Tag: vaping

Despite FDA Approval, E-Cigarettes Need To Remain Banned in India

Vaping has the potential to introduce a large number of young individuals to a life-long nicotine habit, putting them on a highway to future tobacco abuse.

The US Food and Drug Administration recently approved the marketing of e-cigarettes, reigniting a debate around the world, including in India, on whether the ban on e-cigarettes and vaping is justified.

Multiple groups in India have hailed this approval as an acceptance of the notion that vaping is a suitable alternative to smoking and in the best interest of public health. Those in favour of vaping have argued that it is a good tobacco alternative that will help people quit smoking. Those still opposed to the idea have contended that it is more dangerous than other tobacco alternatives, and warrants wariness for its appeal to adolescents and young adults, for whom it can become an addiction gateway.

To be sure, India needs to continue to ban e-cigarettes and their derivatives. Let’s take a considered look at why.

How vaping works

A ‘vape’ is a device that heats nicotine, flavouring substances and any other compounds to form an aerosol, which is inhaled through the mouth and exhaled via the mouth or nose. As such, the vape facilitates the delivery of these products to the lungs, and from there absorption into the bloodstream.

Vapes differ from cigarettes in their contents: they don’t contain tobacco, tar or other substances that are known to cause cancer. They do, however, contain other new components, like aldehydes, heavy metals and silicates which are toxic to humans, and are likely to cause lung damage in the long term.

Vapes, or e-cigarettes more broadly, have been traditionally marketed as an alternative to smoking – that they will help smokers address their nicotine craving while quitting tobacco. So e-cigarettes belong to the ‘harm reduction approach’ to tobacco cessation, which advocates alternate sources of nicotine delivery, such as gum or vaping.

Now, vaping is by no means safe. Although they are safer than cigarettes, because they exclude tobacco and other well-established carcinogens, nicotine is in itself toxic. It is a highly addictive stimulant that causes craving and withdrawal, with long-term use resulting in elevated blood pressure, higher risk of heart attacks and critical blood-vessel-narrowing in the limbs.

Other experts have also argued that vaping is a more efficient form of nicotine delivery – reducing the harsh sensation in the throat and mouth associated with smoking, thus resulting in more nicotine consumption.

Another major concern is the acute lung injury associated with e-cigarette use. Over a period of around eight months, starting in mid-2019, officials reported more than 2,800 cases of vaping-associated lung-injury in the US that were severe enough to cause hospitalisation or death. Although the exact cause was unknown, research by experts at the Centres for Disease Control and Prevention found strong links to a particular constituent of vaping fluid – vitamin E acetate – and possible contaminants, particularly in the bodies of those who were vaping marijuana products.

The conversation around legalising vaping has tended to revolve around its potential to help people stop smoking – but there are increasing concerns that vaping is attracting younger users, particularly those who have had no prior tobacco exposure.

The data is strongest from the US. The 2020 National Youth Tobacco Survey showed that almost a fifth of high-schoolers used e-cigarettes, with nearly 40% of them admitting use for more than 20 days in a month.

This exponential increase in e-cigarette use by the youth, which the US surgeon general called an “epidemic” in 2018, was likely fueled by marketing campaigns targeting younger consumers, manufacturers availing flavours like mint, menthol and chocolate, and – overall – ignorance. A Truth Initiative study in July 2021 found that two-thirds of e-cigarette users aged 15-21 years were unaware that the product contained nicotine.

Dual use is another major health concern – in which individuals use tobacco products like cigarettes along with e-cigarettes. Although the companies that manufacture e-cigarettes argue that the latter will help cease tobacco use, a NASEM report in 2018 found that among those aged 18-35 years, e-cigarette use was associated with more intensive cigarette use, and that those using e-cigarettes the previous year increased their odds of daily cigarette use by 67% and a diagnosis of tobacco addiction by 158%.

The tobacco cessation argument is undermined by manufacturers’ profits being tied to continued use of the product – not reduced use. So it shouldn’t be hard to understand why the largest e-cigarette companies in the world are subsidiaries of the largest tobacco companies. Vaping has the potential to introduce a large number of young individuals to a life-long nicotine habit, putting them on a highway to future tobacco abuse.

Electronic cigarette vaporisers. Photo: EcigClick/Wikipedia Commons CC BY SA 2.0

Does vaping help stop smoking?

The answer to this question is still controversial. The World Health Organisation does not consider the use of e-cigarettes as a viable method to quit smoking, as there is inadequate evidence. A recent clinical trial involving nearly 900 people found that e-cigarette users were able to quit tobacco at nearly twice the rate of other nicotine replacement therapies (including nicotine patches and gum) after one year (18% v. 9.9%).

However, other research has shown that e-cigarette use improves smoking cessation only in highly-dependent smokers – suggesting that an individual’s degree of nicotine dependence affects this.

