FDA Does Intended Use violate the First Amendment?

Status
Not open for further replies.

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
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.

You're absolutely right. But the problem (and liability) isn't with you, even though the chilling effect would be with you, if you knew what you said was being used against someone else.

The problem is with how the FDA and the courts have used the 'intended use' theory of using your words against a company. It's the company, who (in some cases) haven't said or wrote anything wrong (in terms of fraud), where your words are being used against them. That is insane. The reason is because there is a certain mindset that is against business and they have lawyers and judges that also hold that opinion and so rule.

Let's say the Founders really meant what they said - that "Congress shall make no law... abridging the freedom of speech, or of the press..." "No law" is pretty specific, however we have many laws abridging the both speech and press.

There's a difference between speech and fraud - where saying something does something when it doesn't (or where saying something doesn't do something and it does) - is fraud. There is no "abridging" of that speech but the fraud involved is actionable.

The problem with 'intended use' is that it can 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."

So even though the manufacturer or vendor has not made any such references, the FDA can use someone not connected in any way to the manufacturer or vendor in order to nail them. Again, that's insane and only comes from the anti-business mentality that thinks that business is 'fair game', has no rights and therefore they can jail, fine, or close businesses from the utterances of someone not connected in any way to them.

This comes directly from the idea that even though there was no intent to harm by the speaker, that it is only the 'feelings' of the receiver (the "victim") that is operable. In one of the first cases of this miscarriage of justice - a student at the University of Michigan was studying and a group of people were making lots of noises on the lawn by his dorm. He yelled out the window that they sounded like a bunch of Water buffaloes and one person, African American (could have been any similar misunderstanding by any race) thought it was a 'racial slur' even though Water Buffaloes exist only in Asia. So it was the 'feeling of the victim' that mattered and the student who spoke was expelled from UofM.

The one line that is usually used to defeat a strict construction (strict scrutiny) of freedom of speech - "you can't yell "fire" in a crowded theater" was rejected subsequently by other courts as well as conceded by the justice who originally formulated it - Oliver Wendell Holmes, Jr.

The "Intermediate scrutiny" used to restrict commercial speech, while part of law, imo, violates the original intent and words of the 1st amendment - Congress shall pass NO LAW abridging speech. I can imagine James Madison (who wrote it) saying to those who have subsequently made laws abridging speech, asking "What part of "NO" did you not understand??"
 

curiousJan

Super Member
ECF Veteran
Verified Member
Dec 20, 2009
887
696
Central IL
You're absolutely right. But the problem (and liability) isn't with you, even though the chilling effect would be with you, if you knew what you said was being used against someone else.

The problem is with how the FDA and the courts have used the 'intended use' theory of using your words against a company. It's the company, who (in some cases) haven't said or wrote anything wrong (in terms of fraud), where your words are being used against them.

<...snip...>

The problem with 'intended use' is that it can 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."

So even though the manufacturer or vendor has not made any such references, the FDA can use someone not connected in any way to the manufacturer or vendor in order to nail them.

^^^ THIS ^^^
 
  • Like
Reactions: Kent C

AndriaD

Reviewer / Blogger
ECF Veteran
Verified Member
Jan 24, 2014
21,253
50,807
64
LawrencevilleGA
angryvaper.crypticsites.com
Although I think this "intended use" "any source" crap totally violates the spirit of the 1st amendment, OTOH, it does kinda make sense -- people can say whatever they like... but if someone posts/publishes those words on their website or in any other way to enhance a product's salability, then it becomes a marketing tool. Even though it wasn't said by the company doing the marketing, it was posted/published by that company, precisely to enhance salability. It's a fine hair to split, but it can be.

Andria
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
OTOH, it does kinda make sense -- people can say whatever they like... but if someone posts/publishes those words on their website or in any other way to enhance a product's salability, then it becomes a marketing tool.

That really isn't the problem - if the deeming goes through - most vendors will not have anything that smells of that on their sites. The problem is the FDA using 'any relevant source' to get them even though they, themselves, have nothing on their site speaking of it. AND, the FDA has done this in the past, so there is no reason for us to believe they won't do it again.
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
The courts beg to differ, including the Supreme Court.

You're right of course, but the Supreme Court also passed Jim Crow and a bunch of other cases that were subsequently reversed by future Supreme Courts. But as it stands, people and vendors must comply.... then if they can afford it - sue.
 
  • Like
Reactions: LaraC

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
Free Speech has never been an "absolute". There have always been limits as to what you can say, and where you can say it.

