E-cigarettes and other Nicotine Delivery Devices
Recent years have seen a rapid expansion in the market for non-tobacco products that deliver inhaled nicotine, including electronic cigarettes. These do not involve burning processes, instead converting an “e-liquid”, containing nicotine and other excipients, into a vapour that is inhaled by the user.
In general, electronic cigarettes and other non-tobacco nicotine delivery devices (NTNDD) will come under the revised Tobacco Products Directive (TPD2; 2014/40/EU). Article 20 states the need for manufacturers and importers of e‑cigarettes to submit a ‘notification’ six months prior to the intended placing on the EU market (or, if already on the market on 20 May 2016, the notification shall be submitted within 6 months). The notification in question must include “toxicological data regarding the product’s ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect”. Where Member States consider that the submitted information is incomplete, they shall be entitled to request the completion of the information. In addition, Member States shall ensure, among other requirements, that “except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form”.
We provide valuable advice on toxicological issues relating to e-cigarettes, and can support your regulatory submissions within the scope of MHRA, REACH and CLP
Whereas, according to the Medicines and Healthcare Products Regulatory Agency (MHRA), the relevant UK competent authority, any such product “which claims or implies that it can be used for cutting down, quitting and reducing harm is considered to be a medicinal product and must be licensed as a medicine”. As part of the license application process, a supplier must assess the safety and efficacy of the product, including a detailed safety review of all chemical components in the liquid formulation and a comprehensive evaluation of the potential extractables and leachables originating from all parts of the e-cigarette. We have good experience of the MHRA approval process, having assisted a client with obtaining a license for the general sale of their breath-operated product (Voke®) from the MHRA.
Toxicological assessments – E-cigarettes and other NTNNDs
- Preliminary hazard screening of e-liquid ingredients to outline critical toxicology and identify substances of high concern to human health. This screening allows companies to identify possible substances of high human health concern in their formation, prior to analytical testing and EU TPD notification, and therefore to consider e-liquid reformulation
- Expert searches to identify existing toxicology or human exposure data on the product, individual components, emissions, metabolites and/or read-across candidates
- Application of read-across and (Q)SAR to fill data gaps, where identified
- Expert toxicological reviews and human health risk assessments on the product components, formulation ingredients, emissions, and extractables and leachables. Notably, production of toxicity/addictiveness monographs (including assessment of cardiopulmonary and CMR properties) on a range of e-liquid ingredients, that can be used by companies to notify their products in compliance with TPD2
Electronic cigarettes and other NTNDDs may also fall within the scope of both REACH and CLP, as they are regarded as containers of chemical substances. For substances imported at one tonne or more per year per legal entity, it is required that they are registered under REACH and are notified to the Classification and Labelling Inventory. Our internationally renowned team of scientific experts can guide you through your REACH registration process and classification and labelling requirements.
Get in touch if you need help in the preparation of a ‘notification’ for submission under TPD2, in the preparation of a medicine license application, or with your REACH or CLP obligations.
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