E-cigarette regulation in Austria

E-cigarettes can be classified as medicines if they are marketed with medicinal claims and thus regulated under the Austrian Medicinal Products Act, or as tobacco related products and regulated by the Amended Austrian Tobacco Act 2016. E-cigarettes that are marketed with medicinal claims must apply for authorization to do so and comply with restrictions on sale, marketing, advertising, distribution, importation and manufacturing contained in the Austrian Medicinal Products Act. The Tobacco Act contains a requirement to notify the Federal Ministry of Health prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers or importers must also submit an annual report to the Federal Ministry of Health as specified in the law. Nicotine content of e-liquid must be less than or equal to 20mg/mL. Single use e-cigarette cigarettes as well as e-cigarette tanks must not exceed 2mL, and volume of refill bottles must not exceed 10mL. E-liquid should not contain certain additives, and only high quality ingredients should be used in their manufacture. Except for nicotine, only ingredients that do not pose a risk to human health in heated or unheated form can be used in the nicotine-containing e-liquid. E-cigarettes must be able to deliver a dose of nicotine at a consistent level. E-cigarettes and refill containers should be child- and tamper-proof, protected against breakage and leakage, and have a mechanism that ensures filling without leakage. Product packaging must contain health warnings and constituent information as specified in the law. The warning “Dieses Produkt enthält Nikotin: einen Stoff, der sehr stark abhängig macht. Es wird nicht für den Gebrauch durch Nichtraucher empfohlen” for nicotine-containing e-cigarettes, and “Der Gebrauch dieses Produktes kann gesundheitliche Schäden verursachen” for non-nicotine e-cigarettes, must appear on 30 % of each of the two main surfaces of the unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy greatest possible proportion of the area reserved for it, and be parallel to the main text on the surface reserved for the warning. There are provisions that restrict the use of the packaging for advertisement or promotional purposes, as well as advertising, promotion and sponsorship on print and electronic media.

Product classification: Tobacco-related product; e-cigarette; Medicinal; Medical device

Policy domains: Sale; Advertising/Promotion/Sponsorship; Health Warning Labeling; Child Safety; Ingredients/flavors; Safety and hygiene; Reporting/notification; Nicotine volume/concentration