Thursday, July 15, 2010

The E-Cigarette vs. the FDA

I suppose I don't really have to give you or anyone else a refresher on how government ruins everything for the free market. Whether it be through blatant government greed, or simple red-tape bureaucratic ineptness.

My attention was brought to this due to the non-stop outcry around the world on the horrors of tobacco use. But as this particular case unfolds, we are pressed with a very real question: does the government really care about our health?

I have been following a fairly new product around for a bit and believe it (and it's fight with the FDA) to be worthy of mention.

There is a new product on the market that is starting to gain some serious momentum. Well more accurately, as much momentum as the FDA will allow it to get I guess. It's moved from pennys and nickels to a $100 million dollar industry in roughly 12-months.

This is actually not too "new" of a product, it's just recently that it has hit the US shores and managed to anchor itself fairly well.

I'm speaking of the fairly new "smoking alternative" called the E-Cigarette.

The E-cigarette was invented in China, and as a result of this, China is the leader across the boards in the manufacturing of the batteries and other components. Another result would also be the fact that China (of all places) seems to be a lot more accepting of these ingenious devices than our own "democratic" government.

The E-cigarette comes in many different sizes, shapes, and manufacturers. Like any product, all of them naturally have their own pro's and con's. Some of them have great vapor production but have a horrible battery-life. Others have an excellent battery life, but they don't produce enough cigarette-mimicking vapor.

Yes that's right folks: vapor. The E-cigarette is more or less a personal nicotine vaporizer.

There is no actual "smoke," nor is there any actual tobacco, tar, or harmful chemicals. What you actually inhale and exhale is a mixture of Propylene Glycol (or Vegetable Glycol), Nicotine, some natural flavor or another, and water. Now that we mentioned Nicotine, this is the part where the FDA comes rolling in.

The initial argument that the FDA produced after a brief study, was that Diethylene Glycol was a health risk, as it is commonly found in substances such as anti-freeze. What the FDA did here was consciously derail and sabotage the E-Cigarette through their tried and true fearmongering technique of big-worded misinformation.

Here is a part of the original FDA quote:

"The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze."

Is DG (Diethylene Glycol) considered toxic? The answer is yes. But what the FDA failed to mention is that the tested E-Cigarette cartridges had about 1/10 the DG that can be found in aspirin, and about 1/40 the amount found in your typical tobacco cigarette. It can also be found in a variety of consumable products on the market that we use daily. It's actually not an ingredient in anti-freeze. It's an ingredient in coolants. They mixed that up with PG (Propylene Glycol) which is actually put into anti-freeze in order to make the anti-freeze child-safe and/or pet-safe.

Not that it really matters much. But DG is actually not a typical ingredient you find in E-Cigarettes. It is typically used as a humectant for tobacco products; which would explain its presence in one out of the 18 E-cig cartridges tested. The presence of Nicotine typically means you will also find DG. If you were to test real cigarettes for this chemical, you would find it in %100 of the tested cigarettes.

But, strangely, the FDA doesn't set an embargo on big tobacco.

DG and PG are actually considered "Safe for human consumption" in certain quantities by the FDA in several consumable products. To put it into perspective: You would have to consume around 12,000 E-cigarette cartridges loaded up with DG and PG within 24-hours in order to get yourself anywhere near toxic levels of DG/PG. Sounds pretty freaky until you find out that your average E-cigarette user will puff down 1.5 cartridges per day. The heavier puffers will inhale as many as 3.

So why the scary lingo?

I guess it is possible that the FDA made a mistake and used the "toxic/carcinogen" description for the wrong glycol. Plain Ethylene Glycol is indeed pretty toxic. But they didn't find any of that in the E-cigs, maybe they just liked the contents of EG's toxic properties description. So I suppose we could toss lying and/or being utterly incompetent into the equation. Do they actually have "scientists" under the FDA's employ, or is it just another team of monkeys throwing turds and screeching?

An anonymous commenter writes:

"So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts of aspirin and nicotine you'd stare blankly and shrug your shoulders. But when someone starts throwing around a term like diethylene glycol people pay attention because nobody knows what the hell it means and it doesn't sound like something you necessarily want a tall frosty mug of."

