Are nicotine pouches beyond the law?

Why in the News

A study led by the ICMR-National Institute of Cancer Prevention and Research has found that nicotine pouches are reaching Indian cities through online platforms, hookah shops and gig delivery services. The study follows a World Health Organization (WHO) warning issued in May 2026 on the dangers these products carry. No Indian statute clearly governs them. The two laws written for tobacco and for vaping each exclude the product for a different reason, and its status under the drugs law and the food law is contested. The gap is not a drafting accident, since the executive already holds the power to restrict a product’s import and sale on health grounds.

What is a nicotine pouch?

1. The product: A nicotine pouch is a small, tobacco-free sack shaped like a tea bag, containing nicotine, flavourings and plant-based fibres.
2. How it is used: The user places the pouch between the lip and the gum for up to an hour. Nicotine is absorbed directly into the bloodstream.
3. What distinguishes it: There is no smoke, no vapour and no spitting. That absence is what keeps it outside the definitions written for cigarettes and for electronic cigarettes.

Does the Cigarettes and Other Tobacco Products Act, 2003 cover nicotine pouches?

1. What the Act governs: The Cigarettes and Other Tobacco Products Act, 2003 (COTPA) regulates the marketing, advertising and sale of cigarettes and other tobacco products.
2. The definitional limit: The Act’s definition of tobacco products does not extend to every product containing nicotine. A legislature intending to cover every extract of the tobacco plant could have said so.
3. Strict construction applies: Restrictions on the freedom of trade and commerce are construed strictly. Nicotine pouches are not among the products listed in the Act, so they fall outside it.

Is a nicotine pouch a drug under the Drugs and Cosmetics Act, 1940?

1. Nicotine is unscheduled: Nicotine is not listed as a drug in any schedule of the Drugs and Cosmetics Act, 1940.
2. Some nicotine products are approved as drugs: Nicotine patches and gums have been approved as drugs by the Drug Controller General of India for therapeutic use in treating nicotine addiction.
3. The Schedule K exemption cuts both ways: Schedule K under the Drugs and Cosmetics Rules, 1945 lists gums and lozenges and exempts them from licensing and prescription requirements where they contain less than 2 mg of nicotine. An exemption for some nicotine products implies that the rest were meant to be regulated.
4. The counter-reading: A pouch makes no therapeutic claim and does not purport to treat addiction. It functions as a substitute for a cigarette, which places it outside the character of a drug.

Why does the ban on vapes not reach nicotine pouches?

1. What the vaping law does: The Prohibition of Electronic Cigarettes Act, 2019 (PECA) bans the import and sale of vapes.
2. Its enactment carries an implication: A separate statute would not have been needed had vapes been drugs, since the government could then have regulated them or refused licences under the drugs law. The enactment indicates that the drugs law did not give adequate power to ban them.
3. The product does not fit the definition: A nicotine pouch contains no electronic device and produces neither smoke nor vapour, so the 2019 Act does not reach it.

Could a nicotine pouch be treated as food?

1. The statutory definition is wide: The Prevention of Food Adulteration Act and the Food Safety and Standards Act define food as any processed, partially processed or unprocessed substance intended for human consumption.
2. Courts have read it widely: Rulings on supari and chewing tobacco establish that the definition has a very wide amplitude and covers items that are chewed rather than swallowed.
3. The consequence: On that reading a nicotine pouch falls within the definition of food, which would bring it under the food safety regime rather than the tobacco or drugs regime.

What governs the import of nicotine pouches?

1. Two statutes supply the power: The Foreign Trade (Development and Regulation) Act, 1992 empowers the Central government to prohibit, restrict or regulate imports. Section 11 of the Customs Act, 1962 allows the government to prohibit goods wholly or partly by notification, on grounds that include the protection of human, animal or plant life.
2. Who administers it: The Directorate General of Foreign Trade (DGFT) administers the trade statute and publishes the ITC-HS classification (the Indian Trade Clarification code list, which records whether a good is free, restricted or banned).
3. A new customs sub-category exists: After the World Customs Organization updated the Harmonized System, code 2404 91 30 was introduced for tobacco-free single-use oral nicotine pouches and 2404 91 90 for other oral nicotine products not meant for therapeutic use. These replaced a residual category for other manufactured tobacco substitutes.
4. The medicament codes do not apply: Codes for medicaments apply only where a product is strictly a cessation aid, which a pouch is not.
5. The status is “restricted”, not free and not banned: Goods under 2404 91 30 cannot be cleared merely on payment of duty, and they are not prohibited outright as e-cigarettes are. They require a specific licence or permission, and the DGFT cross-references the health and other ministries before deciding.

