FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products

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Rossum

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Guess it keeps a lot of civil servants in bread 'n butter - making up tons of legalese.
Who are they trying to fool? Could you for once - just once - quit insulting the intelligence of the vaping community ?

All that deeming regs can be easily simmered down to a few lines of plain and simple and easy to understand text :

'BG, BT and BP are profiting hugely from maintaining the status quo. So they want vaping to either go away or get limited to the ratty devices they've invested in already.
They've got enough money and friends in high places to make us see it their way.
So, we try to make it look like we're protecting your health, while in reality we're bending over to protect the turf of some interested parties from innovation and efficiency.'
That's a very dangerous meme. If people come to accept it, they'll almost inevitably come to realize their rulers actually regard them more like farm animals than children.
 

MacTechVpr

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Exactly this kind of "gotcha" in curtailment of free speech that politicians try to slip in the back door in the middle of the night. Lovely contradiction. It's tobacco alright…but you can't discuss it as an alternative to tobacco (some people have…). Remove the preponderance of anecdotal evidence. Mute the public.

Not off topic z but right on. We don't matter.

Vape on.

:)
 

DC2

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Kent C

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Exactly this kind of "gotcha" in curtailment of free speech that politicians try to slip in the back door in the middle of the night. Lovely contradiction. It's tobacco alright…but you can't discuss it as an alternative to tobacco (some people have…). Remove the preponderance of anecdotal evidence. Mute the public.

Not off topic z but right on. We don't matter.

Vape on.

:)

Very much on topic. Basically, censoring businesses that want to help you get off cigs. Not only do they condemn them for crimes they don't commit, but they stop them from doing good. That's 'gov'ts' territory! They're no more than thugs in the neighborhood, throwing bricks though store windows, then demanding 'insurance money' from the storeowner, then taking credit for keeping the town safe :facepalm:
 
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AndriaD

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There also is the component that so many adults would *like* to be treated as little children, having absolution from their choices and guaranteed a safe, eternal life.

So they don't have to do that dreadful onerous thing called "thinking." Just try it.. in any given conversation, say the words "ok, now just think about it.." I guarantee you there will be a chorus of groans like you just asked them to dig a 20 ft trench with their teeth.

Andria
 
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Shameless

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ok, now just think about it...

I say we dont know what they put into ejuice
you say read their ingredients or you say just google it (like that would be an answer) would any company say we make this juice in a rat infested basement and use whatever we have on hand when we run out (including pee, and seman (like some young high boy wont really think thats funny), or even worse some kind of addicting drug)
you say all other ingredients are more expensive so why would they, people also said this of tobacco and we found out why they would - to make them more addictive, to keep the market base, etc

I say we dont know that they even know how to mix it right
you say recipes are not rocket science, but I still say we dont know if they know how to read them

I say, it might be a good thing that they are regulated
you say regulation is the killer of this business, you say we are adults and know how to look out for ourselves, but I still say having something that is ingested by people should at least be looked at by some regulating body to make sure they are actually using the ingredients they put on their bottles or that they are doing this in a clean way, or that they handle nicotine properly. We ar adults but we dont go visit all the companies to see how they make it and if their rooms are clean and proper procedures are used. We dont have machines in our homes to test ingredients to make sure they are what they put on the label.

I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?
 

Elizabeth Baldwin

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ok, now just think about it...

I say we dont know what they put into ejuice
you say read their ingredients or you say just google it (like that would be an answer) would any company say we make this juice in a rat infested basement and use whatever we have on hand when we run out (including pee, and seman (like some young high boy wont really think thats funny), or even worse some kind of addicting drug)
you say all other ingredients are more expensive so why would they, people also said this of tobacco and we found out why they would - to make them more addictive, to keep the market base, etc

I say we dont know that they even know how to mix it right
you say recipes are not rocket science, but I still say we dont know if they know how to read them

I say, it might be a good thing that they are regulated
you say regulation is the killer of this business, you say we are adults and know how to look out for ourselves, but I still say having something that is ingested by people should at least be looked at by some regulating body to make sure they are actually using t
he ingredients they put on their bottles or that they are doing this in a clean way, or that they handle nicotine properly. We ar adults but we dont go visit all the companies to see how they make it and if their rooms are clean and proper procedures are used. We dont have machines in our homes to test ingredients to make sure they are what they put on the label.

I originally posed this as a question - why it this bad, wouldnt it be good to have someone make sure the ingredients are safe? And every one that commented came on real strong trying to make me feel small for asking. But all you have done is show me that you are the ones that need to think about it a little more. Ask yourself, wait "just think about it", how could this go wrong? When big pharma or big tobacco take over (which sooner or later we all know its a possibility) what will they do to ejuice? Do we really want a product that we ingest to NOT be reviewed? To have no regulations?

Being the only voice asking the question with so many of you coming on quite strong to tell me I am wrong, kind of sucks. But when you say "just think about it", I actually AM just thinking about it, and I actually was just asking why you felt it would shut down the industry and the responses I got didnt quell my questions, they actually made me wonder why in the world, with everything we have seen happen with other industries, you believe that nothing untoward will happen in this one without regulations?

