FDA deeming rule could happen tomorrow

[sparkky1]

Of all the endless "boring" hours of searching for tobacco addiction ( I like to read ), I have not seen one study that concluded nicotine as the addicting compound, does the FDA have information regarding there claims, I mean is it legal to just make a fact without any science involved ? or is that just one of the perks for the Administration ?

 

[skoony]

@sparkky1 The FDA has contrived many reasons why there are not any actual
studies involving humans to certain the actual addictive qualities of nicotine.
The number one reason is it was deemed to be "unethical" to deliberately expose
someone to addictive substances just to ascertain how addictive they actually
are in the real world. Therapeutical studies of nicotine for medicinal uses has shown
the addictive nature of nicotine has been greatly overstated to say the least.
Regards
mike

 

[Lessifer]

If we had gone down the Drug Route, I don't think would even be seeing the 1st Approvals in a couple of Years. And there would have been No Sales during that time.

Like it or Not, we went down the ONLY Route that was Viable.

Idk, did we? I wasn't around back then. Was there any discussion of approaching legislators about a Recreational Nicotine Act? Second guessing it now doesn't do much good.

There would be no industry if we went the drug route, there will likely be no industry(other than BT) after going the tobacco route. Which was right?

 

[crxess]

From the deeming regs themselves, page 158


So, while it may be true that you will be able to buy bottles that are not regulated by the FDA, any bottle the FDA decides is to be used with a tobacco product(e-liquid) will be regulated.

Never happen. Plastic bottles are not Product Specific. Same for Dropper bottles.

100mL Empty LDPE Bottles 6 Pack - Long Thin Tip - Squeezable PE - Fast US Ship!

* Unicorns may be in trouble again

 

[skoony]

@crxess If there is e-liquid in the bottles they are covered I believe.
I am tired and can't remember the exact references. I have been at the computer
since 7:45 am central time.
mike

 

[Lessifer]

Never happen. Plastic bottles are not Product Specific. Same for Dropper bottles.

100mL Empty LDPE Bottles 6 Pack - Long Thin Tip - Squeezable PE - Fast US Ship!

* Unicorns may be in trouble again

Again, I really don't think it means that plastic bottles won't be available to purchase, or that all bottle will be regulated by the FDA.

Some bottles will be regulated by the FDA, that will be part of the PMTA, whatever container your tobacco product comes in is a component of that tobacco product.

 

[crxess]

Again, I really don't think it means that plastic bottles won't be available to purchase, or that all bottle will be regulated by the FDA.

Some bottles will be regulated by the FDA, that will be part of the PMTA, whatever container your tobacco product comes in is a component of that tobacco product.

Agreed and likely labeled Dispose Safely when empty

Meanwhile $108.00 in my Flavor Apprentice Basket for my primary preference Vapes. Should last a few years

Just going to get this over with

 

[skoony]

Agreed and likely labeled Dispose Safely when empty

There will be a bin at the b&M for that.
Wait,what B&M?
mike

 

[WharfRat1976]

@sparkky1 The FDA has contrived many reasons why there are not any actual
studies involving humans to certain the actual addictive qualities of nicotine.
The number one reason is it was deemed to be "unethical" to deliberately expose
someone to addictive substances just to ascertain how addictive they actually
are in the real world. Therapeutical studies of nicotine for medicinal uses has shown
the addictive nature of nicotine has been greatly overstated to say the least.
Regards
mike

Overstated, yes. Benign, NO.

There are 3 schools,

1. Highly addictive and dangerous

2. Kind of addictive

3. Not addictive

It is kind of hard to tell someone that has used nicotine for over 40 years that it is not addictive.

The FDA of course will always error on the side of caution when it comes to public health. It's a perfect built in excuse to regulate.

 

[zoiDman]

...

There would be no industry if we went the drug route, there will likely be no industry(other than BT) after going the tobacco route. Which was right?

Much like when I Vote, it usually not for Something that I like, but for the Lesser of 2 Evils.

In Our Case, the Lesser of the 2 Evils is the 2nd Choice. The one we went down.

 

[skoony]

It is kind of hard to tell someone that has used nicotine for over 40 years that it is not addictive.

You have a point. IMHO I was addicted to smoking for 38 years. I am not
now certain I was addicted to nicotine. I have substantially reduced the
amount I vape and have started to lower my nic level with no problem.
The reduction in total vaping was not a conscious decision on my part.
It just happened.
Mike

 

[440BB]

The drug route would have killed the market before these last few years of aggressive ecig development, so the tobacco route was definitely the lesser of two evils. This situation still has room for legal challenges, so the game isn't entirely over.

 

[Lessifer]

Much like when I Vote, it usually not for Something that I like, but for the Lesser of 2 Evils.

In Our Case, the Lesser of the 2 Evils is the 2nd Choice. The one we went down.

Between the two, this route allowed us to get here. Again, why are there only two choices, neither of which truly seems to apply?

 

[PhilBrown123]

so depressed heard about this after a ten hour day at work. ever since I started vaping I have spoke higly of it and now pretty soon companies like phillip morris will own the market and we will be in their grasp again. I will go to canada if thats what have to do im only 1hr from the border. thanks uncle sam. one more way to rob us and screw us over. sorry just not liking this. regulation like underage and making sure crap chemicals like formaldehyde and pesticides is one thing but then again they wouldnt dare do that, hell we dont even know everything in ciggarettes!.... just not cool

 

[zoiDman]

Between the two, this route allowed us to get here. Again, why are there only two choices, neither of which truly seems to apply?

Dunno what to Tell you Lessifer? Only relating what the Courts Ruled a Long Time ago.

 

[zoiDman]

Has anyone had a Chance to look at the Official (Draft) PMTA for Electronic Nicotine Delievery Systems (ENDS) Guidance that the FDA now says is OK to Look at?

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf

It kinda makes me want to Puke.

 

[redrebel821]

Has anyone had a Chance to look at the Official (Draft) PMTA for Electronic Nicotine Delievery Systems (ENDS) Guidance that the FDA now says is OK to Look at?

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf

It kinda makes me want to Puke.

Still catching up..but furious at this happening!

 

[zoiDman]

Still catching up..but furious at this happening!

Trust Me. You aint gunna be much Happier when you Look at it.

 

[redrebel821]

Trust Me. You aint gunna be much Happier when you Look at it.

Dude...I've thrown my iPad twice. Then went shopping for nicotine to stock up. Then read some more and threw the iPad again.

 

[nicnik]

This is incredible.
"To obtain marketing 69 authorization under the PMTA pathway, manufacturers are required to establish, among other things, that permitting their products to be marketed would be appropriate for the protection of public health. In establishing this, manufacturers should take into account, and FDA will consider, the ways in which the new product is likely to be used. For example, PMTAs for these products should contain information on whether the product is likely to be used alone or together with other legally marketed tobacco products (such as available delivery systems), as well as the type and range of other products with which it is likely to be used.For example, where a manufacturer seeks authorization of a new e-liquid to be used with ENDS, the manufacturer may need to provide evidence and analysis of the product's likely impact when used in the range of delivery systems available. Similarly, a manufacturer seeking authorization of a stand-alone apparatus component--such as a heating coil or cartridge--may need to provide evidence and analysis of the product's likely impact when used together with the range of other components and liquids available."
In other words if it's for vaping one must also provide evidence of not only how
vaping affects health but how vaping/smoking cigarettes/smoking cigars/using snuss
or chew all together or in parts affects health. none of the later are required to do so
I assume unless it's a new product.
Mike

That is a compelling case for the claims that the FDA is attempting to hand over the market to BT and BP.