American Lung Association against e-cigs

[jpargana]

You seem to be saying that SEEKING APPROVAL from the FDA means not selling product until approval.

What I'm saying is SEEK APPROVAL. If the FDA objects to use of certain materials, then redesign without those materials and SEEK APPROVAL again.

If I were a manufacturer, I'd want to get a stamp of APPROVAL on MY product to distinguish it from competition; What about USP Grade? If I could USP Grade Approval for my pyrex clearo I'd put a USP stamp on it.

The problem is right now the vaping industry is still content to align itself with junkies and "drugs" when it should be aiming for STANDARDS and QUALITY.

Well, the problem is that FDA has been behaving like any other ANTZ organization regarding the e-cig. Just look at how biased FDA's studies were, and how they were conducted and publicized.

I'm not sure if we need, or will ever get, the approval from a biased and corrupt organization, that puts money before people, and ideology before science.

As a vaper, I would feel much more safer if the product I USE had a stamp of APPROVAL from a serious, independent and scientific organization (think of the 100 french doctors who wrote a letter to the EU before the votiong on the 08th, for example). An organization that actually does science, insted of junk-science. An organization free of obvious conflicts of interest.

 

[edyle]

Well, the problem is that FDA has been behaving like any other ANTZ organization regarding the e-cig. Just look at how biased FDA's studies were, and how they were conducted and publicized.

I'm not sure if we need, or will ever get, the approval from a biased and corrupt organization, that puts money before people, and ideology before science.

As a vaper, I would feel much more safer if the product I USE had a stamp of APPROVAL from a serious, independent and scientific organization (think of the 100 french doctors who wrote a letter to the EU before the votiong on the 08th, for example). An organization that actually does science, insted of junk-science. An organization free of obvious conflicts of interest.

Yes, THAT is along the lines of what I was trying to say; would the Cancer Society approve a particular product? Maybe not, I'm not so sure, but surely there is some sort of standards system; the ALA certainly has an interest in the ecig industry; obviously the ALA cannot approve ecigs as a generalization, but they could certainly be approached by individual manufacturers to approve there products;

So for example, I wouldn't expect the ALA to approve plastic tanks, or atomisers with certain low quality seals; probably not cotton wicks; tanks that contain glue on the inside; "stainless steel" tanks that actually have a high content of lead or other heavy metals.

 

[emus]

Yes, THAT is along the lines of what I was trying to say; would the Cancer Society approve a particular product? Maybe not, I'm not so sure, but surely there is some sort of standards system; the ALA certainly has an interest in the ecig industry; obviously the ALA cannot approve ecigs as a generalization, but they could certainly be approached by individual manufacturers to approve there products;

So for example, I wouldn't expect the ALA to approve plastic tanks, or atomisers with certain low quality seals; probably not cotton wicks; tanks that contain glue on the inside; "stainless steel" tanks that actually have a high content of lead or other heavy metals.

I'm venturing to guess you haven't met Dr. Burzynski.

https://www.youtube.com/watch?v=yJSWWaoXfOw

 

[edyle]

Thanks DC2 for the link to AEMSA.
AEMSA Returns to the FDA for Second Session | AEMSA

AEMSA Returns to the FDA for Second Session
Posted on 07/25/2013

images (3)

AEMSA/FDA – “Listening Session” #2

Continuing with our stated Mission and Charter, AEMSA returned to the FDA for a 2nd “Listening Session” on July 12, 2013. Appropriately, AEMSA represented its membership.

During the first “Listening Session” (March 21, 2013), we introduced the FDA to AEMSA’s Structure, Membership, Mission, Standards, Science behind the Standards (SME presentations), how the Standards are applied by our General Members in their facilities and our Inspections (both scheduled and unscheduled). Clearly, by the very nature of AEMSA, these were all directly in relation to Re-Fillable E-liquids and the manufacturing processes.

AEMSA offered to return and present on how these Re-Fillable E-liquids are used by consumers (atomizers, cartomizers, tanks, etc. and representative devices on which they are paired). For this second “Listening Session”, the AEMSA team brought a representative collection of sample hardware products (examples of the most common spectrum). We presented on the evolution, application(s) and contributions these products make towards efficacy. Product samples were made available for FDA representatives to see in both sealed packaging (as sold) and open for hands-on direct viewing. We believe that for the FDA to understand these products, they needed to see and learn about them with direct and actual physical interaction.

The presentation:

- Introduction of the Presentation (included AEMSA’s growth, AEMSA Standards are one delineation of cGMPs, and a brief summary of products evolution): Lou Ritter (Co-Founder and President).

- Atomizers, Cartomizers, Tanks, etc. specifically designed for Refillable e-liquids and their contributions to efficacy: Linc Williams (Co-Founder and Compliance Chairman/Board Member).

