Saturday, July 25, 2009

Fellow Blogger with commentary on the FDA Press Release

This commentary closely mirrors my own, and I deemed it necessary to share...enjoy!


http://www.getvapure.com/news/fda-and-anti-smoking-groups-are-committing-medical-malpractice-on-a-massive-scale/

FDA's Press Release - actual results

This just shocked me - I can't believe I missed it before.....

This is the test results from the FDA - the link directly off their website...

http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf



Simulated Use: Nicotine and tobacco Specific Impurities by Head Space GC-MS (HSGS-MS) and sparging apparatus HSGC is likely to be less sensitive than the GC-MS technique that takes advantage of injecting all of the soluble components and then volatilizing them at 280 C; however, the head space analyzer can beset to a specific temperature to mimic what may be volatilized during use of the products.
The temperature of the heating element in each e-cigarette was determined by inserting a thermocouple and then activating the e-cigarette by drawing air through it. These temperatures ranged from 40 to 65 C. HSGC-MS analysis was conducted at 60 C to simulate the temperature that would be encountered during activation of an e-cigarette.



This is a direct quote from the PDA given in the link - essentially saying that the testing used 2 different machines to test the liquids.
The biggest difference in these machines is the ambient temperature they run at.

-The head space machine can be set to operate at different temperatures - and was set for the test at the median point operating temperature of the working unit, or 60 C.
-The GC, or Sparging unit, operates at a fixed temperature of 280 C.
Hmmm - what I find incredibly odd is the temperature differences in the 2.

Head space unit - 60 degrees C.
Sparging unit - 280 degrees C.

Ummmm - that's quite a difference.... and can anyone out there tell me what happens when you overheat any substance? You CHANGE ITS CHEMICAL STRUCTURE!

now.... guess which test they used to determine the presence of DEG in the liquid?


Here, let me help - here's another quote from the PDF:

Whole Cartridges: Diethylene Glycol An aliquot of each methanol extract prepared in the Detection and Quantitation of Nicotine by HPLC-UV analysis was transferred to a vial for GC-MS analysis. Samples were screened on an Agilent 6890 with a 5975 MSD operated initially in full scan ode and later in SIM mode using the chromatographic parameters from a USP monograph procedure (Reference 5).



Bingo! I'm going to go ahead and say it, folks - THE FDA SKEWED THEIR OWN TEST TO GET THE RESULTS THEY WANTED.

Fair and impartial? I think NOT!

Friday, July 24, 2009

FDA's Press Release, July 22, 2004

First, here's the post put on the FDA website regarding their "testing" and statement from such:


http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm

Let's start with the date of their testing: May 4th, 2009. Hmmm - the last time I looked at a calander, it was July 24th, a full 2 months and change from their report. Why did they suppress this information for all this time? Why bring it out now? If they had concerns over this product, don't you think they would have made this announcement then? After all, they are supposed to be concerned over the greater public health.

Now, let's take a closer look at a couple of the statements in their press release, which, coming from the FDA, went country-wide within hours of its release:
These products are marketed and sold to young people and are readily available
online and in shopping malls. In addition, these products do not contain any
health warnings comparable to FDA-approved nicotine replacement products or
conventional cigarettes. They are also available in different flavors, such as
chocolate and mint, which may appeal to young people.


Ah, yes, the good old "think of the Children" arguement..... tired old tripe. Personally, I would like to see some hard facts that prove their accusation here. I can show you some cold, hard facts that disuade their arguement - NJoy, one of the larger retailers of E-Cigs in the US, conducted a survey of their consumers, and they came up with a median age of 40, committed smokers all, for their consumer base - a far cry from "marketing to children." And, chocolate and mint flavors? Hmmm - I like chocolate, I like mint, and I'm right in NJoy's median age. These are nothing but poor, shoddy arguements engendered to produce hysteria and breed mistrust of these products in the general population.

