Responsibility for the effects of dietary supplements

What is legal liability for the effects of a supplement?

Many manufacturers are not fully aware of the scope of their liability. The duty to inform consumers is a statutory obligation arising primarily from EU regulations and the Czech Food Act. 

Breaches may result in public-law sanctions imposed by regulators, as well as civil liability for damage caused by a product defect.

Liability is divided into three basic levels:

1. Liability for the safety of the composition (prohibition ).

2. Liability for labelling and claims (compliance with ).

3. Liability for mandatory warnings (information on dosage and restrictions).

ARROWS advokátní kancelář’s Czech legal team regularly handles administrative proceedings with SZPI, where the content of websites and leaflets is often key evidence of a breach of Czech legislation.

Legal framework – what obligations apply to you?

Food supplement regulation is harmonised across the EU. In the Czech Republic, you must comply with a combination of EU regulations and Czech implementing legislation.

Key regulations applicable in 2026:

• Regulation (EU) No 1169/2011 on .
• Regulation (EC) No 1924/2006 on nutrition and health claims.
• Regulation (EU) 2023/915 on maximum limits.
• Decree No. 58/2018 Coll. on food supplements.
• Act No. 110/1997 Coll. on food.

The attorneys at ARROWS advokátní kancelář carry out product compliance reviews so that products meet all these layers of regulation simultaneously under Czech law.

Difference between a prohibited medicinal claim and a permitted health claim

A fundamental rule of food law is the prohibition on attributing to any food, including food supplements, properties of preventing, treating, or curing human diseases.

Medicinal claim (Prohibited): Creates the impression that the product is a medicine.

• Examples: “Treats arthritis”, “Reduces pain”, “Protects against viruses”.
• Risk: Immediate fine and classification as .

A medicinal claim creates the impression that the product is a medicine, which is strictly prohibited and penalised for food supplements under Czech and EU rules.

Health claim (Regulated): Describes the relationship between a substance and health. 

Only those included in the EU Register or those that are “on hold” are permitted.

• Examples: “Vitamin C contributes to the normal function of the immune system”.
• Condition: You must adhere to the exact wording or the meaning of the statement.

Breaching these rules may lead to a fine of up to CZK 50 million under the Czech Food Act.

Mandatory warnings on packaging and in leaflets

Under Decree No. 58/2018 Coll. and EU regulations, food supplement packaging must contain specific information. Failure to provide it constitutes an administrative offence under Czech law.

Mandatory information on food supplement packaging:

• The designation “food supplement”.
• The name of the categories of nutrients or substances.
• Recommended daily dosage .
• Warning: “Do not exceed the recommended daily dosage”.
• Warning: “Not intended as a substitute for a varied diet”.
• Warning: “Keep out of reach of children”.
• Amount of active substances and composition.
• Identification of the operator.

In leaflets and on the e-shop, when making a health claim you must also add a statement on the importance of a varied diet and a healthy lifestyle.

Risks and penalties – what you may face

SZPI (the Czech Agriculture and Food Inspection Authority) has the power to impose significant penalties under Act No. 110/1997 Coll. (the Czech Food Act).

How to word notices correctly – practical examples

Incorrect (prohibited) wording:

• “Treats joint pain” (medicinal claim).
• “Gets rid of the flu” (medicinal claim).
• “Increases sexual performance” (overly strong claim).
• “You will lose 5 kg in a week” (prohibited claim about the speed of weight loss).

Correct (permitted) wording:

• “Vitamin C contributes to normal collagen formation for the normal function of cartilage.”
• “Tribulus terrestris supports the function of the reproductive organs” (on-hold claim).
• “Glucomannan, in the context of an energy-restricted diet, contributes to weight loss.”

Practical recommendation: Verify each claim in the EU Register of Health Claims.

Special cases – interactions with medicines and warnings

Although legislation does not explicitly require this for all substances, from the perspective of preventing liability for personal injury it is essential to include warnings for substances with known interactions.

Examples of necessary warnings:

• Vitamin K: “People taking blood-thinning medication should consult a doctor before use.”
• St John’s wort: May reduce the effectiveness of hormonal contraception.
• Ginkgo biloba: May affect blood clotting.

The absence of such a warning may lead to a successful claim for damages for personal injury, even if the relevant Czech decree does not directly impose this specific warning.

Checklist – what must be in the leaflet and on the packaging

Before printing or launching a campaign, check:

On the packaging/label (mandatory):

• [ ] Name: “FOOD SUPPLEMENT”.
• [ ] Product trade name.
• [ ] List of ingredients and highlighted allergens.
• [ ] Amount of active substances.
• [ ] Best-before date and net quantity.
• [ ] Recommended daily dosage.
• [ ] Warning: “Do not exceed the recommended daily dose.”
• [ ] Warning: “Not intended as a substitute for a varied diet.”
• [ ] Warning: “Keep out of reach of children.”
• [ ] Identification of the manufacturer/seller.

In marketing (website, leaflet):

• [ ] Only authorised health claims (or “on hold”).
• [ ] No medicinal claims.
• [ ] Provide contextual information about a varied diet.

Notification – the first step that must not be forgotten

Before first placing a food supplement on the market in the Czech Republic, the operator is required to send the Czech-language label text to the Ministry of Agriculture of the Czech Republic.

• How it is done: by email or via a data box (datová schránka).
• What it means: This is a notification, not an approval. The Ministry does not verify the accuracy of the information; the manufacturer bears responsibility.
• Penalty: Failure to comply with the notification obligation may result in a fine of up to CZK 1 million.

Liability for food supplements is a complex discipline combining law, food chemistry, and marketing. What may look like an attractive advertising slogan can be the reason for a substantial fine.

The attorneys of ARROWS advokátní kancelář provide comprehensive services in Czech food law, from notifications to representation during SZPI inspections.

Do not underestimate prevention—the cost of legal review is a fraction of the fines that may be imposed for non-compliance.

Most common legal questions

1. I am a seller of food supplements, not a manufacturer. Am I liable for the content of leaflets?
If the leaflet was created by the manufacturer and you only distribute it passively, they bear primary responsibility. However, if you create the leaflet yourself or rewrite the information for your e-shop, you become fully responsible for that information.

2. Can I state on my e-shop that the supplement “supports immunity” even if it is not on the packaging?
No, if this claim is not compliant with the regulation. Information on an e-shop is considered food information/labelling and is subject to the same regulation as the packaging.

3. Do I need scientific documentation for every claim?
For authorised health claims, you rely on EFSA’s assessment and you do not need to create your own documentation. For “on hold” claims, you must be able to demonstrate that the claim is based on generally accepted scientific evidence.

4. What if an influencer shares my supplement and claims it “cured” them?
SZPI also monitors social media. If it is clear from the context that this is a collaboration, you may face a fine in the Czech Republic. The influencer agreement should clearly define what they may and may not say about the product.

Legal notice: This article is for informational purposes only and does not constitute legal advice within the meaning of the Czech Advocacy Act. Legislation may change. For assistance with a specific situation, we recommend contacting ARROWS advokátní kancelář at consultation@arws.cz.

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