Someone explain to me

[CaptJay]

This has been bothering me for a while so I thought I'd ask here, among the learned members

As I understand things, the FDA want to have e-cigs classified as 'drug delivery devices' as opposed to 'tobacco' or 'tobacco alternatives'. Hopefully I've understood that much correctly.
The thing I don't understand is; what then, are cigarettes?
They cannot NOT be a drug delivery device as to my mind that is their SOLE function. A cigarette was designed to burn tobacco leaves to deliver nicotine to the user, correct? Which makes it a device designed to deliver a drug. That's all it does. It has no other use.
Unlike an ecig which has the option of NOT delivering nicotine if the user so chooses.

So..how is a cigarette defined differently? To my way of thinking it is MORE of a 'drug delivery device' than an e-cig is...

Am I misunderstanding something here

 

[Slickstick]

it is tobacco.. it just has nicotine in it like many other things.
I brought up the same thing a while ago.
logic and health do not rule here.. money does.

 

[Unperson]

Am I misunderstanding something here

If you're confused by what the FDA is doing then that just means that you're a sentient being currently perplexed by faulty logic; ergo, sane.

 

[Vocalek]

The FDA tried to regulate tobacco cigarettes in the past under the Food, Drug, and Cosmetics Act (FDCA) using as their argument that tobacco cigarettes are a nicotine-delivery device, and the courts shot them down. The case was FDA vs. Brown & Williamson, and it is discussed in Judge Leon's 32-page opinion. Congress had to pass a different law specific to tobacco to hand control of the tobacco industry over to FDA (that's the "Tobacco Act" passed in 2009.)

So now the question in front of the court is whether the electronic cigarette is a nicotine delivery device or a tobacco product. NJOY argued that it is neither thing. Smoking Everywhere said it's a tobacco product because it is meant to be used in place of a regular cigarette. FDA said it's a drug-delivery device combination (like their Nicotrol inhaler).

The Judge agreed with Smoking Everywhere's argument, reasoning that if it were a drug, the intended use would be to treat an illness; however electronic cigarettes are used recreationally, not medicinally.

In his heart of hearts, he may have agreed with NJOY, but if he ruled in that way, there would be no law under which the products might be regulated. I believe that he figured some regulation would be in the best interest of public health and safety and recommended that FDA regulate it under the Tobacco Act.

 

[lonercom]

You are not misunderstanding anything. Cigarettes are classified as tobacco products and have specific laws to regulate their manufacture, promotion and sale. They cannot be classified as a drug/delivery device because congress says so.

We do not have the benefit of a friendly congress to protect us. Us as in the vaping community.

 

[lulubell360]

it is tobacco.. it just has nicotine in it like many other things.
I brought up the same thing a while ago.
logic and health do not rule here.. money does.

Now I'm confused? I thought e-cigs. were not tobacco?

 

[bassnut]

Now I'm confused? I thought e-cigs. were not tobacco?

The nicotine added to e-liquid is produced from tobacco ergo "tobacco product"

As I understand it, the nicotine used in FDA controlled gum, patches, inhalers etc. is made synthetically ergo "not tobacco product".
I might be wrong.

 

[yvilla]

As I understand it, the nicotine used in FDA controlled gum, patches, inhalers etc. is made synthetically ergo "not tobacco product".
I might be wrong.

The nicotine in NRTs is also extracted from tobacco, Bassnut. Synthetic nicotine is way too expensive to produce, and is not the source for any currently marketed consumer product, whether tobacco or drug.

The difference between a "tobacco product" and a "drug product" in this context is strictly a legal one, and it lies in the "intended use" doctrine found in the FDCA. NRT's are intended to treat the "disease" of nicotine addiction, or in other words, are intended for smoking cessation.

 

[CaptJay]

...........
The difference between a "tobacco product" and a "drug product" in this context is strictly a legal one, and it lies in the "intended use" doctrine found in the FDCA. NRT's are intended to treat the "disease" of nicotine addiction, or in other words, are intended for smoking cessation.

