Deeming Regulations have been released!!!!

[seminolewind]

The Brits and possibly the French on the other hand have had the opportunities to work with their gov. and came up with vaping liquid can not be over 20mg (2%) nicotine and tanks can not hold more than 2 ml's . Now that's something I can understand safety wise.

Meanwhile, FDA has no right deeming anything or stating anything or writing regulations until they know more than what they've read on the internet. They say it's not been proven that vaping is used to quit smoking. They refer to the liquid as having toxins and carcinogens in it. This shows most of us that the FDA does not know enough about vaping to deem regulations. Congress should have required the FDA to get some facts first.

 

[mikepetro]

The Brits and possibly the French on the other hand have had the opportunities to work with their gov. and came up with vaping liquid can not be over 20mg (2%) nicotine and tanks can not hold more than 2 ml's . Now that's something I can understand safety wise.

Meanwhile, FDA has no right deeming anything or stating anything or writing regulations until they know more than what they've read on the internet. They say it's not been proven that vaping is used to quit smoking. They refer to the liquid as having toxins and carcinogens in it. This shows most of us that the FDA does not know enough about vaping to deem regulations. Congress should have required the FDA to get some facts first.

The ONLY issue I have with the above is that I vape 36mg juice.

 

[englishmick]

Apparently the cigar industry is in the same boat as we are as far as deeming regulations stand. Just watch the Cigar Dave and other premium cigar reviewers going on on YouTube about the FDA and the coming regulations. Replace the words "cigar industry" with " vaping industry" and it sounds exactly the same. They have the same grandfathered date of February 2007. Every cigar manufactured after that date will have to go through the same arduous process. This will kill hundreds of small manufacturers and retailers and will hurt the consumers. The whole boutique cigar industry will be decimated. Of course they have been given the same excuse of" protecting the children". Because as we all know it is common for children to smoke premium cigars. The question is why we don't fight these regulations together? There are millions of vapers but I am sure there are legions of cigar consumers. In my opinion uniting we have a better chance of beating the FDA.

I'm inclined to doubt that the cigar folks would be keen to jump in bed with vaping. We would bring a lot of enemies to the party. Powerful, enormously wealthy, politically connected corporations. The FDA which is owned and operated by Pharma. Politicians and bureaucrats who are massively dependent on tobacco revenue. None of those groups are natural enemies of premium cigars, would they really want to step into that mess?

On their own they have a good chance of success. Surely a lot of influential people like a good cigar. Apart from hardline anti-nicotine activists I doubt any of the players see premium cigars as a target, they aren't a threat to anyone. Pharma doesn't care about cigars, Tobacco sees cigars as part of their family. Cigars and pipes are likely to slip through without making a ripple, in my opinion. Some suitable accommodation will be made. Their best bet is probably to stay as far away from vaping as they can.

It would be nice to have allies, but there has to be some common interest. An alliance might have some minor tactical benefit for us, but for them it's more likely to be a millstone.

 

[seminolewind]

The ONLY issue I have with the above is that I vape 36mg juice.

Well that's too darn bad , LOL. That is way too much and you'd probably be better off not vaping at all because that stuff is filled with toxins and carcinogens and poisons kids.

 

[Shawn Hoefer]

I knew a kid in high school that would and could convert just about anything into a pipe. He'd smoke out of a cored apple with a straw shoved through the side or a half-crushed pop can with holes pricked into the can at the bend...

Point of the story is ANYTHING can be misused, and abused.

This is something the FDA knows (how many oxycontin addicts, now?) and refuses to acknowledge. Acknowledging it, though, would be an admission of failure on their part. Therefore, they have chosen to attempt to regulate EVERYTHING into the ground.

Sad, really...

Pieces parts... really? It all begins to sound like a bad commercial for a fast food chicken joint.

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[seminolewind]

I'm inclined to doubt that the cigar folks would be keen to jump in bed with vaping. We would bring a lot of enemies to the party. Powerful, enormously wealthy, politically connected corporations. The FDA which is owned and operated by Pharma. Politicians and bureaucrats who are massively dependent on tobacco revenue. None of those groups are natural enemies of premium cigars, would they really want to step into that mess?

On their own they have a good chance of success. Surely a lot of influential people like a good cigar. Apart from hardline anti-nicotine activists I doubt any of the players see premium cigars as a target, they aren't a threat to anyone. Pharma doesn't care about cigars, Tobacco sees cigars as part of their family. Cigars and pipes are likely to slip through without making a ripple, in my opinion. Some suitable accommodation will be made. Their best bet is probably to stay as far away from vaping as they can.

It would be nice to have allies, but there has to be some common interest. An alliance might have some minor tactical benefit for us, but for them it's more likely to be a millstone.

