FDA approval?

[kinabaloo]

While people are making claims that "eCigs" are being treated unfairly, if you look at the situation rationally and legally, they really aren't.

Now the case that they are being portrayed *unfavorably* is certainly valid, but you can pretty much blame this on the slipshod way the industry has handled the product.-K

Legally perhpa, but certainly nothing rational about this!

No! Just because the companies could have done some things better is no excuse. 2 wrongs dont make a right!

 

[kinabaloo]

All of your red herrings aside...

eCigs have been advertised as a smoking cessation aid, in the form of an electronic device, without disclaimer, testing or PRIOR FDA approval.

You can argue anything you want, but that chayce is fact. That is the legal heart of the matter, not the incidental, anecdotal,it-isn't-fair-I-want-a-pony argument many are trying to float.

Every single thing you mentioned, if put into anything in greater than accepted as safe amounts for human ingestion, GRAS or not, then marketed and sold as a treatment or cure for anything would have the same issue.

Period. Since you are floating a non-fact-based scenario, it is up to you to provide facts to back it up. Or not. You would do better to not make feeble attempts to inverse my arguments...I'm not that guy

-K

Leaving aside why one cannot say certan things, only a few companies made those claims, no need to attack the device itself.

 

[kinabaloo]

...
-K

If you really believe that they mostly got it right, you have a very shallow perspective. They defend only drug based medicine; which is a faulty paradigm. So many good things have been stamped out in defence of the profits of a few.

 

[kinabaloo]

Why do electronic cigarettes HAVE to be approved as a "medical device"? I understand that some companies have been making reckless claims regarding it as a quit-smoking tool, but if its "intended purpose," as the FDA would say, is determined to be use as an alternative to smoking cigarettes, then what does that have to do with medicine?

Is there an alternative route to the "medical device" billion-dollar investment? Does the FDA have anything in place to evaluate these for safety alone with no intention to treat a disease?

I just find it hard to believe that every legal drug must have a medical intent in mind.

It's a convenient ploy for maintaing BP and BT's monopolies. Though for seeing things clearly one culd be labelled a 'tinfoil hatter'.

 

[MrKai]

Wouldn't this also mean that buying a pipe or papers from a smoke shop should be illegal?

Obviously no one is using those for smoking tobacco!

Really? Ever hear of RYO Tobacco and automatic personal cigarette machines?

Hyperbolic claims such as "obviously, no one is using these for smoking tobacco" when clearly they are, are not defensible in logical debate and honest discourse.

*More importantly and relevantly* they aren't being sold to diagnose, treat or cure any ailment or disease or in any way medical.


I just do not know why it is so hard for people to grasp that this is not a moral issue or a philosophical one. It is a *legal issue*. LEGAL.

No one...NO ONE is allowed to market ANYTHING as a treatment or cure for ANYTHING regarding human beings in the United States of America without FDA or sub-agency approval...regardless of what it is made of.

What part of this is unclear?

-K

 

[MrKai]

It's a convenient ploy for maintaing BP and BT's monopolies. Though for seeing things clearly one culd be labelled a 'tinfoil hatter'.

or one could point out that "BP" and "BT" are not monopolies

-K

 

[Pav]

I just do not know why it is so hard for people to grasp that this is not a moral issue or a philosophical one. It is a *legal issue*. LEGAL.

No one...NO ONE is allowed to market ANYTHING as a treatment or cure for ANYTHING regarding human beings in the United States of America without FDA or sub-agency approval...regardless of what it is made of.

What part of this is unclear?

-K

Just wondering how it is that something like those Extenze things are sold? I've been seeing those commercials for a long time now and tonight I actually started reading the fine print on the screen. It said something like "this product has not been subject to FDA review..." or something to that effect.

Not sure what's in those things, but pretty sure they're pseudo ...... pills that no prescription is necessary for. How can they be sold? I'm guessing it's a big scam.

