Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Sun Vaporer]

Today there was no movement on the Docket Sheet. We now have 4 days until the Hearing with Judge Leon.


Sun

[Territoo]

Didn't the FDA deny allowing patients dying from AIDS to try AZT because they hadn't approved it yet? Safety first!

There's too much red tape today and this is largely because most people are afraid to even consider being responsible for their own decisions. It seems that everyone wants some kind of large government agency or a large business to blame should their decision to vape be a perilous one. This all comes at a price. A big one.

Robbie

That and the fact that people will sue at the drop of a hat, even if they do stupid things. You vaped a substance that you know hasn't been tested, you get sick, you sue for a gadzillion bucks.

[LoneRanger]

Day early- But it looks like it's going to be a Looooooong weekend. :-(

[lotus14]

Squirrilah -

IMHO, regulation is necessary. It ensures that product standards are up to par and that consumers are getting what they are told they are getting.

The question is: Who gets to set these standards? If the FDA sets these standards in comparison to pharmaceutical NRT's, then suppliers will be taken down, prices will become inflamed AND there will be a waiting period while all testing is done.

The real argument with regulation, I feel, lies in the example of the tobacco free snuss. There are no TSNA's and no tobacco, however, this product was released by the tobacco industry so therefor, is seen as a tobacco product, which actually it isn't. The ecig is more of a tobacco product than this example, yet because the tobacco industry did not release it, it is not being considered as such.

One thing is for certain: Many suppliers are committed to offering quality products and maintaining quality control measures. It's amazing what has happened in the industry over the past 6 months alone. 6 months ago, most suppliers did not have labeling on their products, now they do. Manufacturers were pumping products into the US without any concern for marketing claims, now they are. The tobacco industry has taken decades to do what has happened in such a short time with the ecig.

Regulation is necessary. Can the industry itself do it? I think so. Will self-regulation offer products at reasonable prices with reasonable availability of quality product? Absolutely.

Agreed. Regulation by the FDA is unavoidable. The question is whether they will be regulated as a tobacco product, "reduced harm product," or an NRT. I really don't see how the FDA can insist that they are NRTs if they are not marketed or used by the majority of consumer to stop all use of nicotine.

Hopefully Judge Leon is looking at the recent legislation to see if e-cigs fit into the "reduced harm" category.

[TropicalBob]

I have to correct one misconception: Snus is a tobacco product. Loose snus is pure tobacco. Portion snus is tobacco in a teabag-like pouch. Unlike American chewing tobacco, snus tobacco is pasteurized, a process that dramatically lowers the TSNAs that cause cancer and results in a product that can be used without need to spit. Snus has a remarkable 300-year history of safe use in Sweden to examine.

Dissolvables are 100% pure tobacco with a sweetener and binder added. The Ariva and Stonewall products are finely ground, pure Virginia tobacco. They have the lowest TSNA counts of any tobacco product sold in the world.

Nasal snuff is finely ground, pure tobacco that absorbs whatever flavor is placed near it.

Tobacco-free snus contains neither tobacco nor nicotine and is completely irrelevant to this discussion.

E-liquid contains a chemical extracted from tobacco (nicotine) and mixed with other chemicals that produce the vapor and stabilize the mixture. This chemical concoction is not a tobacco product any more than a Big Pharma nasal spray is. Both use the same drug, extracted from a common plant, and delivered to nicotine addicts.

Okay, back to the lawsuit.

[robbiehatfield]

That and the fact that people will sue at the drop of a hat, even if they do stupid things. You vaped a substance that you know hasn't been tested, you get sick, you sue for a gadzillion bucks.

This is the same mindset I was originally talking about manifested in the direction of greed. It all comes down to taking responsibility for our own decisions. One shouldn't be allowed to sue over self-inflicted injury. This includes cigarette smokers IMHO.

Robbie

[LaceyUnderall]

I have to correct one misconception: Snus is a tobacco product. Loose snus is pure tobacco.

Apologies. I was referring to tobacco free snuff by Smokey Mountain. There are absolutely no TSNA's in this product according to the 2005 report Tobacco-specific nitrosamines in new tobacco products by Irina Stepanov, Joni Jensen, Dorothy Hatsukami, Stephen S. Hecht.

It IS totally relevant because it is classified as a tobacco product, which it shouldn't be IF it contains no tobacco and is in fact Tobacco Free... which by it's TSNA report, it is. It should be classified as an NRT by the standards the FDA is wanting to set for the electronic cigarette.

[robbiehatfield]

Yet they fast-tracked Chantix/Champix through the system and it ended up being a PR nightmare. On steroids. This is what makes them so gunshy.

Problem though is that none of the ingredients in PV niquid are in themselves 'unknown' ingredients (other than the origin/composition). What is 'unknown' is the shiny new delivery method.

Its funny to me (in an ironic way) that this forum has a health forum where hypochondriacs like me can search/post about anything under the sun that is new to us to see if anyone else is experiencing it, yet the only seemingly common effect is a dry throat from the drying properties of PG, yet every night we turn on the TV to countless pharma ads with their unimaginable list of side effects and we don't give that a second thought.

Known ingredients + new delivery method vs new uncharted chemical compounds + limited (and fast tracked) clinical trials. It boggles the mind, doesn't it? One would think that the necessary studies could be expedited based on that alone.

Not to mention all the ads I see on TV where the fine print states that the FDA hasn't tested their products to substantiate the manufacturer's claims. How come they don't bother them? Simple.. like everything else, one need only follow the money.

Robbie

[grimmer255]

Off subject but i like the smokey mountain snuff, it got me off Kodiak medium cut which I once used in the field where I couldn't smoke.....stupid army rules who would of thought a cigarette ash may set off a mortar.
back on subject...I have to agree e-cigs are not a tobacco product because it does not contain tobacco only nicotine which came from tobacco....but since its not primarily used to quit smoking there needs to be a category for it to fall under. But it still needs to be researched and tested to make sure that your skin doesn't fall off your face or go blind.....even though my eyes sight has improved a little since I quit analogs

[Sun Vaporer]

Off subject but i like the smokey mountain snuff, it got me off Kodiak medium cut which I once used in the field where I couldn't smoke.....stupid army rules who would of thought a cigarette ash may set off a mortar.
back on subject...I have to agree e-cigs are not a tobacco product because it does not contain tobacco only nicotine which came from tobacco....but since its not primarily used to quit smoking there needs to be a category for it to fall under. But it still needs to be researched and tested to make sure that your skin doesn't fall off your face or go blind.....even though my eyes sight has improved a little since I quit analogs

Correct Grimmer--We have no idea the long term effects of chonic exposure to PG or VG as well as vaping flavorings. I really want to see some testing as I am sure most of us do. I do not want to be going from the pot to the frying pan with the e-cig, thinking like I did back in the 70's that using "Light" cigarettes was doing myself a favor---what a joke that was.

The manufatures should be ashamed of themselves for not doing some extensive research on these rather then the good old "take the money and run" tactics.

Sun