Five Feasible Options for Regulating China's E-cigarette Industry
The regulation of e-cigarettes is drawing increasing attention. China is the world's largest producer of e-cigarettes, with about 90% of global production coming from Shenzhen, Guangdong. China is also the world's largest consumer of tobacco products, acc
Electronic cigarette regulation issues are attracting more and more attention. China is the world's largest producer of e-cigarettes, and about 90% of the world's e-cigarettes are produced in Shenzhen, Guangdong Province. China is also the world's largest consumer of tobacco, accounting for about one-third of the global total. Strong e-cigarette production capacity and huge potential market demand have witnessed the rapid development of e-cigarette consumption in China in recent years. What is disturbing is that for a long time, the government's supervision of e-cigarettes has been basically blank. Whether they are practitioners in the e-cigarette industry or the vast audience who are using e-cigarettes, they are paying attention to what method the government should adopt to regulate e-cigarettes.
This paper attempts to start with the emergence and development of e-cigarettes in China, sort out the current situation and problems of government supervision, and use the comparison and analysis of regulatory paths in the United States, Japan and other countries to discuss and outlook feasible strategies for e-cigarette supervision in China.
1. Generation and development
It is generally believed that e-cigarettes were first invented by Han Li of the Liaoning Province Institute of Traditional Chinese Medicine, China, in 2003 and obtained a product patent. In May 2004, Ruyan Company began selling e-cigarette products in the China market. After 2005, exports to the international market successively began.
From the working principle point of view, e-cigarettes generally adopt the principle of supercritical physical atomization. E-liquid is atomized through electronic heating, and the user breathes it into the lungs through breathing, thereby achieving the effect of smoking traditional tobacco products. The vast majority of e-cigarettes contain tobacco or nicotine.
In recent years, e-cigarettes have become rapidly popular in society and consumption is booming, and consumption is growing every year. In 2013, the size of China's e-cigarette market reached 3.5 billion yuan, with a growth rate of 150%. In 2014, the e-cigarette market continued to show spurt growth, with market sales increasing by 263% year-on-year, and users increasing by 259%. The total sales of the top ten brands in Taobao sales reached 140 million yuan. Industry research experts predict that the compound growth rate of the e-cigarette market will exceed 30% in the next 5 to 10 years. Considering China's huge smoking population, even a 1 percent replacement rate of e-cigarettes is enough to form a huge market of tens of billions of yuan. At the same time, as foreign countries have successively introduced regulatory measures for e-cigarettes, China's local manufacturers are turning to seek to further expand the domestic market. Faced with a potential consumer market, China Tobacco Corporation (co-located with the State Tobacco Monopoly Administration) has also begun to enter this field and organize cooperative research and development. In 2014, Hubei China Tobacco Industrial Company had e-cigarette products launched.
2. Regulation status of e-cigarettes in China
Despite the rapid rise of China's e-cigarette industry and the popularity of products in the market, government supervision of e-cigarettes is basically blank. The public sector associated with this product seems to be dodging primary regulatory responsibilities, consciously or unintentionally.
Combing the responses and regulatory attitudes of relevant government departments to the Ruyan incident that hit the country in 2006 is undoubtedly a good entry point for understanding the status and problems of e-cigarette supervision in China in recent years.
On May 29, 2006, at the "2006 China Smoking and Health Report" press conference hosted by the former Ministry of Health (now the National Health and Family Planning Commission), the official responded to the regulatory issues of Ruyan, a smoking cessation product for the first time. The main views of the Ministry of Health are:
The product must go to the health department for safety and toxicology tests;
Nicotine (nicotine) is a dangerous chemical and must be regulated by China's Hazardous Chemicals Management Regulations; the management of Ruyan involves multiple government departments, such as the State Administration of Work Safety is responsible for supervising production safety, and the State Administration for Industry and Commerce is responsible for supervising advertising; the consensus of all departments is to increase the management of Ruyan products.
In December 2006, Xinhua Agency reported that the State Tobacco Monopoly Administration, the State Administration for Industry and Commerce, and the State Administration for Work Safety responded to the smoke issue of general concern to the public. The State Tobacco Monopoly Administration maintains that the main component of this product is high-purity nicotine (nicotine) extracted from tobacco, which is a dangerous chemical and harmful to human health; the production and sales of Ruyan should be strictly regulated in accordance with the Regulations on the Management of Hazardous Chemicals.
According to the regulations at the time, the State Tobacco Monopoly Administration and its then competent department, the National Development and Reform Commission, were not included. In other words, at that time, the State Tobacco Monopoly Administration believed that it had no main regulatory responsibility for Ruyan.# p#pagination title #e#
The State Administration of Work Safety responded that the safety of production and transportation of hazardous chemicals is supervised by the State Administration of Work Safety, and the hazards that may be caused by the use of hazardous chemicals in products should be supervised by the relevant product regulatory authorities. Currently, requests are being made on issues related to the supervision of the use of hazardous chemicals in Ruyan.& quot; The State Administration for Industry and Commerce responded that Ruyan advertisements are neither tobacco advertisements, nor drug or health product advertisements, and do not require pre-approval, so they can be released in the media. The State Administration for Industry and Commerce has noticed relevant disputes (about product attributes and safety) and has asked the health, drug supervision and safety supervision departments to identify Ruyan products. In other words, the State Administration for Industry and Commerce's management of Ruyan advertisements relies on the relevant authorities 'judgment on whether the product is a tobacco product and whether it contains toxic substances.
In June 2006, the Food and Drug Administration issued the "Notice on the Classification and Definition of White Blood Cell Recovery Systems and Other Products", which clarified that nicotine electro-nebulizer is not a medical device and advocated that this product is used to successfully eliminate the body's dependence on nicotine in smokers. The physiological needs of nicotine, relieve addiction, relieve withdrawal symptoms; it is not managed as a medical device. quot; According to a report by Science and Technology Daily in 2014, the State Food and Drug Administration believes that the Food and Drug Administration has never explicitly approved the production of e-cigarettes, so e-cigarettes are not medical devices or drugs, but only general commodities.
"The Ruyan incident seems to reflect that in the face of this emerging product, all potentially relevant authorities seem to be claiming that they are irrelevant and afraid to avoid it. It has been nearly ten years since this product attracted widespread public attention in 2006. Unfortunately, whether it is safety appraisal or the results after request, the public is still unable to learn from the media or online platforms. Since China's e-cigarette products are not tobacco products, drugs, or medical devices, they can only be regarded as general products. The government's control of e-cigarettes is still in a blank state; using e-cigarettes as a common consumer product can no longer adapt to the current situation, cannot solve the rapidly accumulating and extremely serious problems, and may further aggravate the lack of government supervision.
