Legal Classification of Herbal Elixirs and Dietary Supplements in Czechia

Are you launching the sale of herbal elixirs? You are facing a choice that will determine both the rules of the game and the level of potential sanctions. The difference between a dietary supplement and a regular food product fundamentally affects labeling, permitted health claims, and inspections under Czech law. In this article, our Prague-based legal team explains how to correctly classify your product and avoid fines from the Czech Agriculture and Food Inspection Authority, which can reach up to 50 million CZK.

Quick Summary

• Critical Classification: If you choose the wrong category (food vs. dietary supplement), you risk a sales ban and high penalties – correct legal qualification is the foundation of a safe business in the Czech Republic.
• Regulation in Detail: Dietary supplements are strictly regulated – notifications, mandatory warnings, active ingredient limits, and inspections by the Czech Agriculture and Food Inspection Authority (SZPI) can occur at any time.
• Claims and Marketing: Health and medicinal claims are subject to strict rules; their unauthorized use is punished with high fines – for herbal products, knowing the "On Hold" list is crucial.

Difference Between a Dietary Supplement and Food: The Legal Reality

At first glance, product classification seems simple. You take a herbal extract, bottle it, and sell it. In reality, however, this decision has profound legal consequences. If it is later discovered that you chose the wrong classification, it is not just an administrative oversight – it is a strategic error with existential risks. The Czech Agriculture and Food Inspection Authority (SZPI) can withdraw your product from the market and impose fines in the millions of Czech korunas.

Under Czech legislation, a dietary 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. Specific regulation is set by Decree No. 58/2018 Coll., on dietary supplements and food composition.

Ordinary food (e.g., tea, syrup, or a herbal drink) does not have this status and is subject to general food labeling rules according to Regulation (EU) No. 1169/2011. The key difference often lies in the dosage and form. If the product is taken by spoonfuls or capsules, it is typically a dietary supplement, whereas a drink in normal portions is considered food.

If you choose the wrong category, you face penalties for placing unsafe food on the market or for misleading the consumer under Czech law.

Basic Differences in Regulation: What Changes with Classification

When deciding how to classify your herbal elixirs, you must understand three fundamental differences in regulation. The first is notification, the second is content and composition, and the third concerns marketing.

A dietary supplement is subject to mandatory notification to the Czech Ministry of Agriculture before being first placed on the market, whereas ordinary food usually does not have this obligation. You must submit the text of the Czech labeling (label) and potentially pay an administrative fee.

The second key difference is content and composition. For dietary supplements, it is necessary to adhere to limits for vitamins and minerals and avoid prohibited substances listed in Annex to Decree No. 58/2018 Coll.. For ordinary food, regulation is more general, but it remains that the food must be safe according to European law.

For both dietary supplements and food, medicinal claims attributing the ability to treat diseases to the product are strictly prohibited and punished with high fines. Health claims (e.g., "supports immunity") are permitted only if approved by the European Commission, or for plant substances, so-called "On Hold" claims.

Our attorneys in Prague at ARROWS law firm deal with this area daily and know where the pitfalls hidden from laypeople lie. When we prepare a label with our client, we don't just check what is there – we also check what should not be there, ensuring everything is in full compliance with the legal definition of the product in the Czech Republic.

MicroFAQ – Basic Classification and Obligations

1. How do I know if my herbal elixir should be a dietary supplement or ordinary food?
The decisive factors are the intended use and form. A dietary supplement is intended to supplement the normal diet in small, precisely defined doses (capsules, drops, spoonfuls of syrup). Ordinary food serves for satiety, nutrition, or enjoyment and is consumed in normal portions (bottled drink, tea).

2. What happens if I choose the category myself without legal consultation?
You risk the SZPI or a court retroactively reclassifying your product. If you sold a dietary supplement as food (and did not notify), you have violated the law. If you sold a medicine as a dietary supplement (a so-called borderline product), you face prosecution also from the State Institute for Drug Control (SÚKL).

