Deeming Regulations have been released!!!!

[Lessifer]

It doesn't matter what you or I believe. What matters is whether we can convince anyone in "authority" of that.

I think we have a chance to convince 'em that nic-free liquids and hardware are not tobacco products.

But vape-stuff that contains nicotine extracted from tobacco?...

Well, the alternative would be to have the FSPTCA amended, I believe.

and so the anti-argument has shifted to but hey once your bottled eliquid is out in the wild where teens have access to it stuff can be added to it because it goes into an open system that you can add practically anything in to versus a completely closed tamper proof system. This has been mentioned by the FDA as well as a hot topic in the news as of late, teens adding stuff to e-cigarettes to vape (although I have different thoughts on that as to type of vaping equipment involved) it has been on my local news quite a bit and in several other states I am aware of and in national media as well.

Yes, but that speaks to the approval. I don't think the approval is likely for a number of reasons, though I can't see how they could hold you accountable for how your product could be later adulterated by the consumer. That would be like saying you can't sell a cup because even if you say it's for use with soda, a teen could put alcohol in it.

They don't even need to go there. If you have a liquid, by itself, you have to prove it's safe to use with any device. I'm not sure if that's any approved device, or if it's actually ANY device. If it's any device, good luck with that, if it's any approved device, you've got a chicken/egg situation between getting devices and liquids approved. If it's a flavor other than tobacco, good luck proving it won't entice teens. If it's an effective product, good luck proving you won't cause smokers to switch and continue using your product. etc.

 

[USMCotaku]

But try finding an example. I couldn't, when I tried.

In particularly preferred compositions, methods, and uses, the thermo-nebulizable carrier is or comprises a low-molecular weight polyol, most preferably in an amount of between 80-92 vol% of the formulation. For example, suitable thermo-nebulizable carrier are or comprise propylene glycol, glycerol, and/or PEG400 (polyethylene glycol) in a total amount of between 80-92 vol% of the formulation.

Patent WO2014113638A1 - Multi-use albuterol maintenance therapy formulations and devices therefor

A patent for an Albuterol "delivery system" specifically mentioning PG

 

[zoiDman]

It doesn't matter what you or I believe. What matters is whether we can convince anyone in "authority" of that.

I think we have a chance to convince 'em that nic-free liquids and hardware are not tobacco products.

But vape-stuff that contains nicotine extracted from tobacco?...

This is what I think get's to Me the Most. We Shouldn't Even Be Having This Discussion about Nicotine Free Liquids or Hardware.

No Nicotine derived from Tobacco in a Product (should) = No Tobacco Product.

And No Tobacco Product = No FDA Authority.

I think this Should be/Shouldn't Been Revised at the Congressional Level. And Shouldn't even have to go to a Court.

 

[skiball]

So from what i understand online sales will not be allowed in the usa. But i did read that sales out of country are ok in the 2 year grace period. As long as the products are for personal use. Can anyone confirm this?

Sent from my LG-E980 using Tapatalk

 

[nicnik]

Patent WO2014113638A1 - Multi-use albuterol maintenance therapy formulations and devices therefor

A patent for an Albuterol "delivery system" specifically mentioning PG

But it's for a nebulizer, not an inhaler. And not marketed or approved for marketing.

 

[Pamawoman]

My apologies. After listening to all that I am so upset I can barely think straight......or as straight as I ever have
The Wall are still intact.........so far......But I want a Zeller Punching bag so it isn't funny.

Almost as much as Deeming, I fear the next thread I enter, where some ANTZ PLANT Clown or just plain Naive individual wants to talk about how FDA Deeming isn't so bad....... I will miss ECF should I slip and speak my mind

Okay, that was my Count to 10.

Now, what do we do next to battle this Crock of ?


Need more people to post their concerns to the John Oliver Last Week Tonight producers. Seems The E-cig industry is Fast heading for Last weeks News

Spoiler: Avalon Television

Avalon Television

I can't even watch ANY of them anymore. I am afraid I am going to hurt someone or kick the dog or throw the iPad against the wall. It is INFURIATING!!!

 

[crxess]

The FDA has perpetrated a Fraud upon the People By Lie and omission.

If challenged in a Court of Law and continued, they could also be found
Perjurious

the willful giving of false testimony under oath or affirmation, before a competent tribunal, upon a point material to a legal inquiry. Origin of perjury Expand. Latin. Middle English. Anglo-French.

E-liquids containing NO-Nicotine must be labeled - Made from Tobacco

Repeated Denials of Opposing testimony to Proposed actions and Fraudulent statements of No opposed alternative suggestions or Recommendations.
As well as who knows how many Buried testimonials they Claim not to exist.

I'd love to hear a Judge order them to turn over ALL Pre-Deeming Documentation including all Opposing testimony........and order an injunction pending Review.

 

[zoiDman]

So from what i understand online sales will not be allowed in the usa. ...

This has not been put in place. But I would Not Rule Out the Realistic possibility of it happening in the near Future.

