HealthPrecheckHealth claim copy vs published FDA/FTC factors for supplement brands and product teamsWriting a supplement or wellness claim? Know what turns a health claim into a regulatory problem before it goes on the label.
Paste your claim. Get a severity-ranked pre-check against the published FDA/FTC framework — the disease boundary, the mandatory 101.93 disclaimer, the substantiation behind any "proven" wording — before a label becomes a warning letter.
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Key Takeaways
- Health claim copy vs published FDA/FTC factors, severity-ranked.
- Actionable fix checklist — never a silent rewrite or auto-publish.
- Honesty: a heuristic pre-check — not a health-claims certification.
Health claim copy first. FDA/FTC factors next.
Decision-support health-claim ranks — not a certification and not a legal audit.
HealthPrecheck — definition
HealthPrecheck pre-checks dietary-supplement and wellness marketing wording against the rules the FDA and FTC set out — the disease-claim boundary and mandatory disclaimer in 21 CFR 101.93, the substantiation standard for objective health claims, and the prohibition on implying FDA approval of a supplement — returning a scored, severity-ranked report with concrete edits before a label, ad or product page goes live.
What this is NOT
- Not a health-claims certification, account connector, or approval guarantee.
- Not an evidence verifier — whether a clinical trial, lab result or registration is real is an advisory checklist item, never looked up.
- Not a substitute for legal review of FDA, FTC or consumer-law obligations.
Controller / Processor — When packs mention privacy roles, we use GDPR Art.4 labels: Controller and Processor (decision-support only).
Label printed. Health claim challenged.
A disease claim by accident
“Cures anxiety”, “prevents diabetes” — naming a disease you treat/cure/prevent turns a supplement into an unapproved drug claim under the FDA/FTC boundary, regardless of any disclaimer. It is the single highest-severity pattern.
Structure/function with no disclaimer
A “supports immune function” statement must carry the mandatory 21 CFR 101.93(c) disclaimer (“not evaluated by the FDA… not intended to diagnose, treat, cure, or prevent any disease”). Without it, even a modest claim is a prohibited one.
“Proven” with nothing named
“Clinically proven” or “studies show” is read as a factual claim requiring competent and reliable scientific evidence on hand before you publish — asserting proof without naming it is a substantiation gap.
Implied FDA approval
“FDA approved” or “FDA certified” on a supplement misrepresents the law — supplements are never pre-approved — and reads as an endorsement that does not exist.
Paste. Scan. Fix.
Severity-ranked findings from your claim against published FDA/FTC factors — including which claim is missing which disclaimer or basis.
Health-claims findings
Disease-claim wording, missing 101.93 disclaimers, unsubstantiated “proven” cues, absolutes and implied approval, each with quoted evidence.
Severity ranks
High / medium / low so you fix the warning-letter-ready gaps first.
Fix checklist
Actionable edits — you still own the final copy.
Copy-ready report
Markdown you can paste into a ticket or label thread.
Everything you need for a health-claims pre-check
Built for supplement and wellness brands shipping label claims every week.
Claim-wording and disclaimer detection
Disease-claim wording, missing 101.93 disclaimers, unsubstantiated “proven” cues, absolutes and implied approval, each with quoted evidence.
Severity-ranked output
High / medium / low so you fix the warning-letter-ready gaps first.
Fix checklist included
Actionable edits — you still own the final copy.
Copy-ready
Markdown you can paste into a ticket or label thread.
From paste to pre-check report in 3 steps
Paste the claim
The exact wording you plan to publish — plus claim kind, surface, and substantiation basis.
Scan
Deterministic engine ranks findings by severity and checks each claim for its required disclaimer and basis.
Review
You edit the copy. HealthPrecheck never rewrites or publishes.
Paste. Scan. Fix.
Severity-ranked findings from your claim against published FDA/FTC factors — including which claim is missing which disclaimer or basis.
A disease claim by accident
“Cures anxiety”, “prevents diabetes” — naming a disease you treat/cure/prevent turns a supplement into an unapproved drug claim under the FDA/FTC boundary, regardless of any disclaimer. It is the single highest-severity pattern.
Health-claims findings — Disease-claim wording, missing 101.93 disclaimers, unsubstantiated “proven” cues, absolutes and implied approval, each with quoted evidence.
FDA/FTC factors · deterministic disclaimer logic · human review
Paste your claim wording with claim kind, surface and basis. Deterministic severity ranks first, each claim checked for the disclaimer and basis its rule expects. Optional AI never invents findings. You review before printing.
Read the methodology →Paste-first health-claim reports — not a compliance suite
| # | HealthPrecheck | Manual FDA/FTC reading / banned-word lists |
|---|---|---|
| 1 | Copy vs health-claim factors in one paste | Hours reading regulation explainers |
| 2 | Severity-ranked fix list with disclaimer logic | Scattered checklist notes or a warning letter |
| 3 | Self-serve from $19/mo | Enterprise compliance suites |
| 4 | Decision-support only | May over-promise approval guarantees |
Methodology before you ship
AI draft · human review · decision-support only.
Read methodology →Open studioTry it on this page
or generate below.
Saved history
Built for supplement brands, product and label teams
Capability cards describe the studio. No fabricated customer counts.
A pasted claim becomes ranked findings against published FDA/FTC factors.
Claim kind, surface and basis tune how aggressively disease-claim and disclaimer risks escalate.
Every finding ships a suggested edit — you still decide.
