Who can produce dietary supplements – a comprehensive guide to requirements and regulations

In recent years, we have observed a dynamic development of the dietary supplements market. According to the 2022 report of the Supreme Audit Office (NIK), as many as 62,808 new dietary supplements were notified to the Chief Sanitary Inspectorate (GIS) in 2017–2020 (almost 21,000 per year). However, greater availability of such products does not mean that anyone can run a business based on the production of dietary supplements. This activity is subject not only to GIS notification but also to strict food law regulations and sanitary requirements. When producing dietary supplements, it is also necessary to take into account the implementation of quality systems in the laboratory such as HACCP or GHP/GMP, as well as the new regulations on food safety and the operation of the State Sanitary Inspection (PIS), proposed in 2025 by the Ministry of Health.

Basic formal and legal requirements

The production of dietary supplements in Poland is not available to every entrepreneur. Who can produce dietary supplements? The manufacturer should:

• have appropriate sanitary and hygienic conditions;
• run a registered business activity in the field of food production;
• meet specific formal and legal requirements – the production of dietary supplements is subject to food law, including Regulation (EC) 852/2004 of 29 April 2004 on the hygiene of foodstuffs, as well as national food safety laws;
• meet specific technological requirements, including the implementation of quality systems in the laboratory, such as HACCP or GHP/GMP.

Definition of a dietary supplement

A dietary supplement is a special food product. It is intended to enrich the normal, daily diet and cannot replace healthy, balanced nutrition. It should be a source of concentrated nutrients (e.g. vitamins, minerals, amino acids, or plant extracts), provided to consumers in a dosage form (capsules, lozenges, tablets, etc.). See: The tableting process of medicines and dietary supplements.

Types include:

• vitamin and mineral supplements,
• plant and herbal preparations,
• amino acid supplements,
• fatty acids,
• probiotics.

Good to know: The Food Safety and Nutrition Act of 25 August 2006 defines supplements as products that cannot be classified as medicinal products — this involves regulations on the concentrations of active ingredients, labeling, and advertising.

Supplement vs. medicine – key differences

While medicines require registration with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, clinical trials, compliance with pharmacopoeia requirements, and strict pharmaceutical GMP standards, supplements are treated as food and are subject to less restrictive requirements. Supplement production requires GIS notification. Although such products are not subject to clinical trials, they must be safe and properly labeled.

Requirements – dietary supplement production

In order to produce dietary supplements, a company must meet a number of requirements specified in Polish law. Every facility producing supplements must have the infrastructure to maintain the highest quality and safety standards. But that’s not all. The manufacturer is obliged to implement systems ensuring full control of the production process — from raw materials to the finished product. All procedures must comply with Good Manufacturing Practice (GMP), which sets sanitary, hygienic, and technological standards.

In recent years, contract manufacturing of supplements has become increasingly important. Why? Because this is a solution for companies that do not want to invest in production facilities and R&D infrastructure. This model allows outsourcing the production process to an external entity with the right experience, infrastructure, and certificates of compliance with applicable standards.

Registration and certification process

Registration and certification of dietary supplements are two different processes.

• Registration means the formal notification of the product to the appropriate authority — in Poland, this is the Chief Sanitary Inspectorate. The whole procedure takes place online and only requires filling out the relevant documentation. GIS may request additional information or corrections if the notification does not meet all formal requirements;
• Certification means awarding the product a certificate confirming compliance with required quality standards. In Poland, this is not mandatory. Obtaining additional documentation for supplement production (e.g. ISO compliance) is voluntary and often used to increase product competitiveness.

GIS notification – consequences of non-compliance

Lack of notification of a dietary supplement to GIS before starting sales can have serious consequences. These range from high financial penalties (up to PLN 5,000 per product, and in the case of gross violations – even higher, up to PLN 50,000), to the immediate withdrawal of the supplement from the market, and additional administrative proceedings and inspections.

Good to know: According to the draft amendment to the Food Safety and Nutrition Act and the State Sanitary Inspection Act, the Ministry of Health intends in Q3 2025 to drastically tighten penalties for breaking the law in the dietary supplements market.

