Introducing so-called sensitive products to the market can be a real challenge. Sensitive products are those that, due to their nature, are subject to highly detailed regulations and additional oversight systems. One of my favorite categories of sensitive products is health-promoting food, especially food for special medical purposes regulated by Regulation 609/2013. However, this time the focus is not on that, but on dietary supplements. These are products often perceived as easy to launch on the market, with production and sales seen as a relaxed way to run a business. From my legal practice, I can say that nothing could be further from the truth. Bringing a dietary supplement to market is a complex process that requires compliance with numerous legal requirements and overcoming many practical challenges. Running a responsible business in the dietary supplement sector can be quite a task—like in a Hitchcock movie: first an earthquake, and then the tension only rises.
Dietary supplement – what is it?
A dietary supplement is, in fact, a food product whose purpose is to supplement the normal diet. It is a concentrated source of vitamins or minerals, or other substances with a nutritional or physiological effect—either individually or in combination—marketed in a form that allows for precise dosing. This includes capsules, tablets, coated tablets, and other similar forms, sachets of powder, ampoules of liquid, dropper bottles, and other similar liquid or powder forms intended to be consumed in small, measured unit quantities. Dietary supplements do not include products that have the properties of medicinal products as defined by pharmaceutical law. As food products placed on the market, dietary supplements must comply with numerous and highly detailed legal requirements. It is also important to remember that the health sector includes many other types of sensitive products that differ from dietary supplements and are subject to different legal regulations.
Legal regulations – what are they and what do they cover?
In Poland, there is a large number of food regulations, including provisions specifically dedicated to dietary supplements as a subcategory of food. Naturally, both EU and national regulations apply. They govern the most important practical issues related to the formulation, labeling, advertising, and distribution of dietary supplements — but not exclusively.
In the European Union, dietary supplements are regulated by several key legal acts. These include, among others:
- 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 – defines dietary supplements as food products;
- Regulation (EC) No 1924/2006 – concerns nutrition and health claims that may be made on foods, including dietary supplements;
- Regulation (EU) No 1169/2011 – on the provision of food information to consumers, which also includes labeling requirements for dietary supplements;
- Regulation (EC) No 178/2002 – lays down the general principles and requirements of food law and establishes the European Food Safety Authority (EFSA), which influences the safety assessment of ingredients and the use of health claims.
Becoming familiar with these regulations is a good starting point for gaining an understanding of the subject of dietary supplements — and this is only a modest beginning.
In Poland, dietary supplements are regulated by national laws that are aligned with EU directives and regulations, including the following:
- The Act of 25 August 2006 on Food and Nutrition Safety – sets out the general principles concerning food safety, including dietary supplements;
- Regulation of the Minister of Health of 9 October 2007 on the composition and labeling of dietary supplements – specifies detailed requirements for the composition and labeling of dietary supplements.
Familiarizing oneself with the regulations is not just a task for the beginning of the journey, as ongoing monitoring of changes in the laws is necessary. Regulations concerning prohibited ingredients change dynamically, requiring manufacturers to continuously update their knowledge and adapt to new rules.
Does a dietary supplement need to be notified before being introduced? Yes — and here’s how!
Notification to the Chief Sanitary Inspectorate (GIS) is an important step when starting business activities. Notification means informing about the first introduction of the product into the territory of Poland — it is not registration. Every dietary supplement must be notified to GIS before being placed on the market, and this must be remembered before an inspection or an investigation occurs if GIS has doubts about the correctness of the notification. And what might the inspection concern?
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The health food industry encompasses the production, distribution, and sale of food products that have a beneficial effect on consumers’ health and well-being. These products often contain nutrients, vitamins, minerals, fiber, probiotics, and other substances that support a healthy lifestyle and help prevent diseases. Health foods are frequently produced according to high standards of quality and safety, and their marketing is based on scientific facts and health benefits. Inspections may precisely concern all these aspects:
- Formulation — the qualitative and quantitative composition and properties of products;
- Labeling and marking;
- Advertising and marketing;
- Distribution.