Where can you find Diethylene Glycol and Propylene Glycol?

You can find it in toothpaste, wine, dog food, mouthwash, cough syrup etc etc etc. You can find it in the fog-machines that pump the air full of the annoying stuff at concerts. You can find it in many of the pharmaceuticals that you ingest orally, get injected with, or apply to your skin.

One would have to be incredibly stupid to think that the FDA doesn't know all these facts. They do. They approved all that other stuff; so why derail this?

The magic word here is Nicotine.

I'm not going to sit here and tell you that Nicotine is the greatest thing to put into your body, it's not. It's essentially a poison and a very effective insecticide. Long-term tests on lab rats never showed any adverse effects of nicotine, but regardless, it is still a foreign chemical that you shouldn't put in your body.

But let's be real here. We've all played around and dissolved metal objects in Coca Cola, it's pretty potent as well. Not to mention that it also contains caffeine, which also has addictive qualities. But you don't see Coca Cola facing any scrutiny unless you count the American Dental Association.

My point being, we'll just leave the unhealthiness of Nicotine at the door and continue.

So we all know where to find Nicotine. Tobacco products are an easy one as well as the various stop-smoking aids on the market in the forms of gum, patches, and those weird little inhalers. Then of course we now have our E-cigs to add to this list. The only difference between these acceptedproducts vs. the unaccepted isn't really the product so much as it is the supplier.

We get tobacco from our lovely tobacco giants, and we get the rest from our lovely pharmaceutical giants. Many of the pharmaceutical giants get their nicotine from the big tobacco giants. So now we have a love-circle between big tobacco, big pharma, and big FDA. Yes, they all sit around and rub each others shoulders while people die.

I would like to quote the great Dr. Ron Paul:

"The FDA, like all federal agencies, ultimately uses its regulatory powers in political ways. Certain industries and companies are rewarded, and others are punished. No regulatory agency is immune from politics, which is why the FDA should not be trusted with power over our intimate health care decisions."

So it would seem that our beloved Dr. Paul doesn't trust them either. They are a roadblock in the free market, and they continually overstep their bounds with the 1st and 4th amendment.

First Amendment you ask? Just ask General Mills. The FDA threatened to label Cheerios as a "drug" due to Cheerios' claim that it can lower your cholesterol.

Seriously people. The FDA actually pulls these stunts with a straight face.

Fourth Amendment you ask? I'll get to that in a moment.

Now back to the E-cig embargo.

As soon as their initial findings were disproved, there was no offer of an apology from the FDA. Instead they immediately shot back with their only fail-safe (seeing as they cannot toss Big Pharma and Big Tobacco under the bus quite yet).

They argued, "The children." Yes, we must think about the children.

The fact that children can feasibly get ahold of these devices via the internet, smoke shop, or mall kiosk is apparently UNACCEPTABLE to the FDA. Yet it's fine that children can get ahold of numerous other things on the internet. Knives, porn, alcohol, energy drinks, and pills to name a few. Any enterprising youngster with his parent's debit card and a copy of the USPS delivery-schedule can make this happen. But even then, what is a kid really going to go for? The $100 E-cigarette kit that they need to purchase online and get shipped to them, or the real-deal in a convenience store down the road for $5 a pack? The fact that not only the FDA, but also the American Lung Assoc, and Cancer Society would spew this at the general populace and actually expect it to be believed, is not just irritating, it's actually insulting.

I believe that upon realizing what a pathetic argument that really was, the FDA and it's parrots were compelled to shoot back that the flavors for E-cigs (E-juice) are appealing to children and adults, hence, unethical.

Such flavors will draw our citizens (against their own free will) into the clutches and jaws of the nicotine beast. They will then be devoured by said beast, smoke millions of tobacco cigarettes, and die. Of course it will be the cheesecake-flavored E-juice's fault and/or everyone else's fault but the free-thinking child/adult that took the first drag.

Ignore all those people who feed themselves and their children bacon dipped in boat lard. We had better go after the despicable "stop-smoking" pushers.

Nobody really bought that one either. Would you?

The next shovel-full argument from the FDA came in the form of an attack on the actual marketing techniques being used by E-cigarette suppliers. This is actually the only real semi-valid argument that the FDA ever produced.