GIS notification – common mistakes

The most common mistakes made by producers during GIS notification result from lack of accuracy when preparing supplement production documentation. These include:

• formal errors, e.g. missing required attachments or incomplete company data of the entity responsible for the product on the Polish market;
• errors in the composition of the supplement, e.g. use of prohibited ingredients or exceeding permissible vitamin/mineral doses;
• failure to respond to GIS requests to supplement the application.

Equally frequent are labeling errors, such as:

• improper labeling, e.g. lack of legally required warnings on the label or missing information on the chemical form of ingredients or recommended daily dose;
• use of claims such as “treats”, “prevents disease”, or “reduces risk” for supplements;
• designing a label that, through appearance or naming, may suggest medicinal effects;
• introducing a label only in a foreign language, without a Polish version.

To avoid the above errors, it is always worth reviewing the GIS registration process and understanding the requirements for supplement production and labeling.

Other quality systems

The basic and mandatory system in dietary supplement production is HACCP (Hazard Analysis and Critical Control Point System). With HACCP implementation, supplements are produced in conditions ensuring high quality and hygiene.

When implementing HACCP, the food manufacturer must remember that the following will be analyzed:

• conditions under which food is produced,
• production documentation of supplements, which is also crucial in HACCP certification.

The HACCP certificate is issued for 3 years, followed by a recertification audit. In addition, annual surveillance audits take place to optimize quality management processes. The second most important certificate in supplement production is Good Manufacturing Practice (GMP). Supplements produced under GMP standards are manufactured in pharmaceutical facilities and are of much higher quality than those without certification. Learn more here about GMP and HACCP certificates.

Voluntary certificates and quality systems

Besides GMP and HACCP, dietary supplements do not require mandatory certification. However, if a manufacturer chooses additional certifications (e.g. ISO 22000), this brings benefits such as increased market credibility and consumer trust.

Good to know: The Galenic Laboratory Olsztyn, part of the Eubioco group, complies with the highest GMP, HACCP, and ISO 22000:2018 standards. We specialize in contract manufacturing of dietary supplements, using modern technological facilities and high-quality raw materials, which ensures that supplements produced in contract manufacturing meet customer satisfaction and recognition.

Production process step by step

The production of dietary supplements must meet standards at every stage — from raw material selection to finished product control. Every ingredient and technological process must comply with national and EU regulations to ensure supplement quality and safety. Both contract manufacturers and independent companies must follow detailed control and documentation rules.

Raw material requirements

Raw materials used in supplement production must be strictly controlled for quality and safety. Under EU regulations, all ingredients must come from sources previously verified and approved as safe. This applies to vitamins, minerals, plant extracts, and other active or filler substances.

Production process control

The production process of dietary supplements is controlled both internally by the production plant and externally by institutions — primarily the State Sanitary Inspection (PIS).

Facilities producing supplements must implement HACCP. Control covers both microbiological and physicochemical parameters, aiming to eliminate heavy metals, pesticides, microbiological contamination, and other potentially harmful substances. Inspections are usually random but may also result from consumer complaints about irregularities.

Supplements must also comply with Regulation (EC) No. 1924/2006 of the European Parliament and Council on nutrition and health claims (with subsequent implementing acts). The State Sanitary Inspection verifies not only sanitary conditions but also product compliance with declared composition and labeling claims. Non-compliance may result in sanctions, including fines.

Polish supplement regulations – changes in PIS operations

In 2025, the Ministry of Health prepared a draft law amending food safety and the operation of the State Sanitary Inspection (PIS). According to the new rules, the register of entities supervised by PIS will be kept exclusively in electronic form. The e-Sanepid platform and SEPIS system will cover not only supplement notifications but also registration and approval of facilities producing and trading non-animal food.

The draft law published on 23 June 2025 also introduces stricter penalties, including:

• financial penalties for improper labeling, presentation, and advertising of supplements, as well as for activities outside the scope of registration,
• increasing maximum fines from 30 times to 100 times the average national salary.

