Deeming Regulations have been released!!!!

[crxess]

Leaving this here by special request.

Looking for Black Helicopters

My Posted response to this Crap:

I Feel Government will one day Realize the Mistake of Allowing Mitch Zeller to take control of the FDA. This insult to a 95%+ Safer Alternative product will in NO WAY - SLOW tobacco CIGARETTE SALES. There is Strong Belief, it will in fact Drive many BACK TO SMOKING - Increasing HEALTH RISK in America.

I, at 62yrs and 4 years NOT Smoking tobacco, sincerely Agree with that Belief.

Never have I seen so much Promotion attempting to Hide a De Facto Ban through Mysterious and ambiguous Qualifications for Consideration of possible Approval of a scientifically Proven Lower Health risk Product. An Application process which is in Place to Disallow further development of tobacco Products and in no way is Modeled for a Reduced Harm industry.
Millions to Billions of Dollars would be required from Business' Grossing Far Less from their business, With -0- Guarantee of Approval through a lack of Standards in place providing Guidance in compliance.

This Seems to be a Fraud perpetrated on the people by a Trusted Government Agency gone Rogue under direction by its Current CTP Director.

A Grass Roots Solution to Ending Cigarette Smoking Being Dismantled under the Guise of Striking a Blow against Big Tobacco using, once again, The Children as a Shield to hide behind.
_________
** Apologies to ECF, I started to lose it and had to stop before allowing my full rage to take over

 

[WillyZee]

Not long after Juul came out, I was intrigued enough to buy one and a fair number of their pods. My reaction to it (and their magic-sauce juice) was: "Meh".

Juul will get FDA approval ... NJoy will also get approval.

However, we will expose this Hijacking of Vaping.


Sent via iPhone

 

[lauragal]

Right, I meant it would need to be sold as something else, like a food additive, by someone with absolutely no ties to vaping. So you could sell a pg/vg/flavoring mix but it would have to have no ties to vaping whatsoever.

Hmmm.....sounds like a good business opportunity! lol

 

[nicnik]

Juul will get FDA approval

Aside from their juice, they'd need to fix their leaking pods problem, rather than just to suggest, as they do, that users should avoid squeezing the pod. Difficult to avoid when removing from the packaging, removing the cap, snapping the pod in place into the device, removing from the device, and replacing the cap. Each of those actions are a bit tricky while avoiding squeezing.

Easy to get a mouthful of 60mg/ml juice, which isn't exactly the most pleasant experience.

One thing the device has going for it, for appeasing the FDA, is that it has temperature control.

 

[lauragal]

Looking for Black Helicopters

My Posted response to this Crap:

I Feel Government will one day Realize the Mistake of Allowing Mitch Zeller to take control of the FDA. This insult to a 95%+ Safer Alternative product will in NO WAY - SLOW TOBACCO CIGARETTE SALES. There is Strong Belief, it will in fact Drive many BACK TO SMOKING - Increasing HEALTH RISK in America.

I, at 62yrs and 4 years NOT Smoking TOBACCO, sincerely Agree with that Belief.

Never have I seen so much Promotion attempting to Hide a De Facto Ban through Mysterious and ambiguous Qualifications for Consideration of possible Approval of a scientifically Proven Lower Health risk Product. An Application process which is in Place to Disallow further development of Tobacco Products and in no way is Modeled for a Reduced Harm industry.
Millions to Billions of Dollars would be required from Business' Grossing Far Less from their business, With -0- Guarantee of Approval through a lack of Standards in place providing Guidance in compliance.

This Seems to be a Fraud perpetrated on the people by a Trusted Government Agency gone Rogue under direction by its Current CTP Director.

A Grass Roots Solution to Ending Cigarette Smoking Being Dismantled under the Guise of Striking a Blow against Big Tobacco using, once again, The Children as a Shield to hide behind.
_________
** Apologies to ECF, I started to lose it and had to stop before allowing my full rage to take over

It's really simple - if FDA's main agenda is to reduce the percentage of people using tobacco, the most obvious solution would be to ban cigarettes. Their agenda is quite clear.

 

[Lessifer]

Juul will get FDA approval ... NJoy will also get approval.

However, we will expose this Hijacking of Vaping.


Sent via iPhone

Juul MIGHT get approval, it'd be interesting to see the environmental reports associated with the nicotine salts, though they'll probably be blacked out for proprietary reasons.

SOME of NJoy's products MIGHT get approval, like the dailies, and maybe the rechargeable cigalikes. Do they have prefilled sealed clearos? I highly doubt any of their liquid lines, including the Artist Collection, will get approval.

 

[salemgold]

Here are the details for the suit Lost Art VS FDA

https://cdn.shopify.com/s/files/1/0743/0327/files/Lost-Art-Lawsuit.pdf?15196720680143068969

 

[crxess]

It's really simple - if FDA's main agenda is to reduce the percentage of people using tobacco, the most obvious solution would be to ban cigarettes. Their agenda is quite clear.

Well, you see, there in lays(or Lies) the problem. Unfortunately the Behind closed door collusion Between Government officials and Tobacco Industry Leaders Lead to a Deal that in Acepting the Tobacco Settlement Agreement and agreeing to Be Regulated, Government would make certain concessions. One of which protects Big Tobacco from being Further regulated on Standing product - 2007(which Blocks all incoming Tobacco companies) and Keeps Government from outright Banning Tobacco Products.

