Rule explainer Not legal advice

What you have to be able to prove about a health claim

Read this before you write that a treatment works. It is the federal rulebook deciding whether a sentence on your site is a claim you must be able to back, what counts as backing, and what changed in 2024 for the reviews at the foot of the page.

The rulesFTC Act Sections 5 and 12, at 15 U.S.C. 45 and 52. The Endorsement Guides, 16 CFR Part 255. The Consumer Reviews and Testimonials Rule, 16 CFR Part 465. Alongside them the FTC's Health Products Compliance Guidance, December 2022. Sources 1 to 7, at the foot of this page.

How the rulebook changed

1938 to 1994The statute takes its shapeSection 12 arrives in 1938 and makes false advertising of food, drugs and devices unlawful. In 1994 Congress adds one word, services, and a practice selling only its own time is inside it.
July 26, 2023The Endorsement Guides are rewrittenThe version in force, pulling reviews, social posts and anything a reader takes to be somebody else's opinion into the FTC's reading of Section 5.
October 21, 2024Reviews stop being guidanceThe Consumer Reviews and Testimonials Rule takes effect. Guides describe how the FTC reads the statute; a rule is a rule, and breaking one carries its own penalty.

Scope

Does it reach you?

Almost every practice owner assumes the FTC is for supplement sellers. Four situations, and three of them are you.

ApplicabilitySection 5 empowers the Commission to act against “persons, partnerships, or corporations”, then names its exceptions: banks, credit unions, common carriers, air carriers, packers. Clinicians are not among them. Source 1.

Your website describes what you treat

The FTC reaches you

Section 12 makes it unlawful to put out a false advertisement to induce the purchase of “food, drugs, devices, services, or cosmetics”. A page describing a procedure and inviting somebody to book is an advertisement for a service. Read on.

You also sell something at the front desk

Two claims to prove, not one

A supplement, a device, a take-home kit. You are advertising a product as well as a service, and the FTC's health guidance is written for exactly that. Coming from a clinician raises what a reader takes the claim to mean, and so what you must hold.

A chart note, a referral letter, the conversation in the room

Not advertising

The statute reaches communications made to induce a purchase. Your record of a visit, your letter to a colleague and what you tell the person in front of you are none of those. What you owe there is your standard of care.

A non-profit clinic or a hospital foundation

Worth asking your counsel

The Act limits the corporations the Commission reaches to bodies “organized to carry on business for its own profit or that of its members”, and a genuine non-profit may fall outside it. Either way, your state's deception law and your board's rule do not move.

When the question is privacy instead →

What counts

There is no list of formats

The FTC's health guidance says advertising covers not only television, radio, print and internet ads but “promotional materials such as brochures or booklets”, social media, “press releases, press interviews, or other media appearances”, and claims carried “indirectly through healthcare practitioners or other intermediaries”. If it exists to bring somebody in, it counts.

Second, the unit of judgement is the page, not the sentence. The FTC assesses the net impression left by all of it: headline, photographs, credentials, and what is missing. A page whose every sentence is true can still make a claim nobody wrote.

Reading noteThe formats list and the net impression test are the guidance's. The statute reaches “representations made or suggested by statement, word, design, device, sound”. Sources 3 and 7.

Does this need proof?

Worked examples

Worked from the statute and the FTC's own guidance. Where a real page lands is a judgement about your facts.

The core of it

Seven lines decide almost everything

Four documents sit behind this page, and between them seven sentences do the work. Left, the text as written. Right, what each means when the advertisement is your own site.

Reading noteThe middle column is verbatim, and where a passage is shortened the cut is marked. The citation in the left margin is where to find it. Sources 1 to 6.

The Act and the rules, as written

Point at either side to link them

Verbatim

In plain English

§45(a)(1)Unfair methods of competition in or affecting commerce, and unfair or deceptive acts or practices in or affecting commerce, are hereby declared unlawful.

§52(a)

It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement … for the purpose of inducing, or which is likely to induce, directly or indirectly the purchase of food, drugs, devices, services, or cosmetics

In plain EnglishThe sentence putting a practice inside this rulebook. You need not sell a product: services are named, and were added deliberately in 1994.

§55(a)(1)

an advertisement, other than labeling, which is misleading in a material respect

In plain EnglishThe entire definition, turning on two words. Not false, misleading. Not about anything, material: something that would change what a reasonable person thinks or does.

§55(a)(1)

the extent to which the advertisement fails to reveal facts material in the light of such representations

In plain EnglishOmission counts, in the same sentence as everything else. What a page leaves out is weighed against what it says, which is how a page of true sentences becomes false advertising.

255.1(a)

Endorsements must reflect the honest opinions, findings, beliefs, or experience of the endorser.

In plain EnglishThe floor under every testimonial on your site. Somebody else's words, meant, not tidied until they say what the person did not.

