I have done my homework, I have read and studied and found facts that lead me to dislike the products you guys seem to love even more. I have read your forum and seen your reactions here. So, since you came to my favorite forum to tell me what to think, I am returning the favor. I come alone. I dont have a small army with me as you guys did. I do not represent anyones opinion but my own. Anyone who retaliates on the other forum will be wasting thier time. I will not respond to you there.
Ten Reasons that E-Cigs will Fail
I. The FDA's Jurisdiction
The first and foremost enemy of your clan is the FDA. Their seizure of Smoking Everywhere shipments are what spurred the distributors, aka the sponsors of your forum here, into the action of stirring you all up to campaign on their behalf. They formed the ECA, a group designed to lobby for the right to sell their product. I think it is more then safe to say their real purpose of raising $15,000 a month was to fight the FDA's jurisdiction and recover their products. You condemn the FDA as having no right to tell you what to do. You claim their accusations are false. You claim their tests are faulty. Yet the wife of the Vice Chair of the lobby you support states clearly that they have no intention of seeking FDA approval. That they wont submit to FDA testing. Why? They have a $100,000,000.00 business at stake, that's why.
These accusations are true, and your leaders know it. They know that if they have to answer to the FDA, they are out of business. They know they have a dangerous and addictive product.
Example:
WARNING: Johnson Creek Original Smoke juice contains nicotine, a poisonous and addictive substance. Johnson Creek Original Smoke juice products and accessories are only intended for committed smokers of legal smoking age and not by non-smokers, children, women who are pregnant or may become pregnant or any person with an elevated risk of, or preexisting condition of, any medical condition which includes, but is not limited to, heart disease, diabetes, high blood pressure or asthma. If you experience any side effects or possible side effects, stop using the product immediately and consult a physician. Product may be poisonous if orally ingested. Johnson Creek Original Smoke Juice is not a smoking cessation product and has not been tested or guaranteed as such. Johnson Creek Original Smoke Juice has not been evaluated by the Food and Drug Administration nor is it intended to treat, prevent or cure any disease or condition. For their protection, please keep out of reach of children and pets.
That is the disclaimer from Johnson Creeks website--word for word. Scary stuff isn't it? They are the only US manufacturer I could find, and they are probably the most responsible. Wicked Liquid just put out a 36ml nicotine juice. Amping up the addiction. That what the FDA was really worried about--unregulated nicotine doses that are unchecked and unverified.
Of course there is the advice that a founding member of the ECA gave you all as well:
04-30-2009, 02:31 PM
And let's also not forget that JC does a LOT for us! If the FDA had any real control, JC would have been shut down a LONG time ago. So by us being able to keep an eye on JC, we are able to keep an eye on the real law governing the FDA.
04-17-2009, 05:20 AM We have NO INTENTIONS of seeking FDA approval. We have full intentions of lobbying to be a self regulating industry.
The claims that he FDA has no jurisdiction over e-cigs is really negated by the fact you people argue that is little more then food additives and nicotine. So its a food stuff and a drug . . . hmmmm. Hmmmm. Sounds like a Food and a Drug should be Administrated by someone. Ohhhhhh right, we have an agency for that. But wait, its really a way to quit smoking right? I mean they sell it as a step down program don't they? No, no no--its not an NRT--its a nicotine delivery system. Ya that's what it is. Its a smoke. Well not really a smoke its a . . . its a . . . what is it this week?
Its a food additive as a binder that facilitates the delivery of a drug. That's what it is from all of your own descriptions, including manufacturers and distributors. So try to pick a lane here kids--it doesn't change to suit your needs. Saying its this then that, changing the marketing strategies--its all just tactics to make money as long as possible. The fact is, the FDA has jurisdiction over nicotine-containing products other than traditional tobacco products, and that power was left undisturbed by the Supreme Court in 2000.
As a matter of fact, Nicotine is a drug, and a similar situation arose in 2001 with nicotine water. The FDA banned it for several years until it complied with federal regulations.
news.lp.findlaw.com/hdocs/docs/tobacco/nich20fda121801pet.pdf
I am betting your distributors knew that, and used scare tactics to motivate their customers to act as their own free little PR firm. They used the new regulation authority the FDA was given over tobacco to motivate you guys as a scare tactic. How many of you stocked up on product due to that situation? How much did the distributors sales increase because of that?
