Altmed

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

I find it amazing that the FDA can approve loads of drugs that have been recalled, medical devices that are clearly dangerous & not recall medications they clearly should, yet when it comes to anything to do with natural medications (which used with knowledge of those products is FAR safer). the FDA seems to want to ban everything natural... Remember the vitamin raids in the late '80's? The tryptophan ban around 1988 b/c one single shipment from China was contaminated - no others were found to be contaminated, yet ALL of them were banned for a long time! The Ma Huang ban, which still exist, yet for those given corticosteroids with a bad reaction, this may be the only thing that can stop someone from developing life-long high BP, diabetes (insulin resistant), brain swelling, catabolism and many more devastating effects, yet they allow doctors to hand out these damaging injections & pills like they are candy, costing everyone - especially the victim of these drugs who can develop life-long disabilities, tons of money & heart ache.

If you google Medtronic lawsuit (re: their fault medical devices), you'll see tons of lawsuits filed, yet because those are "FDA approved medical devices", not one person who has had broken leads, been paralyzed, or in cases of death, their families cannot recover a single thing from the manufacturers because of a law passed by the Bush administration that exempts ANY "FDA-approved medical device" from recovery of ANY damages, and it's clear, these devices tanked in quality ever since that law was enacted.

The FDA needs to stop violating people's rights, they need to hold those medical device companies to standards & STOP infringing on people's rights to buy products that are natural (& some "not-so-natural"), including e-cigs, herbal liquids & other similar devices. This is like banning herbal remedies from the market, which have been proven time & time again to be safer than allopathic medicines prescribed or OTC for the same purposes!

The judge that stopped the FDA's seizure of e-cig products was right - the FDA over-stepped their boundaries!

So, I take a vitamin C... are they going to ban vitamins again or is my hand that puts it in my mouth going to be an FDA banned "drug delivery device" too?

I suppose we should just stop driving cars too, as they emit harmful hydrocarbons? Buses? HE** diesel fuel is even worse and we ALL have to breath those things! We have no escape & no choice!

Humidifiers? Guess those would have to go too... Breathing? Wait! If we breathe, we are taking in all sorts of harmful substances from smog, trees, etc.

Drinking water? I just read a study on chloramines & our water, regulated by the EPA, at the tap in municipal water systems is full of truly dangerous chloramines... Even wastewater engineers are concerned about it & eat shrimp? Not with the concentrations of Prozac in them from wastewater! THey can't get that stuff out of the water & the shrimp are full of it, and God only knows what else!

So, according to the FDA, it's not safe to breathe, drink or use municipal water (packing plants use this water too & there are even lawsuits going on about chloramines and their carcinogenic byproducts, including lead and copper it erodes from the pipes) contaminating food, even baby food), and not even safe to take a bath or shower, or eat seafood. Our beef & vegetables have also been contaminated and have made many people ill &s many have died, but that's OK by the FDA?

No one yet has proven to me a Big Mac is totally safe! (isn't that what that kid in Oregon ate & died?) And the lettuce & onion fiascos? The onions were destroyed by the grower, only tofind one of Taco Bell's supplier's warehouses was the source of contamination!

I have YET to hear of a single person becoming ill from use of an eCigarette, and with 20-30,000 people a DAY switching from smoking, or using 0 nic for those who just enjoy it & would rather not take up smoking or e-cigs with nicotine, the FDA should be thankful someone invented e-cigs!

Walmart & other stores carried pet food that was killing animals! Did they go after Walmart? Nope! They worked with the industry to find the source, which was a plant in Canada, did recalls like any sane response would be, had stores pull the deadly products and it was over!

Ecigs need to be treated like food! If a trend develops of people getting sick from a certain batch from a specific supplier, go to THAT supplier & recall the products, not the entire industry!

Would the FDA rather have us smoke cigarettes? Clearly not, or they wouldn't have spent the $Billions on making everyone paranoid about cigarettes & raised the taxes so darn high. They should have looked at the addition of carcinogenic chemicals to the cigarettes, not the tobacco itself! If ANYONE has EVER read a study on smoking that excluded cigarettes with chemical additives, PLEASE PM ME! I have yet to see a single one!

We eat foods every day that are mislabeled or are not labelled at all, so where is the FDA in those cases?

This FDA witch hunt of eCigs is just like the vitamin & supplement bans of the 1980's, which clearly stomp all over civil rights & my religious beliefs, as well as my health.