- Battery devices, Electronics and Safety Features (generic overview of the spectrum from mini/stick to Variable Voltage to Variable Wattage and the safety features engineered into current production electronics in today’s devices): Brandon Ward of Evolv, LLC (Non- AEMSA member, presenting in a “Guest SME capacity”).

- Conclusion: Lou Ritter

- Note: Scott Eley (AEMSA Vice-President and General Member) and Dr. Matt Melvin (AEMSA SME & Enthalpy Analytical) attended to facilitate Q&A and discussions. Both made substantive contributions.

The FDA panel was comprised of approximately 20 representatives from various departments. The session was scheduled for 1 hour and lasted just shy of 2 hours. We found the FDA representatives interested and engaged in the material. Their questions were relevant, thoughtful and substantive.

Some of the specific topics discussed included:

- Keeping coils wet (necessity for liquids to be in direct contact with the coil).

- Emphasis on E-cig innovation does not equate to Tobacco innovation – E-cig innovation improves consumer product quality and safety (e.g. engineered electronic safety features, etc.).

- Innovations are consumer driven.

- Adoption rates are more than nicotine replacement and physical emulations – the many combinations of gear and re-fillable e-liquids provide user customizations to subjective preferences = contributes to efficacy.

- The cost benefit from advanced devices and refillable liquids to consumers as compared to disposable e-cigarettes and/or prefilled cartos.

The AEMSA team unanimously agreed: the Session was extremely positive, constructive and another substantial step in the process of advocating for Re-Fillable E-liquids and the profound contributions they make towards efficacy.

AEMSA is committed to continuing to advocate for Re-Fillable E-liquids and their profound contributions to THR efficacy.

For more information on joining AEMSA: Join AEMSA | AEMSA

 

[edyle]

Thanks DC2 for the link to AEMSA.
AEMSA Returns to the FDA for Second Session | AEMSA

AEMSA Returns to the FDA for Second Session
Posted on 07/25/2013

images (3)

AEMSA/FDA – “Listening Session” #2

Continuing with our stated Mission and Charter, AEMSA returned to the FDA for a 2nd “Listening Session” on July 12, 2013. Appropriately, AEMSA represented its membership.

During the first “Listening Session” (March 21, 2013), we introduced the FDA to AEMSA’s Structure, Membership, Mission, Standards, Science behind the Standards (SME presentations), how the Standards are applied by our General Members in their facilities and our Inspections (both scheduled and unscheduled). Clearly, by the very nature of AEMSA, these were all directly in relation to Re-Fillable E-liquids and the manufacturing processes.

AEMSA offered to return and present on how these Re-Fillable E-liquids are used by consumers (atomizers, cartomizers, tanks, etc. and representative devices on which they are paired). For this second “Listening Session”, the AEMSA team brought a representative collection of sample hardware products (examples of the most common spectrum). We presented on the evolution, application(s) and contributions these products make towards efficacy. Product samples were made available for FDA representatives to see in both sealed packaging (as sold) and open for hands-on direct viewing. We believe that for the FDA to understand these products, they needed to see and learn about them with direct and actual physical interaction.

The presentation:

- Introduction of the Presentation (included AEMSA’s growth, AEMSA Standards are one delineation of cGMPs, and a brief summary of products evolution): Lou Ritter (Co-Founder and President).

- Atomizers, Cartomizers, Tanks, etc. specifically designed for Refillable e-liquids and their contributions to efficacy: Linc Williams (Co-Founder and Compliance Chairman/Board Member).

- Battery devices, Electronics and Safety Features (generic overview of the spectrum from mini/stick to Variable Voltage to Variable Wattage and the safety features engineered into current production electronics in today’s devices): Brandon Ward of Evolv, LLC (Non- AEMSA member, presenting in a “Guest SME capacity”).

- Conclusion: Lou Ritter

- Note: Scott Eley (AEMSA Vice-President and General Member) and Dr. Matt Melvin (AEMSA SME & Enthalpy Analytical) attended to facilitate Q&A and discussions. Both made substantive contributions.

The FDA panel was comprised of approximately 20 representatives from various departments. The session was scheduled for 1 hour and lasted just shy of 2 hours. We found the FDA representatives interested and engaged in the material. Their questions were relevant, thoughtful and substantive.

Some of the specific topics discussed included:

- Keeping coils wet (necessity for liquids to be in direct contact with the coil).

- Emphasis on E-cig innovation does not equate to Tobacco innovation – E-cig innovation improves consumer product quality and safety (e.g. engineered electronic safety features, etc.).

- Innovations are consumer driven.

- Adoption rates are more than nicotine replacement and physical emulations – the many combinations of gear and re-fillable e-liquids provide user customizations to subjective preferences = contributes to efficacy.

- The cost benefit from advanced devices and refillable liquids to consumers as compared to disposable e-cigarettes and/or prefilled cartos.

