What kind of tests do the FDA want?

[Lorena_Palin]

OK, since getting tested by the FDA is what they seam to want, what would be necessary?

Do the tests have to be conducted by the FDA themselves, or could a thorough set of tests by any well respected university or hospital in the US work?

The things I see as necessary would be:

1: Taking a large sample of the most popular brands of tobacco cigarettes and hooking them up to one of those "smoking machines" and collecting the inhaled mixture. Each of those would be chemically analyzed, and tar, nicotine, carbon monoxide, and all the other hazardous chemicals would be cataloged.

2: The same number of inhalations/intake would be done with all the most popular E-cig models with no nic, low nic, medium nic, and high nic solutions with both PG and VG juices.

3: Lab mice or rabbits in various sealed boxes would be exposed to cigarette smoke from a number of major brands, vapor from nic juice at varying nicotine levels in VG and PG, as well as non-nicotine PG and VG juices. A control box would be set up with regular air set up. Just for kicks you might also try pumping afew with samples set to mimick average air conditions in New York and Los Angelas. Lifespan, physical health (put them on treadmills, measure thier weight, etc...) would be tested, breeding characteristics, birth defects, and birth weight of the animals, as well as and autopsy after the natural death of any of the test animals to check thier lung health, toxins in the liver, and any other medical results.

Do you think that would work?

 

[TropicalBob]

No. The FDA will not be comparing e-cigs to tobacco cigs. E-cigs must be tested on their own. And it is up to those who would sell them to have them tested and approved by the FDA. The FDA will not be conducting tests. It doesn't do tests for product producers. Tests are expensive and time-consuming. All current NRT products were tested and approved.

Drop any idea of using a claim that e-smoking is "safer" than tobacco smoking. That is not and never has been a consideration.

And neither are taxes a consideration, as so many seem to think. Since when did the FDA set or collect taxes? It is an independent regulatory agency charged with food and drug oversight. Huge job. You can't sell snake oil without FDA approval. No unknown, unregulated, untested chemical concoction with an addictive poison as an ingredient, designed to treat nicotine addiction, will be allowed to remain on the market, under FDA guidelines.

 

[mkscr]

Drop any idea of using a claim that e-smoking is "safer" than tobacco smoking.

There is the problem. The above statement is what quite a few are waving around as banners. It's a terrific side benefit for many, but not the idea behind the product itself.

The tax comments don't come from concerns regarding the FDA, it's just an added concern. When and if, the FDA finds other "witch-hunting" activities, "saving the children" will step into the picture.

How else can we support children's health care if we no longer purchase heavily taxed tobacco products?

 

[Vicks Vap-oh-Yeah]

Drop any idea of using a claim that e-smoking is "safer" than tobacco smoking. That is not and never has been a consideration.

This is where the comprimise needs to kick in - it's the entire thesis behind harm reduction products..... and needs to be the shift in governmental thinking. IF they do, indeed, want Americans off tobacco - they MUST give an alternative that is satisfying to the user and approved for long term recreational usage. They have to allow a like for like experience at a substantially reduced risk potential.

Tobacco is, like it or not, recreational nicotine usage. Its a vice that's threaded thoughout our history. Its never going to go away....just like alcohol, because human beings NEED their vices. To take them away breeds discontent and hostility on a frightening scale.

Our government need to be made to see this - that they CANNOT eliminate this vice, and are foolish in the extreme to try. Until that shift happens, we - the ones in the middle, will continue to be leaves at the mercy of the winds.

 

[BigJimW]

No. The FDA will not be comparing e-cigs to tobacco cigs. E-cigs must be tested on their own. And it is up to those who would sell them to have them tested and approved by the FDA. The FDA will not be conducting tests. It doesn't do tests for product producers. Tests are expensive and time-consuming. All current NRT products were tested and approved.

Drop any idea of using a claim that e-smoking is "safer" than tobacco smoking. That is not and never has been a consideration.

And neither are taxes a consideration, as so many seem to think. Since when did the FDA set or collect taxes? It is an independent regulatory agency charged with food and drug oversight. Huge job. You can't sell snake oil without FDA approval. No unknown, unregulated, untested chemical concoction with an addictive poison as an ingredient, designed to treat nicotine addiction, will be allowed to remain on the market, under FDA guidelines.

I do have to agree with Bob. I think more tests should be done to 100% cement the fact that e-cigs are a safer alternative.

But the problem is in the US, it takes YEARS to test something, and I don't think as vaporers, we need to wait that long.

Since e-cigs have been out since 2004, and there has not been ONE single reported death since the release of e-cigs (compared to 400,000 a year smoking analogs), I'm pretty sure they're safe.

I learned that the FDA is not the problem. It was how e-cigs were marketed as a stop smoking aid (which some still do). The FDA is simply doing their job to prove the claims.

I still think the FDA sucks, but Bob is right.

