P3 Pharmacy magazine recently published an article written by our Healthcare Regulatory Lawyer, Susan Hunneyball.
Read the full article below.
“Solicitor Susan Hunneyball reviews the legal situation with regard to vaping products, in the light of new official advice and two potential deaths.
A BBC report in January that there had been two deaths potentially relating to vape products in the UK over the last year is clearly not in pandemic territory. However, it is concerning – not least because of our lack of knowledge about the specific cause of the problem.
The BBC’s article was tied in with advice sent out from Medicines and Healthcare Products Regulatory Agency (MHRA) to healthcare professionals about how to report cases of suspected e-cigarette or vaping product associated lung injuries (EVALI).
There will now be concerns about how effective the reporting will be, given the Covid-19 emergency. Healthcare professionals currently have a lot to deal with, but EVALI notification is triggered by patients with a history of e-cigarette use presenting with respiratory symptoms.
How big is the problem?
UK concern followed reports of deaths across the Atlantic. While cigarette smoking is the leading preventable cause of death, killing 480,000 people in the US each year – that’s nearly one in five deaths – the US Centers for Disease Control and Prevention (CDC) says that as of 18 February, there have been 68 deaths attributable to EVALI. The US cases show links with Vitamin E acetate or tetrahydrocannabinol (THC) contained in the vaped liquids. These links are not reported in the UK deaths, where THC is a controlled drug and Vitamin E acetate, along with other vitamins, is not permitted in the e-cigarettes covered by UK legislation.
Both the NHS and Public Health England (PHE) support the use of vaping over smoking. In 2015, PHE estimated vaping was 95 per cent less harmful than smoking, and research continues to investigate the benefits. The Government has an ambitious policy of being “smoke free” – defined as 5 percent or less of the adult population being smokers – by 2030. Current projections suggest it is likely to miss that target, so there may be a further public policy push for smokers to turn to vaping.
The law today
Nicotine containing e-cigarettes and e-liquids have been regulated since the introduction of the Tobacco and Related Products Regulations which came into force in May 2016. The regulations:
- Restrict e-cigarette tanks sizes, volume of refills and e-liquid strength.
- Require nicotine-containing products or their packaging to be child-resistant and tamper evident
- Ban certain ingredients including colourings, caffeine and taurine
- Impose labelling requirements, including warnings
- Require producers to notify the MHRA of all e-cigarettes and e-liquids before sale.
Other tobacco related legislation also prohibits the sale of e- cigarettes (nicotine inhaling products) to the under 18s. This provision is aimed at sellers. Breaches can lead to fines, and persistent breaches to restrictions on sellers. There is an exception, important for pharmacy, where the nicotine inhaling product is a medicinal product or device and the supply doesn’t breach the Human Medicines Regulations.
The legislation does have a gap. Tobacco and nicotine products that are out of the scope of regulation (such as disposable e-cigarettes that do not contain nicotine and 0% nicotine e-liquids) do not have to meet the requirements.
The Yellow Card Scheme now covers e-cigarette reporting, and it includes the e-liquids used for vaping. There is a specific e-cigarette reporting tool for the electronic scheme. Yellow card reports can be made for products that do not contain tobacco.
Next steps
The jury is still out on the mechanism of vaping deaths apart, that is, from the man in Texas who was killed after an e-cigarette he used exploded in his face and tore his carotid artery causing a massive stroke. Further research may provide detailed answers, but it is bound to be affected if reporting drops because of Covid-19.
The current level of regulation is not intrusive but may not go far enough as it covers only tobacco products. Research will need to lead the way in establishing whether regulation should be extended to all e-cigarette products. Even then, policymakers will have a conflict of interest to navigate if it is considered that additional regulation means smokers are less likely to switch to vaping.”
About the Author
Healthcare Regulatory Lawyer
D.D: 01483 366064
Tel: 01483 451900
Email: susan@gordonsols.co.uk