I've yet to see the FDA go after manufacturing companies who clearly pollute our air with toxins, the drug companies whose drugs were recently found in shrimp - yes! Prozac in shrimp! A full dose if you eat it for your evening portion of protein! I can only guess what higher food chain species are full of! Mercury certainly! Why haven't they gone after that source? That's been a serious problem affecting health for far more than 20 years!

It seems like the FDA's idea is we shouldn't have anything natural or naturally derived in our eCigs or in our food!

This is CLEARLY a civil rights issue, freedom of religion, and freedom of life & liberty... I guess those fighting cigarettes/tobacco & eCigs have never read the constitution!

The anti-supplement/anti-tobacco/ anti-eCig hysteria is foolish at best. I suppose htey'd have us all eating chemically-created food as well. Sounds like Soylent green isn't too far off.

A few quotes from Soylent Green, the 1973 Sci-Fi movie from imbd.com:

Det. Thorn: I know, Sol, you've told me a hundred times before. People were better, the world was better...
Sol: Ah, people were always lousy... But there was a world, once.
[Thorn chuckles]
Sol: I was there, I can prove it! When I was a kid, you could buy meat anywhere! Eggs they had, real butter! Not this... crap!
...
Sol: Why, in my day, you could buy meat anywhere! Eggs they had, real butter! Fresh lettuce in the stores.
Det. Thorn: I know, Sol, you told me before.
...
Det. Thorn: Would you believe bodyguards are buying strawberries for 150 D's a jar?

Yes, the FDA IS just that ridiculous! This is a slippery slope they are on!

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

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

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

I find it amazing that the FDA can approve loads of drugs that have been recalled, medical devices that are clearly dangerous & not recall medications they clearly should, yet when it comes to anything to do with natural medications (which used with knowledge of those products is FAR safer). the FDA seems to want to ban everything natural... Remember the vitamin raids in the late '80's? The tryptophan ban around 1988 b/c one single shipment from China was contaminated - no others were found to be contaminated, yet ALL of them were banned for a long time! The Ma Huang ban, which still exist, yet for those given corticosteroids with a bad reaction, this may be the only thing that can stop someone from developing life-long high BP, diabetes (insulin resistant), brain swelling, catabolism and many more devastating effects, yet they allow doctors to hand out these damaging injections & pills like they are candy, costing everyone - especially the victim of these drugs who can develop life-long disabilities, tons of money & heart ache.

If you google Medtronic lawsuit (re: their fault medical devices), you'll see tons of lawsuits filed, yet because those are "FDA approved medical devices", not one person who has had broken leads, been paralyzed, or in cases of death, their families cannot recover a single thing from the manufacturers because of a law passed by the Bush administration that exempts ANY "FDA-approved medical device" from recovery of ANY damages, and it's clear, these devices tanked in quality ever since that law was enacted.

The FDA needs to stop violating people's rights, they need to hold those medical device companies to standards & STOP infringing on people's rights to buy products that are natural (& some "not-so-natural"), including e-cigs, herbal liquids & other similar devices. This is like banning herbal remedies from the market, which have been proven time & time again to be safer than allopathic medicines prescribed or OTC for the same purposes!

The judge that stopped the FDA's seizure of e-cig products was right - the FDA over-stepped their boundaries!

So, I take a vitamin C... are they going to ban vitamins again or is my hand that puts it in my mouth going to be an FDA banned "drug delivery device" too?

I suppose we should just stop driving cars too, as they emit harmful hydrocarbons? Buses? HE** diesel fuel is even worse and we ALL have to breath those things! We have no escape & no choice!

Humidifiers? Guess those would have to go too... Breathing? Wait! If we breathe, we are taking in all sorts of harmful substances from smog, trees, etc.

Drinking water? I just read a study on chloramines & our water, regulated by the EPA, at the tap in municipal water systems is full of truly dangerous chloramines... Even wastewater engineers are concerned about it & eat shrimp? Not with the concentrations of Prozac in them from wastewater! THey can't get that stuff out of the water & the shrimp are full of it, and God only knows what else!

So, according to the FDA, it's not safe to breathe, drink or use municipal water (packing plants use this water too & there are even lawsuits going on about chloramines and their carcinogenic byproducts, including lead and copper it erodes from the pipes) contaminating food, even baby food), and not even safe to take a bath or shower, or eat seafood. Our beef & vegetables have also been contaminated and have made many people ill &s many have died, but that's OK by the FDA?

No one yet has proven to me a Big Mac is totally safe! (isn't that what that kid in Oregon ate & died?) And the lettuce & onion fiascos? The onions were destroyed by the grower, only tofind one of Taco Bell's supplier's warehouses was the source of contamination!

