Anyone see last nights NBC News story on e-cigs?(video link)

[Bob Chill]

Excellent post bikerbeagle. It really seems that there is a difficult to navigate grey area here. It's not tobacco and it's not a NRT. I don't see how it can be forced into either bucket. I don't think there is a parallel to look back on in history. It's almost like ejuice style nic is a standalone recreational drug at face value. Not nearly as bad as alcohol but not as benign as coffee either (mostly because of the inhalation part and also it's toxicity).

Regulatory bodies have their hands full here. I suppose we just have to hope for a less bad outcome. One thing that seems fairly certain is easy internet ordering of juices that contain nicotine will likely end in the not so distant future. I can deal with that as long as I can hit a local juice store that is similar to a local beer/wine store. Not a perfect solution but I can live with it.

 

[Robino1]

Right now, NO, eliquid is NOT considered by the FDA as a "tobacco product". This is what they are "deeming" in October.

I can't seem to find any resource stating if and/or how nicotine, in its pure form, is currently regulated. If you know of one that matter-of-factly states it, I'd be interested in seeing it. One would logically assume that it would be regulated as a tobacco product since its primary means of production is from tobacco - but tobacco is not the only thing that has nicotine in it. Everything I've read says that it is considered a drug, (or simply watched as a poison / harmful chemical)? ...I don't know. Either way, it is currently legal to purchase and own nicotine, even in it's pure form.

Beyond that, regulation of nicotine-containing products have a line drawn down the middle ...those with tobacco - cigarettes, cigars, smokeless tobaccos, etc - all either are, or potentially can/will be, regulated under the Family Smoking Prevention and Tobacco Control Act ...and those without tobacco, currently coined Nicotine Replacement Therapy - gums, patches, lozenges, etc - are regulated as drugs.

Here is where I get kind of confused. Logically, I see e-cigarettes and ejuices firmly in the latter category ...but the FDA tried to have them determined as such and was shot down in Federal court. At the time, however, non-tobacco nicotine products were termed "smoking cessation therapies" ...which is why the e-cigarette world seemingly did a full on back-pedal about being a 'smoking cessation' device a few years ago? This makes sense because they didn't want to be classified as a drug which would require you to have a prescription or, at the very least, the only place you could get e-cigarettes would be a pharmacy. So, now, we are where we are at - because the community didn't want to be classified as a drug, we are potentially going to be lumped-in and regulated under the FSPTCA as a "tobacco product". It's one or the other. Pretty much a classic situation of "damned if you do, damned if you don't".

It's not only possible ...I would say it's highly likely that's exactly what is going to happen at a minimum.

True, but there has been talk that the FDA may further regulate the production and quality control process of ejuices themselves ...and, then, of course, they are going to tax the beejesus out of it. Not necessarily a bad thing, in my opinion, depending on how far they go, but it's going to change the landscape of ejuice production - smaller mom & pops won't be able to afford/meet the requirements and will go out of business. In this scenario, you can likely see ejuice prices increase 10x ...would you still continue vaping if your ejuice ends up costing $30 for a 10ml bottle? ...how about $50?

Actually, only Vendors can't claim it is a smoking cessation product. We, as consumers, are NOT held to those same rules. As a consumer, I urge you to write your governing body and tell them how ecigs made it possible for you to quit smoking.

Vendors are not allowed to make the claim that ecigs can help you quit smoking. The moment they do, it becomes a matter of proving that they can and then falls under the drug laws. We, as consumers, can shout it from the rooftops and that's fine.

 

[SpinDr480]

I want to learn how to exhale and then inhale it through your nose like that one person did in that video. That was rad!

 

[Robino1]

I want to learn how to exhale and then inhale it through your nose like that one person did in that video. That was rad!

You don't exhale. Fill your mouth with vaper, open it, inhale through your nose as the vapor escapes your mouth. It's called French inhaling.

 

[SpinDr480]

You don't exhale. Fill your mouth with vaper, open it, inhale through your nose as the vapor escapes your mouth. It's called French inhaling.

Haha, I have been standing in front of the mirror for the last 20 minutes and I think I am getting it down. I have heard that term before, now I know what it is. I can't imagine how people could do that with cigs, that would be harsh. But it does taste great french inhaling a vape.

 

[kristin]

I can't seem to find any resource stating if and/or how nicotine, in its pure form, is currently regulated. If you know of one that matter-of-factly states it, I'd be interested in seeing it. One would logically assume that it would be regulated as a tobacco product since its primary means of production is from tobacco - but tobacco is not the only thing that has nicotine in it. Everything I've read says that it is considered a drug, (or simply watched as a poison / harmful chemical)? ...I don't know. Either way, it is currently legal to purchase and own nicotine, even in it's pure form.

Beyond that, regulation of nicotine-containing products have a line drawn down the middle ...those with tobacco - cigarettes, cigars, smokeless tobaccos, etc - all either are, or potentially can/will be, regulated under the Family Smoking Prevention and Tobacco Control Act ...and those without tobacco, currently coined Nicotine Replacement Therapy - gums, patches, lozenges, etc - are regulated as drugs.

Here is where I get kind of confused. Logically, I see e-cigarettes and ejuices firmly in the latter category ...but the FDA tried to have them determined as such and was shot down in Federal court. At the time, however, non-tobacco nicotine products were termed "smoking cessation therapies" ...which is why the e-cigarette world seemingly did a full on back-pedal about being a 'smoking cessation' device a few years ago? This makes sense because they didn't want to be classified as a drug which would require you to have a prescription or, at the very least, the only place you could get e-cigarettes would be a pharmacy. So, now, we are where we are at - because the community didn't want to be classified as a drug, we are potentially going to be lumped-in and regulated under the FSPTCA as a "tobacco product". It's one or the other. Pretty much a classic situation of "damned if you do, damned if you don't".

