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The MHRA is responsible for assessing whether the manufacturer or submitter has met the requirements in their notification for nicotine-containing e-cigarettes and e-liquids before the product comes to market. Trading Standards are responsible for enforcing the safety and quality of nicotine-containing e-cigarettes and e-liquids once they have been supplied to the UK market. The MHRA is also responsible for collecting and monitoring information about safety concerns related to these products through the Yellow Card Scheme.

E-cigarette use in the UK

The UK Governments Smokefree 2030 plan for England, which aims to reduce the prevalence of tobacco smoking and its associated harms, encourages adult smokers to seek safer alternatives to smoking. As part of this, a new Swap to Stop scheme has been announced which promotes replacing tobacco cigarettes with e-cigarettes to support smokers to quit. ^{[footnote 1]}

It is estimated that over 4.3 million adults in the UK use vapes. They contribute to an extra 50,000 to 70,000 smoking quits a year in England. The Government is currently piloting a world first programme to provide 1 million smokers with free vape kits to help them quit.

Evidence reviews by the Office for Health Improvement and Disparities (OHID), and previously Public Health England^{[footnote 2]} show that e-cigarettes have been proven to be an effective smoking cessation tool and evidence shows that, in the short and medium term, vaping poses a much smaller overall risk than smoking. However, vaping is not risk free.^{[footnote 3] [footnote 4]} Vaping is not recommended for non-smokers and children and the long-term risks are currently unknown.

In the UK, nicotine-containing e-cigarettes and e-liquids are regulated under the Tobacco and Related Products Regulations 2016 (as amended) which set the minimum requirements for the safety and quality of e-cigarette products. Before a nicotine-containing e-cigarette product can be placed on the market, it must be notified to the MHRA through the e-cigarette notification scheme to assess whether it meets the notification requirements to be placed on the market in the UK. The MHRA works with Trading Standards who are responsible for enforcing the safety and quality requirements for nicotine-containing e-cigarette products on the UK market to monitor the safety of e-cigarettes by collecting information about suspected safety concerns through the Yellow Card Scheme.

Document e-cigarette use in medical records

Clinicians should ask about and document the use of e-cigarette products and vaping in the medical records for all patients as they would for smoking. Routine documentation will facilitate any future study on long-term effects of e-cigarettes or vaping using medical records.Clinicians should routinely document:

• Name and brand of the product or products used

• Type of products (for example, a pre-filled disposable device or an e-liquid used with a refillable device)

• Duration and frequency of use

• Substances vaped (for example, nicotine, cannabidiol [CBD] or psychoactive substances)

• Strength of substances

Advice for consumers

Under the regulations, only e-cigarette products with a nicotine concentration of up to 20mg/ml (2%) and a volume of nicotine-containing liquid not exceeding 2ml for pre-filled disposable e-cigarettes, cartridges and pods, or 10ml for e-liquid refills, can be supplied to consumers; any e-cigarettes or e-liquids with a nicotine strength and/or volume exceeding these limits are not legally compliant and are not approved for supply in the UK.

E-cigarettes and e-liquids that have been successfully notified and therefore meet the requirements for supply in the UK are published on the MHRA ECIG Publications List. Consumers can view this list and verify whether a product is notified by searching for the brand and product name or ECID number. Consumers should only purchase nicotine-containing e-cigarette products that are included on the MHRA Publications List.

How to report any suspected adverse reactions and safety concerns

Healthcare professionals and members of the public can report any suspected adverse reactions (ADRs) or safety concerns associated with nicotine-containing e-cigarettes and e-liquids to the MHRA via the Yellow Card website. Reporting contributes to the continuous monitoring and safety evaluation of e-cigarettes.

When submitting a Yellow Card report, please provide as much information as possible. The following information is particularly valuable for our assessment of reports:

• name and brand, strength, flavour, and batch number of the product used
• ECID number of the product (this is a 12-digit number that may be printed on the outer packaging or product itself)
• duration and frequency of use
• time to onset of the adverse reaction
• medical history including tobacco use and smoking status, details of any pre-existing respiratory disease, seizure disorders and cardiovascular history

Please include any other relevant information including concomitant medications or substances used.

As of October 2023, the MHRA has received 357 suspected ADR reports associated with nicotine containing e-cigarettes and e-liquids through the Yellow Card scheme and from industry. We routinely publish a summary of this data in our e-cigarette Analysis Print.

Article citation: Drug Safety Update volume 17, issue 4: November 2023: 3.

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