Sharing my FDA interaction....

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SLDS181

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Aug 11, 2009
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So, I received a response back from the FDA, thanking me for my history and comments on e-cigs, and telling me where the lab report was. Here is my reply, which I'm sharing for reference:
edited,

Thank you, I've read the FDA's report. This, however, is why I'm confused over the entire situation. Two brands, and only two, of liquids were used - Smoking Everywhere, and njoy. Of these, the Smoking Everywhere liquids (as the e-cigarette itself is nothing more than a vaporizer) contains trace amounts of two tobacco-specific nitrosamines, in only two of the "flavors", and njoy flavors contained trace amounts in all flavors.

Noting that, all cigarettes contain all of these nitrosamines - and in a significantly greater amount, along with hundreds of other additives that cause the human body a great deal of harm. Yet, the big statement in the FDA's published report was that Diethylene Glycol (DEG) was discovered - in trace amounts. Again, this is a misrepresentation. One single lone flavor contained DEG in trace levels, and none of the others. Again, as DEG is an additive in cigarettes to keep the tobacco, significantly higher levels are found in traditional cigarettes. So how is it the FDA can be considered a responsible institution while making these claims?

In addition, comments were made alluding to as yet unknown effects of Propylene Glycol and Vegetable Glycerin when inhaled. Yet, countless studies have already been conducted on these materials - and many others - for their use in fog machines on stages around the world. It was discovered that massive peak level inhalation could cause irritation, but no long-term harm. As such, it was decided, and provided as a standard in the entertainment industry, that only Propylene Glycol and Glycerins (such as USP grade Vegetable Glycerin) should be used in fog machines, to ensure the safety of the crew and the voices and health of performers.

Compared to the extensive testing by independent laboratories, and the FDA's prior studies on the use of tobacco in cigarettes, lab reports provided by the FDA are grossly inadequate, even to the layman's eye. With the current provided direction of the Obama administration, which is focusing on an improved health for all, including our currently smoking President, how can the FDA make obviously exaggerated claims over what demonstrates to be such a blatant beneficial alternative to FDA approved tobacco cigarettes?

Thank you,

My name and address

I'm working on drafting some letters to be used as templates to send to Senators, county officials, health departments, etc. I am also working on a tri-fold brochure, which could be left in a pocket underneath a flyer. If anyone works in the graphic design field - you can probably come up with a look far better than I can, so get in touch :)
 
One thing I noticed when I read the report is the fact that they said the vaporizers worked at 45-60 degrees. DEG vaporizes at 90. What should have not been surprising is that there was NO diethylene glycol found in the actual vapor. There is, however, diethylene glycol found in FDA approved cigarette smoke because cigarettes burn at well above the DEG vaporization temp of 90 degrees.
 

xpetechp

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I work for the Federal government - CDC (at the NIOSH laboratories) - and I can tell you that if you attack the science reported by FDA, you're attacking the wrong thing. What I'm trying to say here is that if you are planning a coordinated response to stop an FDA ban, you have to get an emotional upheaval going. You need a large number of people to say why they feel e-cigs are a good thing. The government, like any other issue, responds best to an EMOTIONAL issue - governmental science is colored by politics. While the government will listen to some scientific information, it will undoubtably base its response on the emotions surrounding an issue. And you know, the emotions surrounding smoking are entirely negative.

HOWEVER, if your approach is that e-cigs are a way to quit smoking, you will lose. The bit of science that the government listens too (i.e., the CDC) has not included e-cigs in their ways to quit smoking. You need to come up with another approach! E-cigs look like smoking and therefore, are bad. It does not matter if they are healthier. It does not matter if there is no smell. It looks like cigarettes therefore it is bad. Period. I know there is one report that found Diethylene Glycol - any government representative interested in this issue will only remember the DEG was found. It won't matter if it was only in one sample. This report of DEG will block anything else.

Since we call this activity "vaping" perhaps a better approach would be to focus on all the non-nictotine flavors and the personal enjoyment of using a vaporizor. You may even get a better response if you emotionally state how using a vaporizor makes you breathe easier in all this pollution. The important thing to remember here is that no matter how true the science is behind e-cigs, the jury has already decided against e-cigs as a nicotine dosing device. As far as FDA is concerned, the science is in and debate is closed. Focus on using the device for other purposes.

I'm new to vaping, but not new to the government. I have over 20 years in my career with the government and I started with CDC (at NIOSH) back in 2003. If we want a chance, we have to organize, educate our members along a single line that does not include anything to do with smoking cessation or nicotine, be emotional and loud! If we can save the "personal vaporizor" sans the e-cig idea, we can always make our own juices or add nicotine later.

