The formulation is finished.
The manufacturer is selected.
The label is being designed.
Then somebody asks a basic question:
Is this product legally a food supplement at all?
For products sitting close to the boundary between nutrition and medicine, that question should have been answered at the beginning.
EU law defines food supplements as foods intended to supplement the normal diet and providing concentrated sources of nutrients or other substances with a nutritional or physiological effect. Medicinal products, by contrast, can be classified either because of how they are presented or because of how they function in the body.
The European Medicines Agency explicitly identifies food supplements among the common borderline categories alongside medicinal products, medical devices, cosmetics and biocidal products. Borderline classification is performed by national competent authorities on a case-by-case basis.
Getting this wrong can change the entire route to market.
A Capsule Is Not Automatically a Supplement
Capsules, tablets, powders, drops and ampoules are routinely used for food supplements.
Directive 2002/46/EC specifically includes these kinds of dose forms in the definition of a food supplement.
That means the physical format tells you very little on its own.
The Court of Justice of the European Union reached exactly this conclusion in a case concerning garlic capsules. Capsule form alone was not sufficient to classify the product as a medicinal product because many foods and supplements are sold in the same format.
A pharmaceutical-looking capsule can still be food.
A food-style package can still contain a medicinal product.
Classification goes deeper.
EU Law Has Two Routes to Medicinal Product Classification
Directive 2001/83/EC defines a medicinal product in two principal ways.
Medicinal Product by Presentation
A product may be a medicinal product if it is presented as having properties for treating or preventing disease in human beings.
This means marketing matters.
The Court of Justice has confirmed that a product can be presented as medicinal not only through an explicit statement, but also where its overall presentation gives an averagely well-informed consumer the clear impression that the product has disease-treating or disease-preventing properties. Labels, packaging, leaflets and other representations can therefore contribute to classification.
This is why a supplement formulation can create problems after it leaves the R&D department.
The ingredient may be acceptable.
The dose may be acceptable.
Then marketing writes:
“Treats chronic joint inflammation.”
The regulatory position has changed dramatically.
For foods, Regulation (EU) No 1169/2011 generally prohibits food information from attributing properties of preventing, treating or curing human disease, and this rule also applies to advertising and presentation.
A marketing claim is not merely copy.
It can affect product classification.
Medicinal Product by Function
The second route is more technical.
A product can also fall within the medicinal-product definition if it is used or administered with a view to restoring, correcting or modifying physiological functions through a pharmacological, immunological or metabolic action, or for making a medical diagnosis.
This means removing medicinal wording does not automatically solve a classification problem.
A product can potentially be medicinal because of what it does, even when the packaging avoids therapeutic terminology.
The Court of Justice has said that authorities assessing medicinal products by function must consider the product individually and take account of its overall characteristics, including:
- composition
- pharmacological, immunological or metabolic properties
- manner of use
- extent of distribution
- familiarity to consumers
- risks associated with use
Classification is therefore not reducible to one ingredient list or one marketing sentence.
A Physiological Effect Does Not Automatically Make Something a Medicine
This distinction is essential for supplement companies.
Food supplements are legally defined as containing substances with a nutritional or physiological effect.
Medicinal products by function can also modify physiological functions.
So where is the line?
The Court of Justice has made clear that simply having an effect on the human body does not automatically make a product medicinal. The competent authority must assess whether the product has the relevant pharmacological, immunological or metabolic properties and whether its effect is sufficiently significant in the context of the medicinal-product definition.
In the garlic-capsule case, the Court rejected medicinal classification where the physiological effects were no greater than those associated with consuming garlic as a food in reasonable quantities.
That is why statements such as:
“This ingredient affects physiology, therefore it is a medicine.”
are too simplistic.
But the opposite statement is equally weak:
“It is natural, therefore it is a supplement.”
Natural origin does not determine legal classification.
Dose Matters, But There Is No Universal “Supplement Dose”
Brands often ask:
“What is the maximum dose before this becomes a medicinal product?”
There is usually no single EU-wide number that answers that question for every substance.
Dose can be highly relevant because it influences the actual physiological and pharmacological effect of a product. But classification remains an assessment of the complete product and its characteristics, not simply a universal milligram threshold. The Court of Justice has specifically rejected automatic medicinal classification merely because a product contains a substance capable of producing physiological effects.
