FTJoe

Donate it please. One way to keep this stuff going in the right direction is grass roots movement. Find someone in need, or someone having an issue, send it, tell them to hold their thanks but make sure they help someone else out (or two) along the path. If they don't stick with it, that's fine, help someone else out in some other way. And no, I am not a socialist! ;-) On a funny note, my wife saw the FDA thing on the news this morning. First question was did I know about it, second question was can we make money off a ban. I love her! She has the heart of a tobacco executive, absolutely ruthless!!!

Sorry - someone posted this "I think they just want a piece of the action-and complete world domination"... They don't want a piece, they are the rabid dog of the gov who wants to keep tax revenues up and lobby money in their pocket. once the big boys get involved they will be able to get it, it will cost more, and it will be taxed. JMHO

It's in the letters. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm I laughed when I saw the JC one, part of the mis-representation was a testimonial from a customer. Read down and you will find what the FDA is taking issue to in regards to that and keeping a clean house (they are better than most I suspect). I need to go through it all but basically they say if you are going to work with a drug, you have to follow procedures to develop pharmacopeia. Testing batches for microbial contamination, etc. I ordered a ton of Juice from them last night just in case. Part of a mix I do with two VT juices. As presently labeled and promoted, these Johnson Creek Smoke Juice products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Johnson Creek Smoke Juice products are unapproved new drugs marketed in the United States in violation of section 505 of the Act (21 U.S.C. § 355) and are misbranded under section 502 of the Act (21 U.S.C. § 352). Both the "drug" and "device" definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. §§ 321(g) and (h)) encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the Johnson Creek Smoke Juice products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including your Internet website at www.johnsoncreeksmokejuice.com. that reflect these intended uses for the products you market include, but are not limited to, the following: www.johnsoncreeksmokejuice.com "Applause ... If i had to wait two weeks, most likely I would have been back on smoke within a few days and I don't ever want to go there again, with as good as I feel right now. Daniel L. ... I have been off tobacco cigarettes for a week. I have been using an NJOY. I just received my first of many orders from your company. Norman S." "News from Johnson Creek ... "Effect of an E-Cigarette on Cravings and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-Over Trial" - The University of Auckland Faculty of Medical and Health Sciences ... Aim ... To measure the effects of the Ruyan e-cigarette (EC) on craving relief and withdrawal and explore its acceptability and pharmacokinetic properties in comparison to placebo EC (i.e. with cartridges containing no nicotine), Nicorette nicotine inhalator and factory made cigarettes ... Conclusion ... The EC shows promise as a device that might aid cessation." Promotional materials [brochures] "Welcome to E-Smoking! A beginner's guide to E-Smoking ... E-Smoking vs. Cigarette Smoking ... To many who take up e-smoking, it completely takes over for regular cigarette smoking. In fact many report never picking up a cigarette again after starting to e-smoke ... Why E-Smoke? . .. Most people who smoke, do so because they enjoy the tactile, emotional and physical sensations. E-smoking provides pleasures similar to those commonly associated with traditional smoking ... Nicotine ... Nicotine is an alkaloid found in certain plants, predominantly tobacco ... When absorbed in small amounts, whether from cigarettes, cigars or e-cigarettes, nicotine can cause stimulation, a feeling of relaxation, calmness, and alertness. The effects of nicotine can last from minutes to hours, Although addictive, nicotine is widely considered far less dangerous than the ingredients in regular cigarettes." "Archive for the 'News' Category ... Response to the FDA - Why Johnson Creek is Different ... There's no diethylene glycol, there's no tobacco, no known carcinogens ... Comments ... Rick Hageman ... July 31, 2009 at 12:05 pm ... I've tried to quit several times by many methods - always went back because nothing addressed the physical addiction to the act of smoking. I was miserable as a non smoker 'cause I constantly craved the act of smoking. I've successfully abandoned tobacco thanks to the e-cig and Johnson Creek. A Letter From the Founder ... For the past six months, we've been working tirelessly creating a formula that actually produces more vapor, more throat hit ... yet also happens to use fewer ingredients and is 100% tobacco-free! ... Comments ... August 2, 2009 at 3:22 pm . .. I smoked for 40 years and was unable to quit until I purchased my first e-cigarette. I have not had a tobacco cigarette for over 3 months, and I no longer have any desire to have one!" 