FDA approval?

[MrKai]

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

of course the current automatic designs don't do this, but lol yeah a VapAromaStik® that you, erm, wave...thru the air...sure

If it just *happened* to fit hardware used for other purposes, lol.

A not-so-funny aside: Pharma companies have used this ploy for years to sell something that could not be approved for one use for another. Still had to do the FDA song and dance, but it has been known to happen.

-K

 

[rothenbj]

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

I posted this link on a thread in the news section, but I think it also applies here-

VAPIR One v5.0 Vaporizer AIR-2 VAPIR | Vaporizers Giant | Cheap Vaporizers Wholesale Prices | Volcano Air2 Vapir

I would believe a device such as this should fall within the realm of the FDA also since, theoretically, you could grind tobacco up and vaporize it in this creating a drug device to inhale nicotine. What components in here could create a problem for human consumption of nicotine vaporized at 350 degree F. Golly, where is A.S.H. when you need them.

By the way, I may be a little naive, but what disease is the e cig trying to cure?

 

[dragonpuff]

By the way, I may be a little naive, but what disease is the e cig trying to cure?

Some years back, they (don't ask me who exactly decided this, i don't know, but it doesn't matter cuz it spread anyway) classified smoking as a "disease" called "nicotine dependence," which is technically considered a mental disorder since it falls in the category of "substance use disorders."

All of the quit smoking products on the market have been approved by the FDA because the companies that produce them "proved" that they treat this "disease." What the FDA is up in arms about is companies who claim that their e-cigs can help one quit smoking, i.e. "treat" the "disease" of "nicotine dependence." Hence, their allegations of an "unproven medical claim."

End quote

 

[kinabaloo]

I posted this link on a thread in the news section, but I think it also applies here-

VAPIR One v5.0 Vaporizer AIR-2 VAPIR | Vaporizers Giant | Cheap Vaporizers Wholesale Prices | Volcano Air2 Vapir

I would believe a device such as this should fall within the realm of the FDA also since, theoretically, you could grind tobacco up and vaporize it in this creating a drug device to inhale nicotine. What components in here could create a problem for human consumption of nicotine vaporized at 350 degree F. Golly, where is A.S.H. when you need them.

By the way, I may be a little naive, but what disease is the e cig trying to cure?

Mr K and the FDA claim that nicotine is addictive and that smokers are nicotine addicts, and that a smoking alternative is a 'treatment', and that there is no evidence that they are useful in this regard.

Without going over all these points again, one would think that if the e-cig didn't work, it would have no lasting market. But we live in a world controlled by monopolies and their minions, where even a vitamin can make no health claim. Yet some are so hunkydory with the way things are. So sad.

 

[rothenbj]

Some years back, they (don't ask me who exactly decided this, i don't know, but it doesn't matter cuz it spread anyway) classified smoking as a "disease" called "nicotine dependence," which is technically considered a mental disorder since it falls in the category of "substance use disorders."

All of the quit smoking products on the market have been approved by the FDA because the companies that produce them "proved" that they treat this "disease." What the FDA is up in arms about is companies who claim that their e-cigs can help one quit smoking, i.e. "treat" the "disease" of "nicotine dependence." Hence, their allegations of an "unproven medical claim."

End quote

I was being a bit sarcastic with that last comment since I actually knew the answer. If we take obesity and label it a disease, then sugar should be defined as "sugar addiction" and the combination of sugar and caffeine in a product "sugar/caffeine" addiction. Now every product reducing use of these drugs would need to be examined by the FDA. The cans that the soda is sold in would be a drug delivery device needing FDA approval and off course the sin taxes applied accordingly.

 

[Thulium]

...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?

In reality, however, SmokingEverywhere had no reason to want their potential customers to actually quit. Instead they offered their customers the option to keep their addiction but without the tar. If "our product is healthier than our competitor" constitutes a medical claim, the advertising world should come to a screeching halt. Is there a product on the market that isn't less dangerous than cigarettes???

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

I'm not a real big fan of SmokingEverywhere's business practices, but I'm sorry...it really doesn't seem to me that showing your customers how to use your product to improve your health constitutes a "medical claim".

