Legal regulation of food supplements

Are you considering launching a new food supplement in the Czech Republic or the EU? Navigating the web of legal regulations, from notification to composition to advertising, is crucial for success and preventing costly mistakes. This article will provide you with clear and practical answers to what obligations you must fulfill, what risks you face, and how ARROWS can help you ensure a smooth and safe market entry.

Need advice on this topic? Contact ARROWS Law Firm at office@arws.cz or +420 245 007 740. Your question will be answered by "JUDr. Jakub Dohnal, Ph.D., LL.M.", an expert on the topic.

What is a dietary supplement and why is it crucial to distinguish it from a medicine?

The cornerstone of a successful business in the field of dietary supplements is the correct classification of the product. According to Czech legislation (Decree No. 58/2018 Coll.) and the European Directive (2002/46/EC), a dietary supplement is defined as a food. Its purpose is to supplement the normal diet and is a concentrated source of nutrients such as vitamins and minerals, or other substances with nutritional or physiological effects.

On the other hand, a medicinal product, defined by the Medicines Act, is intended to treat, diagnose, prevent disease or influence physiological functions. The difference is therefore in the purpose: a dietary supplement supports and maintains, while a medicinal product treats. However, the line between these categories is often blurred, especially in the case of herbal preparations or products with a high vitamin content, known as "borderline products."

Incorrect classification is not just an administrative offense, but a strategic mistake with existential risks. Imagine investing millions of dollars in the development and marketing of a product that is subsequently withdrawn from the market because the State Institute for Drug Control (SÚKL) reclassifies it as an unregistered drug. This means not only financial loss, but also damage to your reputation and potential criminal liability.

Correct assessment of product classification is the cornerstone of any business strategy. It defines not only the legal framework, but also the marketing opportunities and overall risk of the project. A legal opinion from ARROWS in the early stages of product development will give you certainty and protect your investment from the risk of being transferred from the supervision of the State Agricultural and Food Inspection Authority (SZPI) to the much stricter regime of the SÚKL.

What are the key legal regulations for your business?

The regulation of food supplements is multi-level. At the top are directly applicable EU regulations, followed by EU directives, which member states implement into their national laws and regulations. The most important ones for your business are:

Key EU regulations:

• Regulation (EC) No 178/2002: Lays down general principles of food law, including key responsibilities of operators and product traceability obligations.
• Directive 2002/46/EC: Defines the basic framework for food supplements in the EU.
• Regulation (EC) No. 1924/2006: Regulates the use of nutrition and health claims.
• Regulation (EU) No. 1169/2011: Defines rules for the provision of food information to consumers, i.e. for labeling (labels).

Key regulations in the Czech Republic:

• Act No. 110/1997 Coll., on food and tobacco products.
• Decree No. 58/2018 Coll., on food supplements and food composition.

In this context, it is necessary to know two technical terms. A food business operator is any entity that places a product on the market and bears full responsibility for it. Notification is a mandatory notification of the placing of a food supplement on the market, which is submitted to the Ministry of Agriculture – however, this does not constitute product approval.

Furthermore, the legal framework is constantly evolving. Lists of permitted substances and approved health claims are subject to change based on new scientific findings from the European Food Safety Authority (EFSA). Long-term legal services from ARROWS, which include monitoring legislative changes, are therefore an investment in the sustainability of your business.

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Marketing in the Czech Republic: What steps must you take?

The process of placing a food supplement on the Czech market can be summarized in three key steps that every food business operator must take.

Notification to the Ministry of Agriculture

Before placing a product on the market for the first time, you must submit a notification to the Ministry of Agriculture, which includes a sample of the Czech packaging. This process is often mistakenly understood as an approval procedure. However, the Ministry does not approve the product, it only registers it. The responsibility for compliance with the legislation remains entirely with you.

Composition check

Your product must contain only vitamins, minerals, and other substances in forms that are permitted by European and Czech legislation. Special attention must be paid to so-called novel foods, which are subject to a special approval process at the EU level.

Perfect labeling (label)

Product labeling must meet all the requirements of Regulation (EU) No. 1169/2011. Mandatory information includes the name, list of ingredients with allergens highlighted, quantities of certain ingredients, best-before date, operator details, and nutritional information. Specific information for food supplements, such as recommended dosage and warnings, must also be provided.

A false sense of security after submitting a notification is a common pitfall. Businesses assume that if the ministry has not raised any objections, their product is fine. However, a year later, the SZPI may find errors during an inspection and impose a heavy fine.

The real value of ARROWS' services lies not in simply submitting the notification, but in the complete preparation of documentation and product audit BEFORE this step. This gives you the certainty that your product will pass any future inspection.