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. As described in 21 C.F.R. § 310.544, any product that bears labeling claims that it "helps stop or reduce the cigarette urge," "helps stop or reduce smoking," or similar claims is a smoking deterrent drug product.7 Products that are labeled, represented, or promoted as smoking deterrents, such as the Johnson Creek Smoke Juice products marketed by your firm, are regarded as "new drugs" under section 201(P) of the Act (21 U.S.C. § 321(P)) because there is a lack of adequate data establishing that they are generally recognized as safe and effective for such use. See 21 C.F.R. § 310.544. These products are also "new drugs" under the Act because we are not aware of any data establishing that these Johnson Creek Smoke Juice products are generally recognized among scientific experts as safe and effective for the other drug uses described above and in the products' labeling. "New drugs" require approval of an application filed in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of the Johnson Creek Smoke Juice products or any of their components marketed by your firm are so approved; therefore, marketing these products in the United States violates section 505 of the Act. The Johnson Creek Smoke Juice products marketed by your firm are also misbranded under section 502 of the Act (21 U.S.C. § 352) because they are intended for use as smoking deterrents under 21 C.F.R. § 310.544 but are not covered by an approved new drug application. The Johnson Creek Smoke Juice products are further misbranded under section 502(t)(1) of the Act (21 U.S.C. § 352(t)(1)) because they do not bear adequate directions for their intended drug uses, including smoking deterrence. "Adequate directions for use" is defined in 21 C.F.R. § 201.5 as "directions under which the layman can use a drug safely and for the purposes for which it is intended." Additionally, during our September 1-25, 2009, inspection of your manufacturing facility, Johnson Creek Enterprises, LLC, located at 320 N. Watertown Street, Suite F, Johnson Creek, Wisconsin, investigator(s) from the FDA identified significant violations of Current Good Manufacturing Practice (cGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s), as described above, to be adulterated within the meaning of section 501(a)(2)( of the Act (21 U.S.C. § 351 (a)(2)() in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed during the inspection include, but are not limited, to the following: CGMP Violations Your firm has not established a quality control unit having the responsibility and authority to approve and reject all components, drug product containers, closure, in-process materials, packaging materials, labeling and drug products, and the authority to review production records to assure that no errors have occurred (21 C.F.R. § 211.22(a)). For example, your firm has not established a quality control unit. Personnel with quality control unit responsibility have not been designated. 1. Your firm does not test each batch of drug product to determine conformance with final specifications (21 C.F.R. § 211.165(a)). Specifically, your firm does not test each batch of drug product prior to release. 2. Your firm has not established written procedures designed to prevent microbiological contamination of drug products not required to be sterile (21 C.F.R. § 211.1 13(a)). For example, your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness. 3. Your firm has not conducted specific identification testing when components are accepted based on the supplier's report of analysis (21 C.F.R. § 211.84(d)(2)). For example, your firm accepts a Certificate of Analysis (COA) from the supplier of components. However, your firm does not conduct identity testing on your components or appropriate verification of the supplier's test results. 4. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates (21 C.F.R. § 211.166(a)). For example, your firm does not have a stability testing program for your firm's components and finished drug products. 5. Your firm's drug products do not bear an expiration date determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality and purity at the time of use (21 C.F.R. § 211.137(a)). For example, your firm does not have the stability data to support expiration dating for these products. Please be aware that the FDA has issued a letter addressed to the Electronic Cigarette Association (ECA) which explains in detail how the electronic cigarette industry can begin the drug approval process. For your convenience, we have enclosed a copy of that letter and encourage you to follow through with the recommendations. The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products, nor are the arguments raised here regarding them exhaustive. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please state what actions you will take to address products that you have already distributed. If another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Please direct your response to FDA's Electronic Cigarette Mailbox at FDAElectronicCigaretteMailboxCDER@fda.hhs.gov or the Minneapolis District Office at 612-334-4100. Sincerely, /s/ Gerald J. Berg Director Minneapolis District

