Reply From The FDA

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Secti0n31

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I got this response from the petition as well, and my only response without breaking into a rage is as follows: The burden of proof is on the FDA to prove that all forms of e-cig vapor are, or are not dangerous. It's not the manufacturers' responsibility to submit said products for testing, It's the FDA's responsibility to go out, and get 100 different kinds of e-juice and ecig delivery devices and test ALL of them. That is all.
 

sonicdsl

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It might be interesting if Consumer Reports or the Consumer's Union took a look at vaping products.

Actually, I wonder if the Center for Science in the Public Interest would be good for this? They were quoted several posts ago on an article about how the FDA may be doing more harm than good. They are the ones that got the truth out about popcorn years ago (the oils used to pop it), and trans-fats and high-fructose corn syrup.

They have a way with things, and if they are on our side, well then, that would be a BIG boon to us, I feel. Thoughts?

And I echo MG's and other's sentiments - join CASAA.org now to help save our right to vape! If you can't donate, then do when you can, and if you can, then do. Either way, the more members, the better, and the stronger we will all be!
 

Str8V8ping

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I got one of those letter too . What kills me the most is they can gain 50x the info they think they know with one day of research . Just one employee of the FDA just reading through this forum seeing how many people it helps would be leagues above the effort they have put in as of now . There pretty much saying they hate raisenbran but have never even tried it lol .I highly doubt they even know that ecigs do not have to contain nic and that lots of people that have been using them for a while are using 0 nic juices . Its getting me really mad that all these anti ecig people trying to put bans into legislation know absolutely nothing about what they are trying to ban . It doesn't even make sense . I know this has been said over and over that its ......ed but i really pisses me off lol .

Does anyone think we would have much less problems if we never named it a ecig and just had the name be personal vaporizer ? The FDA is not smart .They see cig in the title and automatically its the same as a cigarette to them
 

fumarole

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It needs to be repeated so that people don't waste time worrying about this problem unduly, as there is nothing to be done about it. The FDA have been paid to kill e-cigs and that is what they will attempt to do, one way or another. They failed to ban them when their attempt to do so was overturned at law, so that means they must find other ways.
  • The FDA is owned by the pharmaceutical industry (it's funded by pharma and 'incentivized' by pharma)
  • The FDA protects pharma's income any way it can
  • Anything that comes along to threaten pharma's income will be blocked by the FDA
  • It doesn't matter if pharma is killing people wholesale
  • It doesn't matter if the new thing will save 1 million lives
  • The FDA is the most corrupt large government agency in the world
Are you getting the message yet? :)

Please stop worrying about this problem as it has no solution except imprisoning the people running the FDA. To save people's lives you have to outmanouever the FDA or quit and go away.

The FDA is a competent and productive organization when you are talking about matters that do not affect pharmaceutical industry income in any way. The research and decisions of the scientists who work for it are left alone by the management. But when something comes up that threatens pharma, the scientist's decisions are overturned by management, who are bought and paid for by the pharma industry. There is so much evidence for this they couldn't even take you to court for libel on this, there would be a chain of witnesses to counter it stretching down the street - even the scientists who work for the FDA publicly state this.

So please stop talking about FDA issues, it's not fixable until you fix the corruption. They have been paid to kill off e-cigs and that is what they will try to do by hook and by crook. They will work together with the alphabet 'health agencies' to attempt this as they are all paid by the same people, who have hundreds of millions of dollars to do the job. All you have is your consumer association and the trade to protect you, so don't forget to donate to CASAA.
 

mostlyclassics

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The burden of proof is on the FDA to prove that all forms of e-cig vapor are, or are not dangerous. It's not the manufacturers' responsibility to submit said products for testing, It's the FDA's responsibility to go out, and get 100 different kinds of e-juice and ecig delivery devices and test ALL of them.

I'm sorry, Secti0n31, but you've got it exactly backwards. If the FDA figures something falls under their purview, it is up to the manufacturer to show that the products are not harmful, and to the FDA's standard of proof. That's the way the regs are written. Look at the cost of testing a proposed drug or medical device: currently it runs around $350 million and takes eight years. And the manufacturer cannot put the drug/device on the market during that period.
 

mg7454

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Actually, I wonder if the Center for Science in the Public Interest would be good for this? They were quoted several posts ago on an article about how the FDA may be doing more harm than good. They are the ones that got the truth out about popcorn years ago (the oils used to pop it), and trans-fats and high-fructose corn syrup.

They have a way with things, and if they are on our side, well then, that would be a BIG boon to us, I feel. Thoughts?

And I echo MG's and other's sentiments - join CASAA.org now to help save our right to vape! If you can't donate, then do when you can, and if you can, then do. Either way, the more members, the better, and the stronger we will all be!


Sonics, that's genius!
I believe the Center for Science in the Public Interest would be great for us!
 