The most common errors and how to avoid them

Risks to be addressed and potential problems and sanctions	How ARROWS can help
Incorrect or delayed product notification (Fines from the SZPI, order to withdraw the product from the market)	Preparation and submission of complete notification documentation to the Ministry of Agriculture, ensuring compliance with legal deadlines.
Non-compliant composition (use of unauthorized substances, exceeding maximum limits for vitamins/minerals, risk to consumers)	Legal audit of product composition against valid Czech and EU lists of authorized substances. Assessment of "novel food" status.
Misleading or incomplete labeling on packaging (Missing mandatory information, incorrect highlighting of allergens, fines, damage to reputation)	Complete revision and preparation of packaging texts in accordance with Regulation (EU) No. 1169/2011, protection against sanctions.
The product acts as an unregistered medicinal product (High fines from the State Institute for Drug Control, risk of criminal prosecution, order to destroy goods)	Preparation of a legal opinion on product classification that minimizes the risk of confusion with a medicinal product.
Insufficient documentation for supervisory authorities (inability to prove the origin of raw materials, safety procedures - HACCP)	Preparation of internal guidelines and documents required by law to prepare you for a smooth inspection by the SZPI..

Advertising and health claims: How to communicate effects and avoid fines running into millions?

Marketing is the key to success, but in the field of food supplements, it is bound by strict rules. The bible for food marketing is Regulation (EC) No. 1924/2006, which distinguishes between nutrition and health claims. A nutrition claim describes a property of a food (e.g., "source of fiber"), while a health claim links a food to health (e.g., "Vitamin C contributes to the normal function of the immune system").

All health claims must be scientifically substantiated and approved by the European Commission after assessment by EFSA. They are listed in the publicly accessible EU Register of Health Claims. Any claims that attribute to a product the ability to treat, prevent or cure human diseases, as well as references to medical recommendations, are completely prohibited.

The regulation applies not only to packaging, but to all commercial communications, including websites, social media, and even texts intended for pharmacists. Even a post by an influencer claiming that your product "cured" them is considered a commercial communication for which you are fully responsible. ARROWS lawyers provide expert training for marketing teams and review all communication materials to ensure consistency across all channels.

Expanding abroad: What challenges await you in the European market?

The European Union operates on the principle of mutual recognition. A product that is legally on the market in one member state should also be accepted in others. However, harmonization is not absolute. Each country has its own notification process, language requirements for labels, and often a different approach to certain ingredients, especially herbs. For example, placing a product on the German market requires notification to the Federal Office for Consumer Protection and Food Safety (BVL) and a German label.

Successful international expansion requires more than just translating labels; a strategic assessment of the regulatory environment in the target country is key. Thanks to the ARROWS International network, which has been built up over ten years, we provide not only administrative services but also strategic advice based on local knowledge, which can prevent costly and unsuccessful investments.

International trade, import and contractual relations

Risks to be addressed and potential problems and sanctions	How ARROWS can help
Failure to comply with notification obligations in another EU country (sales ban, fines from foreign authorities)	Ensuring notification and registration in target countries through our ten-year-old ARROWS International network.
Problems with importing raw materials from countries outside the EU (Goods held at customs, disputes with suppliers, failure to meet quality standards)	Review of contracts with international suppliers, legal advice on customs procedures and import regulations.
Language or legally non-compliant packaging (obligation to repackage goods, fines, negative customer perception)	Ensuring legal review of foreign-language labels in cooperation with local experts from the ARROWS International network.
Unfavorable distribution agreements (loss of control over pricing, unclear liability for defects, damage to brand)	Preparation or revision of international agreements that protect your business interests and minimize risks in your relationships with distributors.
Use of health claims that are not accepted in the target country (e.g., specific "on-hold" botanical claims)	Analysis of the regulatory environment in the target country and recommendations for a safe marketing strategy.

Control by authorities: What are the powers of the SZPI and what penalties are imposed?

The main supervisory authority in the Czech Republic is the State Agricultural and Food Inspection Authority (SZPI). Its inspectors have broad powers, including access to premises, sampling for analysis, documentation checks (traceability, HACCP), and online sales checks on e-shops and social networks.

If a violation is found, the SZPI may impose a fine of millions of crowns, order the product to be withdrawn from the market, or even ban its further sale. One of the most severe penalties is the publication of the non-compliant product on the "Potraviny na pranýři" (Food in the Pillory) website, which can lead to an immediate loss of trust among consumers and business partners.

The greatest damage is often not the fine itself, but the damage to reputation, which can have devastating consequences for a brand. ARROWS' representation before administrative authorities aims not only to reduce financial penalties, but above all to minimize negative publicity and thus protect your company's good name.

Comprehensive legal services from ARROWS: Your partner for secure business

The world of dietary supplements offers enormous potential, but it is full of legal pitfalls. At ARROWS, we deal with these issues on a daily basis and are ready to become your reliable partner. Our experience in providing services to more than 150 joint-stock companies and 250 limited liability companies enables us to provide fast and high-quality service.

In addition, we actively seek synergies for our clients and can connect them if they have interesting investment or business opportunities.

Don't risk your business and reputation. Contact us to arrange an initial consultation where we will discuss how we can specifically help you.

Contact us today for an initial consultation and build your success on a solid foundation of legal certainty.

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