 

[degnr8]

I

I would believe a device such as this should fall within the realm of the FDA also since, theoretically, you could grind tobacco up and vaporize it in this creating a drug device to inhale nicotine.

Yes, you could do that but you could theoretically modify just about anything into a drug delivery system. Copper tubing, tobacco pipes, coke cans, glass vials etc are all modified for drug use. They don't fall under the auspices of the FDA though, because that is not their intended purpose. They even have a hard time with this type of thing in drug laws. There are many many many things that can be used as peraphenalia but aren't inherently so. If you turn an aligator clip into a roach clip, that doesn't make all aligator clips illegal or something that can be regulated by the FDA.

 

[degnr8]

In reality, however, SmokingEverywhere had no reason to want their potential customers to actually quit. Instead they offered their customers the option to keep their addiction but without the tar.

This is a good point & if they'd stuck with that line we wouldn't be in this mess.

I'm not a real big fan of SmokingEverywhere's business practices, but I'm sorry...it really doesn't seem to me that showing your customers how to use your product to improve your health constitutes a "medical claim".

If they'd stuck to just a harm reduction message everything would be cool. It was claiming that it would help you beat your nicotine addiction that constitutes a "specific medical claim". That stupid mis-step is what made them legally medical devices. The only way out of that cluster**** is if the courts determine that SA was simply (and possibly fraudently) marketing a product incorrectly. The approach to take with marketing these things would be as a way to get nic in situations where you can't smoke. Restaurants, airports etc. I keep imagining an ad where a guy kicks back & vapes in front of a nice warm fire while his buddies are out smoking analogs in a blizzard.

 

[MrKai]

I'm not a real big fan of SmokingEverywhere's business practices, but I'm sorry...it really doesn't seem to me that showing your customers how to use your product to improve your health constitutes a "medical claim".

...and I still don't get why people are belaboring it. It isn't vague in any way.

You say "showing your customers how to use your product to improve your health" - this statement is *fine*.

Do you understand the difference between your vague claim and a more specific, actionable one?

As aside: I am not really sure why certain posters (not you) cannot seem to fathom the seeming "dichotomy" that I use and enjoy eCigs and that I find merit in some of the FDAs points.

It just doesn't seem hard to me.

Look at it this way: Tobacco companies for years sold mass-produced cigarettes as "healthy". At some point, they learned this was not the case and obfuscated this.

It isn't even remotely implausible that an unscrupulous marketer in the eCig space, or upstream in China could learn something about the system isn't right and cover it up.

And I'm not playing "devil's advocate" either...my concerns are sincere...and like the person I seemed to have "hijacked" this thread from (dopebeat), I am still mystified somewhat why people think it is cool that eCigs have no real manufacturing standards, a vendor was found to have unlisted stuff in their cart and inaccurate measures.

I mean, how do they get a pass from us, the people that are inhaling this stuff? How would this be different from a tobacco company going "oh THAT? yeah well, don't mind THAT..."

I think I'm going to just go the route dopebeat did, sigh and hand it back over to the conspiracy theorists and such. Confirmation bias is very hard to fight...but it is said that the "most smart" people are the easiest to "fool" because of it. They are "too smart" to do something stupid.

The problem is in this process often smart people lose objectivity; eCigs "have to be safe" because of X...they "can't be worse than tobacco cigs because of Y" etc instead of having an even MORE healthy and agnostic attitude of 'we really don't know enough yet to make a definitive determination yet'...which at the end of the day, is the actual answer based in fact

"It's not what you know, it's what cha can prove" as the Urban Contemporary Poets 'Above the Law' once wrote

-K

 

[Thulium]

...and I still don't get why people are belaboring it. It isn't vague in any way.

You say "showing your customers how to use your product to improve your health" - this statement is *fine*.

Do you understand the difference between your vague claim and a more specific, actionable one?

I understand that there is a difference, but to be frank, no, I don't understand. It makes me a little crazy that every product under the sun makes claims of being "healthier" or helping you to lose weight...but the FDA doesn't lift a finger over those things (at least not until enough people are victimized) but if you tell people you can help them quit smoking, somehow that is a specific health claim.