Just my 2 cents.
 

stevo_tdo

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True. Rulings and supposed bans have always been overturned through history by petions, emotional upheaval or whichever. Pick a day, any day, but coordinate it. Get everyone in your county that is in favor to sign a petition. Next get all the vapors in your county to meet you at the courthouse. Have one ballsy member standing 20 feet ahead of the the group with petitions in hand. Walk into the courthouse (while everyone is vaping) and hand it to whoever is in charge. Simply state your purpose and hand it over. Then walk calmly out to the waiting news station you just happened to give a heads up. Have your **** together with direct quotes to the articles containing the information why the e-cig is safe. Have everyone explain there stories (i'm sure the media will montage this). Have every county in the u.s. try to do this at the same time same day.

That would be a hard thing for the higher ups to ignore.
 

SLDS181

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I'm new to vaping, but not new to the government. I have over 20 years in my career with the government and I started with CDC (at NIOSH) back in 2003. If we want a chance, we have to organize, educate our members along a single line that does not include anything to do with smoking cessation or nicotine, be emotional and loud! If we can save the "personal vaporizor" sans the e-cig idea, we can always make our own juices or add nicotine later.

Just my 2 cents.

You're absolutely right! This email isn't the only way I've been trying to do things, I've asked my friends, family, coworkers, etc to all write an email (they know nothing of the FDA report) with their opinions (which, btw, are VERY positive. Not just with the smoking & non-smoking crowd, but the anti-smoking crowd, too :D )
 

xpetechp

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SLDS181,

The key here is a coordinated response by people who want to vape. I've seen some very good campaigns that forced the government into the political realm away from the scientific. I am a scientist (health physicist) and I'd love to share some of the strategies that worked. Let me know how to join up and help out.

xpetechp
 

SLDS181

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Aug 11, 2009
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SLDS181,

The key here is a coordinated response by people who want to vape. I've seen some very good campaigns that forced the government into the political realm away from the scientific. I am a scientist (health physicist) and I'd love to share some of the strategies that worked. Let me know how to join up and help out.

xpetechp

Health physics, thats radiation biology, right? Cool stuff :D (I'm wierd, I like reading dry and boring stuff)

I'm sure everyone would love to here more - I wouldn't say we're very organized right now though. Spikey has done quite a bit of organizing over in LI, and there are other regional groups, but I wouldn't call us (as a whole) an organization at the moment.
 

PlanetScribbles

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I work for the Federal government - CDC (at the NIOSH laboratories) - and I can tell you that if you attack the science reported by FDA, you're attacking the wrong thing. What I'm trying to say here is that if you are planning a coordinated response to stop an FDA ban, you have to get an emotional upheaval going. You need a large number of people to say why they feel e-cigs are a good thing. The government, like any other issue, responds best to an EMOTIONAL issue - governmental science is colored by politics. While the government will listen to some scientific information, it will undoubtably base its response on the emotions surrounding an issue. And you know, the emotions surrounding smoking are entirely negative.

HOWEVER, if your approach is that e-cigs are a way to quit smoking, you will lose. The bit of science that the government listens too (i.e., the CDC) has not included e-cigs in their ways to quit smoking. You need to come up with another approach! E-cigs look like smoking and therefore, are bad. It does not matter if they are healthier. It does not matter if there is no smell. It looks like cigarettes therefore it is bad. Period. I know there is one report that found Diethylene Glycol - any government representative interested in this issue will only remember the DEG was found. It won't matter if it was only in one sample. This report of DEG will block anything else.

Since we call this activity "vaping" perhaps a better approach would be to focus on all the non-nictotine flavors and the personal enjoyment of using a vaporizor. You may even get a better response if you emotionally state how using a vaporizor makes you breathe easier in all this pollution. The important thing to remember here is that no matter how true the science is behind e-cigs, the jury has already decided against e-cigs as a nicotine dosing device. As far as FDA is concerned, the science is in and debate is closed. Focus on using the device for other purposes.

I'm new to vaping, but not new to the government. I have over 20 years in my career with the government and I started with CDC (at NIOSH) back in 2003. If we want a chance, we have to organize, educate our members along a single line that does not include anything to do with smoking cessation or nicotine, be emotional and loud! If we can save the "personal vaporizor" sans the e-cig idea, we can always make our own juices or add nicotine later.

Just my 2 cents.

