Policy Summary: 

E-cigarettes may be brought to market either as medicines or as consumer products. Those seeking medicines approval undergo the standard licensing process. One e-cigarette product has been licensed to be prescribed through the National Health Service as a medicine.  It is being introduced to the market in October 2019 but will not initially be available for prescription through NHS Scotland.  It may take some time for the owners to obtain all the necessary approvals and permissions which would allow general practitioners to prescribe the product.  Those opting to sell e-cigarette products as consumer products are regulated under two pieces of legislation.  There are UK-wide Tobacco and Related Products Regulations 2016. Single use, nicotine-free products are not covered by this legislation.  There is also the Health (Tobacco, Nicotine etc. and Care)(Scotland) Act 2016 which regulates the sale and purchase of e-cigarettes in Scotland.  This Act restricts the sale of single use, nicotine-free products.

The Tobacco and Related Products Regulations contain a requirement to notify the competent authority prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers must also submit an annual report as specified in the law. Retailers who want to engage in cross-border sales of e-cigarettes must register with the Secretary of State, and must not transact e-cigarettes via cross-border distance sale to consumers in member states where it is prohibited to do so. Under the Scottish Health Act 2016 for nicotine-containing and non-nicotine e-cigarettes, sale to, unauthorized sale by, as well as purchase on behalf of minors under 18 years is prohibited. Sale by retailers that are not authorized by the Scottish government is prohibited.  Retailers must also operate a statutory age-verification scheme under which any customer who appears to be under 25 must be asked to produce proof of their age.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarettes as well as e-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives, and only high quality ingredients should be used in their manufacture. Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in the nicotine-containing e-liquid. E-cigarettes must be able to deliver a dose of nicotine at a consistent level under normal conditions of use.

E-cigarettes and refill containers should be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. Product packaging must contain health warnings and constituent information as specified in the law. The warning “This product contains nicotine which is a highly addictive substance” must appear on 30 % of both the front and back surfaces of unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy entire area reserved for it, and be parallel to the main text on the surface concerned. There are provisions that restrict the use of the packaging for advertisement or promotion.

There are restrictions on e-cigarette advertisement and promotion; cross-border e-cigarette advertising and sponsorship is prohibited.  The Scottish Health Act 2016 gives the Scottish Ministers powers to restrict all promotion and advertising of e-cigarettes.  The Scottish Government plans to introduce restrictions in 2020.

As consumer products, they are subject to a 20% Value Added Tax; however, if they are regulated as Medicines, a 5% VAT is levied instead.

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