These are just a few of the most important aspects to consider before introducing a dietary supplement to the market, as market supervision is thoroughly distributed. The responsibility for food market control lies primarily with sanitary inspection authorities (headed by the Chief Sanitary Inspectorate), but also, to some extent, with trade inspection authorities (the Inspectorate of Commercial Quality of Agricultural and Food Products). They oversee dietary supplements and ensure compliance with the regulations governing this industry.
The entity responsible for providing information about food is the one that places the food product on the market under its name or company. The commercial quality of the product is the responsibility of both the entity indicated on the labeling and the one that produces the food product. Part of commercial quality also includes the quality of labeling and, ultimately, communication and advertising. This area is often overseen by the President of the Office of Competition and Consumer Protection.
Creating a product formula — what is allowed and what is not?
Creating a dietary supplement formula is a process that requires careful selection of ingredients and consideration of the latest scientific research. The most important challenges are:
- Selection of ingredients: Choosing the appropriate ingredients that are legally permitted, safe, and effective can be challenging. It is also necessary to consider interactions between ingredients. Additionally, it may be essential to verify the scientific needs of the population or specific groups such as children, adolescents, women, men, the elderly, athletes, pregnant and breastfeeding women. These are just some of the groups for which selecting the right qualitative and quantitative composition matters.
- Scientific research: Basing the formula on solid scientific studies is crucial to ensure the product’s safety and to make sure that product claims are truthful.
- Legal regulations: Ingredients must comply with legal requirements, which may limit the choice of available substances.
Prohibited substances — which ones exactly?
In dietary supplements, there are many ingredients prohibited due to their potential harmful effects on health. Here are some of the most important banned substances in the European Union (including Poland). In the EU, prohibited ingredients are specified in various legal acts, including Regulation (EC) No 1925/2006, which concerns the addition of vitamins, minerals, and certain other substances to foods. In Poland, the list of banned ingredients aligns with EU regulations but is also additionally specified in national laws, such as the Regulation of the Minister of Health of 13 March 2024 on substances enriching food. Here are a few examples:
- Yohimbine hydrochloride and the yohimbine group;
- DMAA;
- Evodiamine;
- The group of selective androgen receptor modulators (SARMs), including Rad-140 (Testolone);
- Higenamine;
- Hordenine;
- Ibutamoren (MK-677);
- Pancreatin;
- Kava pepper ;
- Velvet bean.
Interest in the product’s composition is not limited to its initial selection but involves continuous monitoring. The manufacturer must constantly verify the composition of their products to ensure they do not contain prohibited substances or contaminants, which applies to all dietary supplements.
Product composition — not just what, but how much?
It’s not just about what ingredients are used, but also how much. It’s worthwhile to review scientific data and use resolutions from the Dietary Supplements Team at GIS as a guideline. To support the idea that the substance alone does not determine the product category, the so-called EU “garlic case” can be cited.
Expecting consumers to decide on their own whether garlic is a medicine or a food product seems completely misguided. The Court of Justice of the EU firmly rejected this interpretation and set limits for Member States on excessively broadening the definition of medicinal products. It also prohibited the practice that increasingly gave medicinal product status to items not meeting the appropriate criteria, thereby encroaching on the territory reserved for food. In that case, the CJEU noted that the mere impact of a preparation on health is not enough to classify it as a medicine, but rather as a different product, such as a dietary supplement. A product must possess actual medicinal properties, and a physiological effect alone is not the only criterion. Health-promoting effects are also demonstrated by food products (supplements), but showing therapeutic effects alone is insufficient to consider them medicines under legal definitions (Judgment of 15 November 2007, Commission v Germany, C-319/05).
Quality control is also recommended. Regular testing of raw materials and finished products is essential to ensure that the qualitative and quantitative composition matches the notification submitted to GIS and the claims on the packaging.
Packaging and labeling — meaning what’s inside must be clearly described on the outside?
