Are Nicotine Pouches beyond the law? 

Why in News?

Nicotine pouches are emerging as a new category of tobacco-free nicotine products in India. A recent study led by the ICMR-National Institute of Cancer Prevention and Research (NICPR) reportedly found their availability through online platforms, hookah shops and gig-delivery networks.

The issue has acquired urgency after the World Health Organisation (WHO) recently warned about the rapid global expansion of nicotine pouches and their aggressive marketing towards young people. WHO estimates that retail sales exceeded 23 billion pouches in 2024, while the global market was worth nearly US$7 billion in 2025. Around 160 countries reportedly have no specific regulation for these products. 

What are Nicotine Pouches?

• These are small sachets generally containing nicotine, plant-based fillers, flavourings and sweeteners, without tobacco leaf. Placed between the lip and gum, they release nicotine through the lining of the mouth.
• They involve neither combustion nor an electronic aerosol-generating device. Tobacco-free describes their composition; it does not mean nicotine-free or harmless.

Why are they a public-health concern?

• Addiction without visible smoking: Discreet use can normalise nicotine consumption in settings where smoking is discouraged. WHO identifies concealability and lifestyle branding among industry marketing tactics. 
• Youth vulnerability: Nicotine is highly addictive, and adolescent exposure can affect attention, learning and brain development. Sweet flavours and packaging resembling confectionery can increase appeal and lower perceived risk. 
• Commercial promotion drives exposure: WHO’s 2026 report highlights high nicotine levels, youth-oriented flavours and social media promotion. These are examples of commercial determinants of health via business practices shaping consumption and health risks. 
• Relative risk requires careful interpretation: Complete switching from cigarettes to certain regulated nicotine pouches may reduce exposure to harmful chemicals. However, this does not establish that all pouches are safe, suitable for non-users or approved cessation medicines. 

India’s Legal Framework:

1. COTPA, 2003: 

• The Cigarettes and Other Tobacco Products Act (COTPA) 2003 regulates specified tobacco products through advertising restrictions, packaging requirements and restrictions on sale to minors and near educational institutions.
• Tobacco-free pouches fall outside its scheduled product categories. The careful legal position is that COTPA coverage cannot simply be assumed because a product contains nicotine; its composition and the statutory definition matter. Equally, exclusion from COTPA does not establish exemption from other laws.

2. Drugs and Cosmetics Framework: 

• Nicotine is not listed as a drug in any schedule of the Drugs and Cosmetics Act, 1940. However, nicotine patches and gums are approved as drugs by the Drug Controller General of India for Nicotine Replacement Therapy (NRT) to help treat nicotine addiction.
• Under Schedule K of the Drugs and Cosmetics Rules, 1945, certain nicotine gums and lozenges containing less than 2 mg of nicotine are exempted from some licensing and prescription requirements.
• Nicotine pouches are different from nicotine gums and patches because they are not intended to treat nicotine addiction. They are generally marketed as recreational nicotine products or substitutes for cigarettes.

Therefore, it is debatable whether nicotine pouches can be treated as drugs under the Drugs and Cosmetics Act. Thus, nicotine pouches remain a regulatory grey area under the Drugs and Cosmetics framework.

3. Prohibition of Electronic Cigarettes Act (PECA), 2019: 

• The Prohibition of Electronic Cigarettes Act (PECA), 2019 bans the production, import, sale and distribution of e-cigarettes/vapes in India.
• However, nicotine pouches are not covered by PECA because they are not electronic devices and do not produce smoke or vapour. They deliver nicotine orally through the gums, unlike vapes, which deliver nicotine through inhaled aerosol.

Could Nicotine Pouches be treated as Food?

• The Food Safety and Standards Act, 2006 (FSS Act) gives a broad definition of “food” as substances intended for human consumption.
• Indian courts have also interpreted the term “food” broadly, including products such as supari and chewing tobacco in certain cases because they are consumed orally.
• However, the Food Safety and Standards (Prohibition and Restriction of Sales) Regulations, 2011 prohibit the use of tobacco and nicotine as ingredients in food products. 