After 1-9 years of being smoke free and being proud of it and offering support to eachother, and forming educational groups, and all feeling like we've taken a giant step towards health and self respect and pride only to have the FDA tossing us back with the tobacco that we've all tried to get away from. Unfortunately over a million people have given up smoking to vape and it seems like that alliance choice has been made for us already. By a government who is supposed to be fair and unbiased and learn something before they make a choice as bad as this one-deeming us a tobacco product.

Englishmick, it certainly would be nice to have an alliance with other smoking cessation devices.

 

[bnrkwest]

I think the FDA needs to do some lab research. Each FDA person that is ruling over tobacco products must use each one in a lab experiment. They must smoke a cigarette, a cigar, a pipe and vape strawberry shortcake. Then they can have some first hand experience of what a tobacco product actually is. They do not need to inhale LOL!

 

[Racehorse]

The only weak point in your argument I can find is we are now using tobacco products.
Not vapor products. Hence we are surly covered under the interpretation governing user
fee's.

There is zero weak point in my argument as far as this goes. (unless you just want to argue for the sake of arguing? )

Even the FDA itself knows they do not have legal authority to impose user fees onvapor products since they were not one of the six categories explicitly named by Congress.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499356.pdf

Top of page 3. Very clear.

User fees for us not gonna happen w/out an act of Congress. Then, the FDA would also have to re-do their regulations. Document above was revised in 2016......as you can see.

Also, if you read the docs that Altria submitted to the FDA, asking for user fees for cigar and pipe tobacco industry, you would see that they did not go after us on that......because they already know we won't be levied any.

 

[Racehorse]

Their main point is, and always has been, that congress has put the burden on the industry to prove these products are safe, not on the FDA to prove they aren't.

Given the Bioterrorism Act it seems logical to me.

This is true for supplement industry as well. Otherwise, a company can manufacture supplements w/new ingredients, w/out using CGMP or anything else and pretty much wipe out an entire population.........something that is really not far-fetched given the level of terrorism going on world wide.

In the case of everyday things that are OTC, like hand sanitizers or rubs, the FDA says they must prove the ingredients are safe and effective. I have no problem with that. Otherwise, a company can manufacture a product that when I put on my skin, my skin peels away and/or burns off.

Lets just say I'm not willing to give up my rights under consumer product liability and safety laws for any industry. Even industries I believe in.

What amazes me is the number of chemicals and stuff in food and products that are legal in the US but illegal in most European countries.

 

[englishmick]

After 1-9 years of being smoke free and being proud of it and offering support to eachother, and forming educational groups, and all feeling like we've taken a giant step towards health and self respect and pride only to have the FDA tossing us back with the tobacco that we've all tried to get away from. Unfortunately over a million people have given up smoking to vape and it seems like that alliance choice has been made for us already. By a government who is supposed to be fair and unbiased and learn something before they make a choice as bad as this one-deeming us a tobacco product.

Englishmick, it certainly would be nice to have an alliance with other smoking cessation devices.

Unfortunately the other cessation systems are made by Pharma, and they want us to go away and leave the field and the profits to them. It makes sense to them for vaping to look more like smoking than to a cessation option.

There is one real difference. All the other smoking cessation devices are marketed for temporary use. Vaping isn't allowed to do that. And a lot of vapers, including me, see it as a fun, cheap, healthy alternative to smoking rather than a way of quitting.

I guess there's another difference. Vaping works and the other options mostly don't. We would put them out of business if we were allowed to. Pharma could make a lot of money off nicotine in the long term, but they have to get us out of the way first.

 

[Alexander Mundy]

There is one real difference. All the other smoking cessation devices are marketed for temporary use.

They won the battle a few years ago for long term use.

Nicotine Replacement Therapy Labels May Change

"The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence."

Federal Register :: Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use

"SUMMARY:
The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the-counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice."

FAQs on Nicorette | Does Nicorette Work | Nicorette

"You should use Nicorette for the full 12 weeks to improve your chances of success. However, if you find that you need to use Nicorette longer than 12 weeks, the FDA has determined that is acceptable to do so in most cases. Talk to your doctor or health care provider if you feel the need to use Nicorette for longer than 12 weeks."

 

[Alexander Mundy]

Amazing thing is that during the exchanges between BP and FDA that ECF links were used by BP to help show their case. If I can dig up that documentation I will, but I ran across it when the deeming first was proposed so that was some time ago.

 

[classwife]

...


rage...

