According to Formulate the Measures for the Administration of e-Cigarettes, national standards and supporting policies for e-cigarettes; It is an important measure to seriously implement the requirements of the CPC Central Committee and The State Council to promote the legalization and standardized governance of the e-cigarette industry, further implement the Law of the People's Republic of China on Tobacco Monopoly and its implementing regulations, solve the prominent problems existing in the e-cigarette market and industry, and protect the health of the people and the legitimate rights and interests of consumers.

On March 11, 2022, the State Tobacco Monopoly Administration published the Measures for the Administration of E-Cigarettes.

On April 8, the State Administration for Market Regulation (Standardization Administration) issued a national standard for e-cigarettes.

 On April 13, the State Administration for Market Regulation and relevant departments of the State Tobacco Monopoly Administration answered questions of public concern.

1. 1. What are the main contents of the E-Cigarette Administration Measures?

A: The Measures for the Administration of e-cigarettes consist of six chapters and 45 articles, which stipulate the production, sale, transportation, import and export, supervision, and administration of e-cigarettes, mainly clarifying the following aspects：

1. 1 The targets of oversight have been clarified. E-cigarettes, aerosols, e-cigarette nicotine, and other new tobacco products are all regulated. E-cigarettes include cartridges, devices, and products sold in combination with devices. Ban the sale of flavored e-cigarettes in addition to tobacco flavor and e-cigarettes that can add their atomizer, and put non-nicotine e-cigarette products under the regulatory scope. Heated cigarettes belong to cigarettes and have been included in the management of cigarettes, which is emphasized in the "Management Measures for Electronic Cigarettes". At present, our country has not approved heating cigarettes for sale in the domestic market, and any market subject may not illegally manage heating cigarettes.

1.2 The regulatory bodies have been clarified. The department of tobacco Monopoly Administration under The State Council (the State Tobacco Monopoly Administration, the same below) is responsible for the supervision and administration of e-cigarettes throughout the country, while the departments of tobacco monopoly administration at the provincial, municipal, and county levels (the same below) are responsible for the supervision and administration of e-cigarettes within their respective administrative regions according to their prescribed functions and powers.

1.3 We have clarified regulatory measures. First, the production, wholesale and retail market entities to implement license management. Second, strict quality control, the establishment of e-cigarette product technical review, sampling and testing, and traceability management system. Third, the implementation of sales channel management. Establish a unified national e-cigarette trading management platform, and bring e-cigarette-related business activities into the management of the platform. Enterprises producing e-cigarette products and enterprises holding e-cigarette brands that have obtained tobacco monopoly licenses according to law shall sell e-cigarette products to e-cigarette wholesale enterprises through the e-cigarette trading management platform. Enterprises or individuals that have obtained the tobacco monopoly retail license and are qualified to engage in the e-cigarette retail business shall purchase e-cigarette products from local e-cigarette wholesale enterprises through the e-cigarette trading management platform, and shall not exclusively engage in the sale of e-cigarette products on the market. Fourth, we will supervise transportation by the law. The transportation of e-cigarettes, aerosol, and nicotine for e-cigarettes shall be subject to the supervision and control of the department of tobacco monopoly administration. Fifth, the department of tobacco monopoly Administration under The State Council pre-examines the initial public offerings and listing of e-cigarette manufacturers, aerosol manufacturers, and e-cigarette nicotine manufacturers at home and abroad. Sixth, supervise and manage the import and export of e-cigarettes and foreign economic and technical cooperation according to law, improve the management measures, optimize the working process, and provide good service for the export of e-cigarettes that meet the relevant requirements.

2. 2. What is the background and main content of the national standard for e-cigarettes? 

A: In November 2021, The State Council issued the Decision on Amending the Regulations of the People's Republic of China on the Implementation of the Law on Tobacco Monopoly (Decree No. 750, hereinafter referred to as the Decision), adding Article 65, "Electronic cigarettes and other new tobacco products shall be subject to the relevant provisions of these Regulations on cigarettes." On March 11, 2022, the State Tobacco Monopoly Administration promulgated the Measures on the Administration of e-cigarettes, which will come into force on May 1. The measures state that "e-cigarette products shall comply with mandatory national standards for e-cigarettes." Therefore, the formulation of mandatory standards for e-cigarettes is an important means to implement the above laws and regulations, as well as an important technical support for the establishment of a regulatory system for e-cigarettes.