Labeling of dietary supplements must comply with legal regulations, which involves several challenges. It’s not only about distinguishing dietary supplements from other products, especially medicinal products. I have often emphasized that this message should be clear, readable, and straightforward (whether in the leaflet, label, or oral product presentation). An average consumer should be able to understand from the message that a dietary supplement is a food product intended to support health and well-being by complementing the diet, not for treating diseases in humans, which could be considered misleading and therefore prohibited.
These are different products, belonging to different categories. As a side note, it can be stated that they may be used together, for example, after consulting a doctor. Also, a person who needs to take a medicinal product may require supplementation. One does not exclude the other, but knowledge from a doctor or pharmacist is crucial to determine how one affects the other (e.g., CJEU ruling, C-369/88 Jean-Marie Delattre). For defining the category, the composition is significant, including the dosage of active substances, assessed under normal conditions of use. However, if the product is not intended to restore, correct, or modify physiological functions in a significant way by causing pharmacological, immunological, or metabolic action, it is not classified as a medicinal product (CJEU ruling of 15 January 2009, C-140/07). Case law can provide valuable guidance.
Therefore, transparency of information, readability, and compliance with regulations (especially regarding nutritional and health claims) are essential. The label must include all required information, such as the composition, recommended daily portion, dosage warnings, and a statement that the supplement does not replace a balanced diet. The information on the label should be clear and understandable for consumers, which requires proper text layout and the use of legible fonts. The label must comply with both EU and national regulations, which may require consultation with a lawyer specializing in food law. The content on the label is often later used in advertising.
Advertising — always responsible!
Advertising of dietary supplements must be conducted in accordance with legal regulations, which involves several challenges.
Advertising is understood as any action — any commercial communication — concerning a specific product, directed at consumers, aimed at indirectly or directly increasing sales. These actions also aim to influence the shaping and changing of people’s attitudes and are most often carried out using mass media, including (and nowadays especially) the Internet. The most important principle is the so-called Evidence-Based Nutrition, which means that all statements should be based on true, relevant, and verifiable evidence. Therefore, it is crucial that every claim is supported by reliable scientific data and publication sources.
For the dietary supplements advertising industry, a catalog of best practices — both recommended and prohibited — can be created. Some of the recommended practices include: ensuring the message aligns with moral and customary standards, completeness, clarity, and reliability of the advertising content. What is prohibited? Advertising content must not be false, ambiguous, or misleading. It should not raise doubts about the safety or nutritional adequacy of other foods. It must not encourage excessive consumption of a given food or imply, suggest, or give the impression that a balanced and varied diet cannot provide adequate amounts of nutrients in general. Content must not refer to changes in body functions in a way that provokes or exploits consumer fear through text, images, graphic representations, or symbols.
Additionally, just like with labels, it is important to clearly state that the product is a dietary supplement. When creating any connection between the product (or its ingredients) and health, proper use of health claims must be observed. Advertising cannot contain false or misleading health claims. All claims must be supported by solid scientific evidence.
Advertising can appropriately and legally use so-called health claims — for example, stating that the vitamin C contained in the product supports the functioning of the immune system. This is just the tip of the iceberg when it comes to restrictions, and describing them all could fill an entire article. The broad catalog of prohibited messages means that the Office of Competition and Consumer Protection (UOKiK) is more likely to detect violations in this category than with others.
An increasingly important aspect and responsibility of the industry is consumer education: Advertising should educate consumers about the benefits of the supplement and rational supplementation, while at the same time not misleading them.
Can it get any harder? It can — meaning the responsibility of the manufacturer.
The manufacturer is primarily responsible for the product. According to Article 14 of Regulation 178/2002, specific requirements regarding food safety are outlined. No unsafe food product may be placed on the market. When the manufacturer decides whether a product is unsafe, they must consider both the normal conditions of use of the food and its handling at every stage of production, processing, and distribution, as well as the information intended for consumers — including on the label — and other information, such as warnings about avoiding certain substances.
