Whats realy going on with the fda"s ban

[GregH]

All of this stricking out at the FDA is not going to help the cause, save the day, or is in anyway productive. Just as you would want your generic durgs approved for efficency, the e-cig must go the same route.

Sun

I completely agree. I, for one, am getting very weary of the hysteria on both sides.

If the e-cig industry wants acceptance and, if necessary, approval/regulation from the FDA, then it needs to step up and talk to them. Perhaps that is going on now outside of the public eye. I like to think so. I don't see how they expect to win if it's not.

I do not really blame the FDA in this; they are attempting to do their jobs by making sure that anything sold for human consumption is, indeed, safe. As previous posters have said, these companies were (and are still) selling clear bottles marked only as MLB, CML, CHOC, etc. We have to admit that is unacceptable, especially for something we are expected to inhale into our lungs. I do, however, believe that the FDA is facing pressure from certain politicians and special interest groups who stand to lose if e-cigs remain on the market. The only way to counteract that pressure is to present the FDA with cold, hard facts in a rational, non-emotional manner. Antagonism never solves anything.

Since the FDA's press release, we have had numerous companies step forward with ingredient listings and third-party analyses. And, so far, these reports have backed up what we, as vapers, have known all along. Now, I strongly believe, it is time for these manufacturers (through the ECA perhaps?) to have a sensible discourse with the FDA and policy makers. The evidence is growing that these things are safer than cigarettes and perhaps safer than the FDA-approved NRTs. Use that information in a calm, rational manner.

 

[zero7starz]

Well couldn't we argue that whatever they found was specific to those brands that they tested? It would be like classifying ibuprofen was dangerous because they found an off chemical in an off brand bottle (example), when in reality it was either a) Specific to that bottle or b)Specific to that brand. So instead of pulling everything with ibuprofen off the shelf, they limit it to /one/ brand of ibuprofen.

And then we can start the same process all over again for them to do this with each and every brand... Because you can't punish all companies for something that happened to one, as long as you don't have proof that they're all doing it/came from the same place.

 

[zero7starz]

I completely agree. I, for one, am getting very weary of the hysteria on both sides.

If the e-cig industry wants acceptance and, if necessary, approval/regulation from the FDA, then it needs to step up and talk to them. Perhaps that is going on now outside of the public eye. I like to think so. I don't see how they expect to win if it's not.

I do not really blame the FDA in this; they are attempting to do their jobs by making sure that anything sold for human consumption is, indeed, safe. As previous posters have said, these companies were (and are still) selling clear bottles marked only as MLB, CML, CHOC, etc. We have to admit that is unacceptable, especially for something we are expected to inhale into our lungs. I do, however, believe that the FDA is facing pressure from certain politicians and special interest groups who stand to lose if e-cigs remain on the market. The only way to counteract that pressure is to present the FDA with cold, hard facts in a rational, non-emotional manner. Antagonism never solves anything.

Since the FDA's press release, we have had numerous companies step forward with ingredient listings and third-party analyses. And, so far, these reports have backed up what we, as vapers, have known all along. Now, I strongly believe, it is time for these manufacturers (through the ECA perhaps?) to have a sensible discourse with the FDA and policy makers. The evidence is growing that these things are safer than cigarettes and perhaps safer than the FDA-approved NRTs. Use that information in a calm, rational manner.

Well I think that is our biggest problem is that we can't seem to find anyone who is willing to step up to bat, here. njoy and SE kinda sorta started to, but if we could finally get every fricken manufacture to step up and be like HEY we tested this and its all fine here LOOK and show them something- from all of them- then we might be able to get through this. But they don't seem to want to!

 

[GregH]

Well I think that is our biggest problem is that we can't seem to find anyone who is willing to step up to bat, here. Njoy and SE kinda sorta started to, but if we could finally get every fricken manufacture to step up and be like HEY we tested this and its all fine here LOOK and show them something- from all of them- then we might be able to get through this. But they don't seem to want to!

Some manufacturers have done that. NJOY and Johnson Creek have released their technical analysis reports. Others might have done theirs as well. The FDA might require more data than what was in those reports; I simply don't know. But if the companies want to remain in business, then they get the required information. Then they present that information to the FDA. Yelling over a fence -- especially with no technical data to back up your claims -- is no way to get approval.

In my admittedly simplistic view, it should really be that simple. Say NJOY and JC can prove their liquid is safe. So they should be allowed to market and sell their goods. Other manufacturers can sell theirs only after they do the same.

 

[PuffinStuff]

Oh, the issue is not regulation or standards. I want to look at the bottle and SEE what's in it.

Oh wait.........My lil bottle of TW DOES have it listed on the bottle, and does tests to ensure quality.

Yes, we need to get some things going. But, the responsible companies are doing it WITHOUT the law telling them that they must. The ones that aren't will either follow suit, or wither and die as people decide they want to know what they are sucking into their lungs.