Couldn't PVs be sold with a disclaimer like that?

 

[MrKai]

Just wondering how it is that something like those Extenze things are sold? I've been seeing those commercials for a long time now and tonight I actually started reading the fine print on the screen. It said something like "this product has not been subject to FDA review..." or something to that effect.

Not sure what's in those things, but pretty sure they're pseudo ...... pills that no prescription is necessary for. How can they be sold? I'm guessing it's a big scam.

...but the simple answer is that they are essentially herbal pills and until someone stupidly makes direct medical claims about them, they are regulated as food, so don't require testing.

Couldn't PVs be sold with a disclaimer like that?

Yes. Until someone stupidly makes medical claims about them. Then you get what we have now. Understand?

eCigs didn't come under fire by the FDA *until* this happened, because they had no legal authority to do so.

Smoking Anywhere has many kiosks in malls around MD, DC, Norther Virginia. The FDA HQ is in Rockville, MD...tho they are moving to the Silver Spring area (closer to DC) I believe.

What happened was a N. Va tv station ran a story on SA and reported they were told that the stuff was promoted to stop smoking.

It is a fair short drive from FDA's Evil Lair™ to pretty much anywhere in the Baltimore/DC Metroplex. My understanding is that field personell were sent to investigate, which start the wheels turning.

Others believe more nefarious origins

For the record, I've personally been to a Smoking Anywhere retail kiosk in Maryland outside of Baltimore and indeed, they have a whole pitch set up for smoking cessation, including looseleaf binders that show how to explain stepping down the nic levels, etc. for the sales staff to use.

This was as recent as 10 days ago.

-K

 

[degnr8]

This has been a very interesting thread to read. I just recently learned about e-cigs so was unaware of the specifics on the legal issues. Thanks Mr. Kai for the enlightenment on the subject. I'm wondering though, if someone were to develop a different product to vape, with no medical claims couldn't pv's then basically put the genie back in the bottle???

 

[grayblue]

...but the simple answer is that they are essentially herbal pills and until someone stupidly makes direct medical claims about them, they are regulated as food, so don't require testing.



Yes. Until someone stupidly makes medical claims about them. Then you get what we have now. Understand?

eCigs didn't come under fire by the FDA *until* this happened, because they had no legal authority to do so.

Smoking Anywhere has many kiosks in malls around MD, DC, Norther Virginia. The FDA HQ is in Rockville, MD...tho they are moving to the Silver Spring area (closer to DC) I believe.

What happened was a N. Va tv station ran a story on SA and reported they were told that the stuff was promoted to stop smoking.

It is a fair short drive from FDA's Evil Lair™ to pretty much anywhere in the Baltimore/DC Metroplex. My understanding is that field personell were sent to investigate, which start the wheels turning.

Others believe more nefarious origins

For the record, I've personally been to a Smoking Anywhere retail kiosk in Maryland outside of Baltimore and indeed, they have a whole pitch set up for smoking cessation, including looseleaf binders that show how to explain stepping down the nic levels, etc. for the sales staff to use.

This was as recent as 10 days ago.

-K

so it sounds like it's only a legal issue for those parties involved in the suit. in that case, as long as no other vendor is claiming eciggs are medical then there shouldn't be a problem. i see lots of of products that are not approved by the fda which are available on the market, so why can't this fall into a similar category. sounds like you're playing devils advocate waaaaay too hard. i understand you wanting to be the law expert around here but it just doesn't make sense to outlaw an entire market based on a few vendors marketing campaigns unless there was some outside persuasion.

i'm with you to where i believe in the fda and that they provide an excellent filter of harmful products into the market, but eciggs aren't compared to the competition and them issuing statements that eciggs should be banned while analogs aren't is just makes me a little suspicious that they are influenced by money hungry competition.

