Read this! Snuffed out - how to get regs wrong, and did pharma play a role?

[RobbyRocket]

Look, as a smoker, and someone passionate about individual rights, the FDA decision irks me. I'm torn, I support Big Tobacco as a smoker, and I think the government should .... out of people's personal lives, once an adult, warn, but at that point, people have to make their own decisions. I completely support vaping. Big Pharma had their hands all over this. Way more than Big Tobacco. I'd guess that big tobacco probably didn't have a role at all in this decision, it's just happens than it may benefit them in terms of causing their cigarette sales to go up. As a smoker, I'm fine with this. However, I am sad for vapers, because once again Big Pharma used hideous lies and misinformation about vaping to scaremonger.

Ok let me break it down like this. People need to chill about tobacco use. We all know the risks, we get it. Ok? I smoke and enjoy smoking. For me it's relaxing stimulating and clarifies and stimulates creative thought and relaxing. Sure there's risks, but lots of brilliant people have smoked in the past, and some really stupid people never touched it. In short, back off. Same for vaping. Many enjoy it, and if it helps them quit smoking, if that's their choice, great. Keeping it real though..you cannot equate tobacco use to vaping. False equivalency. Yea some e-juice has nicotine, but nicotine in and of itself (in form of vaping) has NOT been shown to have any risk, am I right? So if you vape, I'd suggest you keep hammering that point home to the nanny-state'ers.

Lastly, once again, this FDA decision should be no surprise. At the risk of getting political here, (because this is a political issue), Obama sealed the deal when he signed the tobacco legislation years ago. He's a big government, nanny-state apologist, just like Hillary Clinton. They don't care about individual rights except when it fits their agenda to pander to some of their various interest groups, which obviously includes Big Pharma. So just keeping it real, Obama had shown his preachy, authoritarian cards time and again so why should the fda decision be any different than his administration constantly talking down to and lecturing smokers. I for one am looking forward to the election and hoping for major change either with Bernie Sanders or Trump.

 

[Steamix]

150 quid to license a liquid...

Wonder how Mr. Zeller is going to explain that to Halo

 

[puffon]

But affecting business has little to do with it. I still stand that in once this is all settled we will have slightly higher priced products with known safety levels so we may adequately judge risk.

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

I do not support how far the regulations went on the first round but safety claims are largely conjecture at this point. Better safe than sorry. Everyone should want this to some extent.

Big tobacco is still killing their users, FDA approved.

 

[Robino1]

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

My vendor of choice ran the figures. With just the liquid that he sells and all the different combinations of nic, pg and vg, it will cost him over 1 Billion dollars to apply for PMTA.

From my vendor: I just did some quick math... <snip vendor name out> currently has 87 flavors, 8 PG/VG ratio choices and 8 nic strengths. At 330K per submission, we would have to spend 1,837,440,000.00 to get all our flavors certified in all possible combinations. That did not include menthol or any specialty flavor choices like Heavenly Waffles...

I don't even want to think of what the cost per bottle would be handed down to the consumer.

Oh...but then they can just offer menthol and tobacco and one level of nic..maybe two.

Well damn, I just described a Big Tobacco product.

 

[GammaRadiation]

Look, as a smoker, and someone passionate about individual rights, the FDA decision irks me. I'm torn, I support Big Tobacco as a smoker, and I think the government should .... out of people's personal lives, once an adult, warn, but at that point, people have to make their own decisions. I completely support vaping. Big Pharma had their hands all over this. Way more than Big Tobacco. I'd guess that big tobacco probably didn't have a role at all in this decision, it's just happens than it may benefit them in terms of causing their cigarette sales to go up. As a smoker, I'm fine with this. However, I am sad for vapers, because once again Big Pharma used hideous lies and misinformation about vaping to scaremonger.

Ok let me break it down like this. People need to chill about tobacco use. We all know the risks, we get it. Ok? I smoke and enjoy smoking. For me it's relaxing stimulating and clarifies and stimulates creative thought and relaxing. Sure there's risks, but lots of brilliant people have smoked in the past, and some really stupid people never touched it. In short, back off. Same for vaping. Many enjoy it, and if it helps them quit smoking, if that's their choice, great. Keeping it real though..you cannot equate tobacco use to vaping. False equivalency. Yea some e-juice has nicotine, but nicotine in and of itself (in form of vaping) has NOT been shown to have any risk, am I right? So if you vape, I'd suggest you keep hammering that point home to the nanny-state'ers.