II. Health Benefits
There are none--since you lack clinical trails on this product, you cant state health benefits. If you refuse to get it tested, how do you all know what's in it? Because the Chinese manufacturer said it was OK? Please. You all know that independent studies can say what ever you want them too. The FDA's trail were incomplete because of refusal of the manufacturers to submit them for tests.
The distributors, represented by the ECA have no say in that, but they have a position on it. The healthy aspect makes it an NRT.
From the petition to regulate nicotine water, which succeeded:
Nicotine Water is intended temporarily to treat or to mitigate the disease of nicotine addiction.
It is widely recognized that nicotine addiction is a disease. FDA has approved several products, including the nicotine patch, nicotine gum, and the nicotine inhaler, as drug treatments for nicotine addiction. Those products deliver nicotine to people who are addicted to that drug, but who do not want to smoke cigarettes or use smokeless tobacco products.
Garrets own statements about Nicotine Water confirm that the product is intended for those who are addicted to nicotine. Garret has claimed that its product is an "alternative source of nicotine" that is directed at "hard-core smokers [who] may need nicotine medications for years to control their craving." And the categories of individuals that Garret claims will be the primary consumers of Nicotine Water are people who cannot use, or wish to stop using, traditional nicotine delivery products like cigarettes.
Garret says it has marketed Nicotine Water to individuals who are users of nicotine-delivery products. The makers of Nicotine Water claim that they anticipate that the people who will buy its product are primarily people who use, or are addicted to, nicotine, but there is nothing to prevent others from purchasing and using the product. Garrett says that the purpose of the product is to allow someone who is addicted to nicotine to avoid withdrawal symptoms.
Nicotine Water is therefore functionally analogous to nicotine-substitution products, like nicotine gum, that were created to serve the same purpose and are regulated by the FDA as drugs. The only apparent difference is that other nicotine-substitution products are intended as, and marketed as, permanent solutions to nicotine addiction ("cessation aids"), while Garret markets Nicotine Water as a temporary, situation-specific treatment. The distinction is irrelevant to a determination of whether Nicotine Water is intended for use in treatment or mitigation of a
disease under the FFDCA.Cough syrup, for example, is a temporary treatment of the symptoms of a disease, but is no less a drug because it is not intended as a permanent cure. Nicotine Water was developed for the same disease as nicotine-substitution products, to achieve an analogous effect, and should be regulated as a drug.
Sound similar to the situation here? It is, and the FDA succeeded on banning nicotine water. You guys face that same ban. You guys need to research this.
III Composition of Juice
I looked and looked and looked. All I found was that it was PG or VG with nicotine and flavors. Some had it as 1.8% nicotine, with 80% PG/VG, some had it as 60% PG/VG with nicotine and flavors. Johnson creek promised a full disclosure on their bottles and website, but all it said was they had PG or VG. Not much disclosure there. Again, you can say it has fewer deadly chemicals in it, but we don't know for sure because they refuse to submit their product for testing.
Fact is, that without regulation, there is no control over what they put in the nicotine liquid. Its a safety concern for the people who use the product. You guys should be clambering for this regulation, not fighting it.
What would the tobacco companies put in cigarettes if they weren't regulated? You guys are smoking unregulated cigarettes.
IV The Famous New Zealand Study
Now its banned in allotta places in the world. Lets review that shall we?
- In Australia, the sale of electronic cigarettes containing nicotine is illegal.
- In Austria electronic cigarettes are considered medical devices, and nicotine cartridges medicinal products. Therefore electronic cigarettes need to be CE-marked, and nicotine cartridges registered as medicinal products, before either can be legally sold.
- In Brazil electronic cigarettes sales, importation or advertisement of any kind are forbidden. Anvisa, the Brazilian health and sanitation federal agency, found the current health safety assessments about e-cigarettes not to be yet satisfactory to make the product eligible to be approved for commercialization.
- In Denmark, electronic cigarettes are legal, however nicotine cartridges are currently under a temporary ban while they undergo review by Danish health authorities.
- In Canada, compliance of electronic cigarette use with public smoking bans is currently under review. In March 2009, Health Canada called for the immediate cessation of imports, sales, and advertising of electronic smoking products containing nicotine, and advised Canadians not to purchase or use any electronic smoking products. Under the Food and Drugs Act, electronic smoking products containing nicotine require market authorization before they can be imported, marketed, or sold. No market authorization has been granted for any electronic smoking product.
- In Finland, cartridges containing nicotine are illegal to sell, or to purchase with intent to sell, but are not illegal to purchase from overseas sources for personal use only.