 

[degnr8]

I'm sure money hungry competition has had something to do with all of this, but the key difference really is that cigs aren't claiming to treat any kind of medical condition. If sa hadn't been stupid and just called it a smoking alternative letting the consumer make the link to cessation on their own, we wouldn't have this problem. Unfortunately, once those claims are made, they can't be unmade even if it is a different manufacturer/vendor. As somebody else suggested, I think seperating the device from the drug is going to be the critical issue

 

[MrKai]

I'm sure money hungry competition has had something to do with all of this, but the key difference really is that cigs aren't claiming to treat any kind of medical condition. If sa hadn't been stupid and just called it a smoking alternative letting the consumer make the link to cessation on their own, we wouldn't have this problem. Unfortunately, once those claims are made, they can't be unmade even if it is a different manufacturer/vendor. As somebody else suggested, I think seperating the device from the drug is going to be the critical issue

Someone gets it.

"Getting it" doesn't necessarily mean *agreeing with it beyond a limited scope* but I suppose the Internet is a reflection on our fiercely divided, "all or nothing" modern mentality.

The other problem here is that while SA made the idiot claims, the FDA in the "spirit of fairness" tested other brands carts and in them found mislabeling problems (stated nicotine amounts vs actual amounts deviating outside standard acceptable margins, unlisted chemicals present) and used this to bolster their "Public Safety Theater" PR and block delivery of shipments.

SA is suing the FDA on the grounds that they did not have the authority to do this.

Now logically, even if the data provided by the FDA can be proven to be scientifically and statistically inadequate (I believe this is possible...it was a really rather small dataset to be considered authoritative) there are still other areas where the FDA can press simply because SA made unsubstantiated medical claims, anyway.

Basically, if SA was thrown on the fire as a sacrifice, no one would really mind or care outside of SA

If the data used in the NJOY testing is found to be insufficient to draw such a broad conclusion (I believe it is not sufficient, for the record) then they get another chance/buy some time to do it the "right way"...however SA, NJOY and everyone else sells the same "medical device" and if this goes in the favor of the FDA (again, it is a bit too late to claim the "intended use" is NOT to allow committed smokers to inhale nicotine via an electronic vaporizor...nor are they arguing this) then this falls under fda's umbrella and they can stop the sale of the devices until they meet the FDA's guidelines.

If or not the FDA will allow them to be re-classified if they are not sold with, endorsed for, promoted to be used with nicotine, do not claim to treat or cure any illness, etc...then yeah, maybe.

If the FDA says "no" after that and a judge sides with them, then tinfoil is permissible

-K

 

[Pav]

I asked this in another thread, but it seems an appropriate question here too.

Does the FDA regulate any other electronic devices (or hardware like pipes) at all? I can't think of any.

 

[MrKai]

I asked this in another thread, but it seems an appropriate question here too.

Does the FDA regulate any other electronic devices (or hardware like pipes) at all? I can't think of any.

Pretty much anything used medically or surgically. Earlier this year they made a case for wanting to have more regulatory "teeth" in this space.

-K

 

[greenie]

I think seperating the device from the drug is going to be the critical issue

This seems to be key to me too. How would the FDA have jurisdiction over the sale of a PV that comes with carts that have 0 mg Nicotene juice? Would it be that PG juice still would need to be regulated for purity standards? Or not since PG is already in lots of foods?

The fact that PVs and Nicotene are not the same thing and not permanantly linked to each other needs to be emphasized imo.

I am hoping best case scenario would be the sale of PV with zero nicotine carts ( or liquid ) too. I think I could live with that.
If I were the one to make a bargain that's what I would want.

 

[MrKai]

I am hoping best case scenario would be the sale of PV with zero nicotine carts ( or liquid ) too. I think I could live with that.
If I were the one to make a bargain that's what I would want.

...but to paraphrase my man Brian Dunning of Skeptiod fame:

"What is good enough for you is NOT good enough for the FDA."

