Claim Pre-check Checklist
Version 1.0 · Effective November 10, 2026
1. Purpose and outcome
An expert's signature does not make a claim lawful or true. Every claim is therefore checked by Legal before any expert sees it. The brand company remains solely responsible for its claims; this pre-check is a gate, not a guarantee.
Each claim receives one of three results:
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CLEARED: may be listed as written.
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CLEARED WITH EDITS: may be listed only in the edited wording recorded on the form.
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NOT CLEARED: may not be listed. The reason is recorded, and the brand may resubmit with new wording or evidence.
2. What the brand must submit with each claim
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Exact claim wording, and every place it will be used (label, site, ads, advertorial, email, social).
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Product classification (dietary supplement, conventional food, cosmetic, OTC drug, device) and the full label, including ingredients and doses per serving.
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Evidence pack: full text of every study relied on, with page or table reference, population, dose and form of the ingredient, duration and endpoint.
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For dietary supplements: confirmation that FDA was notified of the structure/function claim within 30 days of first marketing (21 U.S.C. 343(r)(6)), or the planned notification date.
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Any consumer testimonials or results figures that will appear next to the claim.
3. Checklist
Tick each line. Any line marked FAIL means the claim is NOT CLEARED unless an edit resolves it.
| # | Check | Rule / source | Pass / Edit / Fail |
|---|---|---|---|
| A | PRODUCT TYPE | ||
| A1 | Product category confirmed; the claim fits the rules for that category (supplement, food, cosmetic, drug, device). | FD&C Act definitions | |
| B | DIETARY SUPPLEMENTS | ||
| B1 | Claim describes an effect on normal structure or function of the body or general well-being, not a disease. | 21 U.S.C. 343(r)(6); 21 CFR 101.93(f) | |
| B2 | No express or implied disease claim: does not say or imply that the product diagnoses, treats, cures, mitigates or prevents a disease, including through characteristic symptoms, product name, pictures, citations of disease studies or testimonials. | 21 CFR 101.93(g) | |
| B3 | Not a disease claim in disguise, e.g. “supports healthy blood sugar” is acceptable; “lowers blood sugar in diabetics” is not; “eases menopausal hot flashes” is acceptable only as a normal life-stage condition, never as treatment of a disease. | 21 CFR 101.93(g)(2) | |
| B4 | The required disclaimer appears wherever the claim appears: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” | 21 CFR 101.93(b)-(c) | |
| B5 | Health claims (disease risk reduction) and nutrient content claims (e.g. “high in”, “good source of”) use only FDA authorised or qualified wording. | 21 CFR 101.14, 101.13 | |
| B6 | No “FDA approved”, “FDA certified” or similar. | FD&C Act; FTC Act | |
| C | COSMETICS | ||
| C1 | Claim stays cosmetic: cleansing, beautifying, promoting attractiveness or altering appearance. | FD&C Act 201(i) | |
| C2 | No claim that the product affects the structure or function of the body (e.g. “repairs DNA”, “stimulates collagen production”, “regrows hair”, “anti-inflammatory”, “heals”), which would make it a drug. | FD&C Act 201(g) | |
| D | SUBSTANTIATION (ALL PRODUCTS) | ||
| D1 | Evidence is competent and reliable scientific evidence: generally well-controlled human clinical trials, judged on the totality of the evidence. | FTC Act s.5, s.12; FTC Health Products Compliance Guidance (2022) | |
| D2 | Evidence matches the product: same ingredient and form, a product dose at least equal to the effective dose used in the studies, and the same population, duration and outcome as the claim. | FTC Health Products Compliance Guidance | |
| D3 | Claim says no more than the evidence shows: no “clinically proven”, “doctor recommended”, “#1” or percentages unless the evidence supports exactly that level. | FTC establishment claims | |
| D4 | Net impression checked, including implied claims created by images, names, before and after pictures and headlines. | FTC Act; Deception Policy Statement | |
| D5 | Testimonials or results figures reflect results consumers can generally expect, or the generally expected result is clearly disclosed. | 16 CFR 255.2 | |
| E | WEIGHT MANAGEMENT | ||
| E1 | No speed or amount of weight loss (e.g. “lose 10 lbs in 2 weeks”). | FTC Gut Check guidance | |
| E2 | No weight loss without diet or exercise, regardless of what is eaten, permanent weight loss, blocking fat or calories, or “works for everyone”. | FTC Gut Check guidance | |
| E3 | Targeting: weight loss and muscle building supplement ads not aimed at under-18s (New York prohibits sales to minors). | N.Y. Gen. Bus. Law 391-oo | |
| F | OTHER RED FLAGS | ||
| F1 | No claims about serious conditions (cancer, diabetes, heart disease, infections, Alzheimer's, depression, COVID-19), pregnancy, breastfeeding or children unless specifically cleared by Legal. | FDA and FTC enforcement priorities | |
| F2 | “Natural”, “clean”, “safe”, “no side effects” used only if accurate and qualified. | FTC Act | |
| F3 | Comparative claims name the comparison basis and are substantiated. | FTC Act | |
| F4 | California Proposition 65 warning need checked for the product. | Cal. Health & Safety Code 25249.6 | |
| G | EXPERT FIT | ||
| G1 | Specialty or specialties qualified to review this claim recorded (e.g. menopause claim: OB/GYN or endocrinology). | 16 CFR 255.3 |
4. Claim record (one per claim)
| Field | Entry |
|---|---|
| Claim ID | |
| Brand company and product | |
| Claim as submitted | |
| Product category | |
| Evidence attached (study, page) | |
| Product dose vs studied dose | |
| Checks failed or edited | |
| Result | CLEARED / CLEARED WITH EDITS / NOT CLEARED |
| Final cleared wording | |
| Disclaimer required | Yes / No |
| Qualified specialties | |
| Checked by, date |
Only the final cleared wording is shown to experts. Any later change to a cleared claim, including by the brand after expert approval, requires a new pre-check and a new expert sign-off.