FDA Big news coming out of FDA

[Lessifer]

@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.

They get that payday either way though. tobacco product approvals ain't cheap.
MRTP approval is even more expensive and less sure than NTP.

 

[Oliver]

@Lessifer - bang on.

The only thing e-cig companies will be able to say about their products is: "really satisfying" "smooth rich flavor" etc, etc. Horribly tobacco-industry-type marketing guff.

To say anything (ANYTHING) about safety, you need MRTP. To say anything about moving away from smoked tobacco, you need meds.

It is just totally self-defeating, as far as I can see.

 

[Rossum]

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.

 

[Bad Ninja]

@Lessifer - bang on.

The only thing e-cig companies will be able to say about their products is: "really satisfying" "smooth rich flavor" etc, etc. Horribly tobacco-industry-type marketing guff.

To say anything (ANYTHING) about safety, you need MRTP. To say anything about moving away from smoked tobacco, you need meds.

It is just totally self-defeating, as far as I can see.

I see what you are saying, but vaping is global, and HUGE.
The genie won't go back in the bottle and they obviously know that.

As dumb as people act, the public really isn't stone cold stupid.

Everyone who has ecigs available knows ecigs as electronic "cigarettes" and as an alternative to smoking.


Will it slow sales industry wide for a while? Maybe. For cig alikes and disposables.
Though I doubt it.
There's just too much money at stake, and too many potential customers.

 

[Lessifer]

@Lessifer - bang on.

The only thing e-cig companies will be able to say about their products is: "really satisfying" "smooth rich flavor" etc, etc. Horribly tobacco-industry-type marketing guff.

To say anything (ANYTHING) about safety, you need MRTP. To say anything about moving away from smoked tobacco, you need meds.

It is just totally self-defeating, as far as I can see.

It's why I've always thought that vapor products need a separate category. Medical is insane, tobacco has too many built in restrictions.

From what I've been told, it would be very difficult(politically and monetarily) to get a separate category into legislation. I just don't see a "good" outcome any other way. No offense to THR, but how long have they been working at it, and how far has it gotten?

 

[Kent C]

No offense to THR, but how long have they been working at it, and how far has it gotten?

When the educational establishment, governmental agencies (apparatchiks) and media are against you, not very far. Ask any non-Democrat/socialist, or any Democrat who would cross them.

 

[GeorgeS]

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 ?.

Because beyond a kids lemon-aid stand, the local church bake sale and similar transactions of limited duration, size and scope if your selling something consumable to the public you better have certified suppliers that maintain proper lot/reference's and mix/make/create your product in a health department approved facility with trained workers as well as maintain proper records and labeling of where and when you got the ingredients that make up your product.

You can't just start marketing and selling "snake oil" to the general public without having your "ducks in order". For example: in the US (or at least where I live) you can't cater a party or event unless all the food was prepared in a health department inspected and approved kitchen by trained and certified workers.

On the one hand if vapor stuff is a "tobacco product" it will be regulated and taxed like a tobacco product. (as seen in Washington DC, the taxes don't need the FDA 'deeming' of anything to exist)

On the other hand if vapor stuff is called what a good many of us use it for - nicotine replacement and a stop smoking aid - it ventures into the 'drug' side of the FDA. While it may the side skirt the fed/state/local tobacco "sin" taxes there's a ginormous problem getting FDA approval for the juices and the gear that turn juice into vapor can be a costly and time consuming process.

 

[Lessifer]

When the educational establishment, governmental agencies (apparatchiks) and media are against you, not very far. Ask any non-Democrat/socialist, or any Democrat who would cross them.

I'm one of those blasted liberals, but even I recognize that the Tobacco label is a poisoned apple. It's very hard to overcome decades of propaganda, even with truth on your side.

 

[evan le'garde]

This is a quote from the proposed rule.

"Under the proposed rule, this exclusion could apply in two circumstances
if the product is intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or
2) if the product is intended to affect the structure or any function of the body, in any way that is
different from effects of nicotine that were commonly and legally claimed in the marketing of
cigarettes and smokeless tobacco products prior to March 21, 2000."

I don't believe nicotine patches and gum would be used recreationally, so obviosly they're subject to these regulations.

I also don't believe a non smoker should be subjected to these regulations. These regulations are based on the side effects of smoking tobacco, i think that is quite clear. Non smokers (young people) don't suffer from any of the above and so shouldn't be subjected to these restrictions.

So the real question is. Why should these regulations be imposed on non smokers who want to start vaping ?, when the regulations are completely unrelated to non smokers.

What if a non smoker, anybody, decides they want to start smoking ?. Then i suppose they'll start smoking, right ?. But what if a non smoker wants to start vaping, they are not doing it "“to reduce withdrawal symptoms, “help reduce symptoms including
things like “relieve withdrawal symptoms while you are on the plane”.
nor would they be associated with an intended use for relief of nicotine withdrawal symptoms.

So obviously my point is that these regulations are being imposed on people who are vaping for no real reason at all, they don't need one, they just want to start vaping.

If a young person has the choice to start vaping rather than making the mistake of starting to smoke how can these regulations possibly help them. If the option wasn't available, and i'm not saying it won't be, but if it isn't, then what are the chances that a young person won't just start smoking instead.

These regulations are making it more difficult for non smokers to take up vaping and they are more likely to start smoking.

These regulations are biased in favour of the tobacco companies.

