FDA Big news coming out of FDA

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pbanj

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@DaveP I think the issue with the "structure/function prong" is that it means that even if you don't consider smoking a disease, if a product (any product) is marketed as being an alternative to smoking, it is making a medical claim: after all, there's nothing quite like smoking in terms of disease burden on the body, even if the behavior of smoking itself isn't a disease.

Under this reading, if I say "beer enables you to stop drinking whisky", I'm making a medical claim for beer because there will be differences in the metabolic effects of both whisky and beer. It's a hyper-legalistic interpretation of the medicines law.

My principal concern with this rule is that, in my mind, vape stores have a unique role and opportunity in helping people migrate from smoking to vaping. As I see it, anyone who's opened a vape store with this in mind is going to have to be extremely careful in how they run their business. I think this is a huge public-health own goal.

Consider: in the UK now we have our National Smoking Cessation Services queueing up to partner with e-cig companies to help educate smokers properly on e-cigs and how to use them. I think this is probably unique in the world. What a damned shame this won't happen in the USA, where there are 4 times as many smokers in need of such advise.

Also, it's absolutely canonical that replacing nicotine helps people to stop smoking. This has been known for a long time. Why on earth this can't just be accepted with e-cigs is, I must say, beyond me.
It all comes down to money. The fda doesn't care about people's health, they only care about money.
 

Bad Ninja

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@DaveP I think the issue with the "structure/function prong" is that it means that even if you don't consider smoking a disease, if a product (any product) is marketed as being an alternative to smoking, it is making a medical claim: after all, there's nothing quite like smoking in terms of disease burden on the body, even if the behavior of smoking itself isn't a disease.

Under this reading, if I say "beer enables you to stop drinking whisky", I'm making a medical claim for beer because there will be differences in the metabolic effects of both whisky and beer. It's a hyper-legalistic interpretation of the medicines law.

My principal concern with this rule is that, in my mind, vape stores have a unique role and opportunity in helping people migrate from smoking to vaping. As I see it, anyone who's opened a vape store with this in mind is going to have to be extremely careful in how they run their business. I think this is a huge public-health own goal.

Consider: in the UK now we have our National Smoking Cessation Services queueing up to partner with e-cig companies to help educate smokers properly on e-cigs and how to use them. I think this is probably unique in the world. What a damned shame this won't happen in the USA, where there are 4 times as many smokers in need of such advise.

All businesses are operated to make a profit. That's why they are businesses.

It's nice if the by-product of making profit is doing a service to others, but government regulatory bodies cannot safely count on the good nature of retail corporations, or the people that run them.



Also, it's absolutely canonical that replacing nicotine helps people to stop smoking. This has been known for a long time. Why on earth this can't just be accepted with e-cigs is, I must say, beyond me.

It CAN be accepted and probably will after some legitimate scientific studies are done.
We have to follow the proper procedure.
Vaping helped me stop smoking, but it takes more than that to make it documented, scientifically accepted fact.
 

evan le'garde

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Well, if we knew for sure, this thread would be less than half the length it is.

One of the things we do know is that the FDA doesn't impose taxes, watch your friendly state and local governments for that angle.

If/when deeming goes through, depending on whether they keep the original grandfather date, manufacturers may have to comply with very costly testing and reporting requirements to have any product on the market, necessitating a price increase. Many smaller companies may go under due to not being able to afford the required testing at all. There's a two year lead time on enforcement of this aspect.

We could easily see sales restricted to face to face only, no more internet selling.

We know regulations will apply to e-liquids containing nicotine. They could try to include no-nic, although personally I don't see how that could possibly be justified. Regulations could include hardware, or maybe they won't. They could ban flavorings, or maybe they won't.

Flavourings can be purchased here : http://www.capellaflavors.com/

These flavourings are not produced for vaping, and never were, and cannot be regulated as such.

