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Registration obligations of companies entering the dietary supplements market

1. Why is registration crucial?

Registration of businesses and products in the dietary supplement industry is required worldwide, but regulations can vary significantly from country to country. Failure to register or to comply with formalities can result in high fines, product recalls, or even closure of the business. Therefore, proper registration of businesses and products not only ensures compliance with regulations, but also protects consumer health and builds brand trust.

1.1 Key reasons for registering your business and products

Registration of activities and products in the dietary supplements industry is crucial because:

  • Guarantees compliance with the law – each country has its own regulations governing the introduction of dietary supplements to the market. Reporting your business and products to the appropriate authorities is a legal requirement that allows your company to operate legally.
  • Ensures consumer safety – Products that go through the registration process are assessed for safety and compliance with standards. This gives consumers the confidence that the product has been properly tested and does not pose a health risk.
  • Builds trust in the brand – transparency and compliance with legal standards strengthen the credibility of the company in the eyes of customers. Consumers are more willing to choose products that are legally registered and meet quality requirements.

1.2 Consequences of failure to register

Failure to comply with registration obligations may result in serious consequences:

  • Financial penalties – in many countries, failure to register a business or product can result in high fines. Depending on the country and regulations, fines can reach up to millions of złoty.
  • Product withdrawal from the market – If a product is not registered or does not meet safety requirements, supervisory authorities may order its immediate removal from circulation.
  • Loss of reputation – consumers care about the safety and legality of products. Lack of registration can lead to a negative perception of the company on the market, which affects long-term customer trust.

2. Scope of registration obligations for companies and products

Registration obligations may include both business activity registrationAnd product reporting. In Poland, for example, every company planning to distribute dietary supplements must register its activity with Chief Sanitary Inspectorate (GIS). In other countries there may be different regulatory bodies, such as the FDA in the US or EFSA in the European Union.

2.1 Business registration

Any company that wants to operate in the dietary supplements market must be registered with the relevant supervisory authorities, which often includes obtaining certificates confirming compliance with quality and safety standards, such as: GMP (Good Manufacturing Practices) and/ or ISO 22000.

2.2 Product registration

Every dietary supplement that comes onto the market must be reported to local regulatory authorities. A product report typically includes information about its ingredients, label, and studies that support its safety and effectiveness.

Thanks to this, customers International Organic Company (IOC) can be assured that by working with a manufacturer with full facility registration, their products meet quality requirements and are compliant with regulations. However, customers who market products under their own brand are still responsible for registering their products and operations in the country of sale.

3. Models of cooperation with International Organic Company and their impact on registration obligations

Working with a contract manufacturer such as International Organic Company (IOC), provides many opportunities to introduce dietary supplements to the market. Depending on the cooperation model, the registration obligations of clients may vary. Below we describe the three most common cooperation models and their impact on the obligations related to the registration of activities and products.

3.1 The customer as an independent person introducing the product to the market

In this model, the client is responsible for registering both their business and their products. IOC acts as a contract manufacturer, but all registration obligations are the responsibility of the customer. The customer reports products to local supervisory authorities and takes full responsibility for compliance with local regulations. This model of cooperation is ideal for companies that want to introduce products to the market under their own brand and retain full control over registration.

How to register a dietary supplement company? Legal obligations when introducing supplements to the market Step-by-step registration of dietary supplements Requirements for companies producing dietary supplements

3.2 Partnership and Distribution

In the case of this model, both IOC, and the customer may be considered as producers. Therefore, registration obligations may be shared between both parties. The customer must still report their activities to local regulators, and products may require registration on both sides – both IOC, and the customer. This type of cooperation model is often used when a product is jointly developed or distributed under multiple brands.

3.3 IOC as a contract manufacturer

In this model IOC plays the full role of the manufacturer, and the customer is only involved in distribution. IOC is responsible for the product's compliance with legal regulations and provides all necessary quality and safety certificates. However, the customer still has to register their business in the country of sale to meet local requirements. This model is most often chosen by companies that want to focus solely on sales and marketing, leaving all production and registration responsibilities to the IOC.

Questions and Answers [FAQ]

Frequently asked questions regarding registration obligations

Are you planning to introduce dietary supplements to the market and wondering what registration steps are necessary? Our FAQ answers key questions about the registration obligations of your business and products. Find out when company registration is required, what documents are necessary when reporting products and what obligations you have depending on the model of cooperation with International Organic Company (IOC). You will also find information on differences in registration requirements in Poland, the European Union, the USA and other key markets. Clear answers to frequently asked questions will help you prepare for the registration process and choose the optimal cooperation model, consistent with your needs and the legal requirements of the target market.

