India’s Nicotine Pouch Debate Shows Why Regulatory Classification Matters

The debate over nicotine pouches in India is increasingly becoming a debate about regulatory classification. Tobacco-free nicotine pouches do not fit comfortably within some of the legal categories created for cigarettes, smokeless tobacco, electronic cigarettes or medicinal nicotine products. Recent commentary has therefore focused on whether existing Indian laws adequately cover them and which authorities should ultimately have responsibility for their oversight.

This is an important question, but it also illustrates a broader challenge facing nicotine regulation. New products can develop faster than legislation designed around older technologies and product categories. When that happens, the policy response should begin with clear classification and an assessment of product characteristics, rather than assuming that uncertainty itself determines whether a product should be prohibited or treated in the same way as another nicotine category.

India’s Existing Framework Was Built Around Different Products

India already has an extensive tobacco-control framework under the Cigarettes and Other Tobacco Products Act 2003 (COTPA). The legislation regulates specified tobacco products, including cigarettes, cigars, bidis, chewing tobacco, snuff, gutka and other products containing tobacco. Tobacco-free nicotine pouches, however, do not contain tobacco leaf and are not currently among the products listed in the COTPA schedule.¹

That distinction matters. Nicotine and tobacco are related regulatory issues, but they are not interchangeable legal categories.

The same problem arises with the Prohibition of Electronic Cigarettes Act 2019 (PECA). Nicotine pouches are non-electronic oral products. They contain no heating element and generate neither smoke nor aerosol. Legislation written specifically for electronic cigarettes is therefore not an obvious regulatory home for an oral product simply because both can deliver nicotine.

The result is not necessarily an absence of law. Instead, it creates a classification question involving several regulatory frameworks.

Drug Classification Requires Careful Distinction

India’s drug-regulatory framework adds another layer of complexity. Nicotine is already used in approved nicotine-replacement therapies, including gums, patches and lozenges intended to support smoking or tobacco cessation. Consumer nicotine pouches, however, are generally marketed differently and may not make therapeutic claims.

Indian authorities have nevertheless taken the position that certain oral nicotine pouches can constitute unapproved drugs. Reporting on a 2026 ICMR-National Institute of Cancer Prevention and Research study states that authorities have relied on the Drugs and Cosmetics Act in addressing their sale.² The regulatory position is also being contested in litigation concerning nicotine pouches sold through duty-free outlets, demonstrating that classification remains legally consequential rather than merely academic.³

This distinction deserves precision. A therapeutic nicotine product intended to treat dependence and a consumer nicotine product intended as an alternative means of nicotine consumption may contain the same active substance while presenting different intended uses, claims and regulatory questions.

Clear rules should therefore establish when a nicotine product falls within medicines regulation and when a separate consumer nicotine framework is more appropriate.

Food Classification Does Not Resolve the Question

Food law provides another possible route, but it creates its own difficulties. India’s Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations expressly state that tobacco and nicotine must not be used as ingredients in food products.⁴

If nicotine pouches were classified as food, this provision would create an immediate regulatory problem rather than provide a straightforward route to market.

The broader lesson is that forcing a new nicotine product into an existing category can produce outcomes that reflect the wording of legacy legislation more than the characteristics of the product itself. Regulation works best when definitions clearly correspond to what is actually being regulated.

Import Classification Is Not the Same as Product Regulation

Import rules add another layer. Recent analysis of the Indian market has highlighted ITC-HS classifications for tobacco-free nicotine pouches and other oral nicotine products and noted that products falling within restricted import categories may require appropriate permissions rather than simply entering the country following payment of customs duties.⁵

Import classification, however, should be distinguished from comprehensive product regulation. Customs rules determine whether and under what conditions goods may cross a border. They do not necessarily establish the standards governing composition, nicotine content, packaging, age of sale, marketing or retail distribution once a product reaches the market.

The controversy surrounding nicotine pouches in Indian duty-free shops illustrates this distinction particularly clearly. Duty-free status concerns customs treatment; it should not automatically be interpreted as evidence that a product has received regulatory approval under every other applicable law.

Availability Creates an Enforcement Question

The debate has become more urgent because nicotine pouches are already reportedly available through multiple channels. Research led by ICMR-NICPR reported availability across seven of ten surveyed Indian cities, including through online platforms, hookah shops and delivery services.²

For policymakers, this means the issue extends beyond theoretical classification. Where products are already entering commercial channels, uncertainty can make enforcement inconsistent and leave manufacturers, retailers and consumers without a clear understanding of the applicable rules.

That is precisely where regulatory clarity becomes valuable.

A defined framework could establish who may sell nicotine pouches, the minimum purchasing age, permitted nicotine levels, ingredient and purity requirements, packaging and warning standards, restrictions on youth-oriented marketing, online age verification, manufacturing requirements and mechanisms for market surveillance.

These safeguards can address legitimate concerns around nicotine dependence and youth access without assuming that every nicotine-containing product requires an identical regulatory response.

Youth Protection Should Be Explicit

Youth use deserves particular attention. Nicotine is addictive, and products designed for adult consumers should not be marketed or sold to children and adolescents. WHO has highlighted nicotine pouches among the emerging nicotine products raising concerns about youth appeal and addiction.⁶

A dedicated framework would allow youth protections to be explicit rather than dependent on uncertain interpretations of laws developed for other products. Age-of-sale requirements, restrictions on marketing directed at minors, responsible packaging, retail controls and enforcement of online sales could all form part of such an approach.

Other jurisdictions have already begun developing product-specific frameworks. Sweden regulates tobacco-free nicotine products through dedicated legislation, while Czechia has introduced requirements covering the composition, labelling and notification of nicotine pouches alongside age restrictions.⁷ These systems are not necessarily models for India to copy directly, but they demonstrate that regulation need not be limited to a binary choice between treating pouches as traditional tobacco products and prohibiting them altogether.

Classification Should Reflect Product Characteristics

The Indian debate ultimately raises a larger policy question: should nicotine regulation continue to depend primarily on categories created around tobacco leaf, electronic devices, medicines and food, or should legislation increasingly recognise nicotine products as distinct categories with different characteristics and risk profiles?

For GINN, the answer should begin with evidence and regulatory purpose.

Nicotine pouches are not cigarettes. They are not electronic cigarettes. They are not automatically equivalent to medicinal nicotine-replacement therapies, and treating them as food creates a direct conflict with India’s existing prohibition on nicotine as a food ingredient. These distinctions do not mean that nicotine pouches should remain outside regulation. They demonstrate why clear, product-appropriate regulation is necessary.

India has an opportunity to move from classification uncertainty toward a framework that establishes enforceable standards while recognising differences between nicotine products. Such a framework should protect young people and non-users, establish appropriate product and manufacturing requirements, provide clear rules for importers and retailers, and enable effective market surveillance.

The challenge presented by nicotine pouches is therefore broader than deciding which existing statute can be stretched far enough to accommodate them. It is about designing regulation capable of responding to a nicotine market that no longer fits neatly within the categories of the past.