FDA issues notice of intent to propose "deeming" regulation by April of 2013 for e-cigarettes and other tobacco products

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Insignificance

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The justification used for banning public use and heavy "sin" taxes on traditional cigarettes is harm and cost to society. They give tax breaks to other alternatives that are considered beneficial - such as the example given earlier about alternative fuel cars - rather than the same punitive actions they give the harmful version. The reason is to give people incentive to use the less harmful version. There's no reason the same argument couldn't be made for e-cigarettes.

I agree, but the FDA already lost the fight to designate e-cigs as a form of nicotine replacement therapy. To me e-cigs are a far superior alternative than the patches and the gum and Zyban (I've tried them all with no success......vaping has gotten me to cutting my regular cigarette intake in half in a span of a week). In the end, if the FDA were to be able to classify e-cigs as such then that would have given them the power to ban them. I know it doesn't make much sense but regulating them as tobacco products is the lesser of two evils.
 

Stubby

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That said, your point is taken as what I fear is the FDA digging up one instance of an idiot chain vaping to the point of getting nicotine poisoning and using that as a cudgel against the industry.

It would be completely unnecessary for the FDA to give any real justification for giving a deeming regulation to e-cigs. All they have to do is follow the letter of the law by placing a deeming regulation, and you have a de facto ban, and all of it perfectly legal. It all depends on how hard nose they want to be.

In the next few months we can expect press releases by the alphabet soup gangs, the fanatics, and all the other ANTZ groups that are making a living off the backs of smokers. No doubt they will be yelling loudly for a hard nose deeming regulation. Never mind the fact that it would be the willful murder of millions of smokers, it's all nice and neat and legal (if this isn't starting to sound like Germany in the 1930s).

I still have some optimism that some amount of rational thinking and perhaps even a bit of empathy will take hold. The regulations could range from doing nothing, to something like banning flavors, to limiting nicotine content, to a full deeming regulation (Which for all practical purposes is a ban). Another option, and probable the best one is for the FDA to simply pass it back to congress in there upcoming report and telling them what a lousy law the Family Smoking Prevention and Tobacco Control Act really is. I actually have a bit of sympathy for the FDA as the law is so badly written it is essentially impossible to improve public health as is. Perhaps someone can jump in and give a history or who actually wrote the bill. It's not a pretty picture.

There is really not much more to be said until April when we get an idea of what the FDA is up to.
 
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pmos69

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I agree, but the FDA already lost the fight to designate e-cigs as a form of nicotine replacement therapy. To me e-cigs are a far superior alternative than the patches and the gum and Zyban (I've tried them all with no success......vaping has gotten me to cutting my regular cigarette intake in half in a span of a week). In the end, if the FDA were to be able to classify e-cigs as such then that would have given them the power to ban them. I know it doesn't make much sense but regulating them as tobacco products is the lesser of two evils.

That's the route being taken by the EU proposed directive - designate e-liquid above 2mg as medicine, with all the corresponding consequences. In the end, there will be no e-liquid with nicotine in the market, unless big-pharma starts producing it, with their usual profit margins. A medical prescription will probably be needed as well.
 

Tail11

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That's the route being taken by the EU proposed directive - designate e-liquid above 2mg as medicine, with all the corresponding consequences. In the end, there will be no e-liquid with nicotine in the market, unless big-pharma starts producing it, with their usual profit margins. A medical prescription will probably be needed as well.

This is what I'm afraid of, FDA regulates and makes liquid a pharmaceutical. With the politicians falling all over themselves saying they want to support small businesses, they sure aren't helping the vaping vendors any.
 

patkin

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I read the CASAA letter to the FDA last night and, the way I see it, the FDA will/might regulate sales of equipment the way they have with eye glasses/contacts where optometrists can't be affiliated... ie: optometrists cannot be on the staff of the vendors and vice versa. That's why we see an optometrist in a separate place even though right next door or adjoining the vendor. If they do that, then the same sites or brick and mortars won't be able to sell nic juice and equipment. They'll have to choose which way they want to go with a link on the site to the other stuff needed or be right next door in terms of brick and mortar. Actually, I see the FDA as going after big tobacco on this since they've gotten involved in ecig sales and are stepping that up but it will hurt mom and pop of course... but not really as they will find work-arounds just like glasses vendors did... good model for them to look at.
 
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patkin

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so we all should buy in bulk and store it for as long as possible blow like 3 month of pay on equipment we use on a regular basis

don't want to high jack thread but I'm just getting a few of the little grippers which is pretty economical and then only have to buy batteries and can get those most anywhere instead of the ego I usually use. (I do have 5 backups of those though) I sure wouldn't blow three months of pay checks but then I'm not into high voltages. However, they do make a vv gripper and 5v mods can be gotten pretty cheap.
 

kristin

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I don't know about big pharma, but it's a stretch to say that the FDA and big tobacco are in cahoots.....let alone funding a government agency. More likely that the legislators are getting paid off.
Keep in mind that it was the FDA that wanted graphic pictures on all tobacco products and wanted the tobacco companies to pay for it....doesn't sound like a cabal to me.

Just so people know, the drug companies currently fund the FDA through required payments to reimburse the FDA for reviewing the drug studies they submit. An FDA whistle-blower reported that his supervisor informed him that the drug companies, not the public, was the FDAs "client." (The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower) It's only recently that the FDA has been given power over the tobacco industry with the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 and you can bet the same relationship will develop as the tobacco companies will start being required to pay the FDA to review their studies and reports.