I understand where you are coming from, but you miss one important thing... The FDA does not want to keep flavors on the market at all. The leader of the FDA, Zeller, has said publicly that once he gets control then flavors are gone. They don't and wont test it. They are going to get rid of it. Sure, they'll be cigalikes left, because they were here in 2007, the grandfather date) but anything after that date will need to submit an application. Have you read the cost of an application for a new product? Only Big Tobacco could afford those sort of costs. Then once the application is submitted for that 1 product, it won't get approved... so they lose that money. How many businesses do you think will fork out close to a million dollars for 1 flavor in 1 strength for a small chance of getting approved?

These regulations will kill the industry. It's not going to help it at all. Ideally your thoughts are good, but in reality they aren't what will happen. The FDA aren't the ones who will test the juice, they want the people making the juice to pay and have all their juices tested and then have so much other costly stuff done before ever submitting an application. A new test for each flavor and for each strength. So, for example, take the flavor vanilla. There would be 3 or 4 tests just for vanilla and 4 applications just for vanilla. One for each MG of nicotine strength. If they sale 0mg, 3mg, 6mg, and 12mg then that many tests would be required. None of the juice makers I know have 4 million dollars to pay the FDA just for one flavor and then probably lose that money.

It will kill over 99% of the business. Sure Big Tobacco will be able to do all their tests and submit all their applications. They'll be the only vape products you can buy.. cigalikes with menthol and tobacco flavors only... as stated by old Zeller himself!
 
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benjamind2013

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Shameless, I agree with much of what you said. However, regulation which helps everyone and provides safety protocols to improve this industry versus regulation which just restricts everything so severely that only a very small number of highly capitalised interests can afford to operate, are two entirely different matters.

I agree that some regulation is needed, however the deeming regulations as drafted by the FDA do not seem to be aimed at only helping the consumer. They appear to be engineered to protect those who stand to lose the most when e-cigarettes become mainstream en masse at which point those who stand to gain will be well positioned to exploit the fact that so much competition and free enterprise has been destroyed by the those deeming regulations as are currently being proposed.
 

Kent C

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@Shameless

The same thing could be said about every product you consume - regulated or unregulated. How do you know the regulators don't do the things that you say people in businesses do? Or taking bribes to look the other way? Your questions are senseless because there would be no way to prove to you any of the questions you ask. If you were to visit the sterile labs (that many of our vendors have done), who's to say that wasn't just a 'performance' and that as soon as you leave, they'd go back to their rat infested ways? There is no answer to any of your questions that couldn't be followed up by more insane questions to bring doubt into the answers. And if there were, more doubt could be brought on.

Basically, you have the mind set of the 'we know what's best for you' crowd. You ask the same questions and nothing would satisfy you until we have what would amount to a police state. Perhaps, if you haven't already, get a gov't job - maybe at the FDA.
 

Elizabeth Baldwin

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I don't understand people who agree that "some regulation is needed". If you agree with any regulations then you have to endorse it all. That means no flavors, no tanks, no mods, just cigalikes with menthol or tobacco.

I'd imagine that's good ammunition for the FDA. "Well, some vapers agree that we need to regulate."

You can't ride the fence. You either want full regulations or you don't want any regulations. There's no middle ground. The FDA will regulate or they won't. If they do regulate, which will happen, then everything about vaping as you know it right now will be gone.

Can you vape menthol or tobacco alone? If so, then ride the fence! But most other people enjoy their flavors.
 

Elizabeth Baldwin

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BTW: The FDA regulating things doesn't make them safer! It just means they have the means to take them off the market and take money for fees. They can even confiscate things from customs and many other horrible things. Their authoritative power hasn't made anything else in the US safer. Look at their track record. They've "approved" all sorts of horrible things that have actually killed people. It isn't about safety!
 

Kent C

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I don't understand people who agree that "some regulation is needed".

Esp. when we've done so well without it. Yeah, you're always going to have idiots that abuse things in any industry. If they don't find a way to harm themselves with ecigs, it will be something else but when you regulate to the lowest common denominator you make it more costly and even harmful for 95% of the market. I'm willing to lose that 5% to 'collateral damage' to keep the rest of us free. They're going to do themselves in some other way, anyway. This is proven every day.
 

Elizabeth Baldwin

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Esp. when we've done so well without it. Yeah, you're always going to have idiots that abuse things in any industry. If they don't find a way to harm themselves with ecigs, it will be something else but when you regulate to the lowest common denominator you make it more costly and even harmful for 95% of the market. I'm willing to lose that 5% to 'collateral damage' to keep the rest of us free. They're going to do themselves in some other way, anyway. This is proven every day.

Absolutely! Like people blowing their face off because they bought a rewrapped battery or didn't check it's limits for what they were using it for. Idiots!

Some of these people don't understand there's no such thing as "some regulations"... it's all or nothing! And it's not looking good at all!
 

benjamind2013

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I agree with Kent wholeheartedly.

