Fda Very Bad News

[Uma]

Tried to write a comment from the link given on the top of the forum here, but instantly felt too intimidated. What, how, do I say?

The email itself throws me off when it states "Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly. We try to respond to each question within 24 to 48 hours.". Help!

[actor92191]

What pisses me off the MOST about all this, even more than banning e-cigs themselves, is the ignorance of the FDA.

They love dropping that gem "we don't know if it's really a safer alternative." So you mean to tell me "we don't know" whether a water vapor with a few common ingredients is safer than a burning, carbon monoxide delivering, tar inducing, 40 carcinogen inhaling, 4000 chemical delivering stick of cancer responsible for the death of millions?

They say let's ban these devices IMMEDIATELY because of potential health risks... but it's okay, you can keep smoking the stuff we literally know, as fact, cause cancer and kill thousands annually. (And yeah... real "health risks" from vegetable glycerin, flavoring, and nicotine in the form of vapor. I think my 6 year old cousin could tell you which is worse for you.)

It's all about the money... that's it. We can all sit here from today 'til tomorrow talking about why they are doing this and what we can do about it, but what it all boils down to (or vapes down to) is what will reel in more money. Whatever reels in more money is what the FDA will follow. That's it. Nothing more to it.

Just a couple of my pennies

[Altmed]

I think it proves that the FDA is looking out for us, and I'm glad that they are. I definitely do not want to buy products from vendors that add mystery ingredients that I do not want. Regulation and taxation is a good thing, as it legitimizes the industry. Yes, it increases the cost to us - but when it's proven to be safer and vendors follow strict guidelines that are made to protect us in the production of the liquid I will feel a lot better about vaping.

To be perfectly honest, I wish there was a way to test and report on the juice that I do buy, because I worry constantly about hidden ingredients that I don't want and I think people deserve to know exactly what's in the juice they buy.

I guess we should stop eating too! Recently, Prozac was found in shrimp, lead & copper in very high levels are found in drinking water thanks to the chloramines that are water districts add to our water, which our foods are processed with too, making them toxic as well. There has been a complaint filed against numerous food processing plants, including baby foods. Even bottled water has been tainting, so there are toxins everywhere.

The FDA is far from consumer protection.

They approve dangerous medical devices that harm/kill people, allow extremely dangerous food additives/synthetic foods, don't require food companies to even label weather our meats are irradiated, colored with potentially deadly allergens in the form dyes, and the steroids in our chickens have totally gotten out of control, Yet the FDA allows the to get away with it, thus many of us can feel anxious, heart racing, or in some situations, stop breathing from being exposed to even the fumes from a kitchen where they are cooking such foods. Thus I have to carry an EpiPen with me everywhere I go, and read labels of everything I eat & even then, I have to avoid certain foods, as the additives not listed can be a huge problem. Diet foods & drinks often contain Olestra (usually in chips & crackers) & the diet drinks that contain aspartame are FAR worse than the alleged cancer-causing saccharine. Aspartame (which is made with wood alcohol and amino acid isolates, phenylalanine and aspartic acid) has been associated with a whole lot worse health problems, many long-term neurological effects, brain damage, and so on (see http://www.wnho.net/aspartame_brain_damage.htm ) & a host of other problems. See http://www.sweetpoison.com/aspartame-side-effects.html for a mind-boggling list, and there are more! Yet!!!

It is perfectly OK with the FDA to market drinks & foods containing aspartame & it seems the company that created aspartame won the "your product is worse than ours" war, likely with better attorneys & highly questionable research. (My opinion & that of many researchers world-wide.) I will use saccharine, but not aspartame. IMHO, it is a deadly, slow-acting neurotoxin, but it's perfectly OK to market it to children as a healthier food, even though research indicates the contrary, the FDA proposed a ban on saccharine in 1977, created a huge scare that it caused cancer, again IMHO due to highly questionable research by their competitors & now we have aspartame in just about every diet drink in America.

Watching out for our health? Not for many years IMHO.

While I agree with full disclosure labeling, it is difficult to resolve the issues of unequal treatment by different companies & industries with the FDA, other than to say it takes a lot of money to get the "right research data" to support your position to get a product approved, even if it is FAR safer than another product. Research statistics can be skewed to show what you want it to show, which sadly is done more often than not.

eCigs are no exception! ONE bad batch of eJuice, a scientist with a negative view on a product & you can loose.