Lastly, once again, this FDA decision should be no surprise. At the risk of getting political here, (because this is a political issue), Obama sealed the deal when he signed the tobacco legislation years ago. He's a big government, nanny-state apologist, just like Hillary Clinton. They don't care about individual rights except when it fits their agenda to pander to some of their various interest groups, which obviously includes Big Pharma. So just keeping it real, Obama had shown his preachy, authoritarian cards time and again so why should the fda decision be any different than his administration constantly talking down to and lecturing smokers. I for one am looking forward to the election and hoping for major change either with Bernie Sanders or Trump.

I will ignore the politics as I am entering this discusssion with the axiom that DHHS, and therefore the FDA, has the general population's best interests in mind. They often go astray, the DEA and drug scheduling rationalized by the commerce clause is total horse...., but all of this happens regardless of who is in office.

I also appologize for any typos as I am on my phone.

Vaping may not contain the same number or types of chemical compounds as smoking, but that is a false comparison as you rightly pointed out. The question the FDA is posing to manufacturers is: does inhailing aerosols regularly, reguardless of composition or source, affect health? Do the compounds that make up the majority if vape aerosols cause any negative effects on their own with persistant and chronic use? Are the minor compounds, either included as flavor or generated upon heating in atmosphere, harmful in any way?

Do you find this unreasonable?

We regulate as seen on TV ads regularly via the FTC, "you cant lie or misrepresent a product under penaulty of law." Do you find widespread marketing of products which could potentially affect the health of its users less important than scissors that can cut pennies?

Are vapes less harmful than cigarettes? Almost definitely but more testing with wider populations is needed. A large body of anecdotes rarely carries weight with the FDA when they require LD50 testing on rats and rabbits and high dose testing on humans in order to obtain GRAS status ( Generally Recognized As Safe). The vast majority of your food additives in the processed food we all love are tested to this extent and reports submitted to the FDA. The FDA is not stopping you from growing to tobacco and extracting nictoine then dissolving it in glycerin and PEG and flavoring it in whatever way they want. The FDA is regulating the marketing of said products with claims or directions for use associated with them. Essentially the FDA is forcine 1930s through 1990s tobacco market evolution into a few years.

THAT is where I have issue. The timeline is too fast.

 

[skoony]

Vaping may not contain the same number or types of chemical compounds as smoking, but that is a false comparison as you rightly pointed out. The question the FDA is posing to manufacturers is: does inhailing aerosols regularly, reguardless of composition or source, affect health? Do the compounds that make up the majority if vape aerosols cause any negative effects on their own with persistant and chronic use? Are the minor compounds, either included as flavor or generated upon heating in atmosphere, harmful in any way?

Do you find this unreasonable?

IMHO it is totally unreasonable and completely unnecessary as any first
year chem. student doing simple and well understood toxicology testing
would indicate the likelihood of vaping ever causing or having the
potential to cause serious harm now or 20-30 years down the road is
so remote as to put the issue of any regulations at all in serious doubt.

But wait there's more. We are in no need of first year chem. students.
The Royal Academy of Physicians and Health England have already
accomplished this monumental task. They have stated at the bare minimum
vaping is at least 95% safer than smoking. Most believe vaping is probably
99% safer than smoking. At 99% safer there is no net effect at the population
level and has no realistic or rational reason to be considered for extra ordinary
regulations at all. Regulations already in place concerning the production,distribution,
and sale of consumable goods that are already in place at the local,state and, Federal
levels are more than sufficient to insure the safety of the juice and hardware.
The courts over time would do the rest as is happening right now with the battery
issues.

Regards
Mike

 

[RobbyRocket]

My issue is that the FDA has become a bloated, authoritarian entity on it's own and does not give a crap about the general public on issues such as these, it's simply about money, and maintaining Big Pharma's leverage. It's about the big picture, the trend over the last few years of government thinking they control the people and not vice-versa. I don't want government agencies telling people what's good and what's bad and through the corporate media constantly reporting propaganda.
It's a matter of principal. Sure, government can issue guidelines about healthy stuff, fine, but it's the constantly being told, like we're little children, I don't like being told to do or not do anything personally. Adults are adults.

 

[Rickajho]

But affecting business has little to do with it. I still stand that in once this is all settled we will have slightly higher priced products with known safety levels so we may adequately judge risk.

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

I do not support how far the regulations went on the first round but safety claims are largely conjecture at this point. Better safe than sorry. Everyone should want this to some extent.

