FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

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Kent C

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I saw that a few days ago.. What I found interesting...

"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."


Warning label that's being proposed for e-cigs..

"This product contains nicotine derived from tobacco. Nicotine is an addictive chemical."

Haven't you heard..?

Some nicotine is more addictive than others... :rolleyes:


Just one more example of where the FDA obviously already stands on all this...

But when related to ecigarettes, it's a 'poison'. :facepalm:
 

tombaker

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but our devices are not part of a finished tobacco product as defined by existing law.
are they trying to change the definition by fiat.
clearly the existing law as written was for regular cigarettes.the filters,papers,materials,and glue being the intended expected use
or as a component or part of the finished tobacco product.
used in the consumption of a finished tobacco product,not used for the consumption of.
the later,our hardware i believe is just paraphernalia.is my take just a distinction with out
any difference?
regards as always
mike
I believe the law, the courts, and most likely the FDA...agree.

You can not take at item, that may be used with something defined (by law), and then say all the laws and regulations flow on top of the device itself.
A clearomizer has purposes well outside of nicotine, this should be understood as a fact, simply because its true.

The FDA has power via the Tobacco Control Acts, over nicotine ONLY.

There simply is no legal basis to regulate, outlaw, or ban, APV hardware. If someone has a legal precedent of the FDA or other agency of outlawing or regulating hardware, batteries or whatever devices....I would like to seeing that in a posting.
 

Gato del Jugo

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Anybody else ever get the impression that there are some here who, ever since 4/24, appear to be repeatedly attempting to make this FDA proposal out to be "no big deal," perhaps in hopes to detract others from any sort of organization, to sway others' opinions & to soften others' initial opposition to this proposal?

What sort of benefit could they potentially gain in doing so, should they be "successful"?

And do they have any sort of undisclosed affiliations which could also potentially gain to benefit from any such "success"?


Many unanswered questions, do arise...
 
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tombaker

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Where does that claim come from? As soon as the FDA starts taking applications for SE or new products, it can start rejecting them. Then what? What if an application is denied on the last day of the 24 month period? Do they still get to keep selling if they do not have new application in before the deadline? If their application is denied, do they have to stop selling immediately? What if the FDA doesn't accept anything before the deadline for other companies to use as a predicate?

There is so much left up in the air that it is impossible to claim to know what the FDA will do or how this will play out.

Regarding flavors, where is the scientific evidence proving that cherry flavoring from FlavorArt is chemically the same and poses no risks different from cherry flavor from Loranne's or tobacco/menthol flavoring from some artificial flavoring company in China (which is likely to be the actual pre-2007 predicate for flavorings?) Do we have ANY scientific proof that ANY of the flavorings are not a health risk for INHALATION, not digestion?

The idea that the FDA would expect a company to submit an application detailing there is no health impact of changing their package of rolling papers from containing 32 papers to 50 papers (which the FDA did require), but the FDA would not care if there is a health difference between inhaling the chemicals found in an artificial tobacco flavoring vs. the chemicals in artificial cherry flavor (especially since there are no long-term studies of inhaling ANY of the artificial flavoring as used in e-cigs) is quite naive.

Regarding people waiting to say what CASAA "tells them to say," CASAA isn't expecting people to just write what we tell them. CASAA just wants to help people write coherent and FACTUAL comments. We realize that 200,000 "copy and paste" comments aren't going to help. But 200,000 comments ranting about "a right to vape" or "the FDA shouldn't do this s**t and should F-off;" or wasting their comment arguing "the FDA doesn't have the authority to regulate e-cigarettes" or "e-cigs aren't tobacco" or "I don't use an e-cig I use a PV" would be even worse.

CASAA is going to provide an analysis of the facts as we understand them and a GUIDE for submitting comments, not "telling people what to say."

The 2018 date came from Bill Godshall. He based that off how long he and others expect the final rule be actually adopted. I had first been using 2.5 years from today, but others are estimating the soonest time they adoption adoption date to be more like 2 years vs 6 months.

Re:Rejecting immediately
FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months following the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date.

Essentially a grace period of 2 years, after the final adoption date. (language is repeated for other pathways, the same way) To address your concerns outline, does it mean that applications should put up at the end of the 24 months and not the start, perhaps that would avoid the most risk under any interpretations, the changes after the comment period should clarify this.

