FDA Does Intended Use violate the First Amendment?

[YoursTruli]

A perfect example if what you are saying here held true then every manufacturer of certain paraphernalia would be held accountable for what the majority of end users openly state is an intended use, what it can be or is being used for, actually, making it illegal to sell. They are selling water pipes, glass tobacco novelty pipes, cigarette papers, dry herb vaporizers and little plastic jewelry bags.

 

[DC2]

It's been BP's contention for a long time that if herbs,spices,foods of any kind, vitamins or other nutritional supplements do have healing and or other medicinal qualities, they should be considered medicines and treated as such under FDA regulation. I kid you not. As dumbfounded as this is BP has been pushing this.

Of course they have been pushing it.
That's their job.

And some day nicotine will be added to that list of things that are "good for you" in certain circumstances.
And they want to corner that market as much as they want to corner any other market.

People think Big Pharma is all about protecting their quit-smoking market...
Or protecting their "treat the diseases from smoking" market...

But too many, in my opinion, are not considering the "nicotine is beneficial" market that has yet to develop.
And it will develop, one way or another, because the evidences is already in that such a market exists.

Just don't let the ANTZ hear about it.
They'll have a tizzy fit.

 

[DC2]

A perfect example if what you are saying here held true then every manufacturer of certain paraphernalia would be held accountable for what the majority of end users openly state is an intended use, what it can be or is being used for, actually, making it illegal to sell. They are selling water pipes, glass tobacco novelty pipes, cigarette papers, dry herb vaporizers and little plastic jewelry bags.

They could if they wanted to, and did just that a few years ago here where I live.
The reason it doesn't happen with noticeable frequency is because no Big Money was really threatened enough.

And now that it's becoming legal more and more, you are more and more unlikely to see what they CAN do.
If they really wanted to.

And with vaping, they clearly want to.

 

[AndriaD]

Of course they have been pushing it.
That's their job.

And some day nicotine will be added to that list of things that are "good for you" in certain circumstances.
And they want to corner that market as much as they want to corner any other market.

People think Big Pharma is all about protecting their quit-smoking market...
Or protecting their "treat the diseases from smoking" market...

But too many, in my opinion, are not considering the "nicotine is beneficial" market that has yet to develop.
And it will develop, one way or another, because the evidences is already in that such a market exists.

Just don't let the ANTZ hear about it.
They'll have a tizzy fit.

That's exactly why I don't think there will ever be a pharmaceutical version of WTA. It would undercut all those ghastly-expensive SSRIs, nevermind all the useless quit-smoking snake oil. And I really believe that if all this goes as poorly for vapers as so many keep saying that it will, WTA will be one of the very first casualties. BP will claim that it does something to the brain that really ought to be reserved to BP, and they will study it, yadda yadda, but what they will really do is KILL IT.

I think some people think BP actually cares about making people healthier, when NOTHING!!! could be further from the truth. BP is only in it to keep making BP richer than god, and if their snake-oil hurts someone, the only reason they care AT ALL is because then that snake-oil might be taken off the market so BP couldn't make anymore filthy lucre on selling it. Clearly they don't care at all if their snake-oil doesn't do what they say it will -- see all that useless NRT still on the market?

Andria

 

[curiousJan]

A perfect example if what you are saying here held true then every manufacturer of certain paraphernalia would be held accountable for what the majority of end users openly state is an intended use, what it can be or is being used for, actually, making it illegal to sell. They are selling water pipes, glass tobacco novelty pipes, cigarette papers, dry herb vaporizers and little plastic jewelry bags.

A lovely little side-effect/bonus of the proposed changes. You do remember that we are discussing something that is not currently in place, right? These changes do not affect only vaping.

 

[YoursTruli]

Of course they have been pushing it.
That's their job.

And some day nicotine will be added to that list of things that are "good for you" in certain circumstances.
And they want to corner that market as much as they want to corner any other market.

People think Big Pharma is all about protecting their quit-smoking market...
Or protecting their "treat the diseases from smoking" market...