The relevant questions are broader:
- What substance is being used?
- In what form?
- At what dose?
- With what bioavailability?
- For what intended use?
- Through what mechanism?
- With what claims?
- For which population?
- How is the product presented?
Dose matters.
Context decides what the dose means.
“But This Ingredient Is Commonly Used in Supplements”
That is useful information.
It is not a classification guarantee.
Authorities assess the actual finished product.
Two products can contain the same ingredient but differ in:
- concentration
- recommended daily intake
- formulation
- route of administration
- intended purpose
- claims
- target population
- presentation
Those differences may change the regulatory assessment.
EMA advises companies facing borderline uncertainty to provide the relevant authority with the product composition, information on constituents, a scientific explanation of the mode of action and the intended purpose.
That is considerably more information than a supplier brochure.
Presentation Can Turn a Food Problem Into a Medicines Problem
Imagine a product containing botanical extracts.
The formulation team positions it as a food supplement.
The label is compliant.
Then the website launches with statements implying that the product:
- treats a diagnosed disease
- prevents an infection
- replaces medication
- corrects a pathological condition
Now the company may have created evidence supporting medicinal-product classification by presentation.
The CJEU has held that medicinal presentation can result from explicit statements or from an overall impression created for consumers.
And Regulation 1169/2011 makes the food-law side equally clear: food information, advertising and presentation must not attribute disease-prevention, treatment or cure properties to foods.
This means classification review cannot stop with the ingredient list.
It needs to include marketing.
Health Claims Are Not the Same as Medicinal Claims
Food supplements can use certain authorised nutrition and health claims under the applicable EU framework.
That does not mean any health-related wording is acceptable.
There is an important regulatory difference between a permitted food claim concerning normal physiological function and a therapeutic statement implying that a product treats or prevents disease.
For example, claims about contributing to a normal physiological function may be permitted where the exact authorised claim and its conditions of use are met.
A statement that a supplement treats a disease is a fundamentally different proposition.
Makrolife Biotech supports supplement companies with health-claim and regulatory review specifically to distinguish scientifically attractive language from claims that can create legal problems.
The strongest marketing statement is not always the statement you are legally allowed to use.
Scientific Evidence Can Create a Classification Question Too
More data are usually valuable.
But companies need to understand what their own scientific evidence demonstrates.
Suppose an in-vitro or human study indicates a clear pharmacological mechanism at the proposed dose.
That result may be commercially exciting.
It may also require a closer look at whether the proposed product still fits the intended food-supplement classification.
The EMA’s guidance on borderline products specifically asks companies to consider and explain the mode of action when classification is uncertain.
This does not mean any biological effect turns a supplement into medicine.
It means scientific positioning and regulatory positioning must be developed together.
Do not finish the science first and ask what it means legally afterwards.
Being Sold as a Supplement Somewhere Else Is Not Enough
Another common assumption is:
“The same product is already sold as a supplement.”
That does not automatically settle EU classification.
Borderline decisions are handled by national competent authorities and made case by case. EMA explicitly recommends consulting the relevant national authority where classification remains unclear.
EU case law also demonstrates why this issue can become commercially difficult. The garlic preparation considered in Case C-319/05 was legally marketed as a food supplement in several Member States while Germany had classified it as a medicinal product. The Court ultimately found that the specific product did not satisfy the medicinal-product definition, but the dispute shows how significant classification can become for cross-border market access.
A successful launch in one jurisdiction is evidence.
It is not an EU-wide classification certificate.
What Happens If the Product Is a Medicine?
The commercial consequence is substantial.
Under Article 6 of Directive 2001/83/EC, a medicinal product generally may not be placed on the market of a Member State unless the appropriate marketing authorisation has been granted.
That is an entirely different route from placing a conventional food supplement on the market.
The regulatory strategy, documentation, manufacturing requirements, evidence package and commercial timeline can all change.
A company that discovers this after:
- manufacturing the first commercial batch
- printing packaging
- signing distributors
- placing stock in an EU warehouse
has identified the problem far too late.
Classification should determine the development route.
Not interrupt it at the end.
When Both Definitions Appear to Apply
EU pharmaceutical law contains a precedence rule.
Where a product satisfies the medicinal-product definition and may also fall within another EU-regulated product category, Directive 2001/83/EC provides that the medicinal-product framework applies in the relevant case of overlap.