By your own words, you admit to being a vaper. So i'm sure that you realise how annoying it is to be told that e-cigs "look like smoking and therefore, are bad". I thought the govt worked on stuff called 'logic'. I use logic every day, and it serves me very well. It is because they look and work so much like cigarettes that makes them such a great cessation device.
To have science that tells us that e-cigs are magnitudes of order healthier than tobacco products too, but are bad because of their cosmetic appearance, kinda defies logic. Don't you think?
Maybe if we put a skull and crossbones symbol on them that will make them better? :confused:
Yeah, that would work. Even if it is kindergarten science :rolleyes:
Informative post, thanks.
 

JustMeAgain

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I work for the Federal government - CDC (at the NIOSH laboratories) - and I can tell you that if you attack the science reported by FDA, you're attacking the wrong thing. quote]

Xpetechp, what you said made me wonder if the focus should be geared toward the CDC rather than the FDA.

They certainly have clout, and I know that many of us feel that the motives behind the FDA's stance are questionable.

Do you think that might worthwhile to channel any efforts toward changing the perception of 'personal vaporizers' (not ecigs :)) through the CDC or are they equally closed-minded?
 

TropicalBob

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That was a gutsy reality-check post, xpete. Thanks. Your points are quite correct, although many here will choke in swallowing them as the truth pill they are.

And, no, the CDC won't step in and regulate e-liquid. The agency that does that is the FDA. There's no way around the FDA, so manufacturers had best get busy at going through the FDA.

I agree that an emotional groundswell can no doubt sway political decisions. I just don't feel e-smoking has the numbers or intensity to create such a groundswell. We are badly outnumbered by the antis.

Do not forget that when the Senate began consideration of the Family Tobacco Control Bill, now the law of the land, one senator stood up and waved a stack of paper, saying it contained more than 1,000 endorsements by health organizations, chambers of commerce, clubs, etc. Count those on the jury that has pre-determined e-smoking's guilt.

We have formidable forces against e-smoking. Better create a tsunami from that groundswell if there's any hope at all.
 

Treece

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I think what we need are for some FDA scientists, researchers, and physicians to step up and tell the truth here--the way nine such scientists did in January of this year in their letter to President Obama. They declared, in no uncertain terms, that management was coercing them into being dishonest. They said so, and it made headlines and got results.

Maybe we ought to be appealing to the professionals in the FDA who have a conscience.
 

Heed

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You may even get a better response if you emotionally state how using a vaporizor makes you breathe easier in all this pollution.

Making ridiculous claims like this or overly emotional appeals is handing the opposition a stick to beat us with:

"See how they provide no evidence to back up their emotional appeals while we have science on our side".

I really have to wonder who's interest is served best by this tactic.

While logic and reason may not win the battle alone, abandoning them for lies and emotional outbursts is a fast track to being mocked -- and rightly so.
 

surbitonPete

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Making ridiculous claims like this or overly emotional appeals is handing the opposition a stick to beat us with:

"See how they provide no evidence to back up their emotional appeals while we have science on our side".

I really have to wonder who's interest is served best by this tactic.

While logic and reason may not win the battle alone, abandoning them for lies and emotional outbursts is a fast track to being mocked -- and rightly so.

There are certainly no lies in saying how much better our breathing is and even medical proof of it.
 

Heed

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There are certainly no lies in saying how much better our breathing is and even medical proof of it.

Did you even read the quoted text? Here it is again:
You may even get a better response if you emotionally state how using a vaporizor makes you breathe easier in all this pollution.
Yes, a lot of people breathe better when switching to vaping -- because they're not smoking as much or at all. Not because vaping is some sort of defence against pollution in the air.
 

surbitonPete

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Did you even read the quoted text? Here it is again:

Yes, a lot of people breathe better when switching to vaping -- because they're not smoking as much or at all. Not because vaping is some sort of defence against pollution in the air.

oh yes I agree the 'defence against pollution' part is a bit daft but the importance of the improvements to our health are no small thing and should be the focus of the argument and not casually dismissed because it 'looks like smoking'. I don't think any of us continue to vape because we 'think' it must be healthier.....we can tell it's healthier and if it wasn't you would have expected it to show up by now.
 
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xpetechp

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Quoted from Heed: Making ridiculous claims like this or overly emotional appeals is handing the opposition a stick to beat us with: "See how they provide no evidence to back up their emotional appeals while we have science on our side". I really have to wonder who's interest is served best by this tactic. While logic and reason may not win the battle alone, abandoning them for lies and emotional outbursts is a fast track to being mocked -- and rightly so.

I don't disagree with you but I think there are many people in this (and other) forum(s) that are woefully naive about how our government makes decisions. Someone mentioned they thought government works on logic - the FDA might work on logic, but politics and emotion ALWAYS TRUMP LOGIC.

