The 6 Month Waiting Game: E-Liquid Approval Rules in the UK

Last fact-checked 24 April 2021 | Report a factual error on this article

Here in the UK, it can take a long time to bring new e-liquid brands to market! Whether you’re planning to start your own e-liquid range or simply looking for the latest vape juice on the market, you can expect a wait of up to 6 months before it can be marketed for sale to the general public. 

As the UK’s leading purveyors of premium and imported e-liquid (... and having created our own line of e-liquid ourselves in the past), we have a pretty solid understanding of the MHRA notification process. In this article, we’ll explain the reasons why the UK authorities make us wait up to a half a year for new vape juices, and we’ll take a look at what these rules mean for the UK vaping industry. 



Registering e-liquids with MHRA: the law

According to British vaping laws (learn more about the TRPR here), if an e-liquid manufacturer wants to sell e-liquid containing nicotine in the UK, they must formally notify the government at least six months before they plan to actually sell the product FOOTNOTE 1. This formal notification gets submitted to the MHRA (the Medicines and Healthcare products Regulatory Agency), and it has to contain specific information including…

  • The name and contact information of the e-liquid creator (or importer)
  • A full list of ingredients
  • Emissions and toxicology data
  • Nicotine dosage 

The manufacturer also has to explain how the e-liquid was produced, and — more importantly — they have to make a formal declaration accepting full responsibility for the quality and safety of their product. 

This notification process is an important public safety tool, because it means that there’s a formal record of every single nicotine-infused vape juice for sale in Britain today. If someone in the UK vapes a new e-liquid and feels ill, they can alert the government via the MHRA’s yellow card system in a matter of minutes. The manufacturer of that e-liquid can be notified, and their juice can be investigated, suspended or withdrawn from sale as quickly as possible. 

MHRA: who they are and what they do

The MHRA, or Medicines and Healthcare products Regulatory Agency, is the UK’s governing body for medicines and medical devices. Every drug sold in the UK, from generic paracetamol tablets to advanced gene therapy treatments, has to be approved by the MHRA. In a nutshell, the MHRA exists to make sure that any product that claims to deliver a medical benefit is safe to use (and does actually work). 

It might seem strange to think of e-liquid as a medicinal product, but if it contains nicotine, then technically, it is. Any Nicotine Containing Product (NCP), falls under the MHRA’s scope and needs to meet stringent safety standards. In addition to a 6-month notification period, e-liquid containing nicotine can’t be stronger than 20 mg/ml, and it can’t be sold in bottles larger than 10ml. There are also health warnings that need to go on the label. 

Do all new e-liquids have to wait 6 months?

The MHRA notification-and-approval process only applies to e-liquids that contain nicotine.  If you’re making 0% shortfill e-liquid, then the TRPR doesn’t apply. There’s no requirement to submit an MHRA notification or wait 6 months. Shortfill e-liquids still need to meet high standards of safety and quality, but these standards are covered by a different set of laws FOOTNOTE 2.

Another exception to bear in mind is that MHRA approval sometimes takes less than 6 months. As soon as an e-liquid is added to the MHRA’s published list, it can be sold here in the UK. The MHRA decides how and when this list gets updated, but if you’re a startup e-liquid producer who wants to speed the process up as much as possible, then it’s probably worth submitting the very best notification you possibly can. You should make sure that you have done all of the necessary tests and that ingredients are listed in the correct format. There’s some really useful guidance on how to submit an MHRA notification, explaining everything from emissions testing to labelling, on the Gov.uk website here.  

What this all means for the UK e-liquid industry

The MHRA notification process might be good for public safety, but from a business perspective it’s pretty challenging. 

E-liquid producers have to invest a huge amount of energy, money, time (and hope) into any new product before they can even get it to the stage where they’re ready to submit the MHRA notification paperwork. Then, having invested everything in their brand-new product, they have to wait another 6 months before they can make a single sale. They’re effectively risking about a year of time and effort before they can get a product onto the shelves. By contrast, if you wanted to brew beer you could be fully registered and selling in 1-2 months FOOTNOTE 3.

Because of this massive half-year gap, it’s much easier for established e-juice businesses to bring out new flavours. If you’ve already got a few MHRA-approved products in your line-up, then it’s easier to ‘afford the wait’ while your latest flavours come online. By contrast, startup juice producers need to effectively risk a full year of time — never mind the expense — just to get a new e-liquid onto the shelves.

Some might argue that this whole notification process stifles innovation. In reality, if you’re passionate about e-liquid and vaping, you can still go ahead and create something special — you just have to do it without nicotine. That’s what we did with Fog Addicts, our 0mg range of e-liquids. We chose to make a nicotine-free shortfill and as a result we were able to focus on making the very best e-liquid we possibly could. Vapers who want to add their own nicotine can still do so (our beginner’s guide shows you how to do this), so the fact that Fog Addicts is nicotine-free isn’t a show-stopping issue for most of our customers. 

I hope this guide helps explain the basics of the MHRA notification process, and shows you how (if you wanted to do it) you could start your own e-juice business some day. Here in the UK, we can claim to have one of the safest vaping industries in the world, and it’s all thanks to regulations like the TRPR, and governing bodies like the MHRA. 

Stay safe and happy vaping!

 

- John Boughey



Footnote 1:

Part 6 of the Tobacco and Related Products Regulations lists every requirement that e-liquid manufacturers need to legally meet if they want to sell e-liquid with nicotine here in the UK. You can see the law for yourself at the link below:

https://www.legislation.gov.uk/uksi/2016/507/part/6/made 

Footnote 2:

Shortfill e-liquid that contains no nicotine is covered by the General Product Safety Regulations, which you can read for yourself at the link below:

https://www.legislation.gov.uk/uksi/2005/1803/contents/made 

Footnote 3: 

To sell beer in the UK, you need to register for a tax called ‘Beer Duty’. The paperwork takes between 14 and 45 days. You can learn more at the link below: 

https://www.gov.uk/government/publications/excise-notice-226-beer-duty/excise-notice-226-beer-duty--2

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