The Ministry of Health & Family Welfare has taken note of the increasing availability of Oral Nicotine Pouches (ONPs) through online and offline channels in the country. ONPs are pre-portioned oral pouches placed between the gum and lip that deliver nicotine through the oral mucosa. They generally do not contain tobacco leaf and may contain tobacco-derived or synthetic nicotine, along with cellulose or other fillers, flavorings, sweeteners and pH-adjusting agents. They are available in varying nicotine strengths, including high-nicotine formulations. Nicotine is highly addictive and can increase heart rate and blood pressure. Nicotine exposure is of particular concern among children, adolescents and young adults, as it can affect the developing brain, including attention and learning, and increase the risk of nicotine dependence. Nicotine exposure during pregnancy may adversely affect fetal development. The use of nicotine pouches also raises concerns regarding oral health and other potential health effects, although evidence on the short- and long-term health effects of nicotine pouch use remains limited and continues to evolve. Recent evidence generated by ICMR-National Institute of Cancer Prevention and Research (ICMR-NICPR) indicates the availability of nicotine pouches, largely of global origin, through retail outlets, online platforms, social media and delivery platforms in India. The products are marketed with varying nicotine concentrations, having attractive flavors and in some instances, with cessation or reduced-harm claims. It is pertinent to note that nicotine pouches are not approved or licensed as nicotine replacement therapies (NRTs) under the existing therapeutic regulatory framework in India. It is further noted that the State Governments of Andhra Pradesh, Tamil Nadu, Haryana and Himachal Pradesh, have in exercise of powers under the Drugs and Cosmetics Act, 1940, initiated action against unauthorized or unapproved or unlicensed, manufacture, sale, distribution and storage of ONPS. In view of the above, all States/UTs are requested to identify nicotine pouch products being manufactured, imported, stored, sold or distributed within their jurisdiction, where such products are found to be unapproved, unlicensed or otherwise marketed in contravention of applicable legal or regulatory requirements, appropriate action may be taken under the relevant provisions of law. The concerned Drug Control, Food Safety and AYUSH authorities may examine such products under their respective regulatory frameworks, as applicable: Drugs and Cosmetics Act, 1940 and Rules thereunder: Nicotine is a pharmacologically active substance and oral nicotine pouches are specifically designed for oral absorption and systemic delivery of nicotine, and considering their composition, intended use, claims, representation and manner of marketing it qualifies as a drug under Section 3(b) of the Drugs and Cosmetics Act. 1940 and the Rules framed thereunder. Thus, unauthorized or unapproved or unlicensed manufacture, sale, distribution and storage of ONPs, is in contravention of Section 18(c) readwith section 27(b)(ii) of the Drugs and Cosmetics Act, 1940. Further, Section 26A of the Drugs and Cosmetics Act, 1940, empowers the Central Government, to prohibit the manufacture, sale or distribution of a drug in public interest, if the Central Government is satisfied, that the use of any drug is likely to involve any risk to human beings or that it does not have the therapeutic value claimed. Food Safety and Standards framework: Regulation 2.3.4 of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 prohibits the use of tobacco and nicotine as ingredients in any food product. Ayush framework: Where nicotine-containing products are represented or marketed as Ayurvedic, Siddha or Unani medicines/products, the manufacture, sale or distribution without the requisite licence is prohibited under the applicable provisions, including Section 33EEC of the Drugs and Cosmetics Act, 1940. The applicability of Section 33EED and the corresponding penal provisions under Section 33-I may also be invoked, as applicable. Poisons and Insecticides framework: In States/UTs where nicotine or nicotine-containing substances are notified as poisons, the concerned authorities may examine the manufacture, possession for sale, sale, distribution or other regulated activities involving nicotine pouches under the applicable State/UT poisons law and rules. It was noted that Karnataka, Punjab, Haryana and Chandigarh have notified extracted nicotine as a poison. Further, nicotine sulphate is included in the Schedule to the Insecticides Act, 1968. Protection of children: Where nicotine pouches are supplied to children, the applicability of Section 77 of the Juvenile Justice (Care and Protection of Children) Act, 2015 may also be examined. In view of the above, States/UTs are advised to undertake coordinated surveillance of nicotine pouches available through retail, online, social media, e-commerce and delivery platforms and, where contraventions of applicable legal or regulatory provisions are established. initiate appropriate enforcement action in accordance with law, in the interest of public health and protection of children. Source : Ministry of Health and Family Welfare