I believe the FDA has the mandate to make sure that if you are using something like gum to get nicotine, that the levels in it have been studied, effects, warnings, etc. They look at the study and determine if the drug/drug delivery system is okay to sell. One of the primary things that has to be in it is a package insert which they approve as well. How to use, how much to use, side effects, what to watch out for. In theory to protect you, in reality to protect the company. We have none of that. They also want people to say its a stop smoking aid for some reason even though I know tons of people that chew it all day long. it is marketed as a stop aid. I think if they want to, they will be able to be all over this from both initials, F (PG) and D (nic/delivery system). As far as wanting a piece, they don't, not until a big boy gets it moving, then taxed. They have no problem if you keep smoking as long as you pay tax.

But then the alternative is calling it a drug delivery device which they do have control over, I think? I understand and approve of what the judge has to say but I think all along the FDA's stance has not been in regards to controlling nicotine but controlling how nicotine is delivered. We know its proving to be fine, but the uninformed will be swayed by talk of contaminants, overdose, etc. Stupid I know, I can pop 50 pieces of nic gum in my mouth, but at least the package has a package insert saying not to. That's a major difference here and is what the FDA is supposed to do, make sure those inserts are correct and there.

If it was me, I would just by what kitsune pointed to (USB charger) and this http://www.shop.wordupecig.com/USB-AC-Wall-Charger-Adapter-with-US-plug-USB-AC-Adapter-with-US-plug.htm and this http://www.shop.wordupecig.com/USB-Cigarette-Lighter-Adapter-USB-Cigarette-Lighter-Adapter.htm Then you can pretty much charge anywhere, PC, wall car with the charger kits pointed to, portable battery packs, etc. Did you ask TW how that is supposed to be used? Does it look like it will fit your wall charger as QuicksilverPR suggested? If so, then all you probably need is the mains charger adapter I pointed to from TW. I think I have a few and do not need.

Understandable but some folks do need to be protected and if the specter of the government wasn't around, I would hate to think what companies might try to get away with. Even with them we have tainted baby food, formula, lead paint on baby toys, imagine without them? Just being a devils advocate, I agree they could certainly look elsewhere for something more worthwhile to concentrate on. Obvious why they are doing this...money and its a sin thing. We are easy targets. I do like the way they phrased the attack, people here were even thinking the people they went after are tainters, imagine what the general public is thinking about all this now, they are finally becoming sly about it. Next up bans referencing the suits and what they allege I'm guessing.

The mains charger adapter allows a tornado to be hooked up to a regular wall type of 510 charger. I should have been more explicit. http://www.totallywicked-eliquid.com/products/tornado-e-ni-accessories/tornado-battery-mains-charger-adaptor-product.html

For anyone with a blu - I found this a while back for my Nephew...he never told me if he tried or if it worked:

They are very responsive. If I had to guess, it'll fit into a charger unit. But even then, not sure it would work for an ego without the thing they call a main. I buy only USB chargers, then I buy car and wall units that push out to a USB port. Good for the chargers, cell phones, MP3 players, any USB device.

