FDA Does Intended Use violate the First Amendment?

[curiousJan]

If the Intended Use portion of the FDA regulation is published, might a First Amendment challenge be successful? If customer reviews, testimonials, even forum posts are used against a company to allow the FDA to claim regulatory purview, are they not infringing on freedom of speech?

I mean if the same approach were utilized across the board there are many foods and herbal supplements that would become drugs overnight. The whole idea is ridiculous, and there must be some way to stop it.

 

[AndriaD]

If the Intended Use portion of the FDA regulation is published, might a First Amendment challenge be successful? If customer reviews, testimonials, even forum posts are used against a company to allow the FDA to claim regulatory purview, are they not infringing on freedom of speech?

I mean if the same approach were utilized across the board there are many foods and herbal supplements that would become drugs overnight. The whole idea is ridiculous, and there must be some way to stop it.

Hopefully some tort lawyers are having the same thought.

Andria

 

[Endor]

I mean if the same approach were utilized across the board there are many foods and herbal supplements that would become drugs overnight. The whole idea is ridiculous, and there must be some way to stop it.

This is an interesting thought. I'm sure Andria is right in that this will be challenged (among other aspects).

Interestingly, the FDA takes a fairly hands-off approach to dietary supplements. High-level GMP is about all they do, along with some high-level regulation around "new dietary ingredients." I think the manufacturers are covered as long as they have the whole "This product has not been determined by the FDA to treat any disease" disclaimer. There is a FAQ page but I'm still not sure how the broken links thing work. Google "FDA dietary supplments faq".

As others much smarter than me have stated (e.g. Carl Phillips, Michael Siegel), the FDA should pursue a similar regulatory framework for e-cigarettes: high-level standards for device safety, regulations around potentially dangerous flavoring ingredients (e.g. no diacetyl or AP), basic GMP to stop companies from mixing eliquid in bathrooms, etc.

Instead, the FDA is under political pressure to ban it completely (which is the current proposal), and if there some collateral damage with your constitutional rights, so be it... it's for the Common Good and The Children.

 

[curiousJan]

Hands off? I don't think so ...

FDA: Walnuts Are Drugs

General Mills, Inc. 5/5/09

Just a couple of examples of the extreme reaches that the FDA has foisted upon companies and consumers. It baffles me that consumers joined a class action against Diamond. Stupid greedy people, that class action is supposedly the only reason Diamond settled the matter with the FDA instead of fighting it through the Court.

 

[AndriaD]

That is so utterly stupid. At one point, I had a moderately high LDL; when I asked my doc if this was a big problem, he said no, because I'm not diabetic, not obese, and do not have hypertension -- his advice? "Eat some cheerios." AND IT WORKED!

I suspected it already due to all this ridiculosity about e-cigs, but now I know for sure: THE FDA ARE COMPLETE IMBECILES.

The right question to ask, in regards to the FDA, is "How do we get rid of it?"

Andria

 

[Jman8]

If the Intended Use portion of the FDA regulation is published, might a First Amendment challenge be successful? If customer reviews, testimonials, even forum posts are used against a company to allow the FDA to claim regulatory purview, are they not infringing on freedom of speech?

I mean if the same approach were utilized across the board there are many foods and herbal supplements that would become drugs overnight. The whole idea is ridiculous, and there must be some way to stop it.

I see it as who is promoting / publishing the words being spoken (or written) and to what end?

I heard about vaping initially via word of mouth, even in the information age. I could've done (google) research on it and found out way more than what I was initially being told, but even on hindsight, I don't see why I would've gone in that direction. The word of mouth aspect is something I don't see how we can lose on other than vaping becomes fully illegal (akin to 'other stuff') or ANTZ steps up its game to make a few examples of what it thinks shouldn't be allowed, and gets some LEO types to go along with it. Example such as 18 year old wears shirt to school that has a pro-vaping reference on it, and is busted / made to take it off, and the kid and kid's parents don't challenge this. ANTZ then floats it to media saying here is example of what you can't do going forward with regards to pro-vaping position.

