FDA Proposed regulation is available

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dave8944

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It seems to me that the current administration just enforces the laws they see fit. With that precedent set, future administration are likely to follow suit. With the growing number of vapers out there, vaping rules are likely to become a political issue in future elections. We will have very little to worry about with these new rules if our numbers are large enough and politicians worry that too heavy a hand will jeopardize a portion of their voting electorate. That's probably the only reason these rules were revised in the first place. Sure the language leaves them open to do a lot of things, but do they dare?
 

Deak_D

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When did the FDA start regualting electronic devices, isn't that out of their line of work. If they are granted the Authority to regulate these little electronic devices, what will be next. They will start to claim that televisions are bad for ya and regulate them. I personally don't see them gaining the authority to regulate them with the law suit they lost a few years ago with joy cigs. If I had to guess they wanna regulate the devices coming out of china.
 

Deak_D

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We all are going about this the wrong way, we are sitting on a forum that the fda nor the government will never read. Maybe we can get one of the more intelligent folks on here to write a professional letter and paste it on the forum for the rest of us to copy....fill in our name and address and flood the fda and our local representative and congress mens office with these letters. lets get loud about this let them know how we fill. You have to think on the lines of what would the gun lobbest do to fight the government or agency. We need to copy what they would do.
 
Jan 19, 2014
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[...] The mission of the FDA, as it impacts us here, is to move towards a tobacco product free world for what they believe to be the overall health benefit accruing to the general public and to protect children in a manner that they deem most effective. Period, full stop, end of story. That translates to making life as difficult as politically possible for the producers and consumers of tobacco products.

Since I agree with half of your last sentence, I won't argue. (Namely that the FDA wants to make life as difficult as possible for the consumers of tobacco products). But I will add that they aren't too bothered by collateral damage. For ex., if they make life difficult for 0% nic. vapers, that's okay with them.

However there are folks out there like Bill Godshall and plenty of other people on this forum who would vehemently disagree with you, insofar as you suggest that the FDA wants to make life difficult for all producers of tobacco products. They would likely do so, in tandem with what appears to be your overall rather charitable view of how the FDA actually works in the tobacco products regulation context:

[...]
All the agencies I've had to deal with shared a few common traits -- the senior management viewed their work as being on a mission, completion of the mission was more important than any impact on the rest of the world including consumers and producers, the onus was on the producer/consumer/etc to convince them to change course on how to achieve their mission, and the lower level employees executed the mission via punch lists and forms.

The mission of the FDA, as it impacts us here, is to move towards a tobacco product free world for what they believe to be the overall health benefit accruing to the general public and to protect children in a manner that they deem most effective. Period, full stop, end of story. [boldface added]

Your words above suggest also that you regard these FDA CTP officials as benign, well-intentioned, but perhaps a bit misguided. Just some really nice people who are going a bit overboard, as a result of their otherwise-laudable altriuism and concern for the well-being of their fellow citizens? Dedicated, honest, admirable, upstanding, well-meaning government servants who just happen to be in error, perhaps? I couldn't disagree more.

My guess is that most of the folks who would also strongly disagree with your perspective share my outlook, which is that the FDA CTP is basically in bed with deep-pocketed firms. Including, but not nec'ly limited to BP, BT, and BV (big vapor). They would cite past actions and fabrications promulgated by the FDA, and/or the financial ties that some of their officials have with deep-pocketed firms. (Not the least of which would be Mitch Zeller himself, who is a former BP lobbyist.)

I agree with these folks who do not share your perspective. Both when it comes to the history of the FDA in the tobacco regulation arena, as well as the specific motives of the folks in charge of the CTP.

I think the record shows that these FDA officials are not nice, merely misguided people. They are both venal and cynical, and completely comfortable with the notion of misleading the public when it serves their personal financial interests to do so - even at the cost of public health, and the lives of smokers.

But as I said, this is not a battle that I'm going to fight. We agree that they're going to try to regulate non-cigAlikes right out of the market, and that's my main concern at the moment. I'll let others supply the details of these other issues regarding FDA's history in the tobacco products regulatory area, as well as the financial ties, past fabrications, etc. associated with folks like Zeller and Hamburg. Or Dr. Samet: http://tobaccoanalysis.blogspot.com/2014_04_01_archive.html

I'd rather devote my ECF time on getting a special media roundup on the FDA's announcement together, by the end of the weekend. My wife told me that she just heard some story about exploding batteries on NPR. Although I think that's the same baloney that Mitch Zeller was shopping around on PBS News Hour on Thurs.
 

