FDA Big news coming out of FDA

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Bad Ninja

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That's why the industry needs to explore other natural sources that can be used for nicotine extraction that aren't tobacco. That way this regulation would not apply.

We can extract it from other sources.
And create it synthetically.

It's just not cost effective to do so.
It's far far too expensive, and too difficult to do it especially on a commercial scale.
 

Kent C

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I'm just not sure How Far the FDA can take some of this?

You and I went to the same "place"....

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)).



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

And:
"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))."

I read US v Travia which was basically some people selling nitrous oxide in balloons at a rock concert. The defendants tried to side step in a number of ways but the 'context' of the 'circumstantial evidence' - how it was used, rather than any 'intent' by the vendor, is part of what determined the case.

So, as far as 'any circumstances surrounding the distribution' could be, say, how, or in what terms we talk about ecigs here?? Or overheard in a vape shop from other customers?? "Stopped smoking 3 packs a day with my first ecig" "cut down to 4 cigarettes a day" etc. etc. So even if the vendors promotion or advertising states nothing about smoke cessation or reduction - the 'circumstances surrounding' may do so.


I can see many 'pocketed' discussion like we (aikanae2, DC2, pamdis, jman, katya, patkin, fritzy, zoidman, me and others) had on the "economic impact' thread - grandfather dates and predicate products, substantial equivalents.... lol
 
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zoiDman

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

And:
"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))."

...

This is what I found Disturbing when I read this FDA Clarification.

And I foresee potential Problems with "including but not limited to the product’s labeling, promotional claims, and advertising" with regard to products that have a "510" Connection.
 
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grandmato5

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Having followed this saga for over 5 years now I don't find any surprises by the FDA in these proposed regulations. There's nothing new here, just clarification in writing in a single proposal. To me this is clearly written to set the stage for the Deeming Order soon (relatively) to come and the court challenges that will, no doubt, follow when the Deeming Order is published in 2016. While I never doubted the Deeming order was coming at some point, this proposal to me proves its now not far from becoming a reality. :( I suspect that any changes in the final regulation (and likely only minor changes) will simply be made based upon comments made during the comment period to attempt to strengthen the FDA's position when the court challenge to the Deeming Order eventually happens.

IMO at least we have a bit clearer picture of when the Deeming order is coming. With a published date of Sept 25th the comment period should end Nov 24th. They then have to review the comments (or at least give the illusion that they seriously reviewed them and I think they will in this case to attempt to cover their butts for the future court challenges) before writing and submitting their final regulations which would go into effect 30 days after publication. Government agencies do next to nothing between Nov 15th and January 15th so I honestly don't see the review coming before January with the minor rewrites coming after that. While I can't imagine it happening even this fast, my guess is we "could" see the final regulation March 1st which wouldn't go into effect until April 1st with the Deeming order to follow after. Just my guess folks ;)
 

zapped

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Having followed this saga for over 5 years now I don't find any surprises by the FDA in these proposed regulations. There's nothing new here, just clarification in writing in a single proposal. To me this is clearly written to set the stage for the Deeming Order soon (relatively) to come and the court challenges that will, no doubt, follow when the Deeming Order is published in 2016. While I never doubted the Deeming order was coming at some point, this proposal to me proves its now not far from becoming a reality. :( I suspect that any changes in the final regulation (and likely only minor changes) will simply be made based upon comments made during the comment period to attempt to strengthen the FDA's position when the court challenge to the Deeming Order eventually happens.

IMO at least we have a bit clearer picture of when the Deeming order is coming. With a published date of Sept 25th the comment period should end Nov 24th. They then have to review the comments (or at least give the illusion that they seriously reviewed them and I think they will in this case to attempt to cover their butts for the future court challenges) before writing and submitting their final regulations which would go into effect 30 days after publication. Government agencies do next to nothing between Nov 15th and January 15th so I honestly don't see the review coming before January with the minor rewrites coming after that. While I can't imagine it happening even this fast, my guess is we "could" see the final regulation March 1st which wouldn't go into effect until April 1st with the Deeming order to follow after. Just my guess folks ;)

There goes my tax return check.
 

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grandmato5

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There goes my tax return check.

No matter when the Deeming order actually comes out I believe very little will change quickly. Although I do expect panic buying to cause problems in supply. :( But I do strongly believe that over time we will see lots of changes that will drastically change the vaping world as we know it now. :grr: Different topic for a different thread, but I believe our states have a greater chance of changing things quickly for the worse if we as vapors don't get involved to defend vaping.
 

zoiDman

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No matter when the Deeming order actually comes out I believe very little will change quickly. Although I do expect panic buying to cause problems in supply. :( But I do strongly believe that over time we will see lots of changes that will drastically change the vaping world as we know it now. :grr: Different topic for a different thread, but I believe our states have a greater chance of changing things quickly for the worse if we as vapors don't get involved to defend vaping.

For this FDA Clarification, here is the Effective Date.


"B. Proposed Effective Date


The Agency proposes that any final rule based on this proposal will become effective 30
days after the date of publication of the final rule in the Federal Register. During the pendency
of this rulemaking, manufacturers will continue to be under an obligation to comply with all
applicable provisions of the FD&C Act and applicable regulations."