But if a vending company is publishing customer words on their company website, to show how Product is really wonderful and liked by its users, I can see that being disallowed given how I understand language of FSPTCA. I do not think challenges to that would win based on 1st Amendment.

What I see as the tricky territory is vaping forums and blogs that ARE NOT in any way funded / sponsored by vaping companies. That's where I see ANTZ trying to hit hard post deeming, and where I hope our side hits hard back. In reality, those will always be around, so I don't see us entirely losing, but because ANTZ holds a lot of sway, then I think if they don't over play their hand, they could take down a few of the popular ones. If they overplay their hand, and I consider that very likely, they could end up creating far more, as it will suddenly be a very cool place to hang out, share thoughts, rally against opposition. Could even be a place to mobilize action and instead of having 20% of the visiting audience that might be interested in politics of vaping, it might be more like 80% of visiting audience wants to mobilize and change the political dynamic.

ANTZ stands as much of a chance going forward as Snoke does in the new Star Wars trilogy.

 

[curiousJan]

So the whole point of FSPTCA advertising restrictions on tobacco product companies is to prevent marketing to minors, yes? Online vendors of ENDS products already, or should, restrict site visitors by age. Therefore the on-site advertising is moot, as are any customer testimonials. My comments and reviews submitted to a vendor regarding a product offered for sale are protected speech, in my opinion. I've not been paid or provided any form of compensation for my input. It is mine to give or not based upon my own free choice. This is especially true for for forum participation or any statements made via social media platforms which could also be used by the FDA to determine "intended use."

This isn't about how well liked products are, this is about whether or not products are successful for a subset of users at keeping said users off of cigarettes. It is about the effects of staying off cigarettes on users' health. Those statements are the ones that the FDA intends to use against the manufacturers and vendors of products.

 

[TheMike21]

Well... Tobacco is unable to advertize at all and It's not only about children but to "reduce" the amount of new smokers. If Tobbacco is gaged and hasn't gotten away with a 1st amenment thing I don't think we will be able to.

The forums and blogs might be a lot more dificult to regulate though, and legislators don't really like making rules they can't enforce.

 

[Kent C]

Example such as 18 year old wears shirt to school that has a pro-vaping reference on it, and is busted / made to take it off, and the kid and kid's parents don't challenge this. ANTZ then floats it to media saying here is example of what you can't do going forward with regards to pro-vaping position.

But if a vending company is publishing customer words on their company website, to show how Product is really wonderful and liked by its users, I can see that being disallowed given how I understand language of FSPTCA. I do not think challenges to that would win based on 1st Amendment.

This is especially true for for forum participation or any statements made via social media platforms which could also be used by the FDA to determine "intended use."

There's a pattern forming:

At the beginning of December, Rolling Stone writer Jeff Goodell asked Secretary of State John Kerry whether Charles and David Koch, two libertarian political activists, should be considered — his remarkable words — “an enemy of the state.” He posed the same question about Exxon, and John Kerry, who could have been president of these United States, said that he looked forward to the seizure of Exxon’s assets for the crime of “proselytizing” impermissibly about the question of global warming. An enemy of the state? That’s the Democrats’ theme for the New Year: totalitarianism. Donald Trump may talk like a brownshirt, but the Democrats mean business. For those of you keeping track, the Democrats and their allies on the left have now: voted in the Senate to repeal the First Amendment, proposed imprisoning people for holding the wrong views on global warming...

Read more at: The Democrats’ Theme for 2016 Is Totalitarianism, by Kevin D. Williamson, National Review

The Liberal Gulag, Revisited, by Kevin D. Williamson, National Review

 

[curiousJan]

Well... Tobacco is unable to advertize at all and It's not only about children but to "reduce" the amount of new smokers. If Tobbacco is gaged and hasn't gotten away with a 1st amenment thing I don't think we will be able to.


The forums and blogs might be a lot more dificult to regulate though, and legislators don't really like making rules they can't enforce.

