State Agency of Medicines: e-cigarettes’ safety unproven

Photo: AP/ Scanpix

State Agency of Medicines (SAM) agrees that e-cigarettes with safety and quality inspected may prove less harmful than ordinary ones; even so, SAM stresses there are no objective data to support this.

Last week, Tartu Administrative Court rejected a complaint by Zandera Ltd desiring to market and sell four e-cigarette products containing 8–19.2 mg of nicotine without medicine marketing authorisation. As confirmed by SAM legal adviser Kaili Lellep, Tartu Administrative Court decision supports the existing practice. 

«State Agency of Medicines has declared that products with nicotine content less than 1.5 mg or with concentration no higher than 4 mg/ml are not defined as medicines by their effect. Such products may be sold as ordinary goods,» explained Ms Lellep. Thus, stores may keep selling cartridge liquids with low nicotine content.

«Products exceeding the abovementioned nicotine content, or making references to medicines, are defined as medicines; advertising and sales thereof is allowed after issuance of sales permit,» explained Ms Lellep.

Liquid alkaloid nicotine used in electronic cigarettes has been classified, by World Health Organisation, as active medicine ingredient; it is being used in treatment of addictions, especially with nicotine addiction.

Numerous supporters of e-cigarettes have underlined that smoking e-cigarettes is much safer than smoking ordinary tobacco. It has also been confirmed, by research, that e-cigarettes are effective in aiding people to quit smoking. «Still, it needs to be considered that with industrially produced nicotine we have to do with a highly toxic and addictive substance, hazardous to health at large amounts,» explained Ms Lellep.

SAM’s stand is, according to Ms Lellep, also supported by European Commission, which has underlined the need to categorise products containing nicotine as medicines.