Regulation Of Nicotine Pouches In The Czech Republic

• Published date: 06 July 2023
• Subject Matter: Media, Telecoms, IT, Entertainment, Food, Drugs, Healthcare, Life Sciences, Advertising, Marketing & Branding, Food and Drugs Law
• Law Firm: Schoenherr Attorneys at Law
• Author: Ms Monika Vold'nov'

Nicotine pouches are small pouches or pads containing nicotine and no tobacco. They are placed under the lip so that the nicotine is absorbed into the body through the mucous membrane. This alternative to traditional tobacco products, especially cigarettes, has been growing in popularity in recent years.

Existing (non-)regulation

Unlike tobacco products and electronic cigarettes, nicotine pouches are not regulated at the European level. Until recently, they were also in a legislative no-man's land in the Czech Republic and were subject only to general product safety legislation. Due to their chemical content (including nicotine), they also had to comply with the requirements of chemical legislation, including the European REACH and CLP regulations.

In response, an amendment ¹ to the Act on Food and Tobacco Products ², effective from 11 May 2021, rather haphazardly inserted a definition of the term nicotine pouch and several obligations for manufacturers, importers, sellers and distributors of nicotine pouches into the Act during the legislative process in Parliament. However, these obligations were mostly unenforceable, because the accompanying decree that was supposed to specify them did not exist and, moreover, the legislator somehow forgot to add fines for violations of the new obligations when amending the law.

Decree on nicotine pouches

The aforementioned Decree ³ was issued by the Ministry of Health two years later, in May 2023, with effect from 1 July 2023. The Decree, in conjunction with the Act on Food and Tobacco Products, follows the model of tobacco and e-cigarette legislation and regulates the requirements for the composition, appearance, quality and characteristics of nicotine sachets. It also contains a notification obligation for manufacturers and importers of nicotine sachets to the Ministry of Health.

As regards quality and composition, nicotine pouches can only contain nicotine (or nicotine salt) and substances that do not pose a risk to human health. They may not contain vitamins, minerals and other ingredients that give the impression of being beneficial to health, addictive substances other than nicotine, they also cannot contain caffeine, taurine or other stimulants and other substances listed in the Annex to the Decree (e.g. capsaicin, estragole or hydrogen cyanide). A single dose of a nicotine pouch may contain a maximum of 12 mg of nicotine. A packet of nicotine pouches must not contain more than 240 mg of nicotine and must...