It wasn't the FDA that "wanted" the graphic warnings. The FSPTCA required the FDA to create the new warnings and that Act was passed by Congress, which was lobbied heavily by ANTZ groups to put in the graphic warnings and put tobacco under the control of the FDA. Some tobacco companies agreed to it because they knew they had enough capital to address whatever the FDA comes up with and it would eliminate some competition - just as with the flavor bans.
 

kristin

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I agree, but the FDA already lost the fight to designate e-cigs as a form of nicotine replacement therapy. To me e-cigs are a far superior alternative than the patches and the gum and Zyban (I've tried them all with no success......vaping has gotten me to cutting my regular cigarette intake in half in a span of a week). In the end, if the FDA were to be able to classify e-cigs as such then that would have given them the power to ban them. I know it doesn't make much sense but regulating them as tobacco products is the lesser of two evils.

I think you missed the point of my post? As a director of CASAA, I was part of the amicus brief filed to argue in Sottera vs. FDA that e-cigarettes should be considered tobacco products rather than drug delivery devices. So, obviously my post you quoted above wasn't about arguing that e-cigarettes should be considered drug delivery devices. I was making the point that just because they are considered "tobacco products" doesn't automatically mean e-cigarettes would or should be regulated and taxed exactly like traditional cigarettes, because even leaf tobacco products are taxed and regulated differently - with traditional cigarettes being the most severe.
 

Insignificance

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Just so people know, the drug companies currently fund the FDA through required payments to reimburse the FDA for reviewing the drug studies they submit. An FDA whistle-blower reported that his supervisor informed him that the drug companies, not the public, was the FDAs "client." (The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower) It's only recently that the FDA has been given power over the tobacco industry with the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 and you can bet the same relationship will develop as the tobacco companies will start being required to pay the FDA to review their studies and reports.

It wasn't the FDA that "wanted" the graphic warnings. The FSPTCA required the FDA to create the new warnings and that Act was passed by Congress, which was lobbied heavily by ANTZ groups to put in the graphic warnings and put tobacco under the control of the FDA. Some tobacco companies agreed to it because they knew they had enough capital to address whatever the FDA comes up with and it would eliminate some competition - just as with the flavor bans.

Well, on all issues I stand corrected.
 

Insignificance

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I think you missed the point of my post? As a director of CASAA, I was part of the amicus brief filed to argue in Sottera vs. FDA that e-cigarettes should be considered tobacco products rather than drug delivery devices. So, obviously my post you quoted above wasn't about arguing that e-cigarettes should be considered drug delivery devices. I was making the point that just because they are considered "tobacco products" doesn't automatically mean e-cigarettes would or should be regulated and taxed exactly like traditional cigarettes, because even leaf tobacco products are taxed and regulated differently - with traditional cigarettes being the most severe.

Ah, well I'll get back to you in regards to your amicus brief the minute I figure out what exactly that is. :)

Thank you for all that you are doing for the cause.

Since you are well-versed in these matters can I ask - do you see the FDA regulating the amount of nicotine available with e-cigs (that is, putting a limit on the amount or, worse, establishing a set level that all manufacturers will have to stick to)?

Thanks again.
 

Petrodus

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kristin

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Ah, well I'll get back to you in regards to your amicus brief the minute I figure out what exactly that is. :)

Thank you for all that you are doing for the cause.

Since you are well-versed in these matters can I ask - do you see the FDA regulating the amount of nicotine available with e-cigs (that is, putting a limit on the amount or, worse, establishing a set level that all manufacturers will have to stick to)?

Thanks again.

You can find the legal documents regarding the lawsuit on CASAA's web site here: CASAA Smoking Everywhere vs. FDA

The amicus brief is listed as "Smokefree Amicus Brief" that we filed with several other groups.

I have no doubt that they will announce that they intend to do some regulations with which vapers will not be happy. At that point, public comments will be opened and it will be vital for hundreds of thousands of vapers to submit comments. Just as with previous comment submissions, CASAA will have a Call to Action with "talking points" for people to use in their commenting and CASAA will probably be spending a considerable amount on press releases and other materials to fight against any unreasonable regulations. It will be extremely important that members get the word out to vapers and e-cigarette retailers (both on and off line) who are unaware of this potential threat, to help CASAA get more comments and raise additional funds for this fight.

People can join CASAA and get on the Call to Action email list at: Become a CASAA Member

Donations can be made here: Donate to CASAA
 
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kristin

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So when will a verdict be rendered? April 1st? Seems logical to me.

The FDA has stated that it will be announcing its deeming regulations in April, but it has been notoriously slow to act, so it could come out in summer or even fall. But that is just announcing the FDA's intentions. Comments from the public will then be taken (via a comment just as we recently had regarding NRT regulations.) After that the comments will (supposedly) be taken into consideration and then I think they will announce the final regulations. (Maybe Bill can correct me if I have this wrong, but that is how things worked other times.) It will be important that we not only submit those comments but that the public and legislators are made aware of any unreasonable regulations. If we can get any federal legislator on our side that will be a tremendous help. But we need vapers and companies to get involved so the regulations don't just quietly get passed.
 
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