Claims-substantiation review checks every statement a fertility or regenerative clinic makes in an ad, a landing page, or a video script against the evidence that statement legally requires. Each claim is sorted by type, matched to an evidence standard, documented with a source and a date, and either approved, rewritten, or cut before any media spend goes live.
ClinicAds' fertility and IVF operating manual says review has to happen before launch. This post is narrower: it is the checklist behind that rule, organized by claim type rather than by campaign stage, and it covers regenerative and orthobiologic clinics alongside fertility because those two lines carry the heaviest claims exposure in the specialty vertical.
- Claims-substantiation review classifies every statement in an ad, landing page, or script by claim type, then checks it against the evidence standard for that type before the campaign launches.
- The FTC's December 2022 Health Products Compliance Guidance sets the bar for health benefit claims at competent and reliable scientific evidence, which generally means randomized controlled trials.
- A fertility success-rate claim passes only when it matches the clinic's own reported CDC or SART data, names its denominator and age band, and states the reporting year.
- Regenerative claims fail review most often: the FDA states that the only approved stem cell products are cord-blood blood-forming cells, and Google Ads has prohibited ads for most stem cell therapy since 2019.
What does claims-substantiation review actually check?
Claims-substantiation review checks three things for every statement in a clinic's advertising: what the statement claims, explicitly or by implication, what evidence that kind of claim requires, and whether the clinic holds that evidence on file today. A claim the clinic cannot document is rewritten or removed. Review happens before launch because paid media multiplies the reach of every claim it carries.
The review covers more surface than most clinics expect. Headlines and body copy are obvious. Image choices, testimonial videos, physician bios, financing pages, and the FAQ section of the website all make claims too, and a regulator reads the net impression of the whole page rather than the literal text of one sentence.
- 1. Inventory every live asset: ads, landing pages, site pages, scripts, email sequences
- 2. Extract each claim, including implied claims carried by images and testimonials
- 3. Classify each claim by type (outcome, efficacy, comparative, safety, price, credential)
- 4. Match the claim to its evidence standard and attach the source with a date
- 5. Mark each claim approved, rewrite required, or remove, and log who signed off
- 6. Hold launch until every claim in the campaign is approved
What evidence does each type of claim need?
Each claim type carries its own evidence standard, and the standard rises with the stakes of the claim. A price claim needs a current fee schedule. A health benefit or efficacy claim needs competent and reliable scientific evidence, which the FTC's December 2022 Health Products Compliance Guidance says generally means randomized controlled trials on the treatment as actually offered.
The table below is the classification ClinicAds uses on specialty accounts. The failure column lists the pattern found most often in inherited accounts, not a complete list of what can go wrong.
| Claim type | Example | Evidence required | Most common failure |
|---|---|---|---|
| Outcome rate | 62% live birth rate | Clinic's own reported data, denominator, age band, year | Most flattering denominator with no age band |
| Efficacy | Reduces knee pain | Competent and reliable scientific evidence, generally RCTs | Citing studies on a different product or protocol |
| Comparative | Highest success rates in the region | Same data source, same year, same denominator for every clinic compared | Comparing own best year to competitors' published average |
| Safety | No downtime, no risk | Documented adverse-event profile; absolute safety claims cannot pass | Absolute language with no qualifier |
| Price and financing | IVF from $9,900 | Current fee schedule showing what the price includes | Base price that excludes medication and monitoring |
| Credential | Board-certified, accredited lab | Registry or accrediting-body record matching the exact wording | Lapsed or mismatched certification wording |
How are fertility success-rate claims checked?
A fertility success-rate claim is checked by matching it to the clinic's own reported data. The Fertility Clinic Success Rate and Certification Act of 1992 requires U.S. assisted reproduction clinics to report outcomes to the CDC, and SART publishes member clinic data as well, so a reviewer can verify the number, its denominator, its patient age band, and its reporting year line by line.
