Vape brand ElfBar has insisted its voluntary withdrawal of disposable devices from the UK market is “not being made on safety grounds”, after its products were found to contain above the amount of nicotine liquid permitted by regulations.
In a rare communication with media, the Chinese-owned brand emphasised to The Grocer that the withdrawal was not the same as a recall.
“We must be clear that a recall of the product has not been discussed or agreed, as no risk to consumers due to the non-compliance in question has been identified,” the company said. “It is our understanding that a recall would only be required if any issues relating to consumer safety were identified.”
The biggest-selling disposable vape brand was been stripped from shelves at Sainsbury’s, Asda, Tesco and Morrisons, earlier this month after products were found to contain 50% more than the regulation 2ml maximum amount of nicotine liquid.
At the time, the company said over-sized tanks were “inadvertently fitted” to UK-bound product.
Two weeks ago, ElfBar announced the voluntary withdrawal of a range of devices, following crisis talks with the Medicines & Healthcare products Regulatory Authority (MHRA) and vaping trade bodies.
Because it is not an enforced recall, “this complicates the process of defining and planning a withdrawal of this magnitude, as a voluntary withdrawal of this type has never been made under these regulations before,” ElfBar told The Grocer. “We are of course supporting our importers to the best of our abilities and urgency.”
The MHRA does have the power to enforce a recall products on safety grounds, and regularly does so with medicines. There are several classes of recalls – from those relating to products with defects that could cause death or disability, to those where harm is very unlikely but there is “non-compliance with the marketing authorisation or specification”.
While it frequently issues recall alerts and advisories through the NHS and healthcare system, it is understood there have been no recalls relating to vaping products to date.
“All of the actions agreed with the MHRA for ensuring such issues in our operations in China never occur again is either underway or already completed,” ElfBar said.
While major supermarkets acted to withdraw some or all of ElfBar’s disposable devices following a Daily Mail investigation into the oversized tanks, other retailers are still to receive any guidance on how to prepare for the withdrawal, with several being told to carry on selling as normal.
ElfBar said the delay was due to its work to “better understand and define what a voluntary withdrawal under UK tobacco-related product regulations entails”.
“As clarity emerges in those requirements our products’ importers will be able to better communicate with the downstream supply chain,” the company added.
The limit on the size of the nicotine liquid containing tank in e-cigarettes was first set out in the Tobacco and Related Products Regulations 2016, and understood to have been designed to protect children from the possibility of ingesting a dangerous amount of the liquid. However, the legislation was written long before fully sealed disposable devices were widely available.
The ElfBar withdrawal effort this month prompted a question from Conservative MP Adam Afriyie asking the secretary of state for health & social care, Steve Barclay, to increase penalties on vape manufacturers in breach of regulations, to which the government responded that there were no plans to. Afriyie also asked Barclay if he had discussed with Trading Standards Authorities about ElfBar overfilling devices, and was told the government was “working closely” with the relevant authorities.
ElfBar told The Grocer it was “working hard to ensure that fully checked products that are 100% compliant with UK regulations are available for the UK market in the shortest possible time”.
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