Food Supplements vs Medicinal Products: Avoiding Reclassification in Czechia
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The boundary between a food supplement and a medicinal product is legally more complex than it may seem. A single careless wording in advertising or on packaging can lead to the product being reclassified by the authorities in the Czech Republic, which brings the risk of significant fines and sales bans. The Czech legal team at ARROWS advokátní kancelář deals with how to avoid hidden pitfalls and set up compliance correctly on a daily basis.
Article contents
Quick summary
- Classification is a legal issue, not a marketing one: Confusing a food supplement with a medicinal product leads to reclassification and fines of up to CZK 50 million in the Czech Republic.
- Presentation determines legal status: The same product can become a medicinal product solely based on how you describe it, as the way the product is presented to the public is also decisive under Czech law.
- Authorities carry out active and systematic inspections: The State Agricultural and Food Inspection Authority (SZPI) imposes significant fines for unauthorised medicinal claims.
- Mistakes have multi-layered consequences: From blocking an e-shop to withdrawing the product from the market, and even administrative or criminal liability of managing directors.
Statutory definition
In the Czech Republic, clear legal definitions apply, but in practice they create interpretative grey areas. The State Institute for Drug Control (SÚKL) decides whether a product is a medicinal product, and the State Agricultural and Food Inspection Authority (SZPI) supervises the food supplement market.
Under the Czech Act on Medicinal Products, a medicinal product is considered to be a substance that can be used in humans to modify physiological functions, or that is presented as such. The key word here is “presented”, so it also depends on how you present the product to the public.
A food supplement is defined as a foodstuff intended to supplement the normal diet and which is a concentrated source of substances with a nutritional or physiological effect. The fundamental difference is that a food supplement must not be presented as a means of treating or preventing disease.
The attorneys at ARROWS advokátní kancelář, a Prague-based law firm, routinely handle disputes over whether specific claims or packaging lead to this classification. In practice, it happens that an herbal tea described as a “supplement to support immunity” turns, at a critical moment, into an unregistered medicinal product.
Related questions on the legal classification of products
1. What does “presentation” mean in legal terms?
It includes all ways in which a consumer learns about the product—labelling on the packaging, websites, social media, or advertising. What matters is the overall impression formed by the average consumer.
2. Can an herbal tea be a food supplement for one manufacturer and a medicinal product for another?
Yes, that is possible. The same tea with identical composition may be a lawful food supplement for one manufacturer, while for another it may be an unlawful medicinal product if it is labelled with wording such as “treats flu”.
3. Do clinical studies also affect classification?
Studies are key for medicinal products, while for food supplements they support safety and the truthfulness of claims. If a manufacturer demonstrates through studies that the product treats a condition, paradoxically this provides evidence that the product should be registered as a medicinal product.
Practical indicators of reclassification
Czech legal practice and case law distinguish between formal categorisation and the product’s actual nature. If a product meets the defining characteristics of a medicinal product, it must be registered as such; otherwise, its sale is unlawful in the Czech Republic.
In case of doubt, SÚKL decides under the Czech Act on Medicinal Products, and the most important criterion is often the product’s presentation and the impression it creates.
Below are examples of claims that are typically considered medicinal and lead to problems:
- “Treats inflammation” or “Eliminates joint pain”.
- “Protects against flu” or “Kills viruses and bacteria”.
- “Lowers high blood pressure” or “Helps with asthma”.
All of these claims go beyond maintaining normal health and enter the area of treatment or prevention of specific diseases. Once the authorities identify them, there is a risk that your product will be assessed as a medicinal product that has not been registered.
The attorneys at ARROWS advokátní kancelář, a Prague-based law firm, carry out compliance reviews of packaging, websites, and marketing materials so that clients do not cross the line under the Czech Advertising Regulation Act.
Related questions on indicators of reclassification
1. Is the claim “supports normal immune function” as risky as “protects against flu”?
No. The wording “contributes to the normal function of the immune system” is a permitted health claim. By contrast, “protects against flu” is a prohibited medicinal claim.
2. What if we write the claim in English or another language?
That will not protect you, because if you target Czech consumers, the information must be understandable to them. The inspection authority also assesses foreign-language claims, and if they are misleading, sanctions follow.
3. If I purchased the product from a foreign company and only resell it, is liability mine or the manufacturer’s?
Liability primarily lies with the party placing the foodstuff on the market in the Czech Republic—i.e., you as the importer or seller. The food business operator is responsible for ensuring that foodstuffs comply with legal requirements.
Borderline products
Czech legal practice uses the term “borderline product” for a product where it is not immediately clear whether it falls under the definition of a medicinal product or a food supplement. In case of doubt, the rule is that if a product meets the definition of a medicinal product as well as another category, the provisions of the Czech Act on Medicinal Products take precedence.
Examples of borderline products include herbal extracts with a high concentration of active substances, traditional Chinese medicine products, or creams with analgesic effects.