At present, China's e-cigarette industry is full of chaos and unsafe. In December 2014, the New York Times published an article in both Chinese and English titled regulatory vacuum and hidden killer chaos in China's e-cigarette quot; At the same time, a large number of e-cigarette products with different flavors and different nicotine content are cheap and accessible on online platforms, and even minors can freely purchase them. The market is chaotic, the quality is uneven, safety is difficult to guarantee, unlimited purchase, etc. The end result of these problems is all a violation of consumer health and economic rights, and will have a huge negative impact on the development of China's e-cigarette industry, the international image of the manufacturing industry, etc. It can be said that it is very necessary and urgent for China to strengthen the supervision of e-cigarettes.
From the perspective of regulatory theory, there are generally two options.
First, following the precautionary principle, before obtaining reliable scientific research results, the government should intervene in advance and implement strict review and approval to protect public health rights and interests. This theory undoubtedly points to relatively strict supervision of drugs.
Second, if the principle of harm reduction is advocated, taking into account the clear and significant harm of traditional cigarettes to the human body and the large number of smokers in China, e-cigarettes can achieve harm reduction to a certain extent. This theory points to relatively loose regulation based on tobacco products.
It can be seen that on the issue of e-cigarettes, different regulatory theories have brought different practical aspects. The experience of the United States and Japan is particularly worthy of attention. On the one hand, the United States and Japan are highly developed and important economies in the world today and have influential political and legal systems; on the other hand, the two countries also happen to represent the two main options for regulating e-cigarettes in the current international community, that is, e-cigarettes are regarded as medicines or tobacco products. Here, we will sort out the regulatory paths of the United States and Japan, and provide insights into how my country will regulate e-cigarettes.
3. The regulatory path of the United States and Japan and its enlightenment #p#paginated title #e#
3.1 US
In October 2008, the U.S. Food and Drug Administration (FDA) issued an order at Los Angeles International Airport to ban the import of e-cigarette products that two tobacco companies (NJOY and Smoking Everywhere) had arrived in Hong Kong. These electronic cigarette products are manufactured in China, and the two companies plan to import them and market them in the United States. The FDA believes that nicotine is a drug defined by the U.S. Food, Drug, and Cosmetic Act. Therefore, e-cigarettes containing nicotine should be reviewed and approved by the FDA for their safety and effectiveness. Companies are not allowed to import and sell e-cigarettes in the U.S. market without FDA approval.
Simply put, the FDA, as a federal government department, has tried to define e-cigarettes as drugs and regulate them in accordance with drug standards. There is no doubt that such relatively strict regulatory measures have attracted strong opposition from the two tobacco companies. They argue that the company itself has not claimed that e-cigarettes are products with health benefits such as smoking cessation. Therefore, the FDA cannot force e-cigarettes to be included in the category of drugs without authorization, but can only regulate e-cigarettes in accordance with tobacco products (although tobacco products are currently regulated by the FDA, generally speaking, regulatory standards such as safety and effectiveness are lower than those for drugs). For details, see:Smoking Everywhere, Inc. v. Food &Drug Admin., 680F.Supp.2d 62.
Since then, the FDA will regulate e-cigarettes as tobacco products. E-cigarette manufacturers must submit product ingredient information to the FDA. If a new e-cigarette product is marketed, a new product application must be submitted and approved by the FDA. At the same time, the FDA has designed tobacco control measures for e-cigarette products, including purchase age limits, packaging health warnings, cigarette vending restrictions, etc.
In summary, the U.S. federal government tried to include e-cigarettes as drugs, but was forced to change course after the court interpreted the law, and eventually regulated e-cigarettes as tobacco products. On the one hand, the initial regulatory direction is to mandatory requirements for companies to provide product information to help the public know the chemical components such as nicotine in e-cigarettes, and to design certain purchase and use restrictions; on the other hand, the FDA has not required e-cigarettes that are already on the market to carry out similar drug standards approval on safety, effectiveness, etc., so that people can still choose and purchase e-cigarettes relatively freely in the market.
3.2 Japan
Japan's Ministry of Finance has long had the legal authority to regulate the country's tobacco products and is the de facto controller of Japan's only local tobacco company, Nihon Tobacco Industries. In the statement on the purpose of legislation in Article 1 of Japan's Tobacco Commerce Law, it emphasizes the important position of promoting the healthy development of the tobacco industry and ensuring the stability of government fiscal revenue.
The regulatory choice facing Japan is whether e-cigarettes should be regarded as tobacco products under the supervision of the Ministry of Finance or as drugs under the supervision of the Ministry of Health. In early December 2010, the Japanese Ministry of Health explained Japan's Pharmaceutical Affairs Law, believing that the law should apply to the regulation of e-cigarettes. Japan's Ministry of Health maintains that tobacco products in the Tobacco Commerce Law refer to products that are composed wholly or partially of tobacco leaves and can be inhaled, chewed or smelled. Tobacco leaf is defined here as the leaves of tobacco plants in the genus Nicotiana. Obviously, e-cigarettes that mainly use nicotine solutions extracted from tobacco do not meet this definition. Therefore, Japan's Ministry of Health believes that e-cigarettes are not tobacco products and cannot be regulated according to tobacco products. Because e-cigarettes contain nicotine, Japan's Ministry of Health advocates that e-cigarettes should adopt a similar regulatory approach to other products containing nicotine, that is, they should be adjusted by the Pharmaceutical Affairs Law and managed in accordance with drugs. Furthermore, e-cigarette manufacturers must submit product applications to the Ministry of Health of Japan to prove their safety and effectiveness, and they can be put on the market until approval is obtained. On December 27, 2010, the Ministry of Health of Japan formally requested local governments to regulate e-cigarettes containing nicotine, prohibit pharmacies from selling or growing e-cigarettes and recall all marketed products. Judging from the actual regulatory effect, Japan temporarily bans e-cigarettes containing nicotine before they can obtain approval from the Ministry of Health of Japan. Only e-cigarettes without nicotine can be sold on the market.
3.3 Enlightenment from the regulatory path of the United States and Japan
It is not difficult to see from the above introduction and analysis that the United States and Japan face similar choices when responding to the issue of e-cigarette regulation, that is, whether e-cigarettes should be regulated as drugs or as tobacco products. As market entities, e-cigarette companies undoubtedly want to place their products in a relatively loose regulatory environment, that is, tobacco product categories rather than drugs. On the other hand, government departments, especially departments related to health and drugs, in view of their function of protecting public health, strive to adopt a relatively strict review and approval system.# p#pagination title #e#
Japan's Ministry of Health obtained regulatory authority for similar drugs through interpretation of the law, while the U.S. FDA lost the case in court and had to consider other regulatory measures in the context of tobacco products. In summary, the regulatory systems of the two countries have at least the following implications for China: the regulatory choices of the United States and Japan are essentially a reflection of their existing institutional environments, which includes the current tobacco distribution system and regulatory model. It also includes the legal definition of drugs and tobacco products, the level of authority of relevant authorities, etc.
