Which Authorities Should Regulate E-cigarettes? Two Chinese Experts Share Their Views

On July 22, 2019, Mao Qun'an, Director of the Planning Department of the National Health Commission, revealed at a press conference that the National Health Commission is conducting research on e-cigarette regulation in conjunction with relevant departments, planning to regulate e-cigarettes through legislation.

On October 30, 2019, the State Administration for Market Regulation and the State Tobacco Monopoly Administration jointly issued a notice on protecting minors from e-cigarette harm, urging e-cigarette companies to shut down online sales websites or apps; urging e-commerce platforms to promptly close e-cigarette stores and remove e-cigarette products; and urging e-cigarette companies to withdraw e-cigarette advertisements published online.

On November 1, 2019, a relevant person from the Ministry of Industry and Information Technology stated: "Currently, our department is actively conducting relevant research and demonstration according to departmental responsibilities to promote the introduction of management measures that guide the orderly development of the e-cigarette industry."

As of November 2019, the National Health Commission, the State Administration for Market Regulation, the State Tobacco Monopoly Administration, and the Ministry of Industry and Information Technology have successively expressed their stance on the domestic e-cigarette industry, stating that they will strengthen regulation of e-cigarettes. For a long time, e-cigarettes have been in a regulatory "vacuum" and are considered "three no" products, meaning no product standards, no quality supervision, and no safety assessment, leaving them in a very awkward position. Industry practitioners have been calling for industry standards and relevant management measures to be introduced as soon as possible.

So, how should we correctly understand e-cigarettes, which department should regulate them, and how should they be regulated to bring them into a standardized and orderly development framework?
 
Recently, a reporter from the Beijing News interviewed Jiang Yang, Vice President of the China Tobacco Control Association, and Fang Jie, Vice Dean of the Urban Governance and Legislative Research Institute at Zhejiang University and a member of the Hangzhou Municipal People's Congress Legislative Affairs Committee.

Beijing News: What are the characteristics of the development of e-cigarettes in our country?

Jiang Yang: 90% of the world's e-cigarettes are produced in China, but we have not conducted relevant research on the safety and effectiveness of e-cigarettes, and can only refer to assessments from international organizations such as the World Health Organization.

Fang Jie: E-cigarettes were initially introduced as a substitute for tobacco, positioned as smoking cessation products with therapeutic and corrective functions. However, as more capital has entered the market, the types of e-cigarettes have diversified, leading to some promotions that may not reflect the actual situation. Consumers have an information asymmetry regarding the actual functions of e-cigarettes and the potential positive and negative consequences.

Beijing News: How do you evaluate the harmfulness of e-cigarettes?

Fang Jie: The World Health Organization has drawn some conclusions after long-term scientific experiments and analyses, stating that nicotine is addictive. Although it is not carcinogenic itself, it may act as a tumor promoter. For example, it may participate in the biological processes of malignant diseases and neurodegeneration; exposure to nicotine during pregnancy and adolescence may have long-term adverse effects on brain development, potentially leading to learning disabilities and anxiety disorders, etc.

Jiang Yang: The Centers for Disease Control and Prevention in the United States defines the toxicity of e-cigarettes as low, indicating that they are less dangerous than tobacco, which contains over 7,000 chemical substances. However, they are by no means safe, as the secondhand aerosol emitted by e-cigarettes contains many harmful compounds, such as propylene glycol, formaldehyde, and heavy metals, many of which are carcinogenic.

Beijing News: How do you view the "smoking cessation" efficacy promoted by some businesses?

Fang Jie: Everything has two sides. E-cigarettes were indeed initially introduced as smoking cessation tools, but according to the information I have collected, the World Health Organization does not recommend using e-cigarettes as smoking cessation aids and suggests that smokers use proven effective cessation methods.

While some people advocate that e-cigarettes have smoking cessation effects, there are also research reports indicating that e-cigarettes can be an obstacle to quitting smoking. For example, some individuals may use both e-cigarettes and traditional cigarettes simultaneously. Additionally, adolescents may start using e-cigarettes due to certain promotions, leading them to begin smoking.

Beijing News: Which department should regulate e-cigarettes?

Jiang Yang: I hope that a neutral agency, such as the National Food and Drug Administration, will regulate e-cigarettes, rather than the State Tobacco Monopoly Administration. In the United States, e-cigarettes are regulated by the Food and Drug Administration (FDA), and similar departments in the UK oversee e-cigarette market entry regulations.

Fang Jie: Determining which department should regulate e-cigarettes requires first defining the nature of e-cigarettes. If e-cigarettes are defined as tobacco or a product similar to tobacco, then they may fall under the jurisdiction of the national tobacco industry regulatory department. However, if e-cigarettes are defined as smoking cessation drugs or products of another nature, they may need to be regulated according to other product categories, such as food and drug administration departments.

Beijing News: What suggestions do you have for e-cigarette legislation?

Fang Jie: First, avoid controversy and control harmful behaviors first. The "Hangzhou Public Places Smoking Control Regulations" stipulate that "smoking refers to the act of inhaling and exhaling tobacco smoke or harmful e-cigarette aerosol, as well as holding lit tobacco products." This legislation adopts a "substantive judgment standard," avoiding the controversy over whether e-cigarettes are harmful and directly controlling the behavior of "inhaling and exhaling harmful e-cigarette aerosol," which is a practical and effective legislative strategy.

Second, focus on protecting minors. The currently revised "Minor Protection Law" needs to include smoking control-related provisions, which should also cover e-cigarette regulation. It is necessary to create a good environment in a timely manner to protect minors from harmful smoke, including harmful e-cigarette aerosol.

Third, elevate the legislative level and strengthen regulatory efforts. On August 28, 2018, the State Administration for Market Regulation and the State Tobacco Monopoly Administration jointly issued a notice prohibiting the sale of e-cigarettes to minors. However, this notice only contains prohibitive clauses without binding clauses. In other words, the notice only has a guiding role in e-cigarette market management, lacking rigid normative effects. Therefore, it is necessary to reflect regulatory strength from a higher legislative level.

Beijing News: Many manufacturers are using various means to promote e-cigarettes. How do you think regulation can be strengthened?

Jiang Yang: The World Health Organization's report shows that there are over 15,000 flavors of e-cigarettes. Some flavors are beyond imagination, such as "Autumn Snow." These manufacturers produce e-cigarettes not to help quit smoking but to satisfy adolescents' curiosity. E-cigarette flavors should be strictly limited; in the United States, only tobacco and mint flavors are allowed.

Beijing News: What international experiences are there in e-cigarette regulation?

Fang Jie: International tobacco control measures generally fall into five categories: source production and purchase restrictions, standardized information disclosure, smoking bans and control, strict law enforcement and supervision, and behavioral demonstration and guidance. The most effective control over e-cigarettes is to manage sales from the source; for example, countries like Brazil and Singapore do not grant sales licenses for e-cigarettes.

Beijing News: On November 1, the State Administration for Market Regulation and the State Tobacco Monopoly Administration jointly issued a notice on further protecting minors from e-cigarette harm. What do you think of the significance of this notice?

Fang Jie: It clearly has positive significance. This notice emphasizes the need for source control, similar to the notice jointly issued by the State Administration for Market Regulation and the State Tobacco Monopoly Administration on August 28, 2018, prohibiting the sale of e-cigarettes to minors. Although both are normative documents rather than laws, the improvement of the governance system and the enhancement of governance capabilities require time. In this process, different levels of norms can cooperate to achieve a co-governance effect.