I'm not talking about commercial advertising. I'm speaking directly to customer reviews and comments.

 

[curiousJan]

There's a pattern forming:

At the beginning of December, Rolling Stone writer Jeff Goodell asked Secretary of State John Kerry whether Charles and David Koch, two libertarian political activists, should be considered — his remarkable words — “an enemy of the state.” He posed the same question about Exxon, and John Kerry, who could have been president of these United States, said that he looked forward to the seizure of Exxon’s assets for the crime of “proselytizing” impermissibly about the question of global warming. An enemy of the state? That’s the Democrats’ theme for the New Year: totalitarianism. Donald Trump may talk like a brownshirt, but the Democrats mean business. For those of you keeping track, the Democrats and their allies on the left have now: voted in the Senate to repeal the First Amendment, proposed imprisoning people for holding the wrong views on global warming...

Read more at: The Democrats’ Theme for 2016 Is Totalitarianism, by Kevin D. Williamson, National Review

The Liberal Gulag, Revisited, by Kevin D. Williamson, National Review

Are you referring to the attempt to enact campaign finance reform, to restrict the "free speech" of corporations in political advertising?

ETA: In my honest opinion the Koch brothers are enemies of the state. Corporate money controlling the legislature and direction of this country is the root of political evil in the U.S.

 

[DC2]

The new "Intended Use" doctrine is a way to bypass Judge Leon's rulings.
It will almost certainly go to court, and likely be defeated.

Or at least I hope so.

 

[Kent C]

I'm not talking about commercial advertising. I'm speaking directly to customer reviews and comments.

Me too. The Senate bill isn't just limited by advertising. It would also include studies that weren't consistent with the current false "consensus". And media stories.

Are you referring to the attempt to enact campaign finance reform, to restrict the "free speech" of corporations in political advertising?

No. "campaign finance reform"?? You're mind must have wandered when you saw "Koch"

The article was about making it a crime to disagree with climate change. Along the same lines where comments by anyone, including vendors, that ecigs helping people stop smoking would be evidence to be used by the FDA to make it a crime showing intended use. Hence the comment "There's a pattern forming", where certain speech (which should be protected by the First Amendment) is a crime and should be punished.

As far as "In my honest opinion the Koch brothers are enemies of the state."... For me, that's as despicable and hateful as you think they are. But I wouldn't make a law against you saying it, like your side would against them.

 

[curiousJan]

No. "campaign finance reform"?? You're mind must have wandered when you saw "Koch"

My mind didn't wander. I didn't open your links, choosing instead to do my own search looking for unbiased sources on the bill that you mentioned. Campaign finance reform was what I found.

The article was about making it a crime to disagree with climate change. Along the same lines where comments by anyone, including vendors, that ecigs helping people stop smoking would be evidence to be used by the FDA to make it a crime showing intended use. Hence the comment "There's a pattern forming", where certain speech (which should be protected by the First Amendment) is a crime and should be punished.

I don't believe those are the same lines at all. This is about a power-grab by the FDA, not partisan bickering. The deeming regs don't make anything a crime. They do hold businesses accountable for actions not their own.

As far as "In my honest opinion the Koch brothers are enemies of the state."... For me, that's as despicable and hateful as you think they are. But I wouldn't make a law against you saying it, like your side would against them.

They can say anything they wish. I expressed my opinion that they should not be allowed to unduly influence the U.S. government or the electoral process. Corporations are not people and should play no part in the process.


Now, can we get back to the topic, please!?!

 

[Kent C]

I don't believe those are the same lines at all. This is about a power-grab by the FDA, not partisan bickering. The deeming regs don't make anything a crime. They do hold businesses accountable for actions not their own.


Now, can we get back to the topic, please!?!

What I wrote was on topic. The case I mentioned wasn't about partisan bickering - you made it that. It was about how gov't wants to shut down speech as does the FDA via 'intended use' and comments made by not just vendors but their customers as well, in order to use it against them.

