E-cigarettes may be brought to market either as medicines or as consumer products. Those seeking medicines approval undergo the standard licensing process. Although one e-cigarette product has been licensed to be prescribed through the National Health Service as a medicine, it is not currently available on the market. Those opting to sell e-cigarette products as consumer products are regulated under the Tobacco and Related Products Regulations 2016. Single use, nicotine-free products are not covered by this legislation.
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. The Tobacco and Related Products Regulations contains 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.
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.
E-cigarette advertisement is prohibited, as is cross-border e-cigarette advertising and sponsorship.
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.
New law (secondary legislation) Guidance (http://www.webcitation.org/query?url=https%3A%2F%2Fwww.gov.uk%2Fguidance...)
Tobacco and Related Products Regulations 2016 (http://www.webcitation.org/query?url=http%3A%2F%2Fwww.legislation.gov.uk...)