Tobacco free nicotine products – How to comply with the regulations
On this page you will find information about the regulations that apply to tobacco free nicotine products, such as nicotine pouches. If you manufacture, import, or sell these products, you are responsible to ensure that they comply with legal requirements. You can also access a list of notified tobacco free nicotine products.
A tobacco free nicotine product is a product without tobacco that contains nicotine for consumption.
Some products are not considered tobacco free nicotine products. The Act on Tobacco Free Nicotine Products states that these products are not tobacco free nicotine products:
- Nicotine-containing products not intended for consumption.
- Tobacco products, herbal products for smoking and electronic cigarettes and refill containers.
- Medical products or medical devices.
- Products classified as a narcotic drug or a substance harmful to health.
Regulations for manufacturers and importers
If you manufacture or import tobacco free nicotine products, you are responsible for ensuring that the products meet legal requirements. Among other things, you must:
- Notify ingredients in tobacco free nicotine products
- Provide health warnings on the packaging, read more Manufacturing and import of tobacco free nicotine products
Regulations for Retailers
If you sell tobacco free nicotine products, you must comply with specific regulations. Your products must meet certain requirements. Read more about the applicable regulations and your responsibilities.
Trade in tobacco free nicotine products
The list of notified tobacco free products
Are you a manufacturer, importer, or retailer wondering if a tobacco free nicotine product has been notified to us? You can find information about notified tobacco free nicotine products in the list we publish.
About the list of notified tobacco free products
The list only includes information about tobacco free nicotine products for which the mandatory notification fee has been paid. The products are also subject to an annual reporting obligation with an associated fee that must be paid.
The list features products that were notified at least six months ago, for which the launch date has passed, and which have fulfilled the annual reporting obligation. Withdrawn products are not displayed. Please note that we have not verified whether all products on the list comply with legal requirements.
Information that is not confidential about notified tobacco free nicotine products is displayed in the list. The list is updated daily.
List of tobacco free nicotine products (tfn.folkhalsomyndigheten.se)
Supervision
Tobacco free nicotine products are subject to supervision. The products are reviewed by supervision. There is no pre-approval or authorization process from us. We can inform you about the applicable requirements. If you handle these products, you are responsible to ensure that they comply with legal requirements.
The smoking ban also applies to tobacco free nicotine products
Tobacco free nicotine products that correspond to smoking in their manner of use but do not contain tobacco are covered by the same rules as tobacco products regarding the smoking ban. The smoking ban does not apply in private homes, including patios and balconies.
| Questions about | Responsible authority | Contact |
|---|---|---|
| Poisoning | Swedish Poisons Information Centre | Acute poisoning – Children (giftinformation.se) |
| Marketing | The Swedish Consumer Agency | konsumentverket.se |
| Excise duty on nicotine goods | The Swedish Tax Agency | Excise duty on nicotine goods (skatteverket.se) |
| Pharmaceuticals, medical devices, and substances such as CBD, HHC, and THC | Swedish Medical Products Agency | lakemedelsverket.se |
Legislation
For information on applicable legislation, see the information in Swedish.
Lagstiftning om tobak och nikotinprodukter (in Swedish)
You need to have knowledge of the legislation
The information on this website is only intended to serve as an aid to you, and does not replace what is stated in the legislation. 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.
Further reading
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Trade in tobacco free nicotine products
On this page you will find information about your responsibilities as a retailer of tobacco free nicotine products, such as nicotine pouches.
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Manufacturing and import of tobacco free nicotine products
On this page you will find information about your responsibilities as a manufacturer or importer of tobacco free nicotine products, such as nicotine pouches.
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Notify ingredients in tobacco free nicotine products
On this page you will find information on how you, as a manufacturer or importer of tobacco free nicotine products, notifies ingredients, fulfill the annual reporting obligation and pay fees to us.
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Report 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 report this to us.
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Notify sales of tobacco free nicotine products
On this page you will find information on how you, as a foreign retailer can notify sales of tobacco free nicotine products such as nicotine pouches to us.