I made a point of saying in a previous post that anything associated with vaping can be purchased by absolutely anybody. What i mean is that vaping is something anyone of the 7 billion people in global society can do. And it shouldn't be compared to smoking, and not designed exclusively to smokers who want to quit. The proposed regulations are based on a ridiculous assumption that only smokers who want to quid will be buy vaping associated goods, but it should really be considered a recreational activity. Vaping has nothing to do with smoking cessation, health, addiction to nicotine or any other supposed reason for vaping. It's just a hobby any non smoker can take up !.
 

Oliver

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..........wow
Right. Wow - going to be a merde-storm in Europe next year. I imagine 90% of vapers don't know that the products they currently use are about to be outlawed.
 

Oliver

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All businesses are operated to make a profit. That's why they are businesses.

It's nice if the by-product of making profit is doing a service to others, but government regulatory bodies cannot safely count on the good nature of retail corporations, or the people that run them.

Sort of a non-sequitur. Surely the principal concern regulators should have is these businesses marketing to non-smokers? The irony of this rule is that, in a sense, that's the only marketing message available to vape companies!

It's massively in vapestore's interests to transition smokers - that's overwhelmingly their core business model, and I can't see it being any different.

It CAN be accepted and probably will after some legitimate scientific studies are done.
We have to follow the proper procedure.
Vaping helped me stop smoking, but it takes more than that to make it documented, scientifically accepted fact.

There's decades of research on this front. Ever since Michael Russell said: "smokers smoke for the nicotine but die from the tar" in the 1970s, nicotine supplementation has been the principal tool for helping smokers to stop. It's totally non-controversial. So the only question, then, is "do e-cigarettes deliver nicotine" - this is not difficult research, and the answer was in over 2 years ago: "yes, they do".

Part of the FDA's "continuum of harm" project requires that the public be re-educated about the relative safety of nicotine - I heard Mitch Zeller say these exact words at the FDLI conference in DC earlier this year. So, the question is: Who is going to do this?

Seems to me a massive own goal not to allow businesses to do it.
 

evan le'garde

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A little like saying if a particular food stuff could alleviate the symptoms of a disease then it should be regulated as medicinal and only available by prescription. Even though that particular food stuff is available to absolutely everyone because they enjoy eating it. I mean if chocolate cured the common cold would it mean that no one would be allowed to purchase chocolate anymore unless they've been diagnosed with a cold ?.

Edit : While i'm on the subject of the common cold, even though it's off topic, i feel the need to make an ammendment to the common belief that there is no cure for the common cold.

If someone contracted an incurable disease/virus, maybe you could think of one, then obviously there is no cure.

The diference with an incurable disease/virus and a common cold virus/strain is that the common cold has a cure built into it, and it fades away after a few days.

I'm pretty confident most people completely over look this fact.:cool:
 
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Oliver

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That really sucks. You should stock up on crap load of devices and RDA/tanks.

And what about the millions of vapers who don't yet know, and the millions of smokers yet to get into the market?
 

zoiDman

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Right. Wow - going to be a merde-storm in Europe next year. I imagine 90% of vapers don't know that the products they currently use are about to be outlawed.

This is what is Frustrating here also.

Because when I leave the ECF and go out into the Real World, if I mention "Deeming" or "Grandfather Dates", vaper's look at me like a Dog does when it Hears a New Noise.

And many/most B&M Vape Shops dismiss or discourage talk of FDA Regulation for fear their Customers will learn how to do DIY.
 

evan le'garde

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The FDA cannot just decide who or which demographic chooses to buy vaping associated goods, and then regulated based on that assumption. No matter how retailers choose to market their goods it's still up the the consumer, whoever they may be, to purchase those goods for whatever reason they want, not because the FDA says you have to be a smoker who wants to quit smoking.
 

evan le'garde

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There are health food shops in the high street that sell goods such as vitamin supplements and all kinds of health foods designed to improve your health. None of those items are regulated as medicinal !. I mean low fat foods are a healthy alternative to high cholesterol foods, but they are not regulated as medicinal. The same arguement can be made that low fat foods are eaten to avoid the ill health caused by high cholesterol, but these food stuff aren't regulated, anyone can buy them, even thin people, imagine that, why would a thin person buy low fat food ?, who cares, but they do !. So why would a non smoker choose to start vaping ?. That's their business, not the FDA's.
 