Investing in the services of top contract supplement manufacturers can significantly increase brand credibility and consumer loyalty. Cooperation with certified laboratories with their own R&D department also guarantees the highest quality standards and minimizes the risk of administrative penalties to nearly zero.

Supplement production documentation and records

Every manufacturer (including contract supplement manufacturers) is obliged to keep supplement production documentation, which forms the basis for inspections and verification of manufacturing processes.

In Poland, regulations require keeping detailed documentation of dietary supplement production, including:

• HACCP documentation,
• raw material specifications confirming compliance with quality requirements,
• production process documentation, including details of each production stage,
• supplier certificates and quality test results for each raw material batch.

Notifications and submissions

Before a dietary supplement enters the market, the manufacturer must notify the Chief Sanitary Inspectorate. The notification must include the composition, name, form of the product, manufacturer details, and a sample label. The notification is filed online, and once submitted, the product may be marketed.

Dietary supplement production in Poland – summary

The dietary supplements market is growing dynamically. However, not everyone can participate. Production requires approved facilities, compliance with strict sanitary and food law standards, and GIS notification. Although the regulations are not as strict as for medicines, the manufacturer’s responsibility is just as significant — both legally and reputationally.

As transparency, proper labeling, and quality standards become key competitive factors, many companies choose contract supplement production. In this model, the contractor is responsible for compliance with quality declarations. To learn more about this type of cooperation and its benefits, see Eubioco’s offer: Contract manufacturing of dietary supplements. Also, check other articles on the Eubioco blog.

Dietary supplement production – FAQ

I. Can anyone produce dietary supplements?

No, supplement production requires strict technological, sanitary, and formal requirements.

II. How much does it cost to start supplement production?

Even a small production line requires an investment of hundreds of thousands of PLN due to the need to purchase machines, develop formulas, equip laboratories, and implement quality systems. An alternative is contract supplement production, which allows market entry without major investments.

III. What is the difference between drug and supplement production?

The main difference is purpose. Medicines are subject to much stricter quality and clinical requirements than supplements.

IV. What does the supplement notification process look like?

Notification (also called registration) means formally notifying the Chief Sanitary Inspectorate. In short, it involves submitting product information online; after verification, the supplement may be sold.

V. Is supplement certification mandatory?

No, certification is not mandatory in Poland, but HACCP and GMP are required. Additional certification (e.g. ISO) increases credibility.

VI. What are the penalties for marketing a supplement without notification?

Penalties can reach hundreds of thousands of PLN, depending on the scale of violation.

BIBLIOGRAPHY

1. Co w Zdrowiu (2025). New regulations on food and sanitary inspection [online]. Available at: https://cowzdrowiu.pl/aktualnosci/post/nowe-przepisy-o-zywnosci-i-inspekcji-sanitarnej [online access: 29.08.2025]
2. DIRECTIVE 2002/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements.
3. Chancellery of the Prime Minister (2025). Draft amendment to the Food Safety and Nutrition Act and the State Sanitary Inspection Act [online]. Available at: https://www.gov.pl/web/premier/projekt-ustawy-o-zmianie-ustawy-o-bezpieczenstwie-zywnosci-i-zywienia-oraz-ustawy-o-panstwowej-inspekcji-sanitarnej [online access: 29.08.2025]
4. Supreme Audit Office (2022). (Un)controlled dietary supplements [online]. Available at: https://www.nik.gov.pl/najnowsze-informacje-o-wynikach-kontroli/niekontrolowane-suplementy-diety.html [online access: 29.08.2025]
5. Regulation (EC) No. 852/2004 of 29 April 2004 on the hygiene of foodstuffs. OJ L 139, 30.4.2004.
6. U.S. Food & Drug Administration (2024). Dietary Supplements [online]. Available at: https://www.fda.gov/food/dietary-supplements [online access: 29.08.2025]
7. Food Safety and Nutrition Act of 25 August 2006. Journal of Laws 2006 No. 171 item 1225.