[Update: Check out the comment section. It turns out my suspicions were justified. Several people cited hearing aids as another example.]
I recently saw an ad on the internet that caught my eye. The product was a sleep aid, described as a treatment for snoring that allows for a more restful sleep:
This got my attention for several reasons. First, the detailed description in the ad sounds almost identical to a product that I own. It physically moves your lower jaw forward when you sleep, making it easier to breathe However, my device is aimed at addressing sleep apnea, whereas this ad doesn’t even mention any benefit in reducing sleep apnea. Second, my device costs thousands of dollars, whereas this item is priced at $65.
[Disclaimer: I know nothing about the effectiveness of this device, and thus don’t take this post as a recommendation.]
Here’s a question for people that know more about this than I do. Is it possible that this company is not allowed to advertise the device as treatment for sleep apnea? The first amendment guarantees freedom of speech, but for reasons that I’ve never understood the courts exempt commercial speech from that protection.
READER COMMENTS
Fazal Majid
Aug 20 2021 at 7:11pm
Because lying is protected by the First Amendment and extending that to commercial speech would be an invitation to chaos.
Scott Sumner
Aug 21 2021 at 1:19am
It’s not just lying. Companies are not allowed to say truthful things without government permission.
BC
Aug 21 2021 at 7:50am
Ironically, right now many people seem to think that non-commercial speech can cause chaos or other harms, e.g., “misinformation” or “hate speech”. I’m not sure that countering “bad” speech with “good” speech works any more or less well with commercial speech than non-commercial speech.
Regardless, if one accepts the idea that free speech should not include speech that might cause harm, then it seems like no speech would be protected. After all, both pro-lifers and pro-choicers could probably explain why pro-abortion and anti-abortion speech, respectively, might cause harm. Economically illiterate “misinformation” abounds on social media that could potentially lead to harmful economic policies. Then, all that would be left would be to apply the principle selectively since, of course, not all speech would actually be censored.
MarkW
Aug 21 2021 at 7:32pm
Because lying is protected by the First Amendment and extending that to commercial speech would be an invitation to chaos.
Why couldn’t commercial misrepresentation be dealt with by a combination of Consumers Reports ratings, online reviews, and class-action lawsuits? Consider this particular case. The product is inexpensive. It’s not dangerous, and the consumer is able to judge for themselves whether or not using the device leaves them feeling more rested. The downside to banning speech about use for sleep apnea is that many people won’t spend the thousands of dollars needed to get the prescription version and won’t get the relief they might have had for a mere 65 bucks.
Christophe Biocca
Aug 20 2021 at 8:03pm
The FDA regulates medical devices for the treatment of sleep apnea, so it’s likely the device in question does not have approval as a treatment for sleep apnea (it might have separate approval for treating snoring, not sure since they didn’t publish an approval number).
Though I find the “thousands of dollars” price tag surprising if you got it less than 2 decades ago. There seems to be a ton of devices that have approval, so I don’t think it’s due to one player having a monopoly on the sale of approved devices.
Mark Brophy
Aug 22 2021 at 1:23pm
The FDA mostly regulates speech in defiance of the Constitution.
Philo
Aug 23 2021 at 2:55pm
The Constitution that is actually in effect is determined by the Supreme Court, which–however many “originalists” it includes–gives us a “living Constitution.” (I am not complaining: maybe that’s a good thing.)
michael thomas
Aug 20 2021 at 8:09pm
The answer is “yes”.
Certification of a regulated medical device is extremely costly and burdensome, and creates a huge barrier to entry for competitors. But there may be nothing “special” about the device itself, other than the fact that it has gone through the FDA’s certification.
The hearing aid industry is a good example: hearing aids cost thousands of dollars and are only distributed through “audiologists”. It’s an enormous cabal protected by the FDA’s regulations that you can’t offer devices that treat or diagnose medical conditions without undergoing FDA certification.