"E-cigarettes can help you quit smoking." is NOT a medical claim, it is a fact: If you're using an e-cigarette, you're not smoking. If you decrease your nicotine intake eventually to zero, it has helped you quit completely.

As aside: I am not really sure why certain posters (not you) cannot seem to fathom the seeming "dichotomy" that I use and enjoy eCigs and that I find merit in some of the FDAs points.

It just doesn't seem hard to me.

Count yourself lucky. I have a hard time keeping an unbiased eye on the FDA. It was easier for me to believe that the FDA just wanted to help keep unscrupulous import sales people from skipping the legalities and selling shoddy products before I read the report. The fact that they could look at those results and then make such ridiculously hyper-paranoid claims that its hard to not think that they may have had an agenda...and considering that it is a documented fact that "Big Pharma" and "Big Tobacco" have significant financial ties to the FDA...it becomes unsettlingly suspicious.

Look at it this way: Tobacco companies for years sold mass-produced cigarettes as "healthy". At some point, they learned this was not the case and obfuscated this.

But we aren't talking about tobacco companies. We're talking about the FDA who makes as much money from tobacco as the tobacco companies themselves.

It isn't even remotely implausible that an unscrupulous marketer in the eCig space, or upstream in China could learn something about the system isn't right and cover it up.

Yes, in fact it was probably SE's attitude as much as anything that is hurting them...but from SE's ads I didn't get a feeling that what wasn't right that SE was trying to take advantage of is the ability to "smoke everywhere". They were operating under the assumption that vaporizing nicotine-laced, tobacco scented fog juice is a combination of products that are all separately tested as safe and legal and would allow a smoker to use their product everywhere.

And I'm not playing "devil's advocate" either...my concerns are sincere...and like the person I seemed to have "hijacked" this thread from (dopebeat), I am still mystified somewhat why people think it is cool that eCigs have no real manufacturing standards, a vendor was found to have unlisted stuff in their cart and inaccurate measures.

I do have the tendency to play Devil's Thadvocate, (The phrase was coined in my honor, after all) but thats not what I'm doing right now. That said, although I do want reasonable manufacturing standards, that isn't what I'm hearing from the FDA. What we're hearing from the FDA is that e-cigarettes have antifreeze and that they have the same carcinogens as cigarettes and they should be banned until the FDA says so.

Considering the FDA's history with Big Tobacco and Big Pharma, I think there's a lot of people who'd rather have an unregulated e-cigarette than the FDA's idea of regulation. A month's supply of unregulated e-cigarettes still has less poison than a single "regulated" analog.

I mean, how do they get a pass from us, the people that are inhaling this stuff? How would this be different from a tobacco company going "oh THAT? yeah well, don't mind THAT..."

Because "THAT" is the stuff we've been taking at far higher levels for years in FDA approved products. The FDA is way too concerned about the splinter in the e-cig's eye and ignoring the plank in their own. (which gives me an idea for the PSA offer thread!)

I think I'm going to just go the route dopebeat did, sigh and hand it back over to the conspiracy theorists and such. Confirmation bias is very hard to fight...but it is said that the "most smart" people are the easiest to "fool" because of it. They are "too smart" to do something stupid.

You really shouldn't. Just because the FDA is dismissing the deadly side effects of products they approve trying to focus on the trace amounts of TSNAs in e-cigs, doesn't mean we shouldn't try to improve e-cigs. E-cigs should have quality manufacturing standards. The risks of using e-cigs should be documented as well....but considering the alternative, I really think that is secondary to maintaining the consumer's right to choose safer and more effective alternatives to smoking.

The problem is in this process often smart people lose objectivity; eCigs "have to be safe" because of X...they "can't be worse than tobacco cigs because of Y" etc instead of having an even MORE healthy and agnostic attitude of 'we really don't know enough yet to make a definitive determination yet'...which at the end of the day, is the actual answer based in fact

"It's not what you know, it's what cha can prove" as the Urban Contemporary Poets 'Above the Law' once wrote

-K

What we can prove is that e-cigarettes sometimes use nicotine that MIGHT be more dangerous than tap water. What we can prove is that the alternatives to using the "maybe not completely safe" e-cigarette is to use the "we know for a proven fact that its killing people every day" cigarette or the "documented cases of mental illness including suicide" Chantix or the "documented ineffective and containing as much or more poison than e-cig" nicotine polacrilex NRT.