The AEMSA team unanimously agreed: the Session was extremely positive, constructive and another substantial step in the process of advocating for Re-Fillable E-liquids and the profound contributions they make towards efficacy.

AEMSA is committed to continuing to advocate for Re-Fillable E-liquids and their profound contributions to THR efficacy.

For more information on joining AEMSA: Join AEMSA | AEMSA

 

[AgentAnia]

Well actually I meant in terms of ecig equipment or eliquids.

Would I prefer ecig equipment or e-liquids approved by FDA? Absolutely not! Here's how much FDA knows about ecigs (from their web page)



Given this is how they think an ecig is charged, I would put NO faith in their ability to understand, evaluate and approve anything connected to ecigs. In fact, to take it further, I would not *touch* any FDA-approved ecig product or device!

 

[edyle]

Would I prefer ecig equipment or e-liquids approved by FDA? Absolutely not! Here's how much FDA knows about ecigs (from their web page)

View attachment 280877

Given this is how they think an ecig is charged, I would put NO faith in their ability to understand, evaluate and approve anything connected to ecigs. In fact, to take it further, I would not *touch* any FDA-approved ecig product or device!

Well you go! An FDA approval is something even you want to be aware of!
)))))

 

[AgentAnia]

@Edward Lewis: As I understand it, the only way FDA could "approve" or regulate anything relating to ecigs (other than e-liquid) would be if a device was a one-piece cigalike. It does not regulate batteries, or tanks, by themselves. The only part of a non-cigalike ecig would be the liquid.

USP is not a government agency:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

USP standards are developed and revised by more than 900 volunteer experts, including international participants, who work with USP under strict conflict-of-interest rules. Since its founding in 1820, USP has helped secure the quality of the American drug supply. Building on that legacy, USP today works with scientists, practitioners, and regulators of many nations to help protect public health worldwide.

Yes, I trust products with USP approval, precisely because it analyzes and evaluates products *independently* of government. USP would not approve or disapprove devices -- batteries or tanks. That would be, I believe, a function of the Consumer Products Safety Commission.

And I must take exception to your statement:

The problem is right now the vaping industry is still content to align itself with junkies and "drugs" when it should be aiming for STANDARDS and QUALITY.

Perhaps that's true of the vaping industry of Trinidad and Tobago, but I've seen nothing to indicate such a thing in the United States. Au contraire.

 

[AgentAnia]

Well you go! An FDA approval is something even you want to be aware of!
)))))

Absolutely! If the FDA goes into the business of approving ecig products, I would definitely want to be aware of those products, not because their approval would give me confidence in such products but so I could avoid them.

 

[edyle]

@Edward Lewis: As I understand it, the only way FDA could "approve" or regulate anything relating to ecigs (other than e-liquid) would be if a device was a one-piece cigalike. It does not regulate batteries, or tanks, by themselves. The only part of a non-cigalike ecig would be the liquid.

USP is not a government agency:



Yes, I trust products with USP approval, precisely because it analyzes and evaluates products *independently* of government. USP would not approve or disapprove devices -- batteries or tanks. That would be, I believe, a function of the Consumer Products Safety Commission.

And I must take exception to your statement:



Perhaps that's true of the vaping industry of Trinidad and Tobago, but I've seen nothing to indicate such a thing in the United States. Au contraire.

I am aware, by the way, that the USP is not a government agency and wonder if there was something in my post that conveyed the impression that it was.

Yes the last statement was meant to be extreme.

And looking at the history provided on CASAA's site I can see why the name "FDA" provokes the reaction that it has; the FDA so far has been fighting ecigs kicking and screaming every step of the way so far by the looks of it. Hopefully they have started to become enlightened this year.

 

[DC2]

And looking at the history provided on CASAA's site I can see why the name "FDA" provokes the reaction that it has; the FDA so far has been fighting ecigs kicking and screaming every step of the way so far by the looks of it. Hopefully they have started to become enlightened this year.

I'll hold my breath....

 

[beckdg]

Well you go! An FDA approval is something even you want to be aware of!
)))))

please do some research on health and these organizations you seem to trust.

start with milk, it's health effects and it's REAL effects when pasteurized. the reason for pasteurization in the first place and why it's no longer necessary.
then move to veggies. look for organic and what that means when it garnishes an FDA approval vs. REAL organicly grown. look for genetically modified and the purposes for which the modification is sought after. a modified seed can be patented and cannot be sold by another entity without paying royalties for one example. and there is a company trying to modify seeds so they can't grow veggies that put out good seed with the crop so farmers have to buy that companies seed year after year.
then look at grain and nuts. where's that lead you?
look into gerson therapy. where's that conducted and why? not in the US and greed... of the FDA, other similar gov't organizations in place to "protect" us... and big pharma... who's had a higher failure rate with cancer than clueless joe farmer down the road.

my son and a couple of my nieces NEED there to be some honesty amongst these organizations... OR a family member intelligent and diligent enough to seek out such information. we've cured eczema, severe allergies and cancer in our family. ALL of which we were told would be life time afflictions and/or certain death THANKS TO THE APPROVAL AND PROPAGANDA YOU'RE TOUTING AS BENEFICIAL.

there seems to be some serious confusion and misdirection of trust in this thread. a vast abundance.