The devices themselves cost, let’s say, in the low hundreds for the most-sophisticated models. So the manufacturers charge an enormous premium for being able to get to the other side of the FDA process (and similar regulatory regimes worldwide).
For years, there have been assistive hearing devices on the market that were essentially hearing aids, but couldn’t be marketed as treating a medical condition because of FDA regulations.
Just recently, the FDA created a category of over-the-counter hearing aids, to open up the market a little bit.
That’s just an example, i’m sure there are others. But it’s notable because of the ridiculous premiums the manufactuers charge, and the very low risk that you would harm someone with the device. (sure, some hearing aids for very profound hearing loss could damage a person with normal hearing’s ears, but mostly these are just tiny headphones.)
Rajat
Aug 20 2021 at 10:05pm
Most western countries have consumer protection legislation that proscribes misleading and deceptive conduct. The US has section 5 of the Federal Trade Commission Act: https://www.ftc.gov/about-ftc/what-we-do/enforcement-authority
See also the FTC’s policy statement on deception: https://www.ftc.gov/system/files/documents/public_statements/410531/831014deceptionstmt.pdf
That’s not to to say it would be misleading for this product to be advertised as a sleep apnea treatment, but that perhaps the supplier doesn’t want to take the risk.
Scott Sumner
Aug 21 2021 at 1:33am
The weird thing is that the ad says the device is “FDA-cleared”. I wonder what that means.
Alan Goldhammer
Aug 21 2021 at 7:38am
It is a provision under the medical device law & regulation; the 510(k) provision that allows for clearance of similar devices without a full regulatory submission. Lots of devices fall into this category. Here is a simplified explanation: https://www.greenlight.guru/blog/fda-clearance-approval-granted
FDA has a similar approach to generic drugs that can be approved based on comparability and not requiring a full new drug application.
BC
Aug 21 2021 at 8:05am
“my device costs thousands of dollars, whereas this item is priced at $65”
I think there is a similar phenomenon with hearing aids vs. hearing amplifiers. The former are classified as FDA-regulated medical devices, custom tuned and fit by a professional, and often are much more expensive than the latter, which are classified as consumer devices.
Phil H
Aug 21 2021 at 10:31am
“for reasons that I’ve never understood the courts exempt commercial speech from that protection”
I’m not sure they do. It’s just tort. The advertising claims become part of your implicit contract, so making unsupported medical claims in advertisements opens you up to liability.
Scott Sumner
Aug 21 2021 at 1:14pm
That’s not correct. Regulators restrict what companies are allowed to say. It’s not just tort law, and it’s not just false information. Companies are routinely banned from saying truthful things.
Phil H
Aug 21 2021 at 1:56pm
While I’m sure that happens – obviously in the case of medical products – I still think it’s essentially an epiphenomenon. The rule is: you can’t say your product has medical effect X unless it really does. The instantiation of that rule is: you have to prove to the FDA that your product has effect X (and all the craziness that ensues around FDA certification). I still think this whole system, complex and messed up though it is, arises out of one simple and sensible rule. And the reason I don’t see much benefit in changing it is that whatever simple and sensible rule you start from, you’re always going to get these rampant complications. Because medical products are complicated, not because of how good or bad the FDA is.
Scott Sumner
Aug 22 2021 at 11:51am
I see great benefits in deregulating commercial speech, including lower prices for consumers.
Lizard Man
Aug 22 2021 at 1:21am
This seems to me to be a lot like environmental regulation, in which having a regulatory agency is the least bad option because litigating under normal civil law would either lead to endless lawsuits because it is too difficult to defend against claims of fraud, or it would be too difficult to prove an instance of fraud and hence functionally consumers would have no protection against fraud.
Eric
Aug 21 2021 at 3:58pm
Insurance companies are not allowed to advertise the existence of state guarantee funds in many states.
https://www.nolhga.com/factsandfigures/main.cfm/location/lawdetail/docid/18
I’m apparently allowed to say it since I don’t sell insurance.
I’ve never understood how this doesn’t violate the first amendment.