255.2(a)

the advertiser must possess and rely upon adequate substantiation, including, when appropriate, competent and reliable scientific evidence … Consumer endorsements themselves are not competent and reliable scientific evidence.

In plain EnglishThe one that surprises people. A patient's account is not evidence the treatment works. Publishing it puts you behind the claim, so you need what you would have needed to say it.

255.5(a)

When there exists a connection between the endorser and the seller of the advertised product that might materially affect the weight or credibility of the endorsement, and that connection is not reasonably expected by the audience, such connection must be disclosed clearly and conspicuously.

In plain EnglishPayment is one kind of connection. A family tie, a free treatment, a discount, a job at the practice. If knowing would change how a reader weighs the words, it goes where they see it.

465.2(a)

It is an unfair or deceptive act or practice and a violation of this part for a business to write, create, or sell a consumer review, consumer testimonial, or celebrity testimonial that materially misrepresents … That the reviewer or testimonialist used or otherwise had experience with the product, service, or business

In plain EnglishThe newest and sharpest, because it is a rule rather than an interpretation. Breaking one carries a civil penalty for each violation, with no warning required first.

In the margin, § is the FTC Act at 15 U.S.C.; the numbered citations are 16 CFR. Quoted text is the statute's or the regulation's own; the right hand column is our plain English rendering. Sources 1 to 6.

Vocabulary

Four words that carry the weight

The seven lines reuse the same terms, and most disagreements about a draft are about one of them.

Material

Would it change what a reasonable person thinks or does? Judged from the reader's side, which is why “we never meant that” is not an answer.

Substantiation

Evidence you hold before the claim goes out, about the claim you actually made, strong enough that the field would accept it. Nothing is filed, nothing approved.

Net impression

What the page conveys as a whole, photographs and layout included. The unit of judgement, and why a true sentence is not on its own a defence.

Clear and conspicuous

Defined in the Guides as difficult to miss and easily understandable by ordinary consumers, and on a web page, unavoidable.

The part almost nobody explains

“Competent and reliable scientific evidence”

Five words that stop some practices publishing at all, usually because they are read as an instruction to run a study.

The standardThe Commission's definition of the phrase, and the expectation of randomised, controlled human testing, are both in the Health Products Compliance Guidance. Source 7.

What people think it says

We would have to run our own trial before we could write that.

Nobody expects a four-clinician practice to run a trial. The evidence can be somebody else's and nearly always is. What cannot be somebody else's is the holding of it: it has to exist, it has to be about the claim you made rather than a neighbouring one, and somebody has to have read it first.

What it actually says

Tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by experts … and are generally accepted in the profession to yield accurate and reliable results.

The Commission's words, middle shortened. It adds that the research must be sufficient in quality and quantity against the whole body of relevant evidence, and that a health benefit claim will generally need randomised, controlled human testing.

The bar moves with the claim, not the page. “We offer this procedure” is checkable on its face. “This procedure relieves the condition” is a claim about what happens to patients. “Nine in ten of ours improve” is harder again, because the guidance says you must have at least the level of support you claim, and a number claims a study.

A disclaimer does not rescue a claim. The guidance is blunt: “Results not typical” does not cure the deception an unusual result creates, and a note at the foot of the page is not prominent enough to qualify it. What works is saying what a typical patient can expect, beside the claim and in the same size.

What changed in 2024

Your reviews are covered by a rule now, not a guide

Testimonials were always inside Section 5. Since October 2024 a separate rule governs how reviews are written, bought, solicited and suppressed, and the difference is not academic: breaking a rule carries a civil penalty for each violation, where deception alone does not until the Commission has already told you to stop.

PenaltiesThe Act sets a civil penalty of “not more than $10,000 for each violation” of a rule, adjusted for inflation each year and so higher now. For deception alone, penalties follow a final cease and desist order. Sources 1 and 6.

What the reviews rule reaches, and the one thing it deliberately leaves alone

Writing, creating or selling a reviewProhibited where it misrepresents that the reviewer exists, had the experience, or what it was

Paying for a particular sentimentProhibited: compensation in exchange for a review expressing a sentiment, positive or negative

An owner or a manager writing oneOnly with a clear and conspicuous disclosure of the relationship

Asking staff, or their families, for oneProhibited where it arrives without that disclosure and you never asked for one

Showing only the good onesProhibited where the page suggests it carries most or all of those submitted

Threatening someone over a reviewProhibited, and an unfounded legal threat is named beside a physical one

A real patient's real reviewUntouched. Publish it, reply to it, leave it up

Asking is fine; manufacturing is not. The rule says a generalised request to people who actually used the service sits outside the parts that would otherwise catch you, so inviting patients to review you is not the risk. The risk is a review that was never genuine, one bought for its sentiment, or a bad one made to disappear. And a testimonial is still a claim: a five-star review saying the pain went away asserts the treatment took the pain away, and the Guides put the practice behind that.