4. Discussion on the regulatory path of e-cigarettes in China
4.1 Boundaries defined by current laws
From a broader perspective, China's e-cigarette supervision is nothing more than five options, namely, not to supervise or only as a general product;
Regulated by tobacco products;
According to drug supervision;
Regulated by medical device;
Comprehensive ban.
Judging from China's rapidly developing e-cigarette market, relatively huge tobacco demand, and numerous problems in the e-cigarette industry, a comprehensive ban on or non-supervision of e-cigarettes (or just supervision as a general product) is not a reasonable choice at the moment, as discussed above. The next question is, which of the three paths will our government follow: tobacco product supervision, drug supervision, and medical device supervision? Among the existing legal frameworks, which is the most feasible?
Article 2 of the Tobacco Monopoly Law of the People's Republic of China promulgated and implemented by China in 1991 defines the concept of tobacco monopoly goods and tobacco products. Tobacco monopoly goods refer to cigarettes, cigars, cut tobacco, recured tobacco leaves, tobacco paper, filter rods, cigarette tow, and tobacco special machinery. Cigarettes, cigars, cut tobacco, and recured tobacco are collectively referred to as tobacco products.
The Tobacco Monopoly Law adopts an enumerative method to define tobacco monopoly commodities and tobacco products. Obviously, e-cigarettes are not listed, so they cannot be directly classified as tobacco monopoly products or tobacco products from the legal definition. However, it is worth noting that such an enumerative definition does not exclude e-cigarettes. It is uncertain whether e-cigarettes containing nicotine may be interpreted by relevant authorities as products extracted from tobacco. However, for now, in the absence of a clear binding legal definition or interpretation, e-cigarettes cannot be directly included in tobacco products.
The Drug Administration Law of the People's Republic of China revised in 2001 defines the concept of drugs in Article 102 of the Supplementary Provisions. Drugs refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, usage and dosage. They include Chinese medicinal materials, traditional Chinese medicine pieces, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radiopharmaceuticals, serums, vaccines, blood products and diagnostic drugs.& quot; On the literal terms of the article, a product that is legally regarded as a drug must meet the requirements for preventing, treating, and diagnosing human diseases, purposefully regulating human physiological functions, and stipulating indications or functions, usage and consumption. These three conditions. In this sense, it is difficult for e-cigarettes to be directly classified into the category of drugs. However, it must be pointed out that from the perspective of the U.S. regulatory path, the claims of manufacturers and operating companies on the health effects of e-cigarettes will effectively encourage the competent authorities to supervise them in accordance with drugs. The situation in China's e-cigarette market is precisely that since the birth of e-cigarettes to this day, a large number of e-cigarette manufacturers and operators have actively claimed the health effects of their products in advertisements, such as health, low harm, and help to quit smoking. Without relevant scientific evidence, these advertising content obviously must be adjusted by the Advertising Law and regulated by the competent authorities. However, the extent to which companies 'claims on the health benefits of e-cigarettes may cause drug regulators to regulate electronics as drugs remains unclear. Article 48 of the Drug Administration Law stipulates that those who pass off non-drugs as drugs or pass off other drugs as such drugs are counterfeit drugs, which may provide some discretion for the drug regulatory authorities to regulate e-cigarettes at the law enforcement level.
Article 76 of the Regulations on the Supervision and Administration of Medical Devices, which came into effect in June 2014, defines the concept of medical devices. As we all know, the key difference between medical devices and drugs is that their effectiveness is mainly obtained through physical means.
In terms of working principle, although e-cigarettes allow nicotine smoke liquid to be inhaled by the human body through the physical method of atomization, it is still the nigudin contained in it that ultimately adjusts human functions and exerts practical effects. In other words, e-cigarettes are mainly effective through pharmacology, metabolism and other methods, while physical methods only play a supporting role here and are essentially different from medical equipment. Therefore, from a legal perspective, e-cigarettes can basically be excluded from the category of medical devices. In future legislative considerations, it is not suitable as a feasible option.# p#pagination title #e#
The above comb can be seen in China electronic cigarettes can not directly, clearly fall into the tobacco products, drugs, medical devices in any of the three legal definition.
4.2 Electronic cigarettes as medicines
In China, regulating e-cigarettes as a drug is the most feasible solution at present, and a certain basis can be found in theory and reality. The precautionary principle requires the government to adopt relatively strict regulatory measures to protect the public interest without sufficient scientific evidence to prove product safety. At present, scientific research on e-cigarettes at home and abroad is relatively insufficient. E-cigarettes are products that directly affect the human body and are closely related to health. The government's adoption of relatively strong regulatory measures has its legitimate basis. From a realistic point of view, the opinions of e-cigarette manufacturers and operators on the health benefits of products also provide a basis for the government to supervise drugs.
A study on the website content of e-cigarette distributors on China's online platforms showed that 89% of distributors advocate that e-cigarettes have health-related benefits, 78% advocate that there is no harm from secondhand smoke exposure, and 67% advocate that they have the effect of quitting smoking. Searching for keywords in a certain treasure e-cigarette, the top 30 products ranked according to sales volume without exception, all emphasized the health benefits of the product in prominent positions in the title and content, such as text or pictures such as smoking cessation and harmlessness.
Judging from international experience, once a distribution company actively declares the health effects of e-cigarettes, there is a strong legitimate basis for regulating them according to the drug. This will not only help prevent companies from transmitting misleading information to consumers, but also protect consumers from reasonable expectations of products due to merchants 'publicity. If e-cigarettes are classified as drugs, it will inevitably involve modifications or interpretations of the current drug definition. The Drug Administration Law has been included in the legislative plan of this National People's Congress and is expected to be revised during the term of this National People's Congress (ie, March 2013 to March 2018). The improvement of the definition of drugs in the current Drug Administration Law is one of the contents of this amendment. In internal discussions, experts on amending the law have suggested that the discretion of the competent authorities can be appropriately expanded to give them the power to decide which products are drugs, so as to increase the crackdown on illegal products. If such changes can be achieved in the near future, it is not impossible for e-cigarettes to be included in the scope of drugs.
In fact, China has always regulated many products containing nicotine as licensed drugs. In the State Food and Drug Administration's public inquiry database, there are currently 24 drugs containing nicotine, including 2 domestic drugs and 22 imported drugs, including chewing gum, patches, transdermal patches, sublingual tablets, chemical raw materials and other product types.