If SÚKL decides that it is a medicinal product, you must withdraw the product from sale until you obtain registration. This means an immediate loss of revenue and investment, because the registration process is both financially and time-consuming.
Related questions on borderline products
1. How does a borderline product differ from a standard food supplement?
A borderline product operates in a “grey zone” due to its composition, function, or presentation. A standard food supplement has a clear nutritional purpose.
2. Can SÚKL decide on a borderline product on its own?
SÚKL decides in administrative proceedings whether a product is a medicinal product, and its decision is binding on other authorities. The manufacturer may appeal the decision to the Ministry of Health of the Czech Republic.
3. Should I consult SÚKL about a product before placing it on the market?
An official preliminary consultation is not a standard process, but it is possible to file a request for a determination of the product’s nature. Strategically, however, it is often more appropriate to carry out a thorough legal audit with an attorney.
Health claims on packaging
The European Regulation sets out rules for nutrition and health claims, which must not be false, ambiguous, or misleading. In particular, they must not attribute to supplements properties of preventing, treating, or curing human diseases. Approved health claims may be used only in the exact wording as listed by the EU, or in wording that has the same meaning for consumers.
The “on hold” list is a specific category for botanical substances whose assessment has been suspended, but which may still be used for the time being. These claims must be scientifically substantiated and must not mislead consumers, even though they have not been finally approved.
The risk is that many manufacturers mistake “on hold” claims for a free pass to make any herbal claim, which is incorrect. The attorneys of ARROWS, a Prague-based law firm, regularly review whether clients’ claims comply with the current EU Register and the so-called on hold list.
Manufacturer inspections in practice
The State Agricultural and Food Inspection Authority (SZPI) is the main supervisory body in the Czech Republic, carrying out inspections both at premises and on e-shops. Inspectors also use test purchases.
In aggregate, fines imposed by SZPI amount to hundreds of millions of Czech crowns each year, with the maximum possible fine reaching up to CZK 50 million.
The most common findings by inspectors include the use of medicinal claims, failure to comply with the notification obligation, or the presence of prohibited substances. Misleading ingredient labelling or a lower content of active substances is also a frequent issue. If inspectors identify a serious breach, they may order an immediate ban on placing the product on the market, require withdrawal from the market, and initiate administrative proceedings.
Notification obligation towards the Ministry
Each food supplement must be notified to the Ministry of Agriculture before it is first placed on the market in the Czech Republic. As part of the notification, the Czech-language label text and information on composition and dosage are submitted.
It is important to understand that notification is not an approval, as it merely fulfils a reporting obligation. Full responsibility for compliance with Czech law lies with the operator, not the authority. The fact that you have reported the product and it appears in the register does not mean the authority has confirmed its safety or the correctness of the texts.
Main threats and solutions
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Risks and sanctions |
How ARROWS helps (office@arws.cz) |
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Reclassification of the product as a medicinal product: If SÚKL (the Czech State Institute for Drug Control) decides that the product is a medicinal product, it must not be sold as food and a fine of up to CZK 20 million may be imposed. |
We conduct an audit of the product’s composition and presentation before market entry: We identify risk areas and propose adjustments. |
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Fine from SZPI for prohibited claims: Fines for breaches of labelling and advertising rules can reach millions of Czech crowns. |
We represent clients during SZPI inspections: We submit objections to inspection reports and statements in misdemeanour (administrative offence) proceedings. |
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Failure to meet the notification obligation: Placing a food supplement on the market without notifying the Ministry of Agriculture is an administrative offence under Czech legislation. |
We ensure proper notification of your products: We review mandatory label requirements and handle communication with the authorities. |
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Incorrect packaging labelling: Missing mandatory information may result in an order to relabel (oversticker) or dispose of packaging. |
Our Czech legal team will review packaging texts: We ensure compliance with Regulation (EU) No 1169/2011. |
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Social media risks: The inspection authority monitors Facebook and Instagram, and you are also responsible for comments or shared reviews. |
We review e-shops and campaigns: We set rules for copywriters and marketing departments. |
Registration of a food supplement versus registration of a medicinal product
Bringing a food supplement to market is administratively straightforward thanks to notification, whereas a medicinal product must undergo a demanding registration procedure with SÚKL (the Czech State Institute for Drug Control). For medicinal products, quality, safety, and efficacy are assessed through studies. Medicinal product registration is a process that takes months to years and requires extensive documentation and high administrative fees. Without a valid registration, a medicinal product cannot be placed on the market in the Czech Republic.
The attorneys of ARROWS advokátní kanceláře help clients set a strategy to remain within the food category under Czech law, or guide them through the registration process.
The on hold list and herbal claims
Botanical substances are a specific area because the European Commission has not yet decided on thousands of health claims that are “on hold”. These claims may be used provided they are scientifically substantiated and do not mislead consumers.
An example is senna, where an on hold claim relating to normal intestinal tract function may be used, but you cannot state that it cures constipation.