The FDA has not documented a single shred of evidence and their own report shows that nobody should expect to find anything approaching the risks of FDA approved products. The only thing it showed is that e-cigarettes might not be completely safe. Personally, I'll take a product with the warning "this product may not be completely safe" over a product with the warning "this product probably won't help you quit smoking, but it might make you want to die" every day of the week.

 

[dragonpuff]

Personally, I'll take a product with the warning "this product may not be completely safe" over a product with the warning "this product probably won't help you quit smoking, but it might make you want to die" every day of the week.

Here here!!

 

[MaDPimP]

The FDA has not documented a single shred of evidence and their own report shows that nobody should expect to find anything approaching the risks of FDA approved products. The only thing it showed is that e-cigarettes might not be completely safe. Personally, I'll take a product with the warning "this product may not be completely safe" over a product with the warning "this product probably won't help you quit smoking, but it might make you want to die" every day of the week.

Those were my exact thoughts. Im not trying to argue that the "smoking cessation" claims were not unfounded and erroneous to make, and although i dont agree with the actions the FDA has taken i could understand why they could attack SE. However, if the company is willing to remove the claim and simply sell them as a cigarette alternative or simply a flavor inhaler I would think that would be enough for a reasonable resolution on the whole situation.

From what I can see most people, myself included, are upset that one company's claim could shut down the entire PV industry. When contaminated batches of i believe asprin were found the asprin industry was not shut down nor were their products being stopped by customs. False/misleading advertising is not necessarily a medical claim. Rainbow vacuums for instance claim to reduce allergies and they are not FDA approved, although this is clearly a medical claim.

I do agree that some type of control needs to be added to ecig protocol but should it really have to go through FDA drug approval before we can get them established and use the product? IMO no.

Lastly, can we really be expected to give the FDA too much credit and not believe they are being influenced by big tobacco and big pharmaceutical companys when one specious claim by one ecig company can close down the entire industry (or at least halt/impede it) while the FDA approved smoking cessation drug chantix, which is still on the market, has this lovely disclaimer:

"Patients taking Chantix have suffered dangerous and serious adverse side-effects. These side effects include agitation, depression, onset of psychiatric illness such as psychosis, mania, bipolar disorder, schizophrenia and hallucinations.[2] Chantix may lead to the recurrence of old psychiatric illness.[3 Some patients have attempted or committed suicide.[4]Chantix patients have reported serious accidents, including car accidents, while on the drug. In early 2008 and mid 2008, FDA issued an alerts about some of these serious adverse side-effects. [5] While the rate at which these side-effects occur is not yet known, the Institute for Safe Medication Practices has reported that, by the end of 2007, Chantix accounted for more reports of serious drug adverse events in the United States than any other drug.[6]" Chantix Patients Report Dangerous Side-Effects

When chantix gets pulled off the market I'll believe the FDA has our best interests at heart and not its wallet.

 

[Jack_Gas]

The government will ban them for two reasons.

#1) Nobody can line their pockets as well as the tobacco companies, and drug manufacturers.

#2) Its really easy to remove THC from weed, and 100 lbs of weed can be reduced into pure THC that would be occupy about 12 OZ. Also smoking weed would no longer be detectable, because vaporizing THC is orderless.

With that in mind, E-smokes will be banned, but if the distributors ship the E-smokes with blank carts, how can they be considered nicotine delivery systems? They could then ship the nicotine separate.

I have really bad asthma (many hospital stays) and with my new E-smoke, I feel like a new man..... All the medicines to stop smoking do not work, but my E-smoke does!