You might be thinking, how does he know this? I work in a program that supports a Department of Labor (DOL) compensation program. We use radiation protection sciences combined with politics and public relations to help DOL determine if someone should be compensated for cancer based on radiation dose. We almost never are questioned on science - it is always emotion. Emotional response move the congressmen/senate staffers that affect how the program is run. Nothing else works.

By the way, the reason why we're never questioned on science is because the government made the laws that set-up the framework of how we determine what is important to the scientist. This is also true for the FDA. CDC is more or less a consultant to FDA - FDA will use CDC data (which is holy writ for almost all Americans) to back up their claims. In this case you cannot fight city hall directly, you have to do an end around.

Some very key points to remember here are:

1. Our science will never beat their science - if FDA says nic juice is bad, then it is. You will just have to get over this on your own.

2. The science we should use (my opinion) should address the general positive effects of vaping; not a means to quit smoking. I'd like to add that I received my 510 on 08/21/09 and I've been analog free since 08/22/09. I'm also showing off my 510 to other employees within CDC - this will be a slow process, but it will make headway.

3. Getting doctors on our side - those willing to make statements will be the most help. But if they are not willing to speak out, they are of no use.

4. I don't know how this forum is set-up, but if the moderator has the ability, there should be a section where we can go to electronically sign e-mail to our elected representatives. This way, people that wouldn't normally write in, would write in, and the message sent would be more uniform.
 
That is a very interesting alternate perspective. The deepest attraction to e-cigarettes for a smoker is rather difficult to quantify into a scientific study like that released by the FDA. How do you "prove" to a non-smoker that the reason that most smoking cessation programs don't work is the little things like the feeling you get from holding something between your fingers, the calm that ministers directly to your soul as you watch little white swirls float in front of your face, the intimate tickle at the back of your throat, and all the other nuances in the ritual of smoking that are mimiced faithfully by personal vaporizers, but leave people attempting to use any of the the NRTs feeling like they are still missing something? The FDA study doesn't say a word about how difficult it is psychologically to abandon smoking completely and for eternity, and how that fear is alleviated by knowing that by use of a PV you DON'T have to give up the things you like about smoking but can still give up most of the horrendous health hazards.
 

larcat

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We need to exploit the population of Vapers.

There are people on this forum who are elderly. There are people on this forum with *serious* health problems associated with smoking.

There are people in both of the above populations who have tried to quit in every way imaginable, and were unable, but have begun vaping and it has let them IMMEDIATELY FEEL BETTER.

Not be healthier in a proveable way, but FEEL better.

Grandmama saying that the E-Cig has let her walk up the stairs without pausing at the landing to catch her breath will do more than a thousand people preaching about how much they love their root-beer flavored vape.

Those are the people we need willing to come forward and bring the emotion.

Then the doctors et. al. can chime in.

Just my 2 cents.

-Larcat
 

larcat

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That is a very interesting alternate perspective. The deepest attraction to e-cigarettes for a smoker is rather difficult to quantify into a scientific study like that released by the FDA. How do you "prove" to a non-smoker that the reason that most smoking cessation programs don't work is the little things like the feeling you get from holding something between your fingers, the calm that ministers directly to your soul as you watch little white swirls float in front of your face, the intimate tickle at the back of your throat, and all the other nuances in the ritual of smoking that are mimiced faithfully by personal vaporizers, but leave people attempting to use any of the the NRTs feeling like they are still missing something? The FDA study doesn't say a word about how difficult it is psychologically to abandon smoking completely and for eternity, and how that fear is alleviated by knowing that by use of a PV you DON'T have to give up the things you like about smoking but can still give up most of the horrendous health hazards.

You have touched on the something that is always dismissed by non smokers here.

I think it is deeper than anyone realizes.

15 drags per cig. 30 cigs a day, 365 days a year for 15 years of my life. I have taken two million four hundred and sixty three thousand, seven hundred and fifty drags on cigarettes.

Imagine a Catholic priest with a rosary. Everytime he is in a stressful situation, he clicks through the prayer beads, and it brings him peace. Endorphins flood his brain and the action is reinforced.

Imagine a concert pianist. Everytime time he hits a note on a piano he is at peace, and the endorphins in his brain reinforce the action.

We KNOW that repetitive fine motor movements blaze self-reinforcing pathways in our brains (you can google that stuff yourself). Add in a HIGHLY addictive stimulant that aids in concentration, and you have yourself a nuclear bomb of an addiction. Only HALF of it is the nicotine.

I've sat there and clicked my prayer beads-dipped in addiction juice two million four hundred and sixty three thousand, seven hundred and fifty times. I'm 28 years old. How many times have you done it?

-Larcat
 
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