FDA regulating e liquid as if it is tobacco product...

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Bobbilly

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Perhaps in Canada this is a Good Position to take.

But in the USA, wanting to Classify Nicotine in an e-liquid as Drug under the Authority of the FDA making e-Cigarettes Medical devices would be the Worst Possible Situation.

And Exactly what the FDA wanted to do in 2010.

But more is known now. And the call should be. HOLD ON HERE what do we want to accomplish. We have made some hasty decisions and need to look at it again. A - both drug and tobacco take too much effort and is detrimental to public health. B what is appropriate regulation.

This is a political issue. Current regulatory bodies are ill equipped to deal with it.



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zoiDman

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But more is known now. And the call should be. HOLD ON HERE what do we want to accomplish. We have made some hasty decisions and need to look at it again. A - both drug and tobacco take too much effort and is detrimental to public health. B what is appropriate regulation.

This is a political issue. Current regulatory bodies are ill equipped to deal with it.



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I Don't really Understand what you are Trying to say?

Or how it Applies to how Nicotine in e-Liquids is Going to be Regulated in the USA by the FDA?
 

DC2

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There actually is no legal basis to call something tobacco that doesn't have tobacco in it. Nicotine is a drug. Not a medicine but a drug.
Nicotine is just a combination of molecules or molecular compounds arranged and combined in a certain way, like pretty much everything else we ingest.
Those things can be good, bad, benign, or any and all of the above.

Milk is, for instance, essentially a collection of chemical compounds.

Everything we ingest has an effect on the body.
Defining something as a "drug" just benefits Big Pharma.

The key is finding out what level of a given substance is good, bad, benign, or whatever.
And generally speaking, the idea that moderation is the key is often a good bet.

Even alcohol, in moderation, can supposedly be good for you.
But determining what constitutes moderation depends on the "toxicity" of that particular substance, and it's effects on the body.

I guess that is a lot of words to say that everything is what it is, but there is not really anything "special" about any of it when you get right down to it.
Classification of substances is often a legal and moral endeavor, and our bodies don't care about such classifications.

I don't know if any of that made any sense, but I didn't get much sleep last night.
:laugh:
 

Bobbilly

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I Don't really Understand what you are Trying to say?

Or how it Applies to how Nicotine in e-Liquids is Going to be Regulated in the USA by the FDA?

I'm most if the decisions being made are based on pre-2009 or earlier information. There is more now and this path needs to be rethought.

Even a judge in the smoke everywhere case didn't think the definition of tobacco meant to include nicotine. It was based on the notion there would always be tobacco as the Carrier of nicotine.




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zoiDman

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I'm most if the decisions being made are based on pre-2009 or earlier information. There is more now and this path needs to be rethought.

Even a judge in the smoke everywhere case didn't think the definition of tobacco meant to include nicotine. It was based on the notion there would always be tobacco as the Carrier of nicotine.

Are you Familiar with this piece of US Legislation?

Family Smoking Prevention and Tobacco Control Act - Wikipedia, the free encyclopedia

Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet
 

Stubby

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Regulating e liquid as if it is tobacco product is like trying to regulate ice cream as if it were the same as a steak. That being said, I will explain my comparison. E liquid has nicotine in it as does tobacco. Ice cream has water in it just like steak has water in it.

To the best of my knowledge nicotine is the only thing that e liquid and processed tobacco have in common. E liquid is vaporized and can't be burned (I just tried to do it). Tobacco cannot be vaporized but can be burned (I know, it's not rocket science).

I guess I just cannot wrap my head around how these bureaucrats think that e liquid is the same as tobacco. It is not. One is solid and can be burned, the other is a liquid and cannot be burned. One has FDA approved ingredients, the other has poisons, carcinogens, and a ton of other crap in it that could remove paint from a wall.

What do you think?

The active ingredient in e-liquid is nicotine, which is extracted from tobacco. Trying to say e-liquid is not a tobacco product is like trying to claim that extracting the active ingredient in ...... "that which shall not be named", (but is legal in two states) is not ...... The courts would laugh at you if you tried to make such a claim. It makes no sense from a legal, or any other prospective. Same goes for nicotine.

The intended use of e-liquid is the same as that of other tobacco products, and the active ingredient is extracted from tobacco. Legally you have an impossible task trying to claim it isn't tobacco.

