Section I: Legal Foundations and the Regulatory Landscape

A. Introduction: Legal Paradox and Systemic Risk

Introducing a dietary supplement to the Polish market poses a serious legal challenge. dietary supplements are simply foods that are intended to supplement the normal diet.^[1] They are regulated by the Act of ^[25] August 2006 on food and nutrition safety ^[2], not Pharmaceutical Law.

This is completely at odds with how people perceive it. The report of the Supreme Audit Office (NIK) clearly states that, despite the law saying otherwise, supplements are perceived by many consumers as medicinal products.^[3] NIK describes it as "threat to public health“because supplements by definition cannot have medicinal properties and cannot replace medications.^[3]

This difference between legal status (food) and public perception (lek) makes offices very suspicious. Regulators (GIS, NIK) are aware of this problem, which is why they strictly enforce the regulations.

In this system, the most important thing is that bears full responsibility The company that introduces the product to the market. The company is responsible for the accuracy of the notification, compliance of the composition, labeling, and marketing communications with regulations.^[4]

B. Key Regulatory Actors in Poland

To get around in Polish supplement market, you need to know the key institutions and regulations.

C. "Soft Power": The Role and Impact of Resolutions of the Dietary Supplements Team

The Dietary Supplements Committee plays a special role in the Polish system. Formally, it is merely a consultative and advisory body, and its resolutions "have no legal force."^[10] However, ignoring these resolutions by entrepreneurs is a strategic mistake.

In practice, these resolutions constitute de facto binding guidelines that are "used in practice by GIS" ^[10] during the evaluation of reported products and during explanatory proceedings. The team fills gaps in the law (especially in non-harmonized areas, such as herbal ingredients or maximum doses), creating market standards.

Case Studies based on the Team's resolutions

1. Vitamin D: In response to numerous notifications of products with high doses, GIS asked the Team for a position.^[21] Based on the analysis of studies, the team determined the maximum safe dose in dietary supplements for the healthy adult population. ^[2] 000 IU (50 µg) per day.^[21] Reporting a product with a higher dose (e.g. ^[4] 000 IU) without solid scientific justification almost guarantees the initiation of explanatory proceedings in terms of qualification as a medicinal product.

2. Caffeine: The Panel has established maximum levels and mandatory warnings that must appear on the label of products containing caffeine: "use not recommended for children and pregnant women; do not consume with other products that are a source of caffeine or other ingredients with a similar effect."^[11]

3. Plant extracts (White mulberry): The resolution of the Team precisely defined the maximum content of the active substance (1-deoxynojirimycin, DNJ) on ^[10] mg per daily dose. Furthermore, it imposed a mandatory warning: "in people using insulin therapy or oral hypoglycemic drugs, use only after consulting a doctor."^[11]

The strategy for minimizing regulatory risk must therefore assume treating the Team's resolutions as hard requirements at the stage of formulating the product recipe.

Section II: Notification Procedure Step by Step

A. Critical Distinction: "Notification" vs. "Registration"

The term "registration of dietary supplements", although commonly used in everyday language (and in queries), is legally imprecise and fundamentally misleading.

• Registration, as used for medicinal products, is a pre-market approval process. The regulatory authority (e.g., the Office for Registration of Medicinal Products) reviews the complete documentation and issues a marketing authorization.

• Notification (application) used for dietary supplements ^[7], is the process of informing the authority (GIS) about the intention to introduce the product to the market.