In the early days, most E-cigarette suppliers DID claim that the new devices were (more or less) smoking-cessation devices. The FDA quickly seized upon these claims saying that the E-cig did not actually wean people off of nicotine so much as simply replace their smoking habit with a different habit. Doesn't sound a whole lot different than the Big Pharma FDA-approved patches, gum, and inhalers. But I'll give it to the FDA that they were at leastpartially correct here, albeit incredibly hypocritical.

Upon this accusation, most of the suppliers of these devices made the simple language correction and moved on towards business-as-usual.

"NOT SO FAST!" The FDA spaketh thusly.

And so began the embargo.

Now the FDA has decided that it (under the banner of public health interests) would fly in the face of the 4th amendment and begin seizing these devices from the USPS and other shipping agents without a lawful ban in place.

Mind you, they are not merely confiscating the overseas shipments that arrive in bulk. They are also seizing the small private orders from regular consumers. Regular people who want or need to quit smoking for one reason or another.

When confronted, they use the argument that the devices need further testing. Hogwash I say. They are merely figuring out a way to regulate it, make money off it, and pass it off to their "approved" pushers.

It's money people. The US Government likes money, and big Tobacco and big Pharma make A LOT of money. The FDA knows exactly what side their toast is buttered on, and they dare not bite the hand that is feeding it to them.

Money is at stake for them. And the new E-cigarette industry is sporting $100 million (and growing) that they would like to get their hands on. But they can't steal that money from the market unless they are given the power to regulate it. As soon as they have the power to regulate it, they will have the say-so in who gets to manufacture and distribute it.

Wanna bet who will get the honors of said manufacture and distribution?

Health risks and/or benefits be damned. If you don't bribe off the regulators, they simply bury you. Such is the sad case of the E-cigarette.

Well, such was the case until the land of the frivolous lawsuits woke up and realized that they just might be getting taken for a ride by the FDA and other unseen trolls. Maybe there wasn't a dollar to sue for. But there was a principled point to be made, fun to be had, and government agencies to humiliate.

Somebody sued.

Not necessarily for money, but for the FDA to lift it's injunction on shipments. They won. The FDA got a lovely cease and desist order from the Honorable Judge Richard Leon.

Judge Richard Leon:

"This case appears to be yet another example of F.D.A.’s aggressive efforts to regulate recreational tobacco products as drugs or devices,"

*Gasp!*

Imagine that, a government regulatory branch overstepping its bounds!

Of course the FDA sent in an appeal. They had to do it. Big Pharma and Big Tobacco cannot allow their market competition to survive and hamper their bottom lines.

I believe the FDA has more than likely been pretty reluctant to re-enter the fray. It ends up painting them as more of a monster than a savior. One almost feels badly for them until one reminds themselves that more people have died as a result of FDA-approved products than non-approved. I won't even talk about cigarette deaths. It tells you where their loyalties come to rest at night. Rest assured though, their loyalties aren't to the consumers or the public health.

4000+ chemicals in tobacco cigarettes vs. the 3 found in E-cigarettes. The FDA is trying to kick people back to the former by means of eradicating the latter.

This is a serious lesson to everyone. Who and what do they really care about?

The FDA appeal is where our story ends, as it is still in the gears of our system at the moment. Send up your prayers at night and ask to whomever you pray, to let our dear FDA be the ones to get their sleeve caught in those gears.

So far, it does not look good for them. But they did enough damage already by those who would now continue with regular tobacco because the FDA barfed some nonsense at a press conference.

That so many will continue dumping thousands of truly dangerous cigarette chemicals into their bodies as a result of the FDA lies and/or gross incompetence is sad. And indeed, it is the only real crime here.

For those who decided to go with actual science as opposed to the FDA's campaign of misinformation, you can find many of their moving success stories here.

Years from now, how many will owe their lives to this new technology?

I'm sure the FDA will figure out a way to not let you find out.