- In Hong Kong, the possession or the sale of electronic cigarettes is illegal.
- In Malaysia, electronic cigarettes are considered medical devices, and nicotine cartridges medicinal products. They can be purchased over the counter at a pharmacy with proper prescription.
- In The Netherlands, use of electronic cigarettes is allowed, but advertising is forbidden pending European Union legislation.
- In New Zealand, the Ministry of Health has ruled that cartridges containing nicotine fall under the requirements of the Medicines Act, and cannot be sold except as a registered medicine.
- In the United Kingdom, electronic cigarette use is currently unrestricted.
- In the United States, the Food and Drug Administration (FDA) considers electronic cigarettes to be a nicotine delivery system, subject to its approval. The agency is currently investigating electronic smoking devices, and has blocked a number of import shipments of electronic cigarette products to the country.
That's the short list. So, everyone was all New Zealand studies say its safe. Let me finish that statement for you--Safe enough to put behind the counter and dispense as a medical device. Convenient edit there guys, way to spin a story.
So really, the New Zealand angle is a smoke screen--or should I say vapor?
V Medical Device Classification
The e-cig is classified by the FDA as a class III medical device. The definition of a Class III Medical device from the FDA:
Class III: General Controls and Premarket Approval
A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).
I don't care what the binder is, its a drug delivery system. PG/VG--whatever. Its flavored drugs turned into vapor so you can inhale it. A highly addictive drug at that. Studies find that one cartridge equals about 20 smokes. How many times a day do you refill? Nicotine is classified as worse for you and more addictive than ....... or ....... Have any of you thought that your "passion" for this device was a little more then you expected it to be? Do you get really mad if you misplace it? How upset do you get when it runs out of battery power? I have read the threads folks--I see the aggravation. Re-evaluate your position for a moment.
Do you want it--or do you need it?
VI Manufacturing
China--home of the e-cig and most of the e-liquids. Now the device itself has a patent pending by Ruyan, but the devices here in the states are really a rip off of that design with a change in the atomization process so there is a variance when the pending patent kicks in. This is handy, since they don't really have to adhere to any tests or quality assurance. Again, as listed above Hong Kong has completely outlawed the possetion or the sale of electronic cigarettes. What country is Hong Kong in? China.
The only manufacturer of the liquid in the states is Johnson Creek. They don't have a patent on their formula do they? They aren't a member of the ECA, are they? They have an ECA logo on their site, but they don't have the ECA Approved logo on their product do they?
From the Johnson Creek website:
Johnson Creek Original Smoke Juice is fully registered with the U.S. Food & Drug Administration pursuant to Section 305 of the United States Public Health and Bioterrorism Act of 2002, P.L. 107-188 What does this mean? It does not mean we are "FDA Approved." The FDA has not yet made a determination on whether or not it will regulate the e-smoking industry, nor what those regulations might be. Johnson Creek Enterprises, Inc. facilities and operations are FDA Registered. The law now requires that all companies who produce products for human consumption, must register their facility and operations with the FDA. Further, all information pertaining to a company's address and nature of business must be current with FDA at all times. Being FDA Registered assures our accounts, customers and the public that Johnson Creek Enterprises, Inc. is a fully disclosed company with the federal government.
Registered--not approved. They wont disclose their formula to the FDA for approval. They wont join the ECA because it is dealing with the government and wants a squeaky clean image. If the only manufacturer in the US is included in their charter, they might have to submit for testing. Why so secretive? I guess because they have secrets. So if they don't tell you what is in it, how do you know what's in it?
VII False Advertising
Now we all know that if I go to the mall, and there is an e-cig kiosk, the product will be sold to me as a way to wean off tobacco and quit smoking all together. Lets not pretend that's not how its done. We all know that's how it got started. I have read the ECA's mission statement that this isn't an NRT, its a cigarette substitute. I have also read how all the distributors have to clean up their act and scrub their sites to have a nice appearance so when they fight the FDA everyone is squeaky clean. Times are a changin is how Lacy put it.
She also stated how she herself received a letter from Phillip Morris to cease and desist copyright infringement. What does that mean? It Means She infringed on their copyright. She engaged in questionable business practices to make this product more familiar to customers so she could make sales. Its deceptive advertising to sell Marlboro or Camel flavored juice, so she had to stop or face legal ramifications. Its a practice allot of distributors have employed.
