Deeming Regulations have been released!!!!

[rosesense]

I’m confused by the claim that “most vape shops that currently mix e-liquids will convert to a retail model.” If small manufacturers, such as ones that produce tanks, “open” device components, handmade drip tips, handmade wooden mod stands, vinyl protective mod covers and similar items that are now deemed tobacco products, can’t afford the cost of PMTAs (let alone trying to figure out they impact public health), what are the retail vape shops expected to sell?


For more information on the Big Tobacco companies stake in the market I suggest reading this article from Forbes: Who Stands To Gain From The E-Cigarette Phenomenon? Who Stands To Gain From The E-Cigarette Phenomenon?

RIA:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf

I believe they are referring to retail shops selling ones like Vuse that are approved. Much like the local mini mart does now.

 

[Katya]

BT could use him as a test subject. That would get PETA off their backs.

FDA shares an interest in reducing the reliance on animal-based studies, and the Agency is committed to the three "Rs" of reduction, refinement, and replacement in animal testing. Although we are hopeful that in vitro assays and computer models can ultimately help to replace much of the need for animal testing, there are still many areas for which non-animal testing is not yet a scientifically valid and available option.

Smoking Experiments on Animals

"If the tobacco industry wants to continue developing and marketing products that cause addiction and kill people, it should do so without the help of the government and without harming animals. You can write to the U.S. Food and Drug Administration and request that it follow the lead of agencies in progressive countries by banning tobacco product and ingredient tests on animals:

Tobacco Products Scientific Advisory Committee
Center for Tobacco Products
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
tpsac@fda.hhs.gov"

I'm not a member of PETA so please don't shoot. It's just another avenue that might be explored. Those deeming regulations will undoubtedly lead to increased animal testing.

@crxess Thanks for the link.

 

[The Ocelot]

Good thinking!

But wait, what about the children?

We want to protect our children, who cares about their children?

The three "Rs" of reduction, refinement, and replacement:
Reduction = of them
Refinement = we reserve the right to choose who is us
Replacement = see reduction

 

[Bronze]

We want to protect our children, who cares about their children?

The three "Rs" of reduction, refinement, and replacement:
Reduction = of them
Refinement = we reserve the right to choose who is us
Replacement = see reduction

Makes perfect sense!

 

[rosesense]

So what if a lot of us posted the vid of the smoking beagles on FB and wherever with the quote about how some testing will have to be done on animals? Lots of animal lovers and they might not take kindly to the FDA's new regs that will increase animal testing. What do you all think?

 

[Rossum]

Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?

Gosh, that's just outrageous. It should obviously be as difficult as possible for consumers to find the type of cigarettes they prefer.

 

[Woofer]

Smoking Experiments on Animals

I nominate Zeller, Stan Glan and the hideous Debbie Wasserman-Schultz.

 

[The Ocelot]

I believe they are referring to retail shops selling ones like Vuse that are approved. Much like the local mini mart does now.

How is a B&M supposed to stay in business selling cigalikes?

With rent, payroll, workers' comp insurance, business license fees, loan payments (they likely took out a loan to start the business), inventory purchasing costs, advertising, inventory shrinkage (insert additional costs I can't think of) - How many Vuse does Johnny have to sell per month to keep from putting a gun in his mouth?

 

[YoursTruli]

 

[Kent C]

Listen son, I really don't know why you get so bent when I, a lowly messenger merely points to the fact about Altria supporting HR2058. Do I know why? No. And if you'd have followed the conversation many threads ago... nobody else can really figure it out either.

But there it is.

And there's this from Dr. Siegel: go to 40:00 and as to 'why' 40:50

 

[Katya]

So what if a lot of us posted the vid of the smoking beagles on FB and wherever with the quote about how some testing will have to be done on animals? Lots of animal lovers and they might not take kindly to the FDA's new regs that will increase animal testing. What do you all think?

I'm writing a letter as we speak.

Smoking Experiments on Animals

"If the tobacco industry wants to continue developing and marketing products that cause addiction and kill people, it should do so without the help of the government and without harming animals. You can write to the U.S. Food and Drug Administration and request that it follow the lead of agencies in progressive countries by banning tobacco product and ingredient tests on animals:

Tobacco Products Scientific Advisory Committee
Center for Tobacco Products
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
tpsac@fda.hhs.gov"

I'm not a member of PETA so please don't shoot. It's just another avenue that might be explored. Those deeming regulations will undoubtedly lead to increased animal testing.

@crxess Thanks for the link.

 

[The Ocelot]

So what if a lot of us posted the vid of the smoking beagles on FB and wherever with the quote about how some testing will have to be done on animals? Lots of animal lovers and they might not take kindly to the FDA's new regs that will increase animal testing. What do you all think?

Safety and toxicology of cyclosporine in propylene glycol after 9-month aerosol exposure to beagle dogs. - PubMed - NCBI
Non-clinical safety and pharmacokinetic evaluations of propylene glycol aerosol in Sprague-Dawley rats and Beagle dogs. - PubMed - NCBI
348. Propylene, 1,2- glycol (WHO Food Additives Series 5)

Beagles have been huffing PG for years (these are only a few studies).

 

[Lessifer]

How is a B&M supposed to stay in business selling cigalikes?

With rent, payroll, workers' comp insurance, business license fees, loan payments (they likely took out a loan to start the business), inventory purchasing costs, advertising, inventory shrinkage (insert additional costs I can't think of) - How many Vuse does Johnny have to sale per month to keep from putting a gun in his mouth?

They will "exit" or "consolidate" into the tobacco store category.

What? You don't think having three products in a total of 6 flavors will be enough to sustain a vape shop?