Matt Salmon even said "We stand ready to work with you. You have some concerns, we do too. Let's work together on this."

But the FDA's stance has less to do with public safety and everything to do with the allmighty dollar. And they won't ban them, just pass regulations and demonize it till people don't want it.

Who's up for filing a class action lawsuit against the FDA for gross medical malpractice?

some good points, but... That is why the FDA takes the stance it does take. Preventing harm to consumers or so they say. The tobacco litigation costs billions and many did win against big tobacco cause it killed people. The tobacco litigation wen on for YEARS.

Before you can sue someone, you first have to prove that you were "damaged", and show that a entity knew their product was killing people and contiued to make it. Big tobacco took some big hits and still sell their products. yes, they are heavily regulated, have warnings, etc and people still die. But it is heavily TAXED. I have said this before and I still hold that Big Tobacco is screaming like crazy to the FDA about e-cigs.

If E cigs could be regulated and TAXED maybe a different story. It is such a tragedy. The FDA is so slow approving anything! There are cancer paitients that go to other countries for treatment because the treatments have not been approved here in the US. Same for thousands of other life saving measures. I think e-cigs fall into this category.

Getting more information out there about how e-cigs are saving lives and improving health will be much more effective than any lawsuit. Knowledge is power.

 

[jimik]

Apparently, the FDA has already begun it's testing of the product and found that it is a danger to kids. The mere sight of this device will intoxicate their little minds and render them unable to resist the desire to vape. Further more, they have deducted that it has "radiator fluid in it" (Lets ignore all the other products that have radiator fluid in them that are fine for consumption though).

I'm awaiting their next press release, perhaps they will offer little shows in a similar context to ...... madness.

 

[chad]

I'm awaiting their next press release, perhaps they will offer little shows in a similar context to ...... madness.

I sense another cult classic movie coming... "Vapor Madness - The Sweet Pill That Makes Life Bitter; Women Cry For It, Men Die For It; Drug Crazed Abandon!"

 

[autrad]

I would love it if we could turn back time and the manufacturers and vendors thought this through before jumping in and selling these things willy-nilly, but we can't do that. The FDA has already declared nicotine a drug and e-cigs a drug delivery device. That's a done deal. IMO, the best we can do is try to convince them that these devices don't fall into their categories of tobacco or NRT. E-cigs are part of a new third category of risk reduction devices (or something to the effect). In order to do that though, we will have to show that the manufacturers and vendors don't look at this as a fun little novelty, but a serious smoking alternative. There are going to have to be tests and regulations.

I'm not saying I like regulations. My first inclination is to yell "Leave me the f**k alone and let me smoke what I want!" But then I just sound like a petulant teenager. What we’re asking for is not only for mom and dad to give us the keys to the car for a hot date, but we’re asking their permission to go buy condoms and a nice motel room. Personally, I always made sure my boys had condoms, but I know a lot of other parents would think that was outrageous.

Agree with what you say about safety and knowing what we're putting in our bodies by vaporizing, (one of the most direct delivery systems to the bloodstream, probably second only to injections). However the government is never really the most cost efficient or effective system to use to institute or carry out anything, because they have the luxury of enforced systems of income, ie ..... taxation. It's always preferable for industries to pull together and form strong self regulatory organizations, do the work efficiently at their own expense and then deliver the results to the government. The government then only has to do double checking and inspections of the industries work. The broadcast industry's National Associations did such a good job of this and it resulted in the de-regulation of the industry by the Federal Communications Commission some 20 years ago and the result has been a lot more media for everyone. I believe this could be an answer for the nicotine vaporizing manufacturers and distributers if they act soon and completely enough, but it will take all of them pulling together to do it.

 

[DC2]

While the FDA seems like the enemy, they really aren't.

You know, at first I wanted to believe that, because I'm not into consipiracy theories.

But then I went back, after a week or so, and read their press release again.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.html

There is a clear agenda in their words.
And they have caused exactly the kind of reaction they were shooting for.

 

[jj2]

The e cig has gotten to big to just disappear. If the FDA bans it, I'd almost expect riots. I'm hoping that the pressure is on just to get ecig companies to produce what's being served. If not, the ban will come. Hopefully for just a short time.
I'm retirement age and have just decided to get plenty of Attys to last for a long time. The next step is to build boo koo PVs. Given enough time, I'll have enough to last my lifetime and my only worry will be if the Attys live through long storage.
If I live too long, I've already had boughts of COPD, I'll just tell my doctor to subscribe the medical things out there (can't remember the name) or I'll take up smoking again. :~) Of course it will have an outragious cost, but then medicare can take care of part of it.
Or, if the politcians actually get national health care, government can pay for it.
I knew there had to be something good about national health care.

