Although e-cigarettes manufactured in China for export to overseas markets are not subject to pre-market approval in China, and are only required to comply with the regulations of the destination country, China’s State Tobacco Monopoly Administration (STMA) still attaches great importance to the quality management of e-cigarettes for export.
On July 18, 2023, STMA released the Guidelines on Promoting the Construction of a Quality Assurance System for Electronic Cigarette Products for Export, which became effective immediately. The new guidelines come as U.S. public health authorities have continued to raise concerns about the quality and safety of e-cigarettes, the vast majority of which are manufactured in China. Similar conceptually to FDA’s recently proposed Tobacco Product Manufacturing Practices, STMA’s Guidelines contain 18 articles, making it clear that the manufacturers are responsible for the quality assurance of e-cigarettes for export. The Guidelines focus on how to construct a satisfactory quality assurance management system, specifying requirements in areas such as quality and safety standards, production process, product packaging, transportation traceability, etc. Some of the requirements are already contained in other e-cigarette regulations in China; for example, the manufacturer must ensure that the e-cigarette for export complies with applicable regulations in the destination country, and must also notify the export on China’s unified national e-cigarette trading platform within 30 days of the export declaration at customs.
Notably, Articles 13 and 14 specify what the local manufacturer must do in case of quality and safety issues with e-cigarettes sold on the overseas market. Specifically, Article 13 requires that if there are quality and safety issues with an e-cigarette for export that have caused or may cause harm to human health, the manufacturer must immediately stop the production of the relevant product, take corresponding measures to avoid and reduce the occurrence of damage, and report to the local STMA authorities. In addition, under Article 14, if an e-cigarette for export is publicized by an international organization or overseas government due to quality and safety issues, the manufacturer must immediately report to the local STMA authorities and accept examinations by the tobacco administration.