As a part of Tandarust Punjab Mission, Commissioner Food and Drugs Administration, Punjab Mr. Kahan Singh Pannu has issued a circular prohibiting sale of E-Cigarettes and even Heat –not- Burn (HNB) devices in the state.

Facts :

• In pursuance of the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the manufacture, storage, sale or distribution of Gutkha, Paan Masala (Containing tobacco or nicotine), processed /flavoured/scented chewing tobacco and any other food products containing Tobacco or Nicotine as ingredient by whatsoever name these are called as final products, whether packaged or unpackaged and / or sold as one product or through packaged as separate products available in the market, is prohibited for a period of one year in the State of Punjab.
• A notification in this context has been issued on October 09, 2018.
• Punjab was the first State in India to declare ENDS (Electronic Nicotine Delivery System /E-Cigarettes) as unapproved under Drugs and Cosmetics Act way back in 2013 under the provisions of Cigarettes and Other Tobacco Products Act (COTPA), 2003, when very few people knew about these harmful products.
• It has been observed that to circumvent the ban on the sale of gutkha, the manufacturers are selling paan masala (without tobacco) with flavourved chewing tobacco in separate sachets but often they are conjoint and sold together by the same vendors in the same premises .
• This is done intentionally so that consumers can buy the paan masala and flavoured chewing tobacco and mix both the articles as a concoction to replace gutkha.
• Hence, instead of the earlier "ready to consume admixture", paan masala and flavoured/scented chewing tobacco are being used to serve the same purpose.
• In view of this processed /flavoured/scented chewing tobacco, Gutkha and Paan Masala containing tobacco and have been banned in the State.
• The online sale was also prohibited by Cyber Crime wing Punjab in 2016.
• Now, an Advisory has been issued by Ministry of Health and Family Welfare, Government of India on Electronic Nicotine Delivery Systems (ENDS) including e-Cigarettes, Heat Not Burn(HNB) devices, Vape e-sheesha, e-Nicotine, Flavoured Hookah and the like products.
• Acting on the Advisory issued by Ministry of Health and Family Welfare, Commissionerate of Food and Drugs Administration has issued a circular calling for stopping the sale or import of electronic cigarettes and heat-not-burn tobacco devices.
• Under these new regulations, promoters will be prosecuted under the Drugs and Cosmetics Act for selling unapproved drugs and could end up serving a year in jail.

Analysis :

• Although, Punjab is the only state where violators have been awarded conviction in two different cases under Drugs and Cosmetics Act for sale of E-Cigarettes yet the use of e-cigarettes which is also called vaping has risen in teenagers.
• There is ample scientific evidence available about the harms of nicotine and that is the reason it is unapproved under the Drugs and Cosmetics Act of India, except as nicotine gums and patches which are approved for cessation.
• Nicotine is also banned under the Poisons Act and Pesticides Act, so we need not promote an unapproved/illegal product with a known lethal dose of 0.5 mg/ kg body weight for cessation, informed CFDA.
• Such devices like electronic cigarettes and heat-not-burn tobacco devices are a "great health risk" and it is quite possible that children and non-smokers using such products could switch to cigarettes once they get addicted to nicotine.

What are e-cigarettes and ENDS ?

• ENDS are devices that heat solution to create aerosol, which also frequently contains flavours, usually dissolved into propylene glycolor and glycerin. e-cigarettes (electronic cigarettes) are most common prototype of ENDS.
• e-cigarettes are handy battery-powered devices that emit doses of vaporised nicotine. It produces the feel of tobacco smoking.
• Unlike regular cigarette, e-cigarettes do not produce smoke but produces an aerosol (mist), which is inaccurately referred to as vapor.
• e-cigarettes have a heating element that atomizes a liquid solution known as e-liquid which usually is a mixture of propylene glycol, glycerin, nicotine, and flavorings.
• Ill effects: A series of studies conducted in Japan and United States (US) had proved that the usage of e-cigarette can cause cancer and heart ailments.

Health Ministry Advisory :

• According to World Health Organisation (WHO) report on Global Tobacco Epidemic 2017, 30 countries like Mauritius, Australia, Singapore, South Korea, Sri Lanka, Thailand, Brazil, Mexico, Uruguay, Bahrain, Iran, Saudi Arabia and UAE have already banned ENDS.
• ENDS including e-cigarettes, heat-not-burn devices, vape, etc. are great health risk to public at large, especially to children, adolescents, pregnant women and women of reproductive age. ENDS are not approved as NRTs (nicotine-replacement therapies) under Drugs and Cosmetics Act and rules made thereunder.
• ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants. They contain nicotine, addictive component of tobacco products. In addition they contain metals, including lead, chromium and nickel and chemicals like formaldehyde with concentrations equal to or greater than traditional cigarettes.
• Use of ENDS may affect development of foetus during pregnancy. It may contribute to cardiovascular disease to people who use ENDS. Moreover, nicotine may function as ‘tumour promoter’ and seems to be involved in biology of malignant diseases. Foetal and adolescent nicotine exposure have long-term consequences for brain development, potentially leading to learning and anxiety disorders.

About COTPA Act, 2003 :

• It was enacted by Parliament in 2003. It prohibits advertisement and regulates tobacco business in India.
• This Act has put restriction on tobacco products which includes cigarettes, gutka, panmasala (containing tobacco), cigar, cheroot, Beedi, Snuff, chewing tobacco, hookah, tooth powder containing tobacco.

Why its hard to regulate them?

• As e-cigarettes contain nicotine and not tobacco, they do not fall within the ambit of the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (COTPA), which mandates stringent health warnings on the packaging and advertisements of tobacco products.

What needs to be done?

• The current unregulated sale of e-cigarettes is dangerous for a country like India where the number of smokers is on the decline (WHO Global Report, 2015) as it increases the possibility of e-cigarettes becoming a gateway for smoking by inducing nicotine addiction and perpetuating smoking by making it more attractive, thereby encouraging persons to become users of tobacco as well as e-cigarettes.
• In the absence of clearer evidence on the effect of e-cigarettes on tobacco cessation, it is imperative that their sale be accompanied by accurate health warnings. This is especially relevant in India, where data in the Global Adult Tobacco Survey 2009-2010 suggests that tobacco control laws, particularly the pictorial health warnings and advertisements, mandated under COTPA, have been highly effective in increasing awareness of the health risks of tobacco (smoking as well as non-smoking).
• The government should also impose appropriate restrictions on the sale and advertisement, online and otherwise, of e-cigarettes, including proper health warnings, in order to plug the existing regulatory vacuum. This should be done with immediate effect, and simultaneously the government should also commission independent scientific research on the benefits and risks posed by these products in the Indian context.