GIS does not issue a "permission". The product can be legally placed on the market (in principle) after the deadline for notification (formerly ^[14] 7 days), and the entire responsibility for its security and compliance with the law rests with the entrepreneur.^[4]

B. Step 1: Prerequisite – Registration of the Facility at the District Sanitary and Epidemiological Station (PSSE)

Before an entrepreneur can submit a product, they must first register their business (establishment). This applies to any entity introducing supplements to the market, including manufacturers and importers.^[9]

The procedure involves submitting an application for entry into the "register of establishments subject to official control of the State Sanitary Inspection" at the appropriate District Sanitary and Epidemiological Station (PSSE).^[9] This application must be submitted at least ^[14] days before the planned start of operations.^[9]

It is worth noting an important nuance regarding e-commerce: selling dietary supplements online does not require approval of the establishment (which involves a physical inspection of the facility), but still requires reporting the activity to the PSSE.^[9]

C. Step 2: Product Notification in the Electronic Notification System (ESP) GIS

After registering the establishment, the entrepreneur is obliged to notify the Chief Sanitary Inspector (GIS) about each dietary supplement introduced to the market in Poland for the first time.^[7]

This process is carried out exclusively electronically via the Electronic Notification System (ESP), available on the e-Sanepid platform.^[8]

Technical and procedural requirements

1. Account: The entity must set up an account in the e-Sanepid system.^[8]

2. Authentication: The application requires the use of an electronic signature or a Trusted Profile.^[25]

3. Documentation: Please complete the detailed online form regarding the product (composition, dosage, etc.) ^[8] and it is mandatory to attach a marking (label) template in Polish.^[12]

Risk Analysis (Practical Challenges): It should be noted that the new ESP system (implemented around February 2024) poses significant challenges. It is indicated that the system's functionality has changed significantly and currently "poses numerous practical challenges."^[23] Businesses must allocate additional resources and time to address potential technical difficulties with the notification system that may unexpectedly delay the planned product launch.

D. The Fee Issue: Legal Status and Regulatory Intentions

In 2017, a draft amendment to the Act was widely discussed, which was to introduce a fee of PLN 1000 for reporting each dietary supplement.^[26] The aim of this proposal was to limit the practice of "flood[ing] institutions with fictitious registrations."^[26]

However, analysis of available materials does not confirm the entry into force of this fee.^[4] At the moment (unless the regulations have changed and are not recorded in the materials), the product notification itself GIS It is free of charge. However, it should be remembered that the regulator's intention (to burden the market with costs in order to regulate it) is clear ^[26], and costs may arise at the stage of possible explanatory proceedings (e.g. costs of expertise).

Section III: Post-Notification Risk Analysis: Explanatory Proceedings

Submitting a notification does not end the regulatory process. It is, in fact, its beginning. The greatest risk for the entrepreneur is associated with the launch of GIS so-called explanatory proceedings.

A. The Essence and Reasons for Initiating the Proceedings

The explanatory proceedings are, in fact, the only real mechanism for substantive control of products in the notification system, which is indirectly confirmed by the report NIK indicating that "the vast majority of supplements on the market are not tested by anyone."^[3]

GIS is entitled (pursuant to art. ^[30] i ^[31] Act on Food and Nutrition Safety) to initiate proceedings as soon as it "has doubts" as to the notified product.^[13]

Main reasons for initiating the proceedings 13

1. General doubts: Inconsistency of the name, composition or labelling declared in the ESP system with the actual state or legal requirements.

2. Doubts about qualifications: The most serious risk. GIS becomes suspicious that the notified product, due to its composition, dose, presentation or marketing communication, is in fact a medicinal product and not a dietary supplement.^[13]

B. Product Qualification: The Crucial "Gray Area"

The responsibility for the correct qualification of the product (food vs. medicine) rests solely with the entrepreneur.^[27] An error in this regard is the most serious regulatory violation. GISWhen assessing qualification, it takes into account a number of product characteristics.^[1]

C. Course and Legal Consequences of the Proceedings

In the course of the proceedings GIS calls on the entrepreneur to submit additional documentation, scientific opinions or expert opinions (e.g. from the Office for Registration of Medicinal Products or scientific units) in order to defend the product's qualification.^[13] The costs of these expertise are borne by the entrepreneur.