Paradoxically, novice users of tobacco, especially on the younger side, may end up with a heavier smoking habit when using e-cigarettes as a cessation tool.

It is notable that the proponents of vaping are the ones contending that vaping is a smoking cessation tool – and not the manufacturers themselves. The office of the Drug Controller General of India has said that it hasn’t received any applications in this regard.

For the vast majority of the population, the benefits of vaping do not outweigh the risks. On the pretext of being an alternative to smoking, e-cigarette use has increased exponentially in those younger than 25 years of age, likely due to deliberate and concerted marketing efforts by manufacturers.

Although vaping is free of tobacco, to suggest it is safe is misleading and untrue. Vaping is hardly a decade and a half old, so it is likely that the chronic respiratory diseases associated with vaping are yet to be fully appreciated. It may be less harmful than cigarettes, but is much more likely to be harmful than other nicotine replacement therapies. And the real-world consequences of this trade-off are almost impossible to determine at a population-level, and will need to be decided on an individual basis.

In places where it is legal and has been approved, vaping is more likely to work among younger adults who are heavily nicotine-dependent and among heavy smokers, and should not be used with anyone else. This nuance is probably also the reason for significant differences in public health policy on this matter, around the world.

A 2019 Public Health England report stated that e-cigarettes were 95% less harmful than smoking, while acknowledging the concomitant risk of youth initiation. A European Respiratory Society report in the same year said the risks of using e-cigarette remain largely unknown, and that that meant neither experts nor policymakers could claim it could be safer than conventional cigarettes (both after long-term use).

India banned the use and sale of e-cigarettes roughly a year ago, citing concerns of a potential smoking epidemic in the younger population. This was a prudent decision in the context of the incidence and pattern of tobacco use in India. India’s tobacco cessation policies have shown success among the youth: the estimated reduction in tobacco use among school children (13-15 years) was above 40% in the last decade.

Additionally, smokeless tobacco – in the form of paan, khaini, gutkha, zardha, etc. – is the pre-eminent form of use in the Indian subcontinent. We don’t know how e-cigarettes will impact this group of consumers. Note, however, that only 4.4% of the 13,000+ Indian adults aged 15-24 years in the 2016 Global Adult Tobacco Survey had heard of e-cigarettes. It is difficult to imagine, then, as to how they might consider e-cigarettes to be an effective cessation tool.

Tobacco cessation is of utmost public health importance, but vaping is not the way to achieve it. There is insufficient data on their long-term effects and on tobacco abstinence – even as a growing body of data and research is showing that e-cigarettes are statistically more likely to become an avenue for millions of adolescents to develop nicotine addiction, at an unprecedented rate, than to be a way to kick the habit.

As a result, legalising vaping and e-cigarettes will undo decades of efforts to control tobacco use, especially in the younger demographic. We need to better understand the longer term effects of vaping, identify who exactly it will benefit and over which other smoking cessation therapies, and how we can prevent it from compounding our existing tobacco-related public health crisis. After that, and if our hypotheses of today are borne out, we need to formulate a good and properly enforceable policy. Until then, e-cigarettes, vapes, etc. should remain banned.

Narayana Subramaniam is a head and neck surgical oncologist at Sri Shankara Cancer Hospital and Research Centre, Bengaluru.

Association of Vapers Organises Mass Protests Against E-Cigarette Ban

“In two weeks of switching I had done what I had never managed to do before – I quit smoking.”

The Association of Vapers India (AVI) led the community of e-cigarette smokers, ‘vapers’ and users of other electronic smoking devices in the country into mass protests against the blanket ban on electronic smoking devices issued by the government earlier this month.

Mass gatherings and demonstrations were organised against the government’s move in Delhi, Hyderabad and Bengaluru while only awareness programmes could be held in Kolkata, Chennai and Mumbai due to the government denying permissions in the latter for protests.

In Delhi, protests took place in Jantar Mantar with the Director of AVI, Samrat Choudhary, at the helm of affairs.

“AVI represents the community of e-cigarette users in the country and those who in the future may switch to e-cigarettes or quit smoking through harm reduction vaping devices. That’s 11 crore smokers in this country who with this ban have been denied the opportunity to switch to a less harmful alternative. Nicotine is still available in so many forms right from gums and patches to homemade beedis. Only in the form of a harm reduction alternative, it is banned,” Samrat Choudhary said while speaking to LiveWire.

“It is astonishing that the government ignored the stay orders of high court of Delhi as well as Mumbai, and even imposed bans on research. We will continue to voice our protest against the ban and organise more such protests in other cities of the country. If the government turns deaf ears to our demands, we will be forced to challenge it legally,” he added.

A number of vapers from AVI and beyond filed applications under the Right to Information (RTI) Act to various government departments and research institutes to learn more about the government’s mind-set that led it adopt such a hard-line view on Electronic Nicotine Delivery Systems (ENDS).

