ScienceDaily.com (10/15/14) from NEJM: "The FDA, E-Cigarettes, and the Demise of Combusted Tobacco"

[cafecraig]

http://www.sciencedaily.com/releases/2014/10/141015190822.htm

EDIT: For those who do not want to click on the link, here is the sciencedaily.com post (not my words, but theirs):

In "The FDA, E-Cigarettes, and the Demise of Combusted tobacco," Nathan K. Cobb, MD, and David B. Abrams, PhD, call on the FDA "to accelerate their regulations to eliminate uncertainty regarding safety, drive the substitution and use of clean nicotine, and hasten the demise of lethal combusted tobacco."

The authors point out that some published studies of e-cigarette devices suggest that they can be as safe and effective as nicotine replacement therapy (NRT) products such as gum, patches and inhalers that are regulated by the FDA.

<...>

 

[DC2]

I haven't read the article, and probably won't do so.
But going from your summary it appears they have some form of a slight clue.

However, this would be a big problem...

However, the authors explain that the "safety of individual devices cannot be assumed" because of "various chemicals and aerosolization techniques resulting in variable nicotine and contaminant delivery."

That's classic Big Pharma (and now Big Tobacco) talk for regulating the little guy (open systems) out of the market.

 

[Kent C]

"However, the authors explain that the "safety of individual devices cannot be assumed" because of "various chemicals and aerosolization techniques resulting in variable nicotine and contaminant delivery."

Hmmm. Wonder where they got that idea?

I'd change:

"If e-cigarettes... are thoughtfully regulated, they could play the same role as NRT, but at a truly national population scale. Their use could shift smokers permanently away from lethal cigarettes to cleaner, safer nicotine products, saving innumerable lives," they conclude."

To:"If cigarettes .... are not regulated and the process of self-regulation that has occurred on many of the more popular ecigarette forums where individuals and veterans who have experienced certain downsides report to the general population and sometimes to the vendors and manufacturers themselves - where much of the products available now vs. at the start @2006 are safer, more reliable, less maintenance and help people quit or greatly reduce their smoking much faster and more permanently than earlier models.

And the demand for such products also affect those vendors and consumers who have never been on those forums - but yet benefit from a trickle-down effect of creating a demand for better and safer products where the less effective and sometimes overpriced products are driven out of the market. "

Or something like that

 

[Anjaffm]

"If e-cigarettes... are thoughtfully regulated, they could play the same role as NRT, but at a truly national population scale. Their use could shift smokers permanently away from lethal cigarettes to cleaner, safer nicotine products, saving innumerable lives," they conclude.

oh my goodness gracious.
Now, limiting the power of e-cigs to the effectiveness of NRT.. hm... I do not think that would be such a good idea.

---------

"the power of e-cigarettes" - courtesy of Carl Phillips, CASAA. I love that expression! It perfectly replaces the term "effectiveness" which is used for medicines. E-cigs are not medicines. And definitely not NRT.

@cafecraig :
sorry to be nagging. But you will find out pretty soon what we mean Just read some info on e-cigs, their benefits and the "arguments" of those who are opposed to them and wish to wipe them from the face of this earth.

 

[cafecraig]

@cafecraig :
sorry to be nagging. But you will find out pretty soon what we mean Just read some info on e-cigs, their benefits and the "arguments" of those who are opposed to them and wish to wipe them from the face of this earth.

That's okay. I have been lurking here since 2009, since I started vaping then, and get what you guys mean. I only provided the link - I did not write any of the OP. Just copied and pasted.

Perhaps I should have just shown the link, and not copied and pasted the sciencedaily.com piece in full. I will try to improve the quality of my communications/posts (detail) in the future.

(BTW: what made me start to vape in 2009 and quit smoking? Banner ad on yahoo.com. Led to my purchase of Joye 510, mesh wick, from Wayne at Heavengifts.com. Wish I saved a screen shot of that banner ad (it wasn't Wayne's). Should have just become a forum member back then, instead of a lurker. My bad.)

 

[WhiteHighlights]

Don't forget the chillun! My emphasis added...

In addition to the FDA regulation of e-cigarettes, Cobb and Abrams suggest the agency use its authority to "cripple the addictive potential of lethal combusted products by mandating reduction of nicotine levels to below those of e-cigarettes and NRT products and eliminating flavorings."

Funny thing, I saw an ad on TV for Nicorette Gum today, Fruit Chill flavor.

 

[cafecraig]

Don't forget the chillun! My emphasis added...



Funny thing, I saw an ad on TV for Nicorette Gum today, Fruit Chill flavor.

