FDA - what can they really do?

[zenvita]

I just saw this from two days ago. The people on this forum know the power that e-cigarettes have given us to stop the tobacco monkey from around our necks. Please sign all petitions you see.

E-Cigarettes Are Illegally Marketed Unapproved Drugs, FDA Letters Say - Bloomberg

 

[Zen~]

I see a lot of folks that have been puzzled by the FDA and their intention to ban eCigs.

The FDA is the Food and Drug Administration folks... and they can make this all come crashing to the ground!

A few key points worthy of mention are as follows:

Don't expect the FDA to do a comparison of e-Cigs to Cigs... The issue, in the mind of the FDA is NOT whether an eCig is "better" for you than an analog... that is not their concern. They are interested in determining if an eCig is "bad" for you in any form... not by comparison to smoking, but by comparison to NOT smoking.

To the FDA, they are interested in this: Is an eCig worse for you than NOT vaping. And of course, it's probably better to NOT blast yourself with massive amounts of un-metered nicotine than to abstain. HOWEVER, many vapers are concerned by the comparison of vaping vs Smoking, and Vaping is OBVIOUSLY less harmful than smoking...

So WHY does the FDA not compare the two? Because the entire eCig "Industry" is playing a game of cat and mouse with the FDA. The industry is making the claims that eCigs are NOT for use as a smoking cessation product, and this is to AVOID the scrutiny of the FDA. If the industry decided to flat-out market e-Cigs as a Smoking Cessation product, the FDA would do the study and make a ruling... they would also then control the market, requiring all products to be lab and clinically tested to PROVE the effectiveness compared to control groups on placebo. The cost would be in the high millions, and the time period would be on the order of a decade or so.

Now, if the FDA got involved (and if the Tobacco Lobby has their way, the FDA will be involved sooner than later) then the small cottage industry that has risen from the ashes of our former smoking habit, will go away. e-Juice will ramp up in price as each product brought to market will have to be tested and proven safe... that means EVERY product that contains nicotine... every flavor... the whole nine yards.

Also of interest... the food and drug administration has distanced themselves from the habit of smoking... that is the realm of the ATF... FDA is concerned with NOT smoking, or smoking cessation "drugs".

 

[5cardstud]

I see a lot of folks that have been puzzled by the FDA and their intention to ban eCigs.

The FDA is the Food and Drug Administration folks... and they can make this all come crashing to the ground!

A few key points worthy of mention are as follows:

Don't expect the FDA to do a comparison of e-Cigs to Cigs... The issue, in the mind of the FDA is NOT whether an eCig is "better" for you than an analog... that is not their concern. They are interested in determining if an eCig is "bad" for you in any form... not by comparison to smoking, but by comparison to NOT smoking.

To the FDA, they are interested in this: Is an eCig worse for you than NOT Vaping. And of course, it's probably better to NOT blast yourself with massive amounts of un-metered nicotine than to abstain. HOWEVER, many vapers are concerned by the comparison of Vaping vs Smoking, and Vaping is OBVIOUSLY less harmful than smoking...

So WHY does the FDA not compare the two? Because the entire eCig "Industry" is playing a game of cat and mouse with the FDA. The industry is making the claims that eCigs are NOT for use as a smoking cessation product, and this is to AVOID the scrutiny of the FDA. If the industry decided to flat-out market e-Cigs as a Smoking Cessation product, the FDA would do the study and make a ruling... they would also then control the market, requiring all products to be lab and clinically tested to PROVE the effectiveness compared to control groups on placebo. The cost would be in the high millions, and the time period would be on the order of a decade or so.

Now, if the FDA got involved (and if the Tobacco Lobby has their way, the FDA will be involved sooner than later) then the small cottage industry that has risen from the ashes of our former smoking habit, will go away. e-Juice will ramp up in price as each product brought to market will have to be tested and proven safe... that means EVERY product that contains nicotine... every flavor... the whole nine yards.

Also of interest... the food and drug administration has distanced themselves from the habit of smoking... that is the realm of the ATF... FDA is concerned with NOT smoking, or smoking cessation "drugs".

Thats interesting but if the FDA is worried about our health why haven't they outlawed barb agues? Char broiled meat has carcinogens in it that are bad for you too. I'm pretty sure if the truth was told it would be a monitary reason.

