2019 Roundup and Analysis of Global and China Vaping Regulations

From the trend of regulatory policy development, countries are continuously strengthening their regulation of e-cigarettes. Most government policies regarding vapor-type e-cigarettes classify them based on whether they contain nicotine and their intended use, mainly dividing them into three categories: general consumer products, pharmaceutical products, and tobacco products. China's national standards for e-cigarettes have been approved and are expected to be officially released by October 2019. Currently, HNB (heated not burned) has been clearly included in regulation, while the regulatory standards for vapor e-cigarette liquids remain unclear. However, referencing the regulatory standards of mature e-cigarette markets in North America and Europe, it is likely that future regulations will define e-cigarette production, sales, and use based on nicotine content.

The regulatory environment for e-cigarettes in various countries is rapidly improving

Among new tobacco products, e-cigarettes have been in the market longer than heated not burned products, and their regulatory policies are more mature. Based on the classification of e-cigarettes according to their attributes and the differences in whether their sale and use are prohibited, the regulatory approaches can be divided into five categories: regulation as tobacco products, regulation as pharmaceutical products, regulation as general consumer products, prohibition of sale, and prohibition of sale and use. From the table below, it can be seen that among the countries or regions that have issued e-cigarette regulatory laws, the majority regulate e-cigarettes as tobacco products or prohibit the sale of nicotine-containing e-cigarettes. In major tobacco-consuming countries, both China and Russia regard them as general consumer products without additional regulatory laws, while the US and some EU countries regulate them as tobacco products, and Indonesia and Japan prohibit the sale of nicotine-containing e-cigarettes.
 
As the penetration and popularity of new tobacco products gradually increase, countries around the world are successively introducing policies regarding new tobacco products, and the regulatory measures for these products are becoming clearer. Currently, government policies regarding vapor-type e-cigarettes are mainly divided into three categories based on whether they contain nicotine and their intended use: general consumer products, pharmaceutical products, and tobacco products.

The US Food and Drug Administration (FDA) has issued comprehensive and detailed regulatory policies for vapor-type e-cigarettes, with very strict regulatory measures;

Japan regulates vapor-type e-cigarettes (VAPE) and HNB (heated not burned) products separately, with very strict regulations on vapor-type e-cigarettes, prohibiting the addition of nicotine to liquids without permission. The import, sale, manufacture, and advertising of nicotine-containing vapor-type e-cigarettes require application and approval, and currently, there are no approved nicotine-containing vapor e-cigarettes in the Japanese market, while non-nicotine vapor-type e-cigarettes are not regulated.

The EU TPD includes all nicotine-containing products under e-cigarette management, requiring manufacturers of new tobacco products to report to relevant authorities before their products enter the market and submit annual reports to relevant authorities regarding sales and other situations. It also requires that the nicotine content in e-cigarette liquids must not exceed 20mg/ml, the capacity of e-liquid in pods must not exceed 2ml, and the capacity of refill bottles must not exceed 10ml. Product packaging must have child-proof features, be tamper-proof and leak-proof, and include health warnings, while advertising and promotional uses are prohibited.

The e-cigarette markets in parts of South America, the Middle East, and Asia remain closed: countries such as Brazil, Argentina, Iran, Saudi Arabia, Singapore, and Thailand have very strict regulations prohibiting the sale, distribution, and import of new tobacco products.
 
From the trend of regulatory policy development, countries are continuously strengthening their regulation of e-cigarettes, with specific measures mainly focused on four aspects:

1. Increasing taxes: For example, the EU is considering increasing taxes on new tobacco products; the Korean parliament is discussing raising the tax rate on electronic cigarettes (including heated not burned products) to the level of traditional cigarettes;

2. Inclusion under tobacco product regulation: The US FDA and the new EU Tobacco Products Directive have included vapor products under tobacco product regulation, legislating and regulating them by relevant departments;

3. Establishing product standards to regulate product processes and quality: For example, the US conducts strict reviews of all products on the market; EUTPD2 has clear regulations on product packaging, specifications, warning labels, etc.;

4. Restricting advertising and channels, such as Korea limiting sales channels to prevent minors from accessing them.
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The domestic industry regulatory system is under construction

As countries strengthen their regulation of e-cigarettes, recent years have seen China and local governments actively forming e-cigarette associations to improve domestic e-cigarette regulatory laws. In January 2017, the Electronic Cigarette Industry Committee of the China Electronic Commerce Association (under the Ministry of Industry and Information Technology) was established in Shenzhen, focusing on work related to members, industry conferences, industry standards, training, and international exchanges. In June 2018, the national mandatory standard plan "E-cigarettes" and the national standard plan "Determination of Nicotine, Propylene Glycol, and Glycerin in E-liquids by Gas Chromatography" entered the review stage. If approved, they will be passed by the National Standards Committee in the next 24 months and 12 months, respectively, effectively regulating the standards and development of China's e-cigarette industry.

Currently, there are numerous e-vapor products and brands of various sizes in the domestic market, with a fragmented industry structure and varying product quality. Issues such as substandard oil storage tanks and excessive nicotine in e-liquids are also common. Therefore, the Forward Industry Research Institute concluded that after the implementation of the "E-cigarettes" industry standard, the industry will have a basis for development, accelerating the elimination of non-compliant small tobacco enterprises. On the other hand, the industry standard will clearly define the limits of nicotine, propylene glycol, extraction solvents, and other substances in e-vapor liquids, which may help reduce the release of harmful substances from e-vapor products.
 
Regional smoking control regulations are gradually including e-cigarettes in the smoking ban

On August 30, 2018, the State Administration for Market Regulation and the State Tobacco Monopoly Administration issued a notice prohibiting the sale of e-cigarettes to minors, aligning the sales management standards for e-cigarettes with those for traditional cigarettes.

On January 1, 2019, the newly revised "Hangzhou Public Places Smoking Control Regulations" officially came into effect, listing e-cigarettes alongside traditional cigarettes in the smoking ban.

On June 26, 2019, the "Shenzhen Special Economic Zone Smoking Control Regulations" officially included e-cigarettes in the smoking control scope.

From the comprehensive list of regional smoking control policies that have been published, it can be concluded that China is beginning to create a healthy and standardized environment for e-cigarettes, and that e-cigarette products may be regulated as tobacco products in the future. Although regulating them as tobacco products will impose certain restrictions on e-cigarettes, the richness of sales scenarios and the improvement of product quality will help facilitate their gradual penetration among smokers.