Malaysia’s Vaping Regulations: A New Era for Public Health and Industry Compliance

The regulation of vaping in Malaysia has been a long-debated issue, particularly with the rise of e-cigarette use and its impact on public health. With the introduction of the Control of Smoking Products for Public Health Act 2024 (“Act 852”), vaping and e-cigarette products are now officially regulated under Malaysian law. The primary objective of Act 852 is to strictly regulate the vaping industry, covering aspects such as sales, marketing, and product distribution.

According to Section 2(1) of Act 852, “smoking substances” refer to any material or combination of substances including nicotine, propylene glycol, glycerol, and triethylene glycol intended for smoking purposes. As e-liquid in vape devices contains nicotine, it can be classified under smoking substance. Meanwhile, an electronic cigarette is defined as a handheld device equipped with an aerosol generator, battery, and liquid storage compartment[1].

Discussed below are the key regulatory requirements under the Act 852 and its impact on businesses operating in this industry.

1. Product Registration

One of the key requirements under Act 852 is the requirement for all e-liquids to be registered with the Ministry of Health Malaysia (“MOH”). The application must be submitted to the Director-General of MOH, as outlined under Sections 3 to 5 of Act 852, with further specifications under Registration of Tobacco Product, Smoking Substance and Substitute Tobacco Product Regulations 2024 (P.U.(A) 262/2024). The registration process involves:

(a) Registration fee of RM5,000.

(b) Product testing, including a laboratory analysis report and summary.

(d) Any additional documents required by the Director-General.

As part of the registration requirement procedures, laboratory testing of the e-liquids must be conducted by one of the nineteen (19) designated laboratories in Malaysia[2]. This ensures that e-liquids and other vaping products meet the required safety and quality standards.

Furthermore, vape device manufacturers and distributors in Malaysia are required to obtain certification and marking from SIRIM QAS International Sdn. Bhd. to ensure compliance with Malaysian Standard MS 2716[3]. This certification confirms that vape products meet safety, quality, and regulatory requirements set by local authorities.

2. Legal Age Restriction

To protect minors from exposure to vaping, Act 852 strictly prohibits the sale of smoking products, including vapes, to individuals under the age of eighteen (18)[4]. Businesses must also implement proper age verification procedures to comply with the Act 852. In reference to the Fifth Schedule, Item 5(b) of Control of Smoking Products for Public Health (Packaging and Labelling) Regulations 2024 (P.U.(A) 261/2024), vape devices must not resemble toys or food to prevent them from appealing to minors. This is further reiterated in the Press Statement of the MOH dated 30 September 2024 (“MOH Press Statement”).

3. Strict Advertising and Promotional Restrictions

A major change introduced by Act 852 is the strict prohibition of advertising and promotional activities related to vaping products. The law bans all forms of direct and indirect marketing, including:

(a) Related goods used in association with smoking substance[5].

(b) Branding or trademarks that promote these products[6].

(d) Marketing that implies vaping can be used as a quit smoking product[8].

(e) Sponsorships, promotions, or public endorsements of vaping products.

With these restrictions, vape businesses must be cautious in their marketing strategies to ensure full compliance with Act 852 and relevant regulations.

4. Nicotine Concentration Adjustment

The MOH closely monitors the nicotine levels in vaping products to minimize potential health risks. Starting October 1, 2025, the maximum nicotine concentration in e-liquids will be reduced from 35 mg/ml to 20 mg/ml[9]. By October 1, 2026, the maximum capacity of a single refill cartridge will be further reduced from 3 ml to 2 ml[10]. Therefore, manufacturers and retailers must strictly adhere to these limits to avoid penalties and ensure that the guidelines are followed.

5. Regulations on Product Display

Act 852 prohibits the public display of vape products outside a licensed premised selling vape products (“specialized stores”). Additionally, the Act bans the sale of vape products through online platforms and vending machines[11]. In specialized stores, vape products may only be displayed inside the stores and must not be visible from the outside[12]. Signage stating "Vape dijual sini" must adhere to a specific format namely Arial font, size 150, black text on a white background. Stricter regulations apply to convenience stores and other non-specialized retailers. In these stores, vape products cannot be publicly displayed and must be stored in closed cabinets. No products may be placed outside the cabinet, and the “Vape dijual sini” signage must comply with the same prescribed format.