 

[SimpleSins]

As much as some people want to think Big Tobacco is behind this, I don't really think so. It would not surprise me at all to find out that there is a lab somewhere that already has in production a red and white Marlboro branded e-cig complete with cartridges. I think they have taken a bit of a loss between the tax hikes, fines, and law suits, and if they saw a chance to recoup some of their loss they would jump on it. I suspect more the hand of Big Brother FDA and Big Pharmaceutical- who stands to lose quite a bundle on several different fronts...A) No more buying their useless Nicorette, Chantix, etc., B) Reduced use of their various pulmonary medications (Spiriva alone costs $200/month).

Following the money does not necessarily lead back to the tobacco industry this time.

 

[Zen~]

Thats interesting but if the FDA is worried about our health why haven't they outlawed barb agues? Char broiled meat has carcinogens in it that are bad for you too. I'm pretty sure if the truth was told it would be a monitary reason.

Thus the reason for my comment about the Tobacco lobby... Money is power.

Oh, and carcinogens are of no concern to the FDA... carcinogens belong to the NIH (National Institute of Health)

So what have we learned?

Nicotine is the FDA
Tobacco and Smoking belong to the ATF
And once you have cancer, the NIH steps in.

SO, eCigs means bad news to the tobacco companies, which in turn leads to fewer people with cancer.
Fewer people with Cancer means fewer people in the health care system, and reduction in pharmaceuticals sold AND a loss to the Insurance Companies (they lose money when premiums go down due to less disease in the control group)
THEREFORE, eCigs offend the three largest lobby groups on planet earth... The Tobacco Lobby, The pharmaceuticals Lobby AND The Insurance Lobby...

And you think this is about the MONEY?

 

[kellogg]

I think the worst that the FDA can do is declare that nicotine in a liquid form is a drug. That will leave big tobacco alone, the government still gets to collect taxes off of cigarettes, and big pharma has a new stream of income.

Remember, if obama's healthcare really does go into effect, big pharma stands to lose alot of money when the government starts to control costs of drugs. By declaring liquid nic a drug, the FDA can appease big pharma.

 

[Zen~]

Following the money does not necessarily lead back to the tobacco industry this time.

Big Tobacco may benefit greatly if the FDA is used to shut down the cottage industry that has built up around this venture... Remember, a ban on eCigs may not lead to the extinction of the hardware, in fact, it will more than likely lead to their regulation and quite possibly their taxation of the nicotine juice.

I don't doubt for a minute that Big Tobacco is poised for entry into this market... but they will do absolutely everything in their power to have it happen on their terms. I think that If you started a homespun cigarette manufacturing business in your garage and started selling your wares via the internet they would staple a summons to your forehead so fast your head would spin. Home "brewers" of eJuice probably fit into the same category, in their eyes.

By the way, I also reserve the right to be wrong... It's entirely possible I'm delusional

 

[son et lumiere]

I like David of FSUSA Quote from the WSJ he said they would become more of black market thing if they became outlawed. I completely agree I dont think banning e cigs would stop anyone who really wanted to get their hands on it.

 

[SimpleSins]

It would not help Big Tobacco much to have these declared a drug delivery system based on the use of nicotine. That opens the door for even more trouble for BT as they're stuck defending themselves that the paper tubes their nicotine comes in isn't a delivery system. I don't think they'll jump in to defend the e-cig industry, but I believe they have a vested interest in not seeing nicotine deemed a drug in this case. They're already set up to do the nicotine extraction for juices, the marketing systems are in place and they could hop into the e-cig market on the turn of a dime. And having the FDA declare the e-cig a nicotine delivery with system with all the regulation that goes with it is not going to be on Big Tobacco's terms. BT already has a loyal cadre of tobacco users; if they can think they can keep them all by marketing a Virginia Slim e-cig, they sure as heck don't want the FDA screwing that up for them.