 

[dragonpuff]

Lastly, can we really be expected to give the FDA too much credit and not believe they are being influenced by big tobacco and big pharmaceutical companys when one specious claim by one ecig company can close down the entire industry (or at least halt/impede it) while the FDA approved smoking cessation drug chantix, which is still on the market, has this lovely disclaimer:

"Patients taking Chantix have suffered dangerous and serious adverse side-effects. These side effects include agitation, depression, onset of psychiatric illness such as psychosis, mania, bipolar disorder, schizophrenia and hallucinations.[2] Chantix may lead to the recurrence of old psychiatric illness.[3 Some patients have attempted or committed suicide.[4]Chantix patients have reported serious accidents, including car accidents, while on the drug. In early 2008 and mid 2008, FDA issued an alerts about some of these serious adverse side-effects. [5] While the rate at which these side-effects occur is not yet known, the Institute for Safe Medication Practices has reported that, by the end of 2007, Chantix accounted for more reports of serious drug adverse events in the United States than any other drug.[6]" Chantix Patients Report Dangerous Side-Effects

Wow, that's the disclaimer now? I'm impressed!

It really amazes me that they're leaving this crap on the market when they seemingly had no major issue yanking vioxx. What, are not enough people suing over chantix yet? Are suicide attempts somehow less dangerous than heart attacks?

Gee whiz!

 

[kristin]

Not ALL nicotine is a drug controlled by the FDA. Nicotine in cigarettes is not controlled by the FDA - even though they tried. It is "recreational nicotine." It is perfectly legal and tobacco cigarettes are specifically ruled NOT to be a nicotine delivery device. That is what e-cigs should be considered - recreational nicotine. I guess that would put them under the ATF regulations!

Even if SE claimed PVs could help you stop smoking, did they actually claim to be an NRT to cure nicotine addiction??

 

[Thulium]

Not ALL nicotine is a drug controlled by the FDA. Nicotine in cigarettes is not controlled by the FDA - even though they tried. It is "recreational nicotine." It is perfectly legal and tobacco cigarettes are specifically ruled NOT to be a nicotine delivery device. That is what e-cigs should be considered - recreational nicotine. I guess that would put them under the ATF regulations!

Even if SE claimed PVs could help you stop smoking, did they actually claim to be an NRT to cure nicotine addiction??

That's what is driving me nuts about all of this: In all the SmokingEverywhere ads I've seen, they specifically say that e-cigarettes have not been evaluated as a smoking cessation program...or something to that effect...and I distinctly remember a notice at the bottom of all the videos saying that they had not been evaluated by the FDA.

But if you are vaping, you are not smoking and therefore it seems like claims that they can help you stop smoking don't have to be medical to be valid. I once bought a box of what was basically just a cigarette filter the entire length of a cigarette that was mint or cinnamon flavored so you could have something to fidget with when you couldn't smoke. It seems like that product should be able to claim that it can be used to help you quit smoking. For that matter, it seems like a 0-nic e-cig could be used to help you quit smoking. Heck, one of my more successful attempts at quitting was helped by the fact that my employer had free arcade games in the break room so my "smoke breaks" got used up playing Hydro Thunder and Gauntlet.

The FDA's assertion that SE's ads constituted medical claims is based on the idea that something becomes a "drug" or "medical device" basically if it is designed or intended to change a bodily function or cure/diagnose/treat a disease. But you don't need a drug or medical device to help quit smoking--you can also quit smoking cold turkey and use any given substitute to help cope with the withdrawals.

I'm sorry, but I fail to see how its a medical claim for anything to help you quit smoking unless your product works like Chantix and actually changes bodily function to treat the addiction. "E-cigarettes can help you stop smoking" is no more a medical claim than "credit cards can help you stop using cash" is financial counseling. Do we really need a PhD to determine that if you use an e-cigarette instead of smoking, you aren't smoking?

 

[~Gazoo~]

Wow, that's the disclaimer now? I'm impressed!

It really amazes me that they're leaving this crap on the market when they seemingly had no major issue yanking vioxx. What, are not enough people suing over chantix yet? Are suicide attempts somehow less dangerous than heart attacks?

Gee whiz!

I agree. The latest chantix TV commercials during the first half advertise the product. The other half is full of warnings. It amazes me that this product ever made it to the market in the first place. But we have the FDA to thank for that.