Can nicotine pouches be sold at duty-free shops?

1. They are on sale now: Nicotine pouches are currently available at a few duty-free stores at Indian airports.
2. The stores are licensed under Indian law: Duty-free stores are licensed under Section 58 of the Customs Act, 1962 and cannot claim to sit entirely outside Indian law.
3. What the Calcutta High Court actually held: In Flemingo Duty Free Shop Pvt. Ltd. v. Shri Kaushik Bhattacharya (2024), the Court held that a duty-free store did not “import” goods into India. It was deemed located outside India for the purposes of the Customs Act, so legal metrology labelling requirements did not apply to it.
4. The holding is narrow: Reading it as excluding all Indian law would leave no court and no police station with jurisdiction over a crime committed inside such a store.
5. The permitted list does not include them: Cigarettes, alcohol, jewellery, watches, food and small electronic items are permitted at duty-free shops. A nicotine pouch qualifies only if it is treated as food, and its restricted customs classification makes an import licence unlikely to have been granted.

Challenges to regulating nicotine pouches in India

1. The sales channel sits outside every enforcement design: Tobacco control law assumes a physical shop with a visible point of sale, so an online order routed through a delivery platform meets no check. Eg. The draft Cigarettes and Other Tobacco Products (Amendment) Bill, 2020 proposed banning online sale of tobacco products and has never been enacted.
   The Fix: Place the compliance duty on the delivery platform and the payment gateway, so liability attaches where the transaction is actually recorded.
2. Youth uptake runs ahead of regulation: Flavoured oral nicotine is marketed as a lifestyle product rather than a tobacco product, which removes the stigma that deters first use. Eg. The Global Youth Tobacco Survey conducted in India in 2019 found that 8.5 per cent of students aged 13 to 15 used tobacco in some form.
   The Fix: Prohibit characterising flavours in oral nicotine products, which is the single measure that has cut youth initiation wherever it has been applied.
3. State action produces a patchwork rather than a rule: Food safety commissioners issue prohibition orders that lapse and must be renewed, so the legal position differs by State and by year. Eg. State bans on gutkha and pan masala are issued under Section 30(2)(a) of the Food Safety and Standards Act, 2006 and are renewed one year at a time.
   The Fix: Notify a national product standard through the food safety regulator, so the position holds across States without annual renewal.
4. A restricted classification is not self-enforcing: Goods requiring a licence still enter through courier consignments and passenger baggage, where the volume of parcels exceeds inspection capacity. Eg. Customs seizures of e-cigarettes at Indian airports have continued in every year since the 2019 ban.
   The Fix: Add the oral nicotine codes to the risk-management system used for courier and baggage screening, so consignments are flagged automatically rather than by sampling.
5. Health evidence is thin at the point where a decision is needed: Long-term data on the cardiovascular and oral effects of tobacco-free nicotine is limited, which lets manufacturers argue harm reduction against combustible tobacco. Eg. The current Indian evidence base rests on an institute-led study of market availability rather than on outcome data.
   The Fix: Commission a national surveillance study on oral nicotine use and its health outcomes, with its results fixed as the trigger for regulatory review.

Conclusion

The legal position is intricate and the remedy is not. The executive already holds the power to prohibit import and sale on health grounds, and a notification exercising it would take minutes to issue. The cost of not issuing it is known from the vaping episode: demand settles first, the ban arrives after, and smuggling replaces the legal market it was meant to close. The question before the government is therefore about timing, not about which statute applies.

Back2Basics

1. What it is: The ICMR-National Institute of Cancer Prevention and Research is an institute of the Indian Council of Medical Research (ICMR), the country’s apex body for biomedical research, functioning under the Department of Health Research.
2. Where it is: It is located at Noida in Uttar Pradesh.
3. Earlier name: It functioned as the Institute of Cytology and Preventive Oncology before being renamed in 2016.
4. Mandate: It works on cancer prevention, early detection and population screening, and carries a substantial tobacco control research programme.

Matching Previous Year Question

“[2023] With reference to India, consider the following pairs: Action: The Act under which it is covered 1. Unauthorized wearing of police or military uniforms : The Official Secrets Act, 1923 2. Knowingly misleading or otherwise interfering with a police officer or military officer when engaged in their duties : The Indian Evidence Act, 1872 3. Celebratory gunfire which can endanger the personal safety of others : The Arms (Amendment) Act, 2019 How many of the above pairs are correctly matched? (a) Only one (b) Only two (c) All three (d) None ANSWER: (b)”