Sales of dietary supplements in Poland – the most important regulations and requirements
The most important information regarding the sale, distribution and advertising of dietary supplements in Poland is based on a key assumption: in the light of the law, dietary supplements are food (foodstuffs), not medicinal products (drugs). This means that the rules for their introduction to the market are less stringent than those for pharmaceuticals, but they still require completion of important formalities.
Who can sell dietary supplements and where?
Dietary supplements can be sold by practically everyoneThis activity is most often conducted by entrepreneurs (e.g. as a sole proprietorship – JDG, or a partnership).
- No need have medical, pharmaceutical or dietary education.
- Not required no special license or permit (as is the case, for example, when running a pharmacy).
Due to the fact that these are food products, the list of places where they are sold is very wideSupplements can be legally sold in places such as:
- online stores (e-commerce) and marketplace platforms (e.g. Allegro),
- health food stores, herbal shops and drugstores,
- fitness clubs, gyms and beauty salons,
- supermarkets, regular grocery stores and even gas stations,
- pharmacies (however, there are specific display rules that clearly separate them from medicines).
Appropriate PKD codes for the business
When registering a company, you should select the appropriate Polish Classification of Activities codes. The most common for this industry are:
- 47.27.Z (previously 47.91.Z) – for retail sales via the Internet (online stores).
- 47.29.Z – for retail sale of other food in specialized stationary stores.
Legal requirements: Sanitary Inspectorate and reporting to the Chief Sanitary Inspectorate
1. Reporting to the Sanitary Inspectorate (Mandatory for everyone)
Each seller must submit an application for entry into the register of establishments subject to the control of the State Sanitary Inspectorate (Sanepid) at least 14 days before start of sales.
Important: This requirement also applies to online stores and sellers operating in the online model. dropshippingThe place where you store the goods must meet the rules of food hygiene (appropriate temperature, humidity, implementation of rules HACCP and the rotation system FIFO/FEFO).
2. GIS notification (Only in certain cases)
The Chief Sanitary Inspectorate (GIS) must be notified of each supplement, but this obligation depends on your role on the market:
- You do NOT have to report the product to GIS, if you're buying goods from a Polish wholesaler and a Polish manufacturer. These products are already legally available for sale. All you need is a Sanitary Inspectorate (Sanepid) registration.
- You MUST report the product to GIS, if you are the one introducing a given supplement to the Polish market for the first time (you are its manufacturer, direct importer from abroad or you create your own brand – the so-called (private-label).
Applications are submitted entirely online via Electronic Notification System (ESP), including the Polish label and detailed composition. Sales may begin immediately after submitting the notification at your own risk, but the Chief Sanitary Inspectorate (GIS) reserves the right to initiate investigation proceedings.
Supplement composition: limits and prohibited substances
There is a strict list of substances that must not be added to dietary supplements in Poland. These include, among others:
- yohimbine,
- DMAA,
- SARMs (e.g. ostarine, ligandrol),
- kava kava,
- ibutamoren,
- pancreatin and greater celandine.
They also apply strict maximum limits for vitaminsFor example: vitamin C up to 1000 mg in a daily dose, and vitamin D up to 2000 IU for healthy adults (and up to 4000 IU for seniors over 75 years of age).
Etiquette and e-commerce sales
A correct product label must absolutely include:
- expression "dietary supplement",
- recommended daily dose and warning against exceeding it,
- information that the product does not replace a varied diet,
- order to store out of reach of children.
In online stores all the above information must be available made available to the customer before making a purchase – directly in the product description on the website, not as a hidden link or attachment.
Restrictions on advertising dietary supplements (New rules)
The law strictly regulates the advertising of supplements. Furthermore, under the new regulations, particularly restrictive rules apply (fully in effect by 2026):
- Prohibition of medicinal claims: It is not allowed to suggest that the supplement cures, prevents, or relieves pain. Only EU-approved supplements are permitted. health claims (NP. "vitamin C helps in the proper functioning of the immune system").
- No more “white coat” image: There is a complete ban on using images of doctors, pharmacists, or medical influencers in advertising. Props suggesting a medical profession, such as stethoscopes, are prohibited.
- Big warnings: Every advertisement must contain a clear message: "A dietary supplement is food, not medicine. It does not cure disease."In graphic materials, this warning must occupy 20% of the areaand in spots the video must be displayed for at least 7 seconds.
Financial penalties and inspections (Sanepid, UOKiK)
Breaking the law – for example, misleading consumers, false advertising, inappropriate composition or failure to notify the Chief Sanitary Inspectorate – carries severe sanctions, including an order to immediately withdraw the product from the market.
- Penalties from UOKiK they can even reach up to 10% of the company's annual turnover.
- Legal changes increase the administrative penalties imposed by Sanitary Inspectorate up to 100 times the average salary, which means fines of over 714 thousand zlotys.
