A Preliminary Study on the Regulatory Systems for New Nicotine Products in Major Countries Worldwide: Taking Chewing Tobacco and Nicotine Gum as Examples

Introduction
In recent years, with technological advancements and the diversification of consumer demands, a plethora of new nicotine products have emerged. Besides electronic cigarettes, various products such as mouth-holding cigarettes, nicotine candies, nicotine sprays, and nicotine patches have gradually gained popularity in the market. These products differ significantly from traditional tobacco products in terms of appearance, composition, usage methods, and mechanism of action. However, the core component, nicotine, has sparked controversies regarding public health, youth protection, and legal regulation.
This article will adopt a legal perspective, taking mouth-holding cigarettes and nicotine candies as examples, to analyze the current regulatory policies and challenges of new nicotine products both domestically and internationally, and propose policy recommendations for improving the regulatory system.
I. Introduction to the Types of New Nicotine Products
1.1 Legal Definition
According to Article 2.4.1.2 of the national standard GB/T 18771.2-2015 "Tobacco Terminology - Part 2: Tobacco Products and Tobacco Processing", in China, a tobacco-containing product is defined as: "A mouth-type tobacco product that releases a portion of soluble substances through saliva when placed between the lips and gums."
The FDA of the United States defines mouth-holding cigarettes as: a tobacco product that does not require heating or combustion, is placed between the gums and upper lip when used, and nicotine is absorbed by the human body, existing in a small synthetic fiber bag.
In terms of form and usage method, nicotine candies (divided into hard candies and soft candies) are a type of tobacco substitute that can be either mouth-held or chewed, usually in the form of candies. When users place it in their mouths and let it dissolve or chew, nicotine gradually releases and is absorbed through the oral mucosa, entering the bloodstream. Nicotine sprays are a nasal spray agent containing nicotine solution. Users spray the spray into the nasal cavity, and nicotine is rapidly absorbed through the nasal mucosa, with a faster onset time.
Nicotine patches are a transdermal absorption product that is applied to the skin and continuously releases nicotine to help maintain nicotine levels in the blood and reduce withdrawal symptoms and tobacco cravings. They are typically changed every 24 hours.
For nicotine candies, nicotine sprays, and nicotine patches, there are no clear legal definitions worldwide.
1.2 Contradiction between Legal Definition and Actual Product Components
Some of the current new nicotine products use extracted nicotine, while others use synthetic nicotine. The trend of using synthetic nicotine is increasing. Apart from the United States, most countries and regions worldwide have no clear conclusion on whether products made using synthetic nicotine belong to tobacco products and how to regulate them. Current laws and regulations are mostly based on the regulatory standards for traditional tobacco products, which are difficult to fully adapt to the rapid changes of new products, resulting in regulatory gaps and legal application disputes. Therefore, how to accurately define the nature of new nicotine products in law is both a major challenge for regulatory authorities and a problem that needs to be urgently addressed in legislative and judicial practices of various countries.
II. Regulation of Nicotine Abroad and Domestically
2.1 Main Uses of Nicotine
In addition to electronic cigarettes and the new nicotine products mentioned in this article, nicotine is also used in the medical field for research in neuroscience (such as the treatment of neurodegenerative diseases) and in the agricultural field as an insecticide.
2.2 Regulation of Nicotine in China
The national standard for electronic cigarettes in China (GB 41700-2022) stipulates that the nicotine used in electronic cigarettes must be extracted from tobacco, meaning that electronic cigarettes in China are prohibited from using synthetic nicotine. In addition, China has not distinguished the regulation of extracted nicotine and synthetic nicotine.
According to the "List of Hazardous Chemicals", nicotine belongs to highly toxic hazardous chemicals. According to the "Catalogue of Toxic Chemicals" published by the Ministry of Public Security of the People's Republic of China, nicotine belongs to Class A organic toxic chemicals, with the number A2045. According to Article 14 of the "Regulations on the Safety Management of Hazardous Chemicals", enterprises engaged in the production of nicotine must obtain a hazardous chemicals safety production license.
