The UK Government’s ‘Smoke-Free Generation’ and changing consumer perceptions of nicotine products are causing a shift in consumer habits. In 2023, e-cigarette compliance will become the focus of attention, and disposable e-cigarettes may soon be banned. So, how will the events of this year impact the production of nicotine products, and what trends and regulations might we see in 2024?
nicotine bag
Nicotine pouches provide a unique opportunity to support tobacco harm reduction for adult smokers. Sweden is the world's most advanced nicotine pouch market, with less than 5% of the country's current smoking population on the verge of becoming smoke-free.
However, in the UK, there is a regulatory gap that allows under-18s to legally purchase nicotine pouches. Additionally, there are concerns that nicotine pouch manufacturers may fall into the same trap as some disposable e-cigarette companies by making products that appeal to young people.
If teen nicotine use becomes a problem, the easiest thing for regulators to do is to classify nicotine pouches along with oral tobacco products like snus, making them illegal. Another response might be to classify these products as nicotine replacement therapies and place them under the Medical Products Regulations, which would restrict their use.
To make these products accessible to adult smokers who wish to quit smoking, manufacturers can take regulatory steps: generate data, design safety frameworks and ensure the quality of products entering the market. It is important that manufacturers display and sell their products in a responsible manner, including avoiding bright colors, not imitating other consumer products (such as soft drinks), and avoiding the use of cartoon/video game characters of any kind.
Non-heated e-cigarette technology
We are yet to see an e-cigarette product approved through the UK Marketing Authorization Application (MAA) route, which enables nicotine products to be marketed as nicotine replacement tools for smoking cessation and prescribed by healthcare professionals. However, non-heated steam technology could facilitate MAA approval by addressing the core issue of dose delivery uniformity (DDU).
One example of non-heated e-cigarette technology involves ultrasound, which atomizes e-liquid to create an aerosol, similar to the technology used in medical nebulizers. The size and amount of droplets can be predetermined based on the size of the grid, ensuring uniformity of vapor and thus improving DDU. As we move into 2024, we'll likely see more manufacturers exploring this approach. In the meantime, e-liquids will be developed specifically for this technology.
product development
Nicotine product manufacturers have been moving towards a quality-by-design (QbD) development process, and we will see this trend continue in 2024. For stability testing of nicotine products, there are no specific guidelines or requirements other than scientific justification of shelf life. Adopting a QbD approach demonstrates a higher level of due diligence that can produce safer, higher quality nicotine delivery systems.
Additionally, manufacturers are beginning to implement extractables and leachables studies during the development process, and new guidelines are expected to be developed by the European Committee for Standardization. Once these guidelines are published, we can expect to see a more standardized approach across the industry.
