E Juice not a tobacco product????

[BigBen2k]

You could start here:
Federal Food, Drug, and Cosmetic Act (FD&C Act)
but unless you've got some mad legal skills, it's pretty easy to misinterpret these things.

 

[dr g]

You could start here:
Federal Food, Drug, and Cosmetic Act (FD&C Act)
but unless you've got some mad legal skills, it's pretty easy to misinterpret these things.

The FD&C act was in pdf form at the other link. I've already been through it ... I've got a lot of experience digging through legislation for various reasons. I still can't find it lol

 

[VV_James]

Is asperin a willow tree product?
Possibly, the bark of the willow tree contains significant quantity's of Acetylsalicylic Acid (Aspirin)
However, not all aspirin is sourced from willow.

Furthermore, if you remove all traces of anything that is not Acetylsalicylic Acid is it still willow?

Do you eat Tomatoes, potatoes, eggplants, tomatillos, papayas, or chocolate?

If so then you may consume more nicotine via dietary ingestion than your vaping. Because all of these plants and more contain nicotine in various amounts!

And again once you have removed all traces of anything that is not nicotine, is it still a potato?

 

[BigBen2k]

The FD&C act was in pdf form at the other link. I've already been through it ... I've got a lot of experience digging through legislation for various reasons. I still can't find it lol

Blame Congress; they wrote it!

 

[DC2]

Can you provide a link to the legislative language of this? I'm having trouble finding it.

The legislative language of which part?

 

[TyPie]

Eggplant has even more nicotine than tomatoes.
MMS: Error
Vegetable Nicotine in ng/g g per 1µg nicotine
Cauliflower 16.8 59.5
Eggplant (Aubergine) 100.0 10
Potatoes 7.1 140
Green tomatoes 42.8 23.4
Ripe tomatoes 4.3 233.0
Pureed tomatoes 52.0 19.2

Then by all means, I vote that we regulate ecigs as a vegetable.
NO, make that, fruit. (my favorite ejuice is derived from peaches....)

 

[TyPie]

In lieu of favorable regulation, a judicial remedy might be sought. Divorcing nicotine from tobacco could clear up some of the political liabilities.

This makes too much sense. This would likely be one helluva legal battle that would actually be FUN to watch.

 

[jpargana]

Ah but once you separate the intended use from the effects of burning tobacco and the evil spectre it conjures, actual science as far as safety comes into play. It is then fair to raise the question of why the product needs to be regulated as much as tobacco is.

This is why the "third classification" route is probably the best we can hope for. Both medicine and tobacco regulation are more than vaping should get.

You're quite right. But before, when I said that I believed 'the classification of nicotine e-juice as a tobacco product is actually fair', I was only talking about the classification by itself, not actually about the taxes that should be applied.
Think of swedish snus, for example: is it a tobacco product? Indeniable... but is it fair that it is taxed more than tobacco , so that the price gap between a pack of cigarettes and a snus-box has actually decreased?? Surely not; it does not make any sense! But at least, people in Sweden can still buy snus, if they wish to. Unlike the rest of the EU, that option has not been taken away.

By trying to classify e-cigs as medicines, with requirements impossible to meet by most manufacturers, the EU is trying, in fact, to ban the e-cig from Europe... without having 'actually' to ban it! Oh, the irony...!

So, if the third classification route does not actually happen in the future (I believe it won't - too many 'undercover' interests at stake), I believe we would be better off with the e-cig classified as tobacco products. Looks like, unfortunately, we will have to settle for the least of two evils - paying unfair and unjustified taxes just to have access to an healthier alternative to cigarettes...

 

[VV_James]

Then by all means, I vote that we regulate ecigs as a vegetable.
NO, make that, fruit. (my favorite ejuice is derived from peaches....)

LOL!

How bout we promote it as a nutritional supplement...
The least regulated category under the FDA's control?

There's precedent...

Omega-3 Fatty Acids EPA & DHA comes from various fish oils... The best comes from Krill Oil, but it's NOT considered a Fish product...
Natural Progesterone & Estrogen is extracted from certain species of Yams, But is NOT considered a Yam product...

The list is in the thousands and in each case is called what it is, not what it was sourced from. and bears the statement Nutritional Supplement, and the statement, "Not evaluated by the FDA."

