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.

Amitabh Bachchan Made the Right Decision in No Longer Promoting Pan Masala

The marketing strategy of the pan-masala industry has two main forms: brand extensions and celebrities, and it is here that film stars play a role.

In hindsight, Amitabh Bachchan made the right decision. He walked out of a contract that promoted pan masala. Based on his statement, he said he was involved in surrogate advertising which, as he realised, contravened a law.

Tobacco is big business in India and elsewhere, and the tobacco lobby is one of the most powerful in many countries. Pan masala, an Indian product innovation, is a segment of a larger tobacco domain called smokeless tobacco. Cigarettes and bidi products make up the other segment.

The smokeless tobacco segment consists of a host of products that are sold in packaged or loose form, are manufactured by a variety of players – many of them not well-known – and invite little or no increase in taxes from both the Central and state governments in every year’s budget.

Both segments of the industry, smoke and smokeless, are under increasing scrutiny by the government, anti-tobacco crusaders and civil society. Both segments have therefore resorted to more subtle, sophisticated and devious means of promotion – to beat the law and to evade a growing number of health-conscious critics.

Surrogate advertising is one such promotional activity. The law prohibits advertisements for products that are harmful to consume. So marketers use other products that are its extension or resemble them to promote or advertise them indirectly. The two major industries that have suffered because of advertising bans are tobacco and liquor, and brands in both industries have resorted to surrogate advertising.

Kingfisher is an apt example of surrogate advertising. It promoted bottled water, soda and a calendar to push sales of its liquor brand. Former Union health minister Anbumani Ramadoss objected to the Bangalorean Indian Premier League cricket team being called the ‘Royal Challengers’. The name, as is evident, reinforced the recall value of the liquor brand ‘Royal Challenge’.

As indicated, pan masala is a smokeless tobacco product. It is addictive and carcinogenic. At one time, it mixed tobacco with several other ingredients. The government therefore banned its use and advertising. Since then, pan-masala manufacturers have been selling tobacco separately and developed non-tobacco products, such as mouth fresheners, to sell under the same brand name.

The ban on advertising has had some impact on public awareness. The second round of the 2016 ‘Global Adult Tobacco Survey India’ report showed that smokeless tobacco manufacturers use a variety of means to get their message across. Almost 21% of India’s 70,000+ samples, drawn from 30 states and two Union territories, had reported an advertisement or promotion of smokeless tobacco products in the last 30 days of the survey.

The highest fractions of the population exposed to these promotions were in Odisha (39.8%) and Uttar Pradesh (36.7%). The states with the lowest exposure  were Kerala (2.7%) and Andhra Pradesh (1.3%).

Interestingly, the respondents identified a range of sources where they had seen the promotional material: points of sale (stores), electronic media (TV, radio, internet, cinema), print media, outdoor (posters, billboards, public transport vehicles, public walls) and surrogate advertisements.

The survey revealed another important insight. More men than women, more young adults than old, more urban adults than rural, and more current users were exposed to the promotional materials. So a variety of factors drive selective exposure – and simply banning a product from mass media can only serve a limited purpose.

Pan masala may well rely on selective exposure. It is big business: the total market for pan masala is valued at above Rs 45,000 crore. Despite the advertising ban and growing health consciousness, its size is expected to rise to around Rs 70,000 crore by 2026.

The marketing strategy of the pan-masala industry is based mainly on two planks: brand extensions and celebrities. The objective is to retain existing customers and entice new ones, especially young adults.

It is here that film stars play a role. Well-known actors such as Amitabh Bachchan, Shah Rukh Khan, Hrithik Roshan, Ajay Devgan, Saif Ali Khan, Anushka Sharma and Priyanka Chopra, among others, have endorsed pan masala or their extensions. And celebrities continue to appear in similar advertisements despite the Advertising Standards Council of India’s guidance: that “celebrities should not participate in advertisements of products which by law require a health warning in their ads or packaging”.

In this context, Bachchan deserves our accolades. It is true that his action was not motivated by a higher moral calling but by fear of crossing a law. Nevertheless, he took the right decision and paved the way for others to follow. And for these others, it may be worthwhile to remember the words of advertising tycoon Leo Burnett:

“Let’s gear our advertising to sell goods but let’s recognise also that advertising has a broad social responsibility.”

Pradeep Krishnatray is a faculty of marketing at ICFAI University, Hyderabad, and former director, Research and Strategic Planning, Johns Hopkins Center for Communication Programs, New Delhi.

COVID Spread: As PIL Seeks Pan Masala Ban, Company Says, ‘We Donated 10 Cr to PM CARES’

The UP government banned pan masala on March 25 because it makes consumers spit, thus increasing the risk of coronavirus. But last month, even as infections are rising, the state made a U-turn.

Lucknow: Can a company’s donation to the PM CARES fund serve as a license to ignore the risks associated with its product at a time of COVID-19?

This is the question which emerges from the plea taken by Dharampal Satyapal Ltd – manufacturer of the ‘Rajnigandha’ brand of pan masala – in the course of a public interest litigation (PIL) moved before the Allahabad high court this week.

The PIL seeks a ban on the sale and use of pan masala in view of its potential to spread the deadly corona virus (its users tend to spit). In response, Rajnigandha stated in its affidavit that it “is aware of its responsibilities in this grim moment. The applicant has contributed Rs 10 crores to the ‘PM Cares’ fund and has spent another Rs. 10 crores to aid and assist organisations involved in the fight against corona.”

The affidavit, which came in the public domain on Monday, goes on to add, “This includes reserving hotel beds for doctors (corona warriors) in Noida, food and ration to the needy, support to the Gurudwara Prabandhak Samiti to continue their ‘langars’ for the needy.”