Procedural Problem (Legal Trap): The key problem is the form of termination of such proceedings. GIS, in the case of a negative assessment, it often informs the entrepreneur about its findings (e.g. "the product does not meet the qualifications as a dietary supplement") in the form of a standard letter, which is not an administrative decision or resolution.^[27]

This form of action GIS is a procedural trap. According to the Code of Administrative Procedure, a standard "appeal" (to a higher authority) or "complaint" cannot be filed against a letter.^[27] The entrepreneur is left with a negative opinion that de facto blocks his market access, without a clear path of appeal.

Legal Strategy: Case Law Analysis ^[27] points to the groundbreaking decisions of the Supreme Administrative Court (NSA). The NSA found that such a letter GIS, informing about the outcome of the proceedings, falls into the category of "acts or activities" in the field of public administration, which are subject to appeal to the Provincial Administrative Court (WSA) pursuant to Art. ^[3] § ^[2] Law on proceedings before administrative courts (ppsa).^[27] This is the only, although non-standard and expensive, path to defense against negative qualification GIS.

Section IV: Product Compliance Requirements: Marking (Labelling)

The marking (label) is one of the key elements subject to inspection. It is also a mandatory attachment for notification in the ESP system.^[12]

A. Legal Basis for Labeling

The labeling of dietary supplements in Poland is subject to a dual legal regime.

1. General EU regulations: Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers.^[14]

2. Specific national regulations: Regulation of the Minister of Health on the composition and labeling of dietary supplements (consolidated text Journal of Laws 2023.79).^[14]

All mandatory information must be presented in Polish.^[12]

B. Mandatory Label Elements in Polish

The table below presents the key mandatory elements that must be included on the label of every dietary supplement introduced to the Polish market.

Section V: Market Compliance Requirements: Advertising and Health Claims

Marketing communication and advertising of dietary supplements are an area as rigorously controlled as composition and labeling, and the potential financial penalties here are sometimes the highest.

A. Legal basis: Regulation (EC) No 1924/2006

The key legal act here is Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.^[18] It aims to protect consumers from false, ambiguous or misleading information.^[18]

This regulation, as well as Polish law, establishes categorical prohibitions 18

1. Prohibition of attributing medicinal properties: Information about foods (including supplements) must not claim to prevent or treat human disease.^[28] Phrases such as “Cures colds” or “Prevents disease” are strictly prohibited.^[28]

2. Prohibition of questioning the diet: Claims must not imply that a balanced and varied diet cannot provide adequate amounts of nutrients.^[18]

3. Prohibition of raising doubts: Claims must not raise doubts about the safety or nutritional adequacy of other foods.^[18]

B. Register EFSA: The Single Source of Permitted Claims

Every health claim (e.g. "Vitamin C contributes to the normal function of the immune system") must comply with the EU Register of Nutrition and Health Claims.^[29] This register, maintained by the European Commission on the basis of scientific opinions EFSA (European Food Safety Authority), includes:

1. Authorized statements

• Non-authorized statements: Prohibited for use. The most common reason for rejection is "lack of a demonstrated cause-and-effect relationship" between the ingredient and the claimed effect.^[20]

C. Strategy and Risk of On-Hold (Pending) Statements

A special category is "botanical" claims (regarding plant ingredients). Thousands of such claims are awaiting evaluation. EFSA (they are "on-hold").^[37] This created a regulatory “grey zone.”

Market analysis indicates that entrepreneurs treat the “on hold” status as a temporary permission to use traditional wording.^[38] For example, a product containing Nigella sativa (black cumin), which is on the "on hold" list, is described as "traditionally supporting immunity."^[38] This is a high-risk strategy. When EFSA ultimately evaluates these claims (and many are rejected 20), entire product lines based on this marketing will require immediate rebranding or be withdrawn from the market.

