Newsletter
Promulgation by the President of Tobacco Hazards Prevention and Control Act
Promulgation by the President of Tobacco Hazards Prevention and Control Act
To completely prohibit quasi-tobacco products such as electronic cigarettes, and to strengthen various tobacco control measures to protect youth from smoking, the amendments to the Tobacco Hazards Prevention and Control Act (“THPCA”) proposed by the Ministry of Health and Welfare (“MOHW”) have been passed by the Legislative Yuan and promulgated by the President on February 15, 2023. The major amendments are summarized as follows:
I. Prohibition on Electronic Cigarettes and Flavored Tobacco Products
The THPCA defines “quasi-tobacco products” as “electronic or non-electronic delivery system or other similar products that contain nicotine or non-nicotine, or other products made from materials other than the materials for tobacco products or materials that change the physical nature of the materials for tobacco products and are used to imitate tobacco products”, and prohibits anyone from manufacturing, importing, selling, supplying, displaying or advertising quasi-tobacco products or their components. As a result, quasi-tobacco products, including electronic cigarettes (ENDS/ENNDS, the official term of and commonly known as electronic cigarettes), will be completely prohibited. In addition, tobacco products may not use additives that are prohibited by the central competent authority to avoid inducing a sense of pleasure in tobacco users, making smokers mistakenly underestimate the harm of flavored tobacco products, or exposing children and young adults to tobacco products out of curiosity.
II. Health Risk Assessment Review of Designated Tobacco Products
On the other hand, the THPCA defines “tobacco products” as “cigarettes, cut tobacco, cigars and other similar products entirely or partly made of the leaf tobacco or natural plants that contain nicotine as raw material which are manufactured to be used for smoking, chewing, sucking, snuffing or other methods of consuming”. For both novel and emerging tobacco products and long-existing tobacco products, if they are with unknown health risks and/or discovered to have specific health risks, the central competent authority may designate said tobacco products as designated tobacco products (“Designated Tobacco Products”). The tobacco businesses shall apply for a health risk assessment (“HRA”) and shall obtain the approval before manufacturing, importing, and selling any Designated Tobacco Product (including heated tobacco products). The necessary components of the Designated Tobacco Products shall also be submitted to a HRA and are regulated under the THPCA.
III. Other Tobacco Control Requirements
The current THPCA also adds the following tobacco control requirements:
1. Smoking age: The legal smoking age is raised from 18 to 20.
2. Expansion of no-smoking places: The no-smoking areas are extended to include school campuses, kindergartens, daycare centers, and family child care homes. Bars and nightclubs are listed as no-smoking facilities but allowed to install smoking rooms.
3. Health hazard warning: The required area containing the health hazard warning on a tobacco product package is increased from 35% to 50%.
The effective date of the THPCA shall be set by the Executive Yuan. Given that the relevant enterprises need certain time for the adjustment, the amendments to the ratio of area of health hazard warning and corresponding punishment are projected to take effect in one year after the promulgation.
To facilitate the implementation of the THPCA and to expeditiously control tobacco products with unknown health risks, the MOHW, on February 15 and 16, 2023, respectively released the drafts of “Regulations Governing the Designated Tobacco Products being deemed tobacco products, other than cigarettes, cut tobacco, cigars, snuff, and chewing tobacco, that are made from the raw materials specified in Paragraph 1, Article 3 of the Tobacco Hazards Prevention and Control Act and that have not changed the physical properties of the raw materials”, “Regulations Governing the Health Risk Assessment on Designated Tobacco Products”, and “Enforcement Rules to the THPCA” for public comment for seven days. It is expected that the Executive Yuan will set the effective date of the THPCA as soon as the relevant sub-regulations are confirmed.
If you have any requests or questions regarding the new legal framework of the tobacco control and management, please feel free to contact our Life Sciences Practice Group for more information.