AP: FDA Sending Warning Letters

[PoliticallyIncorrect]

Actually yes I did, lol! Not sure why the bottom part was originally a link, obviously didn't show up that way, try this:
The Rest of the Story: Tobacco News Analysis and Commentary: Comparison of Carcinogen Levels Shows that Electronic Cigarettes are Much Safer Than Conventional Ones

Ok, that worked.

One thing that jumped out at me half-way through is the incredible similarity between this sentence (from the Rest of the Story blog):

"...what this calls for is the FDA working with the electronic cigarette manufacturers and distributors to study the product and address the identified problems."

And this one (from the AP story):

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices..."

I'm reading the rest. This guy needs to show up on the 23rd this month. He seems to know his $#!+.

 

[rothenbj]

I finally got through reading all the posts on this thread, talk about a lot of chatter in a very short period of time. First, MoonRose (I think that's the right ID), that was a great letter. Second, as far as contributions to Casaa, it's almost embarrassing how little has been contributed. If all the vendors would designate a couple percent of their profits to helping to keep their businesses in business, there would be money available for this group to work more effectively.

What really caught my attention was a news bit I saw on the Five O'clock news tonight. They led into it on telling parents they may not know that they're kids are using tobacco, then ran the story after the next set of commercials and a few more news stories. The gist of the tobacco story was the new devil demons that tobacco is putting on the market to entice those young ones into the evil world of tobacco. They even showed the goods, yes, there they were- SNUS (as opposed to the real stuff, Swedish snus), Orbs, Ariva. The story went on to say how disguised the products were and how they sold them in flavors and....... well, you know the story.

I bring this up in this thread because it's all part of the same theme, there's no safe alternative to smoking, other than total cessation which can be provided to you by your friendly pharmaceutical company. Of course those products normally don't work very well and when they do, they usually don't last and you end up back on cigarettes. Why do you think there is so much effort to stop these newer, safer products? Why do you think the ?non-profit?"health" organizations want to stop these products? Why do you think Altria turns out such a poor SNUS product? Easy, nobody in this fine set of organizations wants anyone really getting off cigarettes. Why for 30 years have these organizations known that smokeless tobacco was considerably safer than cigarettes did they sell the horror stories about "spit" tobacco?

Yes the number of smokers is decreasing, but at a rate that would take about a thousand years for the number to drop to zero. I'm not making that number up. I just took their numbers and figured it out. They say 1,100 kids become permanent smokers each and every day in this country which amounts to a bit over 400,000 new smokers every year. If 440,000 die of smoking related deaths, there is only a net change of 40,000 smokers each year. Divide that into 46 million and see how long state budgets can be augmented, federal money can be raised, tobacco can keep making money on cigarettes and pharma can keep helping solve this health disaster. Let's not forget our ?non-profit?"health" organizations that can keep fighting the good fight. Keeping better and safer products off the market.

We may win the E-cig war over the long run, but we also may not. We can't forget that it is not only an E cig war. It is a harm reduction war that we need to demand that these people that are supposedly trying to help us with have to join. Tell the truth. They seem to have forgotten that smoking is the issue, if in fact it really ever was other than a smoke screen for raising revenue at the cost of the silent minority.

For all you vapers out there that are afraid you will lose your ability to vape, be proactive. Put some money and some time into the good fight. Don't be afraid to make a comment on any article you find offensive. It's tough when you see the same people repeating the same themes over and over again. The more voices the better.

Just as important, look at some of the other products that are out there that will be their next target. Try some of them and see if they may be able to provide the nicotine you need (if you truly need the nicotine) while vaping 0 nic for the hand to mouth habit. SNUS might work for you, or Orbs or Ariva or Stonewalls or Swedish snus. All of these products are safer, provide nicotine at varying levels and can be used quite invisibly. For those that feel something is missing in E liquid, you may just find it in one of these products.

I personally love Swedish snus. I love vaping as well, but it was never enough to get me completely off cigarettes, I still needed that half dozen daily until I crossed the tracks and headed for the dark side. On the 15th, I shall be smoke free for 7 months with no desire for even a drag on a cigarette. If you're curious about it, speak to some of the people over in the smokeless tobacco section.

There is no way personally that I shall ever go back to smoking, especially with the knowledge that I am paying for these clowns with my money to victimize me.

 

[GtrSoloist]

Email addresses for all board members is here: About CASAA.org

Got it, thanks...PM incoming.

States definitely don't want all smokers switching over to e-cigs, they would lose millions in tax dollars and the federal government is in much the same position. Both the states and the federal government rely on smokers continuing to smoke cigarettes for the millions in tax dollars that they pay in.

