Nicotine Pouches and Their Regulation

About Nicotine Pouches and Their Regulation

• About Nicotine Pouch: It is a small, tobacco-free, tea-bag-like sack containing nicotine, favourings and plant-based fibres.
  • Note: Nicotine is a highly addictive chemical compound found naturally in the tobacco plant and used in products like cigarettes, vapes, and nicotine pouches.
• Users place the pouch between the lip and gum for up to an hour, allowing nicotine to be absorbed directly into the bloodstream without smoke, vapour or spitting.
• Regulation of Nicotine Pouches:
  • Cigarettes and Other Tobacco Products Act, 2003 (COTPA): It governs the marketing, advertising and sale of cigarettes and other tobacco products.
    • Since nicotine pouches are not among the products listed in the Act, they fall outside it.
  • Drugs and Cosmetics Act, 1940: Nicotine is not specifically listed as a drug under the Act. However, nicotine patches and gums are approved as drugs for treating nicotine addiction.
    • • Schedule K of the Drugs and Cosmetics Rules, 1945 exempts certain nicotine gums and lozenges containing less than 2 mg of nicotine from licensing and prescription requirements.
  • The Prevention of Food Adulteration Act and the Food Safety and Standards Act: It defines food as any processed, partially processed or unprocessed substance intended for human consumption.
    • Court rulings on supari and chewing tobacco establish that the definition has a very wide amplitude, encompassing items that are chewed rather than swallowed.
    • It is arguable, then, that nicotine pouches could fall within the broad definition of food.
• Import Regulations: The import of nicotine pouches into India is governed by the Foreign Trade (Development and Regulation) Act, 1992 and the Customs Act, 1962.
  • The Foreign Trade Act empowers the Central Government to prohibit, restrict or regulate imports.
  • Under Section 11 of the Customs Act, 1962 the government can prohibit or restrict goods through notification on grounds including the protection of human, animal or plant life.
  • Following the World Customs Organization’s update of the Harmonized System, specific categories were introduced for oral nicotine products that do not involve combustion:
    • 2404 91 30 covers tobacco-free, single-use nicotine pouches such as Zyn or Lyft.
    • 2404 91 90 covers other oral nicotine products not intended for therapeutic use.
  • Medicament codes apply only to products specifically intended as nicotine-cessation aids.
  • Under the DGFT schedule and CBIC rules, products under 2404 91 30 are classified as “restricted”.
    • This means nicotine pouches are not completely banned, unlike e-cigarettes, but they cannot be imported freely by merely paying customs duty. They require a specific licence or permission.
  • In deciding whether to permit such imports, the DGFT may consult the Health Ministry and other concerned ministries.
• Regulation for Duty-free shops:
  • Nicotine pouches are currently available at some duty-free shops at Indian airports, which operate under Section 58 of the Customs Act.
  • In Flemingo Duty Free Shop Pvt. Ltd. v. Shri Kaushik Bhattacharya (2024), the Calcutta High Court held that duty-free shops are treated as being outside India for certain purposes under the Customs Act and therefore do not “import” goods into India.
    • However, Indian laws and regulations still apply to duty-free shops.
    • As nicotine pouches are classified as restricted goods, their sale requires the necessary import licence or permission.