- Knowingly placing harmful food on the market may even result in imprisonment.
5 facts about dietary supplements and border control that will change the way you shop
1. A supplement is food, not a health remedy
As consumers, we often succumb to the "magic pill" illusion, confusing dietary supplements with medicinal products. However, from a legal perspective, the difference is drastic: a supplement is foodstuff, i.e., food in concentrated form. Its purpose is only to supplement the normal diet of healthy individuals, not to treat any disease.
This problem has real medical consequences. GIS materials warn about patients who, after leaving the hospital, throw away their prescriptions, replacing the prescribed medications with supplements that they believe are "equally effective." This is a mistake that can cost lives. Medicinal products undergo rigorous testing. clinical trials confirming their effectiveness. Dietary supplements, as a food category, do not have to prove their therapeutic effect before entering the market.
"Dietary supplements are not drugs – they do not treat or prevent disease. According to the law, dietary supplements are considered food, even though their form (capsule, tablet) is similar to that of drugs."
2. Shocking numbers – notification is not registration
The scale of the Polish market is enormous and has been showing a growth trend for years, outpacing the pharmaceutical industry. According to GIS data, the market comprises approximately 30 dietary supplements, while the number of registered drugs is approximately 23. In 2015-2016 alone, the inspectorate received nearly 20 notifications.
The key to safety is awareness of the legal mechanism: in Poland there is notification system, not a system of permits or registrations. This means that a product can be placed on the shelf almost immediately after being reported, and the Chief Sanitary Inspectorate (GIS) only verifies it "on the fly." With such a large number of reports, full control of each preparation is physically impossible, which makes this responsible entity (producer/importer) assumes the risk and the consumer must exercise the utmost vigilance.
"Currently supplement market The dietary market exceeds the pharmaceutical market in terms of the number of products […]. Statistical data indicate an upward trend compared to previous years.”
3. "Natural" doesn't always mean safe - blacklist of substances
A common myth is that herbal extracts are always safe. As an expert, I must warn you: the herbal ingredients in supplements can interfere with dangerous drug interactions, modifying their metabolism (intensifying or weakening their effect). There is also a real risk of substance accumulation when using several preparations simultaneously, which poses a threat to the liver, for example.
It is worth knowing that GIS maintains an active list of prohibited substances (currently, it lists 7 key substances considered unsafe in supplements). The difference between a supplement and a herbal medicine lies in standardizationIn medicines, the dose of the active ingredient is precisely defined and repeatable, whereas in food "extracts," the content of active compounds can vary dramatically between batches. Children under 6 years of age are particularly at risk, as unjustified supplementation can permanently disrupt their natural immune system.
"Dietary supplements of natural origin (e.g., those containing herbal extracts) can also be overdosed or have a negative effect on the body. […] In the case of herbal medicines, the active ingredients are subject to standardization."
4. Border sanitary control – CED, Meursing code and hidden costs
Importing supplements from outside the EU (e.g., from the USA or China) is a process fraught with bureaucracy. As the importer (responsible entity), you must submit a request for an inspection 48 hours before import. For products containing milk fat, milk protein, starch, or sugar, it is necessary to establish a so-called Meursing's code, which determines the amount of customs duties.
For goods subject to special supervision, it is required Community Entry Document (CED)Border control is not just a formality, but also involves specific expenses:
- Documentation check: PLN 17.
- Inspection of goods: from PLN 17 to PLN 500 (depending on weight).
- Sampling and testing: from 6 PLN to even 1512 PLN.
- Issue Certificates of compliance with health requirements: 35 PLN.
Remember: if a product fails inspection, the inspector may order its destruction at your expense. Buying on your own from "exotic" sites is a gamble, with both your health and your wallet at stake.
"If the result is negative, the state sanitary inspector may issue a decision to: prohibit the sale of the goods, return them to a non-EU country [or] destroy them at your expense."
5. Revolution in law – controlled purchases and severe penalties
Food law is becoming increasingly restrictive. According to current regulations (including Article 103 of the Food and Nutrition Safety Act), for errors in labeling, misleading advertising or suggesting medicinal properties, the entrepreneur may be subject to a penalty of up to thirty times the average salary.
Visual and procedural changes are also coming:
- Blue stripe on the packaging (GIS proposal to make it easier to distinguish food from medicines).
- Controlled purchase: inspectors will be empowered to act as "mystery shoppers" in e-commerce to more effectively eliminate dangerous products from the internet.
- Separation in pharmacies: supplements are to be placed on separate stands so as not to suggest they are related to medicines.
“Appropriate measures are planned to be taken to regulate the trade in dietary supplements […], including increasing fines for incorrect labeling and improper advertising of products.”
