In the recent past, there have been significant regulatory developments around ‘e-cigarettes’ and similar devices, colloquially referred to as ‘vapes’. Below is a brief description of certain key developments from jurisdictions across the world, with consequent opportunities in the Indian context.
A. USA: FDA’s Orders Against JUUL
The US Food and Drug Administration (FDA) announced, on June 23, 2022, that it is banning the sale of ‘JUUL’ e-cigarettes, one of the most well-known brands of vapes, in the USA.
The above decision of the FDA was based on its determination that there was insufficient evidence to demonstrate that marketing of JUUL’s products would be appropriate for the protection of public health . Having said that, the FDA clarified that it had not received clinical information to suggest an immediate hazard associated with the use of JUUL’s products.
However, on July 5, 2022, the FDA stayed the ban, noting that there are scientific issues unique to JUUL which warranted additional review. This stay temporarily suspended the ban but did not revoke it. It was clarified that the stay did not constitute authorization to market, sell, or ship JUUL products.
While the above communications were viewed as a ‘ban’ on vapes, the FDA noted that smokers who wish to transition away from cigarettes and cigars may switch to other ‘ENDS’ (Electronic Nicotine Delivery System) products authorized by the FDA based on their potential to benefit adult smokers. This clearly implies that the FDA’s actions in respect of JUUL do not entail a ‘ban’ on all vapes, e-cigarettes, etc. In fact, the FDA noted that it had authorized 23 ENDS products for usage in the USA.
B. Certain Jurisdictions with Vaping Regulations
In addition to USA, various jurisdictions around the world have embraced
vape products as being effective public-health protection measures. Efforts have been made in such jurisdictions to regulate the sector to ensure that the interests of consumers are protected. A few examples are provided below:
I. United Kingdom
The United Kingdom is a very notable example of a jurisdiction where vaping is legal, subject to effective regulatory control over its various aspects. The regulations relating to vaping and vape products in the United Kingdom primarily aim to ensure high-quality vape products and accessories, in the interest of consumer protection. These regulations govern aspects like, (i) strength and volume, (ii) packaging and labelling, and (iii) banning of certain harmful ingredients. Most importantly, vape manufacturers are required to obtain the government’s approval prior to offering their products for sale.
On July 25, 2022, a bill popularly known as the ‘Vape Bill’ was enacted into law in the Philippines. The law purportedly aims to regulate the import, manufacture, sale, packaging, distribution, use (including age of use), and communication of vapour and heated tobacco products, in the Philippines. The Philippine government’s intent behind this law appears to be to adopt and regulate harm-reduction strategies, as alternatives to cigarette and cigar smoking.
III. European Union (EU)
The European Union Commission has actively passed laws to ensure that while vaping is legal in countries forming part of the EU, the same is regulated to ensure protection of the public. The regulations relate to: (i) safety and quality, (ii) packaging and labelling, (iii) quantity and nicotine concentration, and (iv) monitoring and reporting of developments. Further, recently, the EU Commission has also proposed a ban on youth-friendly ‘flavoured’ e-cigarettes and vaping products – with the aim of preventing adoption of the practice by the youth.
C. Opportunities in the Indian Context
There exist various arguments and studies in favour of the relatively lower health effects of vaping devices in comparison with traditional cigarettes, beedis, etc. By banning e-cigarettes in India in 2019, the Indian Government has allowed for the continued consumption of traditional cigarettes / tobacco-based smoking options, depriving the nicotine consumers of the choice to move to a ‘relatively safer’ alternative. As with all similar bans, the blanket ban on e-cigarettes has also led to a surge in the underground market for such products, which is more dangerous than allowing for regulated products. Consequently, it has also resulted in loss of revenue to the government.
This is in contrast to other jurisdictions noted above, where governments are proceeding towards regulating e-cigarettes with appropriate checks and balances, instead of imposing blanket bans. Following from such examples, the Indian government may reassess its stance on e-cigarettes/vapes, undertake scientific research and based on the same, provide an appropriate regulatory framework for the public.
Upendra Nath Sharma and Akshath Mithal