FDA Does Intended Use violate the First Amendment?

[Kent C]

I anticipate ECF and other sites being around for a long time to come, but hard to say how ANTZ will proceed once the deeming comes about.

I think it is worth considering as well. We have had health comments in ECF scanned by Prue Talbot that end up in studies and articles that are anti-vaping. And from the link which I cited above is how the FDA has used 'intended use' and the extent to which they go to establish it:

“any . . . relevant source,” including but not limited to the product’s labeling, promotional claims, and advertising"

"To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold."

I think ECF would be considered a 'relevant source' and could be, with links to vendors or sales or promotion of contests wrt ecig products, in any thread, could be considered as - "any circumstance surrounding the distribution of the product or context in which it is sold".

This isn't just about manufacturers or vendors advertisements - the FDA has made that clear. They have also made clear that the 'deeming' is just the beginning.

 

[curiousJan]

IMO, the legal fight to pursue is for each of us to take up our own website that promotes vaping in way we are most comfortable with. If relying on our comments on a forum or vending site, then those administrators may have different priorities which could amount to: had to remove your comments (all consumer comments) to comply with what my attorneys say will keep me out of legal trouble.

If we have our own sites, we become admins of that site. Best if using own servers, and if not marketing eCigs products in our messages. Then we'll have something at stake in the fight, and to get us to shut that down would be a challenge. Not too challenging if it is a few dozen of us, as all they'd have to do is take down 10 of the most popular to send a message. More challenging if there's a few thousand of us, none of whom really care about lots of site traffic and do care that messages are shared in effort to overcome what is likely zealous / overreaching regulations.

All this is in vein of worst case scenario, and likely not necessary to go in this direction within 18 months of deeming. I anticipate ECF and other sites being around for a long time to come, but hard to say how ANTZ will proceed once the deeming comes about. I say we ought to be preparing in a whole other way besides stockpiling goods.

You're missing my point. The FDA wants sites from which to gather these statements. If deeming regs come to pass, no one is going to shut those sites down. They will, instead, take the comments and hold manufacturers and vendors accountable. Essentially, you (company/vendor) say your product is recreational, but these consumers say they use it for smoking cessation/health ... Therefore, your product is a drug/NRT product, and we are going to hold you to this completely different set of standards and regulations.

 

[Kent C]

There is a limit to how far we need to venture from the topic at hand, but politics plays in the issues we are discussing. I will say that I don't believe that R this and D that is productive at all.

I agree with this and in the case I provided, as another instance of a violation of the first amendment - in order to show what happened, it is necessary to link to studies that tell the whole story. If it were a Republican rather than a Democrat Senator from RI, then I'd still post the link. The intent wasn't political in the sense of partisan - only that the first amendment is under attack in other areas that provides a precedent for the FDA's actions and viewpoints.

And as some might (and have said) that such abridgement wouldn't hold up in court - the links I subsequently added has shown the suits and judgments where that wasn't the case in those particular cases where the 'intended use' doctrine was used. Perhaps we would be more successful than those cases were.

 

[Jman8]

You're missing my point. The FDA wants sites from which to gather these statements. If deeming regs come to pass, no one is going to shut those sites down. They will, instead, take the comments and hold manufacturers and vendors accountable. Essentially, you (company/vendor) say your product is recreational, but these consumers say they use it for smoking cessation/health ... Therefore, your product is a drug/NRT product, and we are going to hold you to this completely different set of standards and regulations.

That is an interesting point and I admit to missing it.

I think it would be impossible for FDA to go in that direction. Or just easier for companies to not use user comments. But I could see someone on the anti side trying to go in that direction.

I try to stay consistent in my rhetoric as a user, and let anyone who will listen know that vaping, for me, is a smoking alternative and recreational choice.

 

[Kent C]

You're missing my point. The FDA wants sites from which to gather these statements.

I agree. They will use - as they have said - "any relevant source".

 

[Kent C]

I don't see the proposed changes to intended use as stifling, more of a twisting to use to suit the FDA's purpose. Is there the potential for self-censoring so that our words are not used against companies and products that are important to us? Sure. And that is a huge problem.

'Stifling' and 'chilling' effect are near-legalese when it comes to the First Amendment. Anything - such as you point out - using our words against us - whether in a review at a vendors site or here on ECF, has both a stifling and chilling effect on speech.

 

[Kent C]

I'm just wondering how it's possible to discuss a political fight (the deeming) without discussing politics. E-cigs don't exist in a vacuum.

Andria

One solution would be to move these forums to the Outside. The other would be to understand that this is political issue, and (exceptions noted) to an extent, a partisan one.

