Government position a mix of ulterior motives and lack of awareness

Six states have banned vaping, with the central government about to follow suit

India is reeling under a tobacco epidemic, with 1.5 million deaths reported annually. It is home to 120 million (12 crore) smokers, which is12% of the world’s smoking population, according to WHO. But despite the population of smokers rising significantly – the number of men smoking tobacco increased 36% between 1998 and 2015 – the government’s tobacco control efforts have been stunted by its desire to protect the livelihoods of tobacco farmers, India being the third largest producer, which has led to various conflicts of interests. These include owning a significant 32% stake in the country’s biggest tobacco firm, ITC, in violation of Article 5.3 of WHO’s Framework Convention for Tobacco Control (FCTC), which was signed and ratified by India in 2005.

Mitigation efforts

Some efforts have, however, been made. After FCTC was adopted in 2003, India replaced its archaic Cigarettes Act, 1975, with a more stringent tobacco control law, the Cigarettes and Other Tobacco Products Act (COTPA), in 2003, which also brought various local forms of smoked and smokeless tobacco under its ambit to address the large spectrum of tobacco use in the country. Modelled on FCTC provisions, the implementation of the Act has been haphazard. Being left mostly to the states to act on, with some doing better than others, there has been some impact as the latest GATS-2 survey shows 6% decline in tobacco prevalence between 2009 and 2016. While commendable, the decline is not homogenous, some states (northeast and Goa) have reported rise in use, and India still remains the second largest tobacco consumer, necessitating implementation of more effective measures.

The National Health Policy, 2017, has set the target of “relative reduction in prevalence of current tobacco use by 15% by 2020 and 30% by 2025”.

Electronic cigarettes

Tobacco products are regulated by both the Centre and the states. WHO’s highly cautionary stance on ENDS, prevalence of serious misconceptions about vaping, general lack of awareness and a misperception that ENDS will hurt tobacco farmers has led a few states to imposed restrictions on vaping.

States

These include Punjab, Haryana, Karnataka, Jammu & Kashmir (J&K), Kerala and Bihar. The measures vary from outright ban on consumption and sale, to prohibition on import. The ban is the severest in Punjab, where a shopowner was sentenced to three years in prison for selling a vape pen with few cartridges, followed by Bihar which has prohibited both use and sale. Three more states are close to formulating a ban – Maharashtra, Rajasthan and Delhi.

The arguments put forth by the states are in two broad categories – technical and emotional (as can be seen from the circulars issued in Punjab, Karnataka, Bihar, J&K – with one order even banning use –  and Mizoram).

The technical objections mainly stem from the lack of ENDS regulations and confusion among state authorities on whether to treat e-liquids as a food or tobacco product. Most of the circulars cite the Drugs & Cosmetics Act (DCA), which prohibits the use of nicotine in any product other than the gums and patches approved by the Drugs Controller of India. However, a Right to Information (RTI) query put to Director General of Health Services has revealed that e-cigarettes do not come under the DCA, making this objection irrelevant.

The emotional argument centres around teen use and the unfounded allegation of ‘gateway effect’ of electronic cigarettes. This and some other key objections by tobacco control and authorities are addressed in the final section.

Central government

The Centre has taken a negative view of ENDS from the start, influenced strongly by the COP6 declaration and peaking with India being among the few countries that sought the recommendation of an outright ban on the technology during COP7 held in New Delhi in 2016.

In 2014, soon after COP6, the central government formed three committees to look into ENDS and propose measures to deal with them. After studying the issue for eight months, all the three committees recommended an outright ban. As can be seen from their reports, despite the panels comprising eminent and well-networked medical professionals, and with sufficient time on their hands, they could not come across any research or evidence that points to the enormous harm reduction potential of electronic cigarettes. This raises serious questions on the recommendations and the real mandate of the committees.

For almost a year-and-half since the recommendations, the central government was seized with the issue of under which provision to ‘act against’ ENDS, finally settling on COTPA in December 2017. Through indirect statements and its affidavit in the Delhi High Court (see ‘legal situation’), the Centre has made clear it is intent on imposing a national ban on electronic cigarettes.

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Rejoinders to key government arguments

1) Health impact of ENDS is unclear.