Article 29 of the "Regulations on the Safety Management of Hazardous Chemicals" stipulates that chemical enterprises that use hazardous chemicals for production and whose usage reaches the specified quantity (excluding those that are hazardous chemicals production enterprises) shall, in accordance with the provisions of this regulation, obtain a hazardous chemicals safe use license.
According to Article 35 of the "Regulations on the Safety Management of Hazardous Chemicals", enterprises engaged in the business of nicotine must obtain a hazardous chemicals business license.
According to Article 38 of the "Regulations on the Safety Management of Hazardous Chemicals", enterprises that have legally obtained hazardous chemicals safety production licenses, hazardous chemicals safe use licenses, and hazardous chemicals business licenses shall purchase highly toxic chemicals and explosive precursors for making explosives with the corresponding licenses. For other units that purchase highly toxic chemicals, they shall apply to the local county-level public security authorities for a purchase license for highly toxic chemicals.
Article 19 of the "Regulations on the Management of Electronic Cigarettes" stipulates that electronic cigarette manufacturing enterprises, e-liquid manufacturing enterprises, e-liquid nicotine manufacturing enterprises, electronic cigarette wholesale enterprises, and electronic cigarette retail business entities that have legally obtained tobacco monopoly licenses shall conduct transactions through the electronic cigarette trading management platform.
Therefore, if the manufacturer of a new type of nicotine product does not engage in the production and business of nicotine itself but needs to obtain nicotine from a nicotine production and business enterprise, it should apply to the local county-level public security authorities for a purchase license for highly toxic chemicals in accordance with Article 38 of the "Regulations on the Safety Management of Hazardous Chemicals". For enterprises that produce e-liquid (see 3.1 below), they should conduct transactions through the electronic cigarette trading management platform.
2.3 Regulation of Nicotine in Other Countries
The United States, the United Kingdom, and the European Union all regard nicotine as an addictive substance and have stipulated that warning labels such as "This product contains nicotine, and nicotine is a highly addictive substance" must be included on tobacco products.
The United States clearly adopts the same regulatory model for extracting nicotine and synthetic nicotine. Producers and importers of traditional tobacco products (such as cigarettes, cigars, etc.) need to apply to the Alcohol and Tobacco Tax and Trade Bureau (TTB) for permission. New tobacco products do not require permission at the federal level but need to comply with the regulations of each state for new tobacco products. For example, the Cigarette and Tobacco Products Licensing Act of California stipulates that any producer, distributor, wholesaler, retailer, or importer of tobacco products (including electronic cigarettes and other new tobacco products) must obtain permission.
The United Kingdom and most countries in the European Union still have a regulatory gap for new nicotine products. Unless they choose to register as drugs, they currently do not require permission.
III. Regulation of Chewing Tobacco at Home and Abroad
3.1 Regulation of Chewing Tobacco in China
At present, there are no clear laws and regulations for the regulation of chewing tobacco in China. The only reference that can be used is the reply from the State Tobacco Monopoly Administration on April 24, 2024, which states, "Chewing tobacco, except for being managed as tobacco products or registered as a drug, shall be managed in accordance with the provisions of the 'Regulations on the Implementation of the Tobacco Monopoly Law' and the 'Regulations on Electronic Cigarettes' (State Tobacco Monopoly Administration Announcement No. 1 of 2022) regarding e-liquid." Note that this reply only covers chewing tobacco and does not cover new products such as nicotine sugar.
