Food Supplements Versus Medicinal Products in the European Union: Understanding the Regulatory Boundary and What it Means for your Product Development

19 Oct 2026

Introduction 

A product intended to launch as a food supplement can become classified as a medicinal product in the European Union (EU), potentially triggering marketing authorisation requirements, significant delays, increased costs, and restricted commercial claims. The EU boundary between a food supplement and a medicinal product is a legal classification of the finished product, not a choice of commercial route. The chosen regulatory route dictates the pre-market strategy, evidence standards, manufacturing controls, labelling, advertising and enforcement regime. Because Member States apply the EU definitions to individual products, the assessment should begin before the formulation, the daily dose and the commercial communication are fixed. 

For companies developing supplements containing botanicals, nutraceuticals and functional ingredients, understanding where the regulatory boundary lies is critical. In this blog, we explore how authorities distinguish food supplements from medicinal products and the key factors businesses should consider when developing products for the European market. 

Food Supplements in the European Union 

Directive 2002/46/EC [1] defines food supplements as “foodstuffs intended to supplement the normal diet, comprising concentrated sources of nutrients or other substances with a nutritional or physiological effect…marketed in dose form”. Any EC Directive (unlike a Regulation) allows a Member State to retain autonomy of the implementation. Directive 2002/46/EC harmonizes core requirements for vitamins and minerals, but Member State rules remain important for other substances, maximum amounts, product notification and enforcement.  

The presence of a substance in an authorized medicine does not automatically make every food containing that substance a medicinal product. Classification concerns the finished product and its actual characteristics. Equally, presenting a product as a food cannot “neutralize” medicinal properties or therapeutic claims. 

Novel Food status is a separate threshold issue, not a classification safe harbor. If an ingredient was not consumed to a significant degree in the EU before 15 May 1997 and falls within a Novel Food category, authorization under Regulation (EU) 2015/2283 [2] is required before it may be used lawfully in food. Authorization permits food use only under the specified conditions; it does not prevent a particular finished product from being classified as medicinal. 

Medicinal Products in the European Union 

Article 1(2) of Directive 2001/83/EC [3] contains two independent routes to medicinal-product status. A product is medicinal if it is presented as having properties for treating or preventing diseases in humans. It is medicinal by function if it is administered to humans to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. 

Article 2(2) gives the medicine’s framework priority where, after considering all its characteristics, a product falls within both the medicinal definition and another EU regime. It is not a precautionary shortcut. In Hecht-Pharma, the Court held that Directive 2001/83/EC does not apply where medicinal-product status by function has not been scientifically established, even if that possibility cannot be excluded. [4]

Once classified as medicinal, a prepared product generally cannot be placed on the market without marketing authorization. Depending on the product and intended territory, the route may be national, mutual recognition, decentralized or centralized. [5] The applicant must establish quality, safety and efficacy and comply with the applicable manufacturing, pharmacovigilance and product-information requirements. Certain traditional herbal medicinal products may qualify for simplified registration under Articles 16a to 16i, but this remains a medicine’s regulatory route to market. 

Applying the Regulatory Boundary 

The EU definitions are harmonized, but Member States Competent Authorities classify the finished product case-by-case and may reach different conclusions. Lawful marketing as a food in another Member State is relevant but not decisive. However, the Court of Justice requires an evidence-based assessment and proportionality where a Member State restricts a food ingredient by classifying it as medicinal product. [6] Competent authorities commonly assess the following factors in combination: 

• Qualitative and quantitative composition and recommended daily dose; 

• Express and implied claims across labelling, advertising, websites and social media; 

• Intended use, target population, route of administration, instructions and dosage form; 

• Pharmacological, immunological or metabolic properties supported by current scientific knowledge; and 

• Consumer perception, distribution, familiarity and risks, including interactions. 

No single ingredient, dose or dosage form determines the result. Dose may be highly relevant, but capsule format or physiological activity alone is insufficient. The authority must connect the product’s characteristics and recommended conditions of use to the applicable legal test. 

Claims are both a consequence of classification and evidence of presentation. A claim to treat or prevent disease may make a product medicinal by presentation. A food supplement may use only claims permitted under Regulation (EC) No 1924/2006, [7] and food information must not attribute properties of preventing, treating or curing human disease under Regulation (EU) No 1169/2011. [8] For vitamin D, the authorized food claim is “Vitamin D contributes to the maintenance of normal bones”, subject to its conditions of use. “Treats osteoporosis” is a medicinal claim. The assessment extends beyond the label to product names, imagery, websites, testimonials, social media and influencer content. The authorities will consider the totality of marketing for the product and not just the EU-specific presentation. 

In addition to Vitamin D, there are several examples where dual categorization has existed based on presentation and dose. Certain presentations may fit within food supplement frameworks, while higher doses or therapeutic positioning may attract medicinal scrutiny depending on the Member State. As another example, low-dose melatonin in supplements is used for jet-lag or similar sleep claims, but higher-dose, modified-release formulations of melatonin used for the treatment of insomnia would be regulated as medicines. Similarly, CBD is a highly relevant example in the past number of years in the EU, where products containing hemp-derived cannabinoids (which required assessment as a novel food) were under high scrutiny as potential medicinal products.  

Regulatory Implications for Market Access 

The boundary should be managed as a product-lifecycle decision rather than a final label review. A defensible classification position integrates the formula and daily dose, manufacturing specifications, intended population, evidence of physiological action, presentation and commercial communications. 

Question to Ask as Part of Your Product Development: 

• Does the ingredient have medicinal history in any region?  

• Is the dose significantly higher than dietary intake from the typical diet?  

• Are any disease-related claims being made/implied?  

• Is there evidence of pharmacological activity? What is the mechanism of action on the body? 

For a multi-country EU launch, companies should document a country-by-country classification matrix and seek national advice. The supporting file should record the legal basis, scientific evidence, comparable decisions, proposed claims and change-control triggers. A change in dose, formulation, target population or communication can reopen the classification assessment. Additionally, it should be noted that the EC is planning on setting maximum levels for vitamins and minerals, and more is expected to be announced later in 2026. 

Intertek's regulatory experts support companies throughout product development, helping assess classification risks, evaluate market access pathways and develop compliant commercialization strategies across the EU and other global markets, including dossier preparation and stewardship with regulatory bodies globally, contact food.sci-reg@intertek.com and visit: https://www.intertek.com/assuris/food/ 

Disclaimer: This article provides general regulatory information and does not constitute legal advice. Classification depends on the finished product and the rules and administrative practice of the relevant Member State.

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1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02002L0046-20251126
2. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02015R2283-20210327
3. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02001L0083-20250101
4. Court of Justice of the European Union, Case C-140/07, Hecht-Pharma, ECLI:EU:C:2009:5: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62007CJ0140
5. European Medicines Agency, Authorisation of medicines: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
6. Court of Justice of the European Union, Case C-319/05, Commission v Germany, ECLI:EU:C:2007:678: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:62005CJ0319
7. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1924-20141213
8. Regulation (EU) No 1169/2011 on the provision of food information to consumers, Article 7(3): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02011R1169-20250401