6 comments:

  1. Hi John,
    I do agree that Chantrix is an option. I don't really put Chantrix and the E-Cigarette in the same catagory though. Chantrix is a prescribed drug, the E-Cig is not.
    Also, the side effects of Chantrix are a considerable risk. Nearly everyone I know that has used Chantrix has complained of having issues with sleep. Whether it be difficulty in getting to sleep, or having incredibly vivid dreams/nightmares.
    Also, I would say about 3/4 of the people that I know that have used Chantrix have taken up smoking again once they stop taking it.

    If you struggle with smoking (as I do), I would highly recommend the E-Cig. For many, it isn't even the nicotine that they are craving so much as just needing something to fidget with. You can even get it in a 0-nicotine level.

    ReplyDelete
  2. Very nice blog. The world needs to see that Tobacco Control has translated to Tobacco Abstinence in all forms other than those sold by Big Pharma. It is truly about the money.

    We have been fed disinformation on tobacco for decades. The benefits of tobacco nicotine and other tobacco specific alkaloids are ignored or suppressed until BP can produce a highly profitable branded pill.

    E-cigs, Swedish snus, Ariva, Stonewalls, Orbs and many tobacco products are orders of magnitude safer while still supplying what some of us need to stay out of the pharmacy.

    ReplyDelete
  3. Thanks for writing this article. I was doing some research on e-cigs and needed to find out about the FDA report. I had heard the story about the anti-freeze.

    ReplyDelete
  4. I just posted the following over at the NY Post site on Bloomberg's park smoking ban and realized it would add to this discussion nicely as well. The anti-e-cig people are screaming about incredibly small sub-microscopic amounts of a few chemicals that were found in a few samples of the many that were tested. Can they be trusted when they argue that it's a "danger"? Think about that while you read about the juggling the do in the same game with regard to ETS exposures:

    ===

    Mayor Bloomberg announces legislation that would ban smoking in Times Square, city parks and beaches - NYPOST.com#comments#com

    Anon never responded to my comment about his concern over Arsenic, so I thought maybe I should try another in his list. He's concerned over Formaldehyde in second hand smoke. Does it exist? Yes: at an average concentration in a smoking bar of about .007 ppm. Is that dangerous? Hmmm....

    Well, Formaldehyde is also present in the baby shampoo that we use on our tenderest and smallest members of society quite freely. When this was brought up as a concern two years ago the NY Times and Washington Post were quick to assure us that the concentrations were far to small to pose any threat even to vulnerable little babies.

    Actually the baby shampoo concentrations were 610 ppm : that's 87,000 times as "deadly" as the amount that people like Anon warn us about in secondary smoke. Do we see 87,000 times as many babies dying from baby shampoo as bartenders dying from secondary smoke exposure? Of course not: neither group is dying from either exposure in any numbers sufficient enough to be measured even in a country of 300,000,000 people.

    All they have are "computer estimates" of made up formulas and numbers and they rush to assure us that the 87,000 times "deadlier" baby shampoo is harmless while wisps of secondary smoke are striking us down right and left.

    Somebody's telling a fib... and it ain't me!

    Michael J. McFadden
    Author of "Dissecting Antismokers' Brains"

    ====
    So are you still worried about what the Antis, of any stripe, say?

    - MJM

    ReplyDelete
  5. I did my research prior to switching over to ecigs and came across your blog. Completely agree with everything in your blog. If ecigs are used correctly and a step down program (in terms of nicotine content) is followed, it does ASSIST to stop smoking. I really did not believe it. I was suprised as I have tried everything including Chantix. Spent thousands and I am determined not to be beat by own habit. The addiction is nicotine. I am a user of Northwest Vapors that a airline pilot suggested to me after purchasing muliple "high end ecigs". The pilot said he only tried it because he could not smoke in the airports and the long lines to be "padded" down by security was not worth going outside. So I tried it. I am in phase 2 now (the 2nd step down). Honestly, I have a pack of real cigs by my side, but really dont crave them anymore. After NW Vapors, the real cig taste exactly what they are, pollutants. The chemicals in real cigs taste horrible now and I understand better that the only way for me is a step down program with ecigs (again in terms of nictotine content) is the only way for me. This is real and the FDA does lie. I was in the medical field for 12 years and big pharma is a game. I totally endorse this blog and recommend it all those who want to quit for good.

    ReplyDelete
  6. Fine fine writing! Thank you!

    ReplyDelete