 

[dragonpuff]

That's what is driving me nuts about all of this: In all the SmokingEverywhere ads I've seen, they specifically say that e-cigarettes have not been evaluated as a smoking cessation program...or something to that effect...and I distinctly remember a notice at the bottom of all the videos saying that they had not been evaluated by the FDA.

But if you are vaping, you are not smoking and therefore it seems like claims that they can help you stop smoking don't have to be medical to be valid. I once bought a box of what was basically just a cigarette filter the entire length of a cigarette that was mint or cinnamon flavored so you could have something to fidget with when you couldn't smoke. It seems like that product should be able to claim that it can be used to help you quit smoking. For that matter, it seems like a 0-nic e-cig could be used to help you quit smoking. Heck, one of my more successful attempts at quitting was helped by the fact that my employer had free arcade games in the break room so my "smoke breaks" got used up playing Hydro Thunder and Gauntlet.

The FDA's assertion that SE's ads constituted medical claims is based on the idea that something becomes a "drug" or "medical device" basically if it is designed or intended to change a bodily function or cure/diagnose/treat a disease. But you don't need a drug or medical device to help quit smoking--you can also quit smoking cold turkey and use any given substitute to help cope with the withdrawals.

I'm sorry, but I fail to see how its a medical claim for anything to help you quit smoking unless your product works like Chantix and actually changes bodily function to treat the addiction. "E-cigarettes can help you stop smoking" is no more a medical claim than "credit cards can help you stop using cash" is financial counseling. Do we really need a PhD to determine that if you use an e-cigarette instead of smoking, you aren't smoking?

I totally agree; however, there have been a lot of e-cig sellers that do claim to help you quit nicotine by using the various mg levels of nic liquid to step down, just like the pharmaceuticals. I'm not sure what exactly SE claimed to get them in so much trouble (i wasn't here when all that went down), but i've seen a lot of websites like that and those are the companies that are dragging us all down.

That said, i've seen a lot of anti-smoking groups make noisy protests against the idea of e-cigs helping one quit smoking by saying that it doesn't "break the hand-to-mouth habit" and that it "keeps the user hooked on nicotine." These groups are saying that e-cig quit-smoking claims are patently false because they don't break the habit or addiction to nicotine and upholding the idea that abstinence is the only way. By tarring "quit smoking" and "quit nicotine" with the same brush, they are making quit smoking claims into health claims.

As for why the government is on board with that nonsense, ours is a government by the (majority of) people and for the (majority of) people, and if the public has faith in these anti-smoking groups then so does the government. Nuff said.

 

[dragonpuff]

I agree. The latest chantix TV commercials during the first half advertise the product. The other half is full of warnings. It amazes me that this product ever made it to the market in the first place. But we have the FDA to thank for that.

You know, tv ads for prescriptions are illegal in canada and most other industrialized countries, and they have only been allowed in the u.s. for about the last 10 years or so. Pretty much from the second they were first allowed, they were ubiquitous and completely unavoidable.

It makes you wonder...

 

[Thulium]

You know, tv ads for prescriptions are illegal in canada and most other industrialized countries, and they have only been allowed in the u.s. for about the last 10 years or so. Pretty much from the second they were first allowed, they were ubiquitous and completely unavoidable.

It makes you wonder...

So does this... What's Missing on Your FDA Drug Warning Label: Corporate Influence over the Safety Process | Health and Wellness | AlterNet

Ninety-two percent of FDA advisory meetings in the last decade included a member with financial ties to drug companies, according to USA Today -- the FDA calls them sponsors -- and federal law against using experts with financial conflicts of interest was waived 800 times.

Isn't that the very definition of conspiracy? From Wikipedia "in the criminal law, a conspiracy is an agreement between two or more persons to break the law at some time in the future, and, in some cases, with at least one overt act in furtherance of that agreement."

If the FDA simply wanted to regulate e-cigarettes and were simply being proactive in taking jurisdiction, that would be quite reasonable. But since the FDA has made it clear that they are willing to ban them altogether, I tend to think that the FDA is not satisfied with simply regulating e-cigarettes like any other nicotine product but that they want to control them to make sure that their "sponsors" don't get run out of business.