I have YET to hear of a single person becoming ill from use of an eCigarette, and with 20-30,000 people a DAY switching from smoking, or using 0 nic for those who just enjoy it & would rather not take up smoking or e-cigs with nicotine, the FDA should be thankful someone invented e-cigs!

Walmart & other stores carried pet food that was killing animals! Did they go after Walmart? Nope! They worked with the industry to find the source, which was a plant in Canada, did recalls like any sane response would be, had stores pull the deadly products and it was over!

Ecigs need to be treated like food! If a trend develops of people getting sick from a certain batch from a specific supplier, go to THAT supplier & recall the products, not the entire industry!

Would the FDA rather have us smoke cigarettes? Clearly not, or they wouldn't have spent the $Billions on making everyone paranoid about cigarettes & raised the taxes so darn high. They should have looked at the addition of carcinogenic chemicals to the cigarettes, not the tobacco itself! If ANYONE has EVER read a study on smoking that excluded cigarettes with chemical additives, PLEASE PM ME! I have yet to see a single one!

We eat foods every day that are mislabeled or are not labelled at all, so where is the FDA in those cases?

This FDA witch hunt of eCigs is just like the vitamin & supplement bans of the 1980's, which clearly stomp all over civil rights & my religious beliefs, as well as my health.

I've yet to see the FDA go after manufacturing companies who clearly pollute our air with toxins, the drug companies whose drugs were recently found in shrimp - yes! Prozac in shrimp! A full dose if you eat it for your evening portion of protein! I can only guess what higher food chain species are full of! Mercury certainly! Why haven't they gone after that source? That's been a serious problem affecting health for far more than 20 years!

It seems like the FDA's idea is we shouldn't have anything natural or naturally derived in our eCigs or in our food!

This is CLEARLY a civil rights issue, freedom of religion, and freedom of life & liberty... I guess those fighting cigarettes/tobacco & eCigs have never read the constitution!

The anti-supplement/anti-tobacco/ anti-eCig hysteria is foolish at best. I suppose htey'd have us all eating chemically-created food as well. Sounds like Soylent green isn't too far off.

A few quotes from Soylent Green, the 1973 Sci-Fi movie from imbd.com:

Det. Thorn: I know, Sol, you've told me a hundred times before. People were better, the world was better...
Sol: Ah, people were always lousy... But there was a world, once.
[Thorn chuckles]
Sol: I was there, I can prove it! When I was a kid, you could buy meat anywhere! Eggs they had, real butter! Not this... crap!
...
Sol: Why, in my day, you could buy meat anywhere! Eggs they had, real butter! Fresh lettuce in the stores.
Det. Thorn: I know, Sol, you told me before.
...
Det. Thorn: Would you believe bodyguards are buying strawberries for 150 D's a jar?

Yes, the FDA IS just that ridiculous! This is a slippery slope they are on!

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

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

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

I find it amazing that the FDA can approve loads of drugs that have been recalled, medical devices that are clearly dangerous & not recall medications they clearly should, yet when it comes to anything to do with natural medications (which used with knowledge of those products is FAR safer). the FDA seems to want to ban everything natural... Remember the vitamin raids in the late '80's? The tryptophan ban around 1988 b/c one single shipment from China was contaminated - no others were found to be contaminated, yet ALL of them were banned for a long time! The Ma Huang ban, which still exist, yet for those given corticosteroids with a bad reaction, this may be the only thing that can stop someone from developing life-long high BP, diabetes (insulin resistant), brain swelling, catabolism and many more devastating effects, yet they allow doctors to hand out these damaging injections & pills like they are candy, costing everyone - especially the victim of these drugs who can develop life-long disabilities, tons of money & heart ache.

If you google Medtronic lawsuit (re: their fault medical devices), you'll see tons of lawsuits filed, yet because those are "FDA approved medical devices", not one person who has had broken leads, been paralyzed, or in cases of death, their families cannot recover a single thing from the manufacturers because of a law passed by the Bush administration that exempts ANY "FDA-approved medical device" from recovery of ANY damages, and it's clear, these devices tanked in quality ever since that law was enacted.

The FDA needs to stop violating people's rights, they need to hold those medical device companies to standards & STOP infringing on people's rights to buy products that are natural (& some "not-so-natural"), including e-cigs, herbal liquids & other similar devices. This is like banning herbal remedies from the market, which have been proven time & time again to be safer than allopathic medicines prescribed or OTC for the same purposes!