The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a
small sample of cartridges from two leading brands of electronic cigarettes. In
one sample, the FDA’s analyses detected diethylene glycol, a chemical used in
antifreeze that is toxic to humans, and in several other samples, the FDA
analyses detected carcinogens, including nitrosamines. These tests indicate that
these products contained detectable levels of known carcinogens and toxic
chemicals to which users could potentially be exposed.

Taken at beginning face value, with just a quick scan and not a lot of time to analyze it, this statement should send shivers down your spine. Ooooo - scary. They're vaping antifreeze! Toxic! Carcinogens! But think..... look....... read between the lines of this statement. Note how limited this is - and how misleading. Here is, to quote a famous orator, the rest of the story..

diethylene glycol, a chemical used in antifreeze that is toxic to humans

What they fail to mention is that in their testing, they found only 1 out of the 19 cartridges sampled to be contaminated with this particular compound, and then, the concentration was less than 1%. Further, they also fail to mention that DEG is occasionally found in trace amounts in PG, the bulk of what's in the nicotine juice. This has not effected the FDA's label of "Genenrally Regarded as Safe" on PG.

This is called spin. The careful crafting of a statement designed to lead the reader to an opinion that you, the writer or producer of the statement, wish them to have.

the FDA analyses detected carcinogens, including nitrosamines.

And the rest of the story on this comment? If you were to test the FDA-approved NRT gums, lozenges, and patches, you would find comparable concentrations of the same nitrosamines, because the nicotine comes from the same source - tobacco.

Can anyone say double-standard? Methinks I smell a rat.

And, doing further research, the control subject they used in these tests? They used the Nicotrol inhaler as their control subject - a product designed by big Pharma, intended for short term use only, and only available by prescription. Not, in my opinion, a comparable control. Instead, logically, I would think the control subject, the product that the PV should be compared against, is the product it is designed to replace......cigarettes. Is that too much to ask for?

Face it, America.... the regulatory agency that is responsible for your health and well-being in regards to the foods you eat and the drugs you take, who is supposed to be a neutral, "justice is blind" kind of agency, is using deceptive and manipulative practices to sway your opinion to one they wish you to have, just like the big corporations in their advertising practices. They are NOT acting in the best interest of public health, irregardless of what the "company line" may be. That begs the question of who's interests they ARE protecting.

To say that I am disgusted with my government at this point would be an understatement. To say that the FDA has an irrational fear of the E-Cig, and an unspecified, unstated goal to an unnamed entity is as clear as the writing on this page to me. This blatent skewing of available data, of suppressing accurate information to allow the American Consumers to make quality, informed decisions, is as irresponsible and dangerous as yelling "fire" in a crowded theatre.

Saturday, July 4, 2009

Washington's Public Face - Social Dynamics (part 2)

Political Correctness, the craze of the 80's and 90's, was a simple enough concept. "We, as a people, no longer wish to offend." Beautiful, masterful, and almost utopian in its simplicity.

We had such strange connotations such as "vertically challanged" dwarves, "people of color," or "African Americans," for our black citizens, and "cellulite gifted" obese people.

Comedians wrote about it. Joked about it. Everyone was coming out with a new example of political correctness. There were even books rewriting children's fairy tales to "clean them up" as to not offend, frighten, or give the children ideas of the true nature of the world around them. In fact, 'Politically Correct Fairy Tales' can still be found in bookstores all over the country or online at such outlets such as half.com and amazon.com.

Deep underneath the surface of this, however, another insidious cultural shift was taking place which would have long reaching and devistating concequences for us as a country.

With the advent of political correctness, no longer would our elected leaders be able to firmly stand their ground, confident in their convictions, look the world in the eye and say "we're doing this, piss on you!" because we could no longer stand to offend. It started the trend that we could no longer speak our minds or be true to ourselves, but had to sanitize and sterilize our own thoughts. This shift in thinking was subtle, erroding the superiority of the majority, and the patriotism of being an American. It was the start into the trend of majority guilt.

