[비즈한국] On the 6th, the Ministry of Food and Drug Safety (MFDS) issued a pre-announcement of legislation for the "Enforcement Decree and Enforcement Rules of the Tobacco Harmful Ingredients Management Act." As the law is set to take effect this November, the decree includes specific details, and the ministry will collect feedback on the proposed enactment until the middle of next month. With tobacco ingredient testing and information disclosure scheduled to begin next year, attention is focused on whether this will impact potential future lawsuits involving the tobacco industry.
Full disclosure of testing results to begin next year… Tobacco industry says, “We are not yet at the preparation stage”
The proposed enactment includes details regarding the testing of harmful tobacco ingredients, information disclosure, and the designation and management of testing institutions. Tobacco manufacturers and importers must request harmful ingredient testing from authorized institutions within three months of the law’s effective date, and thereafter, must request such testing every two years by June 30th of that year. Test reports must be submitted to the Minister of Food and Drug Safety within 15 days of issuance. For new products, testing must be requested within one month of the start of sales. Information regarding harmful ingredients, as well as data on their toxicity and carcinogenicity to the human body, will be disclosed annually by December 31st via the MFDS website and other channels.
The Tobacco Harmful Ingredients Management Act was enacted 10 years after related legislation, such as the "Partial Amendment to the National Health Promotion Act," was first proposed in 2013. According to the MFDS and the Ministry of Health and Welfare, a total of 12 enactments or amendments had been proposed. The Yoon Suk Yeol administration even included the evaluation and disclosure of harmful tobacco ingredients as one of its national tasks. The scope of disclosed harmful ingredients is expected to increase from the current 8, including tar and nicotine, to 44, which is expected to improve the public's right to know. According to the "Tobacco Mainstream Smoke Component Analysis Method" published by the MFDS after the bill's enactment, the World Health Organization recommends the regulation of 39 components, while Health Canada recommends 44.
Regarding this, the tobacco industry responded that while "full-scale preparations have not yet begun," they are cautious about taking a public stance. A BAT Rothmans official stated, "We will likely understand the situation better once the law goes into effect," and regarding the submission of feedback during the legislative pre-announcement period or future responses, added, "The company has always maintained that if the government requires disclosure, we will comply." A KT&G official said, "There is nothing being prepared separately," adding, "Since this is a government-led regulation, it seems inappropriate for us to voice a position."
Will it impact related lawsuits?
Health authorities and the industry have been at odds for a long time over the "disclosure of harmful ingredients" in tobacco. According to the World Health Organization, tobacco contains approximately 4,000 chemicals. However, the industry has refused to disclose ingredient information, including harmful components, citing "trade secrets," which led the Ministry of Health and Welfare, the MFDS, and the Korea Disease Control and Prevention Agency (KDCA) to conduct their own component and toxicity analyses. In 2018, Philip Morris Korea filed a lawsuit against the MFDS demanding the disclosure of analysis results. When the MFDS announced that the average "tar" content detected in some of Philip Morris Korea's heat-not-burn electronic cigarettes was higher than that of conventional cigarettes, the company demanded the disclosure of experimental data, arguing that "comparing only the total weight of two mixtures that have very different compositions and toxicities could lead to misunderstandings." At the time, the court ruled that some information should be disclosed.
The disclosure of harmful tobacco ingredients is expected to influence future lawsuits involving the industry. The National Health Insurance Service (NHIS) has been engaged in a damage suit against domestic and foreign tobacco companies, including BAT Korea (including its manufacturer), KT&G, and Philip Morris Korea, for over 10 years. They are seeking 53.3 billion won in medical expenses covered by the service due to smoking-related illnesses. The NHIS argued that tobacco companies should be held liable for "product liability" (the principle that those who suffer damages to life, body, or property due to product defects should be compensated) and "tort liability." However, the first-instance court did not accept this. The NHIS filed an appeal in December 2020, and the case is currently undergoing proceedings. Notably, NHIS Chairman Jung Ki-seok personally attended the 11th hearing held on the 15th of last month.
Meanwhile, some argue that the legislation lacks effectiveness as it excludes liquid electronic cigarettes made with synthetic nicotine from the disclosure requirements. Under current law, liquid electronic cigarettes using synthetic nicotine are not classified as "tobacco." With the recent rise in the use of liquid electronic cigarettes, especially among teenagers, there are increasing calls to expand the definition of tobacco ingredients. According to KDCA statistics, as of 2021, the experience rate and usage rate of liquid electronic cigarettes among teenagers were 7.1% and 2.9%, respectively—double that of heat-not-burn electronic cigarettes. A bill to amend the Tobacco Business Act, which would expand the definition of tobacco ingredients from "tobacco leaves" to "tobacco and nicotine," was discussed in a parliamentary committee subcommittee the previous day but failed to pass and remains pending.