Sale of tobacco free nicotine products

Sale of tobacco free nicotine products

When providing tobacco free nicotine products to consumers in Sweden, you should be aware of 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 distributed 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.
• You need to establish and maintain a system for collecting information on any suspected adverse effects of tobacco free nicotine products on human health. This information must be provided to us upon request.
• Take action if you consider or have reason to believe that a tobacco free nicotine 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 rules. Immediately inform us about the details of the deficiencies and of the action taken, and results of such action.
• Only tobacco free nicotine products that comply with the legal requirements in Sweden 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.
• 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.

Publicly available information on tobacco free nicotine products (tfn.folkhalsomyndigheten.se)

Requirements on tobacco free nicotine products

Swedish Consumer Agency (konsumentverket.se)

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.

• Retailers with a physical point of sale who have their registered office or place of business in Sweden must notify the municipality where the physical point of sale is located.
• Retailers who do not have a physical point of sale but have their registered office or place of business in Sweden must notify the municipality where the company has its registered office.
• Retailers who do not have a physical point of sale or a registered office in Sweden must notify the municipality where the company has a permanent place of business.

Please contact the municipality for more information about the notification.

• Retailers who do not have a registered office or permanent place of business in Sweden must notify 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.
• When you end your retail sale to consumers in Sweden.

Voluntary form for notification

You can use the following voluntary form when you notify sales of tobacco free nicotine products to us. In order for the registration to be complete, you must also provide your self-monitoring programme:

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 at the beginning of 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 at the end of 2023.

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

Manufacturers, importers or distributors (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.

Form for notification of deficiencies and the corrective actions taken

You must use the form in the notification system for tobacco free nicotine products when you notify deficiencies and the corrective actions taken to us:

Notification system for tobacco free nicotine products (tfn.folkhalsomyndigheten.se) (in Swedish)