Deeming Regulations have been released!!!!

[nicnik]

I sent an email to Sen. Ron Johnson thanking him for his letter to the FDA. I also submitted the following message to the U.S. Senate Committee on Homeland Security & Governmental Affairs. (I purposely focused on the job angle.)

Dear Senators,

I applaud Sen. Johnson's letter to the FDA regarding the deeming regulations of tobacco products and urge all of you to question if the FDA's egregious overstep is really in the public's best interest.

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.

I know you are all busy and it may be too much to ask, but I beg at least one of you to watch this video about ProVape, the largest US manufacturer of vaping hardware devices. That's right, "Hardware." They make steel battery tubes and boxes, that contain no plant matter whatsoever. Despite that, according the the regulations they are a tobacco product manufacturer. ProVape has worked very hard to become the type of small business America should be proud of, but now they can't afford to stay in business:



I'm a 57-year-old constituent who has voted in every election since I was 18. I am also an ex-smoker. After 40 years of smoking, I have been tobacco free for almost 4 years by vaping. I will vote for candidates who support tobacco harm reduction, not for those who would block a path to health for millions of people in a misguided attempt to "Protect the Children."

Thank you in advance for having common sense.

You write some really good letters. Adding that video to it was a great idea. Who'd want to kill such a business? Really nice video, too.

 

[crxess]

Companies with a ton of money to spend on applying for SE will be greatly advantaged. Also, the moneyed companies will be more in a position to get new technology approved.

This is a Major misconception. There is little to No Guarantee Any form of application will stand any chance of being approved. They All rely the concept of being able to improve public health. and that is in the eye of the FDA alone.

From 2013:Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP). "The FDA is committed to making science-based decisions on all product applications and providing the agency's scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties......

And does this sound familiar?

Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP). "The FDA is committed to making science-based decisions on all product applications and providing the agency's scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties......
It will find any product that raises different questions of public health to be " not substantially equivalent" (NSE) and will not allow it to be marketed.

 

[nicnik]

FDA focuses on young LGBT smokers with $35.7M campaign

"A key reason for high tobacco use among this group of young adults is the real and perceived social stigma, discrimination and anxiety they experience when they 'come out,' the FDA stated."

These are just a couple of the ads. I'd like to see a survey next year on how many young LGBT smokers were influenced enough by this campaign to quit.





It seems to me that the $35.7M would have been better spent directly addressing the real and perceived social stigma, discrimination and anxiety.

They are stigmatizing LGBT smokers.

 

[coldgin96]

Is it more than one or two BT companies supporting the Bishop/Cole ammendment?

To me it would make sense that they would be hedging their bets, plus not wanting the regs to look like they were written for them.

If I understand correctly, if the grandfather date gets moved, so does the substantial equivalent date. Companies with a ton of money to spend on applying for SE will be greatly advantaged. Also, the moneyed companies will be more in a position to get new technology approved.

As far as I am aware, RJR has voiced support for the regulations, but have other BT companies?

Early in my vaping, I was having trouble trusting smaller companies and Chinese companies, to not use toxic substances in the juice and hardware, and I was looking forward to trying BT products when they would become available. I felt it easier to trust them, partly because they'd have a lot more to lose, if they were poisoning people.

This is why my wife and get our juice from two vendors only, Johnson Creek and ProVape. We have been vaping exclusively since 2012, tried a multitude of juices, and the quality kept coming back to them. Besides, J.C. has NEVER lied to me (that I know of). Asked them pretty difficult questions at times too. Sometimes they didn't answer citing, "propriety," but hey were very candid with answers I suspect others wouldn't have been. Never had any reason to doubt ProVape either.

 

[crxess]

has this been discussed? :
https://d1fardvzz27152.cloudfront.n...aliff__fda__re_e-cigarette_regulation__4_.pdf
apologies if I missed it .

Yep, you missed it - there is an independent thread on the matter somewhere.

 

[nicnik]

I too have never had this happen but I don't really display it. It's not that I'm embarrassed but feel that I don't want to be apart of that scene. I feel as if people think I'm trying to show off and what not. He persuaded me that while I'm still in the parking lot walking into the grocery store that I should vape very openly

I really can relate to this. For example,about a year ago, I decided to vape in the parking lot until I get to within 25 ft of the entrance, where it becomes illegal, where I live. But I do get embarrassed thinking people probably, like you mentioned, get the impression that I'm showing off.

 

[lauragal]

I think their return would be far greater, hundreds of dollars for a mod, etc and over many years. They have the advertising dollars so if people couldn't get it at vape shops, many would probably buy from them (new folks anyway). Same way they made many different brands of cigs.

Sorry, I'm behind 13 pages so forgive me if someone else said this already - BT would just add all the crap that is in cigs to juices - I wouldn't trust them with it as far as I could throw them. After all, it's already been approved by the FDA!