According to the reply from the State Tobacco Monopoly Administration, China does not fully adopt the same regulatory policies as electronic cigarettes for chewing tobacco. The future regulatory trend for chewing tobacco in China may fall into three scenarios. 1. If the product is registered as a drug, it shall be managed in accordance with the regulations for registered drugs. The product must comply with the "Pharmaceutical Administration Law" and related provisions. 2. If nicotine is extracted, it shall be regulated as a tobacco product, and must comply with the "Tobacco Monopoly Law" and related regulations, following the tobacco monopoly licensing system. 3. If synthetic nicotine is used, it shall be managed in accordance with the regulations for aerosols in the "Electronic Cigarette Management Measures".
3.2 Regulatory Supervision of Chewing Tobacco in the United States
Like electronic cigarettes, the United States regulates chewing tobacco as a tobacco product. The product must pass the PMTA review to prove that it is beneficial for public health protection. The United States adopts the same regulatory model as for electronic cigarettes for chewing tobacco, regardless of whether the nicotine used in the product is synthetic nicotine or extracted nicotine. This makes the United States the country with the most complete regulatory system for chewing tobacco in the world at present. On January 26, 2025, the FDA approved the PMTA review of 20 chewing tobacco products. For an overview of the regulatory laws for chewing tobacco in the United States, please refer to "Understanding the US Electronic Cigarette Regulatory Law in One Article: Who Regulates? How? How to Comply?". The legal policies for electronic cigarettes are also applicable to chewing tobacco.
3.3 Regulatory Supervision of Chewing Tobacco in the United Kingdom
According to Article 17 of the "Tobacco and Related Products Regulations 2016" (TRPR) of the United Kingdom, chewing tobacco using extracted nicotine is prohibited. While chewing tobacco using synthetic nicotine is currently only regarded as a common consumer product and remains in the regulatory gray area.
3.4 Regulatory Supervision of Chewing Tobacco in the European Union
For chewing tobacco using extracted nicotine, Article 17 of the "Tobacco Products Directive" (TPD) of the European Union explicitly prohibits it. According to the definition of tobacco products in the TPD, tobacco products must contain tobacco extracts. Therefore, for chewing tobacco using synthetic nicotine, the regulatory supervision at the EU level remains in the gray area. Only a few countries, such as the Czech Republic and Romania, have formulated relevant regulations for chewing tobacco without tobacco extracts.
IV. Regulatory Supervision of Nicotine Sugar at Home and Abroad
4.1 Regulatory Supervision of Nicotine Sugar in China
At present, there is no management method for nicotine sugar in China. Its legal attribute is ambiguous, and it is in the regulatory gray area. Article 2.4.1.1 of "Tobacco Terminology Part 2: Tobacco Products and Tobacco Processing" defines chewing tobacco as "oral tobacco products used by chewing." If chewing tobacco may include nicotine sugar using extracted nicotine, then nicotine sugar using synthetic nicotine is clearly outside the scope of chewing tobacco. There is a legal regulatory gap.

4.2 Regulation of Nicotine Sugar in the United States
The United States defines any product containing nicotine from any source as a tobacco product. Therefore, just like e-cigarettes and dissolvable tobacco products, these products need to undergo PMTA review. An overview of the regulatory laws in the United States regarding nicotine can be found in "Understanding U.S. E-cigarette Regulations: Who Regulates? How? How to Comply?". This article also applies to the legal policies of nicotine sugar.
However, unlike e-cigarettes and dissolvable tobacco products, nicotine sugar has been explicitly recognized by the FDA as one of the seven auxiliary smoking cessation products. Other auxiliary smoking cessation products include nicotine patches, nicotine lozenges, nicotine oral inhalers, nicotine nasal sprays, varenicline, and bupropion.
4.3 Regulation of Nicotine Sugar in the United Kingdom
Similar to the United States, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom recognizes nicotine sugar as one of the nicotine replacement therapies to help with smoking cessation. The agency encourages companies to register nicotine sugar as a medicine, but it is not a mandatory requirement. Therefore, products that are not registered as medicines are still regulated as ordinary consumer goods.