You really don't get it do you. Even if we accept your $10.00 profit per bottle, that supplier would have to sell 33,000 bottles of liquids in the next two years or less to make enough profit to cover one PMTA application for one flavor at one nicotine level. That "one" not to your liking? Double it to selling 66,000 bottles for only two applications. And so forth.

And that's with the supplier not making any profit at all to reinvest in the business if they need to stockpile that cash to cover the cost of a single application. Know any business that can sell a product at a zero profit margin for two years and still stay in business?

Of course if you have $330,000.00 lying around to cover the costs associated with the first PMTA application then by all means...

Oh yeah - your application may not be approved and you don't get your $330,000.00 back. Boo hoo.

 

[crxess]

But affecting business has little to do with it. I still stand that in once this is all settled we will have slightly higher priced products with known safety levels so we may adequately judge risk.

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

I do not support how far the regulations went on the first round but safety claims are largely conjecture at this point. Better safe than sorry. Everyone should want this to some extent.

I will ignore the politics as I am entering this discusssion with the axiom that DHHS, and therefore the FDA, has the general population's best interests in mind. They often go astray, the DEA and drug scheduling rationalized by the commerce clause is total horse...., but all of this happens regardless of who is in office.

I also appologize for any typos as I am on my phone.

Vaping may not contain the same number or types of chemical compounds as smoking, but that is a false comparison as you rightly pointed out. The question the FDA is posing to manufacturers is: does inhailing aerosols regularly, reguardless of composition or source, affect health? Do the compounds that make up the majority if vape aerosols cause any negative effects on their own with persistant and chronic use? Are the minor compounds, either included as flavor or generated upon heating in atmosphere, harmful in any way?

Do you find this unreasonable?

We regulate as seen on TV ads regularly via the FTC, "you cant lie or misrepresent a product under penaulty of law." Do you find widespread marketing of products which could potentially affect the health of its users less important than scissors that can cut pennies?

Are vapes less harmful than cigarettes? Almost definitely but more testing with wider populations is needed. A large body of anecdotes rarely carries weight with the FDA when they require LD50 testing on rats and rabbits and high dose testing on humans in order to obtain GRAS status ( Generally Recognized As Safe). The vast majority of your food additives in the processed food we all love are tested to this extent and reports submitted to the FDA. The FDA is not stopping you from growing to tobacco and extracting nictoine then dissolving it in glycerin and PEG and flavoring it in whatever way they want. The FDA is regulating the marketing of said products with claims or directions for use associated with them. Essentially the FDA is forcine 1930s through 1990s tobacco market evolution into a few years.

THAT is where I have issue. The timeline is too fast.

Well, if anyone can use anti double speak to support an argument, you are proficient at it. I'll give you that much........................and little else.

DHHS is it's own intity as is DEA..............and the FDA is a Broken pile of corporate collusion.

You wish to debate FDA on Vaping bring it. As for Scissors cutting pennies.....that is for another forum

There is no First round in this Deeming as far as the FDA is concerned. It is HERE you GO, No changes planned in your favor.
Perhaps you have not bothered listening to Zeller. He is perfectly clear in his Words, his Tone and His Body language that the FDA will operate with impunity and what we prefer is irrelevant!

 

[rico942]

Nicotine is Blamed for altering brain development like it makes people stupid.

Recently binge watched a bunch of YouTube videos on the Apollo program ...

Aside from pocket protectors, the most common feature in Mission Control was an overflowing ashtray. These guys were of genius level intelligence, superior human beings, and they nearly all used nicotine. Hmmmmm ...

Among engineers, the 60s era NASA scientists and technicians were our "Greatest Generation" ...

Seems like pretty good empirical evidence of the effect of nicotine on human cognitive ability ...

 

[Robino1]

Among engineers, the 60s era NASA scientists and technicians were our "Greatest Generation" ...

Which is one of the reasons I have NO TRUST in the FDA. OR the alphabet health groups.

Do they honestly think we don't remember all the smokers that were Brilliant???? My God!

Doctors, lawyers, professors, engineers, presidents... Smokers.

Let's see, the generation that is coming behind mine...... less smokers and they seem lots.... let's just say, less intelligent....

Could it just possibly be that Nicotine makes us more focused so we are more intelligent? We can actually focus and learn!


Nicotine hurts brain cells.... My Donkey's Behind!

 

[sonicbomb]

*1.5% of teenagers had smoked an e-cigarette in the past 30 days

 

[Robino1]

*1.5% of teenagers had smoked an e-cigarette in the past 30 days

I think the people doing those surveys need to vape. They may grow some brain cells

 

[sonicbomb]

I think the people doing those surveys need to vape. They may grow some brain cells

Freedom from the government endorsed slavery to the tobacco leaf, what greater endorsement could there be.