I just don't think you understand how the FDA has used 'intended use' in the past - ie to actually indict companies and impose fines, based on consumer's words. Anyone here who has followed that line would know of what I speak. I have a few posts on it a while back on the court cases the FDA used in order to make their case. You obviously are unaware of them which is fine. But the attempt to use speech against individuals and companies is the 'connection' that you missed. And that forms a pattern, imo.

I thought from your OP, which I 'liked', that you knew. I was mistaken.

 

[TheMike21]

I'm not talking about commercial advertising. I'm speaking directly to customer reviews and comments.

They will be very difficult to stop, specially with a lot of info coming from overseas. Or what will happen if it's an American posting on a UK site? or somebody from the UK posting on a US based site? If you can't really enforce it you don't legislate it. Plus, if you can't find me, you can't fine me

It's similar to the 0 Nic clean air debate, nobody can test your juice on the go for 0 Nic so all vaping is banned indoors.

 

[Endor]

There's a pattern forming:

At the beginning of December, Rolling Stone writer Jeff Goodell asked Secretary of State John Kerry whether Charles and David Koch, two libertarian political activists, should be considered — his remarkable words — “an enemy of the state.” He posed the same question about Exxon, and John Kerry, who could have been president of these United States, said that he looked forward to the seizure of Exxon’s assets for the crime of “proselytizing” impermissibly about the question of global warming. An enemy of the state? That’s the Democrats’ theme for the New Year: totalitarianism. Donald Trump may talk like a brownshirt, but the Democrats mean business. For those of you keeping track, the Democrats and their allies on the left have now: voted in the Senate to repeal the First Amendment, proposed imprisoning people for holding the wrong views on global warming...

Read more at: The Democrats’ Theme for 2016 Is Totalitarianism, by Kevin D. Williamson, National Review

The Liberal Gulag, Revisited, by Kevin D. Williamson, National Review

Why do you do this to me, Kent? Get my blood pressure up and everything... see, once they are successful in killing the first amendment, I could put you in jail for a post like that.

(and yes, I'm being fictitious, well... except about the blood pressure part)

 

[curiousJan]

What I wrote was on topic. The case I mentioned wasn't about partisan bickering - you made it that. It was about how gov't wants to shut down speech as does the FDA via 'intended use' and comments made by not just vendors but their customers as well, in order to use it against them.

Please cite circumstances where consumers comments not published (as in marketing material not review testimonials) otherwise disseminated by a company has resulted in FDA action and/or fines.

I still don't see the issues as being the same. The government attempted to shut down non-person (i.e. corporations, lobby groups, etc.) speech, in particular political advertising. The FDA is attempting to utilize citizens speech to indict business entities.

I just don't think you understand how the FDA has used 'intended use' in the past - ie to actually indict companies and impose fines, based on consumer's words. Anyone here who has followed that line would know of what I speak. I have a few posts on it a while back on the court cases the FDA used in order to make their case. You obviously are unaware of them which is fine. But the attempt to use speech against individuals and companies is the 'connection' that you missed. And that forms a pattern, imo.

I thought from your OP, which I 'liked', that you knew. I was mistaken.

 

[Kent C]

Please cite circumstances where consumers comments not published (as in marketing material not review testimonials) otherwise disseminated by a company has resulted in FDA action and/or fines.

Sorry, I'm not going to take the time to find the posts I mention. Pretty much done with discussing this with you.

 

[Kent C]

Why do you do this to me, Kent? Get my blood pressure up and everything... see, once they are successful in killing the first amendment, I could put you in jail for a post like that.

(and yes, I'm being fictitious, well... except about the blood pressure part)

Fictitious or facetious or not, I think you're right. There are many other things that 'point toward' this same type of fascism - the 'no comments' comment section, or where comments are deleted, loss of tenure for deniers, not publishing anti articles in both ecigs and global warming, not peer reviewing opposite views, not allowing our studies or our guys in seminars - relegating them to comments only, rather than discussions. The next 'logical step' in fascism is to make them crimes, and such proposals have been made. If someone doesn't see a pattern, they are blind.