Oliver

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@evan le'garde Probably a much better analogy than my fatuous Beer/Whiskey version. I don't know whether there's a grandfathering provision for food health claims, but under the "structure/function prong" those certainly are medicinal claims.
 

Lemwise

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Well, in reality nor can we: In May next year 90% of the products currently on the market will be banned under the stupid EU TPD rule which was signed into law last year.
A Dutch webshop owner visited the French vape expo recently where he got to try the new 2ml tanks and he said the flavour and easy of rebuilding is on par with what's available now. You just have to refill more often. Some of the tanks he tested were made in China and he also said the Chinese are well aware of the pending regulations and are prepared for it. Another thing he said is that his company has a filling machine and that the price of nic base will increase by a small margin to cover the cost of having to use extra bottles.

Other than that, people are highly creative animal and will always find ways to do what they want to do. Once something has been invented, it cannot be uninvented.

And btw, nowhere in the TPD does it say that RBA's will be illegal. RDA's will be illegal but as long as the tank has a leak free refilling mechanism, it's good to go.
 
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Oliver

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There are more non smokers in global society that there are smokers and vapers. Why should the FDA be allowed to prevent the majority of the human population to choose to start vaping if they want to ?.
I don't think that's what they are doing. I simply think the mentality has been captured by the anti-thr crowd.
 

Oliver

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A Dutch webshop owner visited the French vape expo recently where he got to try the new 2ml tanks and he said the flavour and easy of rebuilding is on par with what's available now. You just have to refill more often. Some of the tanks he tested were made in China and he also said the Chinese are well aware of the pending regulations and are prepared for it. Another thing he said is that his company has a filling machine and that the price of nic base will increase by a small margin to cover the cost of having to use extra bottles.

Other than that, people are highly creative animal and will always find ways to do what they want to do. Once something has been invented, it cannot be uninvented.

I tried them there too. They're good, but there's a good chance they won't be legal - the technical document for "leak free refilling" has not yet been compiled. Doesn't change the fact that 90% of what people are currently using will be prohibited for completely arbitrary reasons (deals done behind closed doors).
 

Lessifer

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You don't need FDA approv to sell herbal extracts, goat weed supplements, vitamins or ejuice.

You must, however, follow their marketing and packaging guidelines.
I could be wrong, but as I understand it the FDA doesn't have regulatory dominion over supplements. They do have authority over drugs, so as long as you don't make a health claim that would turn your supplement into a "treatment" you're good.

However, thanks to the fsptca the FDA has regulatory authority over tobacco products, so either way they have the authority. You DO need FDA approval to manufacture and sell a tobacco product.
 

Bad Ninja

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@SmokeyJoe,
The regulations are standard fare for every consumable product.

The FDA isnt going to shut the industry down.
If they were, they could have done it already, by regulating/banning nicotine extract sales.


Here's where the money comes Into play:
If you want to make the claim that vaping is a medical smoking cessation device/system you must pay for and receive FDA approval.
This costs billions of dollars.

http://www.forbes.com/sites/matthew...truly-staggering-cost-of-inventing-new-drugs/

They are setting themselves up for a potential payday.
 
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Lessifer

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What hasn't been discussed much in this thread, but which I personally see as a big issue, is the modified risk tobacco product category. Not even the FDA understands what they consider to be MRTP, but they do know that they won't let you use language like "safer" "less harmful" "no tar" "low nicotine" etc.
 

evan le'garde

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@SmokeyJoe,
The regulations are standard fare for every consumable product.

The FDA isnt going to shut the industry down.
If they were, they could have done it already, by regulating/banning nicotine extract sales.


Here's where the money comes Into play:
If you want to make the claim that vaping is a medical smoking cessation device/system you must pay for and receive FDA approval.
This costs billions of dollars.

http://www.forbes.com/sites/matthew...truly-staggering-cost-of-inventing-new-drugs/

They are setting themselves up for a potential payday.


Like a parking ticket for vendors !.
 
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