Three checks catch most problems. The rate must use a named denominator, such as per intended egg retrieval or per transfer, because a per-transfer rate for the same clinic and year is typically well above its per-retrieval rate. The age band must be stated, since outcomes for patients under 35 and over 40 differ sharply. The year must be stated, because CDC data publishes with a lag of more than a year and a stale figure presented as current is misleading.
Comparative claims face a stricter check. A clinic claiming the highest rates in its metro must compare against the same data source, year, and denominator for every competitor, and SART member clinics also agree to the society's advertising standards on how outcome data is presented.
Why do regenerative claims fail review most often?
Regenerative claims fail review most often because the evidence standard is high and the published evidence for most cash-pay regenerative treatments is thin. The FDA states that the only stem cell products it has approved are blood-forming cells derived from umbilical cord blood, so an ad implying that a stem cell, exosome, or orthobiologic injection is an approved treatment for joint, spine, or neurological conditions cannot be substantiated.
Platform policy closes the remaining room. Google Ads has prohibited advertising for unproven or experimental medical techniques, including most stem cell therapy, since 2019. That means a regenerative clinic often loses search entirely for its headline service and has to build demand through education, physician authority, and organic and AI search content that describes evidence honestly.
The phrases that fail most are predictable: regrow cartilage, avoid surgery, cure, reverse, and any claim that a treatment works for a named disease. What usually passes is process language, such as what the procedure involves, who performs it, what the published research does and does not show, and what it costs.
What do testimonials and images add to the review?
Testimonials and images add implied claims, and implied claims are reviewed to the same standard as written ones. Under the FTC's Endorsement Guides, revised in 2023, a patient story that conveys a result is treated as a claim that the result is typical, unless the clinic clearly discloses what patients generally achieve and holds evidence for that disclosure.
Images carry the same weight. A newborn photo beside an IVF offer implies an outcome. An athlete mid-sprint beside a joint injection implies a return to sport. ClinicAds reviews every creative frame for the claim it makes without words, and approved fertility and regenerative creative tends to show the physician, the facility, and the process instead.
How long does review take, and who signs off?
A first claims review of an existing fertility or regenerative account takes 5 to 10 business days across the ClinicAds specialty accounts, and each new asset after that takes 1 to 2 business days. The clinic's medical director signs off on clinical accuracy, and the clinic's own healthcare counsel reviews comparative and efficacy claims. These are agency averages, not guarantees.
That time is part of the budget, not a delay to it. Specialty accounts at ClinicAds run $4,000 to $15,000 per month and target a qualified consult cost of $200 to $600 across a 30 to 180 day window, and a disapproved ad account or a regulator inquiry costs more than any week saved by skipping review. The file is re-run whenever new CDC or SART data is published and whenever a treatment line is added.
Is passing ad platform review the same as passing claims review?
No. Meta and Google check ads against their own policies, such as personal health attribute rules and restricted treatment lists, and an approved ad can still make a claim the clinic cannot substantiate. Platform approval is one gate and substantiation is another, and the FTC does not accept platform approval as evidence.
Does claims review apply to the clinic website, or only to ads?
Both. Every ad sends traffic to a landing page or site page, and the claims on that page are part of the net impression the patient receives. ClinicAds reviews the destination pages before the ads that point to them, because fixing the ad and leaving the page unchanged leaves the exposure in place.
Can a regenerative clinic cite published studies in its ads?
Only when the study tested the same treatment, preparation, and indication the clinic actually offers, and when the ad describes the result accurately, including limitations. Citing a study on a different cell source or a different condition is one of the most common substantiation failures in regenerative accounts.
Who is liable if an agency writes a claim that fails substantiation?
The FTC can act against both the advertiser and the agency that created the claim, so neither party is insulated. That is why ClinicAds requires a documented sign-off from the clinic's medical director on every clinical claim before launch rather than relying on its own copy review alone.
Does this checklist apply to dermatology, vein, and vision clinics?
The method applies and the risk level differs. Dermatology device claims, vein outcome claims, and LASIK pricing claims all go through the same classification, but they rarely reach the efficacy-evidence problem that dominates regenerative care or the denominator problem that dominates fertility.