3. Who should I contact for correct classification?
You can request an opinion from the National Institute of Public Health (SZÚ), which issues expert assessments, but legally binding decisions in case of a dispute are made by Czech courts. Ideally, contact office@arws.cz – our Czech legal team at ARROWS will help you with a legal analysis and ensure your decision is backed by arguments in case of an inspection.

Notification of Dietary Supplements: An Obligation You Must Not Overlook

Once you decide that your product is a dietary supplement, you have an obligation to notify the Czech Ministry of Agriculture according to Section 3d of the Food Act.

Notification means sending the Czech text of your product's labeling to the Ministry; this is not an approval process, but the fulfillment of a reporting obligation.

Notification is carried out:

• Ideally electronically.
• It must be done before the first placement on the market.
• You attach the label text to the notification.

In practice, we encounter entrepreneurs who notify late or not at all. This is an easily detectable violation of the law. The correct procedure is: notify before you start selling and archive the confirmation of submission.

The question of import also frequently arises during notification, an area where our Prague-based attorneys at ARROWS have long-term experience.

What a Dietary Supplement Label Must Contain

A label is a legal document. It must contain data according to Regulation (EU) 1169/2011 and Czech Decree No. 58/2018 Coll.

Mandatory information on dietary supplement packaging includes, among others:

• The designation "food supplement" – a mandatory category label under Czech law.
• Names of the categories of nutrients or substances that characterize the product, or an indication of the nature of those substances.
• Recommended daily dosage.
• Warning: "Not intended as a substitute for a varied diet".
• Warning: "Keep out of reach of children" (the exact wording may vary, but the meaning is prescribed by Czech decree).
• Warning: "Do not exceed the recommended daily dosage".
• Amount of substances with a nutritional or physiological effect in the daily dose (numerical).
• Identification of the business operator (manufacturer, importer, or seller) under whose name the product is marketed in the Czech Republic.
• Minimum shelf life or expiration date.
• List of ingredients in descending order.
• Highlighting of allergens (according to legislation) if present.

A frequent error is the absence of one of the warnings or an incorrect format of the nutrition table (for supplements, a classic energy/fat/sugar table as used for food is not required; instead, the amount of active substances per dose must be stated).

MicroFAQ – Labeling and Notification

1. Can I design the label myself and send it to the Ministry?
Yes, but the risk of errors is high. The label must meet dozens of parameters (font size, placement of data, precise wording). An error on the label means the necessity of relabeling or disposing of packaging.

2. How long is the notification valid?
The notification is a one-time process. However, if you change the composition or significantly alter the label text (new claims), it is necessary to perform the notification again or update it with the Czech authorities.

3. Where can I find a list of notified supplements?
In the Register of Decisions of the Chief Hygienist (for older products) and in the online register of the Ministry of Agriculture of the Czech Republic (RoHaP). If your product is not there, it serves as a signal for inspection authorities to investigate.

Rules for Claims and Marketing

Can you claim that your herbal elixir "supports immunity"? Only under specific conditions. Czech and EU legislation distinguish between three types of claims that can be used in marketing.

1. Nutrition claims – inform about nutrient content (e.g., "source of vitamin C", "sugar-free"). These are permitted if they meet the conditions in the relevant annex.

2. Health claims – declare a relationship between a substance and health (e.g., "vitamin C contributes to the normal function of the immune system"). These claims must be approved by the European Commission and listed in the EU Register.

3. Medicinal claims – attribute to a food the ability to prevent, treat, or cure diseases. These are strictly prohibited for food supplements in the Czech Republic.

Claims that have been submitted for assessment and are pending can be used under certain conditions if they are scientifically substantiated. This particularly concerns botanicals and the so-called "On Hold" list of the European Commission.

Example: For the herb Echinacea purpurea, an "On Hold" claim regarding "normal function of the immune system" can be used. However, you must use a precisely defined part of the plant and comply with the conditions of use.

