Supervision of tobacco and nicotine products and market surveillance of tobacco and similar products
The Public Health Agency of Sweden supervises tobacco and nicotine products at national level. We are also responsible for market surveillance of e-cigarettes, tobacco products and herbal products for smoking. Here you can read about supervision and market surveillance and how we work.
Supervision of tobacco and nicotine products
The Public Health Agency is the responsible supervisory authority for e-cigarettes, tobacco-free nicotine products, tobacco products, and herbal products for smoking. This means that we verify that the economic operators that trade in these products comply with the legislation.
The objective of our supervision is that manufacturers, importers, distributors and online retailers comply with applicable regulation. We ensure compliance with legislation to protect the public's interests and safety. Supervision also contributes to creating fair competitive conditions and equal conditions for all economic operators on the market.
We are responsible for enforcement of legislation on
- product notification
- reporting obligation
- product requirements
- labelling and packaging
- registration in the case of distance sales, for example via the internet, to consumers in a country other than the country where the economic operator has its registered office or business operations, so-called cross-border distance sales
- self-monitoring in cross-border distance selling.
Market surveillance of e-cigarettes, tobacco products and herbal products for smoking
The Public Health Agency is the market surveillance authority for e-cigarettes, tobacco products and herbal products for smoking. This means that we verify that products that are provided to consumers on the Swedish market comply with the regulations in place.
The purpose of market surveillance is to detect and avoid dangerous products and products that do not comply with the legislation. It is also about ensuring a well-functioning internal market. By preventing the sale of products that do not meet the requirements, unhealthy competition and illegal activities are countered, while end users are protected from dangerous products. It can also contribute to increased tax revenue for the state.
Whoever provides a product on the market is responsible for ensuring that it complies with the legislation. No prior inspection of the product is required from us before it can be released. Instead, market surveillance is used to ensure that products on the market meet the requirements.
The Public Health Agency cannot approve or participate in the design of specific products. We can only take a position on specific products in connection with supervision and market surveillance. The prerequisite for this is that the product is available on the Swedish market and that we have decided to initiate a supervisory or market surveillance case. However, we can inform the economic operators about applicable requirements, and thereby facilitate regulatory compliance.
This is how we exercise supervision and market surveillance
Supervision and market surveillance can be both proactive and reactive.
- Proactive supervision and market surveillance is planned and based on an analysis of, among other things, external monitoring, follow-up of previous controls as well as notifications and reports that we receive.
- Reactive supervision and market surveillance is event-driven and is initiated by the tips and information that we receive from, for example, authorities, communication and information systems, companies, or the general public. We evaluate the information and determine whether there is a need to initiate supervision or market surveillance.
Our procedure may include review of documentation and websites, on-site inspection, as well as product testing and content analysis. Which approach we will use depends on the circumstances and needs of the individual case.
When we open a case, we contact the targeted company and inform about what our review will cover. In some cases, we may need information from the company. As a supervisory authority, we have the right to information, documents and product samples that are needed for our supervision. We also have the right to gain access to areas, premises and other spaces. There we can carry out investigations and take samples if necessary for supervision. In these cases, we send a request to the company.
In case of market surveillance, we have the right to carry out unannounced on-site inspections, purchase product samples under a hidden identity and carry out physical inspection of products.
We compile our observations in a report. It is sent to the company, which is given the opportunity to comment on what has emerged in our audit. If we do not discover any shortcomings, we can decide to close the case. In cases where the company has addressed the shortcomings, the case can be closed as well.
We can decide on injunctions and prohibitions
The Public Health Agency strives for voluntary corrections. If we have noted shortcomings, we first of all invite the company to provide a statement on how the shortcomings will be addressed. We can decide on an injunction or a prohibition if necessary for compliance. Such a decision may be combined with a penalty payment. This may become relevant if the company does not voluntarily remedy the inaccuracies. For example, we can decide that a company must take measures or prohibit products from entering the Swedish market.
A written decision clarifies what must be done. It is also an appealable decision, so that the company is treated with legal certainty.
We plan and follow up our supervision and market surveillance
Before each new year, we plan in which areas we will carry out supervision and market surveillance. We present our planning in an Enforcement plan and a Program for market surveillance.
Here you can read (text in Swedish) about the supervision that we plan on carrying out during the year in the areas of alcohol, tobacco and similar products, tobacco-free nicotine products and health-hazardous goods.
Tillsynsplan och program för marknadskontroll 2025 (folkhalsomyndigheten.se)
Every year we follow up and report on the supervision and market surveillance we have carried out.
Here you can read (in Swedish) about the supervision and market surveillance we carried out year 2023 in the area of tobacco and similar products and tobacco-free nicotine products.
Other authorities also have supervisory responsibilities
Other authorities also have supervisory responsibility over tobacco and similar products and tobacco-free nicotine products. For example, the municipalities and the Police Authority have supervisory responsibility over trade, and the Swedish Consumer Agency are responsible of supervision over marketing.
Some products are also covered by other legislation. The Swedish Food Agency, for example, has supervisory responsibility over snus, snuff-like products and chewing tobacco, and the Swedish Chemicals Agency has supervisory responsibility over liquids for e-cigarettes.
Laws, decrees and regulations
We exercise supervision and market surveillance in accordance with:
- the Act (2018:2018) on tobacco and similar products
- the Act (2022:1257) on tobacco-free nicotine products
In connection with these laws there are lower regulations. The complete legislation aims to ensure safety, public health and consumer protection. An important prerequisite to protect public health is that society has an effective control that the legislation is followed. We are responsible for this by exercising supervision and market surveillance at national level.
Further reading
Here you can find information about which rules apply to you who manufacture, import or trade in tobacco and nicotine products.
