FDA Does Intended Use violate the First Amendment?

[retired1]

Yes. However, the individuals themselves were not charged or hauled into court. What they were saying was used as evidence against those who were selling the items.

Intended use is rarely, if ever, used against the end consumer unless other laws are being broken as well. Intended use is usually always aimed at the company who provided the product.

 

[mudmanc4]

Soooo, walnuts are drugs, and contribute to global warming, if a citizen speaks against global warming, they should be imprisoned.

Remind anyone of the old 'peach section' family circle? These people have nothing better to do.

 

[Kent C]

Yes. However, the individuals themselves were not charged or hauled into court. What they were saying was used as evidence against those who were selling the items.

Intended use is rarely, if ever, used against the end consumer unless other laws are being broken as well. Intended use is usually always aimed at the company who provided the product.

You're right - it was words by consumers that were used against the vendors in those cases, so it was more than your: "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."....

....but going back to my other example noted, where anyone could be charged for 'denying', I don't think it is out of the realm of possibility that the FDA might issue an order/regulation about anyone mentioning how 'ecigarettes are a cure to smoking' or similar wording, including social media, forums like this one, etc., but as written, there is nothing in the deeming about that. However, as has been mentioned by Zeller and others, the 'deeming' is just a beginning. It depends upon how intent they are in shutting down dissent - they're pretty good at keeping our guys and studies out of their seminars.

 

[Alexander Mundy]

Yes. However, the individuals themselves were not charged or hauled into court. What they were saying was used as evidence against those who were selling the items.

Intended use is rarely, if ever, used against the end consumer unless other laws are being broken as well. Intended use is usually always aimed at the company who provided the product.

So if say 1,000 customers said that a companies product helped them stop smoking and cleared up their cough it could be used against the company that declared specifically they were not for treating anything or as a stop smoking aid? Or would the company or retailer have to tell the customer it would?

 

[curiousJan]

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.

Intended use may have meant that historically, but I have referenced the proposed changes multiple times in this thread. I believe that a goal of the changes is to broaden the pool to include consumer-driven forums and information-sharing sites that are in no way affiliated with the business.

 

[Kent C]

So if say 1,000 customers said that a companies product helped them stop smoking and cleared up their cough it could be used against the company that declared specifically they were not for treating anything or as a stop smoking aid? Or would the company or retailer have to tell the customer it would?

That's right. And every vendor should (for their own sake - although it may be mandatory at some point) have some wording to that effect. For example, it's illegal to 'cure cancer' in California, even if a cure was found! (that was a while back, things may have changed).

 

[curiousJan]

Yes. However, the individuals themselves were not charged or hauled into court. What they were saying was used as evidence against those who were selling the items.

Intended use is rarely, if ever, used against the end consumer unless other laws are being broken as well. Intended use is usually always aimed at the company who provided the product.

Using my words against a company or product that has proved beneficial to me will result in me self-censoring, a stifling and chilling effect, which in my opinion violates my First Amendment rights. Whether or not I could prove that in a court of law ... dunno? Thus the topic.

 

[AndriaD]

You're right - it was words by consumers that were used against the vendors in those cases, so it was more than your: "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."....

....but going back to my other example noted, where anyone could be charged for 'denying', I don't think it is out of the realm of possibility that the FDA might issue an order/regulation about anyone mentioning how 'ecigarettes are a cure to smoking' or similar wording, including social media, forums like this one, etc., but as written, there is nothing in the deeming about that. However, as has been mentioned by Zeller and others, the 'deeming' is just a beginning. It depends upon how intent they are in shutting down dissent - they're pretty good at keeping our guys and studies out of their seminars.

All I can say is, thank goodness for the 2nd amendment, so we can protect the 1st amendment.

Andria

 

[retired1]

Using my words against a company or product that has proved beneficial to me will result in me self-censoring, a stifling and chilling effect, which in my opinion violates my First Amendment rights. Whether or not I could prove that in a court of law ... dunno? Thus the topic.

Your rights have not been violated. Only if they took action against you would you possibly have a case.

 

[retired1]

To put this in a different light, there are different terms when it comes to the 1st Amendment and what the government can and cannot do in regards to limiting free speech.

First Amendment

The most basic component of freedom of expression is the right of freedom of speech. The right to freedom of speech allows individuals to express themselves without interference or constraint by the government. The Supreme Court requires the government to provide substantial justification for the interference with the right of free speech where it attempts to regulate the content of the speech. A less stringent test is applied for content-neutral legislation. The Supreme Court has also recognized that the government may prohibit some speech that may cause a breach of the peace or cause violence. For more on unprotected and less protected categories of speech see advocacy of illegal action, fighting words, commercial speech and obscenity. The right to free speech includes other mediums of expression that communicate a message. The level of protection speech receives also depends on the forum in which it takes place.

As far as reviews, comments, etc. dealing with e-cigarette products, the government would most likely place this under the blanket banner of commercial speech, which does not enjoy the same strict protections.

Commercial Speech

Commercial speech has been defined by the Supreme Court as speech where the speaker is more likely to be engaged in commerce, where the intended audience is commercial or actual or potential consumers, and where the content of the message is commercial in character.

