The importance of due diligence and its potential implications for the UK Vape Industry

The recent investigations by The Daily Mail concerning the non-compliance of vape products on sale in UK retailers have highlighted the question of due diligence by product manufacturers and how regulatory compliance can be monitored. In the UK, concerns are now rightly being raised over not only illicit non-notified products but also legally notified and supposedly conforming vape products already on the shelf.

This recent finding has resulted in several major UK supermarkets removing Elf Bar’s 600 line of vape products from shelves after laboratory testing highlighted the non-conformance of the nicotine-containing liquid (e-liquid) limit in their products. Testing, commissioned by The Daily Mail, showed that the Elf Bar products tested were as much as 50 percent over the UK legal limit of 2 ml e-liquid content. A spokesperson for the manufacturer stated to the Daily Mail that this was an error due to larger e-liquid tank sizes, standard in other markets, being incorrectly fitted to the UK-bound products. This would mean that the tanks were overfilled, increasing the amount of nicotine-containing liquid in these products. These limits are governed by the Tobacco and Related Products Regulations 2016 (TRPR), the tobacco regulation for the UK, which outlines standards for the safety and quality of all e-cigarettes and refills. The regulations ensure consumers can make informed choices and creates an environment that protects youth from on-ramping to nicotine use via these products.

So, what action have Trading Standards taken, and how have they responded? Since the Daily Mail article, Trading Standard investigations have started, and they have promised to act. However, supermarkets have already removed the Elf Bar products from their shelves and are beginning their own investigations. These large corporations have taken quick action to protect themselves from fines and reputational risk. It’s good to see that action is being taken, but why are we in this situation in the first place? How can it be that it is only after a product has been notified and is legally on sale in major UK retailers that such conformity checks have been performed and detected by a media outlet, rather than the regulators or the manufacturer themselves?

The Responsibilities of the Manufacturer in Product Due Diligence

The Medicines and Healthcare products Regulatory Agency (MHRA) have set out guidelines regarding due diligence for e-cigarettes and refill containers in relation to the TRPR. In the event of a breach of the TRPR regulations, the manufacturer may use in its defense that it has exercised all due diligence to avoid committing the offence. It is the manufacturers’ responsibility to demonstrate that they have exercised this due diligence. The MHRA’s guidance outlines suggested activities to maintain and monitor production standards for each product batch. This guidance includes practical advice around product specifications, regular batch testing, and the need for stability data on representative batches. The MHRA also recommends technical dossiers for manufacturers to enable the ongoing monitoring of their products.

There is a risk of prosecution for a breach of the regulations and the inability to provide evidence of due diligence which could result in criminal proceedings, fines, or other suitable punishments. The manufacturer of Elf Bars has responded to the recent revelations in The Daily Mail article that the products were fitted with higher volume tanks intended for sale in other countries such as the US, where regulations are different, and should not have been used in the UK products. Elf Bar stated that the over-filled products on the UK market were an inadvertent error and that they would be alerting retailers and reviewing their production processes. If, as stated, this was an inadvertent error affecting the Elf Bar products tested, then this indicates that any due diligence program was insufficient to prevent the non-compliant products from being distributed to the UK market.

The Need for Independent Testing

The Daily Mail commissioned an independent testing laboratory to test the Elf Bar products on their behalf. The testing involved purchasing products off supermarket shelves or over the specialist tobacco counter in various UK supermarkets. The testing focused on the volume of e-liquid and was performed on a random test sample of the products. One of the most straightforward solutions for the issue of product non-conformance is for manufacturers to utilize independent testing laboratories to design and execute robust, low-cost quality control testing programs like those commissioned by The Daily Mail. Such data provides confidence in the manufacturing process and provides the ability to prevent non-compliant products from reaching the shelves. Although Elf Bars 600 brand of e-cigarettes have been removed from major supermarket shelves, at the current time, they are still on sale at smaller retail units such as petrol stations and convenience stores. These smaller commercial establishments are unlikely to implement testing programs or remove products unless forced to by Trading Standards.  

Manufacturers Benefit from Due Diligence

There are substantial short and long-term costs for not carrying out due diligence and complying with regulations for manufacturers of consumer products. These include the initial cost of a potential product recall and lost sales, potential criminal proceedings, or hefty fines. Over time this can mean a loss of market share, bad publicity, and a negative brand reputation. The benefits of independent due diligence and quality control are significant to any brand that wants to be around long-term and create shareholder value. They include consumer confidence in product quality and consumer safety for an individual brand and the entire category. This, in turn, builds retailer confidence and enhances the company’s reputation with regulators and standard bodies, which feeds into financial longevity.

Not More Regulation, Just Better Enforcement

Additional regulations are not necessary to solve this problem. Still, essential activities such as following and conforming to the advice on General Due Diligence outlined by the MHRA and their practical advice on compliance should be the norm to ensure ongoing compliance with the relevant sections of the TRPR. The recent investigations by the media and Trading Standards, coupled with increased interest from retailers and consumers, will hopefully result in manufacturers taking a more proactive approach to due diligence and more scrutiny from the regulators. In the case of product testing, procuring such services from third-party certified testing laboratories can allow manufacturers to focus on their core services, gain professional insight into pragmatic quality control programs, and demonstrate the ongoing compliance of their products. Brands that do this and communicate about their post market compliance processes have the chance to enhance brand reputation and corporate governance. It will also ensure that the large, publicly traded supermarkets and retail chains have confidence in the products and return them to their shelves. No respected retail brand wants to be associated with non-compliant and potentially unsafe products.

MHRA has recently met with Elf Bar to discuss the issues of over-filling. While they have agreed that there is no health and safety risk, the products are still non-compliant, and therefore, the voluntary withdrawal of these products was applauded. Actions have been agreed upon between MHRA and Elf Bar to ensure that the problem doesn’t happen again. Questions in parliament regarding the non-compliant products have produced a response indicating that whilst the Department of Health and Social Care will work with MHRA and Trading Standards, there will be no official investigation by them or revision to the regulations (TRPR).

We are encouraged to see there has not been a knee-jerk reaction and call for more regulation, which would limit the availability of e-cigarettes and could drive smokers who have quit back to cigarettes. We continue to advocate for the rigorous enforcement of the existing regulations and strengthening checks on product compliance to protect consumers.

For more information about how Broughton can support quality control testing and post market compliance for nicotine delivery devices, please read our Nicotine Services Brochure.