New FDA quotes in news article

[TropicalBob]

This is a fine, fine article, with all sides expressed. Note the new FDA quotes here. Nice reporting.

Suburban Journals | News | Users love 'e-cigarettes,' but FDA wants to take closer look

 

[Sun Vaporer]

I have to say TB that I have read 15 different versions of what this FDA spokeswoman Siobhan DeLancey said, and it is all over the lot. I do not know what the story is here?


Sun

 

[ladyraj]

Thanks for the link TBob, it was a good read. The prospect of longterm studies for nicotine seperate from tobacco scares me when one considers there is nothing underway to date. Nothing resembling a single or double-blind random assignment of people has reached these eager ears to date! I think the best case scenario is to make a case that e-cig nicotine delivery is equivalent to NRT studies that already exist in literature. Otherwise, it's a case to be built from the ground up and will take years.

 

[HaploVoss]

I just finished reading it. I don't know why but I have mixed feelings about it. It is very well written and reads well, and it obviously is supportive of our position on the e cigarette which is great and we need more of it. I need to re-read it some more.

Take care,
- Hap

 

[kristin]

Very good article!

"I feel their pain," she said. "We don't know if this is any better for them."

But regarding the above quote...SERIOUSLY??? No tar. No carbon monixide.

The absence of those two things right there automatically make them just that much better. What a ridiculous comment.

 

[TropicalBob]

I agree with your assessment, Kristin, that e-cigs simply have to be better than tobacco cigarettes, but she was referring to needed studies and the key word in her statement is "know". We "surmise" that e-cigs are better long-term .. but we do not KNOW. That lack of provable knowledge has damned us since these first came on the market. We all need to KNOW.

 

[End_User-X]

I agree, and there should be clinical studies done on a wide range of e-cigs/PVs, not just a few that were supposed to contain carcinogens.

 

[BigJimW]

There is one part I agree with. Just one, that the FDA says

""There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term," DeLancey said. "What we want to see are well-designed clinical studies. Personal reports are not enough," DeLancy said."

Fair enough. But I can pretty much surmise that this "well-designed clinical study" is not going to come from the FDA. Let an independant lab run the studies and submit the report, and not an agency well known for incompetency and failure..

Also, whenever the FDA or any study group runs clinical trials, they get a group of volunteers to do it. Half get the drug, the other half, a placebo. With an e-cig, you just can't stick one in a lab rats mouth to get the results, nor can it be stuck in some suck machine. I suppose you could give them to well trained lab chimps, but you'd be hard pressed to get any results when they start flinging their feces at you. This "well-designed clinical study" requires human interaction.

The FDA has a BIG base of "volunteers" for this so called "well-designed clinical study" they'd like to see. I doubt we'll ever see it though. Too much of a smoke screen and the FDA has another agenda on their minds.

 

[kinabaloo]

"There are no long-term studies on the health effects of just nicotine, minus the tobacco component." [meaning that there needs to be]

I don't see the logic in that statement; it can only be better.

However, e-liquid does contain something not in tobacco, at least not in great amount - the PG solvent/fog creator. But this has been well-studied; declared safe for use in discos and stage shows where the dosage would be high.

There are some minor concerns some of which are unavoidable with heating, but in the scale of everyday exposure don't mount to much imo, for PG at least, (but they do exist).

So have the longer term studies by all means, but concurrent with continued availablity. It's the only sensible course of action; there are no grounds to say there is a risk in continued use (certainly not when comapred to tobacco combustion, but even aside from that comparison).

The reason that drugs often turn out to have long-term problems is that they are 1) completely new chemicals 2)are often not easily metabolised or produce toxins during metabolism 3) have unexpected effects

1) doesn't apply and 2) and 3) are not at all likely by vaping e-liquid.

 

[creeswanson]

One thing the media generally fails to see is that alot of us make our own juice, I just got my first vape thursday, and I am already making my own using VG....furthermore, I was looking at some flavor extracts today and almost all of them contain PG...(singing) ironyyyyyy....Really it sounds like money and politics to me....

p.s. if anyone hears of a study for this sign me up...

 

[kristin]

I agree with your assessment, Kristin, that e-cigs simply have to be better than tobacco cigarettes, but she was referring to needed studies and the key word in her statement is "know". We "surmise" that e-cigs are better long-term .. but we do not KNOW. That lack of provable knowledge has damned us since these first came on the market. We all need to KNOW.

