FDA So what might really happen with regulations/bans? Should we be stocking up?

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WorksForMe

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I’m not a lawyer, but I can see how the PACT Act could be interpreted to include eliquid if the FDA deems ecigs to be tobacco products. The Act covers cigarettes and smokeless tobacco.

(12) Smokeless tobacco. --
The term smokeless tobacco means any finely cut, ground, powdered, or leaf tobacco, or other product containing tobacco, that is intended to be placed in the oral or nasal cavity or otherwise consumed without being combusted.

J.R.
 

zoiDman

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I’m not a lawyer, but I can see how the PACT Act could be interpreted to include eliquid if the FDA deems ecigs to be tobacco products. The Act covers cigarettes and smokeless tobacco.



J.R.

This is what Makes "Deeming" e-Liquids, that contain Nicotine which has derived from Tobacco Plants, such a Huge and Overarching Statutory Definition.
 

DC2

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I hope you are Correct.
Well, I could be wrong, but I didn't think so up until your post above.
I don't mind being wrong, I just care about getting it right.
:)

If Wikipedia is right, then I am seriously wrong, in a most alarming way.
But do you have language from the FSPTCA itself that backs up what Wikipedia is saying?

Not that I don't believe it, but amending the PACT Act is what I have always thought was needed for such restrictions.

Where is Bill Godshall when you need him?!?!
:)
 

zoiDman

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Well, I could be wrong, but I didn't think so up until your post above.
I don't mind being wrong, I just care about getting it right.
:)

If Wikipedia is right, then I am seriously wrong, in a most alarming way.
But do you have language from the FSPTCA itself that backs up what Wikipedia is saying?

Not that I don't believe it, but amending the PACT Act is what I have always thought was needed for such restrictions.

Where is Bill Godshall when you need him?!?!
:)

You have Probably seen me post Many Times that the ECF needs a Team of Pro Bono Lawyers who we could Bounce things like this off of.

Also, Just because the FDA has the Legal Authority to do something Doesn't Mean that they Will or Should.

In about 9.5 Hours we are going to Enter into the Next Phase of this Battle. And that will be Contacting Members of Congress. Because they have the Power to Approve, Dis-Approve or Amend what the FDA wants to.

At Least, that is the Way I Understand the Rule Making Process.
 

zoiDman

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What the Tobacco Control Act does

Restricts cigarettes and smokeless tobacco retail sales to youth by directing FDA to issue regulations which, among other things:
Require proof of age to purchase these tobacco products – the federal minimum age to purchase is 18 – Sec. 102
Require face-to-face sales, with certain exemptions for vending machines and self-service displays in adult-only facilities – Sec. 102
Ban the sale of packages of fewer than 20 cigarettes – Sec. 102
Allow certain exemptions in adult-only facilities – Sec. 102
Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet

BTW - The Vending Machine Issue was what CA SB-648 Boiled Down to after being Gutted a Few Times.

ETA: Here is a Searchable PDF version of the FSPTCA

http://www.fda.gov/downloads/tobaccoproducts/guidancecomplianceregulatoryinformation/ucm237080.pdf
 
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Kent C

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Well, I could be wrong, but I didn't think so up until your post above.
I don't mind being wrong, I just care about getting it right.
:)

If Wikipedia is right, then I am seriously wrong, in a most alarming way.
But do you have language from the FSPTCA itself that backs up what Wikipedia is saying?

Not that I don't believe it, but amending the PACT Act is what I have always thought was needed for such restrictions.

Where is Bill Godshall when you need him?!?!
:)


"The 2009 Tobacco Control Act did NOT impose any age verification regulations on Internet sales of tobacco products, and I've seen nothing in the FDA deeming regulation that would impose them on Internet sales of e-cigs. Rather, the 2009 PACT Act banned the vast majority of cigarette sales on the Internet (and also applied to smokeless tobacco), but the PACT Act does not apply to e-cigs (and cannot apply to e-cigs unless it is amended by Congress, which isn't going to happen)." Bill G here:

http://www.e-cigarette-forum.com/fo...b1500-assigned-committee-40.html#post13049199
#392
 

bigdancehawk

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I can see very little reason to hoard nicotine. Any "tobacco product" marketed before 2007 can still be legally sold once the regulations go into effect and there is nothing the FDA can do to change that because it's written into the enabling statute. Nicotine were being extracted from tobacco plants and manufactured and marketed by a number of companies long before 2007. It was being used in nicotine gum and patches long before 2007.
 

zoiDman

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I can see very little reason to hoard nicotine. Any "tobacco product" marketed before 2007 can still be legally sold once the regulations go into effect and there is nothing the FDA can do to change that because it's written into the enabling statute. Nicotine were being extracted from tobacco plants and manufactured and marketed by a number of companies long before 2007. It was being used in nicotine gum and patches long before 2007.