This is generally because as laypersons, we just aren't trained to ask the same questions they are...especially if we have a bias. In theory certainly, and statistically in practice, the FDA and their equivalents around the world are skeptical of *everything* and view a thing as a sum of its parts.

So while it would *seem* reasonable to say "if a PV is sold without nic, just flavors, then boom, problem solved, Bob's yer uncle!"

Really? Is it that simple for ya? Here is how something like that is looked at scientifically and skeptically:

"So...what is the PV made of? What about the heating element? Does the heating element break down over time? Does the heating element assembly contain components that upon breaking down, could release harmful chemicals into the vapor stream?"

"What's in this flavoring, exactly? Does the flavoring have any components in it that react with the components of the device? How about when the temperature rises? Are any on the chemicals in the flavoring known to have solvent properties against the components of the vaporizer? What about the filling? What is it made of? Do any of the flavoring components react with the filling above a certain temperature?"

Etc.

Think about it. Most of these questions are really unknowns. I have been loathe to point this out because my intent is not to scaremonger.

However I do believe it is a *little* naive and irresponsible to say "eCigs are safe/safer than X" because an eCig isn't really well-enough defined to be able to make this claim empirically.

The best and most honest answer, based on information we have at this time, is an agnostic one: "we don't really know".

That said...I used to smoke like a chimney so obviously I'm not *that* bright

I *hope* that none of the above is going on deep inside my eCigs but I can't say that I know for sure. No one has really asked these questions and the impression I get is that a lot of people with lay-knowledge don't want these questions answered.

I'm not sure how I feel about that part yet.

-K

 

[Pav]

The best and most honest answer, based on information we have at this time, is an agnostic one: "we don't really know".

-K

Has there really not been any studies of PVs done? Maybe in another country? I thought I read somewhere that New Zealand deemed them safe. Might have to get Brett and Jemaine on that one.

Of course PVs have only been around for a few years so there's no long term studies, correct?

 

[MrKai]

Has there really not been any studies of PVs done? Maybe in another country? I thought I read somewhere that New Zealand deemed them safe. Might have to get Brett and Jemaine on that one.

Of course PVs have only been around for a few years so there's no long term studies, correct?

Scientific evidence, but contribute towards it...assuming they are scientific in nature, of course

Looking up a bunch of stuff online and writing a paper is as much of a "study" as a bunch of tests are.

But no, eCigs haven't been around long enough or really tested in tons of labs repeatedly to have a "long term" no.

The one thing that I can say is, as far as anyone knows, no one has dropped dead from them yet. But no clinical trials have been done certainly.

I'm not sure what the NZ study entailed.

-K

 

[Pav]

Just did some digging on the New Zealand study I was referring to and found this. They call it a bench-top test which sounds like a clinical trial to me. I'm no scientist so I won't pretend I know what all this means, but it seems positive. Still reading it.

http://www.healthnz.co.nz/DublinEcigPoster1.ppt

http://www.healthnz.co.nz/DublinEcigPoster2.ppt

I got these links from this website (scroll past roll your own tobacco section for ecig section)

Health New Zealand Company News, electronic cigarettes

 

[degnr8]

Really? Is it that simple for ya? Here is how something like that is looked at scientifically and skeptically:

"So...what is the PV made of? What about the heating element? Does the heating element break down over time? Does the heating element assembly contain components that upon breaking down, could release harmful chemicals into the vapor stream?"

"What's in this flavoring, exactly? Does the flavoring have any components in it that react with the components of the device? How about when the temperature rises? Are any on the chemicals in the flavoring known to have solvent properties against the components of the vaporizer? What about the filling? What is it made of? Do any of the flavoring components react with the filling above a certain temperature?"



-K

I think you're on to something here. I would like to announce the release of a new product line. The vaper battery powered personal air freshener. You fill the cartridges with essential oils of your choice, which the heating element then vaporizes & disperses throughout the room, car or office Use only as directed. The manufacturer is not liable for any harm resulting from misuse or modification of this product.