 

[crxess]

and so the anti-argument has shifted to but hey once your bottled eliquid is out in the wild where teens have access to it stuff can be added to it because it goes into an open system that you can add practically anything in to versus a completely closed tamper proof system. This has been mentioned by the FDA as well as a hot topic in the news as of late, teens adding stuff to e-cigarettes to vape (although I have different thoughts on that as to type of vaping equipment involved) it has been on my local news quite a bit and in several other states I am aware of and in national media as well.

There have no doubt been more News stories covering this than actual offenders
Anything that helps in pressing an agenda is fair game and Regulators are Pros at it.

.........and yes, this happens in most agencies of Government

 

[zoiDman]

nclobo just posted this in the Sen Johnson thread...

Here is a podcast the Senator conducted with SFATA today. It's a good listen and sounds like he truly is concerned on the impact of small business the regs will have.

Episode 6: U.S. Senator Ron Johnson Speaks with SFATA About FDA Deeming Reg - SFATA | Smoke Free Alternatives Trade Association

 

[skoony]

But it's for a nebulizer, not an inhaler.

Do we not have to inhale them both?
Is this not a distinction with out a difference?
Of course as always correct me if I am wrong.
Mike

 

[nicnik]

Do we not have to inhale them both?
Is this not a distinction with out a difference?
Of course as always correct me if I am wrong.
Mike

I agree, but if you follow the conversation back, you'll see that the discussion was whether or not it's accurate to claim that some inhalers contain PG.

 

[nicnik]

There's nothing wrong with trying everyone, since they may not have the same audience. Plus, topical is topical, no one is a copycat for covering the same news story.

I gave this some more thought, and I think you're right, partly because there's far from any certainty that Oliver's show will take it up, and partly because you're right, anyway.

 

[skoony]

I agree, but if you follow the conversation back, you'll see that the discussion was whether or not it's accurate to claim that some inhalers contain PG.

Yes I remember those discussions. Back then i claimed as I still do now that
it's a distinction with out any difference. PG has been used to inhale medicine.
There is no way to deny this.
Mike

 

[Katya]

Did you notice how our friend Maggie said at 3:36

"All of these requirements seems like common sense to those of us who are working in the field. However, the Tobacco Industry has been pursuing a Variety of Tactics to get Congress to bind the FDA's Hands with respect to these products."

Bind their hands?

The way those regulations are written,

1) Everything the FDA wants to deem now (or in the future) a tobacco product is (will be) a tobacco product. Period. It makes no difference if it's a tobacco product, nicotine product or an acrylic drip tip.

2) Any "tobacco manufacturer" who wants to have their product approved [either via SE (they still didn't even tell us what the substantially similar predicate product is?) or PMTA] needs to invest thousands of man hours and millions of dollars to produce an application that requires, among other undoable things, proving the unprovable (how does one prove that a child will not be attracted to a certain object, for example?).

What the FDA needs to do in response to an application is NOTHING. If they don't respond within a year, the application is automatically denied. Or, as my friend Nate brilliantly pointed out elsewhere, "As the law is now written, FDA has the full legal authority to reject a PMTA application by tweeting "lolsux2bu"."

I have nothing else to add, really. If those regs are not changed (challenged, amended, stopped, rewritten, thrown out of court), we're screwed.

 

[Katya]

Nope, won't do it for profit. I'll only do it for cost and teaching people how to do it.

It will make you a tobacco manufacturer.

 

[markfm]

I don't know if pg use as a cyclosporine carrier has ever made it past trials. I just did another quick check, it sounds like it is still an NIH study area, for both lung transplant and popcorn lung treatment.

Anyone got proof of it really being used in a production, wide use, inhaler or nebulizer? It would be nice, but we shouldn't claim it without the data backing up the claim.

 

[MacTechVpr]

Well, the alternative would be to have the FSPTCA amended, I believe.


Yes, but that speaks to the approval. I don't think the approval is likely for a number of reasons, though I can't see how they could hold you accountable for how your product could be later adulterated by the consumer. That would be like saying you can't sell a cup because even if you say it's for use with soda, a teen could put alcohol in it.

They don't even need to go there. If you have a liquid, by itself, you have to prove it's safe to use with any device. I'm not sure if that's any approved device, or if it's actually ANY device. If it's any device, good luck with that, if it's any approved device, you've got a chicken/egg situation between getting devices and liquids approved. If it's a flavor other than tobacco, good luck proving it won't entice teens. If it's an effective product, good luck proving you won't cause smokers to switch and continue using your product. etc.

Yes, amended to exclude any link or connection to e-cigarettes which are not a like kind product to conventional combustible tobacco in any manner except in the deluded fantasies of our new age revenuers.

Good luck all.

 

[zoiDman]

... "As the law is now written, FDA has the full legal authority to reject a PMTA application by tweeting "lolsux2bu"."
...

I want is to see Burwell and Califf being dragged out of the Shadows and Railed for 5 Straight Days in a Senate Oversight Investigation.

#GoRonGo

 

[USMCotaku]

But it's for a nebulizer, not an inhaler. And not marketed or approved for marketing.

I think you are moving the goal posts a bit, since a nebulizer is a type of inhaler.
Inhaler - Wikipedia, the free encyclopedia