Simply not true. There was a point where that became the case but for decades, near a century (with noted exceptions that were reversed - Alien and Sedition Acts) - it was not. Again, fraud is a separate issue not related to free speech. All the 'hate speech' 'inciting to riot' and "obscenity" stuff is, by comparison, rather 'recent'. Even "fire in a crowded theater" was 1919. 130 years after the founding.
 
  • Like
Reactions: LaraC

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
So you're saying there should be absolutely no limits whatsoever? That it's OK to yell fire in a crowded theater?

I'm saying that what you said "There have always been limits" on free speech is simply not the case. Nothing more. I'm also saying that the 1st Amendment says that Congress shall pass NO law abridging freedom of speech or press. I happen to agree with the Constitution and Madison and the reason behind that as written in Cato's Letters by Trenchard and Gordon - where the Founders got it.

As far as yelling fire in a crowded theater - I've addressed this before:

If a person yells fire in a crowded theater - first one really couldn't stop someone who wanted to do that and second if you could actually ascertain who it was that did it, then they should pay restitution to all who were harmed including the theater owner for any loss of revenue, refund all the customers their money for the tickets, etc. So I disagree with Justice Holmes on that point. First it's unenforceable so why bother tainting the Constitution with a law that absolutely abridges the freedom of speech, (it's like I'd say to Justice Holmes: "What part of 'no law' did you not understand?).... and second, there's a way to handle it without trashing the 1st amendment. OWH should have known better, but he was another one of those 'relativists' on the court. (and as previously stated he recanted later)


"But those who quote Holmes might want to actually read the case where the phrase originated before using it as their main defense. If they did, they'd realize it was never binding law, and the underlying case, U.S. v. Schenck, is not only one of the most odious free speech decisions in the Court's history, but was overturned over 40 years ago."
It's Time to Stop Using the 'Fire in a Crowded Theater' Quote
 
  • Like
Reactions: LaraC

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
You didn't answer the question. Do you think Free Speech is absolute?

Yes I did. Here:
"I'm also saying that the 1st Amendment says that Congress shall pass NO law abridging freedom of speech or press. I happen to agree with the Constitution and Madison and the reason behind that as written in Cato's Letters by Trenchard and Gordon - where the Founders got it."

You can translate that as 'Yes'. Do I know that it isn't present law - Yes. Do I know that it isn't a 'popular idea' - Yes. Do I care about either of those - No.

And you asked two questions - I answered both.
 
Last edited:

retired1

Administrator
Admin
Supporting Member
ECF Veteran
Verified Member
Apr 5, 2013
51,303
46,108
Texas
Yes I did. Here:
"I'm also saying that the 1st Amendment says that Congress shall pass NO law abridging freedom of speech or press. I happen to agree with the Constitution and Madison and the reason behind that as written in Cato's Letters by Trenchard and Gordon - where the Founders got it."

You can translate that as 'Yes'. Do I know that it isn't present law - Yes. Do I know that it isn't a 'popular idea' - Yes. Do I care about either of those - No.

And you asked two questions - I answered both.

So you disagree with any law that allows an individual legal recourse for speech that would be considered maliciously slanderous?
 

bigdancehawk

Ultra Member
ECF Veteran
Verified Member
Jan 27, 2010
1,462
5,477
Kansas City, Missouri
So you disagree with any law that allows an individual legal recourse for speech that would be considered maliciously slanderous?
Whether he agrees with it or not, there has never been any legal authority for the proposition that defamatory speech enjoys unqualified First Amendment protection.
 

Kent C

ECF Guru
ECF Veteran
Verified Member
Jun 12, 2009
26,547
60,051
NW Ohio US
So you disagree with any law that allows an individual legal recourse for speech that would be considered maliciously slanderous?

Again, going back to the Constitution - "Congress shall pass NO law..." I don't know how much clearer I can make that. So IF Congress has passed A law abridging speech/press, then that law is Unconstitutional.

There are arguments that support libel and slander, but this would go so off topic to be done here. It goes to the basic natural rights of life, liberty and property. I recommend anyone interested to read 'Defending the Undefendable' by Walter Block.

Basically, the 1st Amendment isn't the right to just good speech, if so there would be no need for the 1st Amendment - so it also protects speech that isn't so good. Since a person's 'reputation' is not something he "owns" - since his reputation is dependent on the thoughts of others, of which he has no control, then his reputation cannot be 'stolen' from him (as in a right to property), since he doesn't own it in the first place.

Another problem with laws against speech or press is that they give the false belief that anything spoken and written then must be true. Without those laws, it would be less likely that those assumptions would be made. More fact checking would fill in the gaps.

And again (cut and paste):
Do I know that it isn't present law - Yes. Do I know that it isn't a 'popular idea' - Yes. Do I care about either of those - No.
 
Status
Not open for further replies.

Users who are viewing this thread