The rise of illegal and unregulated vaping products poses serious risks to public health and safety. In a recent case in Seri Kembangan, the police discovered an illegal laboratory producing vape liquids mixed with narcotics[13]. In another police operation, a drug syndicate consisting of three men and one woman, aged 26 to 42, was arrested by the police. The syndicate used luxury condominiums to avoid detection, while processing and distributing drug-laced vape liquids.[14] These recent cases highlight the dangers of unregulated vape products in Malaysia.

Therefore, it is important to ensure compliance with Act 852 for a safer industry. The recent enforcement cases serve as a stark reminder of the dangers associated with unregulated and illegally modified vaping products. Compliance with Act 852 is essential not only for the legitimacy of businesses operating in this industry but also for the safety and well-being of consumers. Moving forward, it is imperative for businesses, regulators, and consumers to work together in upholding the legal framework established by Act 852. These incidents underscore the importance of regulatory compliance to prevent the misuse of vaping products and ensure public safety. By ensuring strict compliance, responsible manufacturing, and ethical business practices, Malaysia’s vaping industry can operate within the legal framework while prioritizing public health and safety.

Comparison with other countries

Australia has one of the strictest vaping regulations. Individuals aged eighteen (18) and above may purchase e-cigarettes (max 20 mg/ml nicotine) from pharmacies without a prescription but must consult a pharmacist. Meanwhile, individuals aged under eighteen (18) and patients requiring high-nicotine products require a prescription. Purchases are limited to a one-month supply, and as of March 1, 2024, only tobacco, mint, and menthol flavours are allowed. Similarly, Canada, Denmark, Estonia, and Slovenia, restrict flavours to tobacco including menthol flavours. In comparison, Malaysia's regulations under Act 852 allow the purchase of e-liquids without a prescription but impose strict controls on advertising, display, and nicotine concentration. Unlike other countries, flavoured e-liquids remain available in Malaysia, but future public health concerns may lead to flavour bans in line with global trends.

Conclusion

In essence, Malaysia’s vaping regulations mark a significant step in tobacco control and public health protection. While the law aims to protect public health and regulate the vape industry, its success depends on consistent enforcement and compliance. As the industry adapts to these new regulations, businesses must stay informed, implement responsible practices, and align their operations with legal requirements. To ensure compliance, it is crucial for industry players to stay updated on the latest directives or changes issued by MOH. These updates can be accessed through MOH’s official portal, providing essential guidance on regulatory developments[15]. By adhering to the latest policies and being informed of the regulatory updates, the vaping sector can operate within the legal framework while ensuring consumers’ safety and business credibility.

[1] Clinical Practice Guidelines: Management of e-cigarette or vaping product use-associated lung injury (EVALI) (2021) p. 1. Referred in Brown CJ, Cheng JM. Electronic cigarettes: product characterisation and design considerations. Tob Control. 2014; 23 Suppl 2 (Suppl 2): ii4-10

[2] Rule 2, Approved Laboratories Order 2024 Act 852 (P.U.(A) 263/2024)

[3] Trade Descriptions (Certification and Marking of Electronic Cigarette Device) Order 2022 Act 730 (P.U.(A) 95/2022)

[4] Section 13 of Act 852

[5] Section 7(1) of Act 852

[6] Section 7(1)(b) of Act 852

[7] Section 9(2) of Act 852

[8] Section 7(1)(e) of Act 852

[9] Rule 9(2) of P.U.(A) 261/2024

[10] Rule 9(4) of P.U.(A) 261/2024

[11] Rule 3, P.U.(A) 260/2024

[12] Rule 6, P.U.(A) 260/2024

[13] Retrieved from: https://selangorkini.my/2025/02/polis-bongkar-makmal-haram-proses-cecair-vape-ada-dadah-di-seri-kembangan/