Yes, Government Can use all the Anti-tobacco Campaigning they can muster, at a ridiculous Cost to America, but they Cannot Touch the Product or the Company in relation to Pre-Deemed Product Standards.

I doubt we are even perceived as a Thread in the Eyes of the FDA(Mitch Zeller) Beyond the Aggravation of being Distracted from his ANTI-TOBACCO Efforts By ........how to put this politely........oh,
His Very Supporters - TO BLIND TO REALIZE - Vaping is about NOT, I repeat NOT SMOKING!!!!!

*Disclosure - This is more for those Prying Eyes than you, @lauragal

 

[Mowgli]

I haven't even been able to keep up with this thread.
Here's the kind of reality check that we need John & Jane Q Public to see more of

 

[crxess]

Here are the details for the suit Lost Art VS FDA

https://cdn.shopify.com/s/files/1/0743/0327/files/Lost-Art-Lawsuit.pdf?15196720680143068969

One comment(a) and one Question(b):

(a) California Court - Second Home for Anti-Vaping policy.

(b) Did they first even consider discussing a Filing at this time, with State and National Industry leadership, before moving forward.

** As Stated, and I agree - To many small, maybe poorly prepared, lawsuits could play into FDA's hands if or when they make a Request to incorporate all Suits, in front of a single Federal Judge in DC.

All this is keeping me up at night.............often, all night

 

[lauragal]

I haven't even been able to keep up with this thread.
Here's the kind of reality check that we need John & Jane Q Public to see more of

@Mowgli - I'd like to post this to my FB page if that's ok - do you have a link to this video? Thank you!

 

[crxess]

I haven't even been able to keep up with this thread.
Here's the kind of reality check that we need John & Jane Q Public to see more of

0MG - Thank you so much............ I felt a Chill as I listened. The first time in Days I have felt anything beyond Anger over our plight.

 

[lauragal]

I haven't even been able to keep up with this thread.
Here's the kind of reality check that we need John & Jane Q Public to see more of

Never mind, found it on FB!

 

[crxess]

@Mowgli - I'd like to post this to my FB page if that's ok - do you have a link to this video? Thank you!

ROTFL - linked it on my FB and accidentally got CASAA some publicity replying to one of his commenters. Their site Main page popped up in the reply

 

[lauragal]

I found it by typing in Reality Check in the search box!

 

[nicnik]

I haven't even been able to keep up with this thread.
Here's the kind of reality check that we need John & Jane Q Public to see more of

Great to see that from a CBS affiliate. I think it's an Atlanta station.

 

[Mowgli]

I sent the YouTube link to my buddy (caveman) that still refuses to FB

 

[Vandal]

Shared the Reality Check video on FB and commented. It feels wonderful, seeing a good word like that.

 

[nicnik]

ROTFL - linked it on my FB and accidentally got CASAA some publicity replying to one of his commenters. Their site Main page popped up in the reply

At the end, after asking how is the RCP report not enough to show that e-cigs will be a positive for public health, as is required for approval, he said "Let's talk about that tonight, on Twitter".

I think the Twitter invitation was directed at you, crxess.

 

[The Ocelot]

I really hate the FDA. Long post - a rant- skip it, I just need to get it out of my system.

From facebook:

Me:
When Congress gave the FDA authority to regulate tobacco I'm sure they did not envision that authority would extend to creating a Catch-22 PMTA system that would shut down thousands of small businesses and put hundreds of thousands of citizens out of jobs. Under the regulations anything even remotely connected to vaping can be deemed a "tobacco product," even if it contains no tobacco, or, in fact, any organic material. It's like deeming a glass an alcohol product because there is wine in it.

America needs jobs. America needs to support small businesses in their efforts to innovate. An application system so expensive and so complex that only Big Tobacco companies have the funds to try to be approved ("try" as in there is no guarantee even they will be successful) is detrimental to our economy.

The FDA's reply to me:
If they contain nicotine derived from tobacco, e-cigarettes meet the definition of a “tobacco product” and are regulated accordingly. These new regulations do not ban e-cigarettes, but rather provide pathways for products to enter, or stay on, the market and incentivize manufacturers to conduct research & submit data to establish the public health benefit of e-cigarettes.

Me back:
Yeah, right. After 40 years of smoking I quit 4 years ago with ecigs. Nothing else I tried worked.

I have been reading the Final Regulatory Impact Analysis and it is flawed. Since there isn't enough current information available on the economic impact of the Deeming requirements put on ecigs, the analysis uses outdated statistics to extrapolate what they *think* the market might be. The market has grown beyond what was imagined in 2014.

Your own statement in the Deeming regs suggests a negative impact on small businesses:

"In a broad sense, because producers of ENDS products would need to incur sizable costs to be able to continue selling their products, we can expect the deeming rule to reduce the number of distinct ENDS products available on the market, relative to what would have been observed in the absence of the rule.

"However, chances are good that numbers of distinct ENDS products would fall anyway in years ahead, as competition causes consolidation of sales in the most popular product lines; as a result, the change caused by the rule has to be measured against an inherently dynamic counterfactual. For present purposes, an important point is that, although numbers of distinct ENDS products are expected to decline as the final rule takes effect, FDA expects that a range of delivery systems and e-liquids will remain available to consumers.

"Consolidated" means to me that large companies that can afford to submit PMTAs will buy out smaller ones and the "range of delivery systems and e-liquids" will be limited to products by those same large companies.

I wonder what, if anything, they will say back.