In light of the report of non-compliant products within their UK range, ELFBAR have attended a meeting with the Medicines & Healthcare products Regulatory Agency (MHRA) to discuss corrective actions they will put in place to ensure their products are fully compliant with UK regulations. Meetings have also taken place between one of the UK vaping industry associations and Trading Standards, the outcome of which are fully explained below.
A Daily Mail investigation found that one flavour in the Elf Bar 600 disposable vape range available on the UK market exceeded the UK’s tank capacity limit. Testing has identified that some batches of the watermelon flavoured Elf Bar 600 products were mistakenly fitted and filled with a non-standard 3ml e-liquid chamber, which is commonly used in other countries like the US, but is not compliant with UK regulations where a 2ml maximum is permitted.
Further investigation identified that some batches of the double apple flavoured Lost Mary BM600 disposable vape, also manufactured by ELFBAR, have also been affected by the issue and are not compliant with UK regulations.
While the watermelon flavour Elf Bar 600 and double apple Lost Mary BM600 devices in question have been confirmed to contain more e-liquid than allowed, testing has verified that they are safe to use and the nicotine strength is still compliant with the legal limit of 20 mg/ml.
ELFBAR have agreed with the MHRA recommendation that the affected products be withdrawn from the UK market and will be carrying out a withdrawal of non-compliant Elf Bar 600s and Lost Mary BM600s.
Having received details of the affected batches we have conducted thorough stock checks and removed all affect products from sale.
ELFBAR and the MHRA were joined in the meeting by representatives from the UK’s two trade associations for the vaping industry; the UK Vaping Industry Association (UKVIA) of which Evapo are a founding member, and the Independent British Vape Trade Association (IBVTA).
A representative from UKVIA explained:
“Although ELFBAR is not a member of the UKVIA, as the industry’s lead trade association it was key that we were present at such a critical meeting to represent the interests of all businesses in the sector impacted by this highly regrettable situation.
“If the industry is going to be accepted as playing a leading role in helping Britain achieve its smokefree targets, it has to demonstrate the highest levels of compliance, standards and responsibility.”
ELFBAR are doing everything in their power to rectify the issue and ensure full compliance with UK regulations by working directly with the MHRA and vaping associations like UKVIA.
Lost Mary BM600 double apple update
Further investigation into the issue of non-compliant ELFBAR products has identified that some batches of the double apple flavour Lost Mary BM600 disposable vapes which are also manufactured by ELFBAR are also non-compliant, being filled with around 3.6ml of e-liquid. These devices have also been confirmed to be safe to use.
What are Elf Bars?
Elf Bar 600s and Lost Mary BM600s are both types of disposable vapes, comprised of a fully enclosed tank and built-in battery. They are designed to offer a short-term vaping solution for times when you need a small, lightweight device that you can pop in your pocket, such as nights out, festivals, and formal events.
These devices cannot be refilled with e-liquid or recharged, and once the e-liquid has been used up the device can be disposed of and either replaced with a new one or with your usual vape kit.
The tank inside is filled with 20 mg/ml nic salt e-liquid in a variety of flavours to help keep nicotine cravings at bay whenever needed, and offer a pleasant and smooth vaping experience.
Can I still buy Elf Bar disposable vapes?
Yes, this has been confirmed to be a compliance issue that only affects one flavour within the Elf Bar 600 range and one flavour within the Lost Mary BM600 at this point. The products in question are safe to use, but not compliant with UK regulations. We have removed all affected batch numbers from sale.
Are Elf Bars being recalled?
No, the issue is currently only confirmed to affect batches of one flavour (watermelon) in the Elf Bar 600 range, and one flavour (double apple) in the Lost Mary BM600 range, and there is no mandated recall in place for this or any other Elf Bar products. These disposables are completely safe, but do not meet with UK regulations on maximum e-liquid capacity.
Recalls are usually for products that present a risk to customers and frequently involve customers returning items to their place of purchase. The UK regulator (MHRA), ELFBAR and both vaping industry associations all agree that there is no immediate risk and this is not required.
Instead ELFBAR have agreed to the voluntary removal of any non-compliant products from the UK market.
What are Evapo doing about Elf Bar?
We are monitoring the situation closely. No recall has been suggested by Elf Bar, The MHRA, Trading Standard or either of the two vaping industry associations as the products are safe. Having received details on the exact batches that have been affected we have removed these products from sale and are awaiting details from ELFBAR on how the voluntary withdrawal will be managed.
We will continue to keep our customers updated fully on future developments and the voluntary withdrawal of any non-compliant products.
What are Elf Bar doing about the compliance problem?
ELFBAR have agreed to voluntarily withdraw non-compliant Elf Bar 600 and Lost Mary BM600 products from the UK market. They have met with the MHRA, UKVIA, IBVTA and Trading Standards. We are awaiting further details of the withdrawal.
They have also agreed to stop exporting any non-compliant Elf Bar 600 products to the UK, implement additional controls in their manufacturing centres and support checks across other Elf Bar product ranges.
Why are Elf Bars being recalled?
Elf Bars are not being recalled. Elf Bar have agreed to voluntarily withdraw any non-compliant batches of the Lost Mary BM600 and Elf Bar 600 disposable vape ranges from the UK market in line with MHRA advice. The reason for this is because some batches of two flavours were found to exceed the amount of e-liquid allowed in the UK. The affected products are safe and sold internationally, but not compliant with UK regulations which limit the e-liquid capacity to 2ml.