Fast forward to today, and see the concequences....We now are a nation divided, split assunder by warring factions all demanding to be pandered to. Washington now flits to one small subsect to another, desparately trying to please everyone, and ending up aggravating everyone. We've gone from sticking to our guns to sticking it to the people we're trying to govern. From action on a solid plan for the good of the many, to reacting to the needs of the few whining with the loudest voice of the day.

Political Correctness, in all its glory, is the pregnancy of the nanny state mentality we've given birth to today.... the belief that the government has to direct and mandate each and every decision for the masses, instead of guiding them to make their own decisions.

Why?

We've become a nation obsessed with image. Symbolism over substance. If it looks good, that's all that matters. Washington has taken this one step further, their particular brand of symbolism being throwing money at each and every special-interest group who has the balls to come to Washington and complain. After all, they have to be seen to be doing SOMETHING. Action, whether right or wrong, is all that matters.

But this is a slippery slope. You can't continue to throw money at half-baked, poorly planned directives without the money running out at some point.

You have to know where I'm going with this, people......

The will of the people is being ground into the dirt, replaced by the will of the corporations who, quietly at first, but now quite openly, have been bailing out our government. They have allowed Washington to continue to keep its image, but at the terrible cost transcending money: the erosion of our basic civil liberties. Now, we exist to serve the interests of the monolithic industries, and we have a government far too concerned with its image to protect the rights of Life, Liberty, and the Pursuit of Happiness - these same gifts procured for us at staggering costs by our forbears.

Image. Glammour. The glossy cover of the magazine. The rest of the magazine is all blank pages, and we have a cizenry well on the way to being too naive to notice. Welcome, then, to the shell country of the United Corporations of America.

On this, the 233 anniversary of the birth of our nation, I would like to offer a little history lesson.

Some of the most powerful words ever spoken, penned, and set in stone as a governing statement are "...the right to life, liberty, and the pursuit of happiness..." Right there, larger than life on our Declaration of Independence, these words were a challenge to our oppressors, and our promise to our citizens. Our founding fathers went to war with England over these words. They fought battles, made life-altering sacrifices, counted staggering losses, and endured unimaginable hardships over the right to speak these words.


Their belief in these words forged a juggernaught of incredible strength of conviction, and gave birth to a democracy that has endured through the ages - our America, the land of the Free and the home of the Brave! A country of proud and opinionated people of all races and backgrounds, come together for the purpose of being free to pursue whatever goal we have the audacity to dream, within a loose framework of rules put in place to guarantee the continuance of our nation and the safety of its citizenry.


How low have we fallen, America. We need to wake up, shake off the dependence we're being force-fed, and state, as one voice, that our government needs to work FOR us, the PEOPLE, and not be allowed to perish from the Earth.

Revolutionary thoughts, for a revolutionary day. Enjoy your holiday.

Thursday, June 18, 2009

Social Dynamics and the Demonization of Smoking (part 1)

Smoking is evil.

Smoking will kill you.

Smoking also kills those around you with second-hand smoke.


These 3 declarations are the silver bullets in the smoking gun (pun intended) held in the arsonal of the anti-smoking groups arrayed against anyone excercizing their rights to choose, of their own free will, to smoke or to not smoke.

The campaigns of the past 20-30 years were necessary for a number of reasons. The corporate tobacco companies did, indeed, bend or downright break the rules of common decency in pursuit of the almighty dollar. That needed to be (and has been) exposed as snake-oil salesman skullduggery.

Tobacco consumers did need to know exactly what risks they were taking in their vice. Public awareness did need to be increased on the potential dangers of second hand smoke, and rules did need to be put in place for the betterment of the common population. All these goals have been met, or are on their way to being completed.

For that, I say, the anti-smoking leagues have done their jobs well. Children, even before formalized schooling, are coached on the dangers of smoking. They are bombarded with this message continually, each and every day of their lives. Adults, young and old alike, are aware of the risks inherent in this product and its usage.