But too many, in my opinion, are not considering the "nicotine is beneficial" market that has yet to develop.
And it will develop, one way or another, because the evidences is already in that such a market exists.

Just don't let the ANTZ hear about it.
They'll have a tizzy fit.

I am sure they know there have been enough published studies and article about the medical benefits of nicotine one of the latest being beneficial to MS patients,

Novel Therapeutic Approach by Nicotine in Experimental Model of Multiple Sclerosis

Experimental autoimmune encephalomyelitis is considered as an animal model for multiple sclerosis. The therapeutic role of nicotine has been proven to be effective in both Alzheimer’s and Parkinson’s disease, thus we examined, for the first time, the role of nicotine in the experimental autoimmune encephalomyelitis model.

Results: Our findings showed that treatment with nicotine caused a significant reduction in the severity and onset of the experimental autoimmune encephalomyelitis. Histological analysis indicated that there was very mild and mild plaque in the brain sections of nicotine prevention and treatment groups, respectively.

Conclusion: Our data indicate that nicotine can significantly improve the clinical score and attenuate the demyelinating pathology typically found in experimental autoimmune encephalomyelitis, indicating that nicotine has protective effects in experimental model of multiple sclerosis.

 

[DC2]

I am sure they know...

If you mean that Big Pharma knows, that was of course my point.


If you mean that the general public knows.
Not even close.

Even vapers don't have the slightest clue about the benefits of nicotine for the most part.
And that is the group I was referring to in my post.

 

[YoursTruli]

A lovely little side-effect/bonus of the proposed changes. You do remember that we are discussing something that is not currently in place, right? These changes do not affect only vaping.

I do remember we are discussing something that has not happened as of yet, which makes all of this pure conjecture and supposition, what I have said in response to all of the conjecture and supposition here is a track record of facts. I also realise the deeming does not only affect vaping and includes other alternative tobacco products and as far as I am aware my example of a product currently on the market often stated to have other intended uses by end users is not an alternative tobacco product or included in the deeming to come.....

 

[YoursTruli]

If you mean that Big Pharma knows, that was of course my point.


If you mean that the general public knows.
Not even close.

Even vapors don't have the slightest clue about the benefits of nicotine for the most part.
And that is the group I was referring to in my post.

you would be mistaken if you believe the general public and medical community does not know of the medical benefits of nicotine, especially those of us with these conditions who have been very well informed and number in the millions. When the study regarding the benefits for MS patients came out the MS society made sure the information got out there, it was plastered all over the news, same with the Alzheimer’s and Parkinson’s studies.

 

[DC2]

you would be mistaken if you believe the general public and medical community does not know of the medical benefits of nicotine, especially those of us with these conditions who have been very well informed and number in the millions. When the study regarding the benefits for MS patients came out the MS society made sure the information got out there, it was plastered all over the news, same with the Alzheimer’s and Parkinson’s studies.

I never mentioned the medical community, and I have no idea where they stand.

But I have yet to meet a single person in the wild that understands the benefits of nicotine.
Perhaps I just don't get out enough.

I can tell you this much though...

Nobody in my HR department understands any benefits from nicotine.
In fact, they think it's an evil substance meant to enslave.

And not one single person that I know understood either...
Until I got to work on them.

 

[Jman8]

My concern is my words, or other people's, being used to skirt Judge Leon and classifying our vapes as drug/device combination products because they provide NRT. Boom, banned and delivered with a bow to BP.

What's an actual example of the wording you are talking about? Perhaps you gave that earlier in the thread, but I don't recall. I'd like to see that wording and where you think it would be posted.

I would just state that if you were to stand on a street corner and say the wording aloud, the FDA is unlikely to do anything against you or the company, thus no violation of free speech occurring.

 

[AndriaD]

I never mentioned the medical community, and I have no idea where they stand.

But I have yet to meet a single person in the wild that understands the benefits of nicotine.
Perhaps I just don't get out enough.

I can tell you this much though...