Simple plans that scale
All paid plans include
- Health-claims pre-check studio
- Severity-ranked export
- Rule-based checks (decision-support)
- Email support on paid plans — no hidden add-ons for core studio use
- Limited AI checks: 3/day · 15/mo (fair use)
- Studio demo (no extra LLM fee)
- AI included: 40 runs/day · 300/mo (fair use)
- No separate ChatGPT subscription required
- Priority support · 2 months free with yearly
Feature comparison
What each plan includes — quotas reflect the enforced fair use limits.
| Dimension | Free | Pro | Enterprise |
|---|---|---|---|
| Usage | |||
| AI runs | 3/day · 15/mo | 40/day · 300/mo | 200/day · 3,000/mo |
| Report export | Watermarked | Clean export | Clean export |
| Audit log | Not included | ✓ Included | ✓ Included |
| Product | |||
| Disease-claim boundary: flags “treats / cures / prevents [disease]”, which turns a supplement into an unapproved drug claim regardless of any disclaimer | ✓ Included | ✓ Included | ✓ Included |
| Missing-disclaimer check: a structure/function statement caught without the mandatory 21 CFR 101.93(c) “not evaluated by the FDA” disclaimer | ✓ Included | ✓ Included | ✓ Included |
| Implied FDA approval: “FDA approved / certified” wording on a supplement (which is never pre-approved) flagged as misrepresentation | ✓ Included | ✓ Included | ✓ Included |
| Substantiation cues: “clinically proven / studies show / doctor recommended” without a named basis, graded against the FTC competent-and-reliable-evidence theme | ✓ Included | ✓ Included | ✓ Included |
| BYOK (your LLM key) | Not included | Not included | ✓ |
| SSO | Not included | Not included | Roadmap |
| Support & compliance | |||
| Support | Community | Priority | Custom SLA |
Already paid? Unlock Pro with your license
Licenses are issued manually after your payment is confirmed: we generate one per paid order and send it to the purchase email, typically within a few hours. Enter it below to activate Pro on this device — no account needed. Nothing yet? Write to lixingliangsy@163.com and reference your order email.
Your questions, answered
What does HealthPrecheck check?
A scored, severity-ranked pre-check of one pasted supplement or wellness claim against the patterns 21 CFR 101.93 and the FTC health-claim framework describe — decision-support drafts, never a legal opinion.
Does a good score mean my health claim is compliant?
No. Lawfulness depends on the real product, its actual evidence, the label rendering and your jurisdiction — whether a "clinically proven" figure or a facility registration is true lives outside what any text checker can see. HealthPrecheck only flags the published factors present in the wording you paste.
Can I cancel anytime?
Yes. Self-serve plans cancel anytime; access continues until period end.
Do I need a credit card to start?
No. Start with email signup or Demo mode in the studio, then upgrade when ready.
Do I need my own ChatGPT / OpenAI subscription?
No for Free/Pro. AI runs are included in your plan (fair use) via our platform key. Enterprise can optionally bring your own OpenAI key (BYOK) — configure it at /settings (key stays server-side only).
What is Fair Use / what if I hit the AI limit?
Free includes 3 AI checks/day and 15/month. Pro includes 40/day and 300/month. At the fair-use limit the studio returns a clear QUOTA_EXCEEDED notice with the reset time — the Rule-based demo keeps working; Enterprise BYOK covers heavier volume.
Is checkout secure?
Payments are processed by Waffo Pancake (merchant of record).
What happens after I pay?
You receive access confirmation; fulfillment is tracked via webhook + order logs.
Quick answers
- Ranked findings per run
- FDA/FTC aware
- Disease-claim and missing-disclaimer gaps flagged
- Copy-ready
- Pricing starts at $0 (Free).
More questions
What inputs?
The claim text (the exact published wording), the claim kind, the surface it appears on, your substantiation basis, and strictness.
Health-claims guarantee?
No. Heuristic pre-check — not a health-claims certification and not legal advice.
What comes back?
Ranked findings with quoted evidence — disease treatment wording, a structure/function claim missing its 101.93 disclaimer, unsubstantiated "proven" cues, absolutes and implied FDA approval — plus a fix checklist; always review.
Demo or live?
Demo is labelled; live wording needs a configured AI key.
Who is it for?
Supplement and wellness brands, product and label teams, and agencies publishing health claims.
Primary sources?
Your pasted claim text and the published 21 CFR 101.93 and FTC health-claim framework.
Does it verify my trial, lab results or registration?
No — deliberately not. It never reads a study, lab report, facility registration or FDA record; whether the underlying evidence holds appears as an advisory checklist item only.
Does it write my claim for me?
No. It judges only the wording you paste and suggests concrete fixes; you still write and publish.
How it compares
| Dimension | Manual | HealthPrecheck |
|---|---|---|
| Speed | Hours reading FDA/FTC explainers | Seconds per claim draft |
| Consistency | Varies by reviewer memory | Same FDA/FTC factors every run |
| Output | Free-form checklist notes | Structured pre-check report |
| Best for | Final sign-off | Pre-flight QA per health claim |
When not to use: Skip it when you need a lawyer’s opinion on FDA/FTC exposure, a real clinical trial or lab test to prove an efficacy figure, confirmation that a facility registration exists, or automated publishing. This only pre-checks the claim wording you paste.
- Where health claims get challenged — The places supplement and wellness wording quietly trips the published FDA/FTC rules.
- Health-claim checks that people do not learn to ignore — What to block on, what to warn on, and what to leave alone.
- What a health-claims pre-check cannot see — The honest boundary between risky wording and a challenged claim.
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