 

[AndriaD]

Agreed. There is a limit to how far we need to venture from the topic at hand, but politics plays in the issues we are discussing. I will say that I don't believe that R this and D that is productive at all. There are allies and adversaries everywhere. The people on both sides of the aisle that we need to be targetting are the ignorant. Information and knowledge is power. If we can educate, we can make great strides (discounting those that truly are ruled by the almighty $$.)

I agree about the R and the D; those labels are largely irrelevant in any case -- ALL politicians are crooked, just in different ways and degrees. And clearly they're all insane, since no sane person would want the job.

Andria

 

[curiousJan]

I agree about the R and the D; those labels are largely irrelevant in any case -- ALL politicians are crooked, just in different ways and degrees. And clearly they're all insane, since no sane person would want the job.

Andria

I don't know ... I think there are some idealists that go into it thinking that they could change things. Most end up tainted themselves or driven out by the corrupted, though.

 

[AndriaD]

IMO, the legal fight to pursue is for each of us to take up our own website that promotes vaping in way we are most comfortable with. If relying on our comments on a forum or vending site, then those administrators may have different priorities which could amount to: had to remove your comments (all consumer comments) to comply with what my attorneys say will keep me out of legal trouble.

If we have our own sites, we become admins of that site. Best if using own servers, and if not marketing eCigs products in our messages. Then we'll have something at stake in the fight, and to get us to shut that down would be a challenge. Not too challenging if it is a few dozen of us, as all they'd have to do is take down 10 of the most popular to send a message. More challenging if there's a few thousand of us, none of whom really care about lots of site traffic and do care that messages are shared in effort to overcome what is likely zealous / overreaching regulations.

All this is in vein of worst case scenario, and likely not necessary to go in this direction within 18 months of deeming. I anticipate ECF and other sites being around for a long time to come, but hard to say how ANTZ will proceed once the deeming comes about. I say we ought to be preparing in a whole other way besides stockpiling goods.

I do have my own vape-related site, and really don't make any efforts to promote it for "lots of traffic" -- it's in my sig only for the purpose of informing those who might wish to visit yet another vape related site of its existence. I do have a few ads, but not many; most of the links I have to vendors are there because I like and use those vendors myself, and so would wish to a) inform others of their existence and legitimacy, and b) provide a non-reciprocal (important in search-engine marketing) link to businesses that I hope endure. And the few ads I do have, haven't made me a dime -- I put them up just on general principle mostly, because one of the vendors I patronize has an affiliate program, so I figured, why not.

About the only way that anyone could induce me to take that site down would be to apply pressure to my webhost; if they threaten to suspend my entire acct with them, then I'll have no choice. Though after the deeming, I may well remove the "paid" (not that I get paid for it, because I don't!) advertising, leaving only the personal/volitional.

Andria

 

[englishmick]

IMO, the legal fight to pursue is for each of us to take up our own website that promotes vaping in way we are most comfortable with. If relying on our comments on a forum or vending site, then those administrators may have different priorities which could amount to: had to remove your comments (all consumer comments) to comply with what my attorneys say will keep me out of legal trouble.

That's a fun thought. I've never done that, how difficult / expensive is it to set up your own website?

 

[englishmick]

I agree. They will use - as they have said - "any relevant source".

And what is the definition of "relevant" source? Whatever I say it is suckas!

 

[AndriaD]

That's a fun thought. I've never done that, how difficult / expensive is it to set up your own website?

These days, apparently it's a piece of cake -- I haven't made a dime on template design in several years.

Andria

 

[Alexander Mundy]

Why do we tolerate people like this at all, nevermind let them run anything???

Not to tolerate (in a traditional sense of the word, not the newer politically correct meaning that we can't disagree) them would make us like them. As far as letting them run things, a study of the tactics of the Nazi party is way more than I should get into here.

I think ECF would be considered a 'relevant source' and could be, with links to vendors or sales or promotion of contests wrt ecig products, in any thread, could be considered as - "any circumstance surrounding the distribution of the product or context in which it is sold".

Heck, a link to ECF was used by BP in their argument to FDA to lift time restrictions on OTC gums and patches. Wish I could find the link, but it's documented on the FDA website. Guarantee that all players involved pay personnel to monitor ECF and other like forums and use bot software to look for key words and phrases for review by personnel.

The intent wasn't political in the sense of partisan

I have seen many times where someone posts something political that is directly related to the base of problem at hand and someone else makes a big deal of it because the majority of the politicians underlying the problem are from one party and they got butthurt by that so made it a partisan issue in the discussion. Personally I think it is a partisan issue due to the sheer numbers involved, but usually restrict comment of one party or another because that doesn't appear to be PC on this forum.

