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ICMR's White Paper recommends ban on Electronic Nicotine Delivery System or e-cigarettes

M3 India Newsdesk Jun 20, 2019

The ICMR paper does not accept the popular perception that ENDS or e-cigarettes can serve as smoking cessation aids, stating that the failure to ban these agents that could, in fact, further nicotine addiction and pose as a potential threat to the country's efforts towards smoking cessation programmes.


On May 31, 2019, a writing committee of the Indian Council of Medical Research (ICMR) published a White Paper on Electronic Nicotine Delivery System (ENDS) recommending complete prohibition on ENDS or e-cigarettes in India "in the greater interest of protecting public health, in accordance with the precautionary principle preventing public harm from a noxious agent".

The paper described ENDS or e-cigarettes as battery-powered devices used to smoke or "vape‟, a flavoured solution containing a varying concentration of nicotine, an addictive chemical found in cigarettes and other forms of tobacco products. The promoters of e-cigarettes make them to resemble cigarettes, cigars, and pipes, and common gadgets such as flash drives, flashlights or pens.

Source: FDA. 2019. Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). Retrieved from: https://www.fda.gov/tobacco-products/products-ingredients-components/vaporizers-e-cigarettes-and-other-electronic-nicotine-delivery-systems-ends


The ICMR paper reveals that there are more than 460 different e-cigarette brands with varied configuration of nicotine delivery available in the market, for example, cigar likes (first generation), tank systems (second generation) and personal vaporisers (third generation) with over 7700 flavours!

"The cartridges used in ENDS or e-cigarettes are filled with liquid nicotine, flavouring agents and other chemicals. A typical cartridge contains about as much nicotine as a pack of 20 regular cigarettes and can act as a potential source for nicotine addiction." the paper warned

"E-cigarettes are the most commonly used nicotine products in the United States, and their use is reported to be rising at an alarming rate; about 21 per cent of high-school students and 5 per cent of middle-school students are reported to have used e-cigarettes in the last 30 days in 2018, which represents an increase of 1.5 million youth from 2017 to 2018.", the paper added.


A recent WHO report showed that use of ENDS amongst non-smoking youth has increased by a factor of five and eight, respectively, in three years in Florida, USA, and Poland, to reach a prevalence of 6.9 and 13 per cent.

We see a rising trend in the use of ENDS amongst the youth and adolescents in some European Union countries and in various other parts of the world. The WHO has published an eminently readable report on ENDS.

Cigarettes manufacturers see good business opportunity in e-cigarettes. Altria, the US maker of Marlboro cigarettes, invested $12.8bn in the e-cigarette maker Juul in 2018, buying a 35% stake in the company.

The Guardian reported, "Anti-tobacco campaigners are calling for the UK government to act to prevent a new kind of e-cigarette with a super-cool image from taking off among children, as it has done already in America.


Electronic nicotine delivery systems (ENDS) as a tobacco cessation aid: Myths and reality

The ICMR researchers do not accept the popular perception that e-cigarette is a smoking cessation aid. E-cigarettes may have similar or even weaker efficacy as a cessation aid when compared to nicotine patches, due to different sizes of e-liquid vials, variable amount of nicotine in each vial, uncontrolled number of vapes and variable amount of nicotine in each vape puff. Many ex-smokers have reported stopping cigarette use with the aid of ENDS but continue using the latter product, thus sustaining nicotine dependence.

"In a four-country survey carried out between July 2010 and June 2011 in the United States, the United Kingdom, Canada and Australia, 70.4 per cent of the study subjects reported to have used ENDS as a way to obtain nicotine in smoke-free spaces, indicating that they were using ENDS to satisfy nicotine addiction during periods of forced abstinence", the ICMR review noted.

While recommending complete ban on ENDS or E-cigarettes in India, the ICMR White Paper highlighted several facts and circumstances (produced verbatim) thus:

  • ENDS or e-cigarettes contain nicotine solution, which is highly addictive, and contain other ingredients as flavouring agents and vapourisers, which are also harmful for health.
  • Use of ENDS or e-cigarettes has documented adverse effects on humans which include DNA damage; carcinogenesis; cellular, molecular and immunological toxicity; respiratory, cardiovascular and neurological disorders and adverse impact on foetal development and pregnancy.
  • The magnitude of potential short-term and long-term health risks to the users remains undetermined at the population level since the products are recent and come in diverse forms.
  • Whereas, the degree to which, if at all, the ENDS or e-cigarettes benefit as tobacco cessation aides is not firmly established, evidence suggests that there is a risk of dual use to some extent and initiation to tobacco addiction to non- smokers. Hence, on the balance these products have a net negative impact on public health.
  • Use of ENDS can open a gateway for new tobacco addiction, which is a potential threat to the country’s tobacco control laws and on-going tobacco control programmes.
  • The rapidly increasing trend of use of ENDS or e-cigarettes by young persons, in countries where it was introduced, underscores a potential threat to public health.

E-cigarette status in different countries

The ICMR review states "the sale of e-cigarettes is completely banned in 25 countries, including Brazil, Norway and Singapore, while market authorization is required in 17 other countries. In the United States, ENDS that are marketed for therapeutic purposes are currently regulated by the US-FDA and Center for Drug Evaluation and Research."


Different views

The Tobacco Advisory Group of the Royal College of Physicians (RCP) which has been involved in tobacco control activities in the UK from 1962 encouraged the use of e-cigarettes with specific controls.

Public Health England (PHE) the concerned official agency of the UK Government consistently supported the use of e-cigarettes as the agency believed that it is relatively safe compared to smoking tobacco containing cigarettes and it is a very useful smoking cessation tool.

Since 2007, the RCP promoted the principle of harm reduction in nicotine addiction, arguing, "as most of the harm caused by smoking arises not from nicotine but from other components of tobacco smoke, the health and life expectancy of today’s smokers could be radically improved by encouraging as many as possible to switch to a smoke-free source of nicotine."

In April 2016, the, RCP published a 206 pager report titled "Nicotine without smoke-Tobacco harm reduction". The RCP recommended that in the interests of public health, it is important to promote the use of e-cigarettes, Nicotine Replacement Therapy( NRT) and other non-tobacco nicotine products as widely as possible as a substitute for smoking in the UK. This is contrary to what the ICMR researchers advocate equally forcefully.

The House of Commons Science & Technology Committee in its seventh Report of Session 2017-19 stated in line with the RCP, thus: "E-cigarettes present an opportunity to significantly accelerate already declining smoking rates, and thereby tackle one of the largest causes of death in the UK today. They are substantially less harmful—by around 95%—than conventional cigarettes." This 95% figure, attributed to the Public Health England, is controversial.

Interestingly, Professor John Newton, Public Health England’s Director of Health Improvement, explained while giving oral evidence to the House of Commons Science and Technology Committee that the figure "95%" was not a precise one.

The UK Government's response to the RPC report and its follow up by the House of Commons S&T committee was to issue a few specific recommendations to various agencies.


ICMR shows the way forward

No stakeholder can ignore the horrendous possibility of e-cigarettes smoking by children. On June 5, 2019, the US Surgeon General Dr Jerome Adams suggested that the use of e-cigarettes could be linked to rising tobacco use among young people.

"It's a fundamentally different product we have compared to the e-cigarettes of old," he said. "It delivers much more nicotine, and we're hearing from high school principals and from parents that kids out there now are becoming, rapidly becoming addicted to these products, so I'm worried the numbers are going to get worse this year." he added as per the report in The Hill. Adams was equally worried that any potential restrictions on e-cigarettes could negatively affect adults who could be using the devices to quit traditional forms of smoking.

This writer hastens to add that under the prevailing complexities and uncertainties, the ICMR's present strategy has merit. If we encourage the unbridled use of e-cigarettes, teenagers may be the first to go astray. Though the ICMR review did not explicitly refer to the approach of the UK government to the use of e-cigarettes, it succinctly, lucidly and competently defended itself in taking a different stand. We cannot ignore country-specific issues. When experts lack irrefutable evidence to solve complex questions, they rely on the best studies and use their judgment to find a way forward. ICMR did it for us.

 

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

Dr K S Parthasarathy is a freelance science journalist and a former Secretary of the Atomic Energy Regulatory Board. He is available at ksparth@yahoo.co.uk

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