Just Curious.

Once the FDA Rules have been Finalized, do you think the FDA will have the Immediate Legal Authority to....

Restrict e-Liquid Sales to Face-to-Face Only.

Cap Nicotine Levels of e-Liquids.

Restrict Flavorings to Only FDA Approved e-Liquids.
 

Kent C

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I can see very little reason to hoard nicotine. Any "tobacco product" marketed before 2007 can still be legally sold once the regulations go into effect and there is nothing the FDA can do to change that because it's written into the enabling statute. Nicotine were being extracted from tobacco plants and manufactured and marketed by a number of companies long before 2007. It was being used in nicotine gum and patches long before 2007.

Interesting take on it. And one I haven't seen - other than those who claim the proposed deeming doesn't really affect anything :) So if eliquid, even premixed, were marketed in the US before 2007, that should also be 'grandfathered' in. And it shouldn't be that big a deal to show SE since it would have been PG/VG, nic, and flavoring. Ratios may be a problem.... and whether they were actually sold at that time.

I'm pretty sure the FDA would say you're wrong about this but I do see your point. Everyone has been focusing on hardware mostly in regards to grandfathering.
 

zoiDman

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Interesting take on it. And one I haven't seen - other than those who claim the proposed deeming doesn't really affect anything :) So if eliquid, even premixed, were marketed in the US before 2007, that should also be 'grandfathered' in. And it shouldn't be that big a deal to show SE since it would have been PG/VG, nic, and flavoring. Ratios may be a problem.... and whether they were actually sold at that time.

...

That, Unfortunately, is Not Going to be What Happens.
 

Kent C

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That, Unfortunately, is Not Going to be What Happens.

I tend to agree but as bdh points out, it would be a 'tobacco product', ....and it very well could have been marketed in the US before Feb 15, 2007, plus it would be a lot easier making an SE case with 4 components vs. trying to say a provari with an RDA clearo is the same as a cigalike. lol
 

zoiDman

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I tend to agree but as bdh points out, it would be a 'tobacco product', ....and it very well could have been marketed in the US before Feb 15, 2007, plus it would be a lot easier making an SE case with 4 components vs. trying to say a provari with an RDA clearo is the same as a cigalike. lol

I just Don't see e-Liquids falling under the SE portion of the Proposed FDA Rules. And see SE relating to Hardware Only.

My hope is that Unflavored e-Liquids in 36mg or less will still be Available for Internet Sale. But my Gut Feeling is that e-Liquids Sold over the Internet are going to go Bye-Bye.
 

Kent C

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I just Don't see e-Liquids falling under the SE portion of the Proposed FDA Rules. And see SE relating to Hardware Only.

Why? It says:

"Tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007, are not “new tobacco products” subject to the premarket requirements, and FDA refers to these products as “grandfathered.”

Since even drip tips are considered 'tobacco products' there's no reason why eliquid wouldn't be. In fact they stress that EVEN IF a component doesn't contain nicotine, it is still a tobacco product, so those that DO contain nicotine absolutely will be.
 

zoiDman

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Why? It says:

"Tobacco products that were commercially marketed (other than for test marketing) in the United States as of February 15, 2007, are not “new tobacco products” subject to the premarket requirements, and FDA refers to these products as “grandfathered.”

....

Because of 2 Reason.

The First is that the Wording does Not Include the Words "All" or "e-Liquids".

The Second is that these are Just Proposed Rules and Procedures.

I believe that e-Liquids that Contain Nicotine are going to have Specific Regulations Applied to them. Above and Beyond the Blanket SE Guidelines that the FDA has Propose.

BTW - There is Not Guarantee that a Product that May Qualify under SE will be Approved.
 