So, what's all the continued screaming and yelling about???



After all, this is still a free country.....at least it was the last time I checked. I still can choose where to go to work, what to do at that job in terms of personal effort, and wether I want to buy a house with my hard-earned money or blow it all on new hats. I can choose to ingest alcohol, caffeine, nicotine, an aspirin, or a Monster Burger (Can I have a double order of the special cardiac-arrest chili-cheese french fries with that, please?). I can decide wether to allow my weight balloon to 210, or sweat it down to 150. Good choices and bad alike are arrayed as in a buffet, with me at liberty to pick and choose from amongst the options.

So now, why, when a new innovation hits the marketplace, am I being told that I cannot do this, because the Government (of which I was part of the process to elect) tells me they don't know precicely what it will do to me? Why has this been barred from the menu when so many other choices, equally bad, remain?

The reasons are vast in their multitudes, as to why my beloved PV's are on the front line, heading for a marketplace removal by my Government. Some are headliners, shoved into the public's eye for effect, and far more are behind the curtain, cowering from discovery. The first, strongest, and most effective reason is public perception, brought on and stroked to a fever-pitch by the anti-smoking groups. From my declarations above: Smoking is Evil. This sentiment has been woven tightly into the weave of public perception, and smokers have gone from admired all the way down the social ladder to reviled and persecuted.



Smokers, people. I'll say it again: SMOKERS. The consumers. The users of the products. These are the people that society has chosen to vilify.....NOT the corporate tobacco giants. These monoliths continue to prosper and whisper in the ears of our elected leaders. Altria will have advisory members on the board of the FDA as they hammer into place new regulations regarding tobacco and nicotine products. The Kennedy/Waxman bills, recently passed by both chambers of congress (and due to cross Obama's desk soon) saw to that. Small wonder that many are calling this legislation the "Altria Earnings Protection Act."

Why? Tell me, why have the consumers been handed this heavy bill to pay, and not the giants in the industry?

Why can't innovation and brilliance be allowed to find another, cleaner, safer, better alternative????


I don't have the answers here friends, but I'm very good as coming up with the right questions and my own theories.

There are a lot of sub-issues and behind-the-scenes power plays arrayed in the Tobacco Wars. Lots of money, too....but I'm not going to follow the money trail yet. That one's been done to death, and starts to take on a "conspiracy theory" twist that I've no wish to follow.

So.....

Sub Issue #1 - the anti-smoking groups.
Very few people realize this, because it came about in a time before the infomation explosion that is the internet, but back in the 70's there was formed a group of people who disliked smokers. Mainly, yes, I'll admit, because smokers were demanding their rights to smoke, anywhere they wanted, irregardless of who they bothered with their habit, and the govenrment was on THEIR side.

This group was called ASHES - the American Society to Harass and Embarass Smokers. Their goal - pretty self-evident in their name - the prohibition of tobacco and the demonization of all who use it.

And, to give fair notice, there is NO evidence on the Web to corroborate this.... I've done extensive research on this small fringe group, and turned up nothing...nada...zilch, but I wasn't surprised. This happens all the time: fringe groups like these usually start very small and very QT - then when they gain momentum, they shift their public image to one less aggressive, and bury the origins.

The only reason I know about this group is because I happened to be exposed to a news article when I was growing up regarding it. This small group and their hard-core hatreds of smokers is the forerunner of today's anti-smoking groups.

And, 30 years later, they've nearly realized their goals. Smokers are 2nd class, sub-humans with few rights and many faults, ready to be tossed aside to moulder in the stinking gutters, pitifully begging passersby "hey, buddy, got a light?"

Now, because of the way our Government wishes to present itself to its American voters, there won't be an outright prohibition of tobacco, but that's going to be:

Sub Issue #2: Washington's public face

Stay tuned......