It is not difficult to imagine several benefits of regulating e-cigarettes as drugs. China's drug management implements a relatively strict administrative licensing and certification management system, and is working towards establishing the strictest drug supervision system. In the context of relatively limited scientific evidence, producers take the initiative to apply for product marketing authorization and provide relevant clinical trials and other research information. Drug regulatory authorities organize experts to review product safety, effectiveness and other indicators to decide whether to approve listing. After a product is approved for marketing, it must also undergo supervision throughout the entire life cycle, such as various supervision inspections and unannounced inspections carried out in accordance with certification standards such as Good Manufacturing Practices (GMP). Although good product quality is not regulated by the competent authorities, a relatively strict review, approval, and supervision and inspection system is undoubtedly necessary to regulate the behavior of manufacturing and operating enterprises and maintain market order, and will ultimately benefit consumers. Get products with more guaranteed quality. In addition, after e-cigarettes are included in drugs, current pharmaceutical laws and regulations will inevitably be directly applicable to e-cigarette products. For example, in the regulations on drug labeling and instructions management, drugs must be marked with the main ingredients, usage and dosage, variety specifications, contraindications and other information. This will undoubtedly allow consumers to have a more comprehensive understanding of e-cigarette product information, and then use this new product scientifically and rationally.
However, we should also see the disadvantages of regulating e-cigarettes as drugs. The most significant drawbacks are probably the following: If electronics are regarded as drugs for supervision, before the company obtains drug approval from the competent authority, all e-cigarettes on the market will become illegal. In fact, a ban on e-cigarettes will be issued. Such a ban could cause a large number of e-cigarette consumers to switch to traditional tobacco products. In addition, if the e-cigarette industry reaches an agreement and eventually abandons marketing about health benefits, as happened in U.S. courts, whether there is sufficient basis for regulating e-cigarettes in accordance with drugs is debatable.
The problems that occurred after Japan included e-cigarettes in drug management are also worthy of attention. China has a similar national tobacco monopoly system, and tobacco profits and taxes account for a considerable proportion of both central and local fiscal revenue. Even if e-cigarettes using nicotine are included in the scope of drug management, e-cigarettes burning traditional tobacco leaves are likely to still need to be managed in accordance with the Tobacco Monopoly Law and through the current tobacco monopoly system. Products with almost the same appearance, working principles, and usage methods form a dual-track system under the torque of the current system. It may not only bring about an unfavorable situation of multi-department governance and shirk responsibility, but also make this system design seem inconsistent.# p#pagination title #e#
4.3 Electronic cigarettes as tobacco products
Regulating e-cigarettes as tobacco products can solve the above-mentioned problems caused by drug supervision to a certain extent. Under the harm mitigation theory, considering the clear health harm of traditional tobacco products, using e-cigarettes as a tobacco product will undoubtedly continue to ensure product accessibility on the market and may lead traditional smokers to try this healthier product. If e-cigarettes are classified as tobacco products, it will also involve modifications or interpretations of the current definitions of tobacco products and tobacco monopoly products.
In 2013, media reported that a judicial interpretation of the Tobacco Monopoly Law would be issued, which stipulated that tobacco monopoly should be implemented for e-cigarettes containing nicotine. However, such judicial interpretations have not yet been officially recognized. From the perspective of the current tobacco monopoly system, China's tobacco monopoly system has entered the legal track for more than 30 years, forming a relatively mature management system, and actually plays the role of managing the entire country's tobacco products through human, financial, material, production, supply, marketing, domestic, foreign and trade.
The official website of the China Tobacco Monopoly Bureau shows that the national tobacco industry includes 33 provincial tobacco monopoly bureaus and tobacco companies, with 510,000 employees across the industry. In recent years, tobacco monopoly authorities have gradually carried out research on e-cigarettes, including product development, regulatory policies, etc. It should be said that the tobacco monopoly authorities have shifted from evading regulatory functions after the Ruyan incident to having certain expectations of regulating e-cigarettes as tobacco products. At the same time, profits and taxes generated from operating e-cigarettes are also helpful to government revenue.
Since the founding of New China, tobacco profits and taxes have continued to grow and are an important source of national fiscal revenue. In 2010, the tobacco industry paid 498.8 billion yuan in various taxes and fees, accounting for about 6.0% of the country's total fiscal revenue. In 2014, the total fiscal amount paid by the tobacco industry for the year reached 911.03 billion yuan, accounting for 6.49% of the total fiscal revenue.
Obviously, in recent years, the tobacco industry has made certain contributions to national finance through taxes and state-owned capital gains. Currently, e-cigarettes, as a general consumer product, do not belong to the national tobacco monopoly system. If they are included in tobacco products, the profits and taxes that follow will be obvious. But it must be noted that the challenges faced by regulating e-cigarettes as tobacco products will also be huge. The first is how to integrate the current tobacco monopoly system with a large number of e-cigarette production and processing companies. The vast majority of e-cigarette manufacturers in China are private enterprises in Shenzhen, which exist independently of local tobacco companies and the national tobacco monopoly system. If e-cigarettes are defined as tobacco products overnight through legal amendments or judicial interpretations, how and whether the tobacco monopoly authorities can complete the huge integration task brought about by this conceptual change in a timely and effective manner is undoubtedly a huge problem. Secondly, whether the competent authorities have sufficient resources to perform their regulatory duties under the law is also worthy of attention. The main supervision and management experience of the tobacco monopoly authorities is in the field of traditional tobacco products. The equipment, personnel, technical conditions and other resources needed to supervise new products such as e-cigarettes need to be planned in advance. In addition, in the face of a large number of current market entities distributing e-cigarettes based on various Internet platforms, the competent authorities must effectively assume their responsibilities and perform their duties to carry out relevant law enforcement, which will undoubtedly be full of challenges.
Finally, my country's policy environment is also worth thinking about. The State Tobacco Monopoly Administration of China is not only a member of the Implementation Group of the Framework Convention on Tobacco Control and undertakes the function of controlling tobacco. It must also shoulder the important responsibilities of tobacco product management, tobacco industry development, and profit and tax creation. Such contradictory duty settings exist for more than a day and may continue to emerge on e-cigarette regulatory issues.
V. Conclusion and Outlook
In the current China context, there is no ready-made system that can be used immediately. In China, including e-cigarettes as drugs or tobacco products is the most feasible regulatory path, but both will involve modifications or interpretations of existing laws. Before any regulatory path is established, China's e-cigarette production quality standards will be formulated and improved.
Relevant standards should include but are not limited to e-cigarette production raw materials, nicotine concentration, heavy metal content, cigarette liquid taste and additives. The government's e-cigarette regulatory policies may have the following three different practical impacts: First, considering the clear harm of traditional tobacco, China's e-cigarette regulatory policies should be relatively loose to promote more people who smoke traditional cigarettes to switch to e-cigarettes. Second, e-cigarette regulatory policies should be stricter to prevent people from becoming addicted to nicotine due to the use of e-cigarettes, and then embark on the old path of smoking traditional cigarettes, and ultimately achieve the goal of controlling the national smoking rate. Third, placing e-cigarettes in the category of tobacco products means that e-cigarettes will be subject to a certain degree of supervision, but the price may be that e-cigarettes enjoy China's relatively loose tobacco control policies.# p#pagination title #e#
Note: The content comes from the Zhihu column, the author is fried tofu pudding PLUS, reproduced for reference only.
