Sale of tobacco free nicotine products

Sale of tobacco free nicotine products

When you provide tobacco free nicotine products to consumers in Sweden, you should know the following:

• Sales to consumers refer to retail trade. A retail outlet is a physical point of sale, which is a particular location or other delimited retail space, or a retail website.
• Sales of tobacco free nicotine products to consumers are subject to notification. The municipality and we may charge fees for their supervision of those who notify sales of tobacco free nicotine products.
• Tobacco free nicotine products may only be sold or otherwise handed out to those who have reached the age of 18.
• A retail outlet or website must also have a clear and easily visible message with information about the 18-year age limit.
• If you have questions about marketing and marketing measures at or in connection with a physical point of sale please contact the municipality. If you have any other questions about marketing of tobacco free nicotine products, please contact the Swedish Consumer Agency.
• Only tobacco free nicotine products that comply with the legal requirements may be available to consumers on the Swedish market. As a retailer of tobacco free nicotine product, you have a responsibility to ensure that the products you provide to consumers on the Swedish market meet the legal requirements for product notification, annual reporting and labelling, and complies with the product requirements.

Swedish Consumer Agency (konsumentverket.se)

Requirements on tobacco free nicotine products

Notification of sale to the municipality in Sweden

A notification of sale together with a self-monitoring programme is required in order to be able to conduct retail trade of tobacco free nicotine products to consumers in Sweden.

• A retailer who has a registered office or place of business in Sweden must notify the municipality of where the physical point of sale is located.
• If you do not have a physical point of sale, notification must be made to the municipality where the company has its registered office.
• If there is no physical point of sale and the company does not have a registered office in Sweden, notification must be made to the municipality where the company has a permanent place of business.
• If the retailer does not have a registered office or permanent place of business in Sweden, the notification must be made to us.

Notification of sale to the Public Health Agency of Sweden

A retailer without a registered office or permanent place of business in Sweden who intends to provide tobacco free nicotine products to consumers in Sweden must notify us of the sale.

You must immediately notify us if provided information about the retail outlet or the self-monitoring programme changes. You must also notify us when you end your retail sale to consumers in Sweden.

Form for notification

The regulation in the Public Health Agency of Sweden's regulations on Tobacco Free Nicotine Products about the technical solution that must be used to notify us of the corrective actions taken will be put into use on the 1 January 2024. Until then, you can use the following form:

Form – Notification of sale of tobacco free nicotine products (PDF, 81 kB)(Öppnas i nytt fönster)

Please submit the form together with the self-monitoring programme to us, either by email or by post.

• info@folkhalsomyndigheten.se
• Postal address: Folkhälsomyndigheten, Enheten för produktkontroll, 171 82 Solna, Sverige (Sweden)

Self-monitoring and self-monitoring programme

A retail outlet that engages in sales of tobacco free nicotine products must practice self-monitoring and ensure that an appropriate self-monitoring programme exists and is enforced.

The self-monitoring programme and other information needed for the municipality and us must be attached to the notification of sale. Any changes to submitted information must be reported immediately to the municipality or us.

We are now drawing up regulations on self-monitoring programme for the sale of tobacco free nicotine products. The regulations are expected to come into force on 1 January 2024

Age requirements

Tobacco free nicotine products may only be sold or otherwise handed out to those who have reached the age of 18. The retail outlet must make sure that the recipient has reached that age. It must also be possible for the retailer to verify the recipient's age, for example by presenting valid identification. This applies to all types of sales, including those that take place through vending machines or distance selling or in a similar way.

If there is special reason to assume that the tobacco free nicotine product is intended to be handed over to someone who has not reached the age of 18, the product must not be handed over.

The retail outlet, including websites, must have a clear and clearly visible message with information about the ban on selling or handing out tobacco free nicotine products to those who have not reached the age of 18.

Control purchase

In order to provide a basis for a dialogue between the municipality and a retailer of tobacco free nicotine products about the obligation to ensure that the buyer has reached the age of 18, the municipality may conduct control purchases. The municipality may only hire a person over the age of 18 to conduct a control purchase.

A control purchase may be conducted without the retailer being notified in advance. The municipality must notify the retailer of the control purchase as soon as possible after a completed control purchase. A control purchase may not be used as the basis for an administrative sanction.

We are now drawing up regulations on control purchase of tobacco free nicotine products. The regulations are expected to come into force on 1 January 2024

System for collecting information

Manufacturers, importers and distributors (wholesalers and retailers) of tobacco free nicotine products must establish and maintain a system for collecting information on any suspected adverse effects of these products on human health. This information must be provided to us upon request.

Requirement to take corrective actions

A manufacturer, importer or distributor (wholesalers and retailers) of tobacco free nicotine products that considers or has reason to believe that a product is not safe or is not of good quality or is otherwise not in conformity with the Act on Tobacco Free Nicotine Products or issued rule, must immediately:

• take the corrective action necessary to bring the product concerned into conformity with the Act on Tobacco Free Nicotine Products,
• withdraw the product, or
• recall the product.

If any corrective action is taken, the manufacturer, importer or distributor is also required to immediately inform us about the details of the deficiencies and of the corrective action taken, and of the results of such corrective action.

Voluntary form for notification

To make it easier to notify us of the corrective actions taken, you can use the following voluntary form:

Form – Notification of deficiencies (PDF, 107 kB)(Öppnas i nytt fönster)

Please submit the form to us, either by email or by post.

• info@folkhalsomyndigheten.se
• Postal address: Folkhälsomyndigheten, Enheten för produktkontroll, 171 82 Solna, Sverige (Sweden)

Prohibited products that can pose a serious risk

If we establishes or has reasonable grounds to believe that a specific tobacco free nicotine product, or a type of tobacco free nicotine product, may pose a serious risk to human health, may we prohibit the product from being available to consumers on the Swedish market. This applies even if the product complies with the provisions of the Act on Tobacco Free Nicotine Products.

The Agency has not prohibited any tobacco free nicotine product based on a serious risk to human health. If we were to prohibit a product on this basis, information about the product will be published when it gains legal force.