To utter shock and dismay, the petitioners learnt from the RTI reply that no research had been conducted on the effects of ENDS across both central and state bodies.

Also read: The Juul Comes to School – But Also to the Aid of Adult Smokers in India

Kanav Rishi Kumar from Delhi, an ex-smoker who quit through vaping, said, “It is inhumane of the government to bring an ordinance which puts the public’s health at risk. The government has the audacity to ignore global research and make a decision based on biased studies while it continues to hold 28% stake in the country’s largest cigarette company, ITC.”

“The ban marks a black day for the people of our democratic country. India has a long history of tobacco consumption stretching back centuries. Add to that we also have one of the largest smoking populations in the world. In this scenario, it is imperative that the government promotes scientifically proven, safer alternatives such as e-cigarettes for smokers and smokeless tobacco users. The ban on e-cigarettes defies logic and is biased. We urge the government to revisit their decision in the interest of public health,” said Dhaval Gogate, a pharmaceutist from Pune.

An array of studies and research papers, some of them still warm from print, claim that e-cigarettes can serve as a useful alternative to quit smoking with many doctors even going on to prescribe e-cigarettes to patients who find no other alternative to quit.

“E-cigarettes, unlike conventional cigarettes, do not burn tobacco thereby producing no tar or carbon monoxide, two of the most damaging elements in a conventional cigarette. Moreover, there is no evidence so far that vaping causes harm to other people, which is in contrast to second-hand smoke which kills 800,000 people every year,” said Dr Aparajeet Kar, a pulmonologist from New Delhi who was also at the protest in Delhi.

“While all our claims are backed with scientific studies, we are still waiting for the data on the vaping youth epidemic in India that the government is talking about,” said Olivier Vulliamy, a media professional from Goa, pointing to the teen vaping scare created by the government.

Kamal Bhattacharya, an artist from Bangalore, asked, “Nicotine in the form of cigarettes, gums and patches is widely and easily available. Vaping is just another method to inhale nicotine. Then why the government has banned only this category? The government allowed cigarettes to be sold easily and people got addicted and now they have to take little responsibility to undo this devil by allowing people effective means to wean off.”

Cary Edwards, a media consultant from Chennai who used to smoke more than 40 cigarettes for 23 years before switching to vaping, said, “In two weeks of switching I had done what I had never managed to do before – I quit smoking. Over the last two years of vaping, my wheeze has gone, my voice is clear, I can run up steps and have no crackle in my lungs when I inhale or exhale. It is crystal clear that there is some vested interest for the government behind this decision.”

Also read: India’s E-Cigarette Ban Comes as Setback for Companies Like Juul and Philip-Morris

Another vaper from Bengaluru said that the fight against the vape ban will intensify if the government keeps ignoring the rights of millions of people.

The legal fraternity has said that the ban on e-cigarettes is ultra vires to the constitution.

“When addressing issues of public health, it is imperative upon the state to act as a parent towards its citizens. By snatching away e-cigarettes, which are scientifically proven to be the most effective smoking cessation method, the state has not only condemned its 11 crore citizens to a lesser life and a bleaker future, but has also put at risk their families. The government has abdicated its duty as a parent and has decided to treat its citizens like traders – simply trading their lives and future away for higher revenues and the greater benefits of a select few,” said Pingal Khan, advocate, from Bangalore.

According to Business Insider, on January 18, the Centre for Disease Control USA announced that at least 450 vape-related illnesses had been reported in 33 states across the US till then. The illnesses had also reportedly claimed five lives and doctors feared that more were on the way. On being presented with this data, Kanav Rishi Kumar claimed that this was due to the alteration of the electronic smoking devices by adulterating it with a harmful mix of chemicals.

“A vaping device vaporises the chemical that you put in it. It is the user’s responsibility to use only the subscribed chemicals for that device. Unfortunately in the US, some people were very adventurous and experimented with things which they should not have. They mixed drugs made in the black market and created a weird chemical mixture illegally. This is what led to them getting hurt and even deaths in certain scenarios,” Kanav Rishi Kumar told Live Wire.

On being asked about regulations that can prevent the adulteration of electronic devices, he pointed to the necessity of strict laws to enact the same.

“There needs to be strict quality control checks on the devices being made and a very strict quality control check on the liquids being made for vaporisation. And the third control which is absolutely necessary is the check on the final product being sold in the market. We need to have good, intelligent regulators for this.”

All images courtesy: Association of Vapers India

The Juul Comes to School – But Also to the Aid of Adult Smokers in India

As global and local e-cigarettes gain a foothold, opinion is divided on how the benefits to adult smokers balance with the cost of their popularity with teens.

Note: This article was first published on February 3, 2019 and was republished on September 18, 2019 after the Union cabinet decided to ban e-cigarettes.

