Deeming Regulations have been released!!!!

[Eskie]

In my opinion because some are misled to believe that a free market cannot itself establish beneficial collaborative standards. This notion is a fallacy.

A good modern example is Apple computer which took technologies others considered marginally profitable like Firewire to uniform implementation across their platforms. This competitive step facilitated cost availability and in effect forced the interface's broader implementation which contributed to the advancement of this venerable cross-platform standard and spurred the development of competitive others.

Let's remember even Apple is subject to a variety of regulations and has to register and certify products with the FCC. This applies standards on stuff like RF emissions and exposure. I have no idea how much meeting regulatory requirements tack onto the price of your iPhone or Macbook air, but it is built in somewhere. Every industry is subject to some form of regulation. Some that make sense, and some that do not. Some form of regulation will happen to the vape market. Even if Cole Bishop passes, it does not eliminate regulatory oversight and compliance, only tries to make it more tolerable.

JMO.

But I think the Majority thinking was that if someone could come up with a Safer Cigarette, then they would have it go down the Drug Delivery Route.

It was a Fundamental Flaw to me. And to the 400,000+ people who Die every year from Smoking Related Illnesses.

The reason cigarettes are still on the market was a political decision, not based on harm reduction. It would have been impossible to outlaw cigarettes, and near impossible to impose some requirement BT produce a "safer" cigarette. The best they could do is freeze the market in the state it was in when the TCA was passed and signed. BT got to keep their brands on the market, but no new ones. At the time, it was considered a success, as never before had the federal government gained such control on the tobacco industry, a large industry with a 200 year history of operation in the US. Tobacco supported, and still supports, significant regions in the US as a primary driver of their economy.

As you point out, when this was enacted there was no basis to assume something like vaping would pop up and have such a profound effect on the tobacco market. The FDA has tried to shoehorn in something they "believe" is consistent with the TCA with these regs. Remember, they tried to go at vaping as a drug delivery system and got shot down in court. They were essentially told to reconsider as a tobacco product. so they have, and this what we've got. Legislative action to supply guidance on just how much reach they should have into the vaping industry is one way of addressing it.

Even if the new administration decides by executive action to not enforce the law on the books (because that's what it is now, law), that offers no long term solution to bad regs remaining and simply kicks the can down the road for the next bunch to deal with.

 

[zoiDman]

...

Even if the new administration decides by executive action to not enforce the law on the books (because that's what it is now, law), that offers no long term solution to bad regs remaining and simply kicks the can down the road for the next bunch to deal with.

And this is why So Many see moving the Predicate Date up as being so Critical.

Not that it Fixes the Problem. But that it allows the Market to continue while More Positive Studies by Reputable Sources are Published.

If we could just get 2 or 3 Years down the Road, I believe the weight of Scientific Evidence would Not Be Ignorable. And then Fixing the Problem of Deeming would be Much Easier.

 

[Eskie]

And this is why So Many see moving the Predicate Date up as being so Critical.

Not that it Fixes the Problem. But that it allows the Market to continue while More Positive Studies by Reputable Sources are Published.

If we could just get 2 or 3 Years down the Road, I believe the weight of Scientific Evidence would be Not Be Ignorable. And then Fixing the Problem of Deeming would be Much Easier.

You're right, and that can be a big deal. So far serious study of vaping has been supporting evidence for harm reduction. There are legitimate evaluations at mainstream institutions which, as the results come in, should be very effective to rebut most of the nonsense out there. But it will take several more years (at least) and the farther out any serious damage is potentially afflicted on the vaping industry the better (although harm to the industry is already seen with businesses closing down). It would be pretty bad if 5 years from now, and the vape industry is shut down, to turn around and go "oops, my bad. This stuff is actually good for smokers to use".

 

[MacTechVpr]

I just look at something like the Craft Beer Brewing Industry.

It's got Reasonable Age Limits and Shipping Restrictions so No One can play the "We have to Save the Children Card". It has a Framework of Quality Protections which don't seem Overly Restrictive. And there is the Ability to oversee it at the State and Federal Level.

Shouldn't the e-Cigarette Market be More Aligned with something like that Market? Then the Horrendous Overreach and Heavy Handed approach that was taken with e-Cigarettes.

Given your earlier criticism of FDA's excess, I would simply ask…

Why?

What's in it for us? Especially if we're famously successful, beloved and respected. Trusted. That we're going to be sanctioned but subject to gov's greater stake in our business, so safe? We're doing it anyway if the preceding applies. How with lesser resources of diminished returns does gov's stamp of approval improve the industry's consumer value or safety for that matter?

Sorry for the rhetorical questions (when all the probable answers are in the negative).

...If we could just get 2 or 3 Years down the Road, I believe the weight of Scientific Evidence would be Not Be Ignorable. And then Fixing the Problem of Deeming would be Much Easier.

You might be right z if government were reasonable. But in the face of a declining market from where would the resources originate to justify continuing scientific interest? In essence, who can afford an PMTA?