 

[nitewriter]

TB, (or anyone) aren't most studies done by the FDA financed by pharmaceutical companies? Wouldn't that give them a big rea$on to be bia$ed, or to not want to do the $tudie$ needed for approval?

 

[Sun Vaporer]

The FDA approval process is pretty straight forward. The manufacture of the product submits it application and then follows the FDA requiste guidlines for the type of information and studies that need to be submitted for review. The FDA then has a committee comprised of Health Profesionals that review the submitted documentation and either Approve, Deny, or request additional information.

All of the funding for the studies and information that the FDA requires is paid for by the Manufacture and the studies are done by 3rd parties that adhear to the FDA mandates. The problem with the e-cig is that no one ever did this.

NOTE: that the FDA's current position is that they are not, according to them, "banning" the e-cig, rather demanding that they go though the application and approval process before they can be sold. This process can take years and a whole lot of money. That really constitutes a "defacto ban" due to the time and expense of the approval process on top of the fact that there is no gurantee that the FDA will ever approve it even after the application is submitted and the stuides are done-----

Sun

 

[Lorena_Palin]

I do have to agree with Bob. I think more tests should be done to 100% cement the fact that e-cigs are a safer alternative.

But the problem is in the US, it takes YEARS to test something, and I don't think as vaporers, we need to wait that long.

Since e-cigs have been out since 2004, and there has not been ONE single reported death since the release of e-cigs (compared to 400,000 a year smoking analogs), I'm pretty sure they're safe.

I learned that the FDA is not the problem. It was how e-cigs were marketed as a stop smoking aid (which some still do). The FDA is simply doing their job to prove the claims.

I still think the FDA sucks, but Bob is right.

So...Excuse me if I know absolutely nothing...do they need testing or any of this other crap if we just call the carts/juice tobacco products, and the batteries, atomizers, and other such things be considered in the same class as a tobacco pipe?

 

[STILLSMOK9]

I do have to agree with Bob. I think more tests should be done to 100% cement the fact that e-cigs are a safer alternative.

But the problem is in the US, it takes YEARS to test something, and I don't think as vaporers, we need to wait that long.

Since e-cigs have been out since 2004, and there has not been ONE single reported death since the release of e-cigs (compared to 400,000 a year smoking analogs), I'm pretty sure they're safe.

I learned that the FDA is not the problem. It was how e-cigs were marketed as a stop smoking aid (which some still do). The FDA is simply doing their job to prove the claims.

I still think the FDA sucks, but Bob is right.

Big Jim, forgive me if someone already has stated this, but there probably are not too many(if any) deaths from someone that took up analogs on 2004. I get where you are going but, we have to compare apples with apples.. IMHO

 

[TropicalBob]

Health New Zealand made the most interesting tax proposal I've yet read: Have a panel of medical professionals examine all the items used by nicotine addicts, from unfiltered cigarettes to dissolvable tobacco pellets, including the e-smoking devices, and then create a taxation system that scales in proportion to the health dangers from each product.

Highest tax? The unfiltered cigarette. Then the filtered cigarette. Then chewing tobacco, and cigars, and pipe tobacco, and roll-your-own paraphenalia. E-cigs would be taxed, but way, way down the list, by any reasonable consideration. Snus, nasal snuff and dissolvables would get little taxation. They just aren't dangerous. Not 100% safe, but not dangeorus in the way other addictive sources are.

Taxes must and will be collected, to offset health costs if nothing else. But tax in proportion to the hazard and cost to society. I, for one, am certain on a personal level that my e-cigs are less hazardous to my health than my former 30-a-day cig addiction. I'll pay my fair share for the decreased risk I feel I now enjoy.

 

[Janetda]

First and foremost, there is no way you're going to get Institutional Review Board (IRB) approval to do a well designed study. You would have to have current smokers continuing to use analogs, current smokers switching to only e-cigs, non-smokers and most egregiously, non-smokers who take up e-cigs. What IRB committee is going to approve that? There just isn't going to be a way to prove these are safe. However, I do think it can be shown that they are "safer". The question remains, is "safer" good enough?

 

[lordmage]

all the rain in spain still wont help the cost of tea in china. that said not matter what we want. they will do what they will do. we can either take it or leave it to a place that will take it.

 

[JRS42082]

Health New Zealand made the most interesting tax proposal I've yet read: Have a panel of medical professionals examine all the items used by nicotine addicts, from unfiltered cigarettes to dissolvable tobacco pellets, including the e-smoking devices, and then create a taxation system that scales in proportion to the health dangers from each product.

Highest tax? The unfiltered cigarette. Then the filtered cigarette. Then chewing tobacco, and cigars, and pipe tobacco, and roll-your-own paraphenalia. E-cigs would be taxed, but way, way down the list, by any reasonable consideration. Snus, nasal snuff and dissolvables would get little taxation. They just aren't dangerous. Not 100% safe, but not dangeorus in the way other addictive sources are.