This paper attempts to start with the emergence and development of e-cigarettes in China, sort out the current situation and problems of government supervision, and use the comparison and analysis of regulatory paths in the United States, Japan and other countries to discuss and outlook feasible strategies for e-cigarette supervision in China.
1. Generation and developmentIt is generally believed that e-cigarettes were first invented by Han Li of the Liaoning Province Institute of Traditional Chinese Medicine, China, in 2003 and obtained a product patent. In May 2004, Ruyan Company began selling e-cigarette products in the China market. After 2005, exports to the international market successively began.
From the working principle point of view, e-cigarettes generally adopt the principle of supercritical physical atomization. E-liquid is atomized through electronic heating, and the user breathes it into the lungs through breathing, thereby achieving the effect of smoking traditional tobacco products. The vast majority of e-cigarettes contain tobacco or nicotine.
In recent years, e-cigarettes have become rapidly popular in society and consumption is booming, and consumption is growing every year. In 2013, the size of China's e-cigarette market reached 3.5 billion yuan, with a growth rate of 150%. In 2014, the e-cigarette market continued to show spurt growth, with market sales increasing by 263% year-on-year, and users increasing by 259%. The total sales of the top ten brands in Taobao sales reached 140 million yuan. Industry research experts predict that the compound growth rate of the e-cigarette market will exceed 30% in the next 5 to 10 years. Considering China's huge smoking population, even a 1 percent replacement rate of e-cigarettes is enough to form a huge market of tens of billions of yuan. At the same time, as foreign countries have successively introduced regulatory measures for e-cigarettes, China's local manufacturers are turning to seek to further expand the domestic market. Faced with a potential consumer market, China Tobacco Corporation (co-located with the State Tobacco Monopoly Administration) has also begun to enter this field and organize cooperative research and development. In 2014, Hubei China Tobacco Industrial Company had e-cigarette products launched.
2. Regulation status of e-cigarettes in China
Despite the rapid rise of China's e-cigarette industry and the popularity of products in the market, government supervision of e-cigarettes is basically blank. The public sector associated with this product seems to be dodging primary regulatory responsibilities, consciously or unintentionally.
Combing the responses and regulatory attitudes of relevant government departments to the Ruyan incident that hit the country in 2006 is undoubtedly a good entry point for understanding the status and problems of e-cigarette supervision in China in recent years.
On May 29, 2006, at the "2006 China Smoking and Health Report" press conference hosted by the former Ministry of Health (now the National Health and Family Planning Commission), the official responded to the regulatory issues of Ruyan, a smoking cessation product for the first time. The main views of the Ministry of Health are:
The product must go to the health department for safety and toxicology tests;
Nicotine (nicotine) is a dangerous chemical and must be regulated by China's Hazardous Chemicals Management Regulations; the management of Ruyan involves multiple government departments, such as the State Administration of Work Safety is responsible for supervising production safety, and the State Administration for Industry and Commerce is responsible for supervising advertising; the consensus of all departments is to increase the management of Ruyan products.
In December 2006, Xinhua Agency reported that the State Tobacco Monopoly Administration, the State Administration for Industry and Commerce, and the State Administration for Work Safety responded to the smoke issue of general concern to the public. The State Tobacco Monopoly Administration maintains that the main component of this product is high-purity nicotine (nicotine) extracted from tobacco, which is a dangerous chemical and harmful to human health; the production and sales of Ruyan should be strictly regulated in accordance with the Regulations on the Management of Hazardous Chemicals.
According to the regulations at the time, the State Tobacco Monopoly Administration and its then competent department, the National Development and Reform Commission, were not included. In other words, at that time, the State Tobacco Monopoly Administration believed that it had no main regulatory responsibility for Ruyan.# p#pagination title #e#
The State Administration of Work Safety responded that the safety of production and transportation of hazardous chemicals is supervised by the State Administration of Work Safety, and the hazards that may be caused by the use of hazardous chemicals in products should be supervised by the relevant product regulatory authorities. Currently, requests are being made on issues related to the supervision of the use of hazardous chemicals in Ruyan.& quot; The State Administration for Industry and Commerce responded that Ruyan advertisements are neither tobacco advertisements, nor drug or health product advertisements, and do not require pre-approval, so they can be released in the media. The State Administration for Industry and Commerce has noticed relevant disputes (about product attributes and safety) and has asked the health, drug supervision and safety supervision departments to identify Ruyan products. In other words, the State Administration for Industry and Commerce's management of Ruyan advertisements relies on the relevant authorities 'judgment on whether the product is a tobacco product and whether it contains toxic substances.
In June 2006, the Food and Drug Administration issued the "Notice on the Classification and Definition of White Blood Cell Recovery Systems and Other Products", which clarified that nicotine electro-nebulizer is not a medical device and advocated that this product is used to successfully eliminate the body's dependence on nicotine in smokers. The physiological needs of nicotine, relieve addiction, relieve withdrawal symptoms; it is not managed as a medical device. quot; According to a report by Science and Technology Daily in 2014, the State Food and Drug Administration believes that the Food and Drug Administration has never explicitly approved the production of e-cigarettes, so e-cigarettes are not medical devices or drugs, but only general commodities.
"The Ruyan incident seems to reflect that in the face of this emerging product, all potentially relevant authorities seem to be claiming that they are irrelevant and afraid to avoid it. It has been nearly ten years since this product attracted widespread public attention in 2006. Unfortunately, whether it is safety appraisal or the results after request, the public is still unable to learn from the media or online platforms. Since China's e-cigarette products are not tobacco products, drugs, or medical devices, they can only be regarded as general products. The government's control of e-cigarettes is still in a blank state; using e-cigarettes as a common consumer product can no longer adapt to the current situation, cannot solve the rapidly accumulating and extremely serious problems, and may further aggravate the lack of government supervision.
At present, China's e-cigarette industry is full of chaos and unsafe. In December 2014, the New York Times published an article in both Chinese and English titled regulatory vacuum and hidden killer chaos in China's e-cigarette quot; At the same time, a large number of e-cigarette products with different flavors and different nicotine content are cheap and accessible on online platforms, and even minors can freely purchase them. The market is chaotic, the quality is uneven, safety is difficult to guarantee, unlimited purchase, etc. The end result of these problems is all a violation of consumer health and economic rights, and will have a huge negative impact on the development of China's e-cigarette industry, the international image of the manufacturing industry, etc. It can be said that it is very necessary and urgent for China to strengthen the supervision of e-cigarettes.
