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 to the Act on Food and Tobacco Products, 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 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 contain at least 20 pouches. The latter is intended to limit the sale of nicotine pouches to young people who may find the higher price of larger packs of nicotine pouches a deterrent.
The packaging of nicotine pouches must not resemble a food, cosmetic product or toy. At the same time, the packaging must be secured against unwanted handling, especially by children.
Nicotine pouches must include several mandatory indications on the packaging, including a list of ingredients, the nicotine content per packet and per pouch, and the best before date. Among the mandatory information is a list of various warnings, including a health warning that reads "This product contains nicotine and is highly addictive." covering 30 % of the surface of the package and a warning that the product is not intended for pregnant and breastfeeding women and persons under 18 years of age. The latter warning must be accompanied by the graphic mark shown in the Annex to the Decree imitating the prohibition sign with the number 18 crossed out. At the same time, the labelling must not promote or encourage the consumption of nicotine pouches, imply that they are less harmful than other products (e.g. cigarettes) or that they have environmental benefits. In addition, it must not imply any economic benefits, such as discounts, two-for-one offers, etc.
The aforementioned reporting obligations to the Ministry of Health include the obligation to provide information on nicotine pouches themselves, but also on the market with them. Information on nicotine pouches includes, for example, information on their composition, toxicological data, nicotine doses and safety data sheets prepared in accordance with the EU REACH regulation. This notification is made via the EU-CEG common gateway under the category of tobacco products for oral use. The notification obligation needs to be fulfilled before placing the product on the market. The notification obligation on the nicotine pouches market includes aggregate information on the volume of sales of nicotine pouches and on the preferences of different consumer groups, including young people, non-smokers and the main types of current users.
Under the transitional provisions of the Decree, nicotine pouches that do not comply with the Decree and were manufactured or placed on the market before its entry into force may be resold no later than 12 months after the entry into force of the Decree (i.e. by 1 July 2024).
Other related legislation and conclusion
Nicotine pouches have also been affected by the recent amendment to the Act on Health Protection from Addictive Substances (effective 23 March 2023), which banned the sale of nicotine pouches outside specialist tobacco shops, grocery stores and daily and periodical newspaper outlets. The amendment also explicitly prohibited the sale of nicotine pouches to persons under 18 years of age.
For the time being, the Act on Regulation of Advertising does not restrict advertising of nicotine pouches as it does for tobacco products and electronic cigarettes. However, regulation of the advertising of nicotine pouches can be expected in the future. At the same time, the subjecting of nicotine pouches to excise duty is currently being addressed.
For reasons of legal certainty, the new legislation on nicotine pouches is to be welcomed. Nevertheless, it is questionable whether further specific regulation in the field of tobacco and related products is sufficient given the rapid development of this area and whether it would not be more appropriate to consider a more general legislative approach that would also target new types of products emerging on the market.
By Monika Voldánová, Attoreny at Law, Schoenherr