Yes, company registration is usually necessary, even if you use a contract manufacturer. In Poland, for example, companies planning to introduce supplements to the market must register their activities with Chief Sanitary Inspectorate (GIS) and obtain appropriate permits. In other countries, the obligation to register the business with the local sanitary supervision office is also common.

By using the services of a contract manufacturer such as International Organic Company (IOC), you gain support with production and certification, but as the company bringing the product to market, you are still responsible for compliance with local regulations and ensuring that your business operates legally. Having a registered business builds trust with customers and enables the legal introduction of products to the market.

No, the mere fact that the manufacturer (e.g. IOC) has all the necessary certificates, does not mean that the product can be introduced to the market without reporting to local authorities. In most countries, such as Poland, the USA and the European Union, there is a requirement to report each dietary supplement before it is introduced to the market.

Product Report includes providing detailed information about the composition, safety testing and labeling to ensure that the product complies with local regulations. The obligation to report lies with the company introducing the product to the market, even if the manufacturer is certified and meets quality requirements. By reporting, the product is legally protected and builds trust in the eyes of consumers, who are sure that the product is safe and complies with the regulations.

Registration obligations may vary depending on the chosen cooperation model. IOC. There are three main models:

  • The client as an independent person introducing the product to the market – in this case, you are responsible for registering both your business and your products. All formalities related to product registration, labeling and compliance with local regulations are yours as the company introducing the product to the market. This is the model most often chosen by companies that want to operate under their own brand and have full control over registration.
  • Partnership and distribution – in the case of a partnership, both parties may have their own registration obligations. IOC is responsible for the production process, but you still have to register your business and product in the country where you plan to distribute it. This model of cooperation works well when the product is developed or distributed under multiple brands and in different markets.
  • IOC as a contract manufacturer - here IOC plays the full role of a producer, and you are only involved in distribution. Even though IOC is responsible for all aspects of production and quality, you still have to register your business in the country of sale to be able to legally market the product. This model is most often chosen by companies that want to focus on sales and marketing, leaving all production responsibilities IOC.

Each model comes with a different range of registration obligations, so it’s important to choose the one that best suits your needs and operational capabilities.

What documents are needed to register supplements? Certificates for dietary supplement manufacturers Legal regulations for dietary supplements in Poland / EU / USA Do I have to report dietary supplements to GIS?

4.1 Registration of Business and Products in Poland

In Poland, registration obligations for dietary supplements are regulated by Chief Sanitary Inspectorate (GIS), which supervises the compliance of products with national and EU regulations on food safety and dietary supplements. Each entity wishing to introduce a dietary supplement to the market must report the product to GIS, providing detailed information on:
  • Product composition – All ingredients must be listed along with their quantities. GIS checks whether the product does not contain ingredients prohibited in dietary supplements and whether the doses comply with safety standards.
  • Studies confirming safety – The product must be supported by documentation that confirms its safety. This may include laboratory test results for the presence of heavy metals, pesticides or pathogens.
  • Label template – The label must contain full information about the product, including composition, dosage, method of use, warnings and details about the distributor or manufacturer. It is important that the label complies with the law and does not mislead the consumer.

In addition to reporting products, each entity must also register your business in GIS if it plans to distribute dietary supplements in Poland. This means that the company must obtain entry to the appropriate GIS register, which confirms that its activities are in line with sanitary and epidemiological requirements. Registration of activities also includes compliance with the rules GMP (Good Manufacturing Practices) and HACCP, which guarantee high quality and safety of production.

It is also crucial to update the notifications in case of any changes in the composition, label or name of the product. Each modification requires informing the GIS and may involve an additional conformity assessment process.

Compliance with registration requirements is essential for a company to legally sell dietary supplements on the Polish market, avoiding the risk of financial penalties, product recalls, and potential loss of reputation. Registration also ensures consumer confidence that the product meets the quality and safety standards required by Polish law.

4.2 Registration of activities and products in the European Union

In the European Union, dietary supplements are regulated by European Food Safety Authority (EFSA) and the regulations of individual member states. Many countries require companies to report their products to local health authorities. It is important to remember that the European Union has strict regulations on health claims – all declarations must be approved by EFSA.

4.3 Registering Business and Products in the United States

In the United States, dietary supplements are regulated by Food and Drug Administration (FDA). Companies planning to introduce supplements to the market must register their business with the FDA and meet regulatory standards. DSHEA (Dietary Supplement Health and Education Act). Product registration involves submitting information about ingredients, safety studies, and labeling, and any health claims must be in compliance with FDA requirements.