New Delhi: “I like cucumber best.”

So says 17-year-old Ishaan over Whatsapp. He’s not talking about vegetables, obviously. Cucumber is his favourite Juul flavour, even if it’s not one of the most popular. Those would be mango, or crème brulee.

Right here I’m obliged to say the two things everyone always says when a Juul is mentioned.

  1. It looks like an especially sleek USB thumb-drive.
  2. It’s the iPhone of the smoking industry.

If this gives you no idea about what a Juul is, you’re not alone, but you’re certainly not an elite teen or 20-something from an Indian metro. Yet the Juul, already the subject of serious health policy debates in the US, is now on the cusp of becoming a ubiquitous talking point in India.

At its most basic, a Juul is yet another ‘vaping’ device, or e-cigarette. Vapes are notionally healthier cigarette replacements: While a regular cigarette delivers nicotine with a lot of other substances known to be carcinogenic and toxic, vapes cut out all the extra smoke, offering a nicotine hit mixed with innocuous glycerin in a puff of pleasant, often dessert-smelling vapour.

No tar, no tobacco. And to make life easier: no fire, no smoke and no ash.

Nicotine itself, the logic goes, isn’t the culprit for smokers’ health issues, so might as well keep the good and sieve out the bad. The Juul took this redemptive philosophy one step further –  it has been marketed ostensibly as a device to help people quit smoking.

‘Disrupting’ tobacco

Vapes had a notoriously hard time going mainstream. Most were bulky, finicky devices – a thickish pipe attached to a squat canister of ‘e-juice’. To smoke, you press a button, releasing the electrical charge to vaporise the juice as you pull. They often sizzle audibly. This is the vape at its simplest – think a circa-Y2K Nokia. You can stash them in your bag or walk around with your fist curled around it, but you can’t casually slip it into your wallet.

The Juul has no buttons, no controls, and only a soft sizzle. You ‘juul’ (yes, it’s a verb now) as you would smoke a discreet, ever-lit cigarette: just put it to your mouth and pull, sucking in tasty air, exhaling a tendril or two of fog.

The Juul is so easy to use, so un-intrusive and appealing, that it may be too easy. Its slender, grey body can vanish by sleight of hand if a parent or other authority-figure passes by. They have made their way into the hands of middle-school students in private schools.

Like cigarettes and alcohol before them, vapes, especially Juuls, are already part of teens’ social currency – inaccessible enough to make them ‘cool’, but still within reach. Credit: The Wire

One 13-year-old “anonymous source” in New Delhi told The Wire how teachers learned her classmates were vaping in the bathrooms during lunch break. After a random bag check, “they found, like, three-four kids carrying their own vape pens.”

“One guy in my class, he brought it for the girls,” she said. “He probably got it from his older brother. It was in his pencil box. Maybe it’s like a cool, superiority complex thing? You know, angsty teenagers. But I think this was the first time it came to anyone’s attention that people in our grade were vaping.”

With older students in school, she said, “it’s just expected.”

Her 16-year-old sister chimed in: “My classmates? Oh yeah. They just don’t get caught.”

Vaping: Gateway or a way out?                                                

The intended user of the Juul looks more like Kurush, a 24-year-old from Gurugram, who started smoking tobacco when he was 17. “I switched late last year,” he said at a recent party, pulling from his Juul as he did so. We had already engaged in the ‘iPhone of cigarettes’ ritual.

“I researched a lot,” he said, and concluded that Juuling isn’t harmful at all. He took a pull on his device, and exhaled a plume of smoke without the usual candy aroma. “This is tobacco,” he explained – meaning Juul’s ‘tobacco’ flavour.

Kurush says he misses smoking actual tobacco – the real heat, from real fire, hitting the back of his throat; the smell. He misses the morning routine of a cup of chai, a cigarette and the bathroom; things Juuls can’t replace. But he believes he’s made the right, healthier choice getting away from cigarettes.

Ishaan, the 17-year-old, feels none of this nostalgia. He was never a smoker to begin with. “I just like it cuz it’s a vape,” he texted. He isn’t a regular user, but with close to 15 of his classmates owning Juuls, vaping is now a normal, ritualised part of life.

Regulating the vape 

Kurush and Ishaan represent two sets of Juul customers who will soon be at the eye of a policy storm in India. In 2019, the Juul – still the privilege of teens and young adults who can afford an imported device – is to be formally launched in India. Well ahead of its launch, Indian authorities are already deliberating over questions that have plagued the company in the United States.

On the face of it, Juuls are meant for people like Kurush, or those considerably older – adult smokers who want to wean themselves off tobacco, who can use the Juul as a stepping-stone, or just stick with it for a pure nicotine habit.

But authorities fear that it could make nicotine addicts of a generation of young people who would have never touched a cigarette – just as the global consensus turns against tobacco.

