Electronic Cigarettes Still Under Attack By Health Organizations And Special Interest Groups

[Raven_Blackblade]

Here is a link that I found posted today.

PR-CANADA.net - Electronic Cigarettes Still Under Attack By Health Organizations And Special Interest Groups

 

[harmony gardens]

I've been noticing that these types of articles are starting point out the flawed logic of the FDA prohibiting a safer alternative a little more.

(trying to stay positive)

 

[galaxywd]

You got it ;-)

 

[Vicks Vap-oh-Yeah]

Enter the electronic cigarette. The new product was introduced to the United States market in 2006 and while some health organizations are attacking it as untested and potentially unsafe, users and distributors of the products disagree.

I want a source for this statement....really bad!!! The monster bill has a grandfather clause for products - the cut off date is Feb 2007. If anyone can prove marketing for E-Cigs in the US prior to this date - that's one hurdle cleared for keeping them on the shelves.

Course - we still have to deal with the whole "drug delivery device" thing, but baby steps.

 

[TropicalBob]

I want a source, too. I was writing a technology column in 2007 and first saw electronic cigarettes pop up on gadget blogs in August 2007. E-cigs had to be ordered from China, but these blogs were always competing to be first with information. I wrote about e-cigs, then ordered an e-pipe in December 2007.

The new law requires them to have been on the market in the U.S. prior to the cutoff date, so, like you, I want to know who was selling e-cigs in the U.S. before Feb. 7, 2007. If that were the case, one obstacle would be avoided because their "existing product" status would be grandfathered.

 

[let_there_be_vaping]

Wouldn't the suppliers, like Ruyan Direct, have the date of their first sale to the USA?

 

[dc2k08]

The court documents I read in the njoy Vs Ruyan trial said that njoy began marketing and distributing their product in around April or May 2007, though their company was incorporated in the State of Nevada in September of 2006.

Ruyan America was incorporated in the State of Minnesota in October of 2007 and the documents say 'it is believed the Ruyan products were not sold in the United States until February 2008 at the earliest'.

Njoy's had two patents pending at the time of the trial, one filed in April '07 and the other in October '08. I don't know if these are still pending.

Ruyan had not filed its patents in America (they did file them in China) before these dates and I'm not exactly sure what the situation is now.

 

[Bill Godshall]

Jack Leadbeater of NJOY told me that they started marketing e-cigarettes in the US in 2006. But its a moot point since the Congressionally approved FDA tobacco legislation doesn't have any statutory or regulatory impact on e-cigarettes.

 

[Smokin'Sandy]

I want a source, too. I was writing a technology column in 2007 and first saw electronic cigarettes pop up on gadget blogs in August 2007. E-cigs had to be ordered from China, but these blogs were always competing to be first with information. I wrote about e-cigs, then ordered an e-pipe in December 2007.

The new law requires them to have been on the market in the U.S. prior to the cutoff date, so, like you, I want to know who was selling e-cigs in the U.S. before Feb. 7, 2007. If that were the case, one obstacle would be avoided because their "existing product" status would be grandfathered.

Bob,

Wouldn't that only be applicable if they are tobacco products? I'm afraid the FDA sees them as a drug delivery device which wouldn't matter when they were marketed.

I was trying to see if there was a difference between marketed and commercially marketed on google and by some freak, I came across the FDA site that states what it takes to get a medical device marketed. 8-o

Premarket Notification (510k)

 

[dc2k08]

I think I remember reading in the legislation a snippet about it being up to the FDA as what it can consider a tobacco product so they could potentially class electronic cigarette liquid as a tobacco product perhaps, especially if any of the flavourings are derived from tobacco.

 

[yvilla]

But its a moot point since the Congressionally approved FDA tobacco legislation doesn't have any statutory or regulatory impact on e-cigarettes.

Bill, I'm going to repeat here a post I just made in your "Message from Bill Godshall" thread, because I'd really like to hear your response:

But Bill, I don't think it's so crystal clear that the under the new legislation the FDA couldn't deem ecigs to be "tobacco products" within the scope of the bill, as the nicotine liquid is in fact "derived" from tobacco. This has been acknowledged for example by DeKang, probably the largest eliquid manufactutor of all. And, the FDA would be especially motivated to do that if by chance the Judge in the SE/Njoy litigation agrees that ecigs are not "new drugs" needing to go through the NDA process.

