| Destination-market authorization | Product-specific regulatory status, applicable notifications or authorizations, and the legal entity responsible for placing the product on the market. | Confirm that the exact product, nicotine strength, formulation, and intended use are permitted in each destination. For covered U.S. e-cigarette products, verify applicable FDA marketing authorization before marketing. In the EU, check the requirements under the Tobacco Products Directive (TPD), including the required notification process. | General claims such as “globally compliant” without naming markets, products, or supporting records; authorization for a different product or entity. |
| EU nicotine-liquid limits | Product specification, nicotine concentration test results, bottle-volume details, and EU notification evidence where applicable. | For nicotine-containing e-cigarette liquids covered by the EU TPD, verify the maximum nicotine concentration of 20 mg/mL and the maximum 10 mL capacity for refill containers. | Concentrations or refill-container sizes exceeding the applicable limits, or documentation that does not identify the specific product. |
| Batch-level quality control | Certificate of Analysis (COA) for each batch, product specification, test methods, sampling details, and laboratory identity. | Match the COA’s batch or lot number to the shipped goods. Check that results cover declared nicotine concentration and relevant specification parameters, with units and acceptance limits clearly stated. | Undated or generic COAs; missing batch identifiers; results without units, methods, or defined specifications. |
| Independent laboratory testing | Recent test reports from a qualified laboratory and details of the laboratory’s accreditation scope, where independent testing is used. | Check that the tested sample represents the product and batch being purchased. Where ISO/IEC 17025 accreditation is claimed, verify that the relevant test falls within the laboratory’s accredited scope. | Accreditation claims that cannot be verified, reports for unrelated samples, or refusal to identify test methods. |
| Ingredient and formulation transparency | Full ingredient declaration, ingredient specifications, nicotine source and strength, and change-control procedure. | Confirm that ingredient records are consistent across the specification, safety data sheet, label, and regulatory submission. Require advance notice and approval for material formulation changes. | Undisclosed ingredients, inconsistent nicotine-strength statements, or unannounced formulation substitutions. |
| Hazard communication and handling | Current Safety Data Sheet (SDS), hazard classification, storage and spill guidance, and transport information applicable to the shipment. | Check that the SDS identifies the supplied substance or mixture and is consistent with the product and destination-market requirements. A GHS-format SDS uses 16 sections. | Missing or outdated SDS; handling instructions that do not match the product; unsupported claims that a hazardous material is non-hazardous. |
| Traceability and recall readiness | Lot-coding procedure, manufacturing and release records, retained-sample policy, complaint process, and written recall procedure. | Ask the supplier to demonstrate how a finished product can be traced to its batch records and how affected customers would be notified in a recall. | No usable lot codes, incomplete production records, or no documented complaint and recall process. |
| Manufacturing controls | Site details, process-control documents, sanitation and contamination controls, and any quality-management-system certificates claimed. | Verify certificates with the issuing body and confirm that the certificate covers the relevant facility and activities. Treat certification as supporting evidence, not as a substitute for product-specific compliance. | Certificates belonging to another site or scope; quality claims without auditable supporting records. |
| Packaging, labeling, and shipment | Market-specific label artwork, packaging specifications, tamper-evidence details where applicable, shipping documents, and storage conditions. | Review the final package against the rules of the destination market before shipment. Ensure the product identity, nicotine concentration, warnings, and package size agree with the supporting records. | Labels prepared only for another market; conflicting product details across packaging and shipping documents. |
| Commercial and document control | Supplier identity and manufacturing-site details for due diligence, document revision history, change-notification terms, and written responsibility allocation. | Ensure documents are current, controlled, and linked to the contracted product. Agree in writing who handles regulatory updates, nonconformities, and market-specific documentation. | Unverifiable business or site details; expired records; refusal to notify buyers of material changes. |