As such, commercial speech does not enjoy the same strict protections.

 

[curiousJan]

To put this in a different light, there are different terms when it comes to the 1st Amendment and what the government can and cannot do in regards to limiting free speech.

First Amendment



As far as reviews, comments, etc. dealing with e-cigarette products, the government would most likely place this under the blanket banner of commercial speech, which does not enjoy the same strict protections.

Commercial Speech



As such, commercial speech does not enjoy the same strict protections.

So my providing a review or even an opinion about a style of product, rather than a specific product, is commercial speech? Even when that opinion is not presented by way of a commercial web site? And I'm not being compensated in any way, shape, or form?

I disagree. There are responsibilities and liabilities involved in commercial speech that do not apply to personal opinions. Liabilities, that if applied to personal opinion, would inhibit the free, truthful sharing of information among individuals ... the very basis of free speech, in my honest opinion.

 

[retired1]

Again, YOUR rights are not being violated as the government is not taking action against you personally.

 

[curiousJan]

That type of logic, that if information pertains to a commercial product then the information is commercial in nature, is the same type of logic that has the FDA attempting to classify walnuts and Cheerios as drugs.

 

[retired1]

Logic has nothing to do with it. You can't claim a 1st Amendment infringement when you aren't the one that's being targeted for enforcement.

IF (and that's a very HUGE if), the government were to come after you for stating you used product "x" and haven't smoked a cigarette since then, then yes, perhaps you'd have a case. But to claim a 1st Amendment infringement when you aren't the one that's being targeted is a non-issue from the start.

 

[SeniorBoy]

I own a Blog and I'm certainly not the least bit concerned about either the FDA and or the FTC coming after me, a consumer. My attorney of over 30 years holds the very same view. Period! I also find nothing in the 4/14 deeming or the recently leaked TVECA documents that would even "hint" at enforcement action against consumer free speech.

I think some folks may not even understand exactly how the free speech issue works and is enforced on a Blog or a Forum owned and operated by consumers and not a company. Long before ECF, I ran a very very busy forum of a commercial nature (I derived revenue from tightly screened and vented advertisers) and never once was I ever sanctioned or even warned by either the FDA and or the FTC. I had my share of enforcement like folks who were either regular lurkers or in a few cases posters. This was the bubble period of dietary supplements. I'm going to be a bit circumspect in further details if you don't mind.

Try this:

The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) work together under a long-standing liaison agreement governing the division of responsibilities between the two agencies. As applied to dietary supplements, the FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale. The FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. Marketing on the Internet is subject to regulation in the same fashion as promotions through any other media. Because of their shared jurisdiction, the two agencies work closely to ensure that their enforcement efforts are consistent to the fullest extent feasible.

Source

I have always complied with the letter and spirit of the following FTC document: FTC Publishes Final Guides Governing Endorsements, Testimonials and I would respectfully advise anyone else who operates a venue to embrace these practices because that's the moral and ethical thing to do. AKA "Best Practices"

EDIT: FTC enforcement actions

/Just my 2 cents

 

[Jman8]

So my providing a review or even an opinion about a style of product, rather than a specific product, is commercial speech? Even when that opinion is not presented by way of a commercial web site? And I'm not being compensated in any way, shape, or form?.

Where would your review be provided if not on a vendor/commercial website?

If you had own site that is not marketing eCigs but is just reviewing products, I do not think they can come after that. There are sites right now that review smokes, and don't appear to be commercial in their interests.

 

[AndriaD]

Where would your review be provided if not on a vendor/commercial website?

If you had own site that is not marketing eCigs but is just reviewing products, I do not think they can come after that. There are sites right now that review smokes, and don't appear to be commercial in their interests.

So, in essence, it's not being said that we can't say whatever we feel like about any given product... but that a site which is selling that product, cannot provide any testamonials about that product, on that site...?

Andria

 

[retired1]

Correct

 

[Jman8]

So, in essence, it's not being said that we can't say whatever we feel like about any given product... but that a site which is selling that product, cannot provide any testamonials about that product, on that site...?

Andria

That's what I'm conveying. I don't know the precise law, but do think testimonials for tobacco products aren't treated the same as all other conceivable products and that FSPTCA was partially written to squarely address how the product is marketed/advertised. Especially considering likes of Marlboro Man as way that some people (arguably) got hooked.

As I understand the law, if you wish to claim that use of a tobacco product (i.e. vaping) helped you to stop smoking, that's all fine and good. FSPTCA, of course, doesn't convey this (directly), but IMO they ain't ever going to stop word of mouth advertising, and I'm fairly certain they know this. What they hope to stop / curtail is idea that a vendor would use testimonials / endorsements as way to entice people into using the tobacco product. Thus, an independent site that contains no links / pointers to the vendor site would be tricky in terms of how I understand the law, but probably realistically is so small of peanuts that no one would care. If that somehow became wildly popular, especially among youth, then I could see ANTZ types making big todo about how it is enticing never-users and hooking a whole other generation onto lifelong addiction to nicotine. Or some nonsense like that.

 

[DC2]

Correct

But can a website that receives "advertising" income from from that company allow such testimonials?