I'm wondering it you would amplify your thoughts on this a bit more.

 

[OutWest]

There's a wholesale import shop in Denver that I know had penstyle ecigs and liquid before 2007, but proving it is another matter. Especially since when I had friend drop in to see if they still carried ecigs, they had no idea what she was talking about. But, they were definately in the U.S. before 2007. Again, though, proving it...

 

[Smokin'Sandy]

Bill, I'm going to repeat here a post I just made in your "Message from Bill Godshall" thread, because I'd really like to hear your response:

yvilla,

I know you directed this at Bill and hopefully he'll expound a little, but I'll post what he said in another thread here and hope he doesn't mind.

The US Senate is likely to consider S. 982 (Kennedy's FDA tobacco bill) during the week of June 2.

It is important to know that passage of the legislation will have no negative legal or regulatory impact on e-cigarettes. One of my goals, which now appears unlikely, was to amend the legislation to prevent the FDA from banning e-cigarettes as drug devices (by defining e-cigarettes as a new category of tobacco product).

But the legislation's ban on new smokefree tobacco products (and the false claims by Senate Democrats that Reynolds is target marketing these products to youth) could encourage the FDA to further crack down on e-cigarettes (than if the tobacco legislation weren't enacted).

Sen. Coburn offered, then withdrew, his amendment (i.e. the ECA amendment) that would exempt e-cigarettes from the definition of a tobacco product, during Wednesday night's HELP Cmte markup session (the session that isn't available on the committee's website). Coburn will try negotiating an agreement with Dodd on that amendment prior to Senate floor consideration.

But since S. 982 doesn't define e-cigarettes as a tobacco product (or otherwise apply to e-cigarettes), I'm not convinced that passage of the Coburn amendment would provide any legal or regulatory benefits for e-cigarettes (as the FDA could still rule that e-cigarettes, or certain e-cigarette products, are unapproved drug devices, and take action).

From this thread: http://www.e-cigarette-forum.com/fo...tobacco-regulation-measure-10.html#post296593

 

[yvilla]

Thanks Smokin'Sandy. I had seen that post, and it still doesn't really address the heart of my question - since the legislation does not specifically address ecigs, why or how can Bill be so apparently sure that they cannot simply be deemed by the FDA to be a "tobacco product", given that the nicotine liquid is, in fact, derived from tobacco?

The FDA has already determined that ecigs are "new" drugs/drug-device combinations needing their approval. But what if the court says no, they are not? Wouldn't it be easy then for the FDA to declare them to be a "tobacco product", and thus under their jurisdiction via that route?

 

[Hangar]

The FDA has already determined that ecigs are "new" drugs/drug-device combinations needing their approval. But what if the court says no, they are not? Wouldn't it be easy then for the FDA to declare them to be a "tobacco product", and thus under their jurisdiction via that route?

...this point makes perfect sense to me, and since the nic in these liquids is derived from tobacco I have to admit I've been wondering the same thing lately. Seems to me with this new bill being passed that the FDA will now have an easy "plan B" at their ready if it becomes necessary.

 

[forcedfuel50]

Thanks Smokin'Sandy. I had seen that post, and it still doesn't really address the heart of my question - since the legislation does not specifically address ecigs, why or how can Bill be so apparently sure that they cannot simply be deemed by the FDA to be a "tobacco product", given that the nicotine liquid is, in fact, derived from tobacco?

The FDA has already determined that ecigs are "new" drugs/drug-device combinations needing their approval. But what if the court says no, they are not? Wouldn't it be easy then for the FDA to declare them to be a "tobacco product", and thus under their jurisdiction via that route?

I agree with you, the FDA with its inherent powers will just declare them (e cigs) to be a tobacco product and as much as my powers of denial are in full swing, i have to somewhat agree that they are....sigh...

I would imagine there will be lawsuits, though the reality is, most of the US suppliers have no real resources in which to bring civil action(s).

That leaves big tobacco which is undoubtedly working on their own version of the e cig and has the resources to get it approved.

Just my .02...