Nicotine may not be as harmful as all the stuff in a cigarette, but it’s still an addictive stimulant. How harmful it is is not conclusively known, making it tricky to categorise or regulate. While the US has attempted to crack down on teens’ Juul usage, the UK’s National Health Service has endorsed vapes as a way to quit smoking.

Conflicting studies are behind the confusion. Many researchers say vapes haven’t been around long enough to make any decisive claims about their effects, adverse or otherwise. Some studies support the claim that e-cigs help smokers quit cigarettes, and studies found that teens who smoke Juuls are likelier to smoke cigarettes. Some say that nicotine negatively impacts brain development in adolescents – but these are studies based on teens who smoked cigarettes.

The worry and confusion has arrived in India even before the Juul’s official entry into the market.

Also read: Three Ministries Advance Regulations to Control E-Cigarettes

Indian regulators are pre-emptively cracking down on e-cigarettes, hoping to prevent the spread of what the Ministry of Health called “a great health risk”. E-cigarettes are banned in eight states, and late last year the health ministry advised states to ban the sale and import of e-cigarettes.

Taking a cue from the US, the government seems particularly concerned with the fruity flavours’ appeal to youth.

In response, in August 2018, the Association of Vapers in India (AVI) – a non-profit that promotes e-cigs for their ‘harm reduction’– released a statement panning the advisory as not backed by “science or facts”. The AVI’s director, Samrat Chowdhery, dismissed as “specious” the claim that “flavourings” target young people. Adults aren’t exactly in love with the bitter taste of tobacco, he said.

Viraj Mohan, who just launched an Indian alternative to the Juul – Alt Vapors – also thinks these concerns are misplaced. The American context is “vastly different” from India’s, he says. Age-based regulations, as exist for cigarettes and alcohol, will be more effective than a blanket ban or restricting flavours. Legal adults should have the right to vape in any flavour they want.

“Our market is those adults who have tried quitting smoking 20 times but are constrained by the lack of vapes and the prohibitive costs of international brands,” he said. “We need policies that will account for the net benefit to India’s 100 million-plus smokers and also prevent misuse by minors.”

The appeal to teens is a concern that’s particularly attached to Juul over any other vape company. The company claims its founding purpose was to reduce harm for lifelong cigarette smokers. Critics point out that its marketing strategies – through Instagram posts, packaging and flavours – have been aimed at younger buyers.

Some studies suggest that early Juul ads specifically targeted young people. Credit: Stanford University

In India too, US-based vape retailers already seem to be wooing a niche crowd of young, wealthy millennials.

In September 2018, 24-year-old Krish, who works at The Wire, was invited to an exclusive “secret party” in a Delhi warehouse. It featured the musicians Didi Han, MadStarBase and Zokhuma, with remixes from Drake and FKA Twigs. Krish noticed the vaping samples and stalls at the venue, but only later realised that the event was organised by a US-based vaping retailer Auster – which describes itself as an “e-commerce platform for discerning vapers”.

Revolutionising quitting

Like cigarettes and alcohol before them, they are already part of teens’ social currency – inaccessible enough to make them ‘cool’, but still within reach. Juul’s products and pods – the disposable nicotine capsules – are easily bought online, at smoke shops and even convenience stores across New Delhi.

Its price – Rs 6,000-7,000 for a Juul device and Rs 2,500 for a set of four pods – doesn’t exactly scream accessibility for regular Indian smokers. But it’s not a barrier for well-off young Indians. In fact, it contributes to the Juul’s odd position in India right now – ubiquitous in an exclusive circle, but still virtually unknown outside it.

As a new entrant in India’s vaping industry, Mohan is wary of this circle dictating Indian policymakers’ decisions. It is not representative of his company’s target market, he says, and Alt is not trying to woo young non-smokers. An Alt starter kit – a device and four pods  – costs Rs 2,999; a single pod costs Rs 299.

Alt Vapors will have to bank on Juul’s ability to lobby for vape-friendly regulations  in India. In November of 2018, the tobacco giant Altria bought a massive stake in Juul, the company; with Big Tobacco comes heavy-weight lobbying and research.

Alt Vapors says it will be happy to sell its devices under the same regulations that apply to tobacco, alcohol (in some states), and even driving; that is, consumers over 18 should be able to exercise a legal right to use them.

In fact, Mohan hopes the government will tax vapes at a lower rate, to give them an advantage over more harmful cigarettes. With 106 million lives to change, Alt Vapors believes it has a clear business and moral mandate. It too wants to revolutionise quitting.

Smoking kills. Weaning long-term smokers off nicotine isn’t easy. But the question facing consumers and lawmakers will be more complicated – whether Juul is the salvation of long-time smokers, or an ingenious gateway to addiction for much younger Indians. Juul could be the future of quitting, or it could just be the future of the smoking habit.