Add some zeros, it's Billions of dollars, not millions.

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials."

Am I interpreting the above statement wrong?..... does it not eqaul:

"The agency encouraged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people to quit smoking traditional cigarettes WHICH WILL be through expensive clinical trials.....not to mention the YEARS it will take and as someone else mentioned, the "additives" big Pharma piece of the pie wil include side effects such as suicide, homicidal thoughts and ...........The side effects will discourage people from using them, thus rendering them ineffective....WHICH will then make Tobacco industry happy...AND the Feds won't loose thier precious tax dollars nor will they have to pay Social Security to the 500,000 people who will CONTINUE to die each year from smoking related illnesses....

FDA Approval = Companies with enough money in their coffers to play the game
FDA + Tobacco + Big Pharma = Electronic Cigarette NRT "APPROVED!"
No?

Just checking in case my interpretor is broken, lol!

You're on the right track, however BP is the enemy, BT I would think to be more on "our" side.

The tobacco companies are over a barrel with the tobacco settlement funds they have to pay out, which are on top of the lobbyist money they are throwing at politicians while they continue to lose revenue from their customers dying and being priced out of purchasing their products.

BP on the other hand gets to sell NRT's like patches, gum, and inhalers as well as drugs such as anti-depressants, zyban, and now chantix and the next string of 20 drugs that will supposedly work better than the one that came before.

BP is evil on so many levels... far, far worse than BT in my opinion, because the Pharmaceutical companies claim to be helping while they poison the world.

When was the last time they cured something? Polio? Vaper Please. It's about keeping people alive and buying their meds until they die, not keeping them from getting sick or healing them outright.

My apologies, I digress. The amount of corruption is this country just sickens me.

I truely do believe that there should be standards of QC and safety in this industry. Without this, the FDA does have valid claims. Despite e-cigs being much safer than cigs, they do pose imminent safety risks. Bio-contamination, possibility of ingestion by childeren are my biggest concerns. I have brought up these issues once before but they kinda got shrugged off. The industry MUST set standards of QC and safety to be a proven product. No different than any other product we consume. When the FDA sees strides of this progression, they will be more accomidating to further evaluation. I haven't been here as long as many of you, nor vaping as long as many of you, but I do not see great attempts in making these products more viable in regulation. Standards of quality and safety are accross the map. I believe in this product very strongly but considering how long e-cigs have been around, there are so many inconsistancies where the viability of this product becomes in question. Example...the other day my son climbs on top of my office chair to get to my cabinet where I put my e-liquid. Luckily I walked in when he was trying to open up the cap. What affect would this have had if he were to drink the e-liquid? I know we are fed up with the FDA's stance, but viability must be proven.

I could not agree with you more. There does need to be regulation and there does need to be quality control.

Suppliers should regulate themselves by making sure products have warning labels, list all ingredients and are in childproof containers. There are several juice suppliers that meet most if not all of the above conditions. But there are many more than don't.

QA and QC are musts.

I see a lot of people here getting bent out of shape on verbiage, and the FDA using customer claims against the industry. Make no mistake that these are tactics to win the war of public opinion and an easy means to get the public and more importantly Politicians onboard.

I seem to remember a not so distant scandal involving a government official leaking info to the press, then making a public statement to the press citing the previous information they leaked to begin with as a source to justify their message. (It involved outing a Spy....)

Scare people away from the products and they win.

 

[Cyia]

I posed this on twitter and I have to share it here. Search on youtube, paper airplanes by MIA. The chorus for the song is THE perfect FDA theme song!

 

[LUVMY901]

Not sure if this was asked before?

If the FDA get's e-cig's band, and I start smoking analogs as a replacement nicotine device, will they then ban analogs as a drug delivery device?

 

[Poppa D]

I could not agree with you more. There does need to be regulation and there does need to be quality control.

Suppliers should regulate themselves by making sure products have warning labels, list all ingredients and are in childproof containers. There are several juice suppliers that meet most if not all of the above conditions. But there are many more than don't.

QA and QC are musts.

I see a lot of people here getting bent out of shape on verbiage, and the FDA using customer claims against the industry. Make no mistake that these are tactics to win the war of public opinion and an easy means to get the public and more importantly Politicians onboard.

I agree with this statement.

In fact it seems that it is taken for granted that these products meet or exceed Quality standards, when in fact we dint know if thats true. For example: a bottle of backyard white lightning or a bottle of top shelf liquor, which would you buy?

The government can stop ANY product and its use nation wide due to non compliance to established quality assurance practices. Putting the burden on the producers to comply, to stay in business. This product shouldn't be treated any differently than all other consumables on the shelf today.