We are the vaping community of today, and these regulations are aimed at us, but what about the vaping community of tomorrow, they don't want to smoke tobacco !, we don't want them to smoke tobacco.

It's the non smokers who should be considered when new regulations are being drawn up. I'm talking about your kids, their kids, the future generations, because if the FDA have their way then all those generations will take up smoking. The FDA clearly cannot see the woods for the trees and clearly haven't considered the non smoking community when drawing up these regulations.

 

[Kent C]

I'm one of those blasted liberals

It's very hard to overcome decades of propaganda

More of a ecig-ertarian perhaps - libertarian when it is your ox being gored - defaulting to liberal in all other matters. My hope is some will 'pick up the pattern' and apply it elsewhere. I won't hold my breath though, because that 'decades of propaganda' is also in effect there as well...

 

[Kent C]

So obviously my point is that these regulations are being imposed on people who are vaping for no real reason at all, they don't need one, they just want to start vaping.

If that viewpoint would be adopted, then smokers could quit smoking, say there's no withdrawal factor and then an hour later, say, "I want to take up vaping as a non-smoker."

But... I agree - as stated it really doesn't apply to non-smokers and that isn't 'fair' - but the gov't hasn't really been into the 'being fair' business - even though they say they are.

 

[evan le'garde]

When a person decides to take up the habit of smoking, they are doing it recreationally, it's how everybody (EVERYBODY) starts smoking. Who's to say otherwise about a non smoker (a young person) who wants to start vaping. They too are doing it recreationally, and has nothing to do with proposed regulations. And those people are the entire vaping community of tomorrows generations. And so the proposed regulations make no logical sense in any way, shape or form, and are only a reference to existing smokers/ex smokers, and that's yesterdays generations.

 

[DaveP]

Logic dictates, given the information we have, that government isn't about outlawing electronic cigarettes simply because they may be a health risk. The risk seems to be that tobacco cigarettes might eventually go away because of the ecig alternative and a taxation slot that goes to the states will eventually be empty.

I actually expected a tax on juices and maybe on hardware instead of a crackdown based on descriptions of the item itself. If you call it an alternative to tobacco, it's OK. If you say that it might assist you in ridding your life of cigarettes, then it's a drug and all the rules change.

There was a time when government viewed risky activities as up to the individual to decide upon. On a level playing field, electronic cigarettes would win out over burning tobacco in a paper tube if health and safety were the criteria. It's something to ponder.

Maybe all this is a transitional move toward shifting the tobacco tax to juices containing nicotine. Once the scare is over, we will welcome a tax just to keep things on an even keel. Things that are taxed seem to hang around forever with oversight just to make sure they are relatively safe if used properly and are labelled for disclosure of possible dangers.

 

[evan le'garde]

Logic dictates, given the information we have, that government isn't about outlawing electronic cigarettes simply because they may be a health risk. The risk seems to be that tobacco cigarettes might eventually go away because of the ecig alternative and a taxation slot that goes to the states will eventually be empty.

There was a time when government viewed risky activities as up to the individual to decide upon. On a level playing field, electronic cigarettes would win out over burning tobacco in a paper tube if health and safety were the criteria. It's something to ponder.

You'd think that if any government department had any kind of a backbone they'd just say it how it is. As it is it just looks completely pathetic, the government that is. Obviously they don't mind looking pathetic. These regulations have no real foundations to speak of. As a government you'd think they'd be able to conjure up something that makes sense.

 

[stevegmu]

I don't see anything about outlawing e-cigs, just in how they are marketed...

 

[sofarsogood]

I've had the feeling the FDA is procrastinating since I started vaping a year ago. What the people at the FDA do all day long is look at things people injest. They ask, what good does it do and, what harm does it do? Almost everything does some of both. (An awful lot of things the FDA approves do some good sometimes and a lot of harm a lot of the time. They allow some truely awful things on the market as so-called medicine.) So what good do e-cigs do? Well, people avoid smoking by vaping. What harm do e-cigs do? The second question is fascinating because a lot of people are spending a lot of money and research to find harms caused by using e-cigs and so far they aren't having much luck. Does the FDA have witch hunting down to a science?

 

[evan le'garde]

I've had the feeling the FDA is procrastinating since I started vaping a year ago. What the people at the FDA do all day long is look at things people injest. They ask, what good does it do and, what harm does it do? Almost everything does some of both. (An awful lot of things the FDA approves do some good sometimes and a lot of harm a lot of the time. They allow some truely awful things on the market as so-called medicine.) So what good do e-cigs do? Well, people avoid smoking by vaping. What harm do e-cigs do? The second question is fascinating because a lot of people are spending a lot of money and research to find harms caused by using e-cigs and so far they aren't having much luck. Does the FDA have witch hunting down to a science?

I think the stimuli the government recieves from big tobacco lobbyists causes them to over think things related to vaping.

 

[stevegmu]

Companies like this are why the FDA is proposing these guidelines...They should be shut down for pretending to be an American company...

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[evan le'garde]

How many people do you hear about "going outside to enjoy a nicotine patch ?", hardly recreational is it !?. Maybe the government should start over thinking about alternatives like that, should keep them occupied and maybe they'd forget about e-cigarettes and vaping.

Many a time remember i going round the bike sheds to enjoy a nice nicotine patch, not !.

 

[Kent C]

Once the scare is over, we will welcome a tax just to keep things on an even keel.

"We"??