I don't know ... I think there are some idealists that go into it thinking that they could change things. Most end up tainted themselves or driven out by the corrupted, though.

Agree 100%, I personally know 1 aspiring politician that isn't anymore due to party politics and 1 former government employee that banged his head against the political party of government all the time trying to do the right thing. I was young and hell bent in the 70's to change the political landscape but have subsided to a reality that big wheels keep on turning.

 

[DC2]

I don't know ... I think there are some idealists that go into it thinking that they could change things. Most end up tainted themselves or driven out by the corrupted, though.

This is absolutely true, but it is not limited to our political system.
In fact, I doubt there has ever been any political system on earth in which it wasn't true.

 

[Kent C]

I have seen many times where someone posts something political that is directly related to the base of problem at hand and someone else makes a big deal of it because the majority of the politicians underlying the problem are from one party

There is no doubt that, that happens. Here - I was pointing to another instance of the gov't violating the 1st Amendment and it happened to be from one party. When that happens, some focus on the party, rather than the point being made, missing the point.

Where the partisan issue becomes most apparent is when someone, perhaps not so politically informed, asks questions like - "Why is this happening now?!! I just started vaping and they want to shut it down! Who is behind this??!!!"

And there are answers that, as I've pointed out, have included both parties - basically one main one at the Federal level - Senators' letters to the FDA, etc., and others at the state and local level - which were, at first, mainly representatives who were putting forth a restriction on sale to minors - in some people's minds (not mine) - not an 'unreasonable' request. And these were sometimes sponsored (as some like to point out) by the 'other party' but also sometimes supported by both, but in some cases, the Dems voted 'against' the minor ban - "because it didn't go far enough" - this wasn't just one instance - it was a general view.

Later, when restrictions to smoking designated areas for vaping as well, came up - again, there were some from both parties, but imo, dominated by the Dems - this being part of the reason why 'other regulations didn't go far enough' , so they were 'on board' for further restrictions.

Imo, there are factions of the 'we know what's best for you' types in both parties, but one party seems to have a virtual monopoly on that view. For the Dems, it's the socialist/fascist thinking that is part of the greatest good for the greatest number ethic, and for the Republicans, it's the puritan faction that believes along the lines that 'your body is a temple' or similar views on how one should conduct themselves. Both sides of this 'we know what's best' factions (but not both parties) think that vices are crimes, where vices are actions that only harm the individual themselves (or they think they do) - something where gov't should Not be involved - people have rights and when exercising those rights harms no one, gov't as instituted in the US, has no jurisdiction on those actions ... and where crimes are those actions that harm someone else - something that is a valid function of gov't.

Vaping at the very least, is only a vice and at the very most, is a benefit to individuals for a whole host of reasons - the benefits of nicotine, a hobby, a way to stop smoking, to prevent Alzheimer's, Parkinson's, mental illness, to achieve a 'relaxed focus' and many other things for many individuals. Above all, it harms no one else or violates no others' rights. It is not a gateway to smoking, it's a gateway away from smoking - not only for adults but for teens as well. IOW, it is not a crime to vape.

 

[retired1]

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.

Intended use refers to how a product is advertised for use. This does not apply to reviews, testimonials, etc., but rather how the retailer advertises the product and describes the intended use of that same product.

This is a well known "rule" in the cosmetic industry. You can't make claims that aren't proven true through peer reviewed studies.

 

[Kent C]

Intended use refers to how a product is advertised for use. This does not apply to reviews, testimonials, etc., but rather how the retailer advertises the product and describes the intended use of that same product.

This is not correct. This was discussed here:

TVECA post table of contents for Deeming Final Rule

And the links under "Big News coming out of the FDA" links - the first one from Zoidman and the 3rd one from me - actually lists the cases in which the FDA has used comments from consumers to invoke 'intended use'.

“any . . . relevant source,” including but not limited to the product’s labeling, promotional claims, and advertising"

"To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may
include a variety of direct and circumstantial evidence. Thus, FDA may also take into account
any circumstances surrounding the distribution of the product or the context in which it is sold."

 

[retired1]

In other words, any retail outlet.

This does not apply to JQ Public on the street who's describing its use as the OP is describing.

Again, this applies to the outlets who are doing the selling.

 

[Kent C]

In other words, any retail outlet.

This does not apply to JQ Public on the street who's describing its use as the OP is describing.

Again, this applies to the outlets who are doing the selling.

That wasn't the case where they invoked 'intended use' in other court cases. Quite the contrary, it had nothing to do with any retail outlet but what was said 'circumstantially' by customers. I'd drag out the actual court cases if you want. They are long but the information included in my 'Big News coming from the FDA" tells most of the story. As does Zoidman's link.