Going underground to some may seem rebellious and glamorous, but it doesn't sound fun or even OK to many of us want to be ex-smokers. Who would allow it in the house for a minute if there is a risk attached to it. Who wants to be labeled, classified, and judged even more than we have been to date?

 

[Infernal2]

From the Johnson's Creek letter...

The above statements demonstrate that the Johnson Creek Smoke Juice products marketed by your firm are intended both to affect the structure or function of the body and to mitigate, treat, or prevent disease. See 21 C.F.R. § 201.128 (describing the meaning of "intended use"). In particular, these statements suggest that these products are intended for use as smoking deterrents or to reduce dependence on traditional tobacco products, and are also capable of delivering nicotine. The scientific and medical communities have determined that nicotine is a pharmacological agent,1 that nicotine addiction is a disease,2 and that nicotine withdrawal is itself a recognized medical condition.3 It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness.4 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving.5 As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia and irritability.6 Therefore, the claims noted above demonstrate that the Johnson Creek Smoke Juice products are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease.

This does appear to be a targeted attack obviously here and I wouldn't be surprised if this is how they plan to focus on any violation at least until the final ruling from FDA versus E-cig comes down. However, what is interesting to note, and I think a case could be made, is that by assumptive regulation of this market (and labeling it as a drug delivery device) the FDA is setting itself up to assume a lot of responsibility for regulating this market. In other words, an issue of liability could be brought into question.

As suggested, it opens the argument up for an attempt to have cigarettes labelled as drug delivery devices, if THAT is denied, then they would need to defend under the same Act that other illicit smoked substances are not in fact, drugs.

 

[t9c]

I could not agree with you more. There does need to be regulation and there does need to be quality control.

Suppliers should regulate themselves by making sure products have warning labels, list all ingredients and are in childproof containers. There are several juice suppliers that meet most if not all of the above conditions. But there are many more than don't.

QA and QC are musts.

Let the market and suppliers of e-juice regulate themselves. It's very simple. If you wish there be warning labels, child proof containers, contents labels,etc. then buy from those supplies who conform to your wishes or demand that they will not get your business until they do.

Getting the FDA involved in making these requirements does nothing but increase the cost you will pay for e-juice. If the FDA were an efficient, un-corruptable gov't agency, then and only then would I agree with FDA regulation/approval. But that ain't gonna happen, IMHO.

 

[Satharra]

From the Johnson's Creek letter...



This does appear to be a targeted attack obviously here and I wouldn't be surprised if this is how they plan to focus on any violation at least until the final ruling from FDA versus E-cig comes down. However, what is interesting to note, and I think a case could be made, is that by assumptive regulation of this market (and labeling it as a drug delivery device) the FDA is setting itself up to assume a lot of responsibility for regulating this market. In other words, an issue of liability could be brought into question.

As suggested, it opens the argument up for an attempt to have cigarettes labelled as drug delivery devices, if THAT is denied, then they would need to defend under the same Act that other illicit smoked substances are not in fact, drugs.

My husband I were talking about this last night. For those that old enough to remember Reagan's presidency, most will recall that he quit using jellybeans. The sale of jellybeans shot through the roof based on the President's testimonial that jellybeans helped him quit smoking. I even recall a few commercials about jellybeans that used presidential commentary - taken from news' sources - to promote their jellybeans.

Likewise, in Willy Wonka and the Chocolate Factory, the Oompa Loompas sing about chewing gum and it helping people quit smoking. Since Willy Wonka is a producer of candies, are they next for a letter about Oompa Loompa testimonials?

The Internet world allows for folks to make unsubstantiated claims all over the place. Some of the issues the FDA took with JC was centered around comments to news stories. Comments! Will they begin policing blogs, Facebook, TripAdvisor, and Citysearch next? I think this is a very tenuous argument that moves well beyond the policing e-cigs to policing public commentary.

By the way, where's the FDA in policing in these wackadoo Biofield bracelets? Balance your body and your life with the iRenew BioField Technology Bracelet Energy Balance System I happened to see a television advertisement for this quack bracelet and my Mom called me to see what I thought of it. She recently finished chemotherapy for breast cancer and thought this item might help with some of her neuropathy and balance issues. At best, this is seeing a placebo effect.

 

[Infernal2]

Well admittedly, I do believe this is a marketing issue. I would urge any and ALL suppliers to remove any purported health claims from their websites as well as locking the ability to make customary commentary unless approved by the website owner. I can assure you that the FDA already knows which ones have that information on their sites and removal will only serve to remove an avenue for the FDA. Also, any company selling any drug with purported health effects as associated with these liquids needs to pull those products. Finally, I would urge any and all suppliers to place a disclaimer on their website that all products sold are for entertainment purposes only.

