Cyprus is currently experiencing a peculiar regulatory challenge concerning nicotine pouches, a rapidly expanding product category that, by late 2024, still lacked a clearly defined legal framework. Although the Cyprus Drugs Council officially classified these novel oral nicotine products as pharmaceutical items in October 2024, this designation has inadvertently generated a regulatory void. Consequently, no marketing authorisations have been issued for their legal sale. This leaves both vendors and consumers navigating an environment without specific rules on product strength, taxation, or age restrictions, a situation markedly different from the established regulatory approaches found in many other European Union member states.
The ambiguity surrounding nicotine pouches originates from their exclusion from existing smoking control legislation. Unlike traditional tobacco products or even e-cigarettes, which are subject to specific directives, these small, discreet sachets, designed for sublingual placement, have evaded comprehensive legislative scrutiny. This regulatory oversight gap became particularly evident with the significant influx of untaxed and largely unexamined Chinese-manufactured pouches into the Cypriot market during 2024. These products, frequently boasting considerably high nicotine concentrations, have consequently raised substantial public health concerns among authorities.
Pharmaceutical Services in Cyprus have openly expressed their apprehension, issuing cautionary advisories regarding the potential adverse health effects associated with these products. Reports have highlighted risks such as accelerated heart rates, known as tachycardia, and the possibility of nicotine poisoning, underscoring the urgent necessity for regulatory clarity. Kiosk owners, who are the primary points of sale for these items, have openly acknowledged operating within a legal grey area, uncertain about the precise legal standing of the products they are offering to the public.
The classification of nicotine pouches as pharmaceutical products, while a step towards acknowledging their psychoactive properties, has paradoxically hindered their integration into a regulated market. The stringent requirements for marketing authorisation, a process designed to ensure product safety and efficacy for medicinal use, have not yet been met by any of the available nicotine pouch products. This protracted process, coupled with the absence of dedicated legislation, creates a significant void in consumer protection and public health management.
In contrast, over fifteen EU member states have already established legal frameworks for non-tobacco nicotine pouches, permitting their sale and regulating aspects such as nicotine content and packaging. Sweden and its Scandinavian neighbours, with their extensive history of regulating similar oral tobacco products like snus, provide a precedent for controlled market access. However, Cyprus's current situation means consumers are largely left to make purchasing decisions without the benefit of clear guidelines on product safety or potential long-term health implications. The continued absence of a definitive regulatory stance risks exacerbating public health concerns and fostering an uneven playing field for businesses operating within the island's retail sector.