March 2022
Teresa Huang and Weke Chen
In recent years, the World Health Organization Framework Convention on Tobacco Control (WHOFCTC) and its Conference of the Parties (COP) have successively requested the parties to ban or control various new forms of nicotine and tobacco products, and agencies, scholars, public interest organizations, and the citizens in Taiwan also have proposed to amend the current Tobacco Hazards Prevention Act (THPA). Therefore, the Executive Yuan adopted the draft Amendments to the THPA (hereinafter, the “Draft”) and delivered the Draft to the Legislative Yuan for deliberation on January 13, 2022. The Draft’s important contents are highlighted below:
1. Comprehensive ban on quasi-tobacco products including electronic cigarettes
(1) Under the current legal regime, “electronic cigarettes” are not tobacco products under the THPA and can only be dealt with under the Pharmaceutical Affairs Act when they contain nicotine or other drug substances or when they are claimed to have medicinal effects, or handled under the THPA when their shapes are similar to tobacco products.
(2) In addition to ordinary tobacco products, the Draft adds the definition of “quasi-tobacco products,” which are electronically or non-electronically delivered nicotine or non-nicotine combinations or other similar products that are made of non-tobacco raw materials or materials that change the physical properties of tobacco raw materials so that people may emulate the use of tobacco products. Electronic delivery pertains to what is conventionally referred to as an “electronic cigarette”. Additionally, to prevent operators from selling the products in other manners by evading the principle of electronic cigarettes, the definition of quasi-tobacco products is extended to include non-electronically delivered nicotine or non-nicotine combinations or other similar products. (Article 3, Paragraph 1, Subparagraph 2 of the Draft)
(3) The manufacture, importation, sale, supply, display, advertising, or use of quasi-tobacco products and their components will be completely prohibited in the future, and corresponding administrative penalties will be imposed on manufacturers or importers and other persons who engage in such prohibited activities. (Article 15, Paragraph 1, Subparagraph 2 and Paragraph 2 of the Draft)
2. Conditional deregulation on novel and emerging tobacco products by way of health risk assessment review
(1) In addition, for novel and emerging tobacco products such as heated tobacco products (HTPs) which have been rolled out in recent years, since they work by heating tobacco at high temperatures without combustion for smoking and smelling, they are classified as ordinary tobacco products under the current legal regime. However, although the THPA is applicable, the HTPs cannot be regulated for their special characteristics relative to ordinary tobacco products .
(2) Given the special nature of novel and emerging tobacco products, the Draft adopts an approach where the review will be conducted by the competent authority and the central competent authority will announce specific novel and emerging tobacco products as designated tobacco products. The Draft also authorizes the formulation of the rules on the application for health risk assessment review, whereby operators shall apply to the central competent authority for health risk assessment review before manufacturing or importing such tobacco products, and may manufacture or import such tobacco products only after obtaining an approval. Additionally, the Draft also strengthens the post-market surveillance and control mechanisms, and if there are newly discovered health risks in a tobacco product whose application has been completed, the central competent authority may announce that an application for health risk assessment review shall be filed for the tobacco product within a specified period. (Article 7, Paragraphs 1 and 2 of the Draft)
(3) In the future, the control of novel and emerging tobacco products shall be conditionally lifted only for designated tobacco products that have passed the health risk assessment review. The manufacture, importation, sale, supply, display, advertising, or use of other novel and emerging tobacco products, including novel and emerging tobacco products that have not been announced as designated tobacco products, or designated tobacco products that have not been applied for and passed the health risk assessment review, shall be prohibited. (Article 15, Paragraph 1, Subparagraph 3, and Paragraph 2 of the Draft)
(4) To avoid the current situation that the customs are unable to handle a large number of seized novel and emerging tobacco products, designated tobacco products that have been seized or detained at the customs may be reclaimed by the person who brought or imported them if they pass the health risk assessment review within three months. If they are not reclaimed or applied for or do not pass the health risk assessment review after the period expires, the customs that originally seize or detain them may select to destroy them. (Article 7, Paragraphs 4 and 5 of the Draft)
3. Thorough implementation of tobacco control and reduction of the tobacco consumption market
In addition to the aforementioned quasi-tobacco products and novel and emerging tobacco products, the rest of the Draft will also have a significant impact on the tobacco market in Taiwan, such as adjusting the legal smoking age from 18 to 20 (Article 16 of the Draft), prohibiting flavored cigarettes and other announced additives (Article 10, Paragraph 1 of the Draft), extending the scope of smoking behavior to “carrying a lit or activated tobacco product” (Article 3, Paragraph 2 of the Draft), increasing the area of warning labels on tobacco containers from 35% to 85% (Article 9, Paragraph 2 of the Draft), and expanding the types of indoor and outdoor non-smoking public places (Articles 18 and 19 of the Draft), etc.