We will all be familiar with the various headlines in UK news that have surfaced over the years, blaming vaping for various health concerns, from the EVALI lung disease outbreak to popcorn lung, and even exploding devices. While these can justifiably make people apprehensive about vaping, there have long been key differences between the way vaping products in the UK are regulated when compared to the USA.
These differences are not widely understood but if they were, it would help highlight just why vapes in the UK have generally been far safer than their US counterparts. This is historical however and it should be noted that more recently the USA has responded to it’s vaping industry issues by massively stepping-up controls that will make their market much safer going forward.
UK TPD and TRPR
The UK saw a brief period of “lawlessness” in the vaping market up until the 19th May 2014, when the European-wide Tobacco Products Directive (TPD) introduced new regulatory controls on both e-cigarettes and traditional tobacco products. This laid the foundation for the 2016 UK Tobacco and Related Products Regulations (TRPR) which saw TPD enforced in full here in Britain. These rules and regs hold UK vaping products like EDGE E-Liquids to strict safety standards, denying sale to any which fall outside of these parameters.
When producing an e-liquid, pod or vaping device, UK manufacturers must first carry out strict toxicological analysis. This involves emissions testing the vapour produced to ensure carcinogenic compounds called carbonyls are not produced at levels beyond proven safety thresholds. This is carried out using specialised equipment that has become an industry standard in quality assurance.
The ingredients themselves must also be carefully analysed. Flavourings in particular have been a cause for concern – Diacetyl is one common flavouring ingredient that is safe in food, but not when heated and aerosolised. This was in fact the ingredient linked to the cases of popcorn lung, in both the UK and USA. The UK banned this chemical immediately from use in vape flavours, the USA however at the time was not regulating the use of such harmful compounds.
Vape flavours actually contain many small amounts of compounds that collectively create the flavour profiles we enjoy. Every one of these tiny additions is calculated against safe limits to ensure they are not present at harmful levels, if at all. The results of these calculations then determine the hazards, warning symbols and allergens that must then legally be displayed on product packaging.
Nicotine levels are also capped at 20mg in the UK. A limit only reached by nic salt products like EDGE Smooth GO Pods. The majority of ‘standard’ 50-50 e-liquids will only go as high as 18mg. The USA however still allows in 2022 massive strengths as high as 50mg/ml. For context, 2ml of 50mg e-liquid is the equivalent nicotine dose of around 250 cigarettes. TPD also restricts the volume of e-liquid permissible in a device to 2ml. This is not mirrored yet in America either.
Designs on vaping products cannot legally be seen to represent actual food stuffs, or appeal to young audiences. This was a change seen very early on in the UK’s emerging vaping industry, which in-turn helped remedy initial concerns over a youth vaping epidemic. This was later disproved by a study part-funded by Cancer Research UK, which found the problem to be far less widespread than first feared. Recently however, the issue of UK youths vaping has resurfaced in very real terms, with the rise of disposable vapes which have been regularly mis sold to minors. Trading Standards are acting to remedy this in earnest.
MHRA (Medicines and Healthcare products Regulatory Agency)
Once all the testing has been conducted and packaging warnings established, all product information is submitted to the MHRA for registration. If approved, the product is added to the master list of legal vaping products, and can be sold on UK shelves or online. Any deviations from the rules, even minor ones, will be met with rejection, and the product must be refined until deemed safe.
USA PMTA and State Regulation
The vaping landscape in America was highly unregulated for a number of years following the UK’s TPD implementation. Banned flavourings and unsafe devices were released to sale regularly, that would not have been approved in the UK. In recent years however the US has stepped-up it’s approach, and is now on par with most of the laws we see here in Britain.
The MHRA equivalent in the USA is the FDA (Food and Drug Administration). They are responsible for approving vaping products for sale. Following numerous public health outcries, On May 10, 2016, the FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act. The rule gave them the authority to regulate e-cigarettes, cigars, and vape pens.
This called for all existing vaping manufacturers to submit any and all products currently available for sale to A premarket tobacco application (PMTA). This is an application that must be reviewed and approved by the FDA before a new tobacco product can be legally marketed in the United States. This was the first step in a continued process placing tighter and tighter controls on the vaping industry.
As with most US legislation, different states have tailored their vaping laws slightly, but the over-arcing themes are now largely universal.
The US’s biggest issue has remained youth access. Different state regulations created confusion and in some cases were not present at all. As of December 2019, each state throughout the country has raised the age needed to purchase any vaping products. However, some states raised their ages differently from others. Twenty-seven state raised the age to 18; five raised the age to 19, and 19 raised the age to 21. The UK’s legal age has remained at 18, but following the Khan Review, this may change soon to 21 or above.
Until recent changes brought regs in-line with UK standards, vaping products were appealing and easily accessible to youngsters. They changed the way vaping products were packaged in response. Several states have already imposed a packaging system for products to warn of the danger it can impose on those who use them. They are also there to remind the buyer that children cannot use the products. 29 states currently hold specific vape packaging laws, ensuring these standards are maintained.
Owing to the myriad issues surrounding the harmful ingredients found in US exclusive e-liquids, the FDA imposed a ban on flavours beyond tobacco and menthol for any e-liquid containing nicotine derived from tobacco. The impact of this extreme shift in regulation, caused manufacturers to panic. In response they began using synthetic nicotine instead of tobacco derived.
While this did not necessarily circumvent the law, the FDA was slow to react, being left unsure as to whether synthetic nicotine could be regulated as a tobacco product, or if it now fell into the drug category – which are held to different standards.
On March 11th 2022 however, US congress and the President himself signed into law new rules that closed this loophole. It was decided that synthetic nicotine products must be regulated by the FDA’s Centre for Tobacco Products in the same way that tobacco-derived nicotine products are regulated. This ensures that synthetic nicotine and tobacco-derived nicotine products are all regulated under the Centre for Tobacco Products using the same standard universally.
Since this law passed, the FDA has been able to reject over one million applications for failing to comply with safety standards, demonstrating that the US vaping market is finally catching up with European equivalents. There is still room for improvement, such as with e-liquid capacity and nicotine level caps, but things are looking safer for US consumers.