Only nicotine-containing products (NCP), including electronic cigarettes, which are presented as having properties for treating or preventing disease in human beings, such as nicotine addiction, are considered to be medicinal products.

Medicines regulation requires that licensed products meet appropriate standards of quality, safety and efficacy; that safety in use is monitored, including over the long term; and any emerging risks are effectively managed.

The National Institute for Health and Care Excellence recommends the use of licensed nicotine replacement therapy to reduce the harms of smoking to smokers and those around them.

Smoking is the greatest single cause of avoidable ill-health and death, accounting for 80,000 deaths each year in England alone. The Government is concerned to ensure that an effective, proportionate regulatory framework exists to enable safe and effective products to meet this public health priority.

NCPs which are not presented as medicines are not subject to medicinal licensing. General Product Safety Directive provisions apply to such products.

The United Kingdom Government supports a requirement to introduce an approved regulatory framework. This position will need to take account of the final form of the Tobacco Products Directive. In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) continues to encourage companies voluntarily to license nicotine containing products on the basis of presentation and will continue to decide on whether products are medicinal products on a case by case basis. This is intended to ensure that products are available that meet appropriate standards of safety, quality and efficacy to help reduce the harms of smoking to smokers and those around them.

The MHRA has commissioned two studies at the Tobacco Dependence Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London. The first study was an analysis of nicotine content in the cartridge contents and in the generated vapour of electronic cigarettes and has been published. The outcome of the second study, evaluating toxin and nicotine delivery in electronic cigarette has not yet been reported to the MHRA.

The United Kingdom Government supports a requirement to introduce an approved regulatory framework. This position will need to take account of the final form of the Tobacco Products Directive. In the meantime, the Medicines and Healthcare products Regulatory Agency (MHRA) continues to encourage companies voluntarily to license nicotine containing products on the basis of presentation and will continue to decide on whether products are medicinal products on a case by case basis. This is intended to ensure that products are available that meet appropriate standards of safety, quality and efficacy to help reduce the harms of smoking to smokers and those around them.

The MHRA has commissioned two studies at the Tobacco Dependence Research Unit, Wolfson Institute of Preventive Medicine, Queen Mary University of London. The first study was an analysis of nicotine content in the cartridge contents and in the generated vapour of electronic cigarettes and has been published. The outcome of the second study, evaluating toxin and nicotine delivery in electronic cigarette has not yet been reported to the MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.

The Medicines and Healthcare products Regulatory Agency (MHRA) published an impact assessment (IA) on the regulation of nicotine containing products (NCPs), including electronic cigarettes, on 12 June 2013 which provided estimates of the costs associated with medicinal regulation of NCP. A copy of the IA has been placed in the Library and is available on the MHRA website at:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286834.pdf

The IA estimates that there are several hundred companies offering e-cigarettes for sale in the United Kingdom. One company in the UK is known to be developing UK manufacturing capability and there is growing interest amongst other companies. Regulating these products as medicines would likely result in short term transitional losses for some stakeholders, not least any current importers of unlicensed products unwilling to invest in gaining the necessary authorisations and licenses. In the long term, however, we would not expect owners of the capital invested in the manufacture and supply of NCPs to suffer losses.

The IA makes the assumption that it is likely that manufacturers, European Union marketing authorisation holders, and all other participants in the supply chain would seek to pass their incremental costs onto their buyers, and ultimately to consumers. The extent to which UK consumers would bear the incremental costs is unclear. Pricing of NCPs seems to be constrained at the upper bound by the pricing of tobacco products. The IA suggests that NCP consumers would be unlikely to suffer from substantial price increases if these products were regulated as medicines.

The UK Government's position is that the right form of regulation will support and stimulate the NCP market.

The available evidence is that electronic cigarettes are likely to be substantially less harmful than smoking tobacco cigarettes, however, there remains a paucity of scientific evidence on the long term health effects of using these products. The value of the health gains associated with a single successful quit attempt is very substantial—the Department estimates it to be £74,000. The orders of magnitude of estimated compliance costs suggests that a policy of licensing e-cigarettes would have to create very few additional successful quit attempts for the benefits to justify its costs. It is estimated that implementing policies to reduce smoking prevalence by 1% per year for 10 years in the UK would prevent over 57,000 deaths in that period.