There is an argument that nicotine pouches could fall within the broad definition of food because they are orally consumed. 

However, their nicotine content creates a major legal obstacle under food-safety regulations. Thus, the issue remains a regulatory grey area requiring clear government clarification.

Can Nicotine pouches be imported into India?

Import restrictions flow from two statutes: 

(i) Foreign Trade (Development and Regulation) Act, 1992: It empowers the Union Government to prohibit, restrict or regulate imports; the Directorate General of Foreign Trade (DGFT) administers this and publishes the ITC-HS classification listing which goods are free, restricted or banned. 

(ii) Customs Act, 1962:  Section 11 of the Customs Act allows the government to prohibit goods wholly or partly by notification, on grounds that include the protection of human, animal or plant life.

Thus, even if a product does not fall under COTPA or PECA, it does not automatically follow that its import is unrestricted.

HS Classification: 

• After WHO updated the Harmonised System, a sub-category was introduced for oral nicotine products that do not involve combustion:
  • 2404 91 30 covers tobacco-free single-use oral nicotine pouches.
  • 2404 91 90 covers other oral nicotine products not meant for therapeutic use. 
• Under the DGFT schedule and the rules of the Central Board of Indirect Taxes and Customs, goods under 2404 91 30 are restricted. 
• Unlike “free” items, they cannot be cleared merely on payment of duty, and unlike “prohibited” e-cigarettes, they are not banned outright. Thus, they require a specific licence or permission. 

Can Nicotine pouches legally be sold at duty-free shops?

• Nicotine pouches have reportedly been found at some duty-free stores at Indian airports. Such shops operate under the Customs Act, 1962 and are not completely outside Indian law.
• Duty-free status does not mean that every product can be sold legally. The sale of nicotine pouches would depend on their applicable import and regulatory requirements. 
• Since nicotine pouches are classified as “restricted” for import, their lawful sale would generally require the necessary licence/authorisation. Therefore, their mere availability at a duty-free shop does not establish that their sale is legally permitted. 

Way Forward: 

• Clarify coverage across nicotine products: Establish explicit definitions addressing tobacco-derived and synthetic nicotine, while preserving a separate, evidence-based pathway for therapeutic products.
• Issue coordinated enforcement guidance: MoHFW, CDSCO, FSSAI, DGFT and Customs should clarify classification, permissions and agency responsibilities.
• Protect children and non-users: Where products are legally permitted, apply strong age verification, flavour restrictions, advertising controls, clear warnings, nicotine limits and child-resistant packaging. WHO recommends comprehensive measures covering these areas. 
• Use the correct legal instrument: Import restrictions can address entry, but a comprehensive domestic manufacture and sale prohibition requires an appropriate legal basis. A customs notification should not be assumed to accomplish every regulatory objective.
• Strengthen cessation support: Expand counselling and access to approved cessation treatment through the National Tobacco Control Programme, launched in 2007-08, which already includes cessation and enforcement objectives.
• Generate Indian evidence: Monitor youth uptake, nicotine strength, adverse events, dual use and marketing. Evaluate policy through health outcomes and compliance, alongside seizures.

Legal ambiguity should prompt timely clarification; it should neither become a presumption of unrestricted sale nor justify unsupported claims about the law.

UPSC Mains PYQ: 

Q. In a crucial domain like the public healthcare system, the Indian State should play a vital role to contain the adverse impact of marketisation of the system. Suggest some measures through which the State can enhance the reach of public healthcare at the grassroots level. GS-2 (2024)

Practice Mains Question:

Q. “Emerging nicotine products expose the limitations of product-specific public-health legislation.” Examine with reference to nicotine pouches and suggest a coordinated regulatory response.

Practice Prelims Question

Q. Consider the following statements:

1. Every nicotine-containing product is automatically covered by India’s electronic-cigarette prohibition.
2. Food-safety regulations prohibit nicotine as an ingredient in food products.

Which of the statements given above is/are correct?

(a) 1 only
(b) 2 only
(c) Both 1 and 2
(d) Neither 1 nor 2 

Answer: (b)

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