If the FDA never accepts anything, it would be their error, because the FDCA clearly says they can not ban classes of Tobacco Products, and attempting to reject everything, AFTER, the FDA chairman said they were not banning E-Cigs, would be seen by the courts as transparantly acting contrary to the Acts, and statements. In America, we do have checks and balances, as Sottera proves for E-Cigs.

But the 2018 is from CASAA member Bill Goodshall, saying the market stays open, until 2018 then its Prohibition. If you have clarification from him since the audio presentation on VaporPlace, I would be interested.

Yes we have chemical analysis from the 2007 Chinese Juice, that was done by three different 3rd party labs.

What I am referring to is the category of FDA approved food safe flavoring ingredients. Any combination of these is known to be safe, by the FDA. So long as the juice maker is using these ingredients, they are using approved "Artificial Flavorings" The ratios and means of mixing, are not critical.

Cooking and Boiling of foods causes vapor, yes there is a presumption by me that food safe ingredients are vapor safe also, besides you post, I have seen nothing that suggests otherwise. It could likely be confirmed by examining the approval methodology of the FDA for flavorings...but I am not intending to do that, unless convinced beyond your post that it is necessary.

Are you saying there is a lack of true and valid safety information on flavorings? In other words is CASAA saying its unknown if flavoring have health risk? I don't think this is the case, for your concerns to be weighty in the mix of the regulations, it would have to be a real safty concern like certain buttery flavorings are already known to be. Can you clarify?

The lawyer, I think his name is Azim Chowdhury, and working for the law firm that is representing various Vapers at the firm Keller and Heckman, is the guy who confirmed that you are not limited to a single comment. You can submit more.

I am sure that more comments, is not harmful. In fact the more comments in, makes the FDA read them all, by law, and will take them more time. If there was only a one vote, or one comment rule, I would agree that people should wait, but there is not. More comments the better.

You would do well, to confirm what is known, that multiple comments are allowed, and that they are not wasting a comment, by giving one. That information is wrong. Comments are not limited, organizations should adjust their recommendations accordingly.
 

Katya

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I don't think we are going to win this one in the media anytime soon. My (unscientific) view is that media coverage was very unfavorable towards - e.g. - gay activists during the 80s or OTHER_STUFF activists in the 90s (including junk science, and the same 'concerns, worries, unknowns and fears' to which we are subject).

I don't see the NRA model working for us - that takes single-issue voting, and lots of money, which we also don't have (not yet, anyway).

I don't know what the way forward is, but Roly's point about black markets continues to play on my mind. There's a lot to be said for it. We absolutely need to keep expanding the pool of vapers (preferably those who aren't dual users, and/or BT-cigAlike consumers).

And while I don't like the idea of us depending on what Tennessee Williams did not cite as "the incompetance of strangers" :laugh: ... there's a lot to be said for the idea that the FDA's CTP really is quite ineffective in many ways, not just in the arenas oft-cited by vapers (i.e. their inability/unwillingness to look at science in an objective manner). We are not dealing with the Stasi here, despite what some may believe. Mind you, that doesn't mean that I have kind words for their intentions.

"You can always count on Americans to do the right thing - after they've tried everything else.”
-Winston Churchill

I do have hope. Because I love this country. :)

No, not Stasi--far from it. Trust me, I know. First hand knowledge. But I know totalitarian tactics when I see them. That said, I don't think they will work in America--not in the long run. America is exceptional. FDA is not all bad. Governments are not all bad. Corporations are not all bad. They are people, after all. ;) While some of Monsanto's tactics may be abhorrent, Whole Foods and Greenpeace are not Mother Theresas either. The FDA is sometimes right--GMOs are safe to eat. Everything we eat today is genetically modified. Our dogs and cats are genetically modified--by centuries of selective breeding. Genetically modified yellow rice has the potential to save lives (and eyesight) of millions of children in the third world; even the Pope blessed it. :D

We have to fight for our rights and expose corruption, greed, cynicism and lies. We will win because we are right. I have no idea how long it's going to take, unfortunately. But if we make our case and provide evidence that e-cigarettes are indeed safer than smoking and that we're not harming anyone, we cannot lose. Not in America. America has always been divided--North and South, civil rights, Vietnam. We argue, we debate, yell, scream, study, produce evidence and... move forward.
 

MikeNice81

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I believe the law, the courts, and most likely the FDA...agree.

You can not take at item, that may be used with something defined (by law), and then say all the laws and regulations flow on top of the device itself.
A clearomizer has purposes well outside of nicotine, this should be understood as a fact, simply because its true.

The FDA has power via the Tobacco Control Acts, over nicotine ONLY.

