Dietary supplement vs. medicine vs. novel food Comparison and differentiation

12.3.2026 | ARROWS law firm

The distinction between a food supplement, a medicinal product and a novel food is crucial for businesses, as each category is governed by different regulations and carries different sanction risks under Czech law. In the following text, we explain the exact legislative boundaries, the specific obligations when placing products on the market in the Czech Republic, and the consequences of incorrect classification, which may lead to substantial fines and even product withdrawals from the market.

The illustrative image shows a lawyer during a consultation regarding the distinction between food supplements and medicinal products.

Article contents

Quick summary
Novel food: definition and authorisation process
Authorisation process for novel foods in the EU
Key legal differences: comparison table
Table of risks and common mistakes
When is reclassification a risk? The thin line between categories
Examples of problematic situations
Hygiene requirements and HACCP

Quick summary

Core legal distinction : A food supplement is a food intended to supplement the normal diet, without medicinal effects. A medicinal product is a substance with proven therapeutic or preventive effects that is subject to strict registration. A novel food is a food that was not consumed to a significant degree in the EU before 15 May 1997.
Regulation and sanctions : Incorrect categorisation may lead to substantial fines, which in the Czech Republic can reach tens of millions of Czech crowns, withdrawal of products from the market, or a sales ban. Each category involves different procedures with varying complexity and approval timelines.
Practical business impact : Registering a medicinal product is time- and cost-intensive, and authorisation of a novel food takes years. A food supplement is notified more easily, but incorrect labelling creates significant risk. The attorneys at ARROWS, a Prague-based law firm, deal with these issues daily and can help you determine the correct category.

Food supplement: definition, obligations and framework

Under Act No. 110/1997 Coll., on Foodstuffs, and implementing Decree No. 58/2018 Coll., a food supplement is a food whose purpose is to supplement the normal diet. It must be a concentrated source of vitamins, minerals, or other substances with a nutritional or physiological effect.

Under Czech legislation, food supplements are foods, just like ordinary bakery products or dairy products. They are governed by food law regulations, not medicinal product regulations, even though they are often sold in forms typical for medicines, such as tablets or capsules.

Notification obligation for food supplements

A business that wishes to place a food supplement on the Czech market must fulfil a notification obligation towards the Ministry of Agriculture of the Czech Republic. The notification is made by submitting the Czech-language label text before the product is first placed on the market, most commonly via an online form.

Notification is not an authorisation procedure; at this stage, the authorities do not approve sales or verify the product’s effectiveness. Responsibility for the correct composition, safety and labelling lies solely with the food business operator, who may subsequently be inspected by the relevant inspection authority.

Mandatory information on food supplement packaging

On the packaging of every food supplement, pursuant to EU Regulation No. 1169/2011 and Decree No. 58/2018 Coll., the following must be stated, among other things:

the name “ FOOD SUPPLEMENT ” (must be stated clearly),
the names of the categories of nutrients or substances that characterise the product,
the recommended daily dose and a warning against exceeding this dose,
a warning that the product should not be used as a substitute for a varied diet,
a warning that the product should be stored out of the reach of children,
the amount of vitamins and minerals expressed numerically and as a percentage of the reference intake value.

If the packaging lacks the designation “FOOD SUPPLEMENT”, the product is considered incorrectly labelled. This exposes the business to the risk of sanctions under Czech food law.

Health and nutrition claims for food supplements

This is where breaches of legal regulations most often occur. Labelling and advertising of a food supplement must not attribute to the food properties of preventing, treating or curing human disease, nor refer to such properties.

If a manufacturer uses an unauthorised medicinal claim, they face a significant fine and an order to withdraw the product from the market.

In practice, manufacturers often incorrectly rely on so-called “on hold” claims, which requires careful legal assessment. The attorneys at ARROWS, a Prague-based law firm, handle cases daily where manufacturers face inspections by the Czech Agriculture and Food Inspection Authority (SZPI) precisely due to these breaches, and can help you set up your claims correctly.

Medicinal product: registration, requirements and consequences

Unlike a food supplement, a medicinal product under Act No. 378/2007 Coll., on Pharmaceuticals is defined as a substance with therapeutic or preventive properties. It may also be a substance intended to restore or modify physiological functions or to establish a medical diagnosis.