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

Bad Ninja

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That's not the same thing.

The concert vendors were not prosecuted based on what concert-goers may or may not have have said.

These very same rules apply to supplements, diet pills, etc. right now.

It will affect labels and advertising,but that's about it.

It's a little too late though, as pretty much everyone knows what vaping is all about.
 

zoiDman

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...

These very same rules apply to supplements, diet pills, etc. right now.

It will affect labels and advertising,but that's about it.

It's a little too late though, as pretty much everyone knows what vaping is all about.

If something, somehow, becomes a "Tobacco Product", even if it is a just a 22mm Diameter piece of Stainless Steel that holds a Coil, then doesn't the Other Regulations which govern "Tobacco Products" apply to this piece of Stainless Steel?

Mainly, the Proposed Regulation that "Tobacco Products" will be Sold in Face-2-Face transactions Only.
 

Bad Ninja

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If something, somehow, becomes a "Tobacco Product", even if it is a just a 22mm Diameter piece of Stainless Steel that holds a Coil, then doesn't the Other Regulations which govern "Tobacco Products" apply to this piece of Stainless Steel?

Mainly, the Proposed Regulation that "Tobacco Products" will be Sold in Face-2-Face transactions Only.

With example,
No.
A light bulb is a piece of steel that holds a coil.
So is the lighter in your car, made for cigs, and totally unregulated.
;)
Unless of course you make the claim that it will "cure" or "treat" a condition.

Claiming it will "treat"'or "cure" an addiction to cigarettes would make fall under that category.
 
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zoiDman

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With example,
No.
A light bulb is a piece of steel that holds a coil.
So is the lighter in your car, made for cigs, and totally unregulated.
;)
Unless of course you make the claim that it will "cure" or "treat" a condition.

Claiming it will "treat"'or "cure" an addiction to cigarettes would make fall under that category.

Yeah... But the purpose of a Light Bulb is not to Produce Vapor as an Accessory of a Tobacco Product. ie: e-liquids.


"Purpose of the Proposed Rule

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
amends the FD&C Act and provides FDA with the authority to regulate tobacco products.
Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act,
defines the term “tobacco product” as any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a tobacco product

(except for raw materials other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product). Excluded from the definition of a tobacco product is any article
that is a drug, device, or combination product. Any article that is a drug, device, or combination
product will be regulated as such rather than as a tobacco product."


Don't get me Wrong. I'm not Arguing for inclusion of "Accessories". Just saying that the Language in this Clarification is Disturbing.

Because up Until Now, there was No Clarification on certain Interpretations as to What a Tobacco Product was.
 

KentA

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Bad Ninja

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Yeah... But the purpose of a Light Bulb is not to Produce Vapor as an Accessory of a Tobacco Product. ie: e-liquids.


"Purpose of the Proposed Rule

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
amends the FD&C Act and provides FDA with the authority to regulate tobacco products.
Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act,
defines the term “tobacco product” as any product made or derived from tobacco that is intended
for human consumption, including any component, part, or accessory of a tobacco product

(except for raw materials other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product). Excluded from the definition of a tobacco product is any article
that is a drug, device, or combination product. Any article that is a drug, device, or combination
product will be regulated as such rather than as a tobacco product."


Don't get me Wrong. I'm not Arguing for inclusion of "Accessories". Just saying that the Language in this Clarification is Disturbing.

Because up Until Now, there was No Clarification on certain Interpretations as to What a Tobacco Product was.


Authentic Kanthal coil flameless survival lighter.

Attaches to the end of your "nemesis" flashlight body.

Problem solved.

Clones on fasttech for $12.
 

zoiDman

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Authentic Kanthal coil flameless survival lighter.

Attaches to the end of your "nemesis" flashlight body.

Problem solved.

Clones on fasttech for $12.

Go back and Re-Read post #54. And pay Particular attention to this part...

"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))."


Then go Re-Read post #83.

I'm just say'n that this Might Not be the Time to summarily dismiss what the FDA is saying.
 
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Bad Ninja

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In all seriousness they are gonna go the simplest, most effective, and easiest route to enforce.

Juice.

"He who controls the spice controls the universe".
- Baron V. Harkonnen (Dune)


Without juice, our mods become really expensive flashlights overnight.
No arguments, or enforcement needed. Restricting gear becomes moot.
 

Canadian_Vaper

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I don't know what to say really, whatever the US does Canada usually follows suit, the problem is if they change them to medical devices potentially it could become illegal to have one without a prescription for it.... Kinda like it is with pills...

Looks like we'll have to start getting our nic from eggplant.....

Really I think they'd only be able to control the juice, I think I'll order some 100mg fairly soon, I only vape 3 to 6 mg so a couple gallons should last me a couple years >.>
 
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f1vefour

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I'm in the when vaping becomes prohibitly expensive I will simply quit vaping camp, I shall not allow the FDA to rule over another aspect of my life.

We live in a nanny society folks, some day it will come to a head and there won't be a peaceful resolution. The masses will rise up and be out for congressional blood, like some type of governmental vampire.
 
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