

DC2

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But the Inclusion of Hardware into the Realm of Tobacco Products based of the wording of this FDA Clarification is Very Troubling.
I saw your earlier post on the subject, but didn't reply at that time.
But I am pretty sure that language was already in there.

Did you see anything new that you can point to?
 

Rossum

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So what would be better? A vape classified as a Tobacco product or a vape regulated as a drug?
The unclassified/unregulated vape you'll make from nic that put away in your freezer while you still could will be far better than either. ;)
 

zoiDman

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I saw your earlier post on the subject, but didn't reply at that time.
But I am pretty sure that language was already in there.

Did you see anything new that you can point to?

I have Never seen the FDA publish this type of wording before...

"2. How Intended Use Is Determined


In determining a product’s intended use, the Agency may look to “any relevant
source,” including but not limited to the product’s labeling, promotional claims, and advertising

(see, e.g., Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C. Cir. 1980); United
States v. Storage Spaces Designated Nos. “8” and “49,” 777 F.2d 1363, 1366 (9th Cir. 1985),
Hanson v. United States, 417 F. Supp. 30, 35 (D. Minn.), aff’d, 540 F.2d 947 (8th Cir. 1976)).
For example, FDA may take into account any claim or statement made by or on behalf of a
manufacturer that explicitly or implicitly promotes a product for a particular use (see, e.g.,
§ 201.128 (drugs), § 801.4 (devices)).


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

(see id.; see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)). In the context of
medical products, generally, circumstantial evidence often ensures that FDA is able to hold
accountable firms that attempt to evade FDA medical product regulation by avoiding making
express claims about their products. As FDA has previously stated, however, the Agency would
not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm’s knowledge that such product was being prescribed or used by
doctors for such use (Ref. 5).


Thus, when a product made or derived from tobacco is marketed or distributed for an
intended use that falls within the drug/device definitions, it would be regulated as a medical
product, subject to the limitations discussed further in this document. Courts have recognized
that products made or derived from tobacco marketed with “disease” claims and certain
“structure/function” claims are drugs (see United States v. 46 Cartons . . . Containing Fairfax
Cigarettes, 113 F.Supp. 336, 337, 338 (D. N.J. 1953) (cigarettes marketed for the prevention of
respiratory diseases); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178
F.Supp. 847, 851 (D. N.J. 1959) (cigarettes marketed for weight reduction))."

https://s3.amazonaws.com/public-ins...ivery&utm_medium=email&utm_source=govdelivery

This "Intended Use" determination could have Very Far Reaching Effects. Something I wonder if the Average Vaper is Considering?
 
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DC2

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In determining a product’s intended use, the Agency may look to “any relevant
source,” including but not limited to the product’s labeling, promotional claims, and advertising
Well, I don't know if they used that exact wording before...
But I thought such wording was already in the deeming proposal.

Regardless, this is the approach they took in the court case when Judge Leon shot them down.
And he shot them down specifically with regard to this type of argument.

In other words, the FDA has gone down this road already and was told they were full of it.
I just don't see how they think they have something new to work with here.

It's as if they just decided to ignore the ruling and push forward in spite of said ruling.
But maybe I'm still missing something?
 
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zoiDman

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...

In other words, the FDA has gone down this road already and was told they were full of it.
I just don't see how they think they have something new to work with here.

It's as if they just decided to ignore the ruling and push forward in spite of said ruling.
But maybe I'm still missing something?

I think One Thing that has to be considered is when Judge Leon slapped the FDA Hands for what they Tried to do, that it was Pre-Deeming.

And what is Included in this FDA Clarification deals with Products Post-Deeming.

As I recall, Judge Leon said that the FDA did have the Ability to Regulate e-Cigarettes. But that they Needed to be Deemed a Tobacco Product First.
 
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DC2

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I think One Thing that has to be considered is when Judge Leon slapped the FDA Hands for what they Tried to do, that it was Pre-Deeming.

And what is Included in this FDA Clarification deals with Products Post-Deeming.

As I recall, Judge Leon said that the FDA did have the Ability to Regulate e-Cigarettes. But that they Needed to be Deemed a Tobacco Product First.
Okay, I see where you're going with this...

So the FDA is now trying to INCLUDE in the deeming that which Judge Leon shot down.
In other words, they are trying to DEEM tobacco use to be a disease.

Yeah, like I said, they seem to be ignoring the ruling and pushing forward in spite of said ruling.
But now I see the significance of this, and how it could be a "new" angle.

I'm not sure it's going to fly.
But I guess I can't say with any confidence that it won't.
:shrug:
 
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nicnik

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Hence, the FDA has two influential groups bending their ear at the moment:

1) The states who want to keep their cigarette taxes and their MSA bonds funded by keeping tobacco sales up, and

2) The pharma companies, who spend a lot of money dealing with the FDA and all that GxP / 21 CFR craziness to make that nicotine patch you put on your arm, and who want to know why the same rules don't apply to a guy mixing eliquid in a rented commercial unit in Reseda.

3) Tobacco litigation attorneys who get a huge chunk of the MSA payments.
 
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