Elf Bar 600, supplied in the UK by Deep Vaping Ltd, is undoubtedly the number one selling disposable vape product in the UK market. Breaking news from the Daily Mail this week brought the product's fill level and nicotine levels into the spotlight. The top-selling vape was stripped from shelves due to an illegal level of nicotine and overfill. The company admitted to "inadvertently" breaking the law after it was revealed that the product contained at least 50% more nicotine than allowed under current UK regulations, The Tobacco and Related Products Regulations 2016 (TRPR).

As the number one selling product on the market, it is subject to high levels of scrutiny. There is no mention in the Daily Mail article of nicotine level testing, but reference was made to an overfill of between 3ml and 3.2ml of nicotine. The maximum permitted level of nicotine is 20mg per ml (or 2%) as per the product requirements specified in 36 (4) of the TRPR. Therefore, if the product was at the correct capacity of 2ml, it would contain no more than 40mg of nicotine. With 3.2ml of e-liquid, it would contain 64mg of nicotine, an increase of 60%.

However, it is important to note that the "actual strength" of the nicotine per dose has not increased, as it remains at 2% or 20mg per ml. The vaper is not getting a stronger dose of nicotine, but rather more of it in the extra e-liquid. As a result, a vaper could use one bar containing 20mg of nicotine and then another, and still not increase the dose inhalation or puff. The question remains, "is this a risk to consumer health?".

Elf Bar has fallen foul of regulation TRPR 36 2(b), which states that "a disposable electronic cigarette, a single use cartridge, or a tank, in a volume not exceeding 2 millilitres." This may be viewed as a regulatory issue rather than a consumer risk issue. The tank capacity of disposable electronic cigarettes is a controversial subject in the vaping community, with many arguing that these enclosed systems should have a higher capacity as there is a negligible risk to the consumer in increasing capacity but not strength.

Penalties and enforcement, along with defences, are detailed in Part 9 of the TRPR 48 (d). It may be contended that Elf Bar should have sufficient quality assurance processes in place, such as regular batch testing, to avoid this issue. At this time, Elf Bar 600 has not been subject to a formal recall action by an enforcement agency, and it has not been removed from the "submitted notified" list managed by the MHRA. The product is under review by the MHRA and trading standards officers, and some large retailers, such as Sainsbury's and Booker, have put a remove and hold on the product until further action is taken. It is likely that Elf Bar will conduct a voluntary withdrawal of the offending products from the UK market and replace these with compliant product.

Elf Bar has sent out an initial communication to its distributors/retailers, apologizing for the issue and claiming it was a batch issue. The company has committed to swapping out the offending batch of products. This incident raises concerns about the current process of listing products as "submitted notified" with the MHRA, where the responsibility of correctly listing vape, products falls with the submitter/manufacturer.

In our opinion, the process of achieving "submitted notified" status in the UK should be reviewed with the aim of including independent verification of ingredients, emissions, toxicology, and tank capacity, so that retailers and consumers can be assured that the product is fit for the shelves and 95% safer than smoking. In addition, batch checking and audits of these popular inhalable products should be made.

This incident has resulted in substantial damage to the Brand of Elf, however it remains to be seen if other disposable products fall foul of the regulation following this case and hopefully this will serve as a wake up call for the rogue players in the vape industry to take their obligations of compliance seriously.

2023-02-09 10:46:26