Draft Act on Tobacco-free Nicotine-containing Products

The following is hereby laid down.
Swedish Code of Statutes

Act
on Tobacco-free Nicotine-containing Products

Issued on 30 June 2022

In accordance with the decision of the Riksdag, the following is hereby laid down.

Aim and content of the Act


Product notification

Section 5    Manufacturers and importers shall notify the Public Health Agency of Sweden of all tobacco-free nicotine-containing products they intend to make available to consumers on the market. A new notification shall be submitted for any substantial modification to the product. The notification shall be submitted no later than six months before the product is intended to be made available to consumers on the market. Notification must also be made when the manufacturer or importer withdraws the product from the market.
Section 5    Manufacturers and importers shall notify the Public Health Agency of Sweden of all tobacco-free nicotine-containing products they intend to make available to consumers on the market. A new notification

shall be submitted for any substantial modification to the product. The notification shall be submitted no later than six months before the product is intended to be made available to consumers on the market. Notification must also be made when the manufacturer or importer withdraws the product from the market.

Tobacco-free nicotine-containing products may not be made available to consumers on the market unless such notification has been made. The same shall apply if the notification does not comply with the product notification regulations issued pursuant to Section 48(1).


2. age requirements under Sections 19 and 20.

Section 26    The Public Health Agency shall exercise supervision to ensure this Act and related regulations are followed in respect of:
Section 26    The Public Health Agency of Sweden shall exercise supervision to ensure this Act and related regulations are followed in respect of:

1. product notification, product requirements, reporting obligation and product monitoring under Sections 5, 6 and 14-16, in cases other than those referred to in Section 24, first paragraph;


3. notification of sales and self-monitoring under Sections 17 and 18 where the trader does not have a registered office or permanent establishment for business purposes in Sweden.

Section 27    The Consumer Agency shall exercise supervision to ensure this Act and related regulations are followed in respect of marketing under Sections 9-11 and 12, first paragraph, in cases other than those referred to in Section 24, second paragraph.
Section 27    The Swedish Consumer Agency shall exercise supervision to ensure this Act and related regulations are followed in respect of marketing under Sections 9-11 and 12, first paragraph, in cases other than those referred to in Section 24, second paragraph.

The Consumer Agency’s supervision is subject to the provisions of the Marketing Act (2008:486).


A prohibition may be issued for a period not exceeding six months.

Section 30    If the Public Health Authority finds or has reasonable grounds to believe that a type of or specific tobacco-free nicotine-containing product may pose a serious risk to human health despite the fact that the product complies with this Act, it may prohibit the products from being made available to consumers on the market.
Section 30    If the Public Health Agency of Sweden finds or has reasonable grounds to believe that a type of or specific tobacco-free nicotine-containing product may pose a serious risk to human health despite the fact that the product complies with this Act, it may prohibit the products from being made available to consumers on the market.

Where such products have been made available to consumers on the market, the Public Health Authority may order the manufacturer, importer or distributor of the products to withdraw or recall them.


Mutual provision of information

Section 35    The municipality and the Police Authority shall inform one another of circumstances relevant to supervision.
Section 35    The municipality and the Police Authority shall inform one another of circumstances they become aware of in their activities that are relevant to supervision.

A municipality which has taken a decision in a matter under this Act shall send a copy of the decision to the Public Health Agency, the Police Authority and the county administrative board that is affected by the decision.

Section 36    The municipalities shall inform the Public Health Agency if they become aware of anything that may be of importance to supervision by the Public Health Agency.
Section 36    The municipality shall inform the Public Health Agency of Sweden if they become aware of anything that may be of importance to supervision by the Public Health Agency.

Control purchases

Section 37    A municipality may carry out control purchases in order to provide a basis for dialogue between the municipality and the supplier of tobacco-free nicotine-containing products on the obligation to ensure that the recipient has reached the age of 18. For such purchases, the municipality may only use persons who have reached the age of 18.
Section 37    The municipality may carry out control purchases in order to provide a basis for dialogue between the municipality and the supplier of tobacco-free nicotine-containing products on the obligation to ensure that the recipient has reached the age of 18. For such purchases, the municipality may only use persons who have reached the age of 18.

Control purchases may be carried out without the trader being given any prior notification of the control purchase. The municipality shall notify the trader of the control purchase as soon as possible once the control purchase has been carried out.


Penalties and forfeiture

Section 43    Anyone who intentionally provides consumers with tobacco-free nicotine-containing products that do not meet the requirements concerning declarations of content or health warnings in breach of Section 7 third paragraph shall be sentenced to a fine or imprisonment of up to six months for unauthorised handling of tobacco-free nicotine-containing products.
Section 43    Anyone who intentionally provides consumers with tobacco-free nicotine-containing products that do not meet the requirements concerning declarations of content or health warnings in breach of Section

7 third paragraph shall be sentenced to a fine or imprisonment of up to six months for unauthorised handling of tobacco-free nicotine-containing products.

If the act is minor, it shall not give rise to liability.

2. Tobacco-free nicotine-containing products manufactured or released for free circulation before 1 January 2023, which do not comply with the product requirements under Section 6 or labelling requirements under Sections 7 and 8, are to be allowed to continue being made available to consumers on the market after 1 January 2023 unless they present a serious risk to human health, until no later than 1 July 2023.

3. For tobacco-free nicotine-containing products that have been made available to consumers on the market before 1 January 2024, a product notification under Section 5 shall be made by no later than 1 February 2024.

On behalf of the Government

morgan johansson

lena hallengren

(Ministry of Health and Social Affairs)