Nobody in my HR department understands any benefits from nicotine.
In fact, they think it's an evil substance meant to enslave.

And not one single person that I know understood either...
Until I got to work on them.

Ditto. Everyone I've ever met or talked to apparently believes nicotine is the next thing to the antichrist, A Fate Worse Than Death, The Most Addictive and Deadly Substance Known to Man. Pretty high percentage of newcomers to ECF mentions how they first want to get free of cigarettes, and then OF COURSE get free of nicotine, as if that's just a natural progression, nicotine being The Great Satan and all.

When I informed my 1st husband, rabid and hysterical anti-smoker that he is, that I had finally quit smoking, thanks to e-cigs, the very next words out of his mouth were : "But you're still addicted to nicotine." This from a man who has to take Provigil just to be able to get out of bed, and a 2nd dose in the afternoon to prevent lapsing into a coma before dinnertime.

Andria

 

[curiousJan]

What's an actual example of the wording you are talking about? Perhaps you gave that earlier in the thread, but I don't recall. I'd like to see that wording and where you think it would be posted.

I would just state that if you were to stand on a street corner and say the wording aloud, the FDA is unlikely to do anything against you or the company, thus no violation of free speech occurring.

Any post made to this forum, and others like it, or to any social media platform stating that these devices helped someone stop smoking could be used in the manner I described previously.

 

[englishmick]

I think we are discussing two separate speech issues.
As a free speech purist I believe one can say anything one would like the caveat being that
one also is accountable for said speech. As an example one can yell fire in a crowded theatre.
If there is no fire and people are injured in the resulting panic the shouter is clearly accountable
for the actions of his use of free speech. If there was a fire then the shouter has committed
no transgression and may be considered a hero.

I agree with this. You can say whatever you like but you might get locked up for it. How is this any different from a country without a free speech right?

The only place where it seems to have any real meaning is in those areas that I suspect the writers of the 1st Amendment intended to address, namely a free press and the right of individuals to express opinions. Now speech includes burning flags, nude dancing, and billionaires and imaginary people called corporations giving wheelbarrows full of money to politicians.

It's been BP's contention for a long time that if herbs,spices,foods of any kind, vitamins or other
nutritional supplements do have healing and or other medicinal qualities, they should be considered
medicines and treated as such under FDA regulation. I kid you not. As dumbfounded as this is
BP has been pushing this.

In the early 90's in Indiana a bill was being pushed to make it illegal to grow certain medicinal herbs in your garden, the only one I remember by name is valerian. It failed by a fairly wide margin I think. Their argument then was that these herbs were being used for medicinal reasons, but they hadn't been tested by the FDA so they might not be safe. Some of the herbs on the list were native to the area and had been traditionally used by Native Americans.

They weren't being marketed by garden shops as health aids. But people knew about these supposed effects and talked about it. Which is a bit like what we are dealing with under intended use.

Same reason behind it too. Something that could take money out of the pockets of BP. But in the case of vaping the amount of money is massively larger.

 

[AndriaD]

Any post made to this forum, and others like it, or to any social media platform stating that these devices helped someone stop smoking could be used in the manner I described previously.

You're right. Until I came to ECF, the thought of using e-cigs to actually quit smoking had never crossed my mind. I just wanted a way to "smoke" indoors. But when I came here and saw all the success stories, I thought, hmmmmm.....

Andria

 

[Jman8]

Any post made to this forum, and others like it, or to any social media platform stating that these devices helped someone stop smoking could be used in the manner I described previously.

IMO, they ought to be viewed as if vaping (nicotine) is a drug, and the gear is a drug delivery device. IMO, that's just being honest.

If a vendor puts that up on their site, I'd call that foolish after the Soterra decision. Again, word of mouth can handle that. If vendor feels that strongly about the matter, then have them go the route of regulation as a drug rather as a recreational/tobacco product.

