E-Cigarette Ban Promoting Public Health

EN Team             

E-cigarettes, the consumption of which is popularly known as vaping, is now illegal in India with the government passing an ordinance on 18th September 2019 banning the sale, manufacturing, distribution, import, export, storage, transport and advertisement of the product.

Use of e-cigarettes is 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. Even storage is punishable with an imprisonment up to six months or fine up to Rs. 50,000, or both.

Globally, many countries are evaluating the health risks associated with using e-cigarettes, and India is one of a handful of countries to enforce a complete ban. The reason is the health risks posed by e-cigarettes and, in particular, the perception among adolescents and the youth that vaping is "cool", making e-cigarettes a potential gateway to smoking regular cigarettes.

With cigarettes being associated with fatal lung diseases and death of millions of people around the globe, manufacturers introduced Electronic Nicotine Delivery Systems (ENDS) that were deceptively promoted as a less harmful alternative. They were introduced and popularised by forwarding the argument that they are effective in helping people quit smoking tobacco. However, there are no concrete large-scale studies to show their effectiveness in helping people quit smoking. Health activists argue

that these products actually undermine

the efforts to de-normalise tobacco use.

There is no conclusive evidence of "harm reduction" as well as any cessation benefits of these products. On the contrary newer evidence of harm is emerging, as demonstrated by the outbreak of severe lung disease due to vaping.

The liquid in the e-cigarette usually contains nicotine, which is toxic, highly addictive and known to be a lethal chemical. To make it more appealing to the youth, more than 7,000 varieties of flavours are mixed in the liquid. Apart from nicotine, e-cigarette cartridges can also be used as delivery devices for addictive and harmful substances such as cannabis and opiates.

As per WHO Report on the Global Tobacco Epidemic 2017, the Governments of thirty countries have already banned the product anticipating the possibilities of children, adolescents and youth (and generally non-smokers) initiating 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 and youth are Iikely to switch to cigarette smoking. The report says that 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.

Countries where ENDS are banned include Mauritius, Australia, Singapore, Korea [Democratic People's Republic], Sri Lanka, Thailand, Brazil, Mexico, Uruguay, Bahrain, Iran, Saudi Arabia, and the United Arab Emirates.

Electronic Nicotine Delivery Systems (ENDS) are devices that heat a solution to create an aerosol, which frequently also contains flavours, usually dissolved into propylene Glycolor/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. The main constituents of the solution, in addition to nicotine 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 diverse group with potentially significant differences in the production of toxicants and mechanisms for delivery of nicotine. 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. In addition, 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. 

Study on Mice Establishes Link Between Vaping Nicotine and Cancer

The most recent study that definitively links vaping nicotine to lethal diseases found that e-cigarette vapor causes lung cancer and potentially bladder cancer in mice. The research funded by the National Institutes of Health, USA, was conducted by the New York University and was recently published in Proceedings of the National Academy of Sciences. In the NYU study, researchers found that e-cigarette vapor caused DNA damage in the lungs and bladder and "inhibits DNA repair in lung tissues."

Out of 40 mice exposed to e-cigarette vapor with nicotine over 54 weeks, 22.5% developed lung cancer and 57.5% developed precancerous lesions on the bladder. None of the 20 mice exposed to e-cigarette smoke without nicotine developed cancer over the four years they studied the mice.

Led by Moon-shong Tang, PhD, of NYU School of Medicine, the study also found that 23 of 40 mice (57.5 percent) exposed to E-cig smoke developed bladder hyperplasia, genetic changes that make cells more likely to multiply, and a step toward abnormal tissue growth seen in cancer. Only one of the 17 mice exposed to the zero-nicotine E-cig smoke developed hyperplasia.

The question of whether nicotine itself, separate from tobacco smoke, causes cancer is controversial because of conflicting study results over time that used oft-criticized methods. Almost all researchers agree, however, that chemicals added during the curing of tobacco - nitrate and nitrite - can cause a reaction called nitrosation (the addition of a particle called a nitrosonium ion), according to the study. This is known to convert nicotine into nitrosamines such as NNN (N-nitrosonoricotine) and NNK (nicotine-derived nitrosamine ketone), proven carcinogens in mice and humans.