DanFromRioRancho

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Your words above suggest also that you regard these FDA CTP officials as benign, well-intentioned, but perhaps a bit misguided. Just some really nice people who are going a bit overboard, as a result of their otherwise-laudable altriuism and concern for the well-being of their fellow citizens? Dedicated, honest, admirable, upstanding, well-meaning government servants who just happen to be in error, perhaps?

Good grief No, No, No! I consider them zealots, essentially a dangerous cult, that does not respond well to anything that doesn't fit their world view or their processes.....just trying to give the folks here a thumbnail sketch of exactly what this organization is and how they operate without the distraction of inflammatory language.

It doesn't matter to me whether or not the FDA and/or peripheral politicians are in bed with BP, BT or BV. It doesn't matter to me whether the proposed deeming regulations are interpreted as being better or worse than expected. My practical experience has shown me that those types of elements are distractions at best because the root of our challenge lies in how the FDA views their mission and the difficulties I expect them to create to help them achieve their mission.

Sheesh!
 

Katya

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My practical experience has shown me that those types of elements are distractions at best because the root of our challenge lies in how the FDA views their mission and the difficulties I expect them to create to help them achieve their mission.

Sheesh!

How they view their mission? Have you read Mitch Zeller's CV? Maybe that will shed some light.

He's not even an MD--he's a lawyer and a career anti-tobacco zealot. And he's now in charge. What do you suppose his mission is--based on his beliefs and career--to-date?

Mitchell Zeller, J.D., Director, Center for Tobacco Products Bio
 

DanFromRioRancho

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What do you suppose his mission is--based on his beliefs and career--to-date?

Exactly that which was stated in the original post -- to move towards a tobacco free world.

The motives do not matter, the mission does. The original post should have been expanded to "move towards a tobacco free world at any and all cost".
 

sky4it

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Here you go. ;)

It is our current assessment that these proposed regulations are not in the best interests of consumers. They include some good provisions, but do far more harm than good. They are based on arbitrary claims and rationalizations. Should the regulations be finalized as currently formulated and implied, we are prepared to marshal our resources to file a lawsuit on behalf of consumers.

Yeah and about that last part, I hope so.

We the people,,,uh huh....
The FDA is a charged agency with protecting people from harmful products,,,,, so just what are WE the People, doing to form a more perfect union:

{OTHER STUFF} is legal in two states, stowaways are waiting for the {OTHER STUFF} market explosion and large ripples are hitting the stock market, with no Federal Legislation in site.

I too believe this legislation is pointed at the rebuildable atomizer market, everything from CE5's, to tanks and drippers, but the cigalike ecig companies appear to be unconcerned. Gang, you can vape two to three blu cartridges in a day easily, I have seen them priced upwards of over 20 bucks for five cartridges in Minnesota. This is what they want, they want us all vaping Cig a like ecigs, because they are highly profitable, at least IMO. And as a charged agency just how does this fit into the FDA's jurisdiction of protecting people when some will reroute back to stinkies because of the cost?

But could someone correct me if I am wrong on one point, It does seem that the FDA proposed regs largely stay out of the Ejuice market asking only for product ingredients to be labeled but falling short of needing to approve every Ejuice type? Is this correct? Someone did say on another thread that Ejuice also will have to be reviewed, I did not see that from the proposed regs?
 
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rothenbj

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Exactly that which was stated in the original post -- to move towards a tobacco free world.

The motives do not matter, the mission does. The original post should have been expanded to "move towards a tobacco free world at any and all cost".

That is nothing but a marketing slogan. A whole lot of people make their very good living fighting the good fight. A tobacco free world is an unrealistic goal. Just like prohibition didn't work and the war on drugs is no closer to a victory, a tobacco free world just gives a lot of people jobs.
 

zoiDman

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...

But could someone correct me if I am wrong on one point, It does seem that the FDA proposed regs largely stay out of the Ejuice market asking only for product ingredients to be labeled but falling short of needing to approve every Ejuice type? Is this correct? Someone did say on another thread that Ejuice also will have to be reviewed, I did not see that from the proposed regs?

I believe that at this stage we are just seeing some Initial Guidelines of e-Liquid Regulations. And that there is More, Much More to come.

“Right now, for something like e-cigarettes, there are far more questions than answers,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

He said Thursday’s action is about expanding FDA’s authority to products that have been “rapidly evolving with no regulation whatsoever,” in order to create a foundation for broader regulation in the future, adding, “It creates the framework. We’re calling this the first step. . . . For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function.”

http://www.washingtonpost.com/natio...7c8684-ca39-11e3-93eb-6c0037dde2ad_story.html
 

erazzz

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I was reading over the document myself, so I hope CASAA can help. What the FDA is looking for, some we have, and some we don't have.