Replying is a different rulebook. Nothing here stops you answering a genuine review. What governs the wording of a reply is privacy: confirming in public that the person was your patient is the problem, not the reply. The privacy side →

Records

There is no five year clock here, which is the harder version

Some regulators tell you how long to keep a copy of an advertisement. The FTC sets no such period for a practice's website, which reads as relief until you follow it through: the obligation is to hold the support while the claim is up, so a page nobody has opened in years is a claim you are making this morning.

TimingWhat the guidance fixes is not how long you keep the file but when you must have it: “Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed”. Source 7.

The retention question on one page

15 U.S.C. 45 and 52

Still on your site Taken down. What matters now is what you can show it said. Still up. Every claim on it is one you are making today.

Start: the day the claim first goes out No fixed end

Once the page is down the claim stops being made and what is left is the record. Whether you can answer for it depends on having kept the page as it stood and the evidence as it stood, not only the current version.

The part practices miss. A page written years ago and never revisited is being put out every day it stays up, so the question is not whether the evidence was good when somebody wrote it. It is whether it is good now.

Neither statute sets a retention period for a practice's own advertising. The absence is not permission. Sources 1, 2 and 7.

What sits behind one sentence: enough that somebody else could check it

The claim, as a reader reads itIncluding the one the page implies and nobody typed

What supports itThe study, guideline or review, named rather than gestured at

Who it was run onAnd whether they resemble your patients

The date on the sourceNot the date you found it

When it gets looked at againThe thing that stops a true claim quietly becoming false, because guidance moves and a page does not

One section about our software, then back to the rules

What Verand checks of this, and what it does not

Everything above holds whether or not you buy anything. This is how much of it software can see in a draft, and the right hand column is longer, which is the reason for printing both.

What it checks

Stops a guaranteed or permanent cure. A draft promising a guaranteed, permanent or complete cure, result or recovery cannot publish, nor can one saying a treatment cures cancer, diabetes, Alzheimer's, autism or arthritis. The one hard stop the medical rules add, and nothing releases it.
Stops six more from the baseline every regulated site carries: guaranteed results, guaranteed returns, cannot lose, get rich quick, risk free, zero risk. The last two release on a written, logged reason from a named person. The rest do not.
Flags the superlatives without stopping them. Best dentist, number one clinic, painless dentistry. Whether one is defensible turns on your state board, so a person settles it. Marking is all it does.
Looks for the medical disclaimer and counts cited sources against a minimum of four. Both mark the draft rather than hold it.

What it does not

It does not hold your evidence. Nothing here knows whether the study you have in mind supports the sentence beside it. Substantiation is a file at your practice.
It does not check how old your support is. Nothing here knows whether what sits behind a claim has been superseded since you read it.
It does not read for patient identity. The privacy scan looks for a Social Security number and a date of birth. Two patterns. Not names, not conditions, not a case somebody local would recognise, and we would rather print that than let you assume otherwise.
It does not touch your reviews, your profile or your endorsers. Whether a review was bought, written by your hygienist or quietly taken down is not visible in a draft, so none of the 2024 rule is checked, and nor is disclosure.
It does not publish. Nothing reaches your site without somebody at your practice approving it, and no setting changes that.

Validated against the FTC's rules. AI-researched and operator-reviewed. Your counsel confirms applicability. Not legal advice. How we label review →

Verand for medical and dental practices Can doctors, dentists and therapists use AI to write blog posts? →

Questions

The ones that come up

About the rules, not our software. Each points at the source it comes from.

Can we publish a patient's testimonial?

Yes, under two conditions that catch most practices out. It has to be the person's honest experience, and you have to hold the evidence for what it asserts, because a testimonial is read as a claim the treatment did what the patient says. If their result beats most, say what most get, beside it.

Is a before and after gallery a claim?

Yes. The statute counts representations made by design and device alongside those made in words, so photographs carry claims as sentences do. And a gallery of your best outcomes represents that those outcomes are what the treatment produces.

We are a non-profit clinic. Does any of this reach us?

Possibly not, and it is worth asking counsel rather than assuming either way. The Act limits the corporations the Commission reaches to bodies organised to carry on business for their own profit or that of their members. What does not move is your state's deception law, or your board's rule.

Can we ask happy patients to leave us a review?

Asking patients generally is fine, and the rule says so: a generalised request to people who used the service sits outside the parts that would otherwise catch you. It turns when you ask your own staff or their relatives, and even then the failure is the missing disclosure rather than the asking. What you cannot do is attach the request to a sentiment, because rewarding a positive review is a violation on its own.

Does it matter that a draft was written with AI?

Not to the FTC. Neither statute asks who typed it. The practice that puts the page up answers for what is on it, exactly as it would had an agency written the words. What changes is where the effort goes: producing the draft stops being the work, checking it becomes it.

Sources

Where every line came from

Primary sources only. Quoted phrases are the statute's or the regulation's own words, shortened where marked. Everything else is our plain English rendering.