4.4 Regulation of Nicotine Sugar in the European Union
According to the EU Medicines Directive (Directive 2001/83/EC), a medicine is defined as a substance used for the treatment or prevention of diseases, the alteration of physiological functions, or for medical diagnosis. Regarding whether nicotine sugar is a medicine for smoking cessation, different countries have different judgments and understandings. If nicotine sugar is a medicine for smoking cessation, it must obtain the corresponding marketing authorization. Applicants need to submit sufficient clinical trial data, toxicological assessment, production process description, and quality control materials to prove the safety and efficacy of the product.
V. Legal Lag and the Rapid Development and Iteration of New Nicotine Products
(1) Incompatibility between legal definitions and the development of new nicotine products. With the development of synthetic nicotine technology, new products are constantly emerging. However, existing laws mostly refer to traditional tobacco products and cannot be adjusted in a timely manner, resulting in insufficient regulatory applicability. Taking nicotine sugar as an example, it may be classified as a medicine, or it may be recognized as a tobacco product, or it may belong to a general consumer product that does not require a marketing authorization. Different classifications will directly affect the product approval process, tax policies, and market access standards.

(2) Dispute over the definition of synthetic and extracted nicotine. Currently, in the market, new synthetic nicotine products are developing and evolving rapidly. In 2023, the global market sales reached 7.8 billion US dollars, and it is expected to grow at a rapid growth rate of 34% annually in the future. Currently, except for the United States, most countries have not yet formed a unified standard on whether synthetic nicotine should be treated differently from naturally extracted nicotine. The regulation of most countries is still at the stage of extracting nicotine, which may allow enterprises to take advantage of regulatory loopholes to evade existing legal regulation. The regulation of synthetic nicotine is mostly in a blank area.
From a scientific perspective, whether synthetic nicotine is purer and safer than extracted nicotine remains unknown. More scientific analysis and data support are needed. This article mainly discusses it from the legal perspective. The domestic practice, from the reply of the State Tobacco Monopoly Administration regarding mouth-pieces, shows that there is a tendency to distinguish synthetic nicotine from extracted nicotine. Using extracted nicotine is regulated as tobacco products, and using synthetic nicotine mouth-pieces is regulated as aerosol products.
The United States' practice is not to distinguish synthetic and extracted nicotine, but to manage them uniformly as tobacco products. The United Kingdom and the European Union prohibit mouth-pieces using extracted nicotine but do not prohibit mouth-pieces using synthetic nicotine. It seems to be a distinction between synthetic and extracted nicotine, but it may also be due to the lag in legislation.
The author believes that not distinguishing synthetic nicotine from extracted nicotine and applying a unified regulatory system can not only increase the certainty of the law but also increase regulatory convenience. First, a unified regulatory scale can increase the certainty of the law and is more conducive to enterprises understanding which legal norms should be applied. Second, if the same type of product may be regulated in multiple ways, such as being regulated as tobacco products, medicines, or aerosols, it will cause problems of cross-departmental regulatory coordination. Third, different regulation may lead consumers to make a misjudgment of the product risks. If synthetic nicotine products are regulated as medicines or aerosols, while extracted nicotine products are regulated as tobacco products, it is likely to give consumers the wrong perception that the risk of synthetic nicotine products is lower than that of extracted nicotine products. Therefore, from the perspective of legal logic, regulatory benefits, and social benefits, synthetic nicotine and extracted nicotine products should not be distinguished.
Conclusion
New nicotine products have not only the development and iteration of product forms, but also the development and upgrading of synthetic nicotine, as well as considerations of whether they are less harmful and can help quit smoking. The regulation of new nicotine products is a complex and multi-dimensional issue. Its solutions not only involve the revision of legal provisions but also concern the balance of public health, market order, and social values. In the presence of some regulatory gaps, on the one hand, the competent authorities should accelerate research and introduce good laws; on the other hand, enterprises facing regulatory gaps should abide by good faith and avoid new nicotine products attracting minors, causing negative social emotions and regulatory rebound.