Tobacco Act amendments to regulate e-cigarettes and protect minors

The Bhutan Food and Drug Authority (BFDA) is planning to strengthen its tobacco control framework through proposed amendments to the Tobacco Control Act of Bhutan that would explicitly regulate e-cigarettes and other emerging nicotine products, while introducing stronger measures to protect minors from tobacco use.

The proposed changes are being developed by BFDA as part of efforts to modernize existing legislation and address regulatory gaps that have emerged in recent years.

Recent data show that among individuals aged 15-69 years, 31.4 percent were current users of any tobacco product, while 14.4 percent were current smokers.

Most concerning was the prevalence of tobacco smoking, which was highest at 21.7 percent among those aged 15-25, gradually declining to 4.5 percent in the 55-69 age group.

The data also indicates that 17.7 percent of tobacco users reported using vaping products, with approximately 20.2 percent of these users falling within the 15-24 age group.

E-cigarette imports have increased significantly in recent years, rising from Nu 16.8 million in 2024 to Nu 48.447 million in 2025, reflecting a growing demand for vaping products in Bhutan.

According to BFDA, the current Tobacco Control Act of Bhutan was developed at a time when electronic nicotine delivery systems such as e-cigarettes were not widely prevalent.

“As a result, provisions relating to importation, sale, product standards, and enforcement mechanisms for such products may not have been clearly articulated,” the BFDA said.

The proposed amendments aim to introduce clearer definitions and stronger regulatory oversight to ensure that these products are appropriately controlled in line with Bhutan’s public health objectives.

When asked how young people and children will be protected from tobacco and e-cigarette use, the BFDA said that protecting minors remains a key focus of the proposed amendments.

“Protection of children and youth remains a central objective of the proposed amendments,” the BFDA said.

The authority further explained that the amendments will introduce stricter measures to limit minors’ access to tobacco and related products, and stated, “The BFDA will explicit prohibition on the sale, supply, and distribution of tobacco and related products to minors and regulation of flavored and youth-attractive products that may encourage experimentation and early uptake.”

In addition, the authority said the amendments will strengthen product quality control and regulatory mechanisms, with clearly defined accountability for responsible agencies and business entities.

The BFDA also stated that public awareness initiatives and school-based interventions will be enhanced in collaboration with relevant ministries and stakeholders to help prevent early initiation of tobacco use among young people.

Responding to how Bhutan’s tobacco legislation will be aligned with international standards, the BFDA said Bhutan ratified the World Health Organization Framework Convention on Tobacco Control (FCTC) in 2004, and the proposed amendments aim to further align national legislation with its principles and provisions.

The BFDA stated that this will be done by strengthening protection against secondhand smoke and enhancing measures to protect minors.

Moreover, by “Introducing product regulation authority, including measures related to nicotine content, additives, and disclosure requirements, reinforcing bans on tobacco advertising, promotion, and sponsorship,” BFDA said.

The BFDA also noted that the amendments will strengthen measures to address illicit trade in tobacco products as part of efforts to ensure Bhutan’s tobacco control framework remains consistent with international public health standards.

When asked about the safety and quality standards to be introduced, particularly regarding nicotine limits, the BFDA said the proposed amendments seek to introduce clear and science-based regulatory measures.

“These may include setting maximum nicotine concentration limits in line with international best practices, mandatory disclosure of ingredients and nicotine content, restrictions on harmful substances and youth-attractive flavorings, and requirements for plain packaging and appropriate health warnings,” the BFDA stated.

In addition, the authority said that clear compliance mechanisms will be established to ensure accountability among manufacturers, importers, and regulators.

According to the BFDA, the overall aim of these measures is to safeguard public health while preventing nicotine dependence, particularly among young people.

The BFDA also outlined several key amendments proposed to strengthen the Tobacco Control Act, particularly in relation to e-cigarettes and other emerging nicotine products.

The BFDA said, “The main measures include: protection of minors, explicit inclusion of e-cigarettes and other emerging nicotine products, product quality control, and public smoking and smoke-free zones.”

“At present, the target is to submit and present the Bill during the 6th Session of the National Assembly,” said the BFDA, outlining the timeline for the proposed amendments to the Tobacco Control Act.

The authority added that the amendment process is being carried out in accordance with the Royal Government of Bhutan’s established rules of procedure, including consultations with relevant agencies and the required legislative steps.

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