I think a group other than ours, I'll look around and see what is out there later. My wife is asking if I saw the news, yup. Again for those who missed it, here are the letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm Here's the petition, I think this is what I was thinking of...http://ecigssavelives.info/

All good points, but irrelevant (IMHO). Here's are my couple of points on writing someone and making sure you are altogether dismissed (yes this is tongue in cheek). Point out FDA is terrible and doesn't do their job well, look at all the mistakes they have made in the past request the FDA mind their own business, this isn't a food product or a drug (oops) Point out how stupid all of the FDA's points are Tell them we know this is safe, it's obvious, there's no heavy metals in the juice OR the attys, inhaled PG is good for you Say this is socialistic Say this is fascist (more like it) Say we should be free to do whatever we want, it says so in the constitution/bill of rights Point out the pharma and tobacco lobbyists are bribing reps Point out tobacco is bribing the FDA Point out pharma is bribing the FDA This is/is not a stop smoking aid, alternative, drug delivery system Seriously, while all of the above is probably true, if you are writing a bureaucrat to tell them the FDA is a bureaucracy, they are crooks and we're not going to stand it anymore, I'm not sure that's going to garner a lot of sympathy. Didn't someone draft a nice letter last time a ban came up that we can send?

I have to say I am digging the 1.8s from ENS and the 2.0s from nhaler on the ego. I hated the low resistance 1.6 to 1.7 as they burned.

Here are the warning letters sent - our goobermint hard at work. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/default.htm Face it, right now they are desperate for money. Can't tax, the economy is crud they are desperate. They are all Unapproved New Drug/Misbranded except for JC who has the distinction of Unapproved New Drug/Misbranded/CGMP for Finished Pharmaceuticals http://www.ispe.org/cs/resource_library_section/gmp_section/what_is_gmp

Me too. If you read the FDA complaint against Johnson Creek I just posted (I'll be happy when my juice ships) they are complaining about drugs in the juice (nic). They are complaining about drugs which means drug delivery is not far behind. Am I over-reacting? I hope so. But I have 180 ml of my JC juice on the way!!!!

I completely agree. In a perfect world, I would want regulation. In this world I have no idea how we get it without giving something up. But they will force many into doing "odd" things in order to do what they KNOW is healthier for them, vape. FYI - got my JC order in, I noticed this on their site, as I suspected, because they are an American company making juice, they kind of put themselves out there...stupid stupid stupid, they did the right thing, they registered with the FDA. https://www.johnsoncreeksmokejuice.com/category/fda I'm looking for the clean room video. Look what I found while searching, the complaint against JC, its about the drug part of it all, nicotine, replacement, they even submitted reviews as evidence. Christopher, heads up on this, the forums could be as well. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm "As presently labeled and promoted, these Johnson Creek Smoke Juice products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, Johnson Creek Smoke Juice products are unapproved new drugs marketed in the United States in violation of section 505 of the Act (21 U.S.C. § 355) and are misbranded under section 502 of the Act (21 U.S.C. § 352). Both the "drug" and "device" definitions in sections 201(g) and 201(h) of the Act (21 U.S.C. §§ 321(g) and (h)) encompass products intended either to affect the structure or function of the body or to cure, mitigate, treat, or prevent disease. Based on our review of the Johnson Creek Smoke Juice products and their associated labeling and promotional materials, these products are drug-device combination products, with a drug primary mode of action. Statements in labeling and promotional materials, including your Internet website at www.johnsoncreeksmokejuice.com. that reflect these intended uses for the products you market include, but are not limited to, the following:"

I believe they are going to kill this with a two prong approach. Fluids fall under the food jurisdiction, they said to have found two suppliers that are tainting the juice. That's the Food part of the agency. Fine. But now if you want to add a substance called nicotine, that falls under the D part of FDA. They will claim, rightfully so, that absorption rates are unknown, the other chemicals being brought in with the nicotine are unknown, side effects are unknown, etc. And they will be right, this is actually their job. It sucks and I'm 0 nic so I can actually make out. But how long do you think the hardware will be around if the juice goes away? I have to go clean out one tainter of juice, Johnson Creek before they get shut down. Maybe its all lies, but I saw vids off their site of clean rooms etc. that made me proud of them. You know half the stuf you get is bathtub gin (not VT of course, I'm talking the mixers out there). BTW - schizo had plans to buy something to extract nicotine, maybe he will chime in. If not I will PM him.

