Evidence lives in many places
Official sources, product files, labels and channel requirements are difficult to compare without a consistent structure.
MARKET READINESS
Understand what may need attention before entering a new market.
For beauty and personal-care brands: identify product, label and documentation questions before entering a new market. For cosmetics in the United States, this includes applicable FDA requirements.
BEFORE THE COMMITMENT
Know what is supported, what is missing and what needs expert review.
FDA requirements and FDA approval are not the same. Cosmetic products generally do not require FDA premarket approval; certain color additives have their own approval requirements. Confirm the product category, intended use and claims before deciding which rules apply.
Compass organizes the reviewed evidence, open questions and prioritized next steps. It does not calculate a percentage of FDA approval or certify compliance. The product, destination and assessment scope are confirmed before work begins.
- Read FDA’s official cosmetics guidance
- See what changes in another market
- Explore a fictional sample report
- 01
Evidence tied to the reviewed product
- 02
Missing information and specialist needs
- 03
Prioritized next steps, not an approval score
THE INFORMATION GAP
Scattered requirements create expensive uncertainty.
Uncertainty gets treated as an answer
Teams need to distinguish an apparent gap, a missing document and a question that requires qualified review.
The next step is unclear
A long checklist has limited value if it does not identify priority, ownership and the decision each item affects.
HOW THE REVIEW WORKS
Source-backed research, AI-assisted organization, human review.
Define the target context
Confirm the product, destination market, intended channel and the decision the review needs to support.
Collect and structure evidence
Review supplied materials and relevant public official sources using a consistent readiness framework.
Organize preliminary findings
Use governed AI assistance where useful to classify information, surface gaps and maintain traceability—without replacing human judgment.
Review and prioritize
A human-reviewed report separates observations, open questions and recommended next actions, including where specialist input is appropriate.
REPORT STRUCTURE
A clearer view of what deserves attention.
Product context
Product category, claims, intended use and the market or channel context relevant to the preliminary review.
Label and documentation
Visible gaps, inconsistencies and supporting material that may need further validation.
Source traceability
References to relevant public official sources and a clear separation between evidence and interpretation.
Prioritized next steps
Actions, open questions, likely owners and areas that may require formal submission, testing or specialist review.
IMPORTANT BOUNDARY
A preliminary readiness service—not an approval.
TH3RD GROUP is independent of FDA and other government authorities. This preliminary review does not issue legal opinions, approvals, registrations or government certifications, and does not guarantee compliance or commercial results. Depending on the product and destination, further testing, documentation, formal submissions or qualified regulatory review may be needed. Food, supplements, medicines and medical devices are not automatically included in this cosmetics scope.
BEFORE DEFINING THE SCOPE
Questions to prepare your next step.
Does a cosmetic product need FDA approval, registration or listing?
These are different questions. Cosmetic products generally do not require FDA premarket approval; certain color additives have separate approval requirements. Facility registration and product listing under applicable MoCRA provisions do not mean FDA approval. Confirm product classification, intended use, claims and any applicable exemptions with qualified review. Compass records evidence and open findings within the agreed scope, not a percentage of FDA approval. TH3RD’s preliminary assessment is not a filing service, government certification or legal determination. Foods, supplements, medicines and medical devices require their own category-specific scoping; they are not automatically included.
How are packaging, labels and ingredient statements reviewed?
Identify the exact SKU, current artwork for every panel, dimensions, intended use, ingredient statement, recorded claims and target country. A label/INCI review compares available evidence with the applicable source context; it does not infer a formula, missing text or approval from an incomplete photo. Separate “not observed,” missing evidence and a supported finding. Keep a tracked correction brief and request specialist input where product classification, ingredient restrictions or other requirements require it.
Can a skincare claim change the review the product needs?
The exact wording, intended use and surrounding product presentation matter. Review the package, website, listings and campaign language together with the supporting records. FDA’s guidance distinguishes cosmetic and drug-related claim questions; a phrase cannot be approved in isolation from that context. Keep source quotations separate from TH3RD’s interpretation and from proposed replacement wording. A preliminary review does not create an approved claims list or replace qualified legal and regulatory judgment.
What documents should be organized before export, import or a retailer review?
Begin with the confirmed product identity, current labels, ingredients, claim support, responsible business parties, intended market/channel and available technical records. Record source, version, receipt and review status separately. A document checklist is country- and product-specific; it is not proof that the underlying product is compliant. A readiness report should identify missing evidence, supported findings, accountable next steps and where testing, submissions or specialist review may be needed before a commercial commitment.
Is there an FDA-equivalent approval in another market?
There is no single worldwide approval. For cosmetics, Colombia has INVIMA’s Notificación Sanitaria Obligatoria (NSO); Mexico has COFEPRIS requirements; Brazil’s ANVISA distinguishes registration and registration-exempt regularization; and the European Union has its cosmetics framework and CPNP notification. These are different obligations, not interchangeable FDA certificates. Confirm the destination, product classification, responsible parties and current evidence first. TH3RD can organize country-specific questions and official sources within agreed scope. This orientation does not mean every market is already configured in Compass, and it is not a filing service, authorization or representation before a regulator.
How should a California Proposition 65 question be handled?
Treat a California warning question as a separate scope, not an automatic extension of a federal cosmetic review. Identify the exact product, available formulation and exposure information, destination and the decision that requires qualified review. Do not infer a warning obligation or absence of risk from a keyword, ingredient name or an empty checklist. Use OEHHA’s official information and qualified advice for the applicable evaluation; the preliminary readiness report is not a Proposition 65 clearance.
START WITH THE TARGET MARKET
Bring structure to the questions before the commitment.
Share the product category, target country and channel you are considering. We will confirm whether a preliminary readiness review is an appropriate next step.