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!

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.

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.