Swedish pharma regulator granted control over e-cigs

Written by || 23 July, 2014 || Regulatory news analysis |

Swedish flag grunge 300x180A Swedish court has upheld attempts by the country’s medical products regulator to treat nicotine-containing e-cigarettes as pharmaceuticals, meaning that they must go through a licensing process and cannot be sold in outlets such as groceries and convenience stores.

The regulator, the Läkemedelsverket, last October tried to stop a retailer selling e-cigs on the basis that they have “pharmacological effect and medical use” and are therefore covered by the Medicines Act.

The retailer appealed that prohibition, and sales were allowed to continue while the court considered the case. It has now ruled in favour of the Läkemedelsverket.

“We believe that e-cigs are a great way to stop smoking but an approved product has to be developed first,” the agency’s nicotine specialist Martin Burman was quoted as saying. “Those sold today are neither proven, safe nor effective.”

The regulator would focus on controlling imports, Burman suggested, adding that “municipalities are able to conduct oversight of sales in small shops”.

Swedish customs has also had e-cigarettes in its sights, citing Läkemedelsverket rules to support the seizure of shipments of liquid nicotine which did not have a permit.

What This Means: The sale of e-cigarette hardware and nicotine-free liquid has been uncontested in Sweden, but as in many countries the legal position of nicotine-containing e-liquid has been somewhat hazy.

This latest ruling – which avoids the common and dubious question of whether e-cigs are tobacco products, and addresses instead whether they can be considered as medical products – appears to clarify that, for now. But it remains to be seen whether the issue will come back to court.

– Barnaby Page ECigIntelligence staff

Photo: Nicolas Raymond