The European Commission has said that the majority of e-cigarettes sold in the EU would most likely fall under pharmaceutical legislation if the commission’s proposed revisions to its Tobacco Products Directive were to be accepted. The commission has proposed that e-cigarettes would fall under the legal framework for medicinal products if they contained levels of nicotine above certain thresholds.
It is generally thought that, for cost or technical reasons, most e-cigarette companies would struggle to have their above-the-threshold products authorized under pharmaceutical laws, and that below-the-threshold products would be unacceptable to many consumers.
“The nicotine threshold has been identified by considering the nicotine content of nicotine replacement therapies that have already received a marketing authorization by Member States,” the commission said in a written answer to two questions raised by the Polish MEP, Filip Kaczmarek.
“For electronic cigarettes below the thresholds, the commission proposal foresees that they carry health warnings. They would also have to comply with the General Product Safety Directive as … is the case at the moment.”