Are nicotine pouches above the law? | Explained

Story so far:

A new study led by the ICMR-National Institute of Cancer Prevention and Research found that nicotine sachets are making their way into Indian cities through online platforms, hookah shops and concert delivery services. The study comes after the World Health Organization warned in May 2026 about the dangers posed by these products. However, it is far from decided what, if any, Indian law they are governed by.

What are nicotine patches?

A nicotine pouch is a small bag similar to a tobacco-free tea bag containing nicotine, flavors and plant fibers. Users tuck the pouch between their lips and gums for up to an hour, allowing the nicotine to be absorbed directly into the bloodstream without smoke, vapor or spit. Unlike traditional smokeless tobacco such as snuff or chewing tobacco, nicotine pouches do not contain tobacco leaves, dust or stems. The nicotine used can be extracted from tobacco plants or created synthetically in a laboratory.

Are nicotine pouches regulated in the same way as cigarettes and other tobacco products?

The marketing, advertising and sale of cigarettes and other tobacco products are regulated by the Cigarettes and Other Tobacco Products Act 2003 and Rules (COTPA).

The definition of cigarettes and tobacco products is very specific and does not include “all products containing nicotine”. If the legislature had intended to cover all substances containing nicotine or “extracts of the tobacco plant,” it would have expressly said so. Restrictions on the freedom of trade and commerce must be strictly construed, and since nicotine pouches are not among the products listed in the Cigarettes Act, they do not fall under it.

Does the Drug Act regulate this?

Nicotine is not listed as a drug in any Schedule of the Drugs and Cosmetics Act 1940 (Drugs Act). However, nicotine patches and gum have been approved as drugs by the Drug Controller General of India for therapeutic use in the treatment of nicotine addiction. Schedule K under the Drugs and Cosmetics Regulations 1945 lists chewing gum and lozenges and exempts them from licensing and prescription requirements if they contain less than 2mg of nicotine.

If nicotine were not considered a drug at all, there would be no reason to exempt certain nicotine products in Schedule K. The very fact that only certain nicotine products are exempt indicates that all others are to be regulated by the Drug Act. As a result, a license is required to manufacture, import, distribute or sell these products in India.

On the other hand, it seems reasonable that nicotine pouches are not like nicotine patches or gum to treat nicotine addiction; they are a substitute for cigarettes and other tobacco products. They have no therapeutic claim and are not intended to cure addiction. They are therefore not drugs as defined by the Drugs Act.

Why are they not covered by the law banning vapes?

The importation and sale of vapes was specifically banned by the Electronic Cigarette Prohibition Act of 2019 (PECA). If vapes were drugs, there was no need for special legislation to ban them; Vape manufacturers and importers would require a license for both the liquid and the device from the DCGI, and the government could ban or regulate them under the Drugs Act or refuse to issue licenses even if they were not specifically banned. So it could be inferred that the government felt it necessary to have a specific law to ban vapes because the Drug Act did not give it adequate powers to ban them.

If the government really intended to ban or regulate them in any way, nicotine pouches would be specifically mentioned or referred to as “other products containing nicotine” in PECA or other legislation. Since there is no specific legislation banning nicotine pouches, are they freely allowed to be imported, manufactured or sold?

Can nicotine sachets be treated as food?

The Supreme Court relies on statutory definitions, such as those under the Food Adulteration Prevention Act and the Food Safety and Standards Act, which define food broadly to mean any processed, semi-processed or unprocessed substance intended for human consumption, including beverages, chewing gum and ingredients used in its preparation.

The court interprets food to include any article used as food or drink for humans, including items that enter into the composition or preparation of human food. Landmark decisions, such as on supari or chewing tobacco products, establish that the definition has a very wide amplitude to include chewed or consumed items. It could be argued that nicotine sachets are actually food products and not drugs for the purposes of Indian law.

Can nicotine sachets be imported into India?

In India, import bans are controlled by two main laws: the Foreign Trade (Development and Regulation) Act, 1992 and the Customs Act, 1962. Together, these laws allow the government to restrict or completely block certain goods from entering the country.

The Foreign Trade Act 1992 gives the central government the power to ban, restrict or regulate the import of goods. The Directorate General of Foreign Trade (DGFT) controls this and publishes official rules (ITC-HS classification) that specifically state which items are free, restricted or completely prohibited.