 

[Daddy]

 

[Daddy]

On a serious note.

Wouldn't it be great if this flyer was available for print at local shops? You could fill it out and take a selfie and leave it in the shop. Shop owners could package the pictures once a week and mail to their representatives in DC. Can you imagine a congressmen or woman receiving 100's of pictures of their constituents weekly? I have organized and lead letter writing campaigns in the past. This is definitely a cheap way to get our message out. @SmokeyJoe

From not blowing smoke facebook page:

 

[JerryRM]

I hate when people think there are super secret closed door meetings where "big pharma" and "big tobacco" meet with "FDA" and talk about how to stick it to the users. The fact of the matter is that it is much less convoluted. The FDA is responding to criticisms and concerns and the easiest route for them is to tie it all into tobacco because it is most similar to tobacco. Be glas they didnt call vapes medical devices.

The results are not in, in time the approval process will get easier as one may cite previous submissions regarding safety. Think the GRAS system in food and GRASE in off patent drugs.

Oh, but they did try to call e-cigs "medical devices". Judge Leon of the Federal Court, put the brakes on that !!!

 

[Bad Ninja]

But affecting business has little to do with it. I still stand that in once this is all settled we will have slightly higher priced products with known safety levels so we may adequately judge risk.

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

I do not support how far the regulations went on the first round but safety claims are largely conjecture at this point. Better safe than sorry. Everyone should want this to some extent.

If affecting business didnt encourage industry to influence political decisions lobbyists wouldnt exist.
It would be naive to think the pharma and tobacco industries didnt lobby the FDA to get a favorable judgement.

 

[Woofer]

I hate when people think there are super secret closed door meetings where "big pharma" and "big tobacco" meet with "FDA" and talk about how to stick it to the users. The fact of the matter is that it is much less convoluted. The FDA is responding to criticisms and concerns and the easiest route for them is to tie it all into tobacco because it is most similar to tobacco. Be glas they didnt call vapes medical devices.

The results are not in, in time the approval process will get easier as one may cite previous submissions regarding safety. Think the GRAS system in food and GRASE in off patent drugs.

But affecting business has little to do with it. I still stand that in once this is all settled we will have slightly higher priced products with known safety levels so we may adequately judge risk.

It cost money and man hours. Boo hoo. At $10 profit per 30ml bottle they dont have far to go to ensure they arent killing their users like big tobacco did for decades upon decades.

I do not support how far the regulations went on the first round but safety claims are largely conjecture at this point. Better safe than sorry. Everyone should want this to some extent.

I will ignore the politics as I am entering this discusssion with the axiom that DHHS, and therefore the FDA, has the general population's best interests in mind. They often go astray, the DEA and drug scheduling rationalized by the commerce clause is total horse...., but all of this happens regardless of who is in office.

I also appologize for any typos as I am on my phone.

Vaping may not contain the same number or types of chemical compounds as smoking, but that is a false comparison as you rightly pointed out. The question the FDA is posing to manufacturers is: does inhailing aerosols regularly, reguardless of composition or source, affect health? Do the compounds that make up the majority if vape aerosols cause any negative effects on their own with persistant and chronic use? Are the minor compounds, either included as flavor or generated upon heating in atmosphere, harmful in any way?

Do you find this unreasonable?

We regulate as seen on TV ads regularly via the FTC, "you cant lie or misrepresent a product under penaulty of law." Do you find widespread marketing of products which could potentially affect the health of its users less important than scissors that can cut pennies?

Are vapes less harmful than cigarettes? Almost definitely but more testing with wider populations is needed. A large body of anecdotes rarely carries weight with the FDA when they require LD50 testing on rats and rabbits and high dose testing on humans in order to obtain GRAS status ( Generally Recognized As Safe). The vast majority of your food additives in the processed food we all love are tested to this extent and reports submitted to the FDA. The FDA is not stopping you from growing to tobacco and extracting nictoine then dissolving it in glycerin and PEG and flavoring it in whatever way they want. The FDA is regulating the marketing of said products with claims or directions for use associated with them. Essentially the FDA is forcine 1930s through 1990s tobacco market evolution into a few years.

THAT is where I have issue. The timeline is too fast.

 

[Big Me]

150 quid to license a liquid...

Wonder how Mr. Zeller is going to explain that to Halo

And that is for ALL strengths in that particular flavour. Not £150 for each nicotine level.