Interestingly, the ban on the sale of pan masala was ordered by the Uttar Pradesh government on March 25, in the larger interest of “public health”, shortly after the national lockdown was announced. The Union government too had drawn the attention of all state governments towards the threat that the chewing and spitting of pan masala could pose and accelerate the spread of COVID-19.

Curiously, even as coronavirus cases were on the rise in the state, the UP government chose to lift the ban suddenly on May 6 with the rider that only pan masala that does not contain tobacco or nicotine would be allowed. Questioning the lifting of ban, Lucknow based journalist Sanjay Sharma filed the PIL pointing out how pan masala in any form could become a major source of spreading the coronavirus.

Sharma quoted experts claiming that the pandemic had the potential to spread through aerosols, sputum and saliva, hence the spitting of pan masala could be a major threat to human life through spread of the virus. He had further pointed out that even though chewing of (tobacco-less) pan masala was still banned in public places, there was no check on it and spitting was a common, unabated practice.

On its part, the UP government has failed to give any convincing explanation of what the urgency in lifting the ban was, especially at a time when coronavirus cases are growing all over the state.

Anita Singh, the IAS officer who recently took charge as commissioner of the UP government’s Food Safety and Drugs Administration, came up with the plea that this had to be done in the larger interest of industry as well as farmers. “Both industry and farming community were seriously affected on account of the ban; even farmers were at the receiving end as all the raw material for the masala comes from them. So the industry department initiated the move to lift the ban and the final decision to lift the ban was taken at the highest level”, she told The Wire.

However, it is quite evident that the decision to allow the sale of pan masala is at variance with the guidelines issued both by the Union government as well as the WHO, for prevention of COVID-19.

In its affidavit, the company has pleaded that Rajnigandha “pan masala is just a mouth freshener, which does not contain tobacco.” It has further sought to argue and justify the sale of is product on the plea that the livelihood of thousands of people is linked to the business of pan masala, hence it should remain free of any ban.

It is also worth noting soon after the PIL seeking restoration of the ban was filed before the high court, another leading pan masala manufacturer ran huge advertisements in major national dailies , extolling the virtues of its chewing product.

The next hearing in the case is fixed for July 8.

As Gutkha Stands Banned, Use of Dohra Rises in Uttar Pradesh

Dohra is a mixture of areca nut, catechu, edible lime, peppermint, cardamom and flavouring agents and its use is growing as people perceive it to be safer than gutkha which stands banned in the state.

New Delhi: Oncologists have red-flagged a smokeless tobacco product prevalent in parts of eastern Uttar Pradesh as a possible carcinogen.

The product – called dohra – is a mixture of areca nut (supari), catechu (kattha), edible lime, peppermint, cardamom and flavouring agents. It is mainly consumed in parts of eastern Uttar Pradesh and its use is growing as people perceive it to be safer than gutkha which stands banned in the state, a new study has observed.

“The dohra does not contain any statutory warning label in the form of any sign or picture or written warnings and hence, consumers are unaware of the health hazards it brings along, leading to higher consumption,” pointed out the study published in the Indian Journal of Medical Research (IJMR).

Dohra is used with and without tobacco and sold without any brand name. There is evidence that chronic use of this product is a major risk factor of oral submucous fibrosis in the younger age group which might later progress to oral cancer, researchers said. “People prefer consuming dohra to consuming gutkha considering it to be harmless since there are no warnings,” the study said.

The information on dohra was collected from Jaunpur, Allahabad and Pratapgarh through group discussions with vendors and community members. It was found that dohra is prepared either by users themselves or by small scale units. It is available in betel shops and other roadside kiosks. The shelf life of wet dohra is just a few days while the dry one can last for months. The packets are priced from Rs 5 to Rs 50 depending on the weight. It is available for Rs 500 per kilo in Jaunpur, Rs 1200 per kilo in Allahabad and for Rs 800 per kilo in Pratapgarh.

“Dohra contains areca nut (betelnut or supari) leading to oral submucous fibrosis which is a potentially malignant condition. It decreases salivary secretions, causes dental problems, digestive system problems as well as may cause cancer,” explained Prof Ravi Mehrotra, director ICMR-National Institute of Cancer Prevention and Research, and co-author of the study. “Around 80% to 90% of consuming dohra do so with tobacco. Its continuous consumption tends to make people addicted to it and difficult to quit.”

Professor Mehrotra said urgent steps were needed to make people aware of the dangers of dohra. Otherwise, it could go the same way as gutkha and khaini, which were first sold as unbranded and home-made products but eventually became branded products manufactured at industrial scale.

Smokeless tobacco products are hazardous to human health but are largely unregulated and underreported, observed an editorial in the same issue of IJMR. “Limited data are available on the properties, production, ingredients and health hazards of these preparations. Many of these products are consumed with areca nut (a Group I human carcinogen) and are culturally acceptable,” the editorial said. In fact, it said, tobacco manufacturers regularly try to introduce newer smokeless tobacco products, increasing consumer appeal by adding flavouring, new delivery methods and brand mimicking.

The study team included Vishwas Sharma (Department of Health Research), Amrita Nandan (Society for Life Science and Human Health, Allahabad), Ajay Kumar Shukla (Ganpat Sahay P.G. College, Sultanpur), Anshika Chandra (WHO FCTC Global Knowledge Hub on Smokeless Tobacco, NICPR ), Ravi Kaushik (DHR), Dhirendra Narain Sinha (School of Preventive Oncology, Patna), besides Prof Ravi Mehrotra. (India Science Wire)

Dinesh C. Sharma writes at India Science Wire and tweets @dineshcsharma.