Ok that explains it better - and everyone who replied thanks. I do understand it better - the INTENTION seems to be the thing, which if logic applies should mean we are in the clear - the PV's intentional use is to replace cigarettes but not nicotine whereas NRT's intention is to replace BOTH eventually.
I agree with the judge (and also njoy but people HAVE to have things defined or the world will end apparently).

 

[bassnut]

The nicotine in NRTs is also extracted from tobacco, Bassnut. Synthetic nicotine is way too expensive to produce, and is not the source for any currently marketed consumer product, whether tobacco or drug.

I feel I have no choice but to trust that you're right, yvilla.
...but for the record, I didn't pull my info about synthetic nico out of thin air. I'm not that smart.
There's a plethora of "authorities" floating around here. Makes it kind of interesting if you keep an open and questioning mind.

...and if, in fact, I am wrong...or even not, thanks for paying attention.

If I still have your attention, yvilla, is an apple a chemical delivery system? I know this question must have been tossed around in the past but I'm kind of new.

 

[yvilla]

...but for the record, I didn't pull my info about synthetic nico out of thin air. I'm not that smart.
There's a plethora of "authorities" floating around here. Makes it kind of interesting if you keep an open and questioning mind.

Well, LOL, where did you pull it from then?

I could swear I saw conversations you have participated in with people like Kurt and Dvap, who certainly have not given you misinformation about this. They, and others too, consistently try to give out good information whenever the "myth" of synthetic nicotine being commercially used - whether it be in eliquid or NRT drug products - rears its head.

Anyway, for your edification, here is a reference regarding the natural tobacco source of the nicotine that is extracted and purified for pharm use in Nicotrol:

"Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL Inhaler."

Nicotrol (Nicotine Inhalation System) Drug Information: Uses, Side Effects, Drug Interactions and Warnings at RxList

And here is the abstract of a study looking at the enantiomeric composition of nicotine in both tobacco and pharmaceutical products, apparently done in the attempt to see if the "extraction and purification process" used in obtaining nicotine from tobacco affects the relative amounts of enantiomers, relevant only because it assumes the fact you seem to be debating - that is, that the nicotine used in pharm products is extracted from tobacco:

Wiley InterScience :: Session Cookies

If I still have your attention, yvilla, is an apple a chemical delivery system? I know this question must have been tossed around in the past but I'm kind of new.

Again, you must get your head around the fact that whether any given product is a "drug" product is strictly a legal construct. Of course an apple is a food product. But of course it is also a chemical - everything is! But whether is it a "drug" product for purposes of the FDCA is determined by it's intended use (actually, its determined by all the provisions of Section 201(g)(1) of chapter V of the FDCA). If you ever tried to market one for its miracle disease preventing properties, for example, you would run afoul of the FDA if you didn't go through the NDA (new drug application) process first.

New Drug Application (NDA)

SEC. 201. [21 U.S.C. 321]

 

[Vocalek]

NRT's are intended to treat the "disease" of nicotine addiction, or in other words, are intended for smoking cessation.

But keep in mind that by "smoking cessation", the FDA means "nicotine cessation."

 

[bassnut]

Thanks for the correct info, yvilla.

I got my mind right, boss.
Lesson learned: If you think you might be wrong, don't post.

Re apples as chemical delivery systems:

If you ever tried to market one for its miracle disease preventing properties, for example, you would run afoul of the FDA if you didn't go through the NDA (new drug application) process first.

I think this is what I wanted to know. Thanks, again

This is where I got the notion and it seems I completely misunderstood it:

L-nicotine and d-nicotine are different isomers. L nicotine is the more active form. There is also an S-isomer. L-nicotine is the form used in the gum and patches. L-nicotine can be derived from plants or synthetic.

HMDB: Showing L(-)-Nicotine pestanal (HMDB01934)

The effects of d-nicotine and l-isomer on nicotini... [J Pharmacol Exp Ther. 1982] - PubMed result

 

[CES]

This is where I got the notion and it seems I completely misunderstood it:

You didn't misunderstand completely- i don't think I wrote it very clearly. That's why I posted the links and why the chemists clarified after me in that thread. Sorry to add to confusion.