On April 8, 2022, the State Administration for Market Regulation (SFC) issued the GB 41700-2022 mandatory national standard for e-cigarettes. The standards will be formulated by the State Administration for Market Regulation, the State Tobacco Monopoly Administration, the National Technical Committee for Tobacco Standardization, and other technical institutions. The standard contents mainly include: first, the relevant terms and definitions of e-cigarette and aerosol are clarified; second is to put forward the principle requirements for the design of e-cigarettes and the selection of raw materials; Third, the technical requirements of e-cigarettes, aerosol, and release are put forward respectively, and the corresponding test methods are given. Fourth, the label and instructions of e-cigarette products are stipulated.

3. When will the transition period end? What is the policy for the transition period?

A: According to the Tobacco Monopoly Law of the People's Republic of China and its implementation regulations, since the promulgation and implementation of the Decision on November 10, 2021, the production and operation of e-cigarettes shall obtain access permits, the products shall meet the national standards, and the import and export of e-cigarettes shall comply with relevant regulations and other requirements. Considering the process of promulgation and implementation of the Measures for the Administration of E-Cigarettes, the national standards and supporting policies of E-cigarettes, the tobacco monopoly administrative department of The State Council set up a transitional period after the promulgation and implementation of the Decision, to guarantee the legitimate rights and interests of relevant e-cigarette producers and marketers, better implement relevant regulatory requirements, safeguard the health of the people and protect the legitimate rights and interests of consumers. And clear the relevant requirements of the transition period. Because the Measures for the Administration of e-cigarettes will come into effect on May 1, 2022, and the National Standard for e-cigarettes will come into effect on October 1, 2022, the transition period will end on September 30, 2022.

During the transition period, the existing e-cigarette production and operation entities (i.e. the existing e-cigarette production and operation entities) before the release of the Decision on November 10, 2021, can continue to carry out production and operation activities, and they should apply for relevant licenses and product technical evaluation by the requirements of the e-cigarette Administration Measures, the e-cigarette national standards and supporting policies, and carry out product compliance design. Complete product transformation, and coordinate with tobacco monopoly administrative departments at all levels to carry out e-cigarette supervision in an orderly manner. At the same time, to regulate the order of the e-cigarette market, bring the e-cigarette industry into the legal and standardized track steadily, and connect with the newly revised Regulations on the Implementation of the Tobacco Monopoly Law of the People's Republic of China, the Measures for the Administration of E-cigarettes, the national standards and supporting policies of e-cigarettes, continue to implement the relevant requirements during the transition period: All kinds of investors are not allowed to invest in new e-cigarette production and management enterprises temporarily; Production and business entities of existing e-cigarettes are not allowed to build or expand production capacity, and they are not allowed to set up new e-cigarette retail sites. The departments of tobacco monopoly administration at all levels shall not accept the license applications of enterprises or production sites of e-cigarettes, atomizers, and nicotine for e-cigarettes that are newly established in violation of regulations during the transitional period; It will not accept the license applications of newly added retail market entities in violation of the transitional period; Applications to expand production capacity of e-cigarette, aerosol and e-cigarette nicotine manufacturers that existed before the release of the decision will not be processed (the specific processing time will be notified separately). Market regulatory authorities shall not, according to relevant regulations, issue the business licenses of production enterprises or production points and retail market entities of e-cigarettes, atomizers, and nicotine for e-cigarettes that are newly established in violation of regulations during the transition period.

After the end of the transition period, e-cigarette producers and marketers must carry out production and marketing activities in strict accordance with the Law of the People's Republic of China on Tobacco Monopoly, the Regulations on the Implementation of the Law of the People's Republic of China on Tobacco Monopoly, the Measures for the Administration of e-cigarettes and the national standards of e-cigarettes.

4. 4. What kind of tobacco monopoly license do market entities engaged in the production, wholesale and retail of e-cigarettes need respectively?

A: Those engaged in the production or operation of e-cigarettes, atomizers, and nicotine for e-cigarettes shall apply to the competent department of tobacco monopoly administration for a tobacco monopoly production enterprise license according to law; Enterprises that have obtained the license of tobacco monopoly wholesale enterprises shall obtain the approval of the department of tobacco monopoly administration, and may only engage in the wholesale business of electronic cigarette products after changing the scope of the license. Anyone engaged in the retail business of e-cigarettes shall apply to the department of tobacco monopoly administration for a tobacco monopoly retail license or change the scope of the license.