 

[nicnik]

This is a Major misconception. There is little to No Guarantee Any form of application will stand any chance of being approved. They All rely the concept of being able to improve public health. and that is in the eye of the FDA alone.

From 2013:Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP). "The FDA is committed to making science-based decisions on all product applications and providing the agency's scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties......

And does this sound familiar?

No guarantees, but you're not saying that there is no chance.

 

[Sugar_and_Spice]

Found this article from about a year ago.....BT is pushing the FDA for regulating ecigs..... conspiracy?? Real close....imo
Special Report: When it comes to e-cigs, Big Tobacco is concerned for your health

 

[Sugar_and_Spice]

Sorry, I'm behind 13 pages so forgive me if someone else said this already - BT would just add all the crap that is in cigs to juices - I wouldn't trust them with it as far as I could throw them. After all, it's already been approved by the FDA!

OMG of course they would....ecigs is like death to their business, they are fighting to stay in the game. I think you hit the nail square on the head....

 

[Kent C]

I was thinking in terms of blatant media campaigns.

Bill Godshall Update 2015-09-01

FDA/NCI funded researchers at Rutgers find DHHS’ misinformation campaign against very low risk e-cigs, snus and smokeless tobacco, and low risk cigars and hookah...

FDA/NIH to waste another $3 million to fund 10 activist researchers to further exaggerate risks of hookah/shisha, demonize the products, and advocate even more unwarranted FDA regulations

FDA/NIH to waste yet another $5 million to study mandating nicotine reductions in cigarettes (which prompts smokers to smoke more cigarettes and inhale more deeply) after previous FDA/NCI study (below) found products ineffective for smoking cessation

 

[nicnik]

Found this article from about a year ago.....BT is pushing the FDA for regulating ecigs..... conspiracy?? Real close....imo
Special Report: When it comes to e-cigs, Big Tobacco is concerned for your health

To me, everything seems to point to BT playing both sides, looking to be in a good position, however the deeming and its effects turn out.

 

[Sugar_and_Spice]

To me, everything seems to point to BT playing both sides, looking to be in a good position, however the deeming and its effects turn out.

Yeah, this really looks like they are concerned with health....NOT...

from the article

The health warning on a MarkTen electronic cigarette package is 116 words long.

That's much longer than the warnings on traditional cigarette packs in the United States. Nicotine, the e-cigarette warning says, is "addictive and habit-forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed." It is not intended for women who are pregnant or breast-feeding, or people ... who take medicine for depression or asthma. "Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea and stomach pain," says MarkTen, a leading brand in the United States. The ingredients can be "poisonous."


Seems to me they are talking out their ... because their mouths know better

 

[nicnik]

Yeah, this really looks like they are concerned with health....NOT...

from the article

The health warning on a MarkTen electronic cigarette package is 116 words long.

That's much longer than the warnings on traditional cigarette packs in the United States. Nicotine, the e-cigarette warning says, is "addictive and habit-forming, and it is very toxic by inhalation, in contact with the skin, or if swallowed." It is not intended for women who are pregnant or breast-feeding, or people ... who take medicine for depression or asthma. "Nicotine can increase your heart rate and blood pressure and cause dizziness, nausea and stomach pain," says MarkTen, a leading brand in the United States. The ingredients can be "poisonous."


Seems to me they are talking out their ... because their mouths know better

We can only guess what they're up to. We have no way of really knowing. But that warning on their vape products doesn't exactly say "Buy Me!".

 

[Sugar_and_Spice]

We can only guess what they're up to. We have no way of really knowing. But that warning on their vape products doesn't exactly say "Buy Me!".

Shows willingness to forgo this small share of the industry for the bigger piece of pie. Did you notice where they told FDA that they wanted the small ecig vendors to have the same regs and requirements as BT does. And they admit they know it would effectively force smaller business out.

 

[The Ocelot]

How long?

I don't get HBO, so wasn't that familiar with the show. I was originally under the impression it was filmed a season in advance. From the clips I'd seen on youtube it looked like that although the subjects he covered were topical, they weren't exactly "ripped from the headlines," like his programs on tobacco, 911 funding and Edward Snowden*. Then I read this:

Oliver described his preparations for the show to an interviewer for The Wire: "... I basically have to watch everything. The only thing I kind of watch for pleasure is Fareed Zakaria's show on Sundays... That and 60 Minutes I watch for pleasure, or maybe Frontline... I have a TV on in my office all the time and I'll generally flick around on that from CNN, Fox, MSNBC, Bloomberg, CNBC, Al Jazeera... I'm watching with a certain thing in mind and that is how to see a story told badly."

