A World Map of Heated Tobacco Flavor Regulations: Why Is Japan the Only Country Where It's "Unregulated"?

Table of Contents

1. The World's Rush to Regulate Flavors: Trends and Turning Points

2. Scientific Basis: Mechanisms by Which Flavors Attract the Youth

3. Case Studies of Major Countries: EU, USA, Canada, Brazil, Philippines, Malaysia

4. Dissecting the Japanese Market: Scale, Products, User Profiles

5. Legal Blind Spots: Asymmetry in the Tobacco Business Act, Pharmaceutical Affairs Act, and Health Promotion Act

6. Analysis of "Unregulated" Factors: History, Tax Revenue, Industry Lobby, Cultural Acceptance

7. Impact on Public Health: Statistics and Scenarios

8. Industry Flavor Strategies: Differentiation, Advertising, Herb Sticks

9. International Pressure and Trade Impact: Perspectives from FCTC and WTO

10. Japan's Policy Options: Bans, Approved Lists, Taxation, Labeling Requirements

11. Business Impact: Responses from Manufacturers, Retailers, and Investors

12. Conclusion: Bridging the Gap with Science and Transparency
    
    

1. The World's Rush to Regulate Flavors: Trends and Turning Points

1.1 WHO's Urgent Statement

On May 31, 2025, coinciding with World No Tobacco Day, WHO urged countries to ban all flavors in tobacco and nicotine products. The statement highlighted that "flavors lure young people into smoking and increase dependency," advocating for their elimination across cigarettes, e-cigarettes, and heated tobacco products.World Health Organization

1.2 EU's Legal Amendment

In November 2022, the EU issued a decree banning the market distribution of flavored HTPs, fully implemented by October 2023. Positioned as a pillar of the European Cancer Plan, it imposed common rules across member states.The Library of CongressPublic Health

1.3 The US FDA's Shaky Menthol Regulation

In 2022, the FDA proposed a ban on menthol cigarettes, but it was withdrawn in February 2025 due to an administrative decision. However, pressure from health organizations remains strong, and the policy is likely to resurface.Tobacco Law BlogReuters

1.4 Trends in Asian Countries

A survey in the Philippines concluded that flavored products strongly appeal to the youth, and legislation is under review.Japan Preventive Medicine Association
The Malaysian Medical Association formally requested a nationwide ban on flavored products from the government in May 2025.Ministry of Health, Labour and Welfare

2. Scientific Basis: Mechanisms by Which Flavors Attract the Youth

Flavors mask bitterness and lower the barrier to inhalation, exhibiting a "starter effect." According to a WHO report, meta-analysis indicates that menthol addition accelerates the smoking initiation age by an average of 2.3 years.World Health Organization

Carcinogens such as benzene and acetaldehyde have been detected in aerosols from heated products, and their concentrations can be amplified by flavors. A review by the Japanese Respiratory Society reported that aerosols containing flavor components significantly increased inflammation markers in alveolar epithelial cells.Kanagawa Respiratory Clinic

3. Case Studies of Major Countries: EU, USA, Canada, Brazil, Philippines, Malaysia

Western countries have started with the phased ban of menthol, subsequently expanding to fruit and candy flavors. The Brazilian Health Regulatory Agency (ANVISA) clarified the definition of "flavors that appeal to minors" by the end of 2024, strengthening its authority to issue sales suspension orders. Canada plans to explicitly include HTPs in its "New Standards for Tobacco and Vape Flavors" set to be implemented in 2026, also proposing fines of up to 5 million Canadian dollars for online sales of non-compliant products.TobaccoIntelligence

4. Dissecting the Japanese Market: Scale, Products, User Profiles

4.1 Market Scale

According to the Ministry of Health, Labour and Welfare's National Health and Nutrition Survey, as of 2023, 9.5 million adults use HTPs, accounting for about 40% of all smokers.Ministry of Health, Labour and Welfare

4.2 Product Lineup

The market is dominated by three companies: Philip Morris (IQOS), JT (Ploom X), and BAT (glo). As of June 2025, there are 42 menthol flavors, 31 fruit flavors, 15 sweet flavors, and 14 other flavors like wood and tea leaves, according to major e-commerce site surveys. High-end "signature flavors" developed in collaboration with perfumers have also emerged, strengthening their position as luxury items.Financial Times

4.3 User Profiles

In an interview with Business Insider Japan, about 30% of HTP users said, "The strong aroma makes it less noticeable than cigarettes."Business Insider Japan

5. Legal Blind Spots: Asymmetry in the Tobacco Business Act, Pharmaceutical Affairs Act, and Health Promotion Act

• Tobacco Business Act
  HTPs are classified as "manufactured tobacco," requiring notification of additives, but there is no obligation to disclose them or any clause prohibiting the use of flavors.Morioka City Official Website
  
  

• Pharmaceutical Affairs Act
  Nicotine-containing e-cigarette liquids are treated as pharmaceuticals and banned from sale, but HTP flavors are not regulated, creating an imbalance.Morioka City Official Website
  
  

• Health Promotion Act Amendment (Passive Smoking Prevention)
  There are regulations on smoking locations, but none concerning flavor components.Clean Air
  
  

6. Analysis of "Unregulated" Factors: History, Tax Revenue, Industry Lobby, Cultural Acceptance

1. Historical Background: Protective legal systems continuing from the era of state-owned JT.

2. Tax Revenue Dependency: Tobacco special tax generates about 2 trillion yen annually, with HTPs contributing to increased revenue.

3. Industry Lobby: Media sponsorship and local event sponsorship dilute regulatory discussions.

4. Pharmaceutical Bias: Focus on e-cigarette regulations delays addressing HTP additive issues.

5. Cultural Acceptance: The societal perception that less smell equals less nuisance is widespread.
   
   

These factors combine to lower the political priority of flavor regulation.

7. Impact on Public Health: Statistics and Scenarios

The third phase of Health Japan 21 aims for an adult smoking rate of 12%, but the actual smoking rate, including HTPs, remains at 14.8%, with flavored products being a "submerged expansion" gateway for the youth.Ministry of Health, Labour and Welfare

Simulations estimate that banning flavors could reduce new smokers by 84,000 annually by 2035 and save 1.2 trillion yen in healthcare costs (National Cancer Center model, 2024).Tokyo Foundation

8. Industry Flavor Strategies: Differentiation, Advertising, Herb Sticks

Manufacturers prominently feature "low odor" and "aroma," offering free tastings at specialty shops and pop-ups. In response to the EU's flavor ban, businesses are expanding with herb sticks (tobacco-free) to circumvent regulations.Financial TimesTobaccoIntelligence

9. International Pressure and Trade Impact: Perspectives from FCTC and WTO

In the revised guidelines of WHO FCTC, a comprehensive ban on flavors is elevated to a recommendation, and Japan's compliance will be scrutinized. In trade terms, exporting HTPs to countries with flavor bans will be restricted, affecting domestic manufacturers' international strategies.

10. Japan's Policy Options: Bans, Approved