SCIENCE • EVIDENCE • PRODUCT STRATEGY

Scientific Evidence & Claims Substantiation

Know what your product’s science can support. We help supplement, pharmaceutical and cosmetic teams evaluate evidence, assess proposed claims and plan the next steps in product development.

Discuss your claims

THE RIGHT EVIDENCE. FOR THE RIGHT CLAIM.

Start with the claim.
Then examine the science.

A strong reference list is only useful when the research answers the right question. Does the studied dose match your formula? Were the outcomes meaningful? Does the proposed language say more than the data demonstrate?

Kompete Consulting connects scientific literature review, formulation insight and regulatory strategy. We help you understand what is supported, what remains uncertain and what to do next.

Supplement claims substantiation grounded in the actual formula.

A published study is a starting point. We assess whether its ingredient identity, dose, population, duration and outcomes are relevant to your product and the claims you intend to make.

  • Scientific literature reviews for dietary supplements, natural health products and functional foods.
  • Ingredient identity, extract standardisation, dosage and delivery-format comparisons.
  • Health-claim and US structure/function claim evidence assessments, with market-specific regulatory review.
  • Formulation recommendations that connect the evidence with a realistic serving size and intended use.
  • Scientific rationales and supporting documentation for agreed NPN or other market-access projects.

Food, dietary supplement and NHP claims follow different regulatory pathways. A claim accepted in one market does not automatically transfer to another.

HOW WE CAN HELP

From research questions to practical deliverables.

01

Scientific literature review

Find the research that matters.

We define the question, search the relevant literature and assess study design, results, limitations and contradictory findings. The deliverable is a referenced assessment with a documented scope, rather than a collection of favourable abstracts.

02

Ingredient & formulation assessment

Check whether the evidence fits.

Compare the studied material with your ingredient specifications, extract profile, dose, route and intended population. We identify where ingredient-level evidence is relevant and where extrapolation to the finished product needs stronger justification.

03

Claims substantiation strategy

Make the claim proportional to the evidence.

Review proposed wording, implied messages, market requirements and supporting data together. Recommendations may include narrower language, different positioning, a formulation adjustment or additional research.

04

Safety & toxicological evidence

Understand the limits and unanswered questions.

Review published safety findings, exposure, duration of use, interactions, contraindications and relevant populations. We identify data gaps and coordinate specialist input where a formal safety or toxicological assessment is needed.

05

Scientific & medical writing

Turn technical evidence into usable documentation.

Prepare evidence tables, scientific rationales, ingredient profiles, technical summaries and professional or consumer information. Product-monograph support is tailored to the document type, jurisdiction and agreed scope.

06

Evidence-led product development

Build the evidence into the product brief.

Connect intended benefits with ingredient selection, dosage and delivery format early. When further research is warranted, we help define study objectives, relevant outcomes and a brief for qualified clinical or testing partners.

EXPLORE THE EVIDENCE

What does your claim need?

Expand a claim to see the questions behind a substantiation assessment. These are illustrative review examples, not pre-approved wording or a determination for a specific product.

Ingredient identity and relevanceClinically studied ingredient

Check the exact ingredient, standardisation, dose, population and outcomes. A study of one extract does not automatically support another extract or a lower dose.

Key distinction: An ingredient study should not be presented as a clinical trial of your finished product.

Finished-product performanceVisible results in 14 days

Look for a relevant study that evaluates the claimed outcome at the stated timepoint under representative use conditions. Distinguish instrument measurements, expert grading and participant perceptions.

Key distinction: A measured change in hydration does not by itself establish a reduction in wrinkle appearance.

Sensory or consumer-use evidenceNon-greasy feel

Define what users are evaluating, who the intended users are and how the assessment is conducted. A suitable sensory or consumer-use study may support a carefully worded perception claim.

Key distinction: Consumer opinion about how a product feels does not establish a biological or therapeutic effect.

Comparative evidenceBetter than a competing product

Specify the comparator, outcome, use conditions and basis of comparison. Assess whether the study supports the precise advantage stated and whether the comparison remains current and fair.

Key distinction: A difference on one endpoint should not become an unrestricted claim of overall superiority.

Test scope and tolerabilityDermatologist-tested or hypoallergenic

Review who performed the evaluation, its protocol, population and results, alongside the intended market's requirements. Explain what the testing actually demonstrates.

Key distinction: Testing is not a guarantee that no user will experience irritation or an allergic reaction.

Traceable product and supply-chain recordsVegan, natural or environmental positioning

Review the specific meaning of the statement, ingredient and processing records, supplier declarations and any applicable standard or certification scheme. Environmental claims need a defined, supportable scope.

Key distinction: Vegan, cruelty-free, organic and recyclable describe different attributes and should not be treated as interchangeable.

EVIDENCE-BASED MARKETING

Clear communication starts with an honest assessment.

A statistically significant result is not automatically a meaningful consumer benefit. An ingredient study is not automatically a finished-product trial. And a promising mechanism is not proof that a product works in people.

We help teams translate findings into understandable language while keeping the study conditions and limitations in view. The review can cover packaging, websites, professional materials and the messages implied by imagery or comparisons.

Plan an evidence review →

Relevance

Match the evidence to the actual product and intended users.

Proportion

Keep the wording within the strength and scope of the findings.

