Health Claims vs Medicinal Advertising: Compliance Risks for Supplements & Cosmetics
If you sell dietary supplements or cosmetics and your advertising includes claims about curing diseases, you may face a fine of up to CZK 5 million and the product may be withdrawn from the market. The line between lawful health claims and unlawful medicinal advertising is thin. In this article, you will learn how to avoid inspections by the Czech Agriculture and Food Inspection Authority (SZPI) or the State Institute for Drug Control (SÚKL), and what risks each wording may entail.
Table of contents
Quick summary
- Fine of up to CZK 5 million: Using a medicinal claim for a food supplement is a breach of the Advertising Regulation Act. The Czech Agriculture and Food Inspection Authority (SZPI) and regional trade licensing offices impose substantial fines for such violations.
- Immediate withdrawal from the market: If the State Institute for Drug Control (SÚKL) assesses the product as a so-called “medicinal product by presentation”, it is an unregistered medicinal product, which means a ban on sale.
- Complex legal environment: The boundary between a permitted health claim and an impermissible medicinal claim is subject to strict interpretation by courts and supervisory authorities.
- Active monitoring and inspections: Supervisory authorities use software tools to monitor websites and act on complaints from competitors.
Difference between a medicinal product and a food supplement
In the Czech Republic and throughout the European Union, the distinction between a medicinal product and a food supplement is a fundamental legal one that sets the rules of the game. The lawyers at ARROWS advokátní kancelář encounter this issue very frequently in practice and warn that confusing these concepts in marketing can have serious consequences.
Under the Medicines Act, a medicinal product means a substance or combination of substances that is presented as having therapeutic or preventive properties. The definition rests on two pillars: a medicinal product by function and a medicinal product by presentation.
- Medicinal product by function: A substance that affects physiological functions through pharmacological, immunological, or metabolic action.
- Medicinal product by presentation: A substance that is labelled or presented as such, even if it has no real effect.
A food supplement, by contrast, is, under the Food Act, a food intended solely to supplement the normal diet and that is a concentrated source of vitamins or minerals. Crucially, food supplements do not undergo a registration procedure with SÚKL and their efficacy is not verified by the state.
The difference between what you can say about a food supplement and what you cannot is often a matter of wording and context, assessed by inspectors from SZPI and SÚKL. The manufacturer or distributor only has a notification obligation towards the Ministry of Agriculture prior to first placing the product on the market.
How authorities define medicinal claims
The Advertising Regulation Act and EU regulations do not provide an exhaustive list of prohibited words, but operate on the principle of misleading consumers. The key is not to attribute to foods properties of preventing, treating, or curing human diseases.
While approved health claims may be used for food supplements, any claims about treatment are absolutely prohibited. For example, the wording “vitamin C contributes to the normal function of the immune system” is permissible, but “vitamin C cures the flu” is prohibited.
Between these extremes lies a range of grey areas, such as claims like “relieves pain” or “improves joint mobility”. The attorneys at ARROWS advokátní kancelář deal with these disputes on a daily basis and know that a defence requires precise knowledge of case law.
Related questions on defining claims
1. Which specific wordings lead to proceedings being initiated?
Authorities take action against expressions such as “treats”, “heals”, “stops disease”, “acts against inflammation”, or “cancer prevention”. Images are also risky, for example a doctor in a white coat, a cross symbol, or diseased organs.
2. Can I say that my supplements “support” health?
The word “supports” is generally permissible within approved health claims, provided it relates to a normal physiological function. However, it must not be linked to a specific disease; for example, “supports digestion in ulcer disease” is already a prohibited combination.
3. What if I have registration in another EU country?
If you sell the product in the Czech Republic to Czech consumers, you must comply with Czech regulations, in particular language requirements and the Advertising Regulation Act. Approval of a food supplement abroad does not automatically mean that you may use medicinal claims in the Czech Republic.
Most common areas of non-compliance
The practice of regulators such as SZPI, SÚKL, and regional trade licensing offices shows that inspections focus on several types of channels. Authorities also carry out so-called test purchases, where an inspector orders goods as an ordinary customer.