E-Cigarettes Soon to Be Labelled as ‘Drug’ and Banned

Expert committees of the government have ruled against e-cigarettes being used and sold in India.

New Delhi: A drug consultative committee has concluded that e-cigarettes and similar devices would need to be classified as a “drug” in India under the Drugs and Cosmetics Act and that they should be banned. Section 26A of the Act allows the government to ban drugs or cosmetics which are “likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it.”

Last month as well, the drug advisory board recommended the same for electronic nicotine products – that they should be classified as “drugs” and that the manufacture, sale and distribution of nicotine devices should be banned.

According to LiveMint, the health ministry is due to issue a government notification on this development very soon and it will be among the bookmarked policy moves as part of the “first 100 days agenda” of the second term of the Modi government.

Also read: Three Ministries Advance Regulations to Control E-Cigarettes

The bureaucratic move to ban e-cigarettes happens even as a case on this is pending in the Delhi high court. In March 2019, the Delhi high court stayed the government’s efforts to bring in a ban. India’s trade ministry had said earlier this year that at present, there was no legal basis to ban imports of the device. The government’s possible decision to classify it as an unapproved drug could become the necessary legal basis to do so.

Last month, the Indian Council of Medical Research put out a white paper cautioning against the likely adverse health effects from these devices and recommended its ban.

The health ministry also asked that anyone in government institutes doing research on e-cigarettes should discuss the same with it first.

Also read: Can the Health Ministry Curtail Research on E-Cigarettes?

Electronic nicotine products claim to help current smokers switch from cigarettes to nicotine products. While nicotine patches and gum have been approved by the government for its “therapeutic value” when given in very small dosages, the level of nicotine in e-cigarettes is much higher and the drug advisory board was not convinced of either its safety or efficacy.

Furthermore, companies have apparently not demonstrated to the regulators whether these devices actually help people cease smoking. Many companies like Philip Morris do not claim that their nicotine products actually help smokers completely cease smoking but that they offer an alternative to smoking.

The government estimates that more than 460 brands of e-cigarettes are available in India, with more than 7,700 flavours and different levels of nicotine.

Last August, the health ministry urged all states to ban electronic nicotine devices. Twelve states have done so.

State governments in Punjab and Haryana have been quicker on the matter than the Central government, already banning e-cigarettes because of their nature as unapproved drugs, and have been prosecuting sellers of these products. Haryana has also said that nicotine is a poison, which it is, according to the Poisons Act.

Gujarat Government to Amend Law to Ban the Use of E-Cigarettes

Till now, 12 states in India and 36 countries have banned the e-cigarettes.

Gandhinagar: The Gujarat government will ban the sale and consumption of e-cigarettes and will bring a bill in the upcoming session of the state Legislative Assembly to amend an existing law which regulates the sale of tobacco products.

Minister of State, Home, Pradeepsinh Jadeja has said that addiction of e-cigarettes, which are easily available and bought online in absence of prohibition on their sale, is harmful for youths.

“To ban the e-cigarettes, the Home department will bring a bill in the upcoming session of the Assembly to amend the law (the Cigarettes and Other Tobacco Products– Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution Act) which regulates the sale and consumption of such items,” said Jadeja.

The Assembly session would commence on July 2.

Also read: Temporary Win for E-Cigarettes as Delhi High Court Stays Ban

“We have observed a disturbing trend wherein youths are purchasing the e-cigarettes online, as there is no specific law which bans their sale or consumption in the state,” the minister said.

Till now, 12 states in India and 36 countries have banned the e-cigarettes.

He said the e-cigarettes contain various hazardous chemicals, such as Propylene Glycol and lead, which can cause cancer and lung diseases.

“This is a dangerous form of addiction which is becoming popular among youths and even young children. In India, youths below the age of 18 years are also buying it online,” Jadeja added.

(PTI)

ICMR Calls for Ban on E-Cigarettes

A white paper released by the organisation said that in many countries, disturbing trends have emerged of adolescent people using these devices.

New Delhi: The Indian Council of Medical Research (ICMR) has recommended a complete ban on e-cigarettes and other electronic nicotine delivery systems (ENDS) based on currently available scientific evidence.

In a white paper released today, the council noted that e-cigarettes and other such devices contained highly addictive nicotine solutions that were highly addictive as well as harmful ingredients such as certain flavouring agents and vapourisers.

“Use of ENDS or e-cigarettes has documented adverse effects on humans, which include DNA damage; carcinogenic, cellular, molecular and immunological toxicity; respiratory, cardiovascular and neurological disorders; and adverse impact on foetal development and pregnancy,” a paper released by the organisation noted.

Also read: Health Ministry Put Checks on Publishing or Discussing Research on E-Cigarettes

The document has also rejected the argument that e-cigarettes could help smokers quit tobacco consumption.