D. The Role of Doctors and Advertising Penalties

The law generally allows the use of a doctor's or expert's image in advertising a dietary supplement on the internet.^[28] However, there is a key restriction: such a recommendation cannot suggest the medicinal nature of the supplement or be misleading.^[28]

Advertising violations carry very high penalties. The draft amendment to the Food and Nutrition Safety Act envisaged penalties of up to ^[20] million zlotys for failure to comply with planned advertising restrictions.^[26]

Section VI: Import Scenarios: Introduction of Products from Abroad

The procedure for introducing a supplement to the Polish market varies dramatically depending on the product's country of origin.

A. Imports from the Territory of the European Union (Internal Market)

There is often a misconception among importers that a product legally sold in another EU country (e.g. Germany) can automatically be sold in Poland without any restrictions under the principle of mutual recognition (Regulation 764/2008).^[16]

This is false. The principle of mutual recognition has very limited application in the case of dietary supplements, as it does not address aspects already harmonized at EU level.^[16]

The harmonized aspects (and not subject to mutual recognition) are 16

1. Composition (Vitamins and Minerals): The lists of permitted vitamins, minerals and their chemical forms are harmonised by Directive 2002/46/EC.^[16]

2. Labeling: Labelling rules are harmonised by Regulation 1169/2011 and Articles 6-9 of Directive 2002/46/EC.^[16]

3. Health Claims: The conditions for the use of claims are fully harmonised by Regulation 1924/2006.^[16]

In practice, the principle of mutual recognition applies almost exclusively to non-harmonized ingredients (mainly plant-based). Every EU product must be notified in the Polish system. GIS ^[7], must have a label in Polish ^[12] and is subject to full jurisdiction GIS, including the risk of initiating explanatory proceedings.^[13]

B. Imports from Third Countries (Non-EU)

Importing dietary supplements from outside the European Union is a much more complex process and involves greater entry barriers.^[39] This is a two-step procedure.

Stage 1: Border Sanitary Control

The entrepreneur (importer) must report the goods for inspection to the State Border Sanitary Inspector.^[40] This inspection includes verification of documentation (e.g. health certificates from the country of origin) and, if necessary, physical inspection and laboratory testing of samples.

• Positive result: The authority issues a "certificate" confirming compliance with EU health requirements, which allows the goods to be released for circulation within the EU (after customs clearance).^[40]

• Negative result: The authority issues a "decision prohibiting the introduction of goods into circulation".^[40] This procedure can be handled via electronic platforms, e.g. PUESC.^[41]

Stage 2: National Notification (GIS)

Successful completion of border control and customs clearance does not release the importer from their domestic obligations. After the goods enter Poland, the importer must still submit standard product notification to GIS through the ESP system ^[8], in accordance with the procedure described in Section II.

Section VII: Liability and Sanctions for Non-Compliance

The notification system is based on the full and undivided responsibility of the entrepreneur. The consequences of violating the regulations are severe and multi-level.

A. Absolute Responsibility of the Entity

Full responsibility for the product's compliance with the law (composition, labeling, advertising) rests with the manufacturer.iocthe one who introduces it to the market, i.e. the one who formally submits the notification.^[4]

It should be emphasized that in the event of an audit, "it does not matter who physically submitted the documents" (e.g. an external consulting or law firm) - the legal and financial responsibility lies with the entity that is formally responsible for the product.^[4]

B. Catalog of Administrative and Criminal Penalties

In the event of a violation of the regulations, GIS has a wide catalogue of sanctions 4:

1. Administrative Sanctions (Immediate Response):

• Issuing an administrative decision to suspend trade in a given product.

• Issuing a decision to withdraw a product from the market (recall).

2. Financial Sanctions:

• Imposition of a financial penalty (fine) which may amount to "up to ^[50] thousand zlotys."^[4]

• Potentially much higher penalties (up to ^[20] million PLN, as indicated in the draft 26) may be imposed for illegal advertising.