 

[Vaporer]

I try to keep up but there is so much out abt all this.

Yes, labeling would be nice, if the ingredients meet the standards for human consumption. Ok, that's what the FDA does.
The manufacturers need to submit tests and ask the FDA "what will you approve"? Then meet it. With all the products that Big Tobacco has on the market, nic strips, inhalers, gum, candy like dots, patches....come on....have any of the companies even asked?

Next would be to get Big Tobacco on our side. They have a market here and the more that vape the more they lose if they don't compete with a product of their own!
This argument about another nicotine delivery device and drawing the children into it just doesn't wash with me if you look at the product list above. Most come in flavors, some look like candy and breathe freshening products.

I doubt that hardware will be banned. It can easily be named for another use and sold as individual parts. Been done for years with pot products.

This head butting will go nowhere towards our good and we won't win that fight.
If Big Tobacco can produce new approved nicotine products then the e cig should survive.

Somewhere, somehow the right questions need to be asked or the manufacturers told what is allowed. Is that asking to much? It appears Johnson Creek has went this way with their new formulations and some products removed.
Then, make it, test it, tax it, let us go on our way and let them go on to the many more important things that need their attention.

I've vented enough...................this may not make sense to anyone but me.

Vaporer

 

[Magestorm]

No, the matter at hand is what they should be doing vs what they are doing.

What they should be doing: taking in complaints, and going after the ones causing trouble. This is what is done with all non medical devices and non medicines. ONLY if there is a problem with a product do they step in and throw their weight around. The electronic cigarette is meant as a recreational device, and should be regulated as such. Any risk assessment should be viewed in comparison to real cigarettes.

What they are doing: Classifying these as medical devices and new drugs, requiring the electronic cigarette to be withdrawn from the market. Each brand of e-juice and each PV requiring a New Drug Application and requiring MILLIONS of dollars of testing over 7-14 years before becoming approved. Then, these would likely be prescription only, and expensive.

Here are the possible outcomes:

1. the FDA does a total flat out ban, and pushes these underground, creating a new prohibition no one will take serious, thereby destroying their credibility.
2. The FDA works out a deal with companies to allow sales while getting to still sell their product provisionally, while working to comply with their demands.
3. The FDA does a total ban on these, and the public outrage launched by the public causes them to remove the ban (Yes, this HAS been done before, with sweet n low)
4. The FDA leaves its unofficial decision quiet, and retreats, waiting for more data
5. The FDA backs off and lets us sort our own house out.

Now, #5 isn't likely, but all 5 are possibilities.

the biggest issue is their decision that these are medical devices and new medicine. It's not new. It's been around for 2 decades. Just the delivery is newer, but simple enough that people are smacking their heads and wondering why they didn't do this themselves years ago. there's no hearing, no appeal on this so far. Guilty until proven innocent.

And in the United States, isn't that against what we were founded on?

 

[Vocalek]

It just goes to show how much we all want to stop cigarettes, but not smoking.

I don't view what I do with an e-cigarette as "smoking". I consider myself a former smoker because of this invention. I agree with your thought, but I would reword it: It just goes to show how much we want to stop smoking tobacco, but not give up nicotine.

In a presentation called " Searching for the Hard-Core Smoker in U.S. Population-Based Surveys," presented at the 8th Annual Meeting of the Society for Research on Nicotine and Tobacco in Savannah, Georgia February 20, 2002, researchers Giovino et al presented data showing that
the numer of smokers who want to quit is astonishingly high, ranging from a low of 42% for people who have never tried to quit, up to more than 90% for those who have tried SEVEN TIMES OR MORE to quit. (See Slide #32). www.impacteen.org/generalarea_PDFs/SRNT2002_ Giovino.pdf

For what it's worth (probably not very much when it comes to die-hard nicotine abolitionists like the current tobacco policy-makers), I wrote an essay about a common sense approach in my blog.

The Truth About Nicotine: Common Sense

I'm currently working on another article proposing "Permanant Nicotine Maintenance" as a more effective approach than NRT, In my opinion, "Nicotine Replacement Therapy" should be called "Nicotine Weaning Method". There's nothing therapeutic about it, from my viewpoint, because the amount of nicotine the user can metabolize from the products is purposely kept low. As a result from 85 to 93% of those who try NRT remain classified as "current smokers."

I think the phenomenon we have seen with e-cigarettes shows that we have the technology to flip-flop the failure rate vs. success rate numbers.

 

[Sar]

You know, at first I wanted to believe that, because I'm not into consipiracy theories.

But then I went back, after a week or so, and read their press release again.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173222.html

There is a clear agenda in their words.
And they have caused exactly the kind of reaction they were shooting for.

The problem is that the FDA is not an independent organization. They receive funds from the companies and organizations they are supposed to monitor. The FDA leadership is also a form of political appointment with certain loyalties and agendas.