Illegal distribution of electronic cigarettes

Recently, the Danish Medicines Agency has been made aware that a number of electronic cigarettes, and similar products, are being sold illegally, e.g. via the internet. The products are sold under various product names. The Danish Medicines Agency generally considers electronic cigarettes that contain extracted nicotine to constitute medicinal products due to the products’ pharmacological effect¹.

Before a medicinal product can be legally marketed, distributed or dispensed in Denmark, it must have been granted a marketing authorisation. In addition, a company cannot legally handle, and distribute, medicinal products in Denmark without having obtained a company authorisation from the Danish Medicines Agency. The process of issuing marketing authorisations is the consumers' assurance that the quality, safety and efficacy of the products have been assessed, implying that there is an acceptable balance between the products’ possible side effects and intended effect. 

The Danish Medicines Agency has not licensed any versions of electronic cigarettes. Therefore, any marketing and distribution of the products generally constitutes a violation of the provisions of the Danish Medicines Act.

For further information about electronic cigarettes, please contact Gitte Albæk Christensen, tel. +45 4488 9323 or Matilde Kyst Behrens, tel.: +45 4488 9183.

Danish Medicines Agency, 9 October 2008.

1. According to section 2 of the Danish Medicines Act, a medicinal product means any product that

• is presented as a suitable medicinal product for the treatment or prevention of diseases in humans or animals; or
• may be used in or administered to humans or animals to recover, change or affect physiological functions by having a pharmacological, immunological and metabolic effect, or to make a medical diagnosis.