New alternative to smoking: novel nicotine delivery device gets medicines licence



Friday 12 September 2014

Kind Consumer announced today that it has secured a medicines licence for their nicotine inhaler, an important step forward which ASH believes will pave the way for electronic cigarettes to be given licences as medically-approved stop smoking aids. [1]

The product called Voke, for which the company has received marketing authorisation, uses non-electronic, miniaturised breath operated valve technology which operates without heat or combustion to deliver nicotine. The Kind Consumer product is the first novel nicotine product to be given a licence by the Medicines and Healthcare products Regulatory Agency (MHRA) as an approved aid to help people stop smoking. It will be manufactured and distributed by a wholly owned subsidiary of British American Tobacco called Nicoventures and it is expected to be some months before the product is commercially launched on the market.

Deborah Arnott, Chief Executive of health charity ASH said:

“This new alternative to smoking, which will be on sale in coming months, will allow smokers to choose a product which meets the high standards of medicines regulation and could be provided on prescription to help them stop smoking. There are many electronic cigarettes already on the market that are popular with smokers who are trying to cut down or quit smoking, but none of them so far are licensed as medicines. It is our understanding that a large number of other companies are in discussion with the MHRA and we hope this gives them the confidence to follow the process through.”

Concerns have been expressed that the Kind Consumer device will be marketed by a tobacco company. ASH believes that medicines regulation will minimise the risk that tobacco companies market their products inappropriately as the medicines licence requires that promotion is limited to smokers, that product safety is regulated and that these products can’t be sold to children.

Electronic cigarettes are currently many smokers first preference as an aid to stopping smoking. The evidence shows that smokers have the best chance of successfully quitting by using pharmacological treatment with the support of a trained professional as provided by the Stop Smoking Services. At the moment those professionals are not in a position to prescribe electronic cigarettes or other novel nicotine products. [2] Having such products licenced as medicines will give smokers reassurance about their safety and effectiveness. It will also enable medical professionals to recommend and prescribe products.

The MHRA decision puts the UK in a good position ahead of EU regulations on electronic cigarettes which come into effect in May 2016. It moves us towards an effective regulatory framework where smokers will have a choice between products regulated as medicines and those regulated as consumer products. [3]

Deborah Arnott added:

“While it is hoped that future regulation will improve the quality of nicotine products, smokers who are using existing electronic cigarettes should be reassured that they are still much less harmful than smoking.”

ENDS

Notes

[1] Kind Consumer is a healthcare research and development company which focuses on inhalation technologies. The product for which the company has received marketing authorisation is a medical device utilising a non-electronic, miniaturised breath operated valve technology that has been used to form the basis of a pharmaceutically regulated substitute cigarette intended to deliver pharmaceutical grade nicotine formulation to the lungs as an aerosol released from the device. The non-electronic device will operate without heat or combustion. The device is the subject of a worldwide exclusive distribution agreement with Nicoventures Limited, which is a wholly owned subsidiary of British American Tobacco plc. Nicoventures will also manufacture the device and be responsible for branding and marketing the product. See more at: www.nicoventures.co.uk and www.kindconsumer.com which includes an image of the product.

[2] See NICE guidance: Tobacco: harm-reduction approaches to smoking.

[3] Currently electronic cigarettes come under general consumer protection law. When the revised EU Tobacco Products Directive takes effect in 2016 electronic cigarettes will be required to carry a health warning, there will be upper limits on the amount of nicotine that they can contain, and they will be subject to marketing restrictions including a ban on the promotion of the products to children. Alternatively, manufacturers can apply to the MHRA for a medicines licence for nicotine products to be sold as stop smoking aids. Products receiving approval may be available on prescription and will be subject to the same marketing restrictions as other medicines on general sale.