Electronic Nicotine Delivery Systems

What is Electronic Nicotine Delivery System (ENDS)

Electronic Nicotine Delivery Systems (ENDS) are devices that heat a solution to create an aerosol, which frequently also contains flavours, usually dissolved into Propylene Glycol or/and Glycerin.

Electronic cigarettes, the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporise a solution, which the user then inhales. Electronic Nicotine Delivery System (ENDS) aerosol contains nicotine, the addictive component of tobacco products. The main constituents of the solution, in addition to nicotine (when nicotine is present) are propylene glycol, with or without glycerol and flavouring agents. ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants.

Although ENDS is generally considered a single product class, these products constitute a adverse group with potentially significant differences in the production of toxicants and mechanisms for delivery of nicotine.

Ill-effects of ENDS

In addition to creating dependence, nicotine can have adverse effects on the development of the foetus during pregnancy. It may contribute to cardiovascular disease to the people who use ENDS. Also, nicotine may function as a “tumour promoter” and seems to be involved in the biology of malignant diseases.

Foetal and adolescent nicotine exposure may have long-term consequences for brain development, potentially leading to learning and anxiety disorders. A number of metals - including lead, chromium, and nickel, and chemicals like formaldehyde have been found in aerosols of some ENDS, with concentrations equal to or greater than traditional cigarettes,under normal experimental conditions of use. As such, the evidence is sufficient to warn children and adolescents, pregnant women, and women of reproductive age against ENDS use and nicotine.

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Legal aspects of Nicotine /ENDS use

The Union Cabinet in September 2019 approved the Promulgation of the Prohibition of Electronic Cigarettes (production, manufacture, import, export, transport, sale, distribution, storage and advertisement) Ordinance, 2019. The Ordinance prohibits/bans e-cigarettes including all forms of Electronic Nicotine Delivery Systems [ENDS), Heat Not Burn Products, e-Hookah and the like devices.

Upon promulgation of the Ordinance, any production, manufacturing, import, export, transport, sale (including online sale), distribution or advertisement (including online advertisement) of e-cigarettes shall be a cognizable offence punishable with an imprisonment of up to one year or fine up to Rs. 1 lakh or both for the first offence; and imprisonment of up to three years and fine up to Rs. 5 lakh for a subsequent offence. Storage of electronic-cigarettes shall also be punishable with an imprisonment up to 6 months or fine up to Rs 50,000 or both.

The owners of existing stocks of e-cigarettes on the date of commencement of the Ordinance will have to suomoto declare and deposit these stocks with the nearest police station. The Sub-Inspector of Police has been designated as the Authorized Officer to take action under the Ordinance. The Central or State Governments may also designate any other equivalent officer(s) as Authorized Officer for enforcement of the provisions of the Ordinance.

Nicotine is prohibited for use as an ingredient in any food item under the Food Safety and Standards (Prohibition and Restriction on Sales) Regulation, 2011 of the Food Safety and Standards Standards Act 2006.

Both Nicotine and Nicotine Sulphate are listed as hazardous chemicals in the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 made under the Environment (Protection) Act, 1986.

Nicotine is also listed as an insecticide in the Schedule of Insecticides under the Insecticide Act 1968, and subsequently its use as a pesticide is also highly restricted by Government of India.

There are possibilities that children, adolescents & youth (and generally non-smokers) will initiate nicotine use through ENDS at a rate greater than expected if ENDS did not exist; and that, once addicted to nicotine through ENDS, such children, adolescents& youth are likely to switch to cigarette smoking.

The scientific evidence regarding the effectiveness of ENDS as a smoking cessation aid is scant and of low certainty, making it difficult to draw credible inferences. The Drugs and Cosmetics Act, 1940 & Rules, 1945 permit the use of Nicotine up to 2 mg and 4 mg in gums, lozenges and strips, which may be used as aids for Nicotine Replacement Therapy (NRT). However, such a product should adhere to the provisions of Chapter IV of the Drugs and Cosmetics Act & Rules made thereunder, which require them to be manufactured under a valid drug manufacturing license and also a valid sales license for products containing more than 2mg of nicotine. ENDS are not yet approved as NRTs under the Drugs and Cosmetics Act.

Government action against e-cigarettes

The Government of India issued an advisory in 2018 to all States to consider banning e-cigarettes.

16 States and 1 UT have already banned e cigarettes in their jurisdictions. The State Governments of Punjab (Vide Circular dated 5.9.13); Karnataka (Vide Circular dated 15th ]une, 2016); Mizoram (Vide Circular dated 8th June, 2016); Kerala (Vide Order dated 1st August, 2016); Jammu & Kashmir (vide Circular dated 24th July, 2017); Uttar Pradesh (Vide Order dated 14th November, 2017); Bihar (Vide Order dated 28th November, 2017), Maharashtra, Tamil Nadu, Jharkhand, Himachal Pradesh, Puducherry, Rajasthan and Meghalaya have prohibited the manufacture, distribution, import and sale of Electronic Nicotine Delivery Systems (ENDS).

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The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 - The Act prohibits the manufacture, trade, and advertisement of e-cigarettes in India. Any person who contravenes these provisions will be punishable with imprisonment of up to one year, or a fine of up to one lakh rupees, or both. No person is allowed to use any place for the storage of any stock of e-cigarettes. If any person stores any stock of e-cigarettes, he will be punishable with an imprisonment of up to six months, or a fine of up to Rs 50,000, or both.

Ministry of Health and Family Welfare (GOI) has launched a portal to facilitate reporting of violations under Prohibition of Electronic Cigarettes Act 2019 and Cigarettes and Other Products Act 2003. Portal to Report Violations of Prohibition of Electronic Cigarettes Act, 2019 and Cigarettes and Other Products Act, 2003 over Online Medium

International ban on e-cigarettes

As per the World Health Organization Report on the Global Tobacco Epidemic 2017, the Governments of thirty (30) countries including Mauritius, Australia, Singapore, Korea (Democratic People's Republic), Sri Lanka, Thailand, Brazil, Mexico, Uruguay, Bahrain, Iran, Saudi Arabia, United Arab Emirates etc, have already banned Electronic Nicotine Delivery System (ENDS) in their countries.

Source : Ministry of Health and Family Welfare