Nicotine products - huge opportunity for medical licensing

We’ve heard a lot and talked a lot about how the new Tobacco and Vapes Bill will impact vapes, but much less has been said about the nicotine products that are also captured within the remit of the Bill – and that includes nicotine pouches, strips and lozenges.

A lot of these products were in danger of falling into a bizarre deadlock, where they would be classified as a food but, because of the toxicology status of nicotine, could not be sold as such, i.e. nicotine products would not be allowed at all.

Fortunately, the Bill has now classified nicotine products as their own group of goods. They are classed, not as a food, not as a supplement, but simply as nicotine products.

However, although this is broadly positive news, it does mean that these nicotine products will now be subject to all elements of the Bill – e.g. advertising largely banned and all restrictions applying to vapes will also apply to nicotine products. This includes the scope in the regulations that allows controls on flavours and packaging to be brought in – potentially catastrophic for many nicotine products.

In the UK, we benefit from the MHRA being a pragmatic medical regulator. Regulators are really keen to bring these nicotine products under medical licensing. MHRA has already provided guidance for the medical licensing of e-cigarettes and that guidance can be used and interpreted for other nicotine products.

One of the chief benefits of achieving a medical licence for a nicotine product is that the Tobacco and Vape regulations will not apply. Instead, the guidance associated with marketing medical products will operate. Flavour restrictions will not be in place and packaging limitations will not exist in the same way they do for Tobacco and Vapes. Just one regulatory package could tie in a while range of flavours. It’s achievable and relatively inexpensive - the expenditure on a project like this is significantly less than most people would think and can often be recovered under R&D tax credits.*

With e-cigarettes, all sorts of delays were caused because of access to notified bodies, necessary for the medical device element. But those issues don’t apply to nicotine products like such as pouches, strips and lozenges as they are not classed as medical devices. There could be some difficulty around GMP manufacturing, but there are contract manufacturers that are GMP certified and more and more are getting certified all the time.

However, there is of course a catch – but not one that is insurmountable. If you want to pursue medical licensing for your nicotine products, you need to be acting now. It takes at least 12 months to progress, with most of that time being for the MHRA to process the application.

ADACT Medical has had multiple meetings with MHRA around medical licensing and is perfectly placed to guide manufacturers through the process. If you would like to find out more, you can speak to one of our friendly, expert team today by email or phone +44(0)1302 986 088.

* Please check with your own financial adviser.