3. Criminal Sanctions (Highest Risk):

• If GIS determines that the supplement (e.g. due to contamination or misleading information about its composition) "poses a threat to health or life", the case is referred to law enforcement authorities (prosecutor's office).^[4]

4. Reputational Sanctions:

• Risk of publishing information about the decision or a public warning on the website GIS or in the media.^[4] Such information can permanently damage consumer trust in the brand and the company's entire product portfolio.

Section VIII: Recommendations and Risk Minimization Strategies

A. Conclusion: High Risk Market Requires Proactivity

An analysis of the regulatory framework leads to the conclusion that the Polish dietary supplement notification system is deceptive. The apparent ease of the procedure (online notification via the ESP system) conceals a complex regulatory ecosystem. This system is characterized by:

• A significant impact of de facto regulations ("soft law" in the form of Resolutions of the Team for Dietary Supplements).

• Opaque and risky legal procedures (status of the letter GIS concluding the explanatory proceedings).

• Severe sanctions (financial, administrative and even criminal) for incorrect product classification or misleading.

A reactive approach ("we'll report it and see what happens") is a high-risk strategy. Success in this market requires proactive compliance management at every stage of the product lifecycle.

B. Strategic Checklist (Due Diligence) Before Notification

In order to minimize regulatory, financial and reputational risk, an entity intending to introduce a dietary supplement to the market should conduct a rigorous internal audit before submitting a notification in the ESP system:

1. Formulation Audit:

• It is essential to verify the quantitative and qualitative composition of the product for compliance with the Resolutions of the Dietary Supplements Committee.^[10]

• Action: Check the doses of ingredients (e.g. whether Vitamin D does not exceed ^[2] 000 IU ^[21], whether caffeine is within the limits (11), and whether the recipe does not contain ingredients questioned by the Panel. Any discrepancies must be eliminated or supported by very strong, individual scientific documentation.

2. Qualification Audit:

• An internal product qualification risk assessment should be conducted using the criteria in the Table ^[3] (based on 1).

• Action: Assess whether the dosage, presentation (e.g., ampoules), communication, or risk of use bring the product dangerously close to the definition of a medicinal product. If in doubt, consider changing the formulation or presentation.

3. Label Audit:

• The label design should be verified against the checklist of mandatory elements (Table ^[2], based on 14).

• Action: Ensure that all legally required statements and warnings (“Do not exceed…”, “This dietary supplement cannot be used as a substitute for…”, “Keep out of reach of small children”) are present, visible and in Polish.^[12]

4. Marketing & Claims Audit:

• All planned advertising materials, descriptions on websites and social media should be checked for compliance with Regulation 1924/2006.^[18]

• Action: Verify each health claim with the Registry EFSA.^[29] Strictly eliminate all phrases of a medicinal nature (“treats”, “prevents”, “cure for…”).^[28]

5. Legal Readiness:

• You should develop a legal strategy in the event you receive a negative letter from GIS after any possible investigation.

• Action: Ensure readiness (budgetary and substantive) to appeal against such a letter to the Provincial Administrative Court (WSA) based on the case law of the Supreme Administrative Court.^[27]