5. How to apply for a tobacco Monopoly Production Enterprise License?

A: Enterprises producing e-cigarettes, aerosol, and nicotine for e-cigarettes shall apply for a tobacco monopoly production enterprise license. The applicant may apply at the license processing window of the provincial tobacco monopoly administrative departments (including the Tobacco Monopoly Administration of Dalian City and Shenzhen City, the same below) where his domicile (main business premises or business premises, the same below) is located or at the online administrative license processing platform of the tobacco monopoly administrative department under The State Council. Detailed procedures and required materials can be found on the government website of the department of tobacco monopoly Administration under The State Council.

During the transition period, the tobacco monopoly administrative department will accept license applications from market entities that have registered with the market regulatory authorities before the release of the Decision on November 10, 2021, and have faithfully completed the information declaration of e-cigarette production and operation entities (i.e., manufacturers of stock e-cigarettes, atomizers, and e-cigarette nicotine, etc.); License applications for expanding production capacity of existing e-cigarettes, atomizers and e-cigarette nicotine manufacturers will not be accepted temporarily (the specific acceptance time will be notified separately); License applications from manufacturers or production sites of e-cigarettes, aerosol and nicotine for e-cigarettes that have been illegally established during the transition period will not be accepted. Starting from May 5, 2022, enterprises producing electronic cigarettes, aerosol, and nicotine for e-cigarettes can apply for a tobacco monopoly production enterprise license to the provincial department of tobacco monopoly administration where they are located, and then submit a formal application according to the scheduling requirements.

After the transition period ends, the tobacco monopoly administrative department will accept license applications from market players that comply with laws and regulations and relevant provisions.

6. how to apply for a tobacco monopoly wholesale enterprise license?

A: Enterprises that have obtained tobacco monopoly wholesale enterprise licenses can apply to engage in the e-cigarette wholesale business. Enterprises that have obtained the license of tobacco monopoly wholesale enterprise can only engage in the wholesale business of electronic cigarettes after the approval of the administrative department of the tobacco monopoly to change the scope of the license.

7. How to apply for a tobacco monopoly retail License?

 A: Market entities engaged in the retail business of e-cigarettes (including cigarette bombs, cigarette sets, and the products sold in combination with cigarette sets) can apply for the tobacco monopoly retail license through the prefecture-level or county-level tobacco monopoly license handling window where the business place is located or through the online administrative license handling platform of the administrative department of tobacco monopoly Administration under The State Council. Detailed procedures and required materials can be found on the government website of the department of tobacco monopoly Administration under The State Council.

During the transition period, the tobacco monopoly administrative department will accept the license applications of e-cigarette retail market entities (i.e. the stock of e-cigarette retail market entities) that have registered with the market regulatory authorities before the release of the Decision on November 10, 2021, and have faithfully completed the information declaration of e-cigarette production and operation entities; License applications from new e-cigarette retail market players illegally added during the transition period will not be accepted. Starting from June 1, 2022, players in the stock e-cigarette retail market can submit applications for tobacco monopoly retail licenses to the prefecture-level and county-level tobacco monopoly administrative departments where their business sites are located.

After the transition period ends, the tobacco monopoly administrative department will accept license applications from market players that comply with laws and regulations and relevant provisions.

8. Why should an e-cigarette product technical review be conducted? How to apply?

A: Technical review is a necessary measure to safeguard people's health and the legitimate rights and interests of consumers, and to ensure product quality and safety. The department of tobacco monopoly administration under The State Council shall organize a specialized organization to conduct the technical evaluation. After the implementation of the Measures on the Administration of e-cigarettes, the applicant may apply for technical evaluation to the provincial department of tobacco monopoly administration where the enterprise is located through the e-cigarette technical evaluation management system.

9. When will the e-cigarette trading management platform be launched?

A: Building a unified national e-cigarette trading management platform is an important link to standardize the order of the e-cigarette market and promote the orderly operation of the e-cigarette industry. After the launch and operation of the trading management platform, e-cigarette-related manufacturers, wholesale enterprises and retail market players with tobacco monopoly licenses, as well as e-cigarette products that have passed the technical review shall be traded on the platform.

Since June 15, 2022, vaping-related manufacturers, wholesale enterprises, and retail market players with tobacco monopoly licenses have gradually conducted transactions on the platform.

