Abstract: Aiming at the scientific requirements of health risk assessment for novel tobacco products, this review summarized the relevant documents, such as relevant laws and regulations issued by regulatory agencies such as FDA of the United States, TPD of EU and the application materials published by major international tobacco companies. The principles and other characteristics of those documents were analyzed. Furthermore, a suitable risk assessment framework of novel tobacco products for China was put forward. This framework proposed that China should carry out the risk assessment of novel tobacco products according to a three-layer risk assessment framework, including smoking individual, population and the environmental risks.