- E-shop websites and product descriptions – Automated systems search for keywords such as “treatment” or “inflammation”.
- Social media – Posts and shared customer reviews. You are also responsible for comments on your own profiles.
- Email campaigns and newsletters – Direct communication with customers is considered a commercial communication.
- PR articles and blogs – Health-related articles that directly link to an e-shop selling food supplements.
- Catalogues and leaflets – Printed materials are still subject to inspections, often based on a competitor’s complaint.
Legislative framework and penalties
The basic legal framework is based on several key regulations that define medicinal products, regulate advertising, and set rules for foods.
If SÚKL decides that your product is an unregistered medicinal product, you may face a fine for unlawful handling of medicinal products of up to CZK 20 million. For food supplements, sanctions in practice tend to be in the hundreds of thousands to millions of Czech crowns, but the main risk is a sales ban.
The Advertising Regulation Act prohibits advertising of foods that contains medicinal claims. For breaches, authorities impose fines of up to CZK 5 million on legal entities and self-employed individuals. Non-business individuals face fines of up to CZK 2 million.
Directly applicable EU regulations prohibit attributing to foods properties of preventing, treating, or curing human diseases. These regulations also govern the use of all nutrition and health claims.
Inspection process and sanctions:
- Inspection: It may be initiated remotely or on-site.
- Inspection report: Inspectors record their findings, against which you may file objections.
- Administrative proceedings: If the objections are unsuccessful, administrative proceedings to impose a fine are initiated.
- Measures: In addition to a fine, the authority may order the withdrawal of the advertisement or the product from the market.
Examples of how claims are assessed in practice
Here are a few practical examples of how to distinguish between what is permitted and prohibited:
- “Calcium is needed for the maintenance of normal bones” – This is an authorised health claim and is acceptable provided the product contains a sufficient amount of calcium.
- “This product cures osteoporosis” – Absolutely prohibited; this is a medicinal claim because osteoporosis is a disease.
- “Helps with joint pain” – Risky to prohibited, as pain is a symptom of a disease or injury.
- “Suitable for diabetics” – Problematic and may be misleading for standard food supplements.
- “Milk thistle contributes to normal liver function and detoxification” – This is a so-called “on hold” claim; its use is possible, but it must be substantiated.
The attorneys at ARROWS, a Prague-based law firm, recommend having all marketing claims legally reviewed in advance.
Course of administrative proceedings and deadlines
When an authority initiates proceedings, you enter a formal legal process under the Czech Administrative Procedure Code. The first step is service of the notice of initiation of proceedings or an administrative order.
If the authority issues an administrative order, you have only 8 days to file an objection, which cancels the order and the proceedings continue in the standard way. It is often preceded by an inspection report, against which you must usually file objections within 15 days.
The second step is the taking of evidence and submissions, where you have the right to inspect the file and propose evidence. Deadlines are set by the authority, and ignoring them is a fatal mistake.
The authority will issue a decision imposing a fine, against which an appeal may be filed within 15 days of service. The entire process may take months, but the deadlines for your response are very short. Legal representation is crucial at this stage.
Specific risks and sanctions
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Risks and sanctions |
How ARROWS can help (office@arws.cz) |
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Fine for a medicinal claim (SZPI/Trade Licensing Office): Up to CZK 5 million (legal entities). Commonly imposed in the tens to hundreds of thousands of CZK for first offences. |
Legal audit of marketing. |
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Reclassification of the product as a medicinal product (SÚKL): Sales ban, withdrawal from the market, disposal of stock. Enormous financial loss. |
Defence against reclassification. |
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Illegal distribution of medicinal products : Fine of up to CZK 20 million under the Act on Medicinal Products (if the product is recognised as a medicinal product). |
Compliance and process setup. |
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Inspection and administrative proceedings : Stress, administrative burden, risk of reputational damage. |
Representation during an inspection. |
The line between what is permitted and what is prohibited
The key to the lawful sale of food supplements is working with the EU list of authorised health claims. For example, for a product containing magnesium you may state that it contributes to the reduction of tiredness and fatigue, provided the quantity condition is met.