Cited works and legal sources

1. Drug and dietary supplement differences, how to define the difference | Recepty24 https://recepty24.com/lek-a-suplement-diety-na-czym-polega-roznica/
2. Act on Food and Nutrition Safety (Journal of Laws 2006, No. 171, item 1225) https://lexlege.pl/ustawa-o-bezpieczenstwie-zywnosci-i-zywienia/art-27/
3. LICENSE OF DIETARY SUPPLEMENTS FOR MARKETING – NIK Report https://www.nik.gov.pl/plik/id,13031,vp,15443.pdf
4. How to legally report a dietary supplement to the Chief Sanitary Inspectorate (GIS)? – RPMS Law Firm https://rpms.pl/jak-zgodnie-z-prawem-zglosic-suplement-diety-do-gis/
5. Dietary supplements – Provincial Sanitary and Epidemiological Station in Warsaw https://www.gov.pl/web/wsse-warszawa/obzzik-suplementy-diety
6. Dietary Supplements Team – Chief Sanitary Inspectorate https://www.gov.pl/web/gis/zespol-do-spraw-suplementow-diety
7. Registration of dietary supplements. Introduction to the Polish market. https://producentsuplementow.pl/wprowadzenie-do-obrotu-suplementow-diety/
8. Electronic Notification System (ESP) – e-Sanepid https://e.sanepid.gov.pl/e-services/BZ_POZWPWO
9. Dietary Supplement Registration: A Complete Guide to the Process https://www.skutecznyebiznes.pl/blog/rejestracja-suplementu-diety-kompletny-przewodnik-po-procesie-i-wymaganiach
10. Sensitive products in a nutshell – resolutions of the Dietary Supplements Team https://ajlaw.pl/produkty-sensytywne-w-pigulce-w-praktyce/
11. GIS has determined the maximum content of ingredients in supplements https://www.chpl.com.pl/gis-okreslil-maksymalna-zawartosc-siedmiu-skladnikow-w-suplementach-diety,2841,artykul.html
12. Notification of the first introduction of a product to the market – Biznes.gov https://www.biznes.gov.pl/pl/portal/ou465
13. What is the registration investigation procedure? – Zboralska Law Firm https://zboralska-kancelaria.pl/co-to-jest-postepowanie-wyjasniajace-podczas-rejestracji-notyfikacji-suplementu-diety/
14. Regulation of the Minister of Health on the composition and labeling of dietary supplements (Journal of Laws 2023.79) https://sip.lex.pl/akty-prawne/dzu-dziennik-ustaw/sklad-oraz-oznakowanie-suplementow-diety-17385919
15. Directive 2002/46/EC (Food Supplements) – EUR-Lex https://eur-lex.europa.eu/PL/legal-content/summary/ensuring-safe-food-supplements-in-the-eu.html
16. Regulation 1924/2006 on nutrition and health claims https://sip.lex.pl/akty-prawne/dzienniki-UE/rozporzadzenie-1924-2006-w-sprawie-oswiadczen-zywieniowych-i-zdrowotnych-67656301
17. Special properties of food – claims about reducing the risk of disease https://ncez.pzh.gov.pl/dla-producentow-zywnosci/szczegolne-wlasciwosci-zywnosci-oswiadczenia-o-zmniejszaniu-ryzyka-choroby/
18. What is a safe dose of vitamin D in dietary supplements? – Termedia https://www.termedia.pl/mz/Jaka-jest-bezpieczna-dawka-witaminy-D-w-suplementach-diety-,34590.html
19. New GIS notification system – Food Law Center https://food-law.pl/nowy-system-notyfikacji-gis/
20. Fees for reporting supplements to GIS – Merchant's Guide https://poradnikhandlowca.com.pl/artykuly/oplaty-za-zglaszanie-suplementow-do-gis/
21. Can the result of the explanatory proceedings before the Chief Sanitary Inspectorate be questioned? https://food-law.pl/czy-wynik-postepowania-wyjasniajacego-przed-gis-mozna-kwestionowac/
22. How to Advertise Dietary Supplements? Advertising Rules – Creativa Legal https://creativa.legal/jak-reklamowac-suplementy-zasady-i-zmiany-dotyczace-reklamy-suplementow-diety/
23. EU Register of Health Claims – European Commission https://food.ec.europa.eu/food-safety/labelling-and-nutrition/nutrition-and-health-claims/eu-register-health-claims_en
24. Health claims (Article 13) – EFSA https://www.efsa.europa.eu/en/topics/health-claims-art-13
25. Import from outside the EU: How to legally introduce products to the Polish market? https://adwokat-mc.pl/import/
26. Report goods to border sanitary inspection – Biznes.gov https://www.biznes.gov.pl/pl/portal/ou1522
27. Obtain border sanitary documents – PUESC https://puesc.gov.pl/uslugi/uzyskaj-graniczne-dokumenty-sanitarne