Summary: Be a smart consumer
Before you throw another pill into your basket, follow these three steps:
- Check the status in the registry: On page
rejestrzp.gis.gov.plsearch for letters "S" (means accepting the qualification as a supplement). If you see the symbol "PWT" – the investigation into this product is still ongoing and has not yet been finally verified. - Read the labels: The phrase "dietary supplement" and details of the responsible entity must appear there.
- Choose a balanced meal: Remember that supplements are for healthy people to supplement their diet, not for sick people to replace therapy.
Does your health really need another pill, or maybe just a better balanced meal and a consultation with your doctor?
| Category productu | Supervisory body | Required documents and permits | Key labeling requirements | Mandatory inspections and tests | Penalties for non-compliance | Safety Notice (Inferred) | Source |
|---|---|---|---|---|---|---|---|
| Dietary supplements | Chief Sanitary Inspectorate (GIS) | Electronic notification to the Chief Sanitary Inspectorate about the first introduction to the market, entry into the register of establishments subject to sanitary control (submitted at least 14 days before the commencement of business). | The term 'dietary supplement', recommended daily dose, warning not to exceed the dose, information about not following a varied diet, manufacturer/importer details, Polish language. | Implementation of the HACCP and GHP/GMP systems; random inspections by the State Sanitary Inspectorate; the Chief Sanitary Inspectorate may request the opinion of a scientific unit during the explanatory proceedings. | Fines up to 30 times (according to the draft, up to 100 times) the average salary; for failure to notify the Chief Sanitary Inspectorate, a fine of up to PLN 5000 or a penalty of up to PLN 50,000; for a harmful warehouse, imprisonment for up to 3 years. | Risk of drug interactions, vitamin overdose (especially in children) and toxicity of banned substances (e.g. yohimbine, DMAA, celandine), which may damage the liver and circulatory system. | 1-3 |
| Medicinal products (Medicines) | Chief Pharmaceutical Inspectorate (GIF), Office for Registration of Medicinal Products (URPL) | Marketing authorization issued by the President of the Office for Registration of Medicinal Products; in the case of import from outside the EU, a permit from the Chief Pharmaceutical Inspectorate specifying the place and scope of import. | Marketing authorization number; strict rules regarding the information leaflet and summary of product characteristics; ban on advertising involving persons suggesting a medical profession. | Clinical and analytical studies confirming efficacy and safety; quality tests of each batch (e.g., sterility); constant supervision of manufacturing by the Pharmaceutical Inspectorate. | GIF administrative sanctions (suspension/withdrawal from the market); financial penalties for illegal import or violations of pharmaceutical law. | Patients substituting medications for supplements is a critical therapeutic risk; medications are standardized in their ingredients, which guarantees a consistent therapeutic dose, unlike supplements. | 4-6 |
| Dietary supplements | Chief Sanitary Inspectorate (GIS), State Sanitary Inspection (Sanepid) | Entry into the register of Sanitary and Epidemiological Stations (at least 14 days before the commencement), notification to the Chief Sanitary Inspectorate (GIS) about the first introduction of the product to the market (via the e-Notifications system), commercial invoice, specification of goods (packing list) in the case of import. | The term "dietary supplement", names of substance categories, recommended daily dose, warning not to exceed the dose, information about storing out of reach of children, prohibition of attributing medicinal properties, mandatory statement about the purpose of supplementation. | Official food control, including free sampling for laboratory testing, verification of composition compliance with the list of permitted substances and novel food (Novel Food), border sanitary control in the case of imports from outside the EU. | A fine of up to 30 times the average salary (planned increase to 100 times, approx. PLN 714), fines of up to PLN 5000 for failure to enter the register, sanctions of up to 5 times the gross value of the disputed goods for incorrect labelling. | Risk of organ damage (e.g. liver damage caused by greater celandine), health risks associated with the use of banned substances (e.g. yohimbine, DMAA, SARMs), dangers resulting from confusing supplements with medicines and purchasing products from unreliable sources (import without control). | 7-15 |
| Medicinal products (medicines) | Chief Pharmaceutical Inspector (GIF), Ministry of Health, URPL (inferred) | Permission to operate a pharmacy or pharmaceutical wholesaler, licenses to import medicines, documentation confirming marketing authorization in Poland (for non-pharmacy trade, the active substance must be on the OTC market for at least 5 years). | Strict criteria resulting from the Pharmaceutical Law, clear separation from dietary supplements at the point of sale, specification of composition and medicinal properties. | Strict quality and distribution control under the supervision of the Chief Pharmaceutical Inspectorate, compliance with Pharmacopoeia standards, batch certification, and control of storage and transport conditions. | Criminal sanctions for trading without a permit, administrative penalties imposed by the Chief Financial Inspectorate, possibility of withdrawing business permits. | The use of medicines without medical supervision or from illegal sources may result in serious interactions, overdose or lack of therapeutic effect in the case of a counterfeit product. | 9, 12, 15, 16 |