Traceability

Connect each proposed claim to its sources and assessment rationale.

A DEFINED PROCESS

A clear route through the evidence.

  1. 01

    Define the brief

    Confirm the product, claims, target markets, intended users and decisions the review needs to inform.

  2. 02

    Assess the evidence

    Review relevant studies, product information and regulatory context, including conflicting or unfavourable findings.

  3. 03

    Map claims to support

    Document the connection between proposed wording and evidence, with limitations and unresolved questions.

  4. 04

    Recommend next steps

    Identify wording revisions, formulation changes, additional testing or specialist input.

  5. 05

    Deliver and discuss

    Provide the agreed documentation and walk your team through the findings and practical implications.

WHAT YOU RECEIVE

Useful outputs.
A documented rationale.

Deliverables are agreed at the start, based on your product and the decisions you need to make.

  • Referenced scientific evidence summary
  • Study comparison and relevance table
  • Claim-to-evidence assessment matrix
  • Evidence gaps and recommended next steps
  • Scientific rationale or technical writing package
  • Team discussion of findings and limitations

ILLUSTRATIVE ASSESSMENT FORMAT

Review questionWhat we examinePossible next step
Does the ingredient match?Identity, extract profile and specificationsObtain supplier documentation
Does the dose match?Daily exposure and duration of useReassess dose or claim scope
Was the benefit measured?Endpoints, methods and populationRefine wording or plan further research

COSMETIC CLAIMS IN THE EU

Six questions for a more defensible claim.

EU cosmetic claims are subject to common criteria under Regulation (EU) No 655/2013. We can assess the proposed communication against these principles and identify the documentation needed.

Legal compliance

Does the claim respect the applicable framework without presenting basic legal compliance as a special benefit?

Truthfulness

Does the product actually have the characteristics or ingredients described?

Evidential support

Is the supporting evidence appropriate and verifiable?

Honesty

Does the wording remain within what the available evidence demonstrates?

Fairness

Does the communication avoid misleading comparisons or unfair denigration?

Informed decisions

Can the intended audience understand the message and make an informed choice?

COMMON QUESTIONS

Scientific evidence & claims substantiation FAQs.

What is claims substantiation?

It is the assessment and documentation of evidence supporting what a product claims to do or contain. The work considers the exact wording, implied message, product characteristics and relevant market requirements. The necessary evidence depends on the claim and product category.

Can ingredient research support my finished product?

Sometimes, provided there is a defensible connection between the studied ingredient and your product. Identity, dose, standardisation, formulation, route, population and conditions of use all matter. We assess that connection and flag where finished-product data or other evidence may be needed.

Does every product need a new clinical trial?

No. The answer depends on the product, intended claim, available evidence and regulatory pathway. Relevant existing evidence may be sufficient for some purposes; other claims require more specific data. We assess the gap before recommending additional research.

Do you conduct clinical trials or laboratory testing?

This service focuses on scientific assessment, planning, documentation and coordination. Where new testing is needed, we can help develop the research brief and coordinate with qualified third-party providers. Study execution, fees and specialist responsibilities are agreed separately.

What is the difference between health claims and structure/function claims?

These terms have specific regulatory meanings that vary by jurisdiction and product category. For example, the US distinguishes dietary supplement structure/function claims from health claims concerning disease-risk relationships. We assess the intended wording within the relevant framework rather than transferring a claim category between markets.

Can you help with cosmetic claims?

Yes. We assess performance, ingredient, sensory, consumer-perception and comparative claims, along with the supporting documentation. The scope can include identifying appropriate evidence and developing a testing brief. Claims that imply therapeutic effects need a product-classification review.

Can you help pharmaceutical teams?

Yes, through agreed scientific literature review, evidence synthesis, medical writing and documentation support. The scope identifies the product stage, deliverables and specialist review requirements. This is not a substitute for a sponsor's regulatory obligations or required clinical development.

Can you review safety and toxicological information?

We can review published safety evidence and organise relevant exposure, interaction and contraindication information. Formal toxicological assessments, regulated safety reports or specialist sign-off are scoped separately with appropriately qualified professionals where needed.

Do you prepare product monographs?

We can support scientific content development and evidence organisation for product monographs and professional or consumer information. The document format, required expertise and regulatory status are established at the start. An educational product profile is not the same as an approved pharmaceutical Product Monograph.

Is this a systematic review or meta-analysis?

A standard literature assessment is not automatically a systematic review or meta-analysis. If your project needs a registered protocol, systematic methods or statistical pooling, those requirements and specialist contributions are defined separately.

Can you help with website and marketing claims?

Yes. We can assess claims across packaging, websites, sales materials and other agreed channels, including messages implied by images or comparisons. Recommendations aim to preserve useful product communication while accurately reflecting the evidence and applicable requirements.

What do you need to get started?

Share your formula or ingredient specifications, target markets, intended users, proposed claims, existing studies and desired launch timeline. We then define the evidence-review scope, deliverables and any additional information needed.

LET’S REVIEW YOUR PRODUCT

What are you planning to claim?

Bring your formula, proposed wording, target markets and existing research. We’ll help define the right scope for a scientific evidence review.

Book a consultation ↗
Selected regulatory and scientific guidance

Requirements vary by product and jurisdiction. These primary sources provide background; the applicable framework is checked for each engagement.