From the perspective of regulatory theory, there are generally two options.First, following the precautionary principle, before obtaining reliable scientific research results, the government should intervene in advance and implement strict review and approval to protect public health rights and interests. This theory undoubtedly points to relatively strict supervision of drugs.
Second, if the principle of harm reduction is advocated, taking into account the clear and significant harm of traditional cigarettes to the human body and the large number of smokers in China, e-cigarettes can achieve harm reduction to a certain extent. This theory points to relatively loose regulation based on tobacco products.
It can be seen that on the issue of e-cigarettes, different regulatory theories have brought different practical aspects. The experience of the United States and Japan is particularly worthy of attention. On the one hand, the United States and Japan are highly developed and important economies in the world today and have influential political and legal systems; on the other hand, the two countries also happen to represent the two main options for regulating e-cigarettes in the current international community, that is, e-cigarettes are regarded as medicines or tobacco products. Here, we will sort out the regulatory paths of the United States and Japan, and provide insights into how my country will regulate e-cigarettes.
3. The regulatory path of the United States and Japan and its enlightenment #p#paginated title #e#
3.1 US
In October 2008, the U.S. Food and Drug Administration (FDA) issued an order at Los Angeles International Airport to ban the import of e-cigarette products that two tobacco companies (NJOY and Smoking Everywhere) had arrived in Hong Kong. These electronic cigarette products are manufactured in China, and the two companies plan to import them and market them in the United States. The FDA believes that nicotine is a drug defined by the U.S. Food, Drug, and Cosmetic Act. Therefore, e-cigarettes containing nicotine should be reviewed and approved by the FDA for their safety and effectiveness. Companies are not allowed to import and sell e-cigarettes in the U.S. market without FDA approval.
Simply put, the FDA, as a federal government department, has tried to define e-cigarettes as drugs and regulate them in accordance with drug standards. There is no doubt that such relatively strict regulatory measures have attracted strong opposition from the two tobacco companies. They argue that the company itself has not claimed that e-cigarettes are products with health benefits such as smoking cessation. Therefore, the FDA cannot force e-cigarettes to be included in the category of drugs without authorization, but can only regulate e-cigarettes in accordance with tobacco products (although tobacco products are currently regulated by the FDA, generally speaking, regulatory standards such as safety and effectiveness are lower than those for drugs). For details, see:Smoking Everywhere, Inc. v. Food &Drug Admin., 680F.Supp.2d 62.
Since then, the FDA will regulate e-cigarettes as tobacco products. E-cigarette manufacturers must submit product ingredient information to the FDA. If a new e-cigarette product is marketed, a new product application must be submitted and approved by the FDA. At the same time, the FDA has designed tobacco control measures for e-cigarette products, including purchase age limits, packaging health warnings, cigarette vending restrictions, etc.
In summary, the U.S. federal government tried to include e-cigarettes as drugs, but was forced to change course after the court interpreted the law, and eventually regulated e-cigarettes as tobacco products. On the one hand, the initial regulatory direction is to mandatory requirements for companies to provide product information to help the public know the chemical components such as nicotine in e-cigarettes, and to design certain purchase and use restrictions; on the other hand, the FDA has not required e-cigarettes that are already on the market to carry out similar drug standards approval on safety, effectiveness, etc., so that people can still choose and purchase e-cigarettes relatively freely in the market.
3.2 Japan
Japan's Ministry of Finance has long had the legal authority to regulate the country's tobacco products and is the de facto controller of Japan's only local tobacco company, Nihon Tobacco Industries. In the statement on the purpose of legislation in Article 1 of Japan's Tobacco Commerce Law, it emphasizes the important position of promoting the healthy development of the tobacco industry and ensuring the stability of government fiscal revenue.
The regulatory choice facing Japan is whether e-cigarettes should be regarded as tobacco products under the supervision of the Ministry of Finance or as drugs under the supervision of the Ministry of Health. In early December 2010, the Japanese Ministry of Health explained Japan's Pharmaceutical Affairs Law, believing that the law should apply to the regulation of e-cigarettes. Japan's Ministry of Health maintains that tobacco products in the Tobacco Commerce Law refer to products that are composed wholly or partially of tobacco leaves and can be inhaled, chewed or smelled. Tobacco leaf is defined here as the leaves of tobacco plants in the genus Nicotiana. Obviously, e-cigarettes that mainly use nicotine solutions extracted from tobacco do not meet this definition. Therefore, Japan's Ministry of Health believes that e-cigarettes are not tobacco products and cannot be regulated according to tobacco products. Because e-cigarettes contain nicotine, Japan's Ministry of Health advocates that e-cigarettes should adopt a similar regulatory approach to other products containing nicotine, that is, they should be adjusted by the Pharmaceutical Affairs Law and managed in accordance with drugs. Furthermore, e-cigarette manufacturers must submit product applications to the Ministry of Health of Japan to prove their safety and effectiveness, and they can be put on the market until approval is obtained. On December 27, 2010, the Ministry of Health of Japan formally requested local governments to regulate e-cigarettes containing nicotine, prohibit pharmacies from selling or growing e-cigarettes and recall all marketed products. Judging from the actual regulatory effect, Japan temporarily bans e-cigarettes containing nicotine before they can obtain approval from the Ministry of Health of Japan. Only e-cigarettes without nicotine can be sold on the market.
3.3 Enlightenment from the regulatory path of the United States and JapanIt is not difficult to see from the above introduction and analysis that the United States and Japan face similar choices when responding to the issue of e-cigarette regulation, that is, whether e-cigarettes should be regulated as drugs or as tobacco products. As market entities, e-cigarette companies undoubtedly want to place their products in a relatively loose regulatory environment, that is, tobacco product categories rather than drugs. On the other hand, government departments, especially departments related to health and drugs, in view of their function of protecting public health, strive to adopt a relatively strict review and approval system.# p#pagination title #e#
Japan's Ministry of Health obtained regulatory authority for similar drugs through interpretation of the law, while the U.S. FDA lost the case in court and had to consider other regulatory measures in the context of tobacco products. In summary, the regulatory systems of the two countries have at least the following implications for China: the regulatory choices of the United States and Japan are essentially a reflection of their existing institutional environments, which includes the current tobacco distribution system and regulatory model. It also includes the legal definition of drugs and tobacco products, the level of authority of relevant authorities, etc.
4. Discussion on the regulatory path of e-cigarettes in China
4.1 Boundaries defined by current laws
From a broader perspective, China's e-cigarette supervision is nothing more than five options, namely, not to supervise or only as a general product;
Regulated by tobacco products;
According to drug supervision;
Regulated by medical device;
Comprehensive ban.
