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Draft
Substantiate an ad claim before it runs
Maps every message a consumer takes from your copy (implied ones first) against the evidence you actually hold, and returns an approve, modify, hold, or decline call with replacement wording.
Your prompt
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Before you run it
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What comes back
See an example of what you’ll get
MEMORANDUM - PRIVILEGED · To: Marketing and Compliance · Re: "Clinically proven to reduce stress 47% faster than the leading brand" · April 27, 2026
Executive summary. Hold pending substantiation. The headline carries an establishment claim and a comparative superiority claim, and the file supports neither: the 47% figure comes from a single-arm study measuring participants against their own baseline, and the only comparator data tests Brand A's 2018 formulation on 42 people. A within-product version of the claim can run this week with the modifications in Section 11. The comparative cannot run until a head-to-head study exists.
Messages consumers take.
1. *(implied)* The 2025 study compared this product to the leading brand head-to-head. Comparative, establishment
2. *(implied)* A typical user gets a 47% improvement. Quantified, monadic
3. *(implied)* "The leading brand" is a specific identifiable product, and in this category that reads as Brand A. Comparative
4. *(express)* Clinically proven. Establishment, health-related
5. *(express)* Reduces stress. Monadic, structure-function
Evidence map (selected).
| # | Standard | Evidence relied on | Adequate | Gap |
|---|---|---|---|---|
| 1 | Head-to-head testing of current versions | None. The 2025 study has no comparator arm | No | The subhead attributes a comparison to a study that made none; this is the finding, not a technicality |
| 2 | Typical-results substantiation | Mean only; no distribution supplied | No | Need median and range; a 47% mean with an unreported spread invites the "up to" problem |
| 4 | Competent and reliable scientific evidence | n=240, single arm, PSS-10 self-report | Partial | Uncontrolled self-report will not carry "proven"; "studied" is defensible |
Comparative checks (message 1 and 3). Head-to-head: no. Comparator currency: no; the n=42 crossover tested a 2018 formulation against a 2026 ad. Endpoint match: partial; PSS-10 measures perceived stress, not speed of onset, and the copy promises "faster."
Disclosure versus copy. The existing "*Results may vary" footnote does not cure any of this. A disclosure cannot convert a comparison the study never made into a true statement. Messages 1 and 3 require copy change. Message 2 is curable by disclosure adjacent to the claim, not in the footer.
11. Replacement copy. Headline: "Clinically studied to reduce stress." Body: "In an 8-week study, 240 participants reported an average 47% reduction in perceived stress compared with their own starting scores. Individual results varied." Adjacent disclosure, same type size family: "Based on an 8-week single-arm study of 240 users measuring self-reported stress. Not a comparison to other products." Plus the DSHEA structure-function disclaimer.
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Assumptions I made. "The leading brand" reads as Brand A to consumers in this category [verify - a message survey would settle it and would also settle message 1]. The 2025 study's primary endpoint was PSS-10 change from baseline [verify against the protocol]. The footnote renders below the fold on the hero [verify with the live page].
Where this is weakest. Message 3. I have treated "the leading brand" as identifying Brand A, which drives the standing analysis. If the category has no clear leader, the claim is still unsupported but the competitor risk drops sharply and the disposition could soften.
What only you can decide. Run a narrowed within-product claim now and commission head-to-head testing for a Q4 relaunch: that costs the study budget and roughly five months but produces a claim that survives a challenge. Or hold the whole hero and keep the current creative dark until testing completes, which protects the record and costs you the launch window. Separately: whether the conversion lift from "proven" is worth being the company that used the word on uncontrolled self-report data, and whether to pull the placements already live or let the flight expire.
What would make this materially better. (1) The study protocol and statistical analysis plan. (2) The distribution behind the 47% mean. (3) The date of Brand A's current formulation. (4) A consumer message survey on "the leading brand": it decides messages 1 and 3 together.
Why this prompt is built the way it is
## Framework
1. **Implied messages first.** The express claim is rarely the one that draws the challenge. Where copy is ambiguous, both readings are live and the regulator takes the worse one.
2. **Tag before you evaluate.** Establishment or not, comparative or monadic, quantified or qualitative, health-related or not. The tags select the standard.
3. **Match evidence to the level of the claim.** Single-arm baseline data does not support a comparative superiority claim. Say that plainly rather than calling it insufficient.
4. **Comparatives need three checks.** Head-to-head design, current comparator version, and an endpoint that matches what the copy promises.
5. **Disclosure versus copy.** A footnote asterisk does not cure a false headline. When disclosure works, specify placement, proximity, trigger, and wording.
6. **One disposition.** Approve, approve with modifications, hold pending substantiation, or decline, with the replacement copy attached.
7. **Name the parallel forums.** FTC is not the only risk. The competitor with standing and the self-regulatory body move faster.