Fight them at their own game.

 

[HighHeeledGoddess]

I was just pondering this - If e-cigs/PVs are drug delivery devices because of the nicotine, are sodas, coffee, and chocolate not also drug delivery devices because they deliver caffeine? I drink Diet Coke specifically to get caffeine into my system. Caffeine is very addictive. Can i now file a lawsuit because Coca-Cola did not inform me of the risks of using their addictive "drug delivery device"?

 

[Poppa D]

I'm not diabetic, but if I were, I would HAVE to know how much if any sugar is in any product. This is true for any number of ingredients, many users would NEED to know, if it's in there. Thats just not an option to risk.

I'd like to know what specific temperatures to store it in. I read "very cool, dark place, but not in your refrigerator", whats that mean? Spell it out for the layman, that just wants to drop it in his lunch bucket and go. Can i freeze it, or leave it in the sun, what about humidity? Maybe thats a bit over board, but plenty of people want to know. Yes I know "read the web site", is that really enough?

Theres a lot of people who are trusting it must be safe to use, or because they bought it they have to use it now, that shouldn't touch it at all for "other" medical reasons.

 

[HighHeeledGoddess]

I'm not diabetic, but if I were, I would HAVE to know how much if any sugar is in any product. This is true for any number of ingredients, many users would NEED to know, if it's in there. Thats just not an option to risk.

I'd like to know what specific temperatures to store it in. I read "very cool, dark place, but not in your refrigerator", whats that mean? Spell it out for the layman, that just wants to drop it in his lunch bucket and go. Can i freeze it, or leave it in the sun, what about humidity? Maybe thats a bit over board, but plenty of people want to know. Yes I know "read the web site", is that really enough?

If you have a condition such as diabetes that demands you know these things, it is up to you to be your own advocate and ask the company.

Many medications are labeled with the same storage instructions as the e-juice is, ie - cool, dark place away from humidity.
I've had some JC juice in my basement for a year that I just recently vaped and it was fine. I take my in-use bottles with me everywhere and haven't had any sort of problem. I think you'll be just fine with taking them everywhere. If the juice goes bad you'll know immediately, because it will taste very very nasty. I've only had it go bad inside aties exposed to air for a couple days, this is how I know this.

 

[skylar]

Interesting and informative post regarding the FDA. As a newbie (3 weeks) I have responded to every board on the internet I can find regarding e cigarettes and what they have done for me. I will also begin writing letters and whatever is necessary to help the cause. I have known several people who have worked in government and I must admit some of the stories amaze me.

I also agree that the e cig vendors have about the best customer service I have seen in many years. Every internet company could learn a thing or ten from them.

Having tried other means to quit smoking I find it insane that the FDA would try and ban the first thing that has helped me and many others quit, often to our suprise. The FDA has given the heads up to Chantix and it almost killed me!

I am not much of diy when it comes to stuff like this so I could be totally screwed if a ban were to take place. There is a lot of money backing the ban and many large pockets would benefit from it. I saw a picture of the drug companies idea of a substitute smoking device. I could just puff away on my inhaler (which I no longer use) until I drop dead.

 

[Poppa D]

Producers and manufacturers will have to deal with the necasary guide lines at some time. It would be so much better if they got busy doing it sooner. Its the businesses that effect all of us here, and the many to come. We need the bussinesses involved to responsibly deal with doing business in the USA.
It is unavoidable, we need move on and figure out if, how, and when, just plain get it done.

 

[Infernal2]

While I hate to see some smaller entrepreneurs suffer I really think it would be in the best interest of everyone involved to just learn to mix your own.

 

[Seabrook]

Well this thread has gone up to 177 posts, including mine, and I have a question that I wonder if anybody at all out there can answer definitely -- without a wild guess, LOL. What Does This Mean To We Who Are Already Stocked Up for the Next Two Years?
1. Will it be illegal for us to vape with the materials we have stored up -- will we have to hide it all?
2. Will we be closet vapers?
3. If I vape on the road, will I be pulled over and have my PV confiscated?
4. If I leave my PV in my car, and it is seen, will my car be towed to the police lot?

I could go on and on with silliness, but I want to know if possession of vaping materials is going to be a criminal offense. Please and thank you.