 

[Eskie]

I'm not a member of PETA so please don't shoot. It's just another avenue that might be explored. Those deeming regulations will undoubtedly lead to increased animal testing.

@crxess Thanks for the link.

And lots of human testing. According to that Final Regulatory Impact Analysis, human studies will be the most expensive requirement for a PMTA application (p.90 table 12a, b) with a low of $135,000 for products with a "low average cost" (think closed Vuse systems) to $1,800,000 for a "high average cost" (think open vaping systems). And from personal experience with the FDA regulatory process, I can virtually guarantee that figure is wishful thinking. Human studies are very difficult to plan, especially when (for now) you have no guidance on what exactly will satisfy the FDA for acceptance, time consuming, and expensive to administer. I'm sure as the requirements of the FDA are made known for what human studies will satisfy their bureaucracy, those figures will be adjusted up, buried in some poorly found supplement.

Do you think we can get PETA excited about the fact we use Vegetable Glycerin, so no animals are harmed in the manufacture of juice (there are no poultry or beef flavors out there, right?)?

 

[Katya]

I can virtually guarantee that figure is wishful thinking.

The whole thing is a bunch of lies, not wishful thinking. They know very well what the costs are going to be. They just don't want to disclose it.

Do you think we can get PETA excited about the fact we use Vegetable Glycerin, so no animals are harmed in the manufacture of juice (there are no poultry or beef flavors out there, right?)?

Only if we can prove that we're using pure vegetable glycerin.

 

[crxess]

I have been Diving into the Past to get some insight to into Mitch Zeller. I need a Few Advil ATM and maybe a loaded gun

Zeller -
Our goal should be twofold. First, to deprive the tobacco industry of their new
customers -- our children -- and grow up the next generation of kids not addicted to
nicotine. And second, to help addicted smokers either quit or reduce the harm associated with their continued use of tobacco in a significant and meaningful way.(ME - LIER!!!!)

We Found the Signifigant and Meaningful Way Mitch!!! Let it go already!

Feel Free to Dive in and Find out how long Eliminating Nicotine has been Zeller's Mission in life.
Forget the Fact it is the Tar and everything else in Smoke that is actually Un-Healthy!
Forget the Fact Nicotine is not the Killer.


http://www.who.int/tobacco/media/en/ZELLER2000X.pdf

This Enemy of Vaping, at times, seems to Believe Tobacco would be fine without nicotine

 

[OcalaFlGuy]

Well, I guess if keeping your child safe isn't enough motivation to keep an eye on your kid then perhaps doling out a wad of cash for a replacement gorilla would be. No?

And if that's not enough, then maybe they should be made to catch their own replacement gorilla.

Bruce in Ocala, Fl

 

[Lessifer]

How is a B&M supposed to stay in business selling cigalikes?

With rent, payroll, workers' comp insurance, business license fees, loan payments (they likely took out a loan to start the business), inventory purchasing costs, advertising, inventory shrinkage (insert additional costs I can't think of) - How many Vuse does Johnny have to sell per month to keep from putting a gun in his mouth?

I'm skimming through the FRIA right now, and it's making me sick. All I see over and over is "we estimate great market exit and consolidation" and we don't care.

And then there's this, which is just confusing:
"The commenter’s estimate of the number of electronic cigarette (ENDS) products remaining on the market is difficult to evaluate from the information provided. In our analysis of the proposed rule, we forecasted that all ENDS products would require PMTAs, and that the number of submissions would be far fewer than 633. (Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.) However, we now forecast that some ENDS delivery systems may be able to use the SE pathway and that both e-liquids and delivery systems may be able to use the exemptions pathway after the initial round of marketing authorizations. Given this and the growth we have seen in the ENDS market, we now forecast that a larger number of requests for marketing authorization will be submitted for e-liquids and ENDS delivery systems, as described in Section III.C.3.b.2 of the final RIA."

Estimating 20-80 applications, no estimate of number of approvals...

Now there are predicate products? For delivery systems(still guessing cigalikes) and e-liquids?!

 

[ZeroedIn]

I'm second to last.

Nope, no FB here, and never will be for me.

 

[The Ocelot]

I'm skimming through the FRIA right now, and it's making me sick. All I see over and over is "we estimate great market exit and consolidation" and we don't care.

And then there's this, which is just confusing:
"The commenter’s estimate of the number of electronic cigarette (ENDS) products remaining on the market is difficult to evaluate from the information provided. In our analysis of the proposed rule, we forecasted that all ENDS products would require PMTAs, and that the number of submissions would be far fewer than 633. (Specifically, we forecasted that 20 to 80 premarket tobacco applications would be submitted within the first 24 months and 10 to 20 annually thereafter.) However, we now forecast that some ENDS delivery systems may be able to use the SE pathway and that both e-liquids and delivery systems may be able to use the exemptions pathway after the initial round of marketing authorizations. Given this and the growth we have seen in the ENDS market, we now forecast that a larger number of requests for marketing authorization will be submitted for e-liquids and ENDS delivery systems, as described in Section III.C.3.b.2 of the final RIA."

Estimating 20-80 applications, no estimate of number of approvals...

Now there are predicate products? For delivery systems(still guessing cigalikes) and e-liquids?!

Last night I poured over the PRIA and the RIA. I saw FRIA referenced, is it another report?

I really bothers me that cigars, pipe tobacco and RYO were lumped in with e-cigs. It makes no sense to combine data of combustable and non-combustable products. It also bothered me that since there is much more empirical evidence on cigars it is often used to respond to comments with e-cig info buried under not having sufficient evidence.