Judging from China's rapidly developing e-cigarette market, relatively huge tobacco demand, and numerous problems in the e-cigarette industry, a comprehensive ban on or non-supervision of e-cigarettes (or just supervision as a general product) is not a reasonable choice at the moment, as discussed above. The next question is, which of the three paths will our government follow: tobacco product supervision, drug supervision, and medical device supervision? Among the existing legal frameworks, which is the most feasible?
Article 2 of the Tobacco Monopoly Law of the People's Republic of China promulgated and implemented by China in 1991 defines the concept of tobacco monopoly goods and tobacco products. Tobacco monopoly goods refer to cigarettes, cigars, cut tobacco, recured tobacco leaves, tobacco paper, filter rods, cigarette tow, and tobacco special machinery. Cigarettes, cigars, cut tobacco, and recured tobacco are collectively referred to as tobacco products.
The Tobacco Monopoly Law adopts an enumerative method to define tobacco monopoly commodities and tobacco products. Obviously, e-cigarettes are not listed, so they cannot be directly classified as tobacco monopoly products or tobacco products from the legal definition. However, it is worth noting that such an enumerative definition does not exclude e-cigarettes. It is uncertain whether e-cigarettes containing nicotine may be interpreted by relevant authorities as products extracted from tobacco. However, for now, in the absence of a clear binding legal definition or interpretation, e-cigarettes cannot be directly included in tobacco products.
The Drug Administration Law of the People's Republic of China revised in 2001 defines the concept of drugs in Article 102 of the Supplementary Provisions. Drugs refer to substances used to prevent, treat, and diagnose human diseases, purposefully regulate human physiological functions, and specify indications or functional indications, usage and dosage. They include Chinese medicinal materials, traditional Chinese medicine pieces, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotics, biochemical drugs, radiopharmaceuticals, serums, vaccines, blood products and diagnostic drugs.& quot; On the literal terms of the article, a product that is legally regarded as a drug must meet the requirements for preventing, treating, and diagnosing human diseases, purposefully regulating human physiological functions, and stipulating indications or functions, usage and consumption. These three conditions. In this sense, it is difficult for e-cigarettes to be directly classified into the category of drugs. However, it must be pointed out that from the perspective of the U.S. regulatory path, the claims of manufacturers and operating companies on the health effects of e-cigarettes will effectively encourage the competent authorities to supervise them in accordance with drugs. The situation in China's e-cigarette market is precisely that since the birth of e-cigarettes to this day, a large number of e-cigarette manufacturers and operators have actively claimed the health effects of their products in advertisements, such as health, low harm, and help to quit smoking. Without relevant scientific evidence, these advertising content obviously must be adjusted by the Advertising Law and regulated by the competent authorities. However, the extent to which companies 'claims on the health benefits of e-cigarettes may cause drug regulators to regulate electronics as drugs remains unclear. Article 48 of the Drug Administration Law stipulates that those who pass off non-drugs as drugs or pass off other drugs as such drugs are counterfeit drugs, which may provide some discretion for the drug regulatory authorities to regulate e-cigarettes at the law enforcement level.
Article 76 of the Regulations on the Supervision and Administration of Medical Devices, which came into effect in June 2014, defines the concept of medical devices. As we all know, the key difference between medical devices and drugs is that their effectiveness is mainly obtained through physical means.In terms of working principle, although e-cigarettes allow nicotine smoke liquid to be inhaled by the human body through the physical method of atomization, it is still the nigudin contained in it that ultimately adjusts human functions and exerts practical effects. In other words, e-cigarettes are mainly effective through pharmacology, metabolism and other methods, while physical methods only play a supporting role here and are essentially different from medical equipment. Therefore, from a legal perspective, e-cigarettes can basically be excluded from the category of medical devices. In future legislative considerations, it is not suitable as a feasible option.# p#pagination title #e#
The above comb can be seen in China electronic cigarettes can not directly, clearly fall into the tobacco products, drugs, medical devices in any of the three legal definition.
4.2 Electronic cigarettes as medicines
In China, regulating e-cigarettes as a drug is the most feasible solution at present, and a certain basis can be found in theory and reality. The precautionary principle requires the government to adopt relatively strict regulatory measures to protect the public interest without sufficient scientific evidence to prove product safety. At present, scientific research on e-cigarettes at home and abroad is relatively insufficient. E-cigarettes are products that directly affect the human body and are closely related to health. The government's adoption of relatively strong regulatory measures has its legitimate basis. From a realistic point of view, the opinions of e-cigarette manufacturers and operators on the health benefits of products also provide a basis for the government to supervise drugs.
A study on the website content of e-cigarette distributors on China's online platforms showed that 89% of distributors advocate that e-cigarettes have health-related benefits, 78% advocate that there is no harm from secondhand smoke exposure, and 67% advocate that they have the effect of quitting smoking. Searching for keywords in a certain treasure e-cigarette, the top 30 products ranked according to sales volume without exception, all emphasized the health benefits of the product in prominent positions in the title and content, such as text or pictures such as smoking cessation and harmlessness.
Judging from international experience, once a distribution company actively declares the health effects of e-cigarettes, there is a strong legitimate basis for regulating them according to the drug. This will not only help prevent companies from transmitting misleading information to consumers, but also protect consumers from reasonable expectations of products due to merchants 'publicity. If e-cigarettes are classified as drugs, it will inevitably involve modifications or interpretations of the current drug definition. The Drug Administration Law has been included in the legislative plan of this National People's Congress and is expected to be revised during the term of this National People's Congress (ie, March 2013 to March 2018). The improvement of the definition of drugs in the current Drug Administration Law is one of the contents of this amendment. In internal discussions, experts on amending the law have suggested that the discretion of the competent authorities can be appropriately expanded to give them the power to decide which products are drugs, so as to increase the crackdown on illegal products. If such changes can be achieved in the near future, it is not impossible for e-cigarettes to be included in the scope of drugs.
In fact, China has always regulated many products containing nicotine as licensed drugs. In the State Food and Drug Administration's public inquiry database, there are currently 24 drugs containing nicotine, including 2 domestic drugs and 22 imported drugs, including chewing gum, patches, transdermal patches, sublingual tablets, chemical raw materials and other product types.
It is not difficult to imagine several benefits of regulating e-cigarettes as drugs. China's drug management implements a relatively strict administrative licensing and certification management system, and is working towards establishing the strictest drug supervision system. In the context of relatively limited scientific evidence, producers take the initiative to apply for product marketing authorization and provide relevant clinical trials and other research information. Drug regulatory authorities organize experts to review product safety, effectiveness and other indicators to decide whether to approve listing. After a product is approved for marketing, it must also undergo supervision throughout the entire life cycle, such as various supervision inspections and unannounced inspections carried out in accordance with certification standards such as Good Manufacturing Practices (GMP). Although good product quality is not regulated by the competent authorities, a relatively strict review, approval, and supervision and inspection system is undoubtedly necessary to regulate the behavior of manufacturing and operating enterprises and maintain market order, and will ultimately benefit consumers. Get products with more guaranteed quality. In addition, after e-cigarettes are included in drugs, current pharmaceutical laws and regulations will inevitably be directly applicable to e-cigarette products. For example, in the regulations on drug labeling and instructions management, drugs must be marked with the main ingredients, usage and dosage, variety specifications, contraindications and other information. This will undoubtedly allow consumers to have a more comprehensive understanding of e-cigarette product information, and then use this new product scientifically and rationally.