Yeah, we'd have to do the whole PITA labeling thing, but it would be worth it:

Directions, Vaporize and ingest via inhalation. 1 to 7 servings per day.

SUPPLEMENT FACTS
Serving Size: 1ml
Amount per serving
Nicotine 24mg*
*Daily Value Not Established

Other Ingredients: Propylene Glycol, Vegetable Glycerine, Distilled Water, Natural and artificial flavors.

 

[kristin]

I can't find the rule regarding how this applies to nicotine from other sources?

You won't, because as I explained, things are regulated based on intended use.

If a product - ANY product, including one with nicotine as the active ingredient - has an intended use (ie. marketed or commonly used as) a food, drug (medical) or cosmetic then it automatically falls under FD&C Act of 1938.

If it is intended to be used as a diet supplement, it falls under the FD&C Act amendment passed in 1994.

If it is a tobacco, tobacco derivative or intended to be used as a modified risk tobacco product, it falls under the FSPTCA of 2009, which amends the FD&C Act.

So, it is the intended use of the nicotine-containing product that determines under which regulations it falls, not the source. There is no regulation that currently covers recreational use of nicotine extracted from plants other than tobacco, because it is neither a food, medical drug, cosmetic, dietary supplement, tobacco product or MRTP. But you can be pretty sure that something would be passed pretty quickly giving the FDA regulatory power over it should it start to be widely distributed to the public. Probably the same regulations that will eventually cover another popular drug recently legalized in some States. Or they'll just keep it under tobacco product because most nicotine comes from tobacco and the intended use is identical to tobacco.

But it will still be the marketed, intended use of that non-tobacco nicotine product that determines which regulatory act it falls under.

As an example, cranberry products and cranberry derivatives are not regulated based on the source being cranberries. They are regulated based on the intended use as marketed. If it is being marketed as a fruit or fruit juice beverage, it falls under FD&C Act as a food. If the manufacturer starts advertising the juice as a remedy for urinary tract infections, that product (not ALL cranberry products, just the one making the claim) will put itself under FD&C as a drug treatment. If a company extracts the abundant vitamin C from the cranberries and sells it, it becomes a dietary supplement and is regulated differently than as a food or drug. Just because products share the same simple cranberry source doesn't dictate how it is regulated. Vitamin C also comes from other fruits and vegetables, but each vitamin C product is not regulated based on the source fruit or vegetable, but on the intended use.

What dictates the regulation is the marketed intended use, but there is no "written rule" for that. It's just what happens under all of these Acts.

 

[Coastal Cowboy]

In lieu of favorable regulation, a judicial remedy might be sought. Divorcing nicotine from tobacco could clear up some of the political liabilities.

I agree with this. However, I think it's a near impossibility, since all currently available USP grade nicotine liquids are derived from tobacco.

That said, any move to restrict the sale of flavored liquids with nicotine can be easily gotten around by simply selling the liquid unmixed and letting the consumer do the mixing at home. Flavorings, PG and VG and even unflavored nic have too many other uses for a total ban on online sales to be enforceable.

FDA has to know this.

 

[Mowgli]

Since nicotine patches and gum are designed to not work, frustrate users and return them to smoking should they be catagorized as tobacco products or as cattle products (bull fertilizer)?

 

[kristin]

So, if the third classification route does not actually happen in the future (I believe it won't - too many 'undercover' interests at stake), I believe we would be better off with the e-cig classified as tobacco products. Looks like, unfortunately, we will have to settle for the least of two evils - paying unfair and unjustified taxes just to have access to an healthier alternative to cigarettes...

Just using your post as a jumping off point for the idea posted by several people that a non-tobacco classification will somehow save e-cigarettes from taxation and over-regulation and improve social standing...

The question is, why do people believe that a "third classification" for non-tobacco nicotine would be any better for e-cigarettes or their "image?" The ANTZ are anti nicotine and tobacco zealots. They believe nicotine use of any kind leads to smoking. They believe seeing e-cigarettes being used glamorizes smoking and entices children to start smoking. They believe any addiction is "bad" so nicotine use that likely leads to nicotine addiction is bad. Notice how, now that there is strong evidence that e-cigarettes are far safer than smoking and that much is being accepted, ANTZ (and a lot of the public) still object to e-cigarette use because "you are still addicted" and/or "you are still sucking something foreign into your lungs, which isn't good" and/or "you are still modeling smoking behavior to children." None of those objections have anything to do with where the nicotine comes from.