There is an overwhelming consensus in the scientific community globally that ENDS are not just safer, but way safer, to the extent of being 95% less harmful than combusted cigarettes. The most notable and easily understandable reason for this is that though the nicotine creates the addiction, it is the tar, produced from the burning of tobacco in cigarettes, that kills. Various studies and evidence reviews from very credible institutes and government bodies – the Royal College of Physicians, London, Public Health England, National Academies of Sciences, Engineering Medicine (US), American Cancer Society, etc. – have come to the same conclusion on the relative safety of ENDS. A 3.5-year study published in Nature found ENDS users who never smoked showed no signs of the damage smokers exhibit.

2) The long-term impact of ENDS is not known.

There is no drug that underwent a 20-year trial before it was introduced into the market – two-three years of trials at the most. ENDS have been put through that process and the RCP study states:

“In normal conditions of use, toxin levels in inhaled e-cigarette vapour are probably well below prescribed threshold limit values for occupational exposure, in which case significant long-term harm is unlikely. Some harm from sustained exposure to low levels of toxins over many years may yet emerge, but the magnitude of these risks relative to those of sustained tobacco smoking is likely to be small….Although it is not possible to quantify the long-term health risks associated with e-cigarettes precisely, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.”

Almost a million people are dying in India every year due to tobacco use. India’s tobacco health burden runs into loss of lakhs of crores every year. Are we to wait 20 years before tobacco harm reduction is made available to smokers? That too despite significant evidence that ENDS are far safer. What about the countless lives that will be lost in this time, since data shows smoking kills half of all those who do it – plus 600,000 people a year who don’t, via second-hand smoke – making it the world’s biggest preventable killer, with a predicted death toll of a billion by the end of the century, according to the World Health Organization. The norms that are applied to other drugs and remedies should also be applied in this case.

3) Nicotine is highly addictive, and ENDS contain nicotine.

While it is true that nicotine is an addictive substance, it is not the main culprit in cigarettes. It is the more than 7,000 chemicals in tobacco smoke, at least 250 are known to be harmful, including hydrogen cyanide, carbon monoxide, and ammonia, that makes cigarettes deadly. Nicotine, the active compound in tobacco, is a naturally occurring substance found in many everyday food items, from potatoes, eggplant, cauliflower, tomatoes, etc. In its pure form, the substance is only as addictive as caffeine and in some cases beneficial. Public health experts worldwide now recognise the need to decouple nicotine from tobacco so that proper intervention strategies can be developed, with ENDS playing a major role in it.

Moreover, the government too recognises that nicotine itself is not the culprit by allowing various nicotine replacement therapies (NRTs) to be sold over the counter. For years the pharmaceutical industry has invested millions of dollars in research, development and marketing of NRTs to be utilised by combustible tobacco smokers to “kick the habit”. This same pharmaceutical grade nicotine is exactly what is used in ENDS.

Keeping in mind that what causes harm in tobacco is the combustion of leaf tobacco and the chemical reactions of the additives that form the negative health effects of tobacco and potentiate the effects of the naturally occurring nicotine in leaf tobacco. Combustion is the main health harm from smoking as that creates the chemical reactions and tar that not only affect the user, but also indirectly those who are in the presence of a user who is actively smoking. None of those harms are present with the use of ENDS.

The US FDA Commissioner too recently announced a US policy shift by stating that the focus needs to shift from nicotine to the delivery mechanism, and smokers should be encouraged to transition to safer alternatives like ENDS. In his words:

Led by the best available evidence, the FDA will pursue a regulatory framework that focuses on nicotine and supports innovation to promote harm reduction.

4) ENDS are a gateway to smoking. Kids are being lured into tobacco use through vaping.

Researchers from the University of Stirling and Public Health England collaborated for a study looking at teen vaping trends in the United Kingdom to address the “Gateway Theory”. The study of 60,000 teen respondents found roughly 10 to 20 percent of teens aged 11 to 16 have tried a vaping device at least once, however, only 3 percent used them regularly. Daily users among this age group were overwhelmingly found to already smoke. Only 0.1 percent to 0.5 percent of teens who have never smoked are regular users of a vape device. – Similar results were found in the Population Assessment of Tobacco and Health (PATH) Study out of the United States, which is a national longitudinal study of tobacco use and how it affects the health of people in the United States.

The available evidence does not support the “gateway hypothesis” that ENDs/ELVs encourages nicotine addiction or uptake by youth. The focus instead needs to be harm reduction by allowing youth already using combustible tobacco access to ENDS instead of a perceived risk of “Gateway Theory” that youth who vape will eventually move onto combustible smoking.

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