There simply is no legal basis to regulate, outlaw, or ban, APV hardware. If someone has a legal precedent of the FDA or other agency of outlawing or regulating hardware, batteries or whatever devices....I would like to seeing that in a posting.

There was a machine introduced after the last round of regulations. Since more people started RYO it seemed like a good idea. A machine that could roll about 100 - 200 per hour would be very convenient. Some smoke shops bought the machines. People woould come to the shop with their own papers and tobacco to have the shop roll them while they did other things.

The FDA deemed it commercial manufacture and came down against the shops and machine manufacturer.
 

tombaker

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There was a machine introduced after the last round of regulations. Since more people started RYO it seemed like a good idea. A machine that could roll about 100 - 200 per hour would be very convenient. Some smoke shops bought the machines. People woould come to the shop with their own papers and tobacco to have the shop roll them while they did other things.

The FDA deemed it commercial manufacture and came down against the shops and machine manufacturer.
Thanks for a very interesting example, but the regulations they used against it, are entirely different. They got them on manufacturing apparently. Looking for an example of a perfectly legal product, used in a non-FDA covered usage, that because it can be used in an FDA regulated usage, that the FDA then controls all of the other usages.
 

Harlen

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To me it's simple they will stop the use of cig alike and anything close to it in the same places they do cigarettes .
You will be ables to buy the things that big tobacco make after they tax it as much as cigarettes .
They will take your freedom of choice away (Your to dumb to know what's good for you)
The statement we don't want America to go back to thinking smoking is ok is the big tip off.
There are them that know how to extract nicotine from tobacco so there will be laws that are like drug manufacturing you will do jail time if you make it sale it or use it .
 
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..............;)

Hmm, I believe this post read rather differently before it was editied. While I'm not sure whether the suggestion was correct in all of its specificity (assuming it was intended to be taken seriously, and wasn't merely ironic), I think I can say this at least: "Houston, we have a problem" with persistent disinformation.

It's wack-a-mole on a thread-by-thread basis.

Is the US gov't behind it? At this point, I don't even care. There are a lot more of us. Hopefully someone besides me will do something (hint, hint).
 

aubergine

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Hmm, I believe this post read rather differently before it was editied. While I'm not sure whether the suggestion was correct in all of its specificity (assuming it was intended to be taken seriously, and wasn't merely ironic), I think I can say this at least: "Houston, we have a problem" with persistent disinformation.

It's wack-a-mole on a thread-by-thread basis.

Is the US gov't behind it? At this point, I don't even care. There are a lot more of us. Hopefully someone besides me will do something (hint, hint).

We could just sing. There's an old worker's song that springs to mind. Know it? Catchy tune:



Housewife's Lament

One day I was walking, I heard a complaining
And saw an old woman the picture of gloom
She gazed at the mud on her doorstep ('twas raining)
And this was her song as she wielded her broom

(Ch) Oh, life is a toil and love is a trouble
Beauty will fade and riches will flee
Pleasures they dwindle and prices they double
And nothing is as I would wish it to be.

There's too much of worriment goes to a bonnet
There's too much of ironing goes to a shirt
There's nothing that pays for the time you waste on it
There's nothing that last us but trouble and dirt.

In March it is mud, it is slush in December
The midsummer breezes are loaded with dust
In fall the leaves litter, in muddy September
The wallpaper rots and the candlesticks rust

There are worms on the cherries and slugs on the roses
And ants in the sugar and mice in the pies
The rubbish of spiders no mortal supposes
And ravaging roaches and damaging flies

Last night in my dreams I was stationed forever
On a far little rock in the midst of the sea
My one chance of life was a ceaseless endeavor
To sweep off the waves as they swept over me
Alas! 'Twas no dream; ahead I behold it
I see I am helpless my fate to avert
She lay down her broom, her apron she folded
She lay down and died and was buried in dirt.

(ch) Ohhhhhh, life is a toil and love is a trouble...

(Intended as sympathetic encouragement. How'm I doing? :facepalm:)
Beam.
 
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Jman8

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Anybody else ever get the impression that there are some here who, ever since 4/24, appear to be repeatedly attempting to make this FDA proposal out to be "no big deal," perhaps in hopes to detract others from any sort of organization, to sway others' opinions & to soften others' initial opposition to this proposal?

As a member of CASAA, I'd be one to urge all people reading this to join CASAA. Yet oddly, this wouldn't be enough to sway others of what you are getting at.

