On 8 June, the Riigikogu enacted the Tobacco Act Amendment Act that transposes the new Tobacco Products Directive of the European Union. This directive seeks to approximate the legal provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products. The Tobacco Act has been supplemented with the requirements for distributing e-cigarettes and refill liquids containing nicotine. An electronic cigarette should not contain nicotine in excess of 20 mg/ml and should deliver nicotine doses at consistent levels. Liquids containing nicotine cannot have in their formula such additives as vitamins or substances that create the impression that a product has a health benefit or is safe. The act also imposes a ban on cross-border distance sales of tobacco and related products.
The amended Tobacco Act stipulates that the requirements laid down therein for electronic cigarettes and refill containers shall not apply to those products that fall within the requirements set for medicinal products and medical devices. This provision seeks to rule out simultaneous application of different legal acts to e-cigarettes and their refill containers.
According to the explanatory memorandum for the Tobacco Act Amendment Act, electronic cigarettes may essentially be distributed as medicinal products if the product is meant to treat tobacco addiction and/or mitigate withdrawal symptoms and the urge to smoke in the case of attempts to quit smoking and thus corresponds to the notion of medicinal product (subsection 2 (1) of the Medicinal Products Act) in terms of its presentation and effect. When electronic cigarettes are distributed as medicinal products, the provisions of the Medicinal Products Act shall apply to the nicotine liquid and the device for administering the medicinal product shall comply with the requirements for medical devices. In this case, the requirements of the Tobacco Act will not apply to nicotine refill containers distributed as medicinal products, and refill liquids being medicinal substances will have to comply with the regulatory regime for medicinal products.
The pharmaceutical forms of medicinal products containing nicotine which can be currently placed on the market in Estonia as authorised medicinal products include sprays, chewing gums, transdermal patches and lozenges. In the United Kingdom, for example, electronic cigarettes are placed on the market as medicinal products with the corresponding authorisation and are designed for treating tobacco addiction. Thus, it may well happen that in the future electronic cigarettes will be distributed as medicinal products in Estonia as well.
From now on then, it is first necessary to establish whether an electronic cigarette meets the requirements set out in the Medicinal Products Act. If the opposite is the case, the provisions of the Tobacco Act will apply to the e-cigarette together with the restrictions imposed on all other tobacco products. The restrictions, in particular, concern the availability and propagation of tobacco products among minors. They are an easily influenced target group, and in the interests of public health their access to tobacco products should be limited in all respects.