The key difference lies in the need to demonstrate effects and safety, which must be supported by extensive documentation. The registration procedure with the State Institute for Drug Control (SÚKL) in the Czech Republic or the European Medicines Agency (EMA) is procedurally and financially demanding.

Registration procedure for medicinal products

Before placing a medicinal product on the market, the applicant must obtain a marketing authorisation decision based on comprehensive documentation. This includes:

administrative data,
chemical, pharmaceutical and biological information,
results of preclinical tests,
results of clinical trials in humans,
a safety monitoring system.

The procedure may be conducted via the national route, the mutual recognition procedure, or the centralised procedure. Although the statutory time limit is 210 days, in practice the process is often extended to more than a year.

Marketing authorisation number and medicinal product labelling

Each registered medicinal product must have a marketing authorisation number on the packaging, which is a key identifier. In the Czech Republic, national authorisations have a specific format, as do centralised authorisations valid throughout the EU.

If a business places on the market a product that meets the definition of a medicinal product without a valid marketing authorisation, it commits an administrative offence. This offence may be punished by a fine of up to CZK 20,000,000, and it may also meet the elements of a criminal offence.

Safety and pharmacovigilance

After authorisation, the marketing authorisation holder must ensure pharmacovigilance, i.e., monitoring the product’s safety. If new risks emerge, SÚKL may order a variation to the authorisation or even withdrawal of the product.

No similarly strict post-market monitoring system is in place for food supplements. This is because foods are not expected to have a pharmacological effect comparable to medicinal products.

Novel food: definition and authorisation process

The concept of novel food in the EU is governed by Regulation (EU) 2015/2283. It covers any food that was not consumed to a significant degree in the EU before 15 May 1997 and that also falls within the defined categories.

Novel foods include, for example, chia seeds at the time of their first authorisation, CBD in foods, or insect proteins. If a product falls within this definition, it must not be placed on the market without prior authorisation by the European Commission.

Novel foods authorisation process in the EU

The authorisation process is centralised at EU level and includes the following steps:

Application submission : Electronically to the European Commission.
Validation : The Commission verifies that the application is valid.
Risk assessment : EFSA carries out a scientific safety assessment.
Commission decision : Authorisation to place on the market and an update of the list.

The entire process, from preparing the supporting documentation to the final decision, typically takes 1.5 to 2.5 years. It is a data-intensive process, especially in the areas of toxicology and compositional characterisation.

Safety requirements for novel foods

For a novel food to be authorised, the applicant must scientifically demonstrate that the food does not pose a safety risk to human health. Safe conditions of use and specifications must also be established.

The list of authorised novel foods is available in the Union list of novel foods. This list defines the conditions under which these foods may be placed on the market.

Main legal differences: comparison table

Criterion	Food supplement	Medicinal product	Novel food
Definition:	Food intended to supplement the normal diet; a concentrated source of substances	A substance with therapeutic/preventive effects or used to establish a diagnosis	Food with no history of significant consumption in the EU before 15 May 1997
Legal regime:	Food Act (Act No. 110/1997 Coll.)	Act on Medicinal Products (Act No. 378/2007 Coll.)	Regulation (EU) 2015/2283 + the Food Act
Approval before sale:	Notification only to the Ministry of Agriculture (MZe)	Registration (SÚKL or EMA)	Authorisation by the European Commission (based on EFSA assessment)
Efficacy:	Does not have to be demonstrated	Must be demonstrated (clinical trials)	Primarily safety is assessed, not efficacy
Mandatory labelling:	"FOOD SUPPLEMENT"	Registration number, Braille, medicinal product code	As set out in the authorisation conditions (specific name, warnings)
Health claims:	Only those permitted under Regulation 1924/2006	As per the Summary of Product Characteristics (SmPC)	Only if authorised and not misleading
Regulator in the Czech Republic:	Ministry of Agriculture, SZPI	SÚKL	MZe, SZPI (supervision), European Commission (authorisation)

Risks: what happens if you confuse the categories

The most common risk is a so-called borderline product, where the manufacturer considers the product a food supplement, but the regulator determines that it is a medicinal product. The consequences of such a decision are often devastating for the business.

