ABSTRACT Nicotine Tobacco Products (NTP) should be determined to be appropriate for the protection of public health (APPH). The PMTA guidance to industry (2019) states the requirements for “…manufacturing processes and controls for product design, including a hazard analysis that details the correlation of the product design attributes with public health risk, and any mitigations for identified hazards”. Products reaching the market should undergo a sufficient level of hazard assessment in line with their intended use. We present a step-by-step approach that considers the user – product interface and ensures that an acceptable level of risk has been verified prior to product launch. The assessment is a continuous process that takes place throughout the lifecycle of the product. It requires a 360-degree approach, input from relevant experts and top management engagement. While NTP are not medical devices their risks should still be evaluated and mitigated. Using a detailed understanding of the products and their use, we have developed an approach to identify and mitigate the product risks based on ISO 14971 standard. The approach consists of four steps: Identify, Evaluate, Mitigate, then Monitor. A Risk Management Plan is established as a starting point and assessment with Subject Matter Experts, Quality Assurance, Senior Management and Independent Reviewer is implemented. The Design, Process, and User Interface are analysed for potential failures and all Hazardous situations are then evaluated. Mitigation of unacceptable risks is done by adjusting the design, the process, adding protective measures or as a last resort by informing the user by labelling or warnings. Once all mitigations have been implemented, control measures are verified. A Risk Report is prepared to document that the product is APPH.