Besides, money and control, the FDA seems to care about "unproven" health claims- even if they're from an actual food such as walnuts. Yet, the track record for "proven" health benefits, such as cox2 inhibitors, is also poor. Illogic and legal definitions are the order of the day, so it gets more confusing if you expect the FDA to actually make logical sense,

 

[kristin]

Do people really smoke JUST to get nicotine? Do people drink coffee JUST to get caffeine?

I don't see the FDA calling a Starbucks vente latte a drug delivery device.

 

[bassnut]

Do people really smoke JUST to get nicotine? Do people drink coffee JUST to get caffeine?

I don't see the FDA calling a Starbucks vente latte a drug delivery device.

No and thanks for getting my point about the apples.
I can enjoy a good vape the same way I enjoy an apple.
If I start to get a stomach ache from eating too many apples, I'll cut down. I don't need the FDA watching out for me in either case.

 

[lonercom]

Well said all.

It's important to remember that the FDA was created to get rid of "Snake Oil Salesmen" that made unproven medical claims and to ensure the integrity of the materials sold to the public. That's why the walnut issue. It's not the only case that comes to mind from memory. Recently Cheerios and Quaker Oats ran ads about their ability to reduce cholesterol and came under fire from the FDA. Red Yeast Rice is the botanical equivalent of a popular statin drug and more efficient at reducing cholesterol. It’s VERY cheap but not popular because it’s not a proven drug. (see below)

There is the "Nutritional Supplement" loophole. Which you will see behind an asterisk* with a disclaimer that the claim has not been proven with the FDA, bla bla.

While I sometimes wonder if they have totally lost site of the safety aspect in favor of the control aspect, they do seem to be doing their job to some degree. I think that if manufacturers and distributors had not made the Quit Smoking and Safety claims, the ruckus might have been less. Of course less attention means less business.

Takes me back to the idea of some sort of industry wide compromise that may help. For example:

Thousands of Americans report successfully stopping smoking cigarettes* Many also report feeling better and breathing easier since switching to E-Cigs.*

*These claims have not been verified by the FDA. Consult with your physician when considering switching to this product.

In addition to childproof packaging, a label on the Juice and Cart packaging with verbiage such as:

This product contains Nicotine, which has been found to be HIGHLY Addictive and TOXIC if consumed in large quantity. Improper use or misuse could lead to SEVERE INJURY or DEATH. As with any poison, keep out of reach of children. DO NOT GIVE OR SELL TO PERSONS UNDER 18 YEARS OF AGE. This product has not yet been proved to be any less harmful than regular cigarettes. "If your erection lasts more than 4 hours, get out your webcam and post it."

Perhaps an industry wide agreement would pave the way to increased research funding and less interference with the Government and Antis and buy us all some time to prove this stuff. I’m just sayin’

 

[Thulium]

This product contains Nicotine, which has been found to be HIGHLY Addictive and TOXIC if consumed in large quantity. Improper use or misuse could lead to SEVERE INJURY or DEATH. As with any poison, keep out of reach of children. DO NOT GIVE OR SELL TO PERSONS UNDER 18 YEARS OF AGE. This product has not yet been proved to be any less harmful than regular cigarettes.

I'm with you up until that last sentence.

CASAA.org - LAB REPORTS What further proof do you need?

 

[lonercom]

It aint me brother. I know how effective they are but we're trying to satisfy Big Brother here. Did you see this story yet?

FTC Objects to Kellogg's Rice Krispies Health Claim - WSJ.com

 

[Thulium]

It aint me brother. I know how effective they are but we're trying to satisfy Big Brother here. Did you see this story yet?

FTC Objects to Kellogg's Rice Krispies Health Claim - WSJ.com

Don't get me wrong, I know that companies frequently have their rights to commercial speech abridged by the FDA and other agencies to the point where they can't even say things that are true. However, "E-cigarettes have not been proven to be safer than cigarettes" is patently FALSE. There is plenty of proof that tar and carbon monoxide are responsible for the overwhelming majority of health issues attributed to smoking, so even if there is some unforeseen long term effects of e-cig use making them not completely SAFE, there is no shortage of "proof" that electronic cigarettes are safer than smoking.

On the other hand, I am not aware of any evidence showing that Chantix is safer than cigarettes.