Kent C

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Because of 2 Reason.

The First is that the Wording does Not Include the Words "All" or "e-Liquids".

The Second is that these are Just Proposed Rules and Procedures.

I believe that e-Liquids that Contain Nicotine are going to have Specific Regulations Applied to them. Above and Beyond the Blanket SE Guidelines that the FDA has Propose.

BTW - There is Not Guarantee that a Product that May Qualify under SE will be Approved.

True but if you found a predicate with the right ratio, it should be grandfathered - no need for SE. That is IF....
 

zoiDman

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True but if you found a predicate with the right ratio, it should be grandfathered - no need for SE. That is IF....

It just is Hard to Know what the FDA is going to do. We are All Kinda Guessing and Supposing.

And this what I thought was so Disingenuous about the Comment Period with Regards to e-Cigarettes. The FDA Dumps a Doc in our Laps saying this is what they are Proposing. But that it Isn't Carved in Stone. And when I look for the word "e-Liquid", I don't see Many References.

I can make Guesstimation about what they are Going to do with Regards to Hardware. But Hardware Isn't the Important Issue. Because there are Going to be Ways to sell a Carto or an eGo Battery that the FDA will Not have Power Over. And the FDA Knows this.

It's the e-Liquids. That what the FDA Wants to Regulate. And what the FDA Knows they CAN Regulate.

But the FDA Hasn't Really Said Anything with Regards to e-Liquids.
 

Burnie

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I tend to agree but as bdh points out, it would be a 'tobacco product', ....and it very well could have been marketed in the US before Feb 15, 2007, plus it would be a lot easier making an SE case with 4 components vs. trying to say a provari with an RDA clearo is the same as a cigalike. lol

Back in the day it only had 3, no VG, only PG, Nic, & (suck ....) Flavoring. Sucks to be old and remember this. Lots better now, but juice won't be grandfathered. Nic will be the target, IMHO.

Vape On
Burnie
:vapor:
 

Kent C

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Back in the day it only had 3, no VG, only PG, Nic, & (suck ....) Flavoring. Sucks to be old and remember this. Lots better now, but juice won't be grandfathered. Nic will be the target, IMHO.

Vape On
Burnie
:vapor:


It was well established when I came on board in Jun '09. Did a quick search and found this first mention, although TBob must have PM'd Steve :)

http://www.e-cigarette-forum.com/fo...rgy-may-have-give-up-e-smoking.html#post21885

..but yeah, at gf date, no VG.

114211894.jpg
 

bigdancehawk

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Just Curious.

Once the FDA Rules have been Finalized, do you think the FDA will have the Immediate Legal Authority to....

Restrict e-Liquid Sales to Face-to-Face Only.

Under the rules as currently proposed, there is no such restriction. I doubt they will add it.

Cap Nicotine Levels of e-Liquids.

The current rules, if adopted without change, would give them the authority to deny approval to any product if they have any reason (other than an arbitrary and capricious reason). So, to answer your question, they probably have that authority. Obviously, 100% nicotine is very dangerous stuff. Below that, it becomes a matter of degree. But none of this applies to just plain ol' nicotine which has been marketed and sold, in various strengths, long before 2007.

Restrict Flavorings to Only FDA Approved e-Liquids.

Unless the regulations are changed, no e-liquid can be sold without FDA approval, and the burden of proof will be on the purveyors. But prove what? The purveyors will have no clear idea of what is required to gain approval. There are no objective standards, so I suspect very few, if any, e-liquid purveyors will apply for approval.
 

zoiDman

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Restrict e-Liquid Sales to Face-to-Face Only.

Under the rules as currently proposed, there is no such restriction. I doubt they will add it.

Restrict of Only Face-to-Face Sales of Tobacco Products was/is one of the Main Goals of the FSPTCA.

I would be Very Surprised if the FDA Did Not Apply it to e-Liquids.

What Requirements there will be on FDA Approved e-Liquids is Anyone's Guess. And the Big Part of why I said the Comment Period was Not as it Should Be.

How Can a Person/Company comment on Something when they Don't Know what the FDA Wants to do?

I don't Think the 2007 Date is Going to have Anything to do with e-Liquids. Either Good. Or Bad.
 
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