France

Policy Summary: 

E-cigarettes maybe be brought to market either as medicines or as consumer products. Those seeking medicines approval (either because they make cessation/health claims or contain nicotine above the threshold of 20 mg/mL) must obtain marketing authorization under the standard drug licensing process. So far no manufacturer has undergone this process and no e-cigarette has been licensed as a medicinal product. Those opting for regulation as consumer products are regulated by the decree of 19 May 2016 on vapor products containing nicotine.

E-cigarette manufacturers must notify the appropriate public agency prior to introducing a product to the market and notification requires compliance with a range of product specifications including on pack warnings. Manufacturers must also submit an annual report as specified in the law. Retailers who want to engage in cross-border sales of e-cigarettes must register with the Ministry of Health, and must not transact e-cigarettes via cross-border distance sale to consumers in member states where it is prohibited to do so.

Regardless of nicotine content, as consumer products, e-cigarettes cannot be sold in pharmacies. They must also meet the general safety requirement under the Consumer code. Sale of both nicotine-containing and non-nicotine e-cigarettes to minors (under 18 years) is prohibited.

Nicotine content of e-liquid must be less than or equal to 20mg/mL. 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 under normal conditions of use.

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 “La nicotine contenue dans ce produit crée une forte dépendance. Son utilisation par les non-fumeurs n’est pas recommandée” (“This product contains nicotine which is a highly addictive substance. It is not recommended for use by nonsmokers”) must appear on 30 % of both the front and back surfaces of unit packaging and any other packaging; must be in black Helvetica bold font on a white background; text must be centralized, occupy entire area reserved for it, and be parallel to the main text on the surface concerned. There are provisions that restrict the use of the packaging for advertisement or promotional purposes (e.g. pack must not contain misleading elements, including elements suggesting environmental, economic, or health benefits). Advertising/promotion/sponsorship related to both non-nicotine and nicotine-containing e-cigarettes is prohibited. Use of e-cigarettes is prohibited on public transport, enclosed workplaces and areas with minors.

Product Classifications: