By: Daanish Naithani

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INTRODUCTION

“There is not enough evidence to understand the health impact of vaping”.[1] This statement has become a common gateway to shut down any debate on the use and regulation of Electronic Cigarettes (hereinafter e-cigarettes). To make matters worse, there is no data available regarding its awareness and use for the Indian populace.^[2] In such a background, it is needless to state that the health experts and the Governments (both Central and State level) are torn as to which steps to take to ’regulate’ e-cigarettes.

Through this blog article, my role will be limited only to putting forth the evidence (till 2016) which has come before the public, regarding the health effects of e-cigarettes and acquainting the readers with the steps the State Governments have taken so far to ‘regulate’ e-cigarettes.

Electronic Cigarettes are a type of Electronic Nicotine Delivery Systems (‘ENDS’), which are battery operated instruments or devices, “designed to deliver nicotine or other substances to users in the form of an aerosol”.[3] To understand the implications of ENDS, it would be better to underline some differences between ‘normal’ tobacco containing cigarettes and e-cigarettes. Firstly, ‘normal’ cigarettes contain tobacco while the e-cigarettes do not contain tobacco, and secondly, tobacco smoke is released when normal cigarettes are smoked, whereas e-cigarettes release nicotine vapour. Smoking is different from ‘vaping’ as the latter does not involve burning, and thus does not produce tar or carbon mono-oxide which are the most carcinogenic elements of tobacco smoke.[4] However, it cannot be deduced that the vapour produced from heating the liquid in e-cigarettes is completely harmless. Such vapour produced contains nicotine, and other harmful carcinogenic chemicals (although in small amounts) and is thus not completely harmless. The presence of nicotine, which is a highly addictive substance, in such products makes the regulation of ENDS increasingly pressing.

Globally, countries have chosen varied policy options for the regulation of e-cigarettes. It is being used as a tobacco product, tobacco derivative or related product, therapeutic product, consumer product or poison[5]. This has resulted in differing positions on e-cigarettes, either of ban or of being subject to a restricted regulatory framework.

There is immense confusion on the harmful effects of e-cigarettes as against smoking tobacco as well as on their potential to be tobacco cessation products on one hand or gateway into smoking on the other.

REPORTS ON CESSATION-EFFECTS OF E-CIGARETTES

Institutes in the UK and US conducted scientific studies of the effects of using e-cigarettes, and have published reports in the year 2016. Royal College of Physicians, UK released a report[6] in April 2016 (hereinafter RCP Report) and wherein they found that e-cigarettes appear to be effective when used by smokers as an aid to quitting smoking, and the vapour is 95% safer than smoke from tobacco. The RCP Report recommended the usage of e-cigarettes in the interest of public health, and on the principle of ‘harm reduction.’[7]

However, the RCP Report forewarns us that the long-term health risks of usage of e-cigarettes are unknown, and that advancement in technology may result in advanced versions of e-cigarettes which may have similar “addiction potential”[8] as cigarettes.

The US Surgeon General[9] in their report, stated that e-cigarettes have several harmful effects[10] inter alia, adverse consequences on foetal and post-natal development through exposure to several chemicals in the heated and aerosolised constituents of e-cigarette liquids that could be fatal. It has also been observed in the US that evidence supporting the effectiveness of e-cigarettes as a tobacco cessation device remains unproven. They concluded[11] that e-cigarette is a major public health concern amongst the youth of the country, and actions need to be taken at all levels to protect them. Although the Federal Drug Administration also agreed that use of ENDS is likely to be less hazardous than continued smoking of traditional cigarettes, and could act as a tobacco cessation product, however, it has not permitted the use of ENDS as a tobacco-cessation product.

However, from the studies conducted by these countries, it becomes clear that the RCP Report encourages the usage of e-cigarettes and does not focus on the issue of non-smokers, whereas the US report deals unilaterally with that aspect and takes a rather traditional approach to the consumption of e-cigarettes.

REGULATORY CONUNDRUM IN INDIA

In the absence of a Central Government initiative on this issue, the State Governments have taken varying stands, from banning the product out rightly to declaring it as a ‘poison’.

‘Normal’ tobacco cigarettes are regulated by the Cigarettes and Other Tobacco Products (Prohibition of Advertisement and regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (hereinafter COTPA)[12] and Rules[13] (hereinafter COTPA Rules) framed under the COTPA. It is to be noted that e-cigarettes fall out of its ambit since the legislation only covers tobacco products. At present, no permission is required from the government for the sale of e-cigarettes online as well as in markets. The steps were taken by States and Central Authorities to curb the sale, distribution, and manufacture of e-cigarettes in the market are mentioned below:

1. Director General of Civil Aviation: Using or carrying e-cigarettes in aircraft is prohibited under a cabin safety circular issued under the Director General of Civil Aviation.[14]

1. Karnataka: The Health and Family Welfare Department issued a circular^[15] banning the sale (including online sale), manufacture, distribution, trade, import and advertisement of ENDS, its parts and components in any shape or size of cartridges containing nicotine in the interest of public under the Drugs Control Act, 1940^[16] (hereinafter DCA). Further, the circular also takes the argument of nicotine in food products being banned under the Food Safety and Standard Act, 2006.
2. Punjab: Pursuant to a meeting held[17] on 10^th July, 2013 by the State Drugs Controller, it has been specifically noted in the Minutes of the Meeting, that while nicotine lozenges, gum and patches are approved drugs, e-cigarette is an unapproved drug under the DCA and directed the concerned authorities to be vigilant and take action pursuant to the Act. The concerned authorities can take action under Section 18(c),[18] the conduct under which is punishable under Section 27(b) (ii)[19] of the DCA read with Rule 122 E[20] of the Drugs and Cosmetics Rules, 1945. Further, it has been provided that the action may also be taken under Section 18(a) (iv)[21], which states that any drug which claims to prevent, cure or mitigate any disease or ailment cannot be sold without a license.

Following the said direction, a shopkeeper who was selling a box of e-cigarettes in Mohali was punished with rigorous imprisonment of three years and fine of Rupees one lakh by the presiding Judge, on the basis of the argument that e-cigarettes contain nicotine, which is highly addictive and dangerous for the youth.[22] It was observed by the Court, “It has come up in evidence that Nicotine in gum form is an aid to quit smoking but not in the form of inhalant as is found in the e-cigarette”.[23]

The Punjab and Haryana High Court held[24] that nicotine consumed through water-pipes, is also an ‘unapproved’ drug, and further directed a permanent task force to be set up for “monitoring the abuse of nicotine in chemical form and register criminal cases against violators under the DCA”.[25]Further, under the recently notified Punjab Poisons Possession and Sale Rules, 2014[26] nicotine is included in the ‘List of Poisons’, and it cannot be sold without a license and appropriate labelling and packaging.

Following the directions of the Court, the permanent task force was set up in 2014 and it took the step of issuing awareness notices to e-commerce websites for prohibiting sale of e-cigarettes, as a result of which no e-cigarettes are delivered in the state of Punjab.[27]

1. Maharashtra: It has been reported[28] that the Food and Drug Administration of the Maharashtra Government has issued show cause notices to importers, distributors and dealers of e-cigarettes, as e-cigarettes is an ‘unapproved’ drug under the DCA. It is clear that the sale, distribution, manufacture and importation are banned under the existing law.[29]
2. Kerala: The State Health Department has issued an Order, directing to ban the manufacture, sale, marketing and advertising of e-cigarettes in the State, following study reports that the use of e-cigarettes could lead to cancer and heart diseases[30].

Thus e-cigarettes, currently, are being regulated as an unapproved drug, food product containing nicotine; and as a poison.

CONCLUSION

Even though it seems that the Governments have taken decisions keeping in mind the benefit of the people, it is evident that measures taken by the State Governments are not in the persuasion of hard-hitting evidence. One approach to the existing problem could be to introduce specialist legislation (the UK has introduced such legislation[31]) or to make specific provisions for the same in the existing framework (the US has chosen this path[32]). The enactment may deal various issues such as the nicotine content, labelling and packaging requirements, sale, consumption and distribution, restrictions on the advertisement, restrictions on consumption in public spaces, restrictions on flavouring and other as the Government may deem fit. Needless to state, strong implementation is key for the success of such legislation (specifically for the youth), and apprehensions regarding the fallouts of such policies should not lead to adverse consequences for the entry of such products in the market.

[1] Julia Belluz, ‘How Big Vaping is misinforming the public about e-cigarettes’ (Vox, 28 March 2015) <https://www.vox.com/2015/3/28/8301923/e-cigarette-information&gt; accessed 20 October 2017

[2] Anjali Solanki et al, ‘Electronic Cigarettes: Facts and Myths’ (2014) 56 (265) The Indian Journal of Chest Diseases & Allied Sciences <http://medind.nic.in/iae/t14/i4/iaet14i4p263.pdf&gt; accessed 20 October 2017.

[3] Tobacco Control Legal Consortium, ‘E-Cigarette Regulation’ (Public Health Law Centre, January 2017) <http://www.publichealthlawcenter.org/sites/default/files/resources/tclc-guide-reg-ecigarettes-2016.pdf&gt; accessed 20 October 2017.

[4] ‘E-Cigarettes’ (Smokefree NHS) <https://www.nhs.uk/smokefree/help-and-advice/e-cigarettes> accessed 20 October 2017.