 

[Mark Anthony]

Well said MC.....

 

[moondragon]

This has been a highly informative thread, not just for the discussion itself, but also for all of the links to studies and other articles, most all of which I went off and read (and bookmarked many of them). It was a good refresher on the history in terms of regulation and/or acceptance as harm reduction technique. I try to stay informed about current legislative states (and I do belong to CASAA) but I don't always remember everything regarding studies, etc., so I find periodic refreshers and reviews helpful for myself.

While I was off looking at studies, I came across an article I hadn't seen before. Some of you may have already been aware of it as it had a illustration credited to CASAA, but I'll share the link anyway. It's fairly long, but it was one I could "open up" without being asked to pay for it, and I thought it was a good article.
A fresh look at tobacco harm reduction: the case for the electronic cigarette

 

[Uma]

This has been a highly informative thread, not just for the discussion itself, but also for all of the links to studies and other articles, most all of which I went off and read (and bookmarked many of them). It was a good refresher on the history in terms of regulation and/or acceptance as harm reduction technique. I try to stay informed about current legislative states (and I do belong to CASAA) but I don't always remember everything regarding studies, etc., so I find periodic refreshers and reviews helpful for myself.

While I was off looking at studies, I came across an article I hadn't seen before. Some of you may have already been aware of it as it had a illustration credited to CASAA, but I'll share the link anyway. It's fairly long, but it was one I could "open up" without being asked to pay for it, and I thought it was a good article.
A fresh look at tobacco harm reduction: the case for the electronic cigarette

Excellent find!!! Thanks so much for posting this!
"The dream of a tobacco-free, nicotine-free world is just that—a dream. Nicotine’s beneficial effects include correcting problems with concentration, attention and memory, as well as improving symptoms of mood impairments. Keeping such disabilities at bay right now can be much stronger motivation to continue using nicotine than any threats of diseases that may strike years and years in the future."

The entire article is quotable, love it!

 

[moondragon]

Glad you liked it! It does have a lot of really good quotable paragraphs. It seems to me, to be balanced, in that it doesn't gloss over concerns and criticisms, but acknowledges them yet at the same time providing reasons why the report is making the case in favor of e-cigs.

 

[Uma]

Glad you liked it! It does have a lot of really good quotable paragraphs. It seems to me, to be balanced, in that it doesn't gloss over concerns and criticisms, but acknowledges them yet at the same time providing reasons why the report is making the case in favor of e-cigs.

Exactly! Very well balanced info!
I'm up to this part: "It is of paramount importance that government and trusted health authorities provide accurate and truthful information about the relative risks of smoking and alternatives to smoking. If the public continues to be misled about the risks of THR products, millions of smokers will be dissuaded from switching to these much less hazardous alternatives. One of us recently wrote that, “It’s time to be honest with the 50 million Americans, and hundreds of millions around the world, who use tobacco. The benefits they get from tobacco are very real. It’s time to abandon the myth that tobacco is devoid of benefits, and to focus on how we can help smokers continue to derive those benefits with a safer delivery system” [95]."
I couldn't agree more. (I admit I'm biased, but even if I never smoked, didn't vape, this would ring true in my soul)

 

[moondragon]

Right! and one would think that is what they would have been doing, but it's a strange world these days... I suppose I have had a naive type of faith in the government and its agencies, but getting involved here has opened my eyes some

 

[mackman]

We're the ones who have Cigarettes attached to the letter E- of our business name.

The BIG Tobacco INDUSTRY lied time and again to the AMERICAN people and the WORLD
about how deadly CIGARETTES are... and hundreds of Millions have died... and 1,200 each day are dying.

As long as we have the NAME: CIGARETTE or CIGS attached to our NAME we will be at
at the BULLS EYE OF A ...... TARGET

Old Steer hit the nail on the head. Uninformed people have preconceived ideas and cigarette=deadly, stinky, intrusive etc. To the uninformed if it looks like a cigarette, blows a smoke like vapor from your mouth... to them its a cigarette. When big tobacco tries to take over the industry, overcoming the stigma is lost on the uniformed masses no matter what the educational campaign.

 

[Uma]

Right! and one would think that is what they would have been doing, but it's a strange world these days... I suppose I have had a naive type of faith in the government and its agencies, but getting involved here has opened my eyes some

You and me both, Honey, you and me both.