In other countries, eCigs or vapor devices are as a way to take certain vitamins & herbs to improve health. Sure, over-doing anything can be harmful or deadly. As with ANYTHING, even water - too much can cause death, but we can't ban water now can we?

THe FDA ban of ephedra sinica is no different. Did people abuse it & die? It seems so, although I think it was more than likely the chemical version or the extract, ephedrine, that was the culprit. Mix that with a LOT of alcohol & yes, you can have a heart attack. Use it properly & you can treat if not cure asthma & if given corticosteroids it is one of the few things, in small quantities, that can deactivate them & help flush them out of your system should one have an allergic &/or adverse reaction to the corticosteroids. Most doctors will tell you there is, "No known antidote" to an adverse or allergic reaction to corticosteroids. Some will tell you that you, "can't have an allergic reaction, as cortisol is made by your body naturally!" When a medical professional tries to tell you this, you might refer them to the PDR or "Physician's Desk Reference", as that statement is simply not true!

Here's a list of adverse reactions to corticosteroids, which are FDA approved...

The following adverse reactions have been reported with corticosteroids, drugs which doctors will tell you there is no antidote for, as I said before. Does this list look like anything that should EVER be used, other than in extreme, life-threatening, emergencies? I think not, but the FDA approves their use & the misconceptions by medical professionals are astounding!)

Allergic reactions

Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopthy in premature infants, myocardial rupture following recent mycocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic

Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increase sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine

Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances

Congestive heart failure in susceptible patients, Fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal

Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible subsequent perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic

Negative nitrogen balance due to protein catabolism.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intra-lesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.

Neurologic/Psychiatric

Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic

Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Other

Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration (see WARNINGS), malaise, moon face, weight gain.

The following adverse reactions have been reported with the following routes of administration

Intrathecal/Epidural

Arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.

Intranasal

Allergic reactions, rhinitis, temporary/permanent visual impairment including blindness.

Ophthalmic

Increased intraocular pressure, infection, ocular and periocular inflammation including allergic reactions, residue or slough at injection site, temporary/permanent visual impairment including blindness.

Miscellaneous injection sites

(scalp, tonsillar fauces, sphenopalatine ganglion): Blindness.

====

These reactions can occur from even topical use, as in lotions, yet are more likely from injections.

Does this sound like the FDA is looking out for our best interests? I think not!

I do believe the labs where eCig products are made, in general, do their best to be sure their products are not contaminated.

If approved as a "medical device" by the FDA, there will be no accountability or liability, as per current laws (started 200 that were put into place by the Bush administration. YES! The FDA is seriously behind other countries & responds to hype from those wanting to be heard.

My hope is that the FDA will drop this "Medical Device" nonsense, so this does not occur with eCigs as it hsa with medical devices..

Excerpt from : http://biotech.law.lsu.edu/ieee/ieee25.htm

Medical Device Regulation

Prior to 1976 there was little federal regulation of medical devices. The FDA could bring a court action to have a dangerous device removed from the market. These actions were based on the FDA's authority to embargo adulterated or misbranded products. While these concepts were well understood for drugs, the courts took them to mean that only the proven dangerous devices, or those that were openly fraudulent could be removed from the market. Even when the courts were willing to act, these proceedings took many years, with the device freely available until the final appeals were over. (It took more than 20 years to remove the orgone accumulator from the market.) To escape regulation, the manufacturer need only modify the device and it could start selling it again, forcing the FDA to begin a new court proceeding.

Furthermore, from: http://www.naturalnews.com/022713.html , about one such case (and there are tens of thousands) - state courts cannot even hold a manufacturer responsible!

that "federal law prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have ramifications for a large number of pending lawsuits against manufacturers of devices such as breast implants, defibrillators, artificial heart pumps and valves, drug-coated stents, spinal cord stimulators, and prosthetic hips and knees.

Because there is no federal law that allows consumers to sue medical device manufacturers for damages, state courts have become a common venue for such suits.

(MY NOTE: This is no longer the case, as state courts hands are also tied with the 'no liability' loophole & the quality of medical devices, as such, IMHO has declined significantly!)

