Breaking News – China Finalizes Management Rules for E-Cigarettes

On March 11, 2022, STMA announced the publication of the final Management Rules for E-cigarettes, which will take effect starting May 1, 2022. At the same time, the second draft GB standard on e-cigarettes also was published for comment by March 17. We summarize below some notable changes in the final Management Rules.

The final version deletes the definition for [e-cigarettes," which was [an electronic delivery product that produces nicotine-containing aerosol for human inhalation." Since the Management Rules state that e-cigarettes must comply with the mandatory national standard, one should now refer to the GB standard on e-cigarettes for the definition of e-cigarettes. Notably, the second draft GB standard removes [nicotine-containing" from the definition of e-cigarettes but at the same time adds a requirement that e-atomization materials must contain nicotine. Since the GB standard is still under development, we will continue to keep a close eye on how the potential change to the definition for e-cigarettes would impact the application scope of the Management Rules.

The final Management Rules remove product registration requirements. However, E-Cigarette products, including imported products, still must pass the technical review by STMA before being marketed in China. It, therefore, appears that there has been a loosening of the regulatory requirements in this regard since a registration process is typically more onerous than a technical review. However, the details of what the technical review process will look like remain unclear. Accordingly, in line with our comments to STMA, e-cigarettes manufactured in China solely for export are not subject to product registration or technical review in China. Still, they must comply with the destination country`s laws (or China law, if the destination country has no relevant law).

Industry also expressed concerns about the prohibition in the draft Management Rules on flavored e-cigarettes. In the final version, the prohibition has been changed to [it is prohibited to sell flavored e-cigarettes other than tobacco flavors." However, [tobacco flavors" is not clearly defined, while the draft GB standard still permits the use of various flavoring substances in e-cigarettes, like vanillin, lemon oil, etc.
Other than the above, many other requirements for e-cigarettes in China are still retained in the final Management Rules, including production licensing, purchase of leaf tobacco only from authorized companies, trading on a unified platform, etc.

Since the Management Rules for E-cigarettes will take effect soon, industry should immediately understand all the specifics so that appropriate adjustments can be made in a timely manner. We are also preparing an English translation of the Management Rules, which will be made available upon request.