Over last 40 years Pharmaceuticals has aligned around The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines as they have developed...
Next Generation Nicotine Delivery 2016 – What a difference a year makes
Nov 23, 2016 | Published by Chris Allen
It was the same conference last year where many in the vaping industry realised that changes were coming with regards to the regulations. One year on and there has undoubtedly been a huge shift in attitudes and the realisation that the TPD has not been as restrictive for the industry as first feared. The 2016 event provided a valuable insight into the positive and negative impact of regulations along with how the industry is likely to evolve.
This year’s conference contained companies from the vaping industry that have looked to take the necessary steps to ensure product safety and efficacy. Aside from this, other companies present reflected the title of this conference, ‘Nicotine Delivery'. This conference is not solely about vaping but about determining new user friendly methods to safely deliver nicotine to consumers. Such methods include 'heat not burn', rapid oral mucosal and nebuliser systems.
The TPD deadline has now come but the full effect will perhaps not be felt until May 2017 when all products that don't comply with the TPD must be removed from the market. The presentation by Beryl Keeley demonstrated how effective the UK authorities have been at implementing the TPD in comparison to other EU member states. The term 'light touch' was banded around twelve months ago and that certainly seems to be the case with many businesses we spoke to spending significantly less than they had first budgeted, thus allowing them to now begin on the second wave of notifications.
Tom Pruen of ECITA highlighted the importance of developing standards and a process that's already well under way with CEN (European Committee for Standardisation). Regardless of the TPD or any other deeming standards or regulations it is (and always has been) the responsibility of the producer to ensure they are putting a safe product to market. We are already seeing that many our customers are now gaining assurance of the quality of their manufactured, via:
- Qualification/assessment of product constituents - Ensuring that materials of the correct grade are used during manufacture
- QC Batch Release Testing - Ensuring that a consistent product is manufactured that complies with the products label claim
- Shelf Life Testing - Real time and accelerated stability testing to determine a suitable shelf life (expiry) date for the product
What's clear is that nicotine is a popular drug, not particularly harmful in the quantities generally consumed but historically has been delivered in one of the most harmful ways possible, i.e. the combustion of tobacco products. Therefore, companies are continuing to innovate and find safer and effective ways to deliver nicotine whilst optimising the end user experience. Broughton are recognised as industry leaders in the field of Nicotine Containing Product analysis are committed to helping our clients achieve success in this industry.