Nicotine isn't regulated by what form it takes, but instead by "intended use" in the US.

If the nicotine is contained in a product with an "intended use" as a smoking cessation or other treatment, it is then regulated as a "drug" and must go through clinical trials, studies, etc., and the product must meet strict manufacturing protocols before release to the public. If the nicotine is contained in a product with an intended use of "recreational" (ie. intended for human consumption but not as a treatment of any kind) it is regulated as a tobacco product. (A third classification is a pesticide, but that form of nicotine is not allowed for human consumption.)

It was this "intended use" criteria which kept the FDA from being able to deem non-therapeutic e-cigarettes as unapproved drugs. So long as the manufacturer/retailer made no treatment/health/therapeutic claims, they weren't considered a drug, but that meant the only other option was "tobacco product." The FDA defines a "tobacco product" as any product that not only contains tobacco leaf, but also any derivative (ie. "a compound derived or obtained from another and containing essential elements of the parent substance") of tobacco. Nicotine is clearly a "derivative" of tobacco. While it is also a derivative of other plants, the nicotine in e-liquid is currently all derived from tobacco. However, since nicotine is classified by "intended use" and not the source, even nicotine from other plant material could be deemed a substantial equivalent and treated exactly the same as tobacco-derived nicotine, because of it's intended use. It's obvious to everyone that we use e-cigarettes with the same "intended use" as other tobacco products - mainly, the same way we used to use traditional cigarettes. It may be a far safer form of recreational nicotine use that regulators never foresaw, but it is still technically "recreational use" of nicotine derived from tobacco.

It's important to note that the only "bad" things about being considered a tobacco product is 1) the public perception that all tobacco products are equally harmful and 2) the threat that the FDA will regulate them as if all tobacco is equally harmful. Educating the public and correcting this perception and convincing the FDA and politicians not to regulate low-risk tobacco products identically to high-risk products is CASAA's goal. Changing perceptions and exposing the lie that there "is no safe tobacco product" will also go a long way towards gaining social acceptance. (ie. If the public still believes that all nicotine use should be discouraged because it's equally dangerous, it won't matter if e-liquid gets a separate category. They will just regulate that category as strictly as tobacco - possibly worse. We could end up with less hoops to jump through than drug products, but far more than if we are a tobacco product.) The chance that the FDA will treat a product that is derived from tobacco and used like tobacco as a whole separate category, with less rules than tobacco, is extremely slim. Especially if the public continues to believe that the ultimate goal in smoking cessation is eliminating the nicotine addiction instead of eliminating exposure to smoke.

 

[bikerbeagle]

Great write-up, Kristin. I have no illusions that the FDA would even consider ejuice as it's own separate category - not quite a "smoking cessation" drug and not quite a "tobacco product"; that thought never even crossed my mind. Why should they? Everything is already in place for them to simply 'deem' ejuice a "tobacco product" and then just rubber-stamp all of the current restrictions/bans associated with cigarettes ...which is exactly what I am 99.9% sure is going to happen.

Reading over what is currently provided for in the FSPTCA (modified to add "ejuice" where necessary for dramatic effect ):

Registration and inspection of tobacco/ejuice companies
- Requires owners and operators of tobacco/ejuice companies to register annually and be subject to inspection every 2 years by FDA.

Standards for tobacco/ejuice products
- Allows FDA to require standards for tobacco/ejuice products (for example, nicotine levels) as appropriate to protect public health.

- Bans cigarettes/ejuice with characterizing flavors (except menthol and tobacco).

“Premarket Review” of new tobacco/ejuice products
- Requires manufacturers who wish to market a new tobacco/e-juice product to obtain a marketing order from FDA prior to marketing that new product.

“Modified risk” products
- Requires manufacturers who wish to market a tobacco/ejuice product with a claim of reduced harm to obtain a marketing order from FDA.

 

[Robino1]

They're in the process of banning menthol cigs...... Probably in preparation to put the hammer on flavored eliquid.

 

[DC2]

The Family Smoking Prevention and Tobacco Control Act of 2009 outright banned only the sale of flavored cigarettes, but it gave the FDA the authority to prohibit or regulate other flavored tobacco products (cigars, e-cigarettes, and smokeless tobacco) however they see fit - "deem" necessary. This "deeming" is what is scheduled to happen in October and what all the hubbub is about.

To be clear, the "deeming" will only be an offering of what their intentions are.

After that there will be a public comment period that will last at least one month if not much longer.
The final regulations can not be issued until all of that has occurred.

 

[DC2]

Reading over what is currently provided for in the FSPTCA (modified to add "ejuice" where necessary for dramatic effect ):

You missed the part where they are allowed to reduce the nicotine content to whatever they deem righteous, as long as it is not reduced to zero.

 

[J_Gundy]

So last night I was watching the NBC Nightly News and the last story on was about e-cigs. It was mostly positive but says "Big tobacco" companies are investing in e-cigs. So can e-cigs win the battle and become mainstream? Then why do so many legislatures in states and cities fight it? Loads of questions, but none the less an intresting video to see! What do ya'll think?

Interesting! Thanks for posting this.