Table of risks and typical mistakes

Risks and sanctions	How ARROWS helps (office@arws.cz)
Unauthorised medicinal claims: Using treatment claims for a food supplement leads to a fine (in theory up to CZK 50 million) and a sales ban.	Compliance audit: ARROWS will carry out a detailed review of labels and your e-shop, and adjust wording to ensure compliance with the health claims regulation.
Illegal medicinal product: Selling a product that SÚKL classifies as a medicinal product without registration. A fine of up to CZK 20 million under the Czech Act on Medicinal Products, and criminal-law risk.	Representation in proceedings on product classification: We will assist you in proceedings before SÚKL in defending why your product is not a medicinal product, or guide you through the registration process.
Unauthorised novel food: Selling a novel food without authorisation. Withdrawal from the market, fine.	Novel food status analysis: We will verify the history of consumption and the ingredient’s status. If authorisation is required, we will prepare the application for the Commission/EFSA.
Incorrect notification: Missing notification or incorrect information.	Preparation of the notification: We will ensure a formally correct notification of placing on the market with the Ministry of Agriculture.

When is reclassification a risk? The thin line between categories

SÚKL and SZPI assess products comprehensively. Whether a product is a medicinal product is not determined solely by the manufacturer’s view, but primarily by objective criteria such as the product’s presentation and function under Czech legislation.

Product presentation : If you claim that the product cures, it is a medicinal product “by presentation”, even if it does not contain an active substance.
Product function : If the product contains a substance at a concentration that significantly affects physiological functions, it is a medicinal product “by function”.

Examples of problematic situations

Melatonin : In the Czech Republic, it is primarily considered a pharmacologically active substance; however, there are specific exceptions for food supplements.
Herbal extracts : Plants such as Tribulus terrestris may be considered a medicinal product at high doses, even if they have authorised claims.

The attorneys of ARROWS, a Prague-based law firm, routinely handle disputes over the classification of borderline products. Contact us at office@arws.cz.

Fortified foods

In addition to the categories above, there are foods fortified with vitamins and minerals under Regulation (EC) No 1925/2006. These are ordinary foods, such as juices or cereals, to which nutrients have been added, and they are neither food supplements nor medicinal products.

Seller’s obligations: what do you need to comply with?

Registration with SZPI

Any business operator placing foods on the market in the Czech Republic or operating an online shop selling food must register as a food business operator. This obligation arises directly from the Czech Food Act and is linked to the place of business.

Hygiene requirements and HACCP

You must comply with hygiene regulations under Regulation (EC) No 852/2004. It is necessary to have a critical control points system (HACCP) in place or to follow the principles of good hygiene practice.

Contractual arrangements

If you import food supplements, it is crucial to have contracts properly set up for potential liability relating to composition or labelling. Our Prague-based law firm will prepare distribution agreements for you that protect your interests. Order a legal audit of your contracts at office@arws.cz.

The distinction between a food supplement, a medicinal product, and a novel food is essential for doing business in the life sciences sector in the Czech Republic. The boundaries are not always clear-cut, and interpretation evolves with the decision-making practice of courts and authorities.

The attorneys of ARROWS, a Prague-based law firm, provide comprehensive legal support to manufacturers and distributors:

Product classification (supplement vs. medicinal product).
Validation of labels and health claims .
Notification of food supplements and registration of medicinal products .
Representation during inspections by SZPI and SÚKL .
Addressing Novel Food matters .

If you are not sure which category your product falls into, do not risk multi-million fines. Just write to office@arws.cz.

Most common legal questions:

1. What is the main difference between a food supplement and a medicinal product?
A food supplement is a food intended for healthy people to supplement the diet. A medicinal product is used to treat, prevent, or diagnose diseases and must have proven efficacy.

2. What fine can I receive for selling an unregistered medicinal product?
The Czech Act on Medicinal Products provides for a fine of up to CZK 20,000,000 for this offence.

3. Are CBD products food supplements?
According to the current position of the European Commission and the Czech Ministry of Agriculture, cannabis extracts containing CBD are considered a novel food. This ingredient has not yet been broadly authorised for use in food supplements.

4. Do I have to state “approved by the Ministry of Health” on a food supplement?
No, food supplements are not approved; they are only notified to the Czech Ministry of Agriculture. Stating that they are approved may be considered misleading to consumers.

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 maximum care to ensure accuracy, legal regulations and their 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 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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