A common feature among countries is the tightening of legal frameworks, the development of technical standards, increased scientific assessment and stronger supply chain control. The objective is not only to protect public health, but also to manage the market, combat smuggling, reduce budget revenue losses and protect consumers from floating and unverified products.
Progress in managing new nicotine products
In China, regulators are developing mandatory national standards for heated tobacco products, with the process expected to take 22 months. This reflects the country’s systematic approach: first determining the legal attributes of products, then developing technical standards, and gradually completing mechanisms for market management and tax policy.
Notably, China does not regulate only the final product. The standards for heated tobacco products are being developed to cover cigarettes, heating devices, combined products, raw materials, additives, packaging, labelling and related technical requirements. This approach shows that regulators want to control the entire supply chain, rather than focusing only on the retail stage.
At the same time, the standard-setting process involves regulatory agencies, enterprises and research institutes, reflecting efforts to establish a unified system of standards for the two main product lines.
In essence, this marks a transition from the stage of identification and policy experimentation to the establishment of highly binding standards. Once mandatory standards are issued, enterprises wishing to enter the market will have to meet clearer technical requirements. Authorities will also have a basis for inspecting and handling substandard products, smuggled products or goods circulating outside the official management system.
Without standards, the market can easily fall into a “grey area”, where products continue to exist outside the black market, consumers can still access them, but the state lacks tools to control quality, collect taxes, trace origin and handle violations.
Unlike China, the US built a regulatory framework earlier, especially for heated tobacco and new nicotine products. The US approach places scientific assessment at the centre before a product is allowed to circulate or before any information on its risk level can be communicated.
Under the US Food and Drug Administration (FDA) regulations, applications for new tobacco product marketing authorisation must provide scientific evidence showing that the products are appropriate for the protection of public health.
When reviewing such applications, the FDA assesses risks and benefits for the population as a whole, including current tobacco users and non-users, the likelihood that current users will quit old products, and the risk that non-users may begin using the product.
This approach shows that products cannot rely solely on advertising or corporate claims. To be placed on the market, or to communicate about reduced exposure, products must undergo a review process involving data on health, user behaviour, addiction risks, impacts on non-users and post-market control conditions.
Accordingly, in April 2026, the FDA issued a decision to renew the Modified Risk Tobacco Product - Reduced Exposure designation for several heated tobacco products.
According to the FDA, evidence shows that this system heats tobacco instead of burning it, thereby significantly reducing the formation of certain harmful or potentially harmful chemicals. Complete switching from cigarettes to this product may also reduce the body’s exposure to those substances.
Fighting smuggling and preventing budget revenue losses
Several international health organisations share the view that tobacco management today cannot separate health issues from market issues. When policy fails to keep pace with reality, smuggled goods, counterfeit products and products of unknown origin have room to spread. Consumers are then left unprotected, while the state loses tax revenue and control tools.
The Protocol to Eliminate Illicit Trade in Tobacco Products under the World Health Organisation Framework Convention on Tobacco Control, or WHO FCTC, emphasises that illicit trade increases access to cheap tobacco products, undermines tobacco control policies, causes budget revenue losses and may contribute to the financing of transnational criminal activities.
Therefore, tightening the legal framework is not only about licensing. It is also about traceability, production control, import management, distribution supervision, anti-smuggling measures, and ensuring that products circulating on the market are placed within the official management system.
From international experience, if prohibition is imposed without sufficient control capacity, the underground market may expand, exposing consumers to greater risks. By contrast, if a clear regulatory framework is established, the state can simultaneously control health risks, manage taxes, combat smuggling and require enterprises to take responsibility for product quality.
According to economic experts, the stricter control approaches adopted by the US and China correctly reflect a new regulatory trend as the tobacco product market changes. They help narrow the gap between the legal framework and market reality.
At the same time, scientific assessment should be placed at the foundation. Open dialogue between governments and enterprises on risk levels and technical standards is an important tool for making the management of products and supply chains more transparent and strengthening corporate responsibility.
What is needed now is a policy framework that is sufficiently strict, feasible and transparent. Such a policy must protect public health, especially young people, while enabling competent authorities to control the market, combat smuggling, prevent budget revenue losses and effectively handle products of unknown origin.
In tobacco management, lax control is a risk. However, management that lacks a scientific basis can also create gaps for the illegal market. Therefore, the more appropriate direction is strict management based on standards, data, accountability and rigorous enforcement. This is also the approach many countries are choosing to bring a complex market into a regulatory framework, instead of allowing it to operate beyond control.
