Claims Substantiation Checklist

What it is

A claims substantiation checklist is a systematic process for verifying every factual statement in your communications before it goes public. It documents what evidence supports each claim, who has reviewed that evidence, and whether it meets regulatory standards.

This isn’t just about being accurate—it’s about protecting your organisation legally. Unsubstantiated claims can trigger regulatory action, damage credibility, or expose you to litigation. This template ensures you can defend every claim you make in writing.

When to use it

Use this template when:

Communications include product claims or performance statements
You’re making comparative claims (vs competitors)
Advertising standards apply to your sector
You’re citing research, statistics, or independent data
Regulatory bodies monitor your communications (health, finance, environment, etc.)
You need documented evidence for legal/compliance review
Claims could affect purchasing decisions

Don’t use this template if:

Your communication contains only subjective opinions or personal views
No specific factual claims are made (e.g., “We’re excited to announce…”)
Claims are general marketing puffery with no specific assertions
You’re sharing purely narrative content with no measurable statements

Inputs needed

Before starting, gather:

The draft communication with all proposed claims identified
Any research, studies, data, or testing that supports claims
Internal performance metrics or verification documentation
Regulatory guidelines applicable to your industry/claims
List of who needs to approve substantiation (Legal, Compliance, Technical, etc.)
Timeline for substantiation review

The template

Claims identification and substantiation

Communication: [Title/type]

Regulatory framework: [e.g., ASA Code, EFSA regulations, FDA claims rules]

Prepared by: [Name and date]

#	Claim as stated	Claim type	Evidence held	Evidence quality	Substantiator	Legal review	Approved
1	[Exact quote from draft]	[Type]	[What evidence supports it]	[Source reliability]	[Name]	[ ]	[ ]
2
3

Claim types: Product benefit / Performance / Comparative / Safety / Environmental / Health / Regulatory compliant / Third-party verified / Other

Evidence quality scoring: Independent research / Internal testing / Manufacturer specification / Industry standard / Supplier data / Single study / Anecdotal / No evidence yet

Evidence documentation

For each claim, provide:

Claim: [Exact wording from communication]

Type of claim: [Category above]

Evidence:

Source: [Study, test, standard, or data]
Date: [When evidence was created/verified]
Relevance: [How directly does this support the claim?]
Link/reference: [Where to find the evidence]

Potential challenge: [How might someone dispute this claim?]

Substantiation gap: [Is there missing evidence? What would make this stronger?]

Regulatory position: [Is this claim permitted under relevant rules?]

Sign-off section

Internal stakeholder approvals:

Technical/Product team: Have verified claims are technically accurate
Legal: Has confirmed substantiation meets regulatory requirements
Compliance: Has verified no violations of advertising standards
Communications: Has confirmed claims are clearly stated and not misleading
Final approver: [Role] has approved all claims and substantiation

Evidence custody:

Location where evidence is stored: [Link/folder]
How long evidence will be retained: [Per regulatory requirements or X years]
Who is responsible for maintaining evidence: [Name/role]

AI prompt

Base prompt

I have a communication that includes several factual claims. I need to verify each claim is substantiated and document what evidence supports it. Here are the claims I'm making:

[LIST EACH CLAIM EXACTLY AS STATED]

Background:
- Our industry/sector: [e.g., health supplements, financial services]
- Applicable regulations: [e.g., ASA Code, EFSA regulations, FDA guidance]
- What evidence I have access to: [e.g., internal testing, published studies, certifications]

For each claim, create a claims substantiation checklist that:
1. Identifies the exact claim as stated
2. Categorises the type of claim (product benefit, performance, comparative, safety, etc.)
3. Lists what evidence supports it and the quality/reliability of that evidence
4. Identifies any substantiation gaps (missing evidence that would strengthen the claim)
5. Flags potential challenges someone might raise about the claim
6. Confirms whether the claim complies with relevant regulations
7. Notes what would need to happen for sign-off

Format as a table I can give to Legal and Compliance for review.

Prompt variations

Variation 1 - Comparative claims:

We're making a comparative claim about our product vs competitors: "[EXACT CLAIM]". This is a higher-risk claim type. Create a substantiation checklist that:
- Lists all evidence we have directly comparing our product to named/unnamed competitors
- Identifies gaps in that comparative evidence
- Highlights regulatory risks specific to comparative claims in our sector
- Outlines what evidence would be required to defend this claim if challenged
- Recommends whether the claim should be modified, qualified, or supported with additional testing

Variation 2 - Health/safety claims:

Our communication includes health or safety claims: [CLAIM]. Health claims are heavily regulated. Create a substantiation checklist that:
- Maps our claim against regulations for health claims in [COUNTRY/SECTOR]
- Lists all evidence (studies, testing, approvals) supporting the claim
- Identifies whether this claim needs regulatory pre-approval before use
- Flags any qualified language that must accompany the claim
- Recommends risk level (low, medium, high) for this claim