Additionally, not only immediate but also long-term effects of the food are taken into account — not only for the health of the consumer but also for future generations, potential cumulative toxicity effects, and the particular health sensitivities of specific consumer groups. Therefore, the implementation of self-regulation, internal standards, and procedures beyond legal requirements plays a primary role for the company in overseeing itself. Authorities mainly check whether the business properly supervises itself and intervene (or are expected to intervene) only in critical situations. They verify whether the imposed internal standards are actually being followed. The key factor is the manufacturer’s responsibility for their product.
It is important to pay attention to the commercial quality of products — commercial quality refers to the characteristics of agricultural and food products concerning their organoleptic, physicochemical, and microbiological properties in terms of production technology, size or weight, as well as requirements arising from the method of production, packaging, presentation, and labeling, which are not covered by sanitary, veterinary, or phytosanitary requirements. This is defined in Article 3 of the Act of December 21, 2000, on the commercial quality of agricultural and food products (note: a draft amendment to this act is currently under consideration). The concept of quality can be compared to the so-called adulterated product, meaning a product whose composition does not comply with commercial quality regulations, where changes (e.g., labeling) have been made to conceal its true composition or other properties, if such discrepancies or changes significantly harm consumer interests, for example, by misleading them about the actual characteristics of the product.
Agricultural and food products introduced to the market should meet the requirements concerning commercial quality. However, the Act on the Quality of Agricultural and Food Products and the Food Safety Act are not the only documents setting standards for dietary supplements — there is a whole range of regulations, especially those established at the EU level, as well as based on the Act on Competition and Consumer Protection and the Act on Counteracting Unfair Market Practices. Prohibitions against misleading consumers also stem from EU law.
I have a supplement — but where should I sell it?
The distribution of dietary supplements is an aspect that should not be left until the end. I recommend having a clear plan for it from the very beginning, already at the stage of designing the formula and label. It involves several practical challenges, such as distribution channels, logistics, and, again, compliance with regulations. Choosing the right distribution channels—such as pharmacies, online stores, or health food shops—is important even at the formula stage (for example, the product’s composition might mean it shouldn’t be sold through pharmacy channels or herbal stores). Some dietary supplements require specific storage and transportation conditions to maintain their quality, efficacy, and safety. I suggest planning this carefully, which also requires appropriate labeling. Distribution must be conducted in accordance with legal regulations, including competition law.
What else is worth considering?
Whether we like it or not, there are still a number of legal aspects that must be considered in order to bring a dietary supplement to market. These include drafting contracts related to the supply of raw materials and components used in the production of health-promoting foods, ensuring food safety and production standards (including GMP – Good Manufacturing Practices). It is important to establish procedures for managing risks in case of potential inspections and irregularities, initiation of explanatory proceedings before the Chief Sanitary Inspectorate (GIS), decisions on banning further marketing, or product recalls. Attention should also be paid to intellectual property protection, such as trademark protection. Prior registration of trademarks for health food brands may be necessary before launching the product to secure adequate protection against infringement. Given the effort invested in creating the formula, protecting innovative formulas and production technologies of health-promoting foods is advisable. Trade secret protection may be required to safeguard unique recipes and production processes from disclosure. For further business development, appropriate licensing may be needed, requiring the creation of license agreements concerning technology and active ingredients used in health-promoting foods. Copyrights should not be overlooked, especially regarding the protection of marketing materials such as brochures, advertisements, and online content related to health-promoting foods.
Summary
The health food industry is growing in popularity alongside increasing interest in a healthy lifestyle and conscious nutrition. Proper legal support is crucial to ensure product compliance with regulations as well as the protection of innovations and consumer rights. Bringing a dietary supplement to market is a process that requires careful planning and fulfillment of numerous legal requirements. Key stages include market analysis, formula development, notification to the Chief Sanitary Inspectorate (GIS), labeling, production and quality control, marketing and distribution, and intellectual property protection. The main challenges are competition, legal regulations, and building consumer trust. Adhering to both EU and national laws is essential to guarantee product safety and efficacy, and ultimately to run the business responsibly while gaining a strong competitive advantage.
Any questions? Feel free to reach out! Write to me at juchanska@ajlaw.pl or call +48 506 144 611.