 

[Shawn Hoefer]

I think the FDA needs to do some lab research. Each FDA person that is ruling over tobacco products must use each one in a lab experiment. They must smoke a cigarette, a cigar, a pipe and vape strawberry shortcake. Then they can have some first hand experience of what a tobacco product actually is. They do not need to inhale LOL!

I would not even go that far... just make them spend one night in a room inhabited by a smoker, and another in a room inhabited by a vaper. Habitation need not be concurrent.

Sent from my SAMSUNG-SM-N910A using Tapatalk

 

[skoony]

There is zero weak point in my argument as far as this goes. (unless you just want to argue for the sake of arguing? )

Even the FDA itself knows they do not have legal authority to impose user fees onvapor products since they were not one of the six categories explicitly named by Congress.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499356.pdf

Top of page 3. Very clear.

User fees for us not gonna happen w/out an act of Congress. Then, the FDA would also have to re-do their regulations. Document above was revised in 2016......as you can see.

Also, if you read the docs that Altria submitted to the FDA, asking for user fees for cigar and pipe tobacco industry, you would see that they did not go after us on that......because they already know we won't be levied any.

You have a good point. However over the last 2 years or more I have been shown
many things that purport to show in the regulations what the FDA could not do.
We are users of a class of tobacco products. The user fee's are specifically for classes
of tobacco products. Vapor products are conspicuous by there absence. I can see no
logical reason vaping products would be the only class of tobacco products not having
user fee's. I am sure the apparent over site will be rectified either by the FDA retroactively
asserting its authority or a change in the regulations.
Regards
Mike

 

[Ca Ike]

Yeah, well, thank God young boys out of high school, whose parents aren't rich enough to send them to college, aren't forced to go die for some other people on foreign soil against their will anymore. That's just plain bull.

I joined the military VOLUNTARILY for patriotic reasons but would've burned a draft card. No one forced anyone to fight in the 1st American Revolution. You're not fighting for freedom when you are forced to do it.

Hmm thanks for your service and you have an interesting view point. Though wrong about the revolution. Just like today, lot of volunteers and also a lot of conscripts.

What pisses me off is my family fought in those wars to help preserve our freedoms and I feel their valor was given in vain now. People need to realize the oppression we have now is almost the exact same as Japan and Germany back then. The names are different and the excuses may be different, but the core result is the same. Taking away freedoms a bit at a time until we have none and the gov has all the control.

It doesn't matter if your talking about vaping or guns or speech or even the swing set at your local park. It all boils down to the same thing. Gov duping people to legislate behavior in order to gain control and by extension, money.

 

[Semiretired]

I would not even go that far... just make them spend one night in a room inhabited by a smoker, and another in a room inhabited by a vaper. Habitation need not be concurrent.

Look at insects and animals. Smoke - they steer clear of - not vapor...

 

[Mazinny]

Given the Bioterrorism Act it seems logical to me.

This is true for supplement industry as well. Otherwise, a company can manufacture supplements w/new ingredients, w/out using CGMP or anything else and pretty much wipe out an entire population.........something that is really not far-fetched given the level of terrorism going on world wide.

In the case of everyday things that are OTC, like hand sanitizers or rubs, the FDA says they must prove the ingredients are safe and effective. I have no problem with that. Otherwise, a company can manufacture a product that when I put on my skin, my skin peels away and/or burns off.

Lets just say I'm not willing to give up my rights under consumer product liability and safety laws for any industry. Even industries I believe in.

What amazes me is the number of chemicals and stuff in food and products that are legal in the US but illegal in most European countries.

I agree that we need some regulation, i just don't believe FSPTCA is the correct framework for the ecig industry.

The supplement industry you mentioned is a good example for uneven treatment of different industries by congress and the FDA. The level of scrutiny put on that industry is miniscule compared to the ecig industry. Not even comparable. Even after all the reports that a large percent of products in the market don't even contain the main ingredient they claim is in the product ! Why ? Because powerful lobbyists and politicians from Utah wield great influence. I don't want to go too far off topic, but i just want to reiterate that i am not opposed to fair and logical regulation for the ecig industry. The FSPTCA and the deeming regulations are not that !

 

[Mazinny]

People need to realize the oppression we have now is almost the exact same as Japan and Germany back then. The names are different and the excuses may be different, but the core result is the same. Taking away freedoms a bit at a time until we have none and the gov has all the control.

You my friend just took hyperbole to a new level, even by ECF standards Could you expound ?

I have to be honest, i think including ecigs in FSPTCA and the deeming regulations is illogical and unfair, but i don't feel oppressed . What about it reminds you of the actions of Germany and Japan before and during WWII ?

 

[retired1]

Ummm, if you wish to go down that road, take it to Outside. Otherwise, let's leave the extreme rhetoric out of the general forums.