Secti0n31

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I'm sorry, Secti0n31, but you've got it exactly backwards. If the FDA figures something falls under their purview, it is up to the manufacturer to show that the products are not harmful, and to the FDA's standard of proof. That's the way the regs are written. Look at the cost of testing a proposed drug or medical device: currently it runs around $350 million and takes eight years. And the manufacturer cannot put the drug/device on the market during that period.

That may be true, but there are thousands of consumed products (mostly homeopathic supplements) that aren't regulated by the FDA and all that they have to put on their label is something along the lines of "This product has not been proven by the FDA to do anything medically"

The worst case scenario? They ban e-cigs and Several million people go back to smoking, a few loyalists have stockpiles and can only vape until the stockpile runs out, or they can DIY it.

The likely scenario: The FDA regulates the nic levels, ingredients and most likely disallows all flavors except for plain (unflavored PG) and methol. Which we circumvent by buying candy/food flavorings at grocery stores and again DIYing it.

The Optmistic scenario: The FDA determines that Vaping is less healthy than abstaining from putting anything into your lungs, but is significantly healthier than tobacco products of any kind and then big tobacco ad big pharm both have opportinities to get into the market and compete with the rest of the market despite being a couple of years behind the curve. There may be slight taxes involved similar to the taxes on cigars and chew.

Any of these can happen. It's up to us and people like CASAA to at least TRY to get the idiots to see the forest through the trees
 

DragonflyVaper

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BRAVO...... I love it when the REAL TRUTH is written. Sadly, die hards will call this writing a pessimistic view but I don't, it's the TRUTH.

Bottom line: Population Control EQUALS Preserved Generational Wealth AND Taxation Without Representation We need to be in the streets marching with pitch forks.


The industry as a whole has no plans because it is uncoordinated. Lobbying and PR would help, but is expensive. Clinical trials will not deliver full value for money because evidence of safety and efficacy is by and large irrelevant - all those in a position to take such evidence on board are working for the opposition.

In general, the preferred option is to wait and see what the competition comes up with next, and counter it when it arrives. Basic law says that e-cigarettes can't be killed off directly, but there are enough wrinkles that it might be possible to do it the slow way.

Before we start worrying about clinical evidence or anything of that type, we need to appreciate what the problem is: it's nothing to do with whether e-cigs work, or how well they work, or how safe they are. It's entirely about the money and absolutely nothing else has the slightest relevance.

These are the relevant issues:
  • NRTs and associated quit-smoking drugs are a billion dollar a year global market.
  • Drugs and therapies such as chemotherapy drugs for the treatment of sick and dying smokers are an even bigger money-earner - ten billion a year, fifty billion a year - who knows?
  • This income is under direct threat from e-cigarettes. Every smoker who switches to an e-cigarette takes several thousand dollars out of pharma's pocket. Multiply that by a few million and you see the scale of the problem.
  • The same goes for Snus of course - but in the US, the tobacco giants punch the same weight as the pharma giants, and no one in their right mind starts a fight they can't win. In any case, some of the tobacco and pharma firms are co-owned: the perfect solution.
  • Some States are nearly bankrupt due to inept financial management, and now depend for their solvency on tobacco tax revenue. E-cigarettes are a direct threat to this, and therefore to the power base of the people in charge.
  • The tobacco control industry is funded by pharma. In addition to the financial pressure on them to oppose e-cigs, the practical result of a Sweden scenario would mean many losing their jobs; two very good reasons to oppose harm reduction. So the TC crowd make all the noise, and get the legislation needed by pharma.

In Sweden, the number of smokers was reduced by about 40%, due to the widespread uptake of Snus. Now, 20% of the population are Snusers, and about 12% are smokers. This resulted in the smoking deathrate falling through the floor - a reduction of about 40%. Sweden has the lowest smoking-related deathrate in the developed world.

This was a disaster for pharma in Sweden, since all their smoking-related income collapsed. They are desperate to ensure this does not happen elsewhere - and especially in the USA, their biggest market. They have allocated as much money as it takes to fix the problem, and they do have enough: pharma's declared lobbying spend in 2010 was $267m, and they had more lobbyists in Washington than Congressmen.

The FDA works to pharma's agenda since they pay the bills. In addition, there is a revolving-door staff policy between the two, so that the same people work for both. Enough people in the know have stated that the idea that the FDA is an independent body working for public health is simply laughable - even the scientists who work for it will tell you that.

There are only three things that fix a problem like this:
  • The application of funds in the right places
  • A sudden, strange desire by the party in power to do the right thing, for unexplained reasons
  • The crushing weight of overwhelming public & media opinion, and it becomes a voting issue

It is a waste of time even considering the science or evidence in this situation - utterly and completely pointless. First you have to fix the corruption, or out-manouver the suborned. Any other approach is worthless.