The legal reasoning behind the court's decision centered on the wording of the 1976 Medical Device Amendments law. The law, which set in place an FDA pre-approval process for medical devices, explicitly prohibited states from putting in place "any requirement" that is "different from, or in addition to" FDA requirements. In an 8-1 majority, the court ruled that allowing citizens to sue device companies in state courts amounts to "a requirement" that undermines the FDA approval process.

Writing for the majority, Justice Antonin Scalia wrote that the FDA may approve devices "that present great risks if they nonetheless offer great benefits in light of available alternatives." In other words, there is no requirement that devices actually achieve any reasonable level of safety for all patients. To receive FDA approval and be immunized from lawsuits, medical devices merely have to keep alive slightly more people than they kill."

Does this sound like a caring or concerned FDA? One county in one state had over 6,000 claims against Medtronic for making faulty pace maker & spinal cord stim, or "SCS" units. The judge 's response is that his hands were tied by the 'no liability' clause, that with that many claims, it was certainly not the doctors at fault (although you have to wonder about kick-backs to implant these devices & no mandatory reporting of funds changing hands will be in effect until 2013 (& I with medical corporations, universities & so on, the money your doctor may get for prescribing a certain amount of medication to x amount of patients for a trip, etc. is unlikely to be found anywhere.

eCigs, if they become classified as, "Medical Devices" will likely follow suit, with NO checks & balances!

One need go no further than Google and search, "medical device lawsuit dismissed" to find a multitude of these very types of lawsuits that have been dismissed.

IF eCigs get the "medical device" green light, I'd be FAR more concerned about the safety of our eCigs & eJuice NOT being as safe!

The FDA, if they are REALLY looking out for public safety, would leave eCigs alone, just as they are!

I've never had a problem with mine & have had confidence that the companies making our eCigs have integrity. f the FDA succeeds in classifying eCigs as a "drug delivery system medical device", it could strip away that integrity and protection as it has with other medical devices.

ALL those people in the dismissed SCS 'medical device' cases were left with the costs of removing the devices (or burying their loved ones who died as a result), without any confidence that there was any other device that might be better. Two other companies make similar devices, yet with really no guaranty that another device would be any better.

eCigs, or personal vaporizers, are NOT medical devices! Classification of them being as such could be hazardous to our health!

Altmed

[Popsicle]

Altmed: Not quoting your post because it is frickin' huge, but AMAZING!

[Schizophretard]

Altmed, that post was great! I would add a +1000 but can only do +1. Maybe everyone else can help me give you that +1000. Good Job!

[msrebel54]

The last thing we need is home brewed nicotine. I'd take liquid from China any day over someone mixing it in their kitchen. This is exactly why the FDA wants regulation. The ecig industry is all over the place.

However, you would NOT get this kind of reaction, if people were not afraid of the big bad government. You are right, the LAST thing we need is home brewed nicotine. But people have found a viable alternative to putting smoke from a burning fire with 4000 chemicals into their lungs, and they don't want the government to quash it. In fact, to some it seems INSANE that the government would even consider it. To me, it make perfect sense. It's exactly what I expected them to do. And have been expecting them to do for the last year. They're just now getting around to it, because 30 to 40 thousand more ecigs are sold in the US each week.

They can holler they're marketing them to children (how stupid), or that they're unknown carcinogens in them, and they need more "study" and so on. But ANYONE who's been vaping for a month or so will know the difference. Your health improves IMMEDIATELY, breathing better, more stamina, better taste, better smell, but yet according to the FDA, it might be worse than cigarettes. But we know what it's all about. The FDA, and the entire federal government could give a ____ less about your health when it comes to cigarettes. We cannot let a 300 billion dollar industry be superseded UNLESS we control it.

We would love for you to keep killing yourself, in fact we're going to give you no choice but to keep killing yourself, or quit, which we know you can't do. So we gotcha. And we get to make 3 to 5 dollars a pack tax money as the government, and Phillip Morris gets to make about the same thing, depending on what part of the country you're in.

Along comes this "ecig" and throws a monkey wrench into it. We can't have that. Damn those Chinese for inventing it!

Bottom line, enjoy it while you can, another six months, year, who knows? I've been a smoker for 45 years, and haven't had or wanted a cigarette for a month. And these SOB's want to tell me they're LOOKING out for my own good?

Well, it will only get worse until 1776 happens all over again. And then we're in a world of hurt.

I've seen a few posts that say 'write your congressman'. Do you really think they care? Now, if it was 'send your congressman a million dollars', then they MIGHT listen.