[5] Ryan David Kennedy et al, ‘Global approaches to regulating electronic cigarettes’ (2016) 26 (4) Tobacco Control British Medical Journal < http://tobaccocontrol.bmj.com/content/tobaccocontrol/26/4/440.full.pdf&gt; accessed 20 October 2017.

[6] Royal College of Physicians, ‘Nicotine Without Smoke: Tobacco Harm Reduction’ (2016)

<https://www.rcplondon.ac.uk/sites/default/files/media/Documents/Nicotine%20without%20smoke.pdf&gt; accessed 20 October 2017.

[7] ibid.

[8] ibid (n 7).

[9] US Department of Health and Human Services, ‘E-Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General—Executive Summary’ (2016) <https://www.cdc.gov/tobacco/data_statistics/sgr/ecigarettes/pdfs/2016_sgr_entire_report_508.pdf&gt; accessed 20 October 2017.

[10] ibid.

[11] ibid (n 11) 184-187.

[12] Cigarettes and OthSer Tobacco Products (Prohibition of Advertisement and regulation of Trade and Commerce, Production, Supply and Distribution) Act 2003, s 3(b).

[13] Cigarettes and Other Tobacco Products (Prohibition of Advertisement and regulation of Trade and Commerce, Production, Supply and Distribution) Act Rules 2003 <http://www.mohfw.nic.in/sites/default/files/760348325.pdf&gt; Accessed 20 October 2017.

[14] Director General of Civil Aviation, Cabin Safety Circular File No AV 15025/Cabin Safety/2016-CS Effective: 01st Nov 2016 (New Delhi 17 October 2016) <http://dgca.nic.in/circular/csc/CSC_022016.pdf&gt; accessed 20 October 2017.

[15] HFW/126/CGE/2016 dated June 15 2016 Food Safety and Standards Act 2006; Drugs and Cosmetics Act 1940 Government of Karnataka Circular No HFW/126/CGE/2016 (15 June 2016) <http://www.sochara.org/sites/default/files/e-cig%20ban_GO-Karnataka_0.pdf&gt; accessed 20 October 2017.

[16]Under the Drugs and Cosmetics Act, 1945, Nicotine is permissible only in nicotine replacement therapy.

[17] Letter No Drugs (7) Pb-2013-16988-89 dated 5 September 2013 <http://pbhealth.gov.in/ban_e-CIgg.pdf&gt; accessed 20 October 2017.

[18] Drugs and Cosmetics Act 1945, s 18(c)

[19] ibid.

[20] ibid (n 16) 134.

[21] ibid (n 16) 11.

[22] State of Punjab v Pravesh Kumar Sessions Case No 03/19.05.2015, Decided On: 07.04.2016 <https://casaa.org/wp-content/uploads/sessions-court-judgment.pdf&gt; accessed 20 October 2013.

[23]Id. ¶23 of the Judgment of the Court.

[24] Burning Brain Society v Union of India (2013) 1 RCR (Cri) 736.

[25] ibid.

[26] Punjab Poisons Possession and Sale Rules, 2014, The Schedule to the Rules, <https://drive.google.com/open?id=0Bw_wf3FZd4CkWVFLQWh4MHV1S2M&gt; accessed 20 October 2017.

[27] National Tobacco Control Programme: Achievement of Punjab Government <http://pbhealth.gov.in/2(b).pdf> accessed 20 October 2017.

[28] Press Trust of India, ‘Maharashtra FDA issues notices to e-cigarette importers, distributors’ Economic Times (Mumbai, 30 May 2015) <https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/maharashtra-fda-issues-notices-to-e-cigarette-importers-distributors/articleshow/47484677.cms&gt; accessed 20 October 2017.

[29] Institute for Global Tobacco Control ‘Subnational Laws Regulating E-cigarettes: A Policy Scan. Baltimore’ (Johns Hopkins Bloomberg School of Public Health, September 2015). <http://globaltobaccocontrol.org/sites/default/files/ecig_subnational_scan.pdf&gt; accessed 20 October 2017.

[30] Special Correspondent, ‘State bans e-cigarettes’ The Hindu (Thiruvananthapuram, 2 July 2016) <http://www.thehindu.com/todays-paper/tp-national/tp-kerala/State-bans-e-cigarettes/article14466591.ece&gt; accessed 20 October 2017.

[31] The Tobacco and Related Products Regulations 2016 <http://www.legislatio n.gov.uk/uksi/2016/507/pdfs/

uksi_20160507_en.pdf> accessed 20 October 2017.

[32] 21 CFR Parts 1100, 1140, and 1143, Department of Health and Human Services, Part III, Federal Register Vol. 81 No 90 (May 10 2016) <https://www.gpo.gov/fdsys/pkg/FR-2016-05-10/pdf/2016-10685.pdf&gt; accessed 20 October 2017.

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(Daanish is currently a student at Government Law College, Mumbai.)