They want studies on if those fun fruit/candy/desert or whatever flavors are actually helpful to adults and not being marketed to children, which we currently do not have a study for that. They also want more supporting research on the benefits of e-cigs.

I was surprised that the document was relatively honest, at least from the parts I read, they apparently have read much of the research that has been published on emissions from e-cigs and how that compares with tobacco. They also have read studies on e-cigs compared to nicotine patches. The information was straightforward and did show the e-cig had less toxins than the cigarette and was comparable to nicotine patches and inhalers. However, they are still wanting "long term studies" to show proof of benefits. When you comment, this is what they want from you, not just "general" comments or success stories. They want evidence and proof.

I think it is wise to wait and see what CASAA has to say. =)
 

DeeLeeKay

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Why are we letting the FDA deem these as a tobacco product when they are clearly not a tobacco product? Just because the nicotine is derived from the tobacco plant, doesn't mean that they are a tobacco product. Is caffeine a coffee product? Not really, because it is also found in tea. Just like nicotine is found in other vegetables.

If nicotine is anything, it is a supplement. Upon consumption nicotine turns into a vitamin. Does this mean the FDA can now go after vitamins?
 

Worzel

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I still say to wait for CASAA's suggestions, but If anyone jumps the gun on commenting to regulations, like I did, don't comment AS A VAPER! Don't go on about how they saved your life, because they can come back and say that there is no proof that your life has been saved by vaping. Besides, they will sit there, roll their eyes, and disregard, because apparently, they DO NOT CARE about our life stories!

IMO, go on and question their motives, like how "e cigarettes" (they only know them by that name) will only be produced by BT, because the smaller, family owned vendors, the ones who are working to make "e cigarette use" a more healthy alternative, will be knocked out of the game by their regulations, and who knows what chemicals will end up in them. Urge them to look on the US vendor websites, because they will see that the ingredients are already listed, because there is a whole selection of flavors, nicotine strength, and bases, and "e liquid" is pretty much custom made to order, and the only ingredient not FDA approved is the nicotine itself.

Also, urge them to do further research on underage "use of e cigarettes" for every kid that uses them to "look cool" how many are actually using them instead of using traditional tobacco products. Agree with the ban of underage sales, but suggest they keep sales to 18 and over, but actual "e cigarette use" to 16 with parental consent.

Those are some examples, but pretty much suggest that they need more research before they go off half cocked with their new regulations, because they themselves stated over and over that they are not sure about the risks or benefits about "e cigarettes."

These are a bunch of stuffed shirt lab apes who don't care about people, they care only about what they could make off of this whole thing. We have to "speak to them" like that, like dumb lab apes.

And furthermore, we need to be "vapers in the wild." I know many of us are annoyed when we are stopped and asked what "we are smoking" at the most inconvenient of times, but we need the curiosity of people, especially smokers, to made our cases heard, and to bring up our numbers!
 
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Oliver

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I still say to wait for CASAA's suggestions, but If anyone jumps the gun on commenting to regulations, like I did, don't comment AS A VAPER! Don't go on about how they saved your life, because they can come back and say that there is no proof that your life has been saved by vaping. Besides, they will sit there, roll their eyes, and disregard, because apparently, they DO NOT CARE about our life stories!

I think you're half correct about this. I've been wondering, though, whether vapers who have actual evidence of their own health improvements (say, improved COPD scores) should be submitting this. After all, we certainly do want a lot of responses to the consultation, and those responses need to be evidence based, as far as I understand it.

The question is, though, what the FDA will consider to be evidence. I would suggest that an accompanying letter from a physician would be enough, but I don't know. So far they only seem to be considering 'bound volumes', to quote Carl Phillips (i.e. scientific journals) to be admissible.
 

Oliver

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Why are we letting the FDA deem these as a tobacco product when they are clearly not a tobacco product? Just because the nicotine is derived from the tobacco plant, doesn't mean that they are a tobacco product. Is caffeine a coffee product? Not really, because it is also found in tea. Just like nicotine is found in other vegetables.

If nicotine is anything, it is a supplement. Upon consumption nicotine turns into a vitamin. Does this mean the FDA can now go after vitamins?

It's Humpty Dumpty legislation:

"`When I use a word,' Humpty Dumpty said, in rather a scornful tone, `it means just what I choose it to mean - neither more nor less.'"

http://comparativelawblog.blogspot.com/2006/12/humpty-dumpty-and-law.html
 
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