Our attorneys in Prague at ARROWS law firm can assist you with an audit of your texts to avoid fines while maintaining marketing impact.

Approved Health Claims: Where to Look

All permitted claims can be found in the EU Register of nutrition and health claims and in the "On Hold" claims list (available, for example, on the website of the Czech Agriculture and Food Inspection Authority (SZPI) or in the EFSA database).

If you do not find a claim in these lists, you may not use it. The use of an unapproved claim or a medicinal claim is one of the most common reasons for fines in the Czech Republic.

MicroFAQ – Marketing and Claims

1. Can I write "traditional herbal recipe"?
Yes, if it is true. However, be careful about connections to medicinal effects. "Traditionally used for flu" is already an impermissible medicinal claim.

2. Can I use customer reviews where they claim to have been cured?
No. In commercial communication (including your website and social media), you may not use reviews that contain prohibited medicinal claims. You are responsible for the content you present.

3. What is the penalty for misleading advertising?
The fine can reach up to 50 million CZK; in practice, for smaller infractions, it ranges in the tens to hundreds of thousands, but it increases with repeated violations.

Risk Table for Manufacturers of Herbal Elixirs

Risks and Sanctions	How ARROWS Helps (office@arws.cz)
Incorrect product classification: Confusion between food, dietary supplement, or medicinal product. Risk of market withdrawal and fines.	Legal analysis and qualification: Our Czech legal team will evaluate the composition and purpose, recommend the correct category, and provide arguments for the authorities.
Incorrect or missing notification: Selling without fulfilling the notification obligation.	Securing notification: We will check the label and handle the notification at the Czech Ministry of Agriculture for you.
Prohibited claims in marketing: Use of medicinal claims or unapproved health claims (fine up to 50 million CZK).	Marketing audit: We will review your e-shop, packaging, and social networks.
Unauthorized composition: Content of prohibited herbs or exceeding limits.	Composition check: We verify the composition according to Decree No. 58/2018 Coll., the Novel Food Regulation, and other Czech regulations.
SZPI Inspection: Poor communication during an inspection, signing an unfavorable protocol.	Representation during inspections: We will represent you in proceedings before the SZPI, defend your rights, and minimize sanctions.

Composition and Content: What You Can and Cannot Do

Decree No. 58/2018 Coll. and other regulations set limits and prohibitions under Czech law.

1. Prohibited substances: contains a list of plants and substances that are prohibited in food supplements (e.g., amygdalin, certain types of ephedra in pure form, etc.).

2. Restricted substances: Some substances have maximum limits set (e.g., synephrine, monacolins from red fermented rice – according to EU regulations).

3. General safety: Even if a plant is not explicitly prohibited by the decree, you as a manufacturer must guarantee its safety. The National Institute of Public Health (SZÚ) issues guidelines containing recommended safe limits for many herbs. Exceeding these recommendations may lead the SZPI to evaluate the product as unsafe.

Our Prague-based attorneys at ARROWS law firm regularly consult on product compositions and compare them with current legislation and SZÚ recommendations so that clients do not risk selling unsafe food products.

Allergen Information: A Necessary Obligation

If your herbal elixir contains any of the 14 main allergens (e.g., celery, sulfur dioxide, nuts – e.g., almonds, macadamia nuts), you must clearly highlight this in the ingredients list (e.g., in bold or a different font).

Safety and Quality: Testing and Control

The manufacturer is responsible for ensuring that the product is safe. In practice, this means the obligation to have established procedures (HACCP) and to conduct laboratory testing under Czech and EU standards.

We recommend testing specifically for:

• Microbiology (bacteria, molds).
• Heavy metals (lead, cadmium, mercury).
• Active ingredient content (proving that the product contains what it declares).

You may voluntarily apply to the National Institute of Public Health (SZÚ) for a Certificate of Health Safety. While this does not replace notification, it serves as a strong argument for customers and inspectors that the product is compliant with Czech health standards.