And having it's authority affirmed by subscription who is then to complain that FDA constrains any part of production it deems appropriate, i.e. mech's, DIY, etc., to arrive at its vision of a satisfactory un-natural concatenated monopoly further reducing market scale?

To assume a remnant that resembles vaping as we know it is a tenuous proposition…a vape biz lotto, the myth that some will be blessed while others not.

The proof is history, that despite that formidable tax revenues brought by expansive FDA, etc. regulations of the combustible tobacco industry it is not one iota safer, or the product better. Arguably, far worse.

As I said, we survived as a species quite well without them.

Good luck.

 

[zoiDman]

Given your earlier criticism of FDA's excess, I would simply ask…

Why?

...

I Don't understand your Question.

 

[beckdg]

How so?

If I'm Not Legally Restricted to put something into a Consumable Product, and No Intent to Harm can be Proven, what Laws have been Violated.

Or does the Court(s) now start to Operate like the FDA evaluates a PMTA? And just Make It up as it goes?

If...

You set the argument up to knock it down.

Then you moved the goal post.

So since you have such great lawyers, would you mind lending me some?

I'm going to make a bleach and ammonia joose and call it summers day cleanse.

I have no idea if it's safe or not.

Tapatyped

 

[zoiDman]

If...

You set the argument up to knock it down.

Then you moved the goal post.

So since you have such great lawyers, would you mind lending me some?

I'm going to make a bleach and ammonia joose and call it summers day cleanse.

I have no idea if it's safe or not.

Tapatyped

I think it would be Very Easy for a Jury/Judge to find that Bleach and Ammonia present a Clear and Present Danger if inhaled. And it would be a Tough Sale for my lawyers to convince a Jury/Judge that I Didn't have an Intent to Harm others.

BTW - How would this Identify Harm - Then Charge with a Felony prevent Harm from happing in the First Place? Because isn't that what a Public Health Policy should be doing? Preventing Harm.

 

[beckdg]

I think it would be Very Easy for a Jury/Judge to find that Bleach and Ammonia present a Clear and Present Danger if inhaled. And it would be a Tough Sale for my lawyers to convince a Jury/Judge that I Didn't have an Intent to Harm others.

BTW - How would this Identify Harm - Then Charge with a Felony prevent Harm from happing in the First Place? Because isn't that what a Public Health Policy should be doing? Preventing Harm.

Depends.

How much stock do you hold in public health policy preventing anything?

Best I can decipher, the penalties of serious offenses are much better deterrents.

From my prior career in the food industry I can tell you there's a much larger probability that there's spit or some other biohazard in your meal than you think... even with an A grade from the health department on the front door.

Tapatyped

 

[MacTechVpr]

I Don't understand your Question.

Why…should we expect the present regulatory schemes to produce a constructive or beneficial result? What can we, merchants and users, expect from the self-funding, self-justifying, unaccountable process we are seeing? Even if they rolled back virtually all of it?

The stickler for me in particular is the funding part. That we allow the further expansion of such rule-making agency models, not responsive to Congress and not reliant upon their approval for funding. A government in parallel.

FDA's flagrant independent expansion of congressional intent I believe ought to be thwarted here. Expect more government otherwise if Congress persists in pretending such will not metastasize into something far greater. But wait, it already has. What we're having the privilege of witnessing, laid bare as vaping is a distinctively novel industry…the voracious appetite of bureaucracy to expand its domain. And a Congress which has remained indifferent to it.

But budget battles and the vagaries of incumbency will be a far less arduous affair once the burdens of bureaucratic enterprise are suitably delegated along with (Is it a tax or is it a fine?) authority.

Like I said, reasonable government. But I contradict myself.

Good luck.

 

[zoiDman]

Depends.

How much stock do you hold in public health policy preventing anything?

Best I can decipher, the penalties of serious offenses are much better deterrents.

From my prior career in the food industry I can tell you there's a much larger probability that there's spit or some other biohazard in your meal than you think... even with an A grade from the health department on the front door.

Tapatyped

I don't think that anyone who isn't Severely Emotionally Clouded thinks that Public Health Policy prevents all possible Harm. Especially when an argument is being made that a product is Harm Reduction verses Harm Elimination.

I think a Quasi-Food/Beer type Regulatory Framework could be established that could Regulate the e-Cigarette Market while not Stifling it. It would Also stand a chance of being Passable thru a Divided Congress.

But that would take New Thinking at the HHS/FDA/NIH. Not sure how the New Administration wants to move forward on e-Cigarettes?

Guess like Many Things we will have to Wait and See.

 

[zoiDman]

Why…should we expect the present regulatory schemes to produce a constructive or beneficial result? What can we, merchants and users, expect from the self-funding, self-justifying, unaccountable process we are seeing? Even if they rolled back virtually all of it?

The stickler for me in particular is the funding part. That we allow the further expansion of such rule-making agency models, not responsive to Congress and not reliant upon their approval for funding. A government in parallel.