Taxes must and will be collected, to offset health costs if nothing else. But tax in proportion to the hazard and cost to society. I, for one, am certain on a personal level that my e-cigs are less hazardous to my health than my former 30-a-day cig addiction. I'll pay my fair share for the decreased risk I feel I now enjoy.

I tend to disagree with you. The latest tobacco tax hike in the U.S. had nothing to do with the hazards to self or society, it was just an easily targetable group which Obama decided was a good place to get more money for his communist ideals. He could have put it anywhere, but he put it on smokers. Why? Because if you're going to make someone mad about taxes, make it the smokers. Noone cares about our rights. Time and time again, we are the only acceptable group to discriminate against. Even alcoholics have a "disease", but we're just a bunch of people too stupid to read the writing on the wall. (at least that is the majority of people's opinion of us)

Obesity is the single biggest problem in our country today, but put a 300% tax on those 99 cent double cheeseburgers from McDonald's and see how long it lasts.

 

[TropicalBob]

You missed my whole point. Yes, the latest tax hike is unjust. And it imposes its burdens on the least affluent, least educated segment of American society. As a group, that's what cigarette smokers are.

So hit America's poor with a huge tax. And what happens? I can almost guarantee you that food is coming off kitchen tables. Children will go hungry so mom and maybe dad, if he's present, can buy their expensive cigarettes. Addiction demands trump everything and limited family funds will buy cigarettes first, well ahead of food. It sucks. The tax hike just takes that much more food from the children (hey, save the children; roll back tobacco taxes).

A graduated tax rate for tobacco and nicotine products is the only sane way to tax these unhealthy products. That's the point I was making.

 

[BigJimW]

And it imposes its burdens on the least affluent, least educated segment of American society.

I hear ya there.

 

[OutWest]

You missed my whole point. Yes, the latest tax hike is unjust. And it imposes its burdens on the least affluent, least educated segment of American society. As a group, that's what cigarette smokers are.

So hit America's poor with a huge tax. And what happens? I can almost guarantee you that food is coming off kitchen tables. Children will go hungry so mom and maybe dad, if he's present, can buy their expensive cigarettes. Addiction demands trump everything and limited family funds will buy cigarettes first, well ahead of food. It sucks. The tax hike just takes that much more food from the children (hey, save the children; roll back tobacco taxes).

A graduated tax rate for tobacco and nicotine products is the only sane way to tax these unhealthy products. That's the point I was making.

The recent tax hike also creates more petty theft as people try to make ends meet while still feeding their addiction. And, it also causes more armed robbery of places that sell tobacco, due to increased demand on the black market. I agree with ya - if you're going to heavily tax a product such as tobacco, a graduated tax would make much more sense.

 

[BigJimW]

The recent tax hike also creates more petty theft as people try to make ends meet while still feeding their addiction. And, it also causes more armed robbery of places that sell tobacco, due to increased demand on the black market. I agree with ya - if you're going to heavily tax a product such as tobacco, a graduated tax would make much more sense.

But when was the last time the government did anything that made any sense?

No getting the genie back in this bottle. All we can do is watch the public health disaster in the making that this Kennedy/Waxman bill, and the actions of the government, will cause.

 

[Sar]

OK, since getting tested by the FDA is what they seam to want, what would be necessary?

Do the tests have to be conducted by the FDA themselves, or could a thorough set of tests by any well respected university or hospital in the US work?

The things I see as necessary would be:

1: Taking a large sample of the most popular brands of tobacco cigarettes and hooking them up to one of those "smoking machines" and collecting the inhaled mixture. Each of those would be chemically analyzed, and tar, nicotine, carbon monoxide, and all the other hazardous chemicals would be cataloged.

2: The same number of inhalations/intake would be done with all the most popular E-cig models with no nic, low nic, medium nic, and high nic solutions with both PG and VG juices.

3: Lab mice or rabbits in various sealed boxes would be exposed to cigarette smoke from a number of major brands, vapor from nic juice at varying nicotine levels in VG and PG, as well as non-nicotine PG and VG juices. A control box would be set up with regular air set up. Just for kicks you might also try pumping afew with samples set to mimick average air conditions in New York and Los Angelas. Lifespan, physical health (put them on treadmills, measure thier weight, etc...) would be tested, breeding characteristics, birth defects, and birth weight of the animals, as well as and autopsy after the natural death of any of the test animals to check thier lung health, toxins in the liver, and any other medical results.

Do you think that would work?

I wrote a summary of the FDA classifications and how it relates to testing difficulty in another post:

http://www.e-cigarette-forum.com/fo...sts-complain-obama-corruption.html#post379306

But normally a device does not need "FDA Approval" but rather "FDA Clearance" which is much simpler to obtain.