 

[cozzicon]

It would not help Big Tobacco much to have these declared a drug delivery system based on the use of nicotine. That opens the door for even more trouble for BT as they're stuck defending themselves that the paper tubes their nicotine comes in isn't a delivery system. I don't think they'll jump in to defend the e-cig industry, but I believe they have a vested interest in not seeing nicotine deemed a drug in this case. They're already set up to do the nicotine extraction for juices, the marketing systems are in place and they could hop into the e-cig market on the turn of a dime. And having the FDA declare the e-cig a nicotine delivery with system with all the regulation that goes with it is not going to be on Big Tobacco's terms. BT already has a loyal cadre of tobacco users; if they can think they can keep them all by marketing a Virginia Slim e-cig, they sure as heck don't want the FDA screwing that up for them.

Exactly... isn't a cigarette a drug delivery device then?

 

[Warped3k]

I moved this thread to the e-cigarette news sub-forum for you.

 

[BlueMoods]

Doesn't matter who is behind what. It's about MONEY plain and simple. If the government can't think of a way to make money off it, it will be illegal. Plain and simple. If having it either provided them money directly as taxes do, then it's legal. If banning it allows them to raise taxes to fund enfocement of the ban, it's illegal. Simply MONEY, not health, not if it's a quitting device or not, they really don't car. right now it's taking away tax revenue that was once gained form us buying cigarrettes so, they want that revenue back before the loss gets any bigger.

 

[durtman]

Some of the recent radio adds i've heard have had straight up lies in them. One claimed "pure water vapor" and "taste just like the real thing with none of the health risks." Stuff like that just gives them ammo. They want to evaluate the things, aka, get paid to approve them.

I'd read something that said there is an avg of 20,000 to 30,000 people trying e-cigs weekly nowadays, compared to 20-30,000 users total in 2006. Definitely a noticeable amount.

 

[yvilla]

Exactly... isn't a cigarette a drug delivery device then?

Cozz, I just responded to this very question in the SE & NJoy v the FDA thread:

In 1996 the FDA did attempt to assert regulatory authority over the tobacco cigarette as a drug or drug/device combination, under precisely the same provisions in the Food, Drug and Cosmetic Act that it is now claiming apply to ecigs and eliquid, and using precisely the same arguments.

The case went all the way to the US Supreme Court, and ultimately, the FDA was shot down. The Supremes said "no" to the FDA in the year 2000.

Here's the decision (which did figure considerably in Judge Leon's decision in the current case, for it's precendential value and reasoning): http://www.law.cornell.edu/supct/html/98-1152.ZO.html

It's a fascinating read, if you have the time or the inclination.

PS: The decision in Brown & Williamson is why it took an act of Congress nine years later, that is, the passage of the sweeping new tobacco legislation last year, for the FDA to finally be allowed to regulate tobacco products; but it can do so only as "tobacco products" and under the provisions of the new legislation, and not as "drug" products under the drug provisions found in Chapter 5 of the FDCA.

And Zen, you didn't stay long enough yesterday for this topic to come up - but now under the FSTPCA, that legislation from last June that is now Chapter 12 of the FDCA, all tobacco products ARE firmly under the regulatory powers of the FDA, and NOT the TTB (formerly the ATF). http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

 

[Zen~]

And Zen, you didn't stay long enough yesterday for this topic to come up - but now under the FSTPCA, that legislation from last June that is now Chapter 12 of the FDCA, all tobacco products ARE firmly under the regulatory powers of the FDA, and NOT the TTB (formerly the ATF). http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf

I'm sorry I missed that... And it's clear that your information is based on actual research as opposed to my conjecture based on my dealing with agency folks on a day to day basis. You give them a lot more credit for being organized than I seem to. That being said, I'm sure your info is more accurate than my knee-jerk reactions. One of the things I find most interesting about all of this is how the agencies pass the responsibility when something gets tough to handle... I spend some time each year on the hill dealing with legislation having to do with the Navy and their involvement with small business innovation research, and it is amazing how they stove-piped all the information.

At the end of the day, I think we're all correct when we say this is all about money... it's just a matter of sorting out the players.

There's a saying on the hill that with which I think we can all agree... "the two most dangerous things when it comes to getting bills passed into law are 1)Really Smart people and 2) Really Dumb people". Folks that are well-intentioned but misinformed can do a LOT of damage!

 

[10171156]

I think the fda is just the beginning of big gov setting it's peices up to tax a up coming multi billion dollar industry. As BT may soon go away, BG needs to maintain it's cash flow. Not a bad plan for a money making(TAKING) from us. And I thought BG worked for us. The man is sticken us again....