“While such benefits have not been firmly established, there is also evidence that there is risk of people continuing to use both them as well as tobacco products. In addition, these devices could encourage non-smokers to get addicted to tobacco,” it said.

A committee headed by K. Srinath Reddy of the Public Health Foundation of India analysing over 300 research articles from across the world and prepared the white paper.

It noted that manufacturers add to the allure of the devices using various  flavours and attractive designs, and that in many countries, disturbing trends of adolescent people using these devices have emerged.

“Use of ENDS or e-cigarettes can open a gateway for new tobacco addiction. On balance, these have a negative impact on public health.”

The committee included experts from ICMR, the All India Institute of Medical Sciences, New Delhi; the Post-Graduate Institute of Medical Education and Research, Chandigarh; the Ministry of Health and Family Welfare; and the Food Safety and Standards Authority of India.

Reddy noted that, at present, there are more than 460 different e-cigarette brands providing different configurations of nicotine delivery systems, that they come in over 7,700 flavours and that they are fast becoming a fad among youngsters.

“Studies have found that youths using e-cigarettes and other such devices are more likely to use regular cigarettes later,” he said. “They increase the likelihood to experiment with regular products and increase the intention to indulge in cigarette smoking.”

Also read: Check Your Vocabulary Before Using ‘Coffee’ and ‘Cancer’ in the Same Sentence

Ravi Mehrotra, the director of the National Institute of Cancer Prevention and Research, Noida, and a member of the panel, added that in the wake of low barrier to entry, the market for e-cigarettes and other such devices has been growing rapidly, with the industry bringing in a diverse set of products through a variety of channels.

Balram Bhargava, the director-general of the ICMR said scientific and research data provided in the white paper could help the government formulate necessary policies on e-cigarettes and other such devices.

Sunderarajan Padmanabhan writes for India Science Wire and tweets at @ndpsr.

Temporary Win for E-Cigarettes as Delhi High Court Stays Ban

Last month, the central drug authority had issued a letter to all state drug controllers saying that they should not allow the sale, online sale, manufacture, distribution, trade, import or advertisement of electronic nicotine delivery systems.

New Delhi: A vaping device importer has successfully got a temporary stay on the central government’s ban on e-cigarettes in India from the Delhi High Court.

Last month, the Central Drugs Standards Control Organisation (CDSCO) had issued a letter to all state drug controllers saying that they should not allow the sale, online sale, manufacture, distribution, trade, import or advertisement of electronic nicotine delivery systems (ENDS).

The note specified that this ban would extend to nicotine devices like e-cigarettes, heat and not burn devices, vapes, e-sheesha, e-nicotine flavoured hookah, etc.

ENDS products are marketed as an alternative to cigarettes, as they don’t have some of the harmful ingredients that go into pre-rolled cigarettes. However, the electronic devices release nicotine, which is itself contained in cigarettes, is addictive and is toxic if consumed beyond certain safe limits.

Also Read: The Juul Comes to School – But Also to the Aid of Adult Smokers in India

While e-cigarette companies say that their ENDS devices are “less harmful” than cigarettes, there is no definitive research that has ascertained what other harms can be caused by the e-cigarettes, different or in addition to the harm from cigarettes.

This notwithstanding, the petitioner in the case, who is also an e-cigarette vendor, told the court that these devices are “not akin to a cigarette and have been internationally recognised as a healthier alternative to traditional tobacco smoking.”

In August 2018, the central health ministry issued an advisory to all states not to allow the sale of e-cigarettes. A few months later, the Delhi high court clarified that this advisory would not be binding on states who could take their own “informed decision.” By March 2019, 12 states had banned e-cigarettes.

Both these orders have been passed by Justice Vibhu Bakhru. A number of litigants have approached the courts asking for e-cigarettes to be allowed in India, including a “housewife,” a “former cigarette smoker,” and two e-cigarette vendors.

Bakhru said that ENDS does not appear to be a “drug” as defined in Section 3 of the Drugs and Cosmetics Act, and thus the CDSCO may not actually be able to regulate on it. The judge also said that the devices are not being sold as therapeutic devices with medicinal value, for the treatment of any disease.

Also Read: Three Ministries Advance Regulations to Control E-Cigarettes

E-cigarettes companies have been vying for a share of the Indian market, with public and private lobbying going on to break into India. So far, the Indian government has not been keen to allow the formal entry although ENDS is easily available for a price in all major cities and also available for sale online.

In January, The Wire reported that three ministries were looking to stem the entry of e-cigarettes. Apart from the Health Ministry, the customs department has also issued circulars saying consignments of ENDS should be referred to state drug controllers. The Ministry of Electronics and Information Technology is also seeking to amend rules for online advertisements, which will prevent the advertising of ENDS.

The case in the Delhi high court on the regulation of e-cigarettes will come up for hearing again in May.