4.4 Registration of activities and products on the Asian market

In Asian markets such as China and Japan, regulations can vary greatly. In China, products must be approved by China Food and Drug Administration (CFDA), and the regulations regarding ingredients are very restrictive. Japan, on the other hand, has categories of supplements called FOSHU (Food for Specified Health Uses), which require special permits and clinical trials to confirm health effectiveness. Companies planning to expand into the Asian market should carefully examine registration requirements and adapt products to specific regulations.

5. Documentation and certification required for registration

Registration of activities and products on the dietary supplement market requires providing specific documentation and obtaining appropriate certificates. These documents confirm the quality, safety and effectiveness of products, which is crucial for compliance with regulations and building consumer trust.

5.1 Quality and safety certificates

In many countries, the registration requirement is to present certificates confirming compliance with quality and safety standards. The most commonly required certificates include:

  • GMP (Good Manufacturing Practices) – GMP certification ensures that products are manufactured to high quality and hygiene standards. This is often a basic requirement for producers of dietary supplements globally.
  • ISO 22000 – The ISO 22000 certificate concerns the food safety management system and is recognized worldwide. It provides assurance that production processes are in line with international food safety standards.
  • Analytical certificates – Product samples may require detailed laboratory testing to confirm the absence of contaminants such as heavy metals, pesticides, or pathogens. These certificates are often required for product registration.
Notification procedures for supplement products Registration of dietary supplements in different countries Differences in product registration in Poland and the EU What are the penalties for failure to register dietary supplements?

5.2 Standard Health Claims and Their Acceptance

Health claims on dietary supplements are strictly regulated. Any health benefit claim must comply with local regulations and be supported by scientific evidence. Examples of health claim requirements:

  • The European Union - In the EU, health claims must be approved by EFSA (European Food Safety Authority) and be on the list of permitted claims. Companies cannot use claims that are not approved by EFSA.
  • United States – The FDA requires that all health claims on supplement labels be supported by scientific evidence and accompanied by a disclaimer that the product is not a drug. In the U.S., it is common to use structure/function claims that describe effects on the body without claims to cure disease.
  • Japan - In the Japanese market, health claims must be in line with the category FOSHU (Food for Specified Health Uses). Products with health claims in this category require additional clinical trials and approval by the Japanese Ministry of Health.

5.3 Documentation of composition and safety tests

Each dietary supplement must be supported by detailed documentation that includes:

  • Composition of the product – Detailed description of all ingredients along with their dosages and source.
  • Security Research – Documents confirming that the product does not pose a health risk, for example through test reports for the presence of heavy metals, pesticides or microorganisms.
  • Stability studies – Tests that confirm the durability of the product over time, including compliance with the shelf life stated on the label.

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6. Summary: Key differences in registration obligations depending on the cooperation model

Registration obligations may vary depending on the cooperation model between the customer and the contract manufacturer, such as International Organic Company (IOC). Knowing these differences is crucial for the client to be able to choose the best cooperation model and meet all registration requirements in the markets in which they plan to operate.

6.1 Key scenarios of registration obligations

Below are the key scenarios and registration obligations depending on the client’s role:

  • The client as an independent person introducing the product to the market – In this case, the client reports both their business and products to the appropriate authorities in the country where they sell. This is the most common model of cooperation for companies that want to introduce products under their own brand and take full legal responsibility.
  • Partnership cooperation - In situations where both IOC, and the client are both producers, the registration obligations may be shared. The client may be required to register the activities and products in his country, and IOC is responsible for production that meets quality requirements. This model often works well when distributing products in different markets under multiple brands.
  • IOC as a full-fledged producer - When IOC is responsible for all aspects of production, the customer is only responsible for distribution. However, the customer must remember that even in this model, it is necessary to register the business in the country of sale, which allows to meet local legal requirements.

6.2. Recommendations for clients depending on the cooperation model

To ensure full compliance with regulations, we recommend that clients:

  • A thorough analysis of registration requirements – Before choosing a cooperation model, it is worth getting acquainted with the legal requirements in the target markets to know which obligations rest with the client and which with the IOC.
  • Consultation with local regulatory specialists – Markets such as the European Union, the United States and Japan have specific regulations regarding dietary supplements, so it is worth working with experts to avoid mistakes.
  • Selecting a cooperation model according to operational possibilities – Companies that have their own logistics and marketing resources can choose a model where they report their products themselves, while smaller companies may prefer full production and registration through IOC.

Selecting the right cooperation model is crucial for compliance with regulations and for effective expansion in the dietary supplements market.

If you have any questions, please contact us!

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