Variation 3 - Contested/borderline claims:

We're unsure whether this claim is substantiated adequately: "[CLAIM]". Create a substantiation checklist that:
- Identifies what evidence we currently have
- Lists what additional evidence would make this claim clearly defensible
- Rates how strong our current substantiation is (weak/moderate/strong)
- Recommends whether to use this claim, modify it, add qualifications, or support it with additional evidence
- Outlines what would happen if someone challenged this claim legally

Variation 4 - Multiple claims across sectors:

Our communication makes claims across different areas: [List claims]. Different types may have different substantiation requirements. Create separate substantiation checklists for:
- Environmental/sustainability claims (if any)
- Health/wellness claims (if any)
- Performance/technical claims (if any)
- Comparative claims (if any)

For each type, identify the specific regulatory requirements and what evidence is needed.

Variation 5 - Third-party claims:

We're citing third-party evidence: "[CLAIM BASED ON THIRD PARTY]". We need to verify the original source is reliable. Create a checklist that:
- Identifies the original source of the claim (not just our summary)
- Assesses the credibility of that source
- Confirms we have permission/rights to use the claim
- Identifies how clearly we're attributing the claim
- Flags any misrepresentation of the original evidence

Human review checklist

Example output

Communication: Product packaging claim about “clinically proven to reduce appearance of fine lines”

Regulatory framework: ASA Code, EU Cosmetics Regulation 1223/2009

#	Claim as stated	Claim type	Evidence held	Evidence quality	Substantiator	Legal review	Approved
1	Clinically proven to reduce appearance of fine lines	Health/efficacy	Published double-blind study, 2023; independent testing	Independent research	Dr. Sarah Chen, R&D	✓	✓
2	Results visible within 4 weeks of daily use	Performance	Internal consumer trials (n=87); published study	Internal testing + published validation	Dr. Sarah Chen, R&D	✓	✓
3	Contains advanced peptide complex	Product benefit	Ingredient certification; supplier documentation	Supplier data	Product Manager James	✓	✓

Evidence details for Claim 1:

Source: Published peer-reviewed study “Peptide complex efficacy in dermal ageing” (Journal of Cosmetic Science, 2023)
Relevance: Direct testing of our formulation on fine line reduction vs placebo
Potential challenge: Study was small (n=87); competitor might argue results not generalisable
Regulatory position: Compliant with ASA Code if “clinically proven” is supported by reliable evidence. This study meets threshold.
Substantiation strength: Strong – independent, published, replicable

Sign-off: Legal confirms claim and substantiation comply with ASA Code and EU Cosmetics Regulation. Claim can proceed with supporting evidence retained in file for regulatory inspection.

Approval Workflow Mapper – Document sign-off processes for substantiated claims
Content Approval Tracker – Track approval status during substantiation review
Tone Style Checker – Ensure claims are presented accurately, not overstated
Accessibility Review Checklist – Ensure evidence/disclaimers are accessible

Tips for success

Extract claims first, substantiate second. Read the draft and highlight every factual assertion before worrying about evidence. You can’t substantiate what you haven’t identified. Be thorough—“advanced formula” and “trusted by thousands” are claims too, not just technical statements.

Distinguish between claims and evidence. A competitor benchmark is not evidence of superiority unless you have data comparing you both. A celebrity endorsement is not evidence of efficacy. Be honest about what your evidence actually shows.

Know your regulatory rules. Different sectors have different claim rules. Health claims are stricter than beauty product marketing. Comparative claims need specific evidence. Financial claims need approval. Understand what applies to you before assessing substantiation.

Store evidence properly. Document not just what evidence exists, but where it lives, how long you’ll keep it, and who maintains it. If challenged by regulators or customers, you need to produce the original evidence quickly. Poor documentation is almost as bad as no evidence.

Get technical people to verify, not just approvers. Your product team needs to confirm claims are technically accurate. Your legal team needs to confirm regulatory compliance. Both perspectives matter. Don’t let either skip their role.

Common pitfalls

Over-relying on supplier claims. If a supplier says their ingredient has “clinically proven benefits,” that’s not your evidence. You need the original research. Supplier data is useful but is usually biased toward their product. Get independent verification when possible.

Treating unrelated evidence as supporting. A study showing ingredient X has property Y doesn’t prove ingredient X at your concentration in your formulation creates that effect. Close enough is not the same as relevant.

Missing qualified language requirements. Some claims need mandatory qualifications: “May help,” “typical results,” “under dermatologist supervision.” Omitting required qualifications makes substantiation inadequate. Check regulations for mandatory language.

Signing off without actually reviewing. When approvers don’t examine the evidence themselves, you lose the benefit of their expertise and potentially their legal cover. Make sure Legal actually reads the study, not just a summary.

Keeping evidence in people’s inboxes instead of a system. “The study is in Sarah’s email folder” is not evidence management. Create a proper storage system, version control, and access protocol. Years later when you need to defend the claim, personal email accounts are not adequate.