Section 11 of the Customs Act, 1962 empowers the government to issue notification in the Official Gazette to ban goods in whole or in part. A government can ban goods for many reasons, including: national security: protecting the country and public order; health and safety: protection of human, animal or plant life; economic protection: saving foreign exchange or preventing damage to local businesses; environmental protection: conservation of natural resources and prevention of pollution; and law enforcement: preventing smuggling, counterfeit money or illegal drugs.

After the World Customs Organization updated the Harmonized System, a subcategory was introduced for oral nicotine products that do not involve combustion: 2404 91 30 includes tobacco-free single-use sachets of the Zyn or Lyft type and 2404 91 90 includes other oral nicotine products not intended for therapeutic use. This replaced the former classification: 2403 99 90 covered “other manufactured tobacco substitutes”, while 3004 40 90 / 2404 91 10 covered only nicotine pouches or lozenges strictly classified as medicines or smoking cessation aids, such as nicotine gums, lozenges or patches intended to help people.

As per the Directorate General of Foreign Trade (DGFT) schedule and Central Board of Indirect Taxes and Customs (CBIC) rules, items with IHS code 2404 91 30 (oral nicotine pouches without tobacco) are classified as ‘restricted’. This means that, unlike “free” items, they cannot be canceled simply by paying duty. Unlike “banned” electronic cigarettes (e-cigarettes), they are not completely banned on paper, but require a special import license or permit from the DGFT.

How does DGFT decide to grant import license?

DGFT refers to Ministries of Health and other Ministries. If the Central Drugs Standard Control Organization (CDSCO) classifies recreational nicotine sachets as unapproved drugs, the DGFT will not issue an import license unless the importer holds a valid No Objection Certificate (NOC) at pharmaceutical level and license to manufacture/import the drug. However, if nicotine sachets are considered to be food, there should be no reason to refuse an import licence.

What about duty free shops?

Nicotine sachets are currently available at several duty-free shops in Indian airports. Such trades are licensed under Section 58 of the Customs Act and cannot be said to be entirely outside Indian law.

Nothing in a license issued under the Customs Act exempts them from the application of all other laws of India.

Isn’t duty free considered trade outside of India and is it really the passengers who buy from the shop who are ‘importing’ into India when they go through customs at the airport?

In the case of Flemingo Duty Free Shop Pvt. Ltd. v. Shri Kaushik Bhattacharya (2024), the Calcutta High Court held that a duty-free trade does not “import” goods into India because they are deemed to be outside India for the purposes of the Customs Act and consequently would not be covered by the Legal Metrology Act requiring goods sold there to be marked in a particularly Indian manner.

This decision should not be taken to support the view that no Indian law applies to duty-free trade. If no Indian laws apply to duty free shops, what happens if there is a murder there or some group of travelers ransacked the shop? Could they argue that no crime has been committed because no Indian law applies to that space? Shouldn’t the Indian police have the power and duty to investigate and arrest the miscreants? Would they not be prosecuted in an Indian court?

They are exempt from the application of the Customs Act only in relation to the payment of duties, cesses and other taxes to the Government of India on the items sold.

What items are allowed to be imported and sold in duty-free shops?

Duty-free shops are also limited in the items they can import and sell. Since only passengers entering or leaving the country can purchase goods in these stores, they can only sell items that passengers can take with them on the plane or into the country. These are listed in the baggage rules. If duty free had no restrictions on what it could sell, could it sell narcotics, guns and ammunition, all kinds of opioids? Surely no country would allow that. That would be absurd.

Cigarettes, along with alcohol, jewellery, watches, food and small electronics, are specifically listed in the list of items allowed to be sold in duty-free shops. Nicotine pouches are not specifically listed as items allowed to be sold in these stores. Due to the specific classification under the Customs Act, which places them as restricted, it is unlikely that a license will be issued for their import.

What is the legal status?

While there may appear to be complex legal issues surrounding the importation and sale of nicotine pouches, it is actually a fairly straightforward issue for the government to address; it will not take more than a few minutes to issue a notification under the Customs Act and the Foreign Trade Act banning the import and sale of nicotine sachets in India on health grounds.

If the government moves as slowly as it did with vapes, pouches will become the fad and demand will settle. A ban announced after this point will only lead to smuggling on the scale we now see with vapes and cause health damage that will be difficult to mitigate.

(Murali Neelakantan is a lawyer)