I see regulations as a huge deal, but the first round of proposed regulations is not detrimental to overall game. Bigger deal than these regulations is it will allow legal industry to grow, at least a little while, and it is signaling black marketers a way to bypass regulations should anyone get it into their head that going heavy handed is a 'good idea.' These 2 things are bigger than current proposed regulations.

And do they have any sort of undisclosed affiliations which could also potentially gain to benefit from any such "success"?


Many unanswered questions, do arise...

I am one who is very okay disclosing my affiliations (all zero of them, unless CASAA counts), as long as those asking are doing the same. It occurs to me that a planted person would likely engage in deflecting suspicion from themselves and, like FDA proposal does with kids, scapegoat others so as to take away any suspicion toward themselves and their underlying message - which is FDA is in charge of this matter, and you are doomed.

Compared to what ANTZ is doing right now in many states, FDA proposal seems like peanuts.
 

MikeNice81

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Compared to what ANTZ is doing right now in many states, FDA proposal seems like peanuts.

I remember when people were saying, "oh these anti-smoking laws are peanuts. They're no big deal." It always starts small. You go for low hanging fruit. Then that thing that wasn't feasible before becomes the low hanging fruit. Eventually you end up with nearly everything you wanted. That has been part of the playbook for years. We didn't get the massive walls of regulation we have in this country over night.
 

Jman8

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I remember when people were saying, "oh these anti-smoking laws are peanuts. They're no big deal." It always starts small. You go for low hanging fruit. Then that thing that wasn't feasible before becomes the low hanging fruit. Eventually you end up with nearly everything you wanted. That has been part of the playbook for years. We didn't get the massive walls of regulation we have in this country over night.

And I recall several vapers saying we ought to only vape where we smoke, because, ya know, then vapers will be respected.

Too many vapers ready to roll over on what looks a lot like strict control on activity that is relatively harmless.

I advocate for vaping everywhere, with respect. Vape like you belong there. I find this works. I would say it works more often than not, yet as I am batting 1.000 in my experience, it is tempting to say it always works, especially if one has the "with respect" thing down pat.

IMO, this is the most reasonable position to be taking in response to state regulations. How many freedom-loving vapers can go this far and publicly advocate for it?

I am yet to hear of a place on this planet that is inherently 'bad' for vaping.

This is our current fight. This is point I hope we win on now. FDA regulations are important, but this first round of proposals has bought us time to focus on the current campaign sweeping the nation at the behest of ANTZ. Don't ignore FDA regulations, and do comment on what is said. Please, please, please comment. But realize our actual fight is occurring on another front, at this moment.
 

Kent C

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No, not Stasi--far from it. Trust me, I know. First hand knowledge.

The true question isn't whether it is Stasi or not. The question would be what was the path to Stasi-like results and are we on that path? And if we are, you may be right - it won't happen here, but what has to happen to derail the current train? That's the question and for here, it's only rhetorical. I submit we are on that path - it's intentionally gradual so as not to 'upset' anyone - as DC has said - boiling the frog.... We need to either hop out of the pot or find someone who knows how to turn off the stove.
 

Kent C

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Is the US gov't behind it? At this point, I don't even care. There are a lot more of us. Hopefully someone besides me will do something (hint, hint).

Yeah... as in "hint, hint, nudge, nudge, wink, wink"

Sounds like a confession to me. :laugh: ... or perhaps just a Freudian slip.
 
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Oliver

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As someone else proposed in another thread, if someone succeeds in the next couple years in genetically engineering a high-nicotine-yield strain of tomato, eggplant, or chili pepper, which winds up being a more cost-effective source of nicotine than tobacco is, there will be two results: 1) the FDA's authority to regulate e-cigs will no longer exist, so long as it relies on a Section 911 classification, and 2) that vegetable will become a fabulously profitable cash crop.

Indeed. And this is just one of several very powerful arguments the industry can use to propose its own regulatory standards.

"Look, technology will make these rules redundant, so let's create regulations that do the job properly", and in so doing move it out of the Tobacco Act's stipulations.
 

Kent C

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Indeed. And this is just one of several very powerful arguments the industry can use to propose its own regulatory standards.

"Look, technology will make these rules redundant, so let's create regulations that do the job properly", and in so doing move it out of the Tobacco Act's stipulations.

I tend to agree. One thing the government hates (and then writes into legislation on other issues) is 'loopholes' and the people or lawyers that find them. Officials find a way to close them or try to anyway.
 
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