We DO know.

It's common knowledge & medically proven that exposure to tar and carbon monoxide is unhealthy ie unsafe.

There is no exposure to tar and carbon monoxide with vaping.

It is medically proven that if you discontinue using tobacco cigarettes, you are eliminating the danger of that tar and carbon monoxide exposure.

By vaping and not using tobacco cigarettes, you are eliminating those two dangers.

Eliminating danger = safer.

Ergo, vaping is safer than tobacco smoking.

(That's not even counting the hundreds of other "unsafe" ingredients found in tobacco smoke and not in vapor. But the elimination of exposure to just two major unsafe components makes it unarguably safer.)

I completely agree e-liquid should be regulated for consistancy & to ensure impurites aren't present beyond already approved substances and tested for long term exposure (let's be honest, there ARE going to be long term effects of some kind), but it doesn't need further testing to prove that it is "safer" than tobacco cigarettes.

But the FDA has a serious double standard and demands to hold e-cigs to a higher standard. They want e-cigs to either be an NRT (and therefore be used to discontinue nicotine addiction, which we know isn't proven) or be shown to be as safe as not smoking at all. Even Chantix doesn't meet those standards more than 44% in the first 12 weeks, yet they have FDA approval.

What they want to "know" is that it's really an NRT. That's the only thing we don't KNOW and isn't proven. We Do know they are safer.

She's talking in circles.

 

[JustJulie]

Dr. Siegel picked this article up in his blog:

The Rest of the Story: Tobacco News Analysis and Commentary

Not surprisingly, he criticizes DeLancey's statement that the FDA doesn't know whether vaping is any better than smoking.

 

[kristin]

The FDA claims this came to their attention because of "smoking cessation" claims. They equated that with being an NRT (which, in this case, is actually NOT the case.) They said people were contacting them asking if e-cigs were really NRTs. (Their own words.)

If they were really concerned, they could simply have ordered a cease and desist on all claims of smoking cessation (NRT) a la Cheerios, NOT try to get control over them as NRTs. There are plenty of companies that never made NRT or smoking cessation claims. Even if they did, a simple "not evaluated by FDA" disclaimer would have sufficed. There is a SERIOUS double standard here.

 

[Sun Vaporer]

Kristin--Your logic makes perfect sense, but just remember NRT's like Nicotrol et al, are not approved for long term use nor have they been studied for long term use (over 6 months). So there is in fact a difference with NRT's and the e-cig by the mere fact that for most e-cig users, we are in it for the long haul and they simply never studied long term exposure like that. But, I would totally concur that it is not even in the same league as cigarettes.


Sun

 

[CJsKee]

There is one part I agree with. Just one, that the FDA says

""There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term," DeLancey said. "What we want to see are well-designed clinical studies. Personal reports are not enough," DeLancy said."

Fair enough. But I can pretty much surmise that this "well-designed clinical study" is not going to come from the FDA. Let an independant lab run the studies and submit the report, and not an agency well known for incompetency and failure..

Also, whenever the FDA or any study group runs clinical trials, they get a group of volunteers to do it. Half get the drug, the other half, a placebo. With an e-cig, you just can't stick one in a lab rats mouth to get the results, nor can it be stuck in some suck machine. I suppose you could give them to well trained lab chimps, but you'd be hard pressed to get any results when they start flinging their feces at you. This "well-designed clinical study" requires human interaction.

The FDA has a BIG base of "volunteers" for this so called "well-designed clinical study" they'd like to see. I doubt we'll ever see it though. Too much of a smoke screen and the FDA has another agenda on their minds.

Someone (sorry, can't remember who or where ) posted this: Long-term effects of inhaled nicotine. Very interesting results! Surely two years could be considered long-term?

 

[kinabaloo]

We DO know.

It's common knowledge & medically proven that exposure to tar and carbon monoxide is unhealthy ie unsafe.

There is no exposure to tar and carbon monoxide with vaping.

It is medically proven that if you discontinue using tobacco cigarettes, you are eliminating the danger of that tar and carbon monoxide exposure.

By vaping and not using tobacco cigarettes, you are eliminating those two dangers.

Eliminating danger = safer.

Ergo, vaping is safer than tobacco smoking.