Traceability and documentation

You must be able to prove from whom you purchased raw materials and to whom you sold the product (one step forward, one step back). This traceability is crucial during a potential product recall under Regulation (EC) 178/2002.

SZPI Inspections: What to expect and how to defend yourself

The Czech Agriculture and Food Inspection Authority (SZPI) conducts regular and targeted inspections (often based on a tip from a competitor or a dissatisfied customer).

During an inspection, you have the right to:

• Be present during sampling and request a so-called supplementary sample for your own independent analysis.
• Access the case file.
• Provide comments on the inspection report.

If the SZPI identifies a deficiency, it may impose measures and subsequently initiate administrative proceedings regarding a fine.

Our attorneys in Prague at ARROWS law firm can represent you from the very beginning of the inspection, ensuring your legal rights are protected.

Import and trade: If you manufacture abroad

If you import elixirs from countries outside the EU, you are in the position of an importer and bear full responsibility for compliance with European and Czech law.

Selling an unapproved "novel food" is a serious violation and leads to an immediate sales ban. Beware of "Novel Foods". If your product contains an exotic herb that was not consumed to a significant degree in the EU before 1997, it is subject to approval by the European Commission.

If you are unsure about the status of a raw material, consult the Novel Food Catalogue or contact our Czech legal team at office@arws.cz for a legal assessment.

Insurance and liability

We recommend having product liability insurance for damage caused by a defective product. This covers cases where your product might cause health harm to a consumer.

The attorneys at ARROWS law firm in Prague are insured for professional liability up to hundreds of millions of CZK, providing our clients with absolute security when providing legal advice.

Conclusion

Legal protection for a manufacturer of herbal elixirs requires diligence. The distinction between a dietary supplement and ordinary food is fundamental and determines your entire business strategy. Correct classification, flawless labeling, verified composition, and legal marketing are the pillars of a safe business in the Czech Republic.

Our Prague-based attorneys at ARROWS law firm handle these issues comprehensively, from label audits and notifications to representation during SZPI inspections. Investing in legal prevention is a fraction of the costs represented by fines and product recalls.

If you want to be certain that your herbal elixirs comply with Czech legislation, contact ARROWS law firm at office@arws.cz.

FAQ – Most frequent legal questions regarding the protection of herbal elixir manufacturers

1. How do I know if my herbal drink is a dietary supplement or a foodstuff?
The form and purpose are decisive. A small measured dose (spoon, dropper) with concentrated content indicates a dietary supplement. General consumption for thirst or taste indicates a foodstuff.

2. Is notification mandatory?
Yes, for dietary supplements, notification to the Czech Ministry of Agriculture is mandatory before being placed on the market (Section 3d of the Czech Food Act).

3. What claims am I allowed to use?
Only approved health claims according to the EU Register, so-called "On Hold" claims for herbs (if evidence-based), and general nutrition claims. Medicinal claims are strictly prohibited.

4. What if the SZPI comes for an inspection?
Cooperate, but defend your rights. Request a supplementary sample. In case of doubt, immediately call our Prague-based attorneys at ARROWS law firm at office@arws.cz. 

5. What is the "On Hold" list?
A list of health claims for botanical substances that are awaiting final EU assessment but can currently be used under certain conditions. It is a key tool for herbal marketing.

6. How can I secure legal assistance effectively?
Have an initial audit of labels and terms and conditions performed. This eliminates 80% of the most common risks. For a specific proposal, contact ARROWS law firm at office@arws.cz. 

Disclaimer: The information contained in this article is for general informative purposes only and serves as a basic orientation. Although we ensure maximum accuracy, legal regulations and their interpretation evolve over time. To verify the current wording of Czech regulations and their application to your specific situation, it is essential to contact ARROWS law firm directly (office@arws.cz). We bear no responsibility for any damages or complications arising from the independent use of information from this article without our prior individual legal consultation and professional assessment. Every case requires a tailor-made solution; therefore, do not hesitate to contact us.

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