Scott Sumner
Aug 22 2021 at 11:53am
Good example. Many industries have similar examples.
Michael Rulle
Aug 23 2021 at 11:03am
As Michael Thomas stated, I assume it is illegal to promote a product for a disease/condition that the FDA says falls under its regulatory jurisdiction and they have not approved it. Also, words like FDA “cleared” are strange enough I assume it does not mean what I want it to mean. We have seen these kinds of adds forever. Would I try it for snoring? For $65 I probably would before I paid 4000—but I would view it as a cheap option—-almost like a lotto ticket (which is not cheap)—-and would expect it to fail!.
Like most people, I assume these kinds of products (pretend they do say it cures sleep apnea—-or snoring for that matter) I immediately do not believe it. But, if the product interests me I will try and find an objective website (for example CNET) which adds value (even if I cannot tell the if Google Pixel is better than iPhone after reading it!)
The clearest sign something is likely made up is if one can only find ratings by entities which seem only linked to the particular type of product advertised. Amazon is no longer trustworthy——although if you hunt you can often find what seems to be objective ratings.
At what extreme should free speech be outlawed? “this chewing gum made from sweet extracts from Paraguayan cacti cures cancer of the lung in 93% of all cases”. One years worth for $200.
There will always be people who will believe it. Can you sue the media outlet who advertised it? No. The Company? Yes—but it won’t exist. In a way we already permit this. “Anti-oxidants”—-Broccoli, Organic foods etc. But these are written by health magazines——selling hope by the page. Everything sold in a health food store has in small print (“not approved by FDA”) or something to that effect.
That is why I lean toward open ended free speech——there is enough info out there.
Capt. J Parker
Aug 23 2021 at 1:33pm
I’ve worked in the medical device industry for many years and I am familiar with FDA regulatory processes.
The device pictured is indeed an FDA regulated medical device. The company was allowed to sell the device in interstate commerce via the 510K regulatory process. You can see the 510K authorization here. The 510K process is a process by which FDA determines if the manufacturer’s device is substantially equivalent to a device that was already on the market prior 1976 when FDA was first given legal authority to regulate medical devices by Congress, or substantially equivalent to a device that has been found by FDA to present a low enough risk that the more rigorous PMA (Pre-Market Approval) process is not required. Since FDA is not, according to law, making a determination of how well a specific 510K device actually functions, FDA tells manufactures that they are not permitted to claim their 510K device is “approved” by FDA, hence the term “FDA Cleared.”
Now, as for the question of “sleep aid” vs sleep apnea: A key part of the FDA approval process is FDA’s review of the device’s labeling. FDA can reject statements in the labeling that it believes are not supported by data presented to FDA during the approval process. Once the labeling has been finalized and the product “cleared” for interstate commerce, manufacturers and their agents are prohibited by FDA from making claims about the product that are not backed up by statements in the labeling. Why the VitalSleep people only went after a “sleep-aid” claim and not a sleep apnea claim, I can’t say. The LRK classification product code shown on the 510k allows for both types of claims. My guess would be that to get a sleep apnea claim would have required data that the manufacturer didn’t have and didn’t want to bother getting or couldn’t get even if the wanted to.
How FDA’s regulation of speech squares with the first amendment is an interesting and still evolving legal question. One issue that FDA had been very strict about is anything that hinted at manufacturer’s attempts to commercialize an off-label use of a device or a drug. Off-label uses happen all the time. They are perfectly legal because FDA does not have legal authority regulate the practice of medicine. What FDA believes that it can do is to prohibit manufacturers from saying anything about their products that isn’t strictly in the labeling that was part of the approval process. If some third party wrote medical a paper that said a drug that was cleared by FDA for treating enlarged prostates was also great at preventing male pattern baldness, the drug manufacturer was prohibited by FDA from distributing copies of that paper or even telling people that the paper existed and where to find it. The court case US v. Caronia changed the landscape some by ruling that government could not impose legal sanctions for speech that was truthful and not misleading.
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