But if made on a site that is not marketing eCigs (via paid sponsorships or commercial interests), then I see it as non-issue. Pretty sure ANTZ would disagree (strongly) and want to have that site taken down by any means necessary. Or if say a site like Facebook, just make it so policy on the site is that no mention of tobacco related posts are permitted.

To be clear, I think (given my understanding of laws / regulations), you as consumer ought to be permitted to say it wherever/whenever, but that publisher of the site can say "not here" and that doesn't violate your free speech. Well, I guess technically it does (in my book), but disallowing certain things to be said in certain places strikes me as normal every day life ever since I've been alive.

 

[curiousJan]

IMO, they ought to be viewed as if vaping (nicotine) is a drug, and the gear is a drug delivery device. IMO, that's just being honest.

Do you realize that the classification of drug/device combo would result in their removal from the market for at least 10-20 years while the necessary studies are performed and would likely make everyone possessing niquid and/or devices criminals?

If a vendor puts that up on their site, I'd call that foolish after the Soterra decision. Again, word of mouth can handle that. If vendor feels that strongly about the matter, then have them go the route of regulation as a drug rather as a recreational/tobacco product.

But if made on a site that is not marketing eCigs (via paid sponsorships or commercial interests), then I see it as non-issue. Pretty sure ANTZ would disagree (strongly) and want to have that site taken down by any means necessary. Or if say a site like Facebook, just make it so policy on the site is that no mention of tobacco related posts are permitted.

To be clear, I think (given my understanding of laws / regulations), you as consumer ought to be permitted to say it wherever/whenever, but that publisher of the site can say "not here" and that doesn't violate your free speech. Well, I guess technically it does (in my book), but disallowing certain things to be said in certain places strikes me as normal every day life ever since I've been alive.

I've stated my specific concerns quite clearly, and you keep repeating this. I'm not running these circles any more.

I hope I'm wrong, but I'm not willing to bet on it ... which is why I began this discussion.

 

[Jman8]

Do you realize that the classification of drug/device combo would result in their removal from the market for at least 10-20 years while the necessary studies are performed and would likely make everyone possessing niquid and/or devices criminals?

Sure. Which is good reason not to make this a testimonial/review comment to a vendor. And, removal from the market seems like what we are up against any way you spin things with the FDA.

I've stated my specific concerns quite clearly, and you keep repeating this. I'm not running these circles any more.

I hope I'm wrong, but I'm not willing to bet on it ... which is why I began this discussion.

If the concern is it will be removed from the market, then you are just talking about a specific product, not all of vaping. IMO, chances are very likely FDA just warns the vendor and realizes it can't control what consumers say. So, just not have it on vendor sites strikes me as reasonable way to go. On forums and blogs, if FDA wants to play hardball, then I think they face uphill battle and court cases that they'd lose on. Otherwise, all ANTZ would have to do is play role of consumer and could then arguably get all products removed by the bizarre rationale you are using.

 

[SeniorBoy]

FYI: 12/28/15 - by Dr. Carl V Phillips - CASAA comments on FDA proposed “intended use” regulation of ecigs

The pdf submission which contains among many things this:

"E-cigarette manufacturers’ statements that their products can be an attractive alternative to
smoking, and that many people have successfully used e-cigarettes to reduce or completely
replace their smoking, are beneficial to consumers and public health. That message is
communicated by many parties who are concerned with public health and are outside FDA
jurisdiction, and thus the message could never be fully censored by FDA action (despite the
outlandish suggestions of some commenters on this proposal that FDA try to do just that)."

The CASAA Blog page

Thank you Carl and CASAA!

 

[Jman8]

I would also just add that if FDA or anyone (say ANTZ) went in direction of trying to control consumer speech outside of vendor sites, that I would like to live in a political reality where pro-vaping enthusiasts are expressing themselves often (as in daily, maybe 10 times a day) on non-vendor platforms, the message they are not supposed to say (according to FDA). A very visible civil disobedient, hopefully coordinated action would be very interesting and likely overwhelm FDA to the point of them getting the message loud and clear that you will not stop this and we will not go quietly on this matter.