The system is completely corrupt and any discussion of normality - evidence-based decisions and the like - is about as relevant as discussing farming on the planet Jupiter. And about as sane. We can continue to accumulate evidence, as available, but ultimately it is not going to fix the crux of the matter: the people with the power are being paid by the opposition.

It needs to be recognized that hundreds of thousands of lives don't count for a nickel here. Well, strictly speaking, that is wrong - they count for millions taken out of pharma's pocket.
 

D103

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@ Fumarole

Your post dated 12/16/11 is far and away the best most concise and comprehensive summary of the e-cig/TC/FDA/Pharma situation I have read up to date - Excellent!! I firmly believe that all e-cig users and other smokeless tobacco users really need to read your post and think about the obvious implications in order to fully understand what we are up against.

Thank you for your insightful, well thought out summation of our plight!
 

mg7454

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EleanorR

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Sonics, that's genius!
I believe the Center for Science in the Public Interest would be great for us!

Umm, I'm sorry sonic and mg, but NO. We DO NOT want to get in bed with the Center for "Science" in the Public Interest ["CSPI"]. They are the masters of Junk Science and PR demagoguery, and scientifically informed people know it. (Their primary usefulness is to the ambulance-chasing industry.) Joe Six-Pack might remember them as the Benighted Geniuses who tried to get Chinese food basically banned as unhealthy.

Stay away from Sid Wolfe and all his pomps and works!
 

fumarole

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@ Fumarole

Your post dated 12/16/11 is far and away the best most concise and comprehensive summary of the e-cig/TC/FDA/Pharma situation I have read up to date - Excellent!! I firmly believe that all e-cig users and other smokeless tobacco users really need to read your post and think about the obvious implications in order to fully understand what we are up against.

Thank you for your insightful, well thought out summation of our plight!

Thanks. Did you mean this one on the 17th?
http://www.e-cigarette-forum.com/forum/legislation-news/249012-reply-fda-7.html#post4803100

I simply try to point out that it is a waste of time acquiring research on e-cigarettes that shows their safety or efficacy, that isn't the issue. The FDA is bought and paid for by those with a commercial need to kill e-cigs off, and that is the only relevant factor.
 

mg7454

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Umm, I'm sorry sonic and mg, but NO. We DO NOT want to get in bed with the Center for "Science" in the Public Interest ["CSPI"]. They are the masters of Junk Science and PR demagoguery, and scientifically informed people know it. (Their primary usefulness is to the ambulance-chasing industry.) Joe Six-Pack might remember them as the Benighted Geniuses who tried to get Chinese food basically banned as unhealthy.

Stay away from Sid Wolfe and all his pomps and works!

Okay,

didn't know that!

Thanks for the information!

I would still like to see a petition written & organized to be signed by Doctors;

to be sent to All of the Government powers involved!
 

Bill Godshall

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CSPI is affiliated with Public Citizen, which joined CTFK, ACS, ALA, AHA and Legacy in filing an amicus brief urging the DC Court of Appeals to reject Judge Leon's ruling on e-cigarettes, and to instead uphold the FDA's import ban.

CSPI and Public Citizen were created by Ralph Nader decades ago. CSPI spends most of its time and money making false and fearmongering claims about common products, and CSPI has urged the FDA to ban many different drugs and to excessively regulate many other products. CSPI's Michael Jackobson is the a prominant "food police" activist who has advocated mandatory restrictions for salt in food products, banning trans fats, taxing soda pop, and has called restaurant food "heart attack on a plate".

In sum, CSPI is an aggressive nanny state activist group that wants far more government bans and regulations for whatever products they don't like.
 
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D103

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Thanks. Did you mean this one on the 17th?
http://www.e-cigarette-forum.com/forum/legislation-news/249012-reply-fda-7.html#post4803100

I simply try to point out that it is a waste of time acquiring research on e-cigarettes that shows their safety or efficacy, that isn't the issue. The FDA is bought and paid for by those with a commercial need to kill e-cigs off, and that is the only relevant factor.

Yes, but the post is dated 12/16/11 at 11:56pm - I totally agree with you that safety and efficacy are NOT the real issues!
You listed all the salient points very well.
 
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EleanorR

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CSPI is affiliated with Public Citizen, which joined CTFK, ACS, ALA, AHA and Legacy in filing an amicus brief urging the DC Court of Appeals to reject Judge Leon's ruling on e-cigarettes, and to instead uphold the FDA's import ban.

CSPI and Public Citizen were created by Ralph Nader decades ago. CSPI spends most of its time and money making false and fearmongering claims about common products, and CSPI has urged the FDA to ban many different drugs and to excessively regulate many other products. CSPI's Michael Jackobson is the a prominant "food police" activist who has advocated mandatory restrictions for salt in food products, banning trans fats, taxing soda pop, and has called restaurant food "heart attack on a plate".

In sum, CSPI is an aggressive nanny state activist group that wants far more government bans and regulations for whatever products they don't like.

That's what I meant to say. He said it better! :D
 
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