UK Agency Offers Guidance on E-Cigarette Rules
The new requirements require nicotine-containing products or their packaging to be child-resistant and tamper evident, ban certain ingredients, include new labeling requirements and warnings, and also require all e-cigarettes and e-liquids be notified to MHRA before they can be sold.
England's Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on new regulations affecting users of e-cigarettes and establishments that sell them.
MHRA regulates medicines, medical devices, and blood components for transfusion in the UK. The Tobacco Products Directive 2014/14/EU introduced new rules for nicotine-containing electronic cigarettes and refill containers (Article 20) effective in May 2016, and MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers in the UK and is responsible for implementing the majority of provisions under Article 20.
The directive introduced new rules that ensure minimum standards for the safety and quality of all e-cigarettes and refill containers (otherwise known as e-liquids), that the information is provided to consumers so they can make informed choices, and that children are protected from starting to use the products.
The new requirements:
- restrict e-cigarette tanks to a capacity of no more than 2 ml
- restrict the maximum volume of e-liquid for sale in one refill container to 10 ml
- restrict e-liquids to a nicotine strength of no more than 20 mg/ml
- require nicotine-containing products or their packaging to be child-resistant and tamper evident
- ban certain ingredients, including colorings, caffeine, and taurine
- include new labeling requirements and warnings
- require all e-cigarettes and e-liquids be notified to MHRA before they can be sold
Consumers and healthcare professionals can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card reporting system; products suspected to be defective or non-compliant may be reported to TPDsafety@mhra.gov.uk.
Part 6 of the Tobacco and Related Products Regulations 2016 contain the requirements for e-cigarettes and refill containers.
The regulations do not cover nicotine-containing products that are authorized as medicines.