As a side note, tobacco certainly can be vaporized. Vaporizing tobacco (heat not burn) has been around for some time. Check out the Ploom. It is one of a number of available products that vaporize tobacco.

I have heard the argument of we are not tobacco for a number of years, and it always misses the real point. The real point is that there are ways of using tobacco and nicotine that are vastly less harmful then cigarettes. Combustion is the real killer, not tobacco or its extractive nicotine. That's is where the real questions lie. Trying to sidestep the issue by claiming we are not tobacco is a losing proposition. Supporting THR (tobacco harm reduction) is the only way to win. When it becomes common knowledge that there are ways of using tobacco that are about 99% less harmful then smoking the game is over. That is why CASAA supports all forms of THR, not just vaping.

To many people in the vaping community have mistakingly turned against tobacco, when tobacco is not the problem.

Agreed that the mere fact that derivation occurs is not, alone, sufficient reason to regulate it in the same fashion.

But I think you missed my point, which is what is the intended use of that derived product. If nicotine is derived from tobacco, and intended for human consumption, then it is like other tobacco products, containing nicotine, that are intended for human consumption. If I were using nicotine derived from tobacco as an agent to mix with paint to put on my house, I'm thinking FDA wouldn't care at all. ANTZ might, but FDA, not really.

If you are selling basketballs and lipstick as intended for fuel to be put into a gas tank, with claims that "this is so much better than gasoline," I believe you will get the attention of a couple people. If it turns out those claims have some validity, that basketballs and lipstick are actually better than gasoline, I believe a whole lot of people will sit up and take notice. Some of those people will be those who currently see need to regulate gasoline. And some of that segment will say that because both are derived from oil, they ought to be regulated in similar fashion, even while they are vastly different products.

You are correct, intended use is everything.
 

bigdancehawk

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If you want to Argue that it is Illogical, or that Cheese Isn't a Dairy Product because it Comes from Milk, or that Gasoline Isn't a Oil Product, go right ahead.

So if e-Liquids that contain Nicotine that was Derived from Tobacco are Not Tobacco Products, what are they.

And do you Recognize the FDA's legal Authority to Regulate Them?

Whether I recognize it or not is inconsequential. They are going to regulate it unless the enabling statute is changed, which is most unlikely.

I was making the point that just because something originates from a substance doesn't mean that it should be regulated in a manner similar to the original substance. The FDA was created to regulate food products and therapeutic drugs. E-juice is a recreational drug derived from tobacco, like vodka and whiskey, both of which are derived from grain. E-cigarettes are recreational products and should be regulated as such, not subjected to standards that would be more appropriately applied to therapeutic drugs and not by an agency with no experience or expertise in regulating recreational products. The fact that it's derived from tobacco is immaterial. I know they're going to do it irrespective of my opinions, but that won't stop me from speaking out on the subject.
 
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zoiDman

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Whether I recognize it or not is inconsequential. They are going to regulate it unless the enabling statute is changed, which is most unlikely.

I was making the point that just because something originates from a substance doesn't mean that it should be regulated in a manner similar to the original substance. The FDA was created to regulate food products and therapeutic drugs. E-juice is a recreational drug derived from tobacco, like vodka and whiskey, both of which are derived from grain. E-cigarettes are recreational products and should be regulated as such, not subjected to standards that would be more appropriately applied to therapeutic drugs and not by an agency with no experience or expertise in regulating recreational products. The fact that it's derived from tobacco is immaterial. I know they're going to do it irrespective of my opinions, but that won't stop me from speaking out on the subject.

So I take it that you do Not agree with the 1st Paragraph in the Post Above yours?
 

bigdancehawk

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So I take it that you do Not agree with the 1st Paragraph in the Post Above yours?

I can't imagine why you would think that.

I'm saying, at the risk of repeating myself, that from a regulatory point of view it should not matter what a product is derived from or what name we may give it. Unfortunately, however, that doesn't seem to be the FDA's view. Despite paying a bit of lip service to the "continuum of risk" concept, they do not apply it in an insightful way. With e-cigarettes, the "continuum" is more accurately viewed as a drop from a high cliff, rather than a gentle slope. The enabling statute is even worse, as it was written without any consideration whatsoever to the possibility that an ordinary consumer product derived from tobacco could or would provide a relatively safe pathway to smoking cessation and harm reduction for millions of people.