Thursday, June 4, 2009

Vapor War: the irrational War on Electronic Cigarettes in Slate.com

First and foremost, here is the link to the news article found within the electronic pages of Slate.com, and the basis of this blog post of mine.

http://www.slate.com/id/2219690



I do wish to commend Slate for a well-constructed piece. This article brings home several questions all consumers of Electronic Cigarettes are asking. Unfortunately, the ones with the answers we seek, namely our government officials in the FDA, are not offering up any answers except the standard tripe statements which have had all of us consumers on edge for the past months, some I've already addressed earlier in this blog, and some more yet to be debunked.

An excerpt from the article:

The American Lung Association, along with the American Cancer Society Cancer
Action Network, the American Heart Association and the Campaign for Tobacco-Free Kids, recently called for e-cigarettes to be removed from the market. The groups say e-cigarettes have yet to be proven safe and that kids may be attracted to the products, some of which come in flavors like chocolate and strawberry.
"Nobody knows what the consumers are actually inhaling," says Erika Sward,
director of national advocacy at the American Lung Association.

The boldface emphysis is mine, and what I want to take a closer look at. Nobody knows what we are actually inhaling? I know. That's an easy answer - Do I win the Double Jepardy Trophy???

Let's just take a look at the old ingredient label, shall we? Totally Wicked is based in the UK, and takes its certification standards seriously. I trust them to manufacture a quality product to UK standards. In my bottle of E-juice, there are exactly 16 ingredients....in order of volume, the top 4 are:

  1. Propylene Glycol - 65%
  2. Glycerine - 20%
  3. Water - 10%
  4. Nicotine - >3% (let's say, for the sake of argument - 2.5%)


Can we add? These 4 ingredients are 97.5% of the contents of my bottle. Flavoring ingredients, such as tobacco leaf oils, are mixed into this cocktail - making up the remainder of the contents. Take a look at a box of cheese crackers, or a can of spaghetti sauce, or any of the other stuff sold in this country as a basic foodstuff, and tell me that you can understand all of those ingredients! By this comparison alone, my e-juice is a simpler formula than anything else I eat or drink, and certainly simpler than any commercial cigarette out there, with it's 4000+ chemicals, 60 or so of which are known carcinogens. And tell me, for that matter, where is the ingredient list on a pack of cigarettes? Hmmmm?


But, what are these 4 big ingredients? Let's take them one by one.

Propylene Glycol (PG) - the biggest chunk of stuff in my vape, is used in various preparations, including theatrical smoke machines, prescription inhalers and cough syrups, and is an additive in cigarettes and food products, such as artificial flavors. PG is GRAS (generally regarded as safe) by the FDA, and the MSDS shows only minor throat irritation by inhalation.

So, the largest portion of the product that I am inhaling is already used in other vaporization techniques, in inhalers used by asthmatics, and in the food I eat. Does this sound like a dangerous substance?

And, there's more. Back in the 1940's, a scientific study was conducted using a military base and a children's hospital ward. The experiment was on the properties of PG as a germ killing air sanitization substance. You guessed it, they vaporized PG and pumped it into the air in the children's ward and the military bases' barracks, monitoring the occupants for various symptoms. Here's the link: http://www.ajph.org/cgi/reprint/36/4/390.pdf Their conclusion: PG vapor in the air does not comprise any health risks, and was shown to reduce the amount of airbourne infectious agents already present in the air. A germ-killing vapor.

Curiously, in the 60+ years since this study, there have been no studies to prove this suposition wrong. In 2007, the EPA re-registered PG for an air sanitizing agent in hospitals, restaurants, restrooms, mass-transit facilities, and others.

Conclusion - of the liquid in my PV, the bulk of it is approved by various government agencies already as an inhalant, and may actually be beneficial in killing germs already in my body.... Oh, yea, let's ban this dangerous stuff - FAST!