Her words:
04-29-2009, 07:05 PM
They came after us about a year and a half ago or so... just do as they ask and they will leave you be. But... don't forget they have the right to do that, so you can't really get mad at them for defending their territory. Some are using variations of their names and I have seen variations of logos used as well. Now is the time to go through your sites and give them a good scrub down. Times are a changing
Times are a changin. Indeed they are Lacey--Indeed they are. So basically, Everyone had to clean up their act so they could go to court. Like a crack dealer putting on his best suit to impress the judge.
The FDA report led the state of Oregon to ban the sale of e-cigarettes and sue Florida-based Smoking Everywhere, a leading e-cigarette retailer with two Sarasota locations, for making false safety claims and marketing its wares to children. So now because you have changed your marketing strategy, everything is hunky dory, right? I mean you really want people to continue using your product right? According to your lawyers you do--now.
But, Courts have held that evidence of consumer use is relevant in determining a products "intended use." National Nutritional Foods ...n v. Mathews, 557 F.2d at 334 (FDA may determine intent from relevant objective evidence, including consumer use); Action on Smoking & Health v. Harris, 655 F.2d 236, 239-240 (D.C. Cir. 1980) (consumer use can be relevant in determining manufacturer intent).
Oh crap--that legalese--look at that. Consumer use helps determine the intent of the device.
VIII Clinical tests
So the FDA's limited test were all wrong. Your studies proved that--so why not submit to FDA studies---I mean you have the money to get studies done, right? In the 1950's, Doctors found cigarettes were good for you and that you should smoke them to get that healthy glow. Independent studies showed that anyway--and your friends at Phillip Morris sponsored them.
Your studies are worthless, just as the 1950's studies were. They were bought and paid for and insult my, and everyone else's intelligence.
IX The Big Reveal
So there is Lacey, marching in with the rest of the busload of people touting the best thing ever--tasty nicotine!! Telling everyone that e-cigs are great and there is no issues with them and how safe they are. But in truth its a beleaguered lot, desperately clinging on hoping to squeeze out a few more bucks out of a few more people or defending their addiction. If you had been upfront about who you were and your affiliation with the ECA, then I wouldn't haven't called your friends shills. It was obvious that you all came in with an agenda, and had I not called you on it, you would have continued your tirade. Now you expect me to believe the wife of the Vice Chair of a lobby is just there with her friends stating what she believes in the product as a consumer? Your livelihood is on the line, and you are just there because you believe the big bad government is unfair?
In my opinion you are there to scare your customers and line your pockets. No, you are not the only one, but in this forum and to your customers you are the voice of the lobby you helped create.
However, you made me get up and find the truth for myself. That sets distrust as the basis for any discussion we might have had. You weren't honest about who you were or why you were there. Par for the course as I have discovered, as everything you state is true is no more than propaganda to keep your failing industry alive. Every government around the world is killing your product. The people who make it wont let it into one of their largest cities. I cant imagine how hard it would be to walk away from a $100 million dollar business, but I guess we will find out as e-cigs wither and die just like every other snake oil that has ever been.
Must be hard to have the whole world against you.
X The Promise Fulfilled
So as I promised I have shown up, here on your turf. I did my homework, and found the truth behind your truth. The fact is that you treat people with no respect if all you do is distort facts and spin half truths to fit your desires.
I am, as they say, a man of my word. I did what I said I would. Ask your distributors if they would do the same for you folks. Ask if they are fighting for your rights, or the rights to line their own pockets. I guess you will all find out as the drama unfolds, and your precious nicotine sticks get reclassified by the FDA, and you guys end up paying the price. You had a good run, but even Lacy admits its going to get regulated now. The only thing they are fighting for is to get back the shipments of one of their largest dealers so they can profit as much as possible before the new regs kick in. In the event the US bans these things all together, make sure you all have your paperwork and print the promises these distributors gave you. You will need them for the class action lawsuits.
As for the distributers, I have copied allot of your posts off the forums and will keep them on file as this situation comes to a close. I wish you luck as the lawsuits start flying from those you once called friends turn on ya. I will personally enjoy the drama of that lil disaster. You will know its me from the laughing.
To the one distributer that has the picture of the cat smoking an unapproved drug delivery device--I have taken a photo of that pic next to your posts with your contact info in the signature and forwarded it to a friend of mine at PETA. I hope you have fun dealing with all the red tape and lash back from that. Seriously--torturing a poor cat? That's evil even to me.
So, I am a jackass that doesn't really know whats goin on. Well, I did the research. How do you like me now?
Let the bashing begin . . .