We'll (our side)might can keep this thing tied up in court for a few months, maybe even more than a year, but we all know eventually if the hens are suing the fox, and the judge is a fox, we know where it ends up. How can you fairly sue the federal government when the judge WORKS for the federal government? It's like asking me am I guilty?

Again, enjoy them while you can, stock up, and get ready to quit altogether, or spend the big bucks to kill yourself.

[Uma]

Altmed, that post was great! I would add a +1000 but can only do +1. Maybe everyone else can help me give you that +1000. Good Job!

Amazing indeed! +1'd

Along those lines is this newspaper article I discovered tonight. There is a comment section (hint hint)

http://thehill.com/opinion/letters/58659-fdas-drug-and-e-cigarette-warnings-counterproductive?page=2#comments

[FTJoe]

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?

Edited September 10, 2010 by FTJoe

[Schizophretard]

Didn't someone draft a nice letter last time a ban came up that we can send?

Was it DDave?

[FTJoe]

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/

Edited September 10, 2010 by FTJoe

[Kragax]

First of all, I would like the .Gov for once again intruding in my life and trampling my rights. I find it offensive that they feel they have the right to force me back into using a product that although it will kill me, puts money in thier pockets. Now, I live in Western New York State, where the cost of a pack of analogs runs between $9.00 - $11.oo a pack. Our beloved governor is screwing with the Indians ($4.80 a pack) to try to get them to collect thier blood money for them as well. With the scare of a NY ban on E cigs I did stock up on nicotine and othe supplies and could hold out for quite a while. Hopefully long enough to get down to zero nic. I think Ill always vape. Next week are the primary elections in "our" state and trust me I will be there to make my feeling known. Its too bad we can't vote the FDA out. At 57 years of age I think Im old enough to make my own choices. This country is being destroyed from the inside right now and its time to give THEM some "change" WE belive in. The Republic is growing weak, God help us all. /Rant.

[FTJoe]

First of all, I would like the .Gov for once again intruding in my life and trampling my rights.

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.

[Compenstine]

Thanks for the link I just sent my comment

Comment:

I just want to express my experience with the E-Cig. I'm 48 and had been smoking cigarettes since I was 12 years old. I had been trying to quit for the last 10 years without success.I tried the patches, gum,Ziban and still smoked 2 packs a day. It took 1 week on an e-cigarette to kick smoking for good. I have been using my e-cig now for 1 year and have my taste back. I have this summer started riding a bike and climb stairs without a second thought. I no longer cough every 5 minutes. I no longer have chest pain. My family is no longer in danger of second hand smoke. Please don't kill me and my family by taking my only working option away.

I received this canned response to my comment:

Dear K,

Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research.

The U.S. Food and Drug Administration today issued warning letters to five electronic cigarette distributors for various violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices.

Also today, in a letter to the Electronic Cigarette Association, FDA said the agency intends to regulate electronic cigarette and related products in a manner consistent with its mission of protecting the public health. The letter outlines the regulatory pathway for marketing drug products in compliance with the FDCA.

For a drug product to gain FDA approval, a company must demonstrate to the agency that the product is safe and effective for its intended use. The company must also demonstrate that manufacturing methods are adequate to preserve the strength, quality and purity of the product.

"FDA invites electronic cigarette firms to work in cooperation with the agency toward the goal of assuring that electronic cigarettes sold in the United States are lawfully marketed," the letter to the association read.

FDA has determined that the electronic cigarette products addressed in the warning letters to the distributors, and similar products, are subject to FDA regulation as drugs. Under the FDCA, a company cannot claim that its drug can treat or mitigate a disease, such as nicotine addiction, unless the drug's safety and effectiveness have been proven. Yet all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes.

The companies receiving warning letters today are: E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson's Creek Enterprises LLC.

Certain companies received warning letters for additional reasons. For example, E-Cig Technology markets drugs in unapproved liquid forms, such as tadalafil, an erectile dysfunction drug, and rimonabant, a weight loss drug that has not been approved for use in the United States. These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so that the drugs can be vaporized and inhaled.

You can locate more information at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm.

Best regards,

CAO

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info

This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

[Compenstine]

Interesting. Thanks for the link. Any ball park quotes?