David

 

[Smokin'Sandy]

Thanks Smokin'Sandy. I had seen that post, and it still doesn't really address the heart of my question - since the legislation does not specifically address ecigs, why or how can Bill be so apparently sure that they cannot simply be deemed by the FDA to be a "tobacco product", given that the nicotine liquid is, in fact, derived from tobacco?

The FDA has already determined that ecigs are "new" drugs/drug-device combinations needing their approval. But what if the court says no, they are not? Wouldn't it be easy then for the FDA to declare them to be a "tobacco product", and thus under their jurisdiction via that route?

I would hope so and that is really what I'm hoping for. Especially if they were commercially marketed before Feb of 07.

 

[Smokin'Sandy]

I agree with you, the FDA with its inherent powers will just declare them (e cigs) to be a tobacco product and as much as my powers of denial are in full swing, i have to somewhat agree that they are....sigh...

I would imagine there will be lawsuits, though the reality is, most of the US suppliers have no real resources in which to bring civil action(s).

That leaves big tobacco which is undoubtedly working on their own version of the e cig and has the resources to get it approved.

Just my .02...

David

I think it would be a good thing if they are tobacco product and marketed here before Feb 07. Not such a good thing if after that because snus, orbs, and the other tobacco products will probably soon be banned because of their late market entry (and flavors). They will have to do testing in order to show that they are a less harmful tobacco product.

In regards to the e-cig, I would think the testing for the less harmful tobacco product would probably take longer than introducing them as a drug/medical delivery device combination, but I don't really know.

I would agree that if they are a tobacco product and late market entry, the only ones that can afford to do the testing and regulations will be the tobacco companies. If they are a drug, then in comes the pharmaceutical companies. Same story, a little different dance...

 

[.308]

I want a source for this statement....really bad!!! The monster bill has a grandfather clause for products - the cut off date is Feb 2007. If anyone can prove marketing for E-Cigs in the US prior to this date - that's one hurdle cleared for keeping them on the shelves.

Course - we still have to deal with the whole "drug delivery device" thing, but baby steps.

Concerning the whole drug delivery device thing, what if it were marketed for use with PG and flavoring, not nicotine. PG and flavoring are not drugs. It would go through just like bo....errr water pipes. To expand on that topic, the FDA DOES NOT have jurisdiction over tobacco pipes, water pipes, combustion vaporizers, hookahs, etc. Aren't THOSE ALL DRUG DELIVERY DEVICES? What about COFFEE CUPS and ESPRESSO MAKERS? Want to regulate those too?

OH AND NOT TO MENTION YOU CAN GO TO A GAS STATION AND BUY A .... PIPE AND THEY WANT TO BAN E-CIGS? WTF.

 

[Smokin'Sandy]

Concerning the whole drug delivery device thing, what if it were marketed for use with PG and flavoring, not nicotine. PG and flavoring are not drugs. It would go through just like bo....errr water pipes. To expand on that topic, the FDA DOES NOT have jurisdiction over tobacco pipes, water pipes, combustion vaporizers, hookahs, etc. Aren't THOSE ALL DRUG DELIVERY DEVICES? What about COFFEE CUPS and ESPRESSO MAKERS? Want to regulate those too?

OH AND NOT TO MENTION YOU CAN GO TO A GAS STATION AND BUY A .... PIPE AND THEY WANT TO BAN E-CIGS? WTF.

It makes you wonder doesn't it? Again, it seems, that tobacco is okay for the FDA, but not an extract of it (nicotine). Even though tobacco has nicotine and the bill calls "anything extracted from tobacco" a tobacco product, unless it fits the definition of a drug. It doesn't make a lot of sense. Like you said...WTF?

That's like saying the extract of the coffee bean (caffeine) is a drug when it's separated from the bean itself. Doesn't the body naturally extract any drug regardless of the delivery device? Crazy stuff. You know, I think they do that with caffeine actually. All that no-doze and headache medicine out there. wow.

I have to edit this and say that I wasn't being sarcastic or demeaning or anything. It really did just dawn on me that extracted caffeine is a drug (I think, I haven't checked).

I just checked and it seems that the FDA does regulate caffeine when used as a stimulant in medications or added to food. I'm amazed really. Maybe it's the concentration of the extraction or something.

Of course I went totally away from what you were saying though. I would like to see the hardware available. We would just have to worry about the nicotine then.