However, we should also see the disadvantages of regulating e-cigarettes as drugs. The most significant drawbacks are probably the following: If electronics are regarded as drugs for supervision, before the company obtains drug approval from the competent authority, all e-cigarettes on the market will become illegal. In fact, a ban on e-cigarettes will be issued. Such a ban could cause a large number of e-cigarette consumers to switch to traditional tobacco products. In addition, if the e-cigarette industry reaches an agreement and eventually abandons marketing about health benefits, as happened in U.S. courts, whether there is sufficient basis for regulating e-cigarettes in accordance with drugs is debatable.
The problems that occurred after Japan included e-cigarettes in drug management are also worthy of attention. China has a similar national tobacco monopoly system, and tobacco profits and taxes account for a considerable proportion of both central and local fiscal revenue. Even if e-cigarettes using nicotine are included in the scope of drug management, e-cigarettes burning traditional tobacco leaves are likely to still need to be managed in accordance with the Tobacco Monopoly Law and through the current tobacco monopoly system. Products with almost the same appearance, working principles, and usage methods form a dual-track system under the torque of the current system. It may not only bring about an unfavorable situation of multi-department governance and shirk responsibility, but also make this system design seem inconsistent.# p#pagination title #e#
4.3 Electronic cigarettes as tobacco products
Regulating e-cigarettes as tobacco products can solve the above-mentioned problems caused by drug supervision to a certain extent. Under the harm mitigation theory, considering the clear health harm of traditional tobacco products, using e-cigarettes as a tobacco product will undoubtedly continue to ensure product accessibility on the market and may lead traditional smokers to try this healthier product. If e-cigarettes are classified as tobacco products, it will also involve modifications or interpretations of the current definitions of tobacco products and tobacco monopoly products.
In 2013, media reported that a judicial interpretation of the Tobacco Monopoly Law would be issued, which stipulated that tobacco monopoly should be implemented for e-cigarettes containing nicotine. However, such judicial interpretations have not yet been officially recognized. From the perspective of the current tobacco monopoly system, China's tobacco monopoly system has entered the legal track for more than 30 years, forming a relatively mature management system, and actually plays the role of managing the entire country's tobacco products through human, financial, material, production, supply, marketing, domestic, foreign and trade.
The official website of the China Tobacco Monopoly Bureau shows that the national tobacco industry includes 33 provincial tobacco monopoly bureaus and tobacco companies, with 510,000 employees across the industry. In recent years, tobacco monopoly authorities have gradually carried out research on e-cigarettes, including product development, regulatory policies, etc. It should be said that the tobacco monopoly authorities have shifted from evading regulatory functions after the Ruyan incident to having certain expectations of regulating e-cigarettes as tobacco products. At the same time, profits and taxes generated from operating e-cigarettes are also helpful to government revenue.
Since the founding of New China, tobacco profits and taxes have continued to grow and are an important source of national fiscal revenue. In 2010, the tobacco industry paid 498.8 billion yuan in various taxes and fees, accounting for about 6.0% of the country's total fiscal revenue. In 2014, the total fiscal amount paid by the tobacco industry for the year reached 911.03 billion yuan, accounting for 6.49% of the total fiscal revenue.
Obviously, in recent years, the tobacco industry has made certain contributions to national finance through taxes and state-owned capital gains. Currently, e-cigarettes, as a general consumer product, do not belong to the national tobacco monopoly system. If they are included in tobacco products, the profits and taxes that follow will be obvious. But it must be noted that the challenges faced by regulating e-cigarettes as tobacco products will also be huge. The first is how to integrate the current tobacco monopoly system with a large number of e-cigarette production and processing companies. The vast majority of e-cigarette manufacturers in China are private enterprises in Shenzhen, which exist independently of local tobacco companies and the national tobacco monopoly system. If e-cigarettes are defined as tobacco products overnight through legal amendments or judicial interpretations, how and whether the tobacco monopoly authorities can complete the huge integration task brought about by this conceptual change in a timely and effective manner is undoubtedly a huge problem. Secondly, whether the competent authorities have sufficient resources to perform their regulatory duties under the law is also worthy of attention. The main supervision and management experience of the tobacco monopoly authorities is in the field of traditional tobacco products. The equipment, personnel, technical conditions and other resources needed to supervise new products such as e-cigarettes need to be planned in advance. In addition, in the face of a large number of current market entities distributing e-cigarettes based on various Internet platforms, the competent authorities must effectively assume their responsibilities and perform their duties to carry out relevant law enforcement, which will undoubtedly be full of challenges.
Finally, my country's policy environment is also worth thinking about. The State Tobacco Monopoly Administration of China is not only a member of the Implementation Group of the Framework Convention on Tobacco Control and undertakes the function of controlling tobacco. It must also shoulder the important responsibilities of tobacco product management, tobacco industry development, and profit and tax creation. Such contradictory duty settings exist for more than a day and may continue to emerge on e-cigarette regulatory issues.
V. Conclusion and Outlook
In the current China context, there is no ready-made system that can be used immediately. In China, including e-cigarettes as drugs or tobacco products is the most feasible regulatory path, but both will involve modifications or interpretations of existing laws. Before any regulatory path is established, China's e-cigarette production quality standards will be formulated and improved.
Relevant standards should include but are not limited to e-cigarette production raw materials, nicotine concentration, heavy metal content, cigarette liquid taste and additives. The government's e-cigarette regulatory policies may have the following three different practical impacts: First, considering the clear harm of traditional tobacco, China's e-cigarette regulatory policies should be relatively loose to promote more people who smoke traditional cigarettes to switch to e-cigarettes. Second, e-cigarette regulatory policies should be stricter to prevent people from becoming addicted to nicotine due to the use of e-cigarettes, and then embark on the old path of smoking traditional cigarettes, and ultimately achieve the goal of controlling the national smoking rate. Third, placing e-cigarettes in the category of tobacco products means that e-cigarettes will be subject to a certain degree of supervision, but the price may be that e-cigarettes enjoy China's relatively loose tobacco control policies.# p#pagination title #e#
Note: The content comes from the Zhihu column, the author is fried tofu pudding PLUS, reproduced for reference only.