Should Elf Bars be removed from sale?
At the time of writing a batch of the watermelon flavour in the Elf Bar 600 range and the double apple flavour in the Lost Mary BM600 range are safe, but non-compliant. We have received details and advice from Elf Bar to identify the batch number of any non-compliant products and only the affected products have been removed from sale. This is in line with MHRA, Trading Standards, UKVIA and IBVTA advice which is only to remove specifically identified non-compliant Elf Bar 600 and Lost Mary BM600 products from sale.
Why is there a 2ml capacity limit on Elf Bar?
There is a 2ml capacity limit on all vaping devices and tanks that contain nicotine and are not authorized as medical devices. This regulation originated from the European revised Tobacco Products Directive 2014 (TPD) which was enacted into UK law under the Tobacco and Related Products Regulations 2016 (TRPR).
At the time the specific measure of limiting devices to 2ml and refill containers to 10ml was highly controversial as it was not based on any evidence or clear explanation as to why it would benefit the vaping industry or wider society in general. In reality the measure has created an increase in the negative environmental impact of the vaping industry and higher costs to consumers. However, the regulation is in place and of course we will work closely with Elf Bar to ensure the issue is resolved.
Are Elf Bar vapes bad for you?
Elf Bars are a form of e-cigarette, an electronic device that is designed to offer smokers a tool to assist them switch from smoking to vaping.
E-cigarettes help users to manage their nicotine cravings, but do not contain the harmful substances like tar and carbon monoxide that are found in cigarettes and other tobacco products.
Vaping has been found by Public Health England, now called the Office for Health Improvement and Disparities, to be 95% less harmful than smoking. Many healthcare authorities like the NHS, the UK Health Security Agency, and Cancer Research UK support vaping as an effective alternative to smoking and recommend e-cigarettes for those looking to make a stop smoking attempt.
Will Elf Bars be banned in the UK?
It is highly unlikely that there will be a ban on Elf Bars in the UK. ELFBAR have met with the Medicines & Healthcare products Regulatory Agency (MHRA) to ensure a swift resolution is put in place to resolve the recent non-compliance issue.
ELFBAR have confirmed that it was only some batches of one flavour of their Elf Bar 600 range and one in their Lost Mary BM600 range that were fitted with the non-standard tank size, and the rest of the range remains fully compliant with UK regulations. Furthermore, while these vapes exceed the 2ml legal limit for nicotine containing e-liquid, testing has revealed no other compromises or issues that make the devices unsafe to use, and the nicotine strength is still in line with UK regulations.
While unfortunate, the issue has arisen due to the fact that Elf Bar products are sold in many different countries, all of which have different regulations for vaping products. The disposable vapes in question were mistakenly fitted with the 3ml tanks that are standard in other countries like the US, but exceed the UK limit of 2ml.
Are the non-compliant Elf Bar 600 watermelon vapes dangerous?
No, some batches of the Elf Bar 600 watermelon vapes have been confirmed to exceed the UK limit of 2ml of e-liquid, but have been found otherwise safe to use. Elf Bars are sold internationally with the larger 3ml e-liquid chamber due to different countries having different regulations for vaping products, however in the UK e-liquid tanks are limited to a 2ml capacity making the affected products non-compliant.
Why do different countries have different e-liquid capacity limits?
Vaping regulations differ from country to country depending on the approach each country has taken to tobacco control and harm reduction. Here in the UK we are known to have embraced e-cigarettes as a harm reduction tool and smokers are encouraged to consider the use of an e-cigarette to switch to vaping when making a stop smoking attempt. Having strict regulations in place is what has helped facilitated this.
Other countries may take a different approach to vaping regulations, such as the US where tank size and nicotine containing e-liquid bottle size is not limited, but vaping has not been utilised as an alternative to smoking by the government like it has in the UK.
Why have supermarkets removed Elf Bar 600s from their shelves?
As this is a non-compliance issue and not a safety issue ELFBAR have agreed to voluntarily withdraw any non-compliant batches of their Elf Bar 600 and Lost Mary BM600 ranges from the UK market in line with MHRA advice.
Tesco, ASDA and Sainsbury’s have opted to remove all Elf Bar 600 watermelon and Lost Mary BM600 double apple devices from their shelves rather than wait for confirmation of the affected batches, while Morrisons alone have chosen to completely remove the entire Elf Bar range from their stores. They will likely make a decision on when to return these products to sale when more details of the voluntary removal of non-compliant products are available.
Have the watermelon Elf Bar 600s got too much nicotine in them?
No. The affected devices exceed the UK’s limit on tank size which is 2ml, this means that they contain more nicotine simply because they contain more e-liquid, but not that the nicotine strength is higher than the legal limit of 20 mg/ml. This is because UK regulations limit nicotine to 20mg per ml of e-liquid, and not the overall nicotine content of the entire bottle, tank or chamber.
Technically the devices usually can hold up to 2ml of 20mg/ml nicotine strength e-liquid. The non-compliant but safe batch of watermelon flavour Elf Bar 600 and double apple Lost Mary BM600 devices contain over 3ml of the same strength e-liquid.
Sources
ELFBAR 10/02/2023
UKVIA 10/02/2023
nhs.uk 2022
ukhsa.blog.gov.uk 05/03/2020
cancerresearchuk.org 24/03/2021