 

[HighHeeledGoddess]

Well this thread has gone up to 177 posts, including mine, and I have a question that I wonder if anybody at all out there can answer definitely -- without a wild guess, LOL. What Does This Mean To We Who Are Already Stocked Up for the Next Two Years?
1. Will it be illegal for us to vape with the materials we have stored up -- will we have to hide it all?
2. Will we be closet vapers?
3. If I vape on the road, will I be pulled over and have my PV confiscated?
4. If I leave my PV in my car, and it is seen, will my car be towed to the police lot?

I could go on and on with silliness, but I want to know if possession of vaping materials is going to be a criminal offense. Please and thank you.

I really don't think the cops are going to mess with this. Cops see me using my PT in the car all the time. I always figure they likely assume I am answering the demands of an inter-lock on my ignition (which I don't have) because of the wire. I also know police have seen me with my battery box.

Let's face it, beat cops are out there to generate revenue for the state. Is "busting" you for a PV going to be worth their time when they could be out looking for some high ticket bust, like a DUI or what have you? I really don't think the police are going to be out there like storm troopers attempting to seek and destroy e-cigs.

 

[lmrasch]

Well this thread has gone up to 177 posts, including mine, and I have a question that I wonder if anybody at all out there can answer definitely -- without a wild guess, LOL. What Does This Mean To We Who Are Already Stocked Up for the Next Two Years?
1. Will it be illegal for us to vape with the materials we have stored up -- will we have to hide it all?
2. Will we be closet vapers?
3. If I vape on the road, will I be pulled over and have my PV confiscated?
4. If I leave my PV in my car, and it is seen, will my car be towed to the police lot?

I could go on and on with silliness, but I want to know if possession of vaping materials is going to be a criminal offense. Please and thank you.

I don't have an answer for you on that, kind of wondering myself...but I can tell you, I am a law abiding citizen and work very hard at following the law of the land, have a pretty sensitive concious...

BUT....I would NOT follow that law if it did become illegal. I am not going to have the FDA or any state FORCE me back to something that I KNOW is much unhealthier for me. NOR will I take the myriad of useless NRTs that I have tried in the past and failed to be able to quit smoking. I will secretly vape and be as discreet as possible. If they raided my home and decided to arrest me, it might make some good news:

"Woman who successfully quit smoking using the Electronic Cigarette which has recently been labeled an illegal drug delivery device has been arrested after police raided her home and confiscated $500.00 worth of hardware and hundreds of dollars of illegal nicotine juice. While under interrogation, the police offered the woman a smoke at which time the woman was advised that they would drop all charges if she continues to use real FDA approved cigarettes."

The woman refused her right to smoke and is in county jail, awaiting trial."

The good side I could see happening with this is that I had over $1000.00 worth of hardware and thousand of mls of juice to begin with and the arresting officer's are now smoke free.......

On the serious side tho...I don't think anyone would get their homes raided and hauled off to jail...that was just my attempt at a joke....LOL!

 

[spacekitty]

I know that I'm jumping into this discussion kinda late, and I'm sorry the I haven't taken the time to read each and every post yet (whew!!), but I did make sure that nobody had posted this article yet...
E-cigs: E-cigarette companies get FDA warning - latimes.com

It pretty much goes over the same things that most of the other ones do/did, except that the author points out the fact that the letter the FDA sent to the ECA (Electronic Cigarette Assoc.) was addressed to a person who resigned 9 months ago!! And when interviewed, said that he thought the group had disbanded... Just shows what a bunch of IDIOTS the FDA are!!!

Personally, I think that they are just grasping at straws, because they know they can't ban the liquid... the ingredients are too easy to get and/or manufacture. So they are going after the devices themselves and the companies that they think have some violations that they can actually site codes on.
It's sort of like the RIAA did with the downloading of music... They realized it was fruitless to try to drag every college kid into court for downloading the latest CD's, so they went after the file sharing sites and the software developers instead.

I live in CA and the anti-smoking laws are getting tougher all the time!! We narrowly escaped a ban on e-cigs recently, but the Governator came thru for us... and it was changed to just prohibit the sale to minors, which I'm all for!!

I have read that beautiful letter, and seen talk of petitions, but I fear that anything sent to the FDA will just fall on deaf ears... I think part of the blame lies with President Obama for giving the FDA more control over the tobacco industry last year, so why not get a letter writing campaign and/or petition going to him?? Or maybe the Surgeon General, too?? Let them just slap a warning on e-cigs like they do on the Cancer Sticks and be done with it... LOL!!

If anyone is interested, there is a really good Free Petition site here:
http://www.thepetitionsite.com/create.html

You can not only post it here (or where ever else you want), but it will get a lot of exposure just by being on there, too, with all of the members they have... and everyone has a chance to add their own personal message to the letter when it is sent!!

Ok, I'll shut up now...