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ExordiumBiotech
Compliance & claims review

What a product says is part of the product.

Compliance and claims review helps identify regulatory considerations before product language reaches a label, a package or a website — alongside the formulation and development work, not after it.

This is informational and technical product-development support. It is not legal advice and not a guarantee that any agency will accept a product, a label or a claim.

Request a claims review
An unlabelled white supplement bottle and blank carton beside marked-up draft artwork sheets — illustrative imagery

What gets reviewed.

Claims rarely appear in one place. The review follows the same sentence through the formula, the label and the marketing, because that is where it usually drifts.

Product claims
The things a product is said to do — in the brief, on the label, in the deck and on the website — read against what the formula and the evidence actually support.
Ingredients and formula
Ingredient identity, use levels and category fit reviewed as a regulatory question alongside the technical one, while the formula can still change.
Label content
Panel content, ingredient declaration, net contents, directions, warnings and the claim language printed alongside them.
Packaging and artwork
Carton, bottle and insert copy checked for claim drift between the approved language and what the designer laid out.
Website and marketing
Product pages, ad copy, email and social claims — where language tends to escalate furthest from the formula.
Positioning language
The category a product is presenting itself as, and whether the words used push it toward a different regulatory category.

When it enters development.

Claims reviewed at the end become a rewrite. Claims considered during development shape the formula while it can still change.

  1. During research

    Category and claim direction shape which ingredients are worth investigating. Knowing the claim you want early narrows the chemistry.

    Research

  2. During formulation

    Use levels, ingredient choices and format influence what can reasonably be said. Cheaper to adjust here than after artwork.

    Formulation

  3. During development

    Prototype, presentation and label copy develop together, so the words and the product stay consistent.

    Product development

  4. Before a pilot run

    Artwork and label content are reviewed before packaging is printed for a pilot batch.

    Pilot production

Dietary supplements

Structure and function, not treatment.

  • Structure/function claim considerations, and how they differ from disease claims.
  • Language that describes an effect on normal structure or function versus language that describes treating, preventing or curing a condition.
  • Where the required disclaimer and label content conventions apply.
  • Ingredient identity, declared use levels and category fit for a dietary supplement.
  • Substantiation as an open question: what evidence exists for a claim, and what would be needed to support it.

Cosmetics, skincare & topicals

Where cosmetic language becomes a drug claim.

  • The cosmetic versus drug claim boundary — appearance-focused language against language describing a physiological effect.
  • Common escalation points: anti-acne, anti-inflammatory, wound, barrier-repair and anti-ageing phrasing.
  • How a single marketing sentence can move an otherwise cosmetic product into a different regulatory category.
  • Ingredient-driven implications, where the ingredient itself carries claim expectations.
  • Consistency between the label, the website and the advertising for the same product.

Boundaries

What this service is not.

Stated plainly, because the difference matters. Where a matter needs legal advice or specialist regulatory representation, the right step is an outside specialist or attorney, and we will say so rather than work past the edge of our scope.

  • Not legal advice, and not a substitute for a qualified regulatory attorney.
  • Not FDA representation, submission, registration or correspondence on your behalf.
  • No guarantee of FDA compliance, label compliance, or acceptance by any agency.
  • No FDA approval, endorsement, certification or affiliation of any kind — and no claim of one.
  • No clinical substantiation, clinical trial design or claim-substantiation studies.
  • Not a final sign-off. Responsibility for what is published stays with the brand.

How a review starts.

  1. 01

    Send the materials

    Whatever exists: the formula or ingredient list, draft label copy, artwork, the product page or the claims you would like to make.

  2. 02

    Scope the review

    We confirm the product category, what the review will cover and where the obvious risk sits before starting.

  3. 03

    Written observations

    Claim-by-claim notes: what looks supportable, what reads as higher risk, what would need evidence, and what belongs with a specialist.

  4. 04

    Revise together

    Alternative phrasing where language can be brought closer to what the product actually does — or a change to the formula itself.

Reviews run either as part of a development project or on their own for a product already in progress elsewhere. Common questions about claims review.

Start with the project as it is today

Have claims you want read before they are printed?

Tell us where the project stands today. Every brief is reviewed for technical fit, development readiness and current laboratory capacity — you do not need all the technical answers first.

Do you guarantee FDA compliance? →
Submit a project brief

Six short steps. No account, no pricing gate.

Or contact the laboratory directly