FDA's flagrant independent expansion of congressional intent I believe ought to be thwarted here. Expect more government otherwise if Congress persists in pretending such will not metastasize into something far greater. But wait, it already has. What we're having the privilege of witnessing, laid bare as vaping is a distinctively novel industry…the voracious appetite of bureaucracy to expand its domain. And a Congress which has remained indifferent to it.

But budget battles and the vagaries of incumbency will be a far less arduous affair once the burdens of bureaucratic enterprise are suitably delegated along with (Is it a tax or is it a fine?) authority.

Like I said, reasonable government. But I contradict myself.

Good luck.

There's an Old say'n Mac. "If you Keep Doing what your doing then you'll Keep Getting what you Get."

I think this applies very well to the FDA.

I think until Congress gets off there Azz and starts looking at the FDA (as well as All Government Agencies) nothing will change in the Long Run.

The FDA is Broken on a Fundamental Level. And we may get a Reprieve here and there depending on the Administration, the Core Problems don't Change.

 

[MacTechVpr]

There's an Old say'n Mac. "If you Keep Doing what your doing and you'll Keep Getting what you Get."

I think this applies very well to the FDA.

I think until Congress gets off there Azz and starts looking at the FDA (as well as All Government Agencies) nothing will change in the Long Run.

The FDA is Broken on a Fundamental Level. And we may get a Reprieve here and there depending on the Administration, the Core Problems don't Change.

Don't get me wrong, I'm not in any manner suggesting we throw practicality or pragmatism to the wind. However, we mustn't hurt ourselves in any such process by unwarranted subscription or compliance. Then avoidance is essential to any political solution or negotiation. Anything that validates FDA authority at this point I feel empowers them. They've fully exposed the multi-headed beast in every variance from the intent and letter of the law. Not the least of which is using the very interest and participation of business and the public against us to formulate their strategies and position.

This is not a genuinely impartial actor working in the public's interest and the evidence is clear. But I am greatly concerned about the structural example that their framework represents and not only with regard to this industry and community.

Good luck all.

 

[zoiDman]

Don't get me wrong, I'm not in any manner suggesting we throw practicality or pragmatism to the wind. However, we mustn't hurt ourselves in any such process by unwarranted subscription or compliance. Then avoidance is essential to any political solution or negotiation. Anything that validates FDA authority at this point I feel empowers them. They've fully exposed the multi-headed beast in every variance from the intent and letter of the law. Not the least of which is using the very interest and participation of business and the public against us to formulate their strategies and position.

This is not a genuinely impartial actor working in the public's interest and the evidence is clear. But I am greatly concerned about the structural example that their framework represents and not only with regard to this industry and community.

Good luck all.

So with regards to the current e-Cigarette Market/Situation, what is the Solution IYO?

 

[coldgin96]

 

[Katya]

So with regards to the current e-Cigarette Market/Situation, what is the Solution IYO?

Here's my solution...

President Trump's Deregulators Should Tell The FDA's Anti-Vaping Jihadists to .... Out

 

[HBcorpse]

Got some new juice in from Ohm Slaw Vapors...very good by the way.

The fact that they had to put this on their labels is F------ MENTAL.
Really looking forward to some kind of relief from this new administration...
Fingers crossed.

 

[MacTechVpr]

Here's my solution...

President Trump's Deregulators Should Tell The FDA's Anti-Vaping Jihadists to .... Out

I agree. We need regulator roto-rooters. G'luck.

(Say that 3x fast.)

 

[90VG]

Got some new juice in from Ohm Slaw Vapors...very good by the way.
The fact that they had to put this on their labels is F------ MENTAL.
Really looking forward to some kind of relief from this new administration...
Fingers crossed.

0mg/ml "this product created from tobacco"

Big lol.

 

[classwife]

False Advertising

 

[90VG]

Speaking of 3 letter agencies...

I went to a public meeting of the BLM once. It was to listen to opinion about closing more off road trails to motorized vehicles. That was their idea. So I got a chance to speak, and I talked about how these canyon roads going over small creeks are not getting damaged by vehicles. They get annihilated every year by the flash floods. Any small life (riparian) living anywhere near that water is dead. They weren't interested in real facts. I asked them if we were having a vote, since this closure effects the residents of this valley.

"No, this is a public comment, not a vote", BLM director stated.

I then asked, "Is anyone here an elected official?"

BLM: "No, we work for the BLM."

Me: "So you are having a public comment section, but you are going to do what you want regardless? And there is no representation of the people that this will effect?"

BLM: "But we are having a public comment section so we can get your opinion."

Me: "But there is no vote. You don't have to listen to anything we say, you just do what you want. This is a dog and pony show to make it look like you listen, when all you really care about is keeping you job and hiring your liberal arts major buddies."

I was already prepared to leave as security was walking to me, I got out with out incident. What was funny is one of the BLM ladies, I had dated her, and I knew she agreed with me. She turned bright red on stage when I waved.

In the end, not a single person there wanted the road closed. But it's closed now......