10. What are the outstanding features of the national standard technical content of e-cigarettes?

A: The e-cigarette Regulations explicitly prohibit the sale of flavored e-cigarettes other than tobacco flavors and e-cigarettes that can add their aerosol. Based on the regulatory requirements of the Measures for the Administration of e-cigarettes, in line with international regulatory trends and drawing on international regulatory experience, the national standards for e-cigarettes put forward scientific and applicable technical contents. Its outstanding features are as follows: First, it stipulates that e-cigarettes are "electronic delivery systems used to produce aerosols for people to smoke", and includes non-nicotine e-cigarettes in the scope of the definition of e-cigarettes. Second, given the strong attraction of fruits, food, drinks, and other flavored e-cigarettes and non-nicotine e-cigarettes to minors, easy to induce minors to smoke, the standard stipulates that the product flavor should not show other flavors except tobacco, and requires that "aerosol should contain nicotine", that is, non-nicotine e-cigarette products are not allowed to enter the market. Third, based on the principles of the use of additives, the standard lists 101 additives that are allowed to be used and includes them on the "white list" of additives after sufficient safety risk assessment, experimental verification, and extensive consultation.

11. The National standard for e-cigarettes will be officially implemented on October 1 this year. What is the consideration for setting the implementation date?

A: According to the relevant provisions of Article 25 of the Standardization Law of the People's Republic of China, products and services that do not meet the mandatory standards shall not be produced, sold, imported, or provided. After the standards are officially implemented, e-cigarette products on the market must meet national standards. Considering after the release of the national standard for e-cigarettes, e-cigarette manufacturers need to carry out compliance design of products according to the requirements of the standard, complete product transformation, and apply for product testing and technical evaluation from relevant departments, all of which will take a certain amount of time, so the implementation transition period of 5 months is set. During the implementation of the transition period, e-cigarette manufacturers should carry out standard publicity and consistent training, an in-depth understanding of the standard technical content, and achieve product standards as soon as possible.

12. What will the tobacco monopoly administration departments at all levels focus on in terms of e-cigarette-related government services?

A: Tobacco monopoly administrative departments at all levels will actively carry out policy publicity, guide e-cigarette producers and marketers to be honest and trustworthy, fulfill their product quality and safety responsibilities, and carry out production and marketing activities by laws and regulations. By the reform requirements of "regulation and service", improve the standardization and facilitation of government services, improve the government service platform, strengthen the business guidance and government services for relevant business entities, and guide the e-cigarette production and business entities to apply for relevant licenses and product technical evaluation by the "e-cigarette Administration Measures", "e-cigarette" national standards and relevant policy requirements. The legitimate rights and interests of administrative counterparts are fully protected.

13. 13. What measures have the tobacco monopoly administration departments taken recently to investigate and punish violations of laws and regulations related to e-cigarettes?

A: The department of tobacco monopoly administration will, by the Law of the People's Republic of China on the Protection of Minors, the Law of the People's Republic of China on Tobacco Monopoly, the Regulations on the Implementation of the Law of the People's Republic of China on Tobacco Monopoly and the Measures for the Administration of e-Cigarettes and other provisions, urge all kinds of e-cigarette market players to carry out production and business operations by the laws and regulations, and investigate and punish behaviors in violation of the relevant policies of the transitional period. Work with and cooperate with relevant departments to strengthen special control, focus on cleaning up e-cigarette sales outlets and e-cigarette vending machines around primary and secondary schools, delete online e-cigarette sales information, investigate and punish illegal cases such as selling e-cigarettes to minors, and detect typical illegal and criminal cases of new drugs such as "an e-cigarette on top", such as adding synthetic cannabinoids. Effectively protect and safeguard the legitimate rights and interests of minors and consumers.

14. 14. How to report the illegal production and operation of e-cigarettes?

A: If anyone finds any illegal acts such as selling e-cigarettes to minors, producing and selling fake or substandard e-cigarettes, or selling e-cigarettes through the information network, he or she may call the tobacco market supervision service hotline 12313 or provide clues of illegal acts through the reporting channels published on the government websites of local departments of tobacco monopoly administration. The departments of the tobacco monopoly administration will verify and deal with such illegal acts according to law. We will protect the legitimate rights and interests of consumers.

15. What are the next regulations regarding e-cigarettes?

A: The department of tobacco monopoly Administration under The State Council will soon publish relevant policy documents on e-cigarette license management, technical review, and evaluation, product traceability, etc. It will successively introduce supporting policies and implementation rules for e-cigarette product quality supervision and random inspection, identification testing, product packaging, etc. It will coordinate relevant departments to study and formulate policies on warning signs, inspection and testing institutions, taxation, delivery, entry and carry, etc. Establish and improve the supporting policy system.