Sanctions and their application in practice
Breaches of the rules can have devastating consequences for a company. In addition to financial losses, there is a risk of reputational damage and loss of customer trust. The amount of an administrative fine depends on the seriousness, duration, and consequences of the unlawful conduct. For repeated offences or misleading practices, fines can reach millions of Czech crowns.
Measures of a general nature and bans allow SZPI to prohibit placing a food on the market, which in practice means a halt to sales in the Czech Republic. This measure can be issued very quickly. In extreme cases, the conduct may be classified as the criminal offence of endangering health through defective food or deceiving the consumer. Statutory bodies should observe the duty of due managerial care under Czech law to avoid personal liability.
Protection strategy
Prevention is cheaper than dealing with the consequences of an inspection. We recommend conducting a legal audit of your product portfolio and having labels and composition reviewed by an expert. A review of marketing and the e-shop is also necessary, removing prohibited medicinal claims and replacing them with permitted health claims. It is also important to verify that notification processes are properly set up.
Contractual arrangements with suppliers are essential, especially if you import goods into the Czech Republic, so that you can transfer liability appropriately. Finally, we recommend ongoing monitoring of legislation, as the rules change frequently.
Practical safety examples
- The first example is an herbal tea with vitamin C labelled as a food supplement to support immunity. If the claim reads “Vitamin C contributes to the normal function of the immune system”, the situation is safe and the labelling is correct.
- The second case is the same tea with aggressive marketing promising a cure for flu. These are medicinal claims, which may lead to reclassification as a medicinal product and a high fine.
- The third example is ginkgo biloba placed in the category “Memory medicines” or with a link to an article about treating dementia. Even indirect claims or categorisation may be considered a risky breach of the rules.
Legal dealings with authorities
If you receive a notice of the commencement of an inspection, do not panic, but act, as deadlines run. Contact an attorney so that communication with the authority is handled by a professional and your procedural rights are safeguarded. If you disagree with the inspector’s findings, defend yourself by filing objections to the inspection report—this is a key moment in your defence. An appeal may be filed against a fine decision, followed by an administrative action before the Czech administrative courts.
The attorneys at ARROWS, a Prague-based law firm, have extensive experience representing food business operators at all stages of proceedings.
Specific risks related to imports and social media
An e-shop operator is responsible for the information published on the website, including user reviews, if you moderate them or use them in marketing. If an influencer claims that a product cures an illness and is paid by you, you as the advertiser are also liable for this breach. Influencer marketing is subject to the same rules as other advertising under Czech law.
When importing, special attention should be paid to supplements from non-European countries, which often contain substances not permitted in the Czech Republic. High doses of certain substances may lead to immediate classification as medicinal products.
Conclusion
The distinction between a food supplement and a medicinal product is a fundamental legal concept with real impacts on your business in the Czech Republic. Ignoring these rules does not pay off in an era of digitised enforcement mechanisms.
The attorneys at ARROWS, a Prague-based law firm, can help you set up your business so that it is safe, compliant, and sustainable in the long term. We provide a comprehensive service—from notifications and packaging reviews to representation in disputes.
Do you have doubts about your product? Contact us at office@arws.cz for a non-binding consultation. Prevention is always cheaper than a fine.
FAQ – Most common legal questions regarding food supplements
1. What should I do if SZPI (the Czech State Agricultural and Food Inspection Authority) claims that my statement is medicinal?
Exercise your right to a defence. Together with an attorney, analyse whether the statement can be defended as a health claim, or whether the authority has exceeded its powers, and submit well-founded objections.
2. Is the notification of a food supplement subject to a fee?
Submitting the notification to the Ministry of Agriculture is currently not subject to an administrative fee in the Czech Republic, but costs may arise in preparing the supporting documentation and for legal representation.
3. Can I use claims from the “on hold” list without concern?
You can, but with caution. You must monitor whether the claim has been removed or negatively assessed, and the claim must not be phrased as a medicinal (curative) claim.
4. Am I at risk of criminal prosecution for selling a supplement with a medicinal claim?
Primarily, this is an administrative offence (a misdemeanour) under Czech law. Criminal liability arises in serious cases involving fraud, endangering the public, or large-scale consumer harm.
5. Am I responsible for texts written for me by a marketing agency?
Yes— as the food business operator, you bear the public-law liability under Czech legislation. However, you may subsequently seek compensation from the agency in a private-law dispute if it breached the contract.
Notice: The information contained in this article is of a general informational nature only and is intended for basic guidance on the topic. Although we strive for maximum accuracy, legal regulations and their interpretation evolve over time. To verify the current wording of the regulations and their application to your specific situation, it is therefore necessary to contact ARROWS, a Prague-based law firm, directly (office@arws.cz). We accept no liability for any damages or complications arising from the independent use of the information in this article without our prior individual legal consultation and professional assessment. Each case requires a tailored solution, so please do not hesitate to contact us.
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