He admitted to another interviewer that he is concerned about dealing with old news:

"If something happens on a Monday, realistically all the meat is going to be picked off that bone by the time it gets to us — there's probably barely a point in doing it... I think we'll be attracted to some extent by stories that are off the grid... Our show may end up skewing more international in terms of stories."

If we can get the attention of someone on the show, it wouldn't take much research for them to discover this story has legs.

*The interview with Snowden is worth watching. It takes awhile for Oliver to actually meet up with Snowden, but when he does the show presents a clear example of how average people are clueless and uninterested in much of what goes on in the government, but when the issue is made personal, no matter how ludicrous, they become quite attentive. I was especially impressed when Snowden attempted to answer questions intelligently and Oliver kept shutting him down for being boring. No, I'm glazing over, try again... Satire for sure, but right on point.

https://www.youtube.com/watch?v=XEVlyP4_11M

 

[The Ocelot]

Not to sound ignorant, but I do not put a lot of stock in CDC anything anymore. They had me at More Teens using e-cigarettes...........ignoring the Drop in Teen smoking.

And perhaps that more teens are using ecigs because they didn't exist before. Has it never occurred to the government that they can't legislate curiosity out of teens?

 

[nicnik]

I don't get HBO, so wasn't that familiar with the show. I was originally under the impression it was filmed a season in advance. From the clips I'd seen on youtube it looked like that although the subjects he covered were topical, they weren't exactly "ripped from the headlines," like his programs on tobacco, 911 funding and Edward Snowden*. Then I read this:

Oliver described his preparations for the show to an interviewer for The Wire: "... I basically have to watch everything. The only thing I kind of watch for pleasure is Fareed Zakaria's show on Sundays... That and 60 Minutes I watch for pleasure, or maybe Frontline... I have a TV on in my office all the time and I'll generally flick around on that from CNN, Fox, MSNBC, Bloomberg, CNBC, Al Jazeera... I'm watching with a certain thing in mind and that is how to see a story told badly."

He admitted to another interviewer that he is concerned about dealing with old news:

"If something happens on a Monday, realistically all the meat is going to be picked off that bone by the time it gets to us — there's probably barely a point in doing it... I think we'll be attracted to some extent by stories that are off the grid... Our show may end up skewing more international in terms of stories."

If we can get the attention of someone on the show, it wouldn't take much research for them to discover this story has legs.

*The interview with Snowden is worth watching. It takes awhile for Oliver to actually meet up with Snowden, but when he does the show presents a clear example of how average people are clueless and uninterested in much of what goes on in the government, but when the issue is made personal, no matter how ludicrous, they become quite attentive. I was especially impressed when Snowden attempted to answer questions intelligently and Oliver kept shutting him down for being boring. No, I'm glazing over, try again... Satire for sure, but right one point.

https://www.youtube.com/watch?v=XEVlyP4_11M

Both the FDA deeming, and the entire ANTZ campaign against vaping, would not suffer from the problem of it being old news for quite some time, yet.

Someone told me that he thinks we should encourage John Oliver to make fun of vapers, as part of the project, that there's some good material there for laughs. In good humor, of course. Sounds like potential fun, to me. But LOTS and LOTS of laughs to be had, exposing ANTZ absurdities.

 

[crxess]

To me, everything seems to point to BT playing both sides, looking to be in a good position, however the deeming and its effects turn out.

Now your getting it!

And for those thinking we are a threat to BT - at this point, not even close.
First, they are world wide
Second, in many countries, over 50% or the Population are Smokers
Third, Many countries long ago outright Banned e-cigs and others are following
Fourth, our little Industry is 1/3 BT's annual US advertising Budget

Yes, BT is playing Both sides. Protect current interest, Protect Future interest, attempt to Gain public and FDA trust that they are becoming more responsible, and make us think they give a crap about our preferences.

Look at every angle in which we have been attacked and it is impossible to Blame BT alone. The list is to long to post now(to late at night for me) but there are literally over 100 organizations that have signed off with Lobbyist AGAINST Vapor Products. Not little Groups, Big Organizations including coalitions of smaller groups and Hugh Corporations, Many many Health organizations and down the line.
***ALL with Financial interest in seeing Vapor Products out of their way***

Tobacco is Profitable for anti-tobacco Business.

 

[The Ocelot]

Both the FDA deeming, and the entire ANTZ campaign against vaping, would not suffer from the problem of it being old news for quite some time, yet.

Someone told me that he thinks we should encourage John Oliver to make fun of vapers, as part of the project, that there's some good material there for laughs. In good humor, of course. Sounds like potential fun, to me. But LOTS and LOTS of laughs to be had, exposing ANTZ absurdities.

The story is ripe for satire. If we can get the situation to his attention I don't think we would need to encourage him in any direction. He'll make the most of it.