The whole thing should have been rewritten to exclude e-cigarettes and other products that don't involve tobacco combustion (e.g., snus). Then an appropriate statute and suitable regulations could have been written for those products. A debate about whether something is or isn't accurately called a "tobacco product" provides absolutely no useful insight into how it should be regulated. It's just semantics.
 

Bobbilly

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The active ingredient in e-liquid is nicotine, which is extracted from tobacco. Trying to say e-liquid is not a tobacco product is like trying to claim that extracting the active ingredient in ...... "that which shall not be named", (but is legal in two states) is not ...... The courts would laugh at you if you tried to make such a claim. It makes no sense from a legal, or any other prospective. Same goes for nicotine.

The intended use of e-liquid is the same as that of other tobacco products, and the active ingredient is extracted from tobacco. Legally you have an impossible task trying to claim it isn't tobacco.


.

Actually Nicotine is a potent parasympathomimetic alkaloid found in the nightshade family of plants.

It is just happens to be most economical to take it from tobacco leaves.

Is there a difference between tobacco nicotine and eggplant nicotine

Are NRT regulated as a tobacco product?

And finally has a government agency ever been wrong?

http://www.ijdp.org/article/S0955-3959(14)00064-4/fulltext


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zoiDman

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I can't imagine why you would think that.

I'm saying, at the risk of repeating myself, that from a regulatory point of view it should not matter what a product is derived from or what name we may give it. Unfortunately, however, that doesn't seem to be the FDA's view. Despite paying a bit of lip service to the "continuum of risk" concept, they do not apply it in an insightful way. With e-cigarettes, the "continuum" is more accurately viewed as a drop from a high cliff, rather than a gentle slope. The enabling statute is even worse, as it was written without any consideration whatsoever to the possibility that an ordinary consumer product derived from tobacco could or would provide a relatively safe pathway to smoking cessation and harm reduction for millions of people.

The whole thing should have been rewritten to exclude e-cigarettes and other products that don't involve tobacco combustion (e.g., snus). Then an appropriate statute and suitable regulations could have been written for those products. A debate about whether something is or isn't accurately called a "tobacco product" provides absolutely no useful insight into how it should be regulated. It's just semantics.

Isn't this Exactly what is going on Right Now in the FDA?
 

zoiDman

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No. It's being places under a regulatory structure that is meant to restrict it


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Isn't that kinda the Definition of Regulations? A system that Restrict certain Aspects of how a Product can be Made and or Sold?

Realistically. Can you Envision a Market that they are going to want to Heavily Tax that isn't Regulated?
 

Bobbilly

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Isn't that kinda the Definition of Regulations? A system that Restrict certain Aspects of how a Product can be Made and or Sold?

Realistically. Can you Envision a Market that they are going to want to Heavily Tax that isn't Regulated?

Most regulation is set up to ensure safety and certain protects without unduly preventing it from being sold.

Tobacco acts are regulations designed to hamper the sale of products. It ensures that few companies can compete limiting them to a few players.

Once deemed. I predict it will become just another tobacco product as it is easier than to actually make it a MRTP. I think that category was placed there as a joke. I might be wrong if Swedish match get in but I highly doubt it.


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zoiDman

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...

Tobacco acts are regulations designed to hamper the sale of products. It ensures that few companies can compete limiting them to a few players.

...

Well, at least we do Agree on this.

Because e-Liquids are going to be Only Sold by a Very Select Few in the Near Future.
 

Stubby

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Actually Nicotine is a potent parasympathomimetic alkaloid found in the nightshade family of plants.

It is just happens to be most economical to take it from tobacco leaves.

Is there a difference between tobacco nicotine and eggplant nicotine

Not likely any real difference. except for the fact that tobacco has a far more of it. So what is your point.
Are NRT regulated as a tobacco product?

NRT's are regulated as a drug because they went through clinical trials as a quit smoking aid (actually quit nicotine but that is besides the point). It goes back to intended use. Their intended use is not recreational as all other tobacco products are. If some e-liquid maker went through the clinical trials and got approved by the FDA as a quit smoking aid they to would be classified as a drug. If you can't understand the concept of intended use you will never understand the real issues.

And finally has a government agency ever been wrong?

Completely irrelevant to the current issues.
 
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