BMJ – A court in the German state of North Rhine-Westphalia has struck down a state health ministry regulation classifying liquid nicotine used in electronic cigarettes as a medicine1 comparable to nicotine plasters, which in Germany can only be sold in pharmacies.
The court ruled that liquid nicotine used in e-cigarettes is not a medicine and therefore its sales cannot be regulated by Germany’s pharmaceutical laws.
North Rhine-Westphalia’s health minister, Barbara Steffen, said that the ministry would review the ruling before determining whether to file a legal appeal. She noted that the ruling contradicts growing sentiment at the European level to classify liquid nicotine as a medicine.
Indeed, the European parliament is now considering a proposal from the European Commission to revise the Tobacco Products Directive, which also includes a provision on e-cigarettes and liquid nicotine.2The new directive had been scheduled for a vote in the European parliament in early September, but was postponed until October.
The ruling in Germany, issued 17 September by the High Administrative Court of North Rhine-Westphalia,3covers three separate court cases initiated by producers and sellers of liquid nicotine. One case involved a woman who operates a retail shop in Wuppertal selling e-cigarettes and related products. Local health officials forbid her to sell liquid nicotine and she contested the ban in the Administrative Court of Düsseldorf, which upheld the regulation. She appealed the decision to the higher court.
In all three cases, the High Administrative Court reached the same conclusion: liquid nicotine is not a medicine and e-cigarettes are not medical products. In support of the ruling, the court argued that e-cigarettes, unlike nicotine patches, are not specifically marketed as a medical product designed to help people quit traditional tobacco-containing cigarettes.
“These [nicotine] liquids are neither suitable nor intended to achieve a lasting cessation of smoking [tobacco],” the court stated, asserting that the German Cancer Research Center and newest studies had reached the same conclusion.
Christoph von Ascheraden, who chairs the Committee for Addictions and Drugs at the German Medical Association, told the BMJ that the association supported classifying e-cigarettes in Germany and in Europe as a “pharmaceutical product requiring respective licensing and distribution through pharmacies” as medication for smoking cessation.
“Nicotine is a potentially toxic and addictive substance, therefore nicotine-containing e-cigarettes should not be freely accessible,” he said. “All other ingredients of an e-cigarette require further research, as their effects on human health are still widely unknown.”
Cite this as: BMJ 2013;347:f5739