Interesting! To be clear, the full text of the Cobb & Abrams recommendations states that flavorings such as menthol be removed from combustible cigs:

"The CTP can use its product-standard authority in conjunction with e-cigarette growth to cripple the addictive potential of lethal combusted products by mandating a reduction in nicotine levels to below those of e-cigarettes and NRT products and eliminating flavorings such as menthol that make cigarettes more palatable."

The full text of the Cobb & Abrams report may be found here:

http://www.nejm.org/doi/full/10.1056/NEJMp1408448

I should have posted that link to begin with, probably.

Here is an interview with Dr. Nathan Cobb. He takes Q&A from NEJM, in which he suggests that USP grade nicotine be regulated for (when used in e-cigs), the amount of nicotine be regulated (to match claims of e-cig sellers), non-combustible Nicotine delivery systems should be more accessible, and he claims that Big Tobacco wants to "protect their existing market.. and have come out with devices.. to start to move some of the conversations around regulation, in ways that benefit them in more constrained environments, meaning more regulation, more monitoring, and more laboratory analysis." He continues to say that physicians should tell patients that "if you have quit smoking.. using an e-cigarette.. don't change what you are doing, the most important thing is that you have quit.. don't rock the boat."

Essentially, he is saying that if regulation pertaining to using USP grade nic, and the labeling matching the amount of nic in e-cigs, is put in place, e-cigarettes would be viewed more favorably by the medical community. In general, he is advocating for sensible regulation that enables e-cigs to be more accessible and reliable/trustworthy while also reducing the capacity of BT to control and manipulate the e-cig product category.

(Maybe someone here should contact him about how BT is trying to regulate non-BT market participants out of business, and why. That is pursuant to DC2's comment above, which is true.)

http://www.nejm.org/action/showMedi...attach_1&area=&viewType=Popup&viewClass=Audio

 

[Berylanna]

Cigarette nicotine delivery is user-controlled: draw harder, get more. Buy different kinds, get different experiences. There is no way on Earth that combustibles can be replaced by something that does NOT give the user delivery control that is at least a good percentage of the control we have with combustibles. Bottom line: In pharmacology, delivery control is SO important that a lot of people have died from taking generics that had a different delivery profile than the original drug, because of differences in INACTIVE ingredients. Too little heart medicine delivered, you can die. Same with insulin. Same with lots of things.

But e-cigarettes are a CONSUMER product and need a CONSUMER product delivery profile.

 

[aikanae1]

Cigarette nicotine delivery is user-controlled: draw harder, get more. Buy different kinds, get different experiences. There is no way on Earth that combustibles can be replaced by something that does NOT give the user delivery control that is at least a good percentage of the control we have with combustibles. Bottom line: In pharmacology, delivery control is SO important that a lot of people have died from taking generics that had a different delivery profile than the original drug, because of differences in INACTIVE ingredients. Too little heart medicine delivered, you can die. Same with insulin. Same with lots of things.

But e-cigarettes are a CONSUMER product and need a CONSUMER product delivery profile.

And that is the elephant in the room. The FDA (and their buddies) believe "nicotine is a drug".
I don't think those directing the FDA / pharmaceticals have the moral framework to ever approve nicotine as a recreational product.

 

[Tache]

And that is the elephant in the room. The FDA (and their buddies) believe "nicotine is a drug".

The slant forgotten is that nicotine is actually much closer (if not actually) a VITAMIN (google Niacin)!

 

[aikanae1]

Vitamins have been controversial for years - the FDA and pharmeceticals also consider them "drugs" too.

 

[DrMA]

What an interesting read... A mix of cautious optimism and careful regulatory oversight. Imagine if ANTZ took this kind of approach instead of knee-jerking and going straight for the red button unleashing all of the slurry they've been gushing since vaping emerged. Isn't Legacy like ANTZ Mecca? What's gotten into them?

 

[dragonpuff]

The slant forgotten is that nicotine is actually much closer (if not actually) a VITAMIN (google Niacin)!

It's funny you mention that because I'm actually far more sensitive to B6 (pyridoxine) than I am to nicotine. I can vape 24mg nicotine all day, but if I take a couple B complex I... well...... let's just say you don't wanna be around me for a while

Besides, it's not a matter of what it is, it's a matter of how it's defined. Nicotine can be a natural vitamin all day long, but if they can legally and practically define it as a "drug" so they have more control over it and can make more money off of it, then a drug it will be.

 

[aikanae1]

If the FDA could control alcohol and sugar, they would. But they'd approve GMO and saccerine. That's why there appears to be such a close link with who profits.

 

[xhuffer]

"User control". Haha. I remember working with a guy who would smoke 2 cigs at a time. When I asked him why he said "More nicotine". We can't make this stuff up folks.