If people started extracting cannabinoids from carrots, with the same effects on the brain and similar intended use as the most common source of cannabinoids, would it suddenly be OK to sell and use just because it didn't come from the "other" plant? Would the drug suddenly be acceptable in society just because it came from carrots instead? Or would society likely say, "Regardless of the source, it's the same drug, with the same intended use, so should be regulated the same?"

Getting nicotine from a non-tobacco source isn't going to make it more acceptable in society, especially when it's intended use is the same as tobacco-derived nicotine. If the FDA loses a lawsuit and has to regulate non-tobacco nicotine separate from tobacco-nicotine (which I believe is unlikely, as they have the same intended recreational use), but say it happens, what is there to stop the FDA from deeming regulations on non-tobacco nicotine that are exactly the same as they would tobacco-derived nicotine? The FDA would just deem that non-tobacco nicotine cannot be sold in flavored liquid, cannot be higher than 4 mg (or whatever) and must be sold in pre-sealed cartridges. ANTZ would still claim it looks like smoking and that is a problem and we have to "protect the children." The states will still apply high "sin taxes" based on it being "a highly addictive, recreational drug, regardless of the source."

Winning a lawsuit for non-tobacco nicotine to be separate from tobacco nicotine is no guarantee that we'd end up with more reasonable regulation. Look what happened with reduced risk tobacco products. They got their third classification and yet the standards are set so impossibly high that no one can get their product to qualify.

What we SHOULD be fighting for is reasonable, attainable standards to qualify as a modified risk product and that "sin taxes" should only be allowed for high-risk products.

 

[DC2]

How bout we promote it as a nutritional supplement...
The least regulated category under the FDA's control?

I've brought this up a number of times, but nobody seems interested.
If you ask me, it is the most accurate classification of all, and perhaps the least troublesome.

 

[kristin]

I've brought this up a number of times, but nobody seems interested.
If you ask me, it is the most accurate classification of all, and perhaps the least troublesome.

Trying to classify a nicotine product as a dietary supplement was attempted in 2005 and failed.

The FDA deemed that nicotine "does not meet the definition of a dietary supplement" and the "mere presence of nicotine in foods such as cauliflower, eggplant, potatoes, and tomatoes, without any evidence that these foods were promoted for their nicotine content, does not constitute 'marketing' nicotine as a food or dietary supplement" under the Dietary Supplement Health and Education Act.

According to the FDA, nicotine is "an article authorized for investigation as a new drug" and "21 U.S.C. 321 (ff)(3)(B) states that the term 'dietary supplement' does not include 'an article authorized for investigation as a new drug...for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food...."

"Nicotine was authorized for investigation as a new drug on December 2, 1987. To the best of FDA's knowledge, nicotine was not marketed as a food or dietary supplement before the date nicotine was authorized for investigation as a new drug."

http://www.ahpa.org/Portals/0/pdfs/06_0629_FDA_NicLite_ltr.pdf

 

[Butters78]

Sorry if this had been said already but I'm not attempting to read the whole thread.

Tobacco isn't as evil as many people think. Only when combustion is added to the mix is where there should be concern.

Look at swedish snus and nasal snuff. Both have been around for hundreds of years and both have been shown to cause little to no adverse effects.

 

[DancingHeretik]

I really think that the best thing for the FDA to do would be to keep watching and having occasional hearings to investigate how things are going. That is, assuming they actually are sincerely concerned for people's welfare and not just looking to control us.

Vaping actually works as smoking cessation. But, they can't call it a smoking cessation drug (They already tried). But, since it does work for many people and is saving lives, it would be wrong to control it or tax it to the point of extinction. So, if they really care AT ALL, they will just continue to investigate and wait until more info is in about the benefits vs. dangers.

I don't think it would be morally right to tax e-cigarettes as tobacco products. If anything, e-cigs should be given out freely to smokers, just like condoms given out to teenagers or clean needles given out to druggies. It's a public health issue.

