Supplement claims substantiation: match every claim to its evidence before it reaches a label or an ad
Keep one file per claim, with the evidence for and against it, before the claim appears on a label, a website or an ad.
In Short
- Labels and ads: two rulebooks.
- Health claims: usually human RCTs.
- UK ads: authorised claims only.
Marketing, regulatory and quality teams at supplement brands need one file that shows why each claim is allowed and what evidence supports it. Opened: the FTC Health Products Compliance Guidance (December 2022, guidance rather than a rule), 15 U.S.C. 52 and 55(a) (GovInfo 2023 edition), 21 U.S.C. 343(r)(6), and section 15 of the UK CAP Code on the ASA website (a self-regulatory code). Not opened: EU Regulation 1924/2006 and the EU register, because the EU legal sites refused automated access, the GB claims register, Health Canada rules and FTC case orders. It is orientation, not legal advice. Sources checked 5 Oct 2026.
Two US tracks: label and advertising
Label structure/function statements fall under 21 U.S.C. 343(r)(6), which requires substantiation that the statement is truthful and not misleading, a prominent boldface disclaimer, and notice to FDA no later than 30 days after first marketing.
More on two US tracks: label and advertising
Advertising falls under the FTC Act: 15 U.S.C. 52 makes a false advertisement for food, drugs, devices, services or cosmetics unlawful, and 55(a) defines it as misleading in a material respect, taking into account what the advertisement fails to reveal. The FTC guidance treats packaging and labelling statements as advertising too, so one claim can sit under both.
What competent and reliable means
The FTC guidance quotes its standard: tests, analyses, research or studies conducted and evaluated in an objective manner by experts in the relevant field, generally accepted in the profession to yield accurate and reliable results, and sufficient in quality and quantity. It says that, as a general matter, substantiation of health-related benefits will need to be randomized, controlled human clinical testing, and that the FTC considers parameters such as sample size, duration and outcome measures.
FTC evidence factors (summary of the guidance)
More on what competent and reliable means
The guidance explains how the FTC applies the law; it is not itself a regulation.
Totality of Evidence and Qualifiers
The guidance says evidence is weighed in the context of the totality of relevant research. If a stronger body of evidence runs contrary to a claimed effect, even a qualified claim is likely to be deceptive.
More on totality of Evidence and Qualifiers
It also warns that consumers may read words such as preliminary or pilot as positive attributes rather than limits, and that a disclaimer which contradicts an express claim does not cure it. In practice, record the search for contrary evidence alongside the studies that support a claim, and keep both with the claim file.
UK non-broadcast ads: CAP Code section 15
Rule 15.1 requires nutrition or health claims to be supported by documentary evidence that they meet the conditions of use in the applicable register, presented without exaggeration; 15.1.1 allows only listed nutrition claims and authorised health claims, or claims with the same meaning to consumers. Rule 15.2 accepts general health benefit references only alongside a specific authorised claim.
UK ad line check (invented lines)
- Rule 15.1: documentary evidence of the conditions.
- Confirm the current register wording.
More on uK non-broadcast ads: CAP Code section 15
Rules 15.6.3 and 15.6.6 bar claims citing an individual health professional's recommendation and claims about a rate or amount of weight loss. The register and EU Regulation 1924/2006 were not opened here.
One claim file per claim
Give every claim its own record: exact wording, where it appears (label, website, retailer listing, advertisement), each market, the legal route, the studies relied on with design, dose, population and duration, how they match the product as sold, the search for contrary evidence, the reviewer, the date and the decision. Put the file under change control, so a formula, dose or serving change sends the claim back for review before new labels or ads go out.
Worked example: claim file CF-118 (invented capsule)
| Field | Entry | Owner |
|---|---|---|
| Wording | 'Supports normal joint comfort' | Marketing |
| Where used | Label rev 3, website, retailer listing | Marketing |
| Evidence | Two RCTs at the labelled dose; contrary search logged | Regulatory |
| Decision | Approved for US; UK use not approved | Regulatory and legal |
- Wording
- Entry
- 'Supports normal joint comfort'
- Owner
- Marketing
- Where used
- Entry
- Label rev 3, website, retailer listing
- Owner
- Marketing
- Evidence
- Entry
- Two RCTs at the labelled dose; contrary search logged
- Owner
- Regulatory
- Decision
- Entry
- Approved for US; UK use not approved
- Owner
- Regulatory and legal
More on one claim file per claim
People approve every claim; the file shows why.
Questions
Does the FTC health products guidance have the force of law?
No. The FTC calls it guidance. It explains how the FTC applies the FTC Act's prohibition on deceptive advertising to health-related claims.
Does a structure/function disclaimer protect an advertising claim?
Not on its own. The FTC guidance says a disclaimer that contradicts an express claim does not cure it, and substantiation is still needed.
Can a UK supplement ad say a product supports general health?
Under CAP Code rule 15.2, a general health benefit reference is acceptable only when accompanied by a specific authorised health claim.
Does V5 substantiate or approve claims?
No. V5 keeps claim files, formula versions and label versions linked with approval history. Your regulatory and legal teams approve claims.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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