(That's not even counting the hundreds of other "unsafe" ingredients found in tobacco smoke and not in vapor. But the elimination of exposure to just two major unsafe components makes it unarguably safer.)

I completely agree e-liquid should be regulated for consistancy & to ensure impurites aren't present beyond already approved substances and tested for long term exposure (let's be honest, there ARE going to be long term effects of some kind), but it doesn't need further testing to prove that it is "safer" than tobacco cigarettes.

But the FDA has a serious double standard and demands to hold e-cigs to a higher standard. They want e-cigs to either be an NRT (and therefore be used to discontinue nicotine addiction, which we know isn't proven) or be shown to be as safe as not smoking at all. Even Chantix doesn't meet those standards more than 44% in the first 12 weeks, yet they have FDA approval.

What they want to "know" is that it's really an NRT. That's the only thing we don't KNOW and isn't proven. We Do know they are safer.

She's talking in circles.

Nice post.

Wanted to add this:

When one thinks about it, NRT - nicotine replacement therapy. Leave aside 'therapy', and what this means is a safer way to get nicotine. At some time the term NRT has come to mean NET - nicotine elimination therapy.

On the anecdotal level, the PV is successful as NET for maybe 20% or so, but then there is no good evidence that nicotine itself is dangerous (and even doubt that it alone is addictive).

The important thing is that the PV is very effective as NRT in the original sense of being a replacement for smoking. The hard truth is that a majority of smokers will not be able to quit nicotine (or at least, do well without it, even long-term) but the majority can quit smoking - and that's to be welcomed.

 

[mallie233]

In reality, the FDA receives funds from big tobacco companies which allows them to keep their product on the market. Tobacco companies are losing money because of e-cigs and they are angry. Of course the FDA is going to do anything they can to get them banned, because their "client" isn't happy. If the tobacco companies merged with e-cig manufacturers you could bet millions of dollars that this case would be dropped.
The FDA isn't looking out for our best interest or else cigarettes would have been banned a loooooong time ago. It's pretty much proven that the effects of cigarettes are deadly. Why should tobacco companies be able to print a little label on the side of their box warning people but e-cigs get BANNED?

This is the only logical conclusion I can come to.

 

[kristin]

Kristin--Your logic makes perfect sense, but just remember NRT's like Nicotrol et al, are not approved for long term use nor have they been studied for long term use (over 6 months). So there is in fact a difference with NRT's and the e-cig by the mere fact that for most e-cig users, we are in it for the long haul and they simply never studied long term exposure like that. But, I would totally concur that it is not even in the same league as cigarettes.


Sun

Sun, I understand that - read this part of my post:

But the FDA has a serious double standard and demands to hold e-cigs to a higher standard. They want e-cigs to either be an NRT (and therefore be used to discontinue nicotine addiction, which we know isn't proven) or be shown to be as safe as not smoking at all.

THEY (FDA) want to call it an NRT because they see "smoking cessation = nicotine cessation ie. NRT" but this new product doesn't fall into the same definition. For most e-cig users, smoking cessation = no tobacco smoke, not no nicotine. Therefore, it's not being used as an NRT, but it is still stopping smoking.

For the first time in history, there is a smoking cessation device that is NOT solely an NRT.

 

[Our House]

Kristin--Your logic makes perfect sense, but just remember NRT's like Nicotrol et al, are not approved for long term use nor have they been studied for long term use (over 6 months). So there is in fact a difference with NRT's and the e-cig by the mere fact that for most e-cig users, we are in it for the long haul and they simply never studied long term exposure like that. But, I would totally concur that it is not even in the same league as cigarettes.


Sun

This doesn't jive though. Not trying to be argumentative here, but something is wrong. Seriously wrong. Consider this:

Why doesn't "intended use" apply here the same way the FDA is trying to apply it to NJOY (because they didn't make any health/cessation claims) in court right now?

Only SEVEN percent of the population uses NRTs correctly to quit smoking/nicotine. These products are an EPIC failure to do what the manufacturers advertise. The other 93% of users either revert back to smoking cigarettes or continue to use nicotine (in some form) long term through these "approved" methods. Yet the FDA doesn't cite "intended use" against NRTs. Why not?

 

[Our House]

And Kristin, before you misconstrue my post, I totally agree with you that smoking cessation != nicotine cessation. The example above is an argument against the FDA's "logic", using the FDA's own terms. (just to show how shoddy their logic is)