What are we signing up for? Half the folks here are giving props to the FDA for busting the evil juice makers!! ;-)

I'll wait for this to calm down, everyone is just posting. Here are my points: 1) The one company advertised something odd in their juice. I would never buy it, but it raises an issue of safety. 2) JC is a pretty upfront company, not sure what that is all about other than it is a US manufacturer of juice. 3) As far as I know, regulation, wich I'm all for, that usually comes after studies. I'm pretty sure as far as drugs go, FDA doesn't do the studies, the companies do and they cost money. 4) If its just about the juice, and not nicotine, not sure who does "studies", it usually just testing to make sure things are "safe' and as advertised. 5) Do you think a chinese juice company will be allowed to import juice once regulated? 6) Do you think a small internet company will be allowed to sell juice once regulated? Maybe its me, but this appears to be going down a bad road. What study is a tobacco company doing right now? Is it e-cig or smokeless?

http://www.e-cig.com/shopping/shopdisplayproducts.asp?id=19&cat=Healthcare+E-Liq They have "healthcare liquid". I've seen the marketing videos from Johnson Creek. Their juice factory at least looks very impressive, clean rooms and all. I am sure the FDA will use what they find to springboard to more bans, it actually can prove their "unhealthy, unsafe and untested" claims. I still believe there is no overt bribing. This is a push from legislators, via the FDA, backed by lobby money from tobacco and pharma, as well as a fear of dwindling tax revenues.

I guess this is worth burning the 2000th post...seems to be the whole article, filed by Dow Jones Newswire. http://www.advfn.com/news_UPDATE-FDA-Warns-Five-E-Cigarette-Makers-Says-Products-Need-FDA-Approval_44310571.html Johnson Creek is one of the juices in my mix. Going to order a bunch tonight!!!

I'll burn my second to last post with my input for safety sake. I believe an ego should be able to charge off the EGO fast charger, the USB 510 charger just slower, and a 510 wall unit with the extension found at TW. On the other hand, a 510 should not be charged with the Ego fast charger. I believe the difference is the regular USB 510 chargers are 150-200 ma output. The fast chargers are 400-500 ma output and that will fry a 510. Can you read the little sticker on it? I'm also referencing my post earlier on the subject here. There is a blurb that you can't use an 510 charger on an ego battery but I'm pretty sure that's not true (I do it all the time).

ddave - we are brothers!! Vernor Vinge I love, but I go a little more mainstream since I've been reading SF forever. Heinlein, Asimov, Clarke, Niven, Pohl, ****, Silverberg, Bradbury, Bova, Ellison, Farmer, Zelazney, Haldeman, Scalzi, Westerfield, Simmons and, too many more. No Fantasy except I did go through a Koontz phase and while not a King fan, The Stand and the Gunslinger series.

My netbook runs OSX, Windows 7 and Ubuntu. Going to maybe put an SSD on it to make it scream!!!!!!!!!!!!!! Netbookinstaller lets you put up cute little icons as well on the startup screen. Anyway, I have 8 computers in the house, about 6 TB of Raid storage, 2B on my build, one on a Dell server running FreeNAS, daughter has a MAC cause she killed her HP (grrr), my Netbook and four ThinkPads. And ddave - while its more than a dime, I got the M$ Windows 7 student upgrade (daughter) for $25 or $30 bucks I think. Beauty is, you install it fresh, then install it again on top of itself clean, and it does a full install thinking its an upgrade!!!! OSX $30 also (upgrade) but they are still not used to people without macs installing it.

I do pretty good with a low res 901 on my ego. Half Mentha, a little Dulcis and a decnent amount of Johnson Creek Arctic Menthol. Wife likes the medium res cartos from vaporsetc. She's half Johnson Creek, quarter VT Mentha quarter VT Dulcis. I hear grain alcohol helps as well, I don't have the patience for that. Low res 510s were fine as well.