Vegetable Glycerin (VG) - this is the next biggest chunk of stuff - and is used, again, in food products all over the world.....the glycerin I have seen, and purchased, in a craft store was marketed to extend cake frosting. It is made from vegatable oils. Again, for commercial sale to anyone with a couple of bucks, this is a food product and, as such, is safe for human consumption. Dangerous? Unknown? I'm thinking the answer to that one is, again, NO.


Water (good old H2O) - Unless you are on the bandwagon to ban dihydrogen monoxide, the only danger to water is drowning if you jump in over your head....

Nicotine - The studies on what nicotine does to the body are long, complete, complex, and easy to find. Nicotine is an approved drug by the FDA for usage in smoking cessation as an over the counter product.

The flavoring ingredients I'm going to not worry about at this point, as their concentrations in formula are too low to investigate.

Well, there you go. This is what we're inhaling. Simple, logical, easy. And, in my opinion, its certainly cleaner than walking down the street during rush hour and inhaling the exhaust fumes from a bus or car.

My question to these "public health groups" is: I want to know why you have a hard time connecting the dots? I'm not a research scientist, a chemist, a "smoking cessation expert." How is it that I can do a bit of research and come up with this, and you can't.

The answer, of course, is these bully organizations don't want to connect the dots, they want to remove the product. Period. Which means, the agenda they have put forth to the public is not the agenda they are following.

Follow the logic, if nothing else.

Monday, June 1, 2009

E-Cigarettes: The Gateway Arguement

Another of the arguements I continue to hear from "professional" cigarette cessation experts is: "This product will become a gateway to real cigarettes for teens and young adults."

Never mind the "teens and young adults" portion of this arguement....I've gone over that before. But - the gateway...... Oooooo. Sounds scary, doesn't it. This word is yet another carefully engineered term created and used to manipulate the consumer in a direction that they (the "expert") want you (the uninformed consumer) to take.

Is the E-Cig a gateway? NO. Unequivocably not. But I'm willing to back my statement up with my experiences, instead of insisting you take my word for it.

I purchased my first PV kit in March. 1 atomizer, 2 batteries, and some smoke juice. I vaped on this for a week. Loved it. Had no want, desire, or need for a traditional tobacco cigarette. This was my Holy Grail, the thing I had been waiting for since I first lit up in the 80's. Then, disaster: 1 week to the day, I burned up my only atomizer. Replacements were on order, but not shipped yet......Oh, God, what could I do?

I smoked. Went back to the nasty tobacco cigs. Without hesitation. I had to have my hand to mouth, my little cloud, the cylinder between my fingers when I drove, for this is the driving force behind my personal addiction, far greater than the nicotine I'm inhaling. I will say now, with passion: Those were the worst 2 days of my life!

Now, the FDA is fixing to ban this wonderful new toy of mine, because they are afraid that I, using an electronic gizmo, will entice someone else to smoke cigarettes? That this will become so attractive to a non-smoker that they will feel the irristible urge to light up?

Come on.....pull the other one. The only way this could possibly become a gateway is if they now pull it off the market. The genie has been released from the bottle. If they pull this product, they create the gateway - a self-fulfilling prophecy. Period.

This is an invasion of my personal liberty to do what I will with my body as long as I'm not harming anyone else. Tell me, what do you think will happen to me, what will I do, if they do, indeed, pull my alternative off the market, in the name of protection? I'm sure you can connect the dots here....

I could fill this page with other consumers' stories that mirror mine.....the e-cigarette-forum and petition both are full of such personal experiences. Many have gone further on their journeys than I have, and have cut to zero nicotine solutions. What's going to happen to them? What will they be forced back into in their pursuit of happiness?

Granted, there are some who don't share my own experiences.....there are some who find this product not quite my Nirvana, but simply a substitute for their own addiction.

But, almost universally, there is the same sentiment: going from an E-Cig to traditional tobacco cigarette is the same as going from Lobster to Fish Sticks.

Care to try another arguement?