The judge that stopped the FDA's seizure of e-cig products was right - the FDA over-stepped their boundaries!

So, I take a vitamin C... are they going to ban vitamins again or is my hand that puts it in my mouth going to be an FDA banned "drug delivery device" too?

I suppose we should just stop driving cars too, as they emit harmful hydrocarbons? Buses? HE** diesel fuel is even worse and we ALL have to breath those things! We have no escape & no choice!

Humidifiers? Guess those would have to go too... Breathing? Wait! If we breathe, we are taking in all sorts of harmful substances from smog, trees, etc.

Drinking water? I just read a study on chloramines & our water, regulated by the EPA, at the tap in municipal water systems is full of truly dangerous chloramines... Even wastewater engineers are concerned about it & eat shrimp? Not with the concentrations of Prozac in them from wastewater! THey can't get that stuff out of the water & the shrimp are full of it, and God only knows what else!

So, according to the FDA, it's not safe to breathe, drink or use municipal water (packing plants use this water too & there are even lawsuits going on about chloramines and their carcinogenic byproducts, including lead and copper it erodes from the pipes) contaminating food, even baby food), and not even safe to take a bath or shower, or eat seafood. Our beef & vegetables have also been contaminated and have made many people ill &s many have died, but that's OK by the FDA?

No one yet has proven to me a Big Mac is totally safe! (isn't that what that kid in Oregon ate & died?) And the lettuce & onion fiascos? The onions were destroyed by the grower, only tofind one of Taco Bell's supplier's warehouses was the source of contamination!

I have YET to hear of a single person becoming ill from use of an eCigarette, and with 20-30,000 people a DAY switching from smoking, or using 0 nic for those who just enjoy it & would rather not take up smoking or e-cigs with nicotine, the FDA should be thankful someone invented e-cigs!

Walmart & other stores carried pet food that was killing animals! Did they go after Walmart? Nope! They worked with the industry to find the source, which was a plant in Canada, did recalls like any sane response would be, had stores pull the deadly products and it was over!

Ecigs need to be treated like food! If a trend develops of people getting sick from a certain batch from a specific supplier, go to THAT supplier & recall the products, not the entire industry!

Would the FDA rather have us smoke cigarettes? Clearly not, or they wouldn't have spent the $Billions on making everyone paranoid about cigarettes & raised the taxes so darn high. They should have looked at the addition of carcinogenic chemicals to the cigarettes, not the tobacco itself! If ANYONE has EVER read a study on smoking that excluded cigarettes with chemical additives, PLEASE PM ME! I have yet to see a single one!

We eat foods every day that are mislabeled or are not labelled at all, so where is the FDA in those cases?

This FDA witch hunt of eCigs is just like the vitamin & supplement bans of the 1980's, which clearly stomp all over civil rights & my religious beliefs, as well as my health.

I've yet to see the FDA go after manufacturing companies who clearly pollute our air with toxins, the drug companies whose drugs were recently found in shrimp - yes! Prozac in shrimp! A full dose if you eat it for your evening portion of protein! I can only guess what higher food chain species are full of! Mercury certainly! Why haven't they gone after that source? That's been a serious problem affecting health for far more than 20 years!

It seems like the FDA's idea is we shouldn't have anything natural or naturally derived in our eCigs or in our food!

This is CLEARLY a civil rights issue, freedom of religion, and freedom of life & liberty... I guess those fighting cigarettes/tobacco & eCigs have never read the constitution!

The anti-supplement/anti-tobacco/ anti-eCig hysteria is foolish at best. I suppose htey'd have us all eating chemically-created food as well. Sounds like Soylent green isn't too far off.

A few quotes from Soylent Green, the 1973 Sci-Fi movie from imbd.com:

Det. Thorn: I know, Sol, you've told me a hundred times before. People were better, the world was better...
Sol: Ah, people were always lousy... But there was a world, once.
[Thorn chuckles]
Sol: I was there, I can prove it! When I was a kid, you could buy meat anywhere! Eggs they had, real butter! Not this... crap!
...
Sol: Why, in my day, you could buy meat anywhere! Eggs they had, real butter! Fresh lettuce in the stores.
Det. Thorn: I know, Sol, you told me before.
...
Det. Thorn: Would you believe bodyguards are buying strawberries for 150 D's a jar?

Yes, the FDA IS just that ridiculous! This is a slippery slope they are on!

he thinks you are using carts. not cartomizers. listen to what i said. not trying to be rude just not trying to confuse you. lol