If you use the wording “Magnesium prevents chronic fatigue syndrome”, you are breaking the law because you are referring to a disease. The product must contain a significant amount of the relevant substance under the applicable rules; otherwise you must not use the claim.
ARROWS attorneys have access to up-to-date databases and know how to work with the so-called “on hold” list for botanicals as well. Knowledge of these details is essential for safe marketing.
How to proceed when contacted by an authority
If you receive a request to provide an explanation or a notice of an inspection, you must proceed carefully.
What not to do:
- Do not respond hastily without consultation. Your first statement becomes part of the file and is difficult to take back.
- Do not be arrogant. Officials have extensive powers.
- Do not miss deadlines. Late filing of an objection or an appeal often cannot be remedied.
What to do:
- Contact experts immediately. For example at office@arws.cz.
- Secure evidence. Save the current state of the website, check batches and product documentation.
- Request access to the file. Find out exactly what the authority has on hand.
Practical steps to protect your company
- Advertising and website audit: Review product descriptions and remove words such as “treatment”, “disease”, “recovery”, “inflammation” or “pain”.
- Packaging check: Packaging is the first thing the inspectorate sees and it must comply with the rules on the provision of food information.
- Team training: Marketers and copywriters must know the basic rules so that creative content does not conflict with the law.
- Legal assessment of new products: Before placing on the market, have the composition and proposed texts reviewed.
When to contact attorneys
The ideal time is preventively, before launching a campaign. The second-best time is immediately after receiving the first written communication from an authority. The attorneys at ARROWS, a Prague-based law firm, have a team of specialists in pharmaceutical and food law under Czech legislation.
Prevention in the form of a text audit costs a fraction of what dealing with a subsequent fine and the necessary product rebranding will cost.
Conclusion
Claiming medicinal effects for unregistered products is gambling with your company’s future. The risk of fines, product withdrawal and brand damage is real and high given the digitalisation of supervision.
The attorneys at ARROWS, a Prague-based law firm, are ready to help you set up your business so that it complies with regulations and is commercially successful at the same time. If you are dealing with an issue or want peace of mind, contact us at office@arws.cz.
FAQ – Frequently asked legal questions
1. What is the difference between the claim “supports health” and “cures”?
“Cures” is a claim reserved for medicinal products and is prohibited for foods. “Contributes to normal function...” may be a permitted health claim if it is authorised by the EU and the product meets the compositional conditions.
2. Do Czech rules also apply to foreign e-shops?
If you target Czech consumers—for example, you have a website in Czech or prices in CZK—you must comply with Czech regulations, including the Czech Act on the Regulation of Advertising.
3. Is it enough if I add a “disclaimer” to the product description that it does not replace medical care?
No. If you use a medicinal claim in the description, even a disclaimer will not relieve you of liability for breaching the law, because misleading advertising remains misleading.
4. What are the deadlines for responding to a request from an authority?
Deadlines vary depending on the type of document; often it is 8, 10 or 15 days. Always read the instructions at the end of the document and, if in doubt, call an attorney immediately.
5. Can an authority ban my sales immediately?
Yes. If there is suspicion of a health risk or a serious breach, the authority may issue a measure prohibiting placing on the market even before the administrative proceedings are concluded.
Notice: The information contained in this article is of a general informational nature only and is intended to provide basic guidance based on the legal status as of 2026. Although we take the utmost care to ensure accuracy, legislation and its interpretation evolve over time. We are ARROWS advokátní kancelář, an entity registered with the Czech Bar Association (our supervisory authority), and for maximum client protection we maintain professional liability insurance with a limit of CZK 400,000,000. To verify the current wording of the regulations and their application to your specific situation, it is necessary to contact ARROWS advokátní kancelář directly (office@arws.cz). We accept no liability for any damages arising from the independent use of the information in this article without prior individual legal consultation.
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