Conventional thinking, says Professor Tang, has been that smoke from cured tobacco deposits nitrosamines into a smoker's organs and blood, with nitrosamine blood tests the best measure of their potential to cause cancer.

Such tests in a 2017 study found that levels of a compound related to NNK, called NNAL, were 95 percent lower in E-cig smokers than in tobacco smokers, leading some experts to conclude that a switch to E-cigs might save millions of lives. However, the new study finds that mammalian cells contain their own nitrosonium ions, which directly react with nicotine to form nitrosamines, including NNK. Many studies have also shown that human and mouse cells also have ample supplies of cytochrome p450, which further converts NNN and NNK into compounds (e.g. formaldehyde and CH3N=NOH) that can react with DNA to form damaging adducts (e.g. gamma-OH-PdG and O6-methyl-dG), the researchers say.

Tang's team had shown in a February 2018 PNAS article that E-cig smoke induces DNA damage in the mouse lung and bladder, and that nitrosation in cultured human lung and bladder cells converts nicotine into derivatives that increase DNA code changes (mutations) with the potential to transform normal cells into cancer cells. Specifically, the earlier study found that nicotine is transformed into nitrosamines, then into DNA damaging agents, which ultimately form DNA adducts.

The current study results confirm that nicotine from E-cig smoke can cause cancer in the lungs, and precancerous growth in the bladders, of mice. Furthermore, the results argue that nicotine, once inside cells, is converted into nitrosamines that do not leave cells and, therefore, could never be captured by tests that measure nitrosamine levels outside of cells (e.g. blood tests).

"Our results support the argument that the nicotine-derived DNA adducts are likely the main causes for carcinogenesis in mice exposed to E-cig smoke," says study author Herbert Lepor, MD, the Martin Spatz Chair of Urology at NYU Langone Health. "Our next step in this line of work will be to expand the number of mice studied, to shorten and prolong E-cigarette exposure time, and to further investigate the genetic changes caused by E-cigarette smoke."

In India, nicotine is prohibited for use under the Food Safety and Standards (Prohibition and Food Safety and Standards Act) 2006; as an ingredient in any food item under the Restrictions on Sales Regulation, 2011 and 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 Iisted as an insecticide in the Schedule of lnsecticides under the Insecticide Act 1968, and subsequently its use as a pesticide is also highly restricted by Government of lndia.

The Drugs and Cosmetics Act, 1940 and Rules, 1945 permit the use of Nicotine up to 2 mg and 4 mg in gums, Iozenges 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 manufact-ured under a valid drug manufacturing license and also a valid sales license for products cont-aining more than 2mg of nicotine. ENDS are not yet approved as Nicotine Replacement Therapy (NRT) under the Drugs and Cosmetics Act.

In 2014, the Ministry of Health & Family Welfare conducted a roundtable discussion on Electronic Nicotine Delivery Systems (ENDS), wherein eminent doctors, specialists, scientists and officers of Health and Drug depart-ments conclu-ded that available scien-tific evidences indicate that the ENDS and similar techno-logies that encourage tob-acco use, are hazardous for an active as well as passive users and have an adverse impact on public health.

The intent behind the ban in India is to ensure e-cigarettes do not become an 'epidemic' among children and young adults. There are 267 million tobacco users in India, and one million persons are thought to die of tobacco-related diseases every year. Over 38 per cent are exposed to second-hand smoke at home. And, alarmingly, 28.6 per cent of those afflicted are in the 15-plus age group and 14.6 per cent in the 13-15 age group. E-cigs are entry-level products. Minors use it because of the flavours and none of the foul smell and smoke associated with traditional cigarettes. Manufacturers package a wide variety of e-liquids in flavours like mango, chocolate, bubble gum, fruit tobacco, menthol to make them more appealing. These flavours make teens vape on endlessly without realising that an average e-cig pod contains nicotine equal to a normal cigarette pack of 20. E-cigarette users could graduate to smoking. While supporters argue that the vape ban only deprives smokers of safer options, the government and anti-tobacco activists are firm on their stand that the efforts made to reduce the number of tobacco smokers by more than two percentage points in the past decade could be reversed if vaping is encouraged.

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