No, when I inquired it was just more to ask if they could. The cost factor was to wide for them to make any quote without more information on how many fluids I wanted tested and what they would tested for. I had talked to other labs that did quote me 25K on the low side to 100k or more depending on the testing to be done.

[bobthesalesclerk]

All the joye/janty vendors should go to the FDA and work something out...same with all the good juice vendors.

Let's ban blu, esmoke, green cig ect so that if e-cigs do become regulated people don't have to waste there time/money buying crappy products that don't work

[Christopher]

No, when I inquired it was just more to ask if they could. The cost factor was to wide for them to make any quote without more information on how many fluids I wanted tested and what they would tested for. I had talked to other labs that did quote me 25K on the low side to 100k or more depending on the testing to be done.

Yea that sounds about right. Our last quote was for 75k per batch.

[Uma]

When I first joined VT, I read a sticky thread that listed possible side effects of vaping, both pro's and con's from trusted sources, the vaporers themselves. Would the FDA be calmed if the vendors included such a "warning" on their sites and liquids?

I can't believe JC did something wrong. I haven't decided on the other 4, mainly because I don't know who the heck they are. do you?

[Christopher]

More supplier need to add warnings agree. We require that certified suppliers at least require an 18 and up warning but other than that most suppliers don't add a warning. Our store contains the following and ALWAYS has since the site was opened

WARNING: Vapor Talk E Liquid contains nicotine, a poisonous and addictive substance. Vapor Talk 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. Vapor Talk products are not smoking cessation products and have not been tested or guaranteed as such. Vapor Talk E Liquid 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.

It's also part of our terms when a customer checks out. (All customers must agree to the terms) To top that off we also added warning on our bottles (VERY few suppliers have warnings on their bottles) It's time suppliers started to jump on the band wagon already. For their own protection at least.

[FTJoe]

I can't believe JC did something wrong. I haven't decided on the other 4, mainly because I don't know who the heck they are. do you?

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

Edited September 10, 2010 by FTJoe

[Uma]

yet, someone said the president of ECA had quit and the group scattered. (over at ecf). I didn't read the entire thread, just a glimpse. That's the ONLY letter the FDA sent out? The ONLY person/group they sent it out to? ...

My head hurts. i feel like I'm sitting on a spinning barstool.

Will reread later

[Christopher]

yet, someone said the president of ECA had quit and the group scattered. (over at ecf). I didn't read the entire thread, just a glimpse. That's the ONLY letter the FDA sent out? The ONLY person/group they sent it out to? ...

My head hurts. i feel like I'm sitting on a spinning barstool.

Will reread later

No there where 5 letters sent out which you can read: here

The first 5 companies on the list are the electronic cigarettes companies currently involved.

[Uma]

That means the FDA sent the "how to make us happy" letter to the 5 in question plus 1 letter to the ECA which no longer exists. right?

I remember a long time ago... about 5 months back, when threads were popping up left and right at ecf (I lurk there trying to understand diy and mods) from posters inquiring "what if we could have our vitamins, etc included in our mix? would that be vapable?" ect. I thought it was looney at the time and didn't pay much attention. Looks like some actuallly got too exhuberant and did indeed forget the legalities and so forth. I hope that's all this was about. So far, it looks like the makers were trying to make customers happy... not fooled like I first assumed. I hope they all learn their lesson and we can all go back to normal. What a day.

[THEREALALUCARD]

There has been a lot of information and misinformation in the news lately in regards to the e-smoking industry in general as it relates to the FDA. We do not anticipate any real issues with the FDA as they begin to develop rules and regulations for the industry. In fact, we feel that we already adhere to any regulations they're likely to impose, such as; child safety caps, plastic shrink banded caps, etc. We were also the first company to voluntarily list our ingredients on our bottles and print warnings for children and pets. We're also quite proud of the ultra sanitary conditions and use of personal protective equipment in which we bottle our Smoke Juice. Johnson Creek Original Smoke Juice and Red Oak, a PG-Free Smoke Juice, are proudly made in America, with the highest grade ingredients available. Ultimately, we do not know what the FDA will choose to do with the e-smoking industry, but whatever they do decide, we're ready and we welcome their involvement.

https://www.johnsoncreeksmokejuice.com/category/fda

[Uma]

Thanks for that TheRealAlucard!

[FTJoe]

Too funny. Where is the regular alucard? How do we know you are the real one, show me your fangs!!