Three Ministries Advance Regulations to Control E-Cigarettes

A proposed amendment to the IT Act will ban the advertisement of e-cigarettes in India.

New Delhi: Various forms of e-cigarettes face growing resistance from the government in their efforts to break into the Indian market. At least three ministries have advanced new regulations on the marketing or import of Electronic Nicotine Delivery Systems – widely known as vapes – while the medical community debates their actual effects on health.

The Ministry of Electronics and Information Technology (MEITY) has proposed an amendment to the Information Technology (Intermediary Guidelines) Rules 2018 to ban the advertisement of e-cigarettes.

Also Read: Why the E-Cigarette Industry Needs Global Regulations

Meanwhile, the Central Board of Indirect Taxes and Customs has issued a circular – referring to an advisory from the Union health ministry – that all import consignments of e-cigarettes must be cleared by the drug controller first.

Electronic Nicotine Delivery Systems (ENDS) include various types of e-cigarettes, which deliver nicotine without some of the known harmful substances from cigarettes containing tobacco. Some work on the principal of ‘heat not burn’, where tobacco or nicotine solutions are heated to temperatures lower than cigarettes.

According to the Global Adult Tobacco Survey (2016- 2017), awareness of e-cigarettes is already the highest among adolescents (4%). A World Health Organisation report in 2014 said nicotine may function as a “tumour promoter” and recommends that countries prohibit the advertisement of ENDS and any “implicit or explicit claims” about its effectiveness.

Curbing advertisements

The most striking curb on e-cigarettes comes from the proposed amendments to the IT Act. The legislation was enacted in 2000 to boost and regulate e-commerce transactions, to prevent digital crime and – more recently – to curb fake news on social media.

Section three of the proposed rules states that “intermediaries” should ensure they do not publish information on anything that threatens public health or safety. It goes on to specifically mention tobacco products, intoxicants including alcohol and also specifically mentions ENDS.

The inclusion of ENDS is surprising because Section 3 is brief, but with some grave prohibitions listed.

For example, it directs intermediaries to not publish anything that threatens the “unity, integrity, defence, security or sovereignty of India”, or that is obscene, pornographic, paedophilic, invasive of privacy or racist.

Public health professionals working on tobacco control say the proposed amendment is a good idea. “E-cigarettes are not yet approved for manufacture or sale under the Drugs and Cosmetics Act,” said Dr Rakesh Gupta, deputy director of the health department, Punjab. “Nicotine is a highly addictive chemical which can lead to neurological, cardio-vascular and lung disease and can be lethal if ingested accidentally.”

Also Read: Taking Steps To Completely Ban E-Cigarettes, Delhi Government Tells Court

Advocates for e-cigarettes in India, however, say that the government is curbing the spread of useful information. “This proposed amendment to the IT Act is another instance of the government clamping down on safer alternatives to tobacco, which kills a million Indians every year,” said Samrat Chowdhery of the Association of Vapers India.

A screenshot of the guidelines. Credit: meity.gov.in

Health implications

A health ministry advisory issued in August 2018 contradicts the lobbyists’ claims. It says ENDS is a “great health risk to public at large, especially to children, adolescents, pregnant women and women of reproductive age.” It says that young people may get addicted to nicotine (the addictive component of tobacco products) and then are “likely to switch to cigarette smoking.”

It also advises all states to ensure that nicotine devices are “not sold (including online), manufactured, distributed, traded, imported and advertised.”

In November, a Delhi high court order said this advisory is not binding on states.

Even so, nicotine is already regulated and even banned by at least four Indian laws. It is already listed as a hazardous chemical and as an insecticide. It is also prohibited as an ingredient in food products.

The Drugs and Cosmetics Act will also need to approve ENDS as a valid nicotine replacement therapy, before ENDS products can obtain drug manufacturing or sale licenses. India’s drug controller has not yet approved these products.

Electronic cigarette vaporisers. Credit: Wikipedia

Regulating imports

A recent customs department circular which The Wire has a copy of, has also cramped access to Indian markets.

The circular refers to the health ministry’s advisory and says that it should be implemented. It says all ENDS import consignments should be referred to the respective drug controllers of the state, who can then check the compliance of the products against the Drugs and Cosmetics Act. Based on those reports, non-compliant consignments can be denied clearance and punitive action can be taken against those in violation.

Also Read: High-Nicotine E-Cigarettes Flood US Market Despite FDA Rule

A finance ministry official explained to The Wire that this regulation would apply to consignments that arrive at maritime ports as well as inland posts. “While the Delhi high court has said that the advisory is not binding and the circular asks drug controllers to decide, ENDS still will need to be approved by the central drug controller first, before it is let into the market,” he said. “State drug controllers are likely to also adhere to this.”

The Central Drugs Standard Control Organisation (CDSCO) is a body under the Union health ministry, which issued the advisory in the first place.