Notify deficiencies in tobacco free nicotine products
If you, as a manufacturer, importer, or distributor, become aware of any deficiencies in tobacco free nicotine products, such as nicotine pouches, you must take the corrective action and notify us.
A manufacturer, importer, or distributor of tobacco free nicotine products who consider or has reason to believe that a product is not safe, not of good quality, or otherwise not in conformity with the Act on Tobacco Free Nicotine Products or issued rules, must immediately:
- Take the corrective action necessary to bring the product concerned into conformity with the Act on Tobacco Free Nicotine Products,
- Recall the product from the market so that it is not sold or released to consumers.
- Withdraw the product if it has already been sold or released to consumers.
If a corrective action is taken, the manufacturer, importer or distributor are also required to immediately inform the Public Health Agency of Sweden about the details of the products deficiencies and of the corrective action taken, and the results of such corrective action. Please note that there may be other laws that require you to notify other authorities.
Form for notification of deficiencies
You can use the following form when you notify deficiencies to us:
Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se)
Which actors are considered distributors?
Distributor is a collective term for, for example, wholesalers and retailers.
How to comply with the regulations for tobacco free nicotine products
On the page on how to comply with the regulations, you will find more information on tobacco free nicotine products.
Tobacco free nicotine products – How to comply with the regulations
You need to have knowledge of the law
The information on this website is only intended to serve as an aid to you, and does not replace what is stated in the law. There may also be other laws or regulations from other authorities that you need to be aware of. We continuously update the content but we cannot guarantee that the information is always up-to-date.