ETA: We could call it a Smoking Cessation Technique, like behavior modification or therapy. And, leave the issue of the nicotine alone entirely. I like that idea!

 

[trav901]

It really doesn't matter what we call it or what we want to call it, the FDA is going to call it a tobacco product.

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) is what gives the FDA authority to regulate tobacco products.
And this is the definition that the FSPTCA uses for determining what is a tobacco product...

I would call an ecig (batt, atty, cart) a "device" which could be used to argue it's not a tobacco product by FDA definition. However, juice could be defined as a tobacco product under this definition. But then again I'm not a lawyer...

 

[dr g]

You won't, because as I explained, things are regulated based on intended use.

If a product - ANY product, including one with nicotine as the active ingredient - has an intended use (ie. marketed or commonly used as) a food, drug (medical) or cosmetic then it automatically falls under FD&C Act of 1938.

If it is intended to be used as a diet supplement, it falls under the FD&C Act amendment passed in 1994.

If it is a tobacco, tobacco derivative or intended to be used as a modified risk tobacco product, it falls under the FSPTCA of 2009, which amends the FD&C Act.

So, it is the intended use of the nicotine-containing product that determines under which regulations it falls, not the source. There is no regulation that currently covers recreational use of nicotine extracted from plants other than tobacco, because it is neither a food, medical drug, cosmetic, dietary supplement, tobacco product or MRTP. But you can be pretty sure that something would be passed pretty quickly giving the FDA regulatory power over it should it start to be widely distributed to the public. Probably the same regulations that will eventually cover another popular drug recently legalized in some States. Or they'll just keep it under tobacco product because most nicotine comes from tobacco and the intended use is identical to tobacco.

But it will still be the marketed, intended use of that non-tobacco nicotine product that determines which regulatory act it falls under.

As an example, cranberry products and cranberry derivatives are not regulated based on the source being cranberries. They are regulated based on the intended use as marketed. If it is being marketed as a fruit or fruit juice beverage, it falls under FD&C Act as a food. If the manufacturer starts advertising the juice as a remedy for urinary tract infections, that product (not ALL cranberry products, just the one making the claim) will put itself under FD&C as a drug treatment. If a company extracts the abundant vitamin C from the cranberries and sells it, it becomes a dietary supplement and is regulated differently than as a food or drug. Just because products share the same simple cranberry source doesn't dictate how it is regulated. Vitamin C also comes from other fruits and vegetables, but each vitamin C product is not regulated based on the source fruit or vegetable, but on the intended use.

What dictates the regulation is the marketed intended use, but there is no "written rule" for that. It's just what happens under all of these Acts.

There HAS to be a written rule somewhere. So far I have seen none that say what you say regarding non-tobacco nicotine. What it looks like is there are two separate issues, one of nicotine being a tobacco product and one of tobacco products being intended for human consumption. This leaves open the question of nicotine from non-tobacco sources.

As far as I can tell, most nicotine coming from tobacco is what makes it a tobacco product, and non-tobacco natural nicotine would not be. The MN law linked to earlier more or less acknowledges to this.

 

[Coastal Cowboy]

There HAS to be a written rule somewhere. So far I have seen none that say what you say regarding non-tobacco nicotine. What it looks like is there are two separate issues, one of nicotine being a tobacco product and one of tobacco products being intended for human consumption. This leaves open the question of nicotine from non-tobacco sources.

As far as I can tell, most nicotine coming from tobacco is what makes it a tobacco product, and non-tobacco natural nicotine would not be. The MN law linked to earlier more or less acknowledges to this.

It's not statutory law governing the definition, now. It's case law.

Mash here.

As Kristin has said over and over and over again, it's not about the origin of the product. It's about the product's intended use and how it's marketed. The DC District Court said so, and the three-member panel of the DC Circuit Court of Appeals agreed.

FDA tried to appeal to the full Court, but had that appeal denied. When the full Court of the DC Circuit denies your appeal, there is no chance of a writ of certiorari being granted by the US Supreme Court, so FDA gave up.

They've been in this six month, "we're gonna issue deeming regulations" mode almost since the Soterra decision was handed down by the DC Circuit panel.

I still think they punt again next month.