We already have regulation for flavours and additives such as PG and VG.

The CDC wants to tell everyone that vaping is bad for them and that they should stop. The U.N. WHO probably want to do the same as well.

However, these same organisations are advising everyone to subject their newborn sons to deliberate genital mutilation (I will call it EXACTLY what it is) under the guise that circumcision reduces the theoretical chances of getting a urinary tract infection when the cold hard facts are that girls are FIVE TIMES more likely to contract a UTI in their lifetime and nobody is advocating female genital cutting and are in fact doing the opposite!!!!!!

You think I want to take advice from these lunatics?
 

Kent C

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Absolutely! Like people blowing their face off because they bought a rewrapped battery or didn't check it's limits for what they were using it for. Idiots!

Some of these people don't understand there's no such thing as "some regulations"... it's all or nothing! And it's not looking good at all!

Or the open bottle of nicotine - no 'child proof' cap would have save that child - only responsible parents. There are so many others too numerous to mention and no regulation or police state could have stopped any of them.

The thing about these 'pro-regulation' types (even to some extent the 'reasonable regulation' types) is that they say follow the money - it's BT or BP anyway, so the regulations are the way they make money not about safety. IF it were about safety, then (according to them) BT and BP wouldn't have anything to do with it, because, again, according to them, BT and BP doesn't care about people or people's safety. That's called having your cake and eating it too.
 

benjamind2013

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Of course its about money and not safety or health benefits.

Look at infant circumcision - 100+ infants die every year because of claims that it will reduce the theoretical chance of something that is so highly unlikely to happen that any supposed health benefits are nonexistent.

The only benefits are those of a financial nature and those benefits only apply to the scum who perpetuate such disgusting cruelty. What is so surprising is they do this in a country where we have been conditioned to accept abortion because of human rights to bodily autonomy.

What about the millions of male infants who lose the most sensitive parts of their genitals so someone can make a quick dollar? What about their human rights?
 

Kent C

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Of course its about money and not safety or health benefits.

Then why would you enable them by condoning 'some' or 'reasonable' regulation. (which when that happens starts the slippery slope to more and more). You're playing into their hand according to your views.
 
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benjamind2013

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Then why would you enable them by condoning 'some' or 'reasonable' regulation. (which when that happens starts the slippery slope to more and more). You're playing into their hand according to your views.

Only if the aim is to monopolize the e-liquid/e-cig market.

These specific regulations are a perfect example of that aim.

However, some regulation (ie. Testing of individual components of flavourings, ie. specific chemicals) is necessary to ensure we are not consuming or breathing toxic substances.

I presume 99.9% of flavours are harmless and therefore should not require any further regulation.
 
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Steamix

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There is regulation and there is regulation.

Imagine you making a burger. FDA's idea is that the very same burger needs to be tested. Put a slice of cheese on, it needs to be tested again. Added an extra glob of mustard ? Test it again. Same with the ketchup. Test it again. Hold the onions ? Test....

Reputable vendors use USP grade base materials. Means that these have been tested already. Cuz if you wanna grade it USP ( or equivalent ), you must be able to document it.

None of that is a guarantee against shady business - in any line of business. Mixin in some cheaper industrial grade PG ( after having obtained the approval on the sample ). Bleding in some cheap, pesticide-laden tobacco ? Don't matter. Cigs are toxic anyway, so who cares about a few micograms more ? Milk's a bit iffy already? Make chocolate ice cream with it ( common practice - chocolate's strong flavour is good for masking iffy ingredients ). Beef's a bit greasy ? Spicy marinade will a give it a few for days on the shelves...

FDA approval as carte blanche as seal of quality ? Really ? Then how come there's FDA 'tested and approved' medication on the market that is obviously doing more harm than good ?

Whenever I buy something , I am not just forking over some money, I am also fronting a certain degree of trust/good faith. Businesses who aim to stay in the same know that. And act accordingly...
 

B2L

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I think its easy to be alarmist about new government regulations.

But shouldnt we already be alarmed that ANYTHING could be in the juices we vape?

Shouldnt we want the juices to be tested and to know they meet safety levels?

I mean the FDA approved nic gum and nic patches and nic lozenges. Shoulndt we want to know that the companies that use nicotine in our vapes actually know what they are doing? Know how to put the right amount of nic in the juice and know how to handle it safely?

It's easy to be alarmist about new government regulations because, overwhelmingly, they are alarming.

I know you said you were out and I'm not here to beat a dead horse, but don't you find it a bit ironic that all FDA approved substances carry a warning for a myriad of side effects as long as your arm, most of which include death? If it were about safety, do you think there's a snowballs chance that Chantix would have ever been approved?

The fact that all of their "approved safe" products carry these warnings which have been determined through (assumedly) scientific trials and now we must eliminate (for all extensive purposes) vaping because we just don't know if it's safe says to me that it's all about someone's pockets being greased.

Maybe it will be approved if we agree to include a warning such as "if your e-cig fires continuously for more than 4 hours, see your doctor" :facepalm:
 
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