But this rule is often overstated.
It does not mean that regulators can simply call every uncertain supplement a medicine because doubt exists.
A 2025 Court of Justice judgment clarified that the precedence rule applies where the product actually satisfies the conditions for classification as a medicinal product and there is overlap with another regulated category. The rule does not replace the underlying classification assessment.
First establish what the product is.
Then determine which framework governs it.
“Borderline” is not itself a legal product category.
Supplements Are Not the Only Borderline
This issue extends beyond food supplements.
EMA lists common borderline situations involving:
- medicinal products
- medical devices
- cosmetics
- biocides
- herbal medicines
- food supplements
The distinction frequently comes down to questions such as:
What is the intended purpose?
How does the product achieve its principal effect?
What does the consumer understand the product to do?
What does the scientific evidence show about its mode of action?
A topical product can sit between cosmetics and medicines.
A physical-action product can raise questions between devices and medicines.
A botanical oral product can sit between foods and medicines.
That is why classification must happen before the regulatory workstream is chosen.
Classification Should Come Before Testing
This is also a laboratory strategy issue.
Different product categories require different evidence.
If a brand assumes it is developing a food supplement, it may commission:
- nutritional analysis
- contaminant testing
- microbiology
- active-ingredient quantification
- shelf-life testing
- label verification
Those may all be appropriate tests.
But if the finished product actually falls under medicinal-product legislation, those tests alone do not constitute a medicinal-product authorisation package.
Testing the wrong regulatory question very precisely is still the wrong strategy.
Makrolife provides food and supplement analysis alongside regulatory classification and market-launch assessment so the analytical programme can be built around the correct product category.
Classification should define the testing plan.
Not the other way around.
The Same Applies to Product Development
The ideal sequence is:
Product concept → classification → formulation → testing → claims → label → market-entry documentation
Not:
Formulation → manufacturing → packaging → marketing → classification problem
Early classification can influence decisions about:
- ingredient selection
- dose
- target group
- product format
- scientific studies
- claims
- label language
- testing strategy
- intended EU markets
A regulatory review performed early can still influence the product.
A regulatory review performed after manufacturing can mainly tell you what needs to be redone.
Seven Questions to Ask Before Calling It a Supplement
Before finalising an EU supplement concept, brands should be able to answer:
1. What Is the Intended Purpose?
Is the purpose supplementation of the normal diet, or is the product being positioned to treat or prevent a disease?
2. What Does the Product Actually Do?
Is the intended effect nutritional or physiological, or is there evidence of a pharmacological, immunological or metabolic action relevant to medicinal classification?
3. What Is the Daily Dose?
Evaluate the complete recommended daily intake, not just the amount per capsule.
4. How Is the Product Presented?
Review the label, website, advertising, distributor materials and consumer-facing communication.
5. What Claims Will Be Used?
Determine whether the proposed wording fits the food and health-claims framework or moves toward therapeutic presentation.
6. What Is the Regulatory History of the Ingredient and Product?
Previous classifications and market use are useful context, but should not replace an assessment of the actual finished product.
7. Which Countries Are Being Targeted?
Where classification is genuinely borderline, early dialogue with the relevant national competent authority may be necessary. EMA explicitly recommends this route when companies are uncertain.
If these questions cannot be answered, the product is not ready for label design.
Common Classification Mistakes
“It Is Natural, So It Cannot Be a Medicine”
Wrong.
The medicinal-product definition is based on presentation and function, not whether the substance originated from a plant, animal or laboratory. Directive 2001/83 expressly recognises substances of vegetable, animal and chemical origin.
“It Is in a Capsule, So It Is a Supplement”
Wrong.
Dose forms such as capsules are used by both supplements and medicines. The CJEU has explicitly rejected capsule form alone as decisive.
“We Removed the Medical Claims, So It Is Definitely Food”
Not necessarily.
A product may potentially qualify as medicinal by function even without medicinal presentation.
“The Ingredient Is Used in Other Supplements”
Relevant, but not conclusive.
Classification concerns the actual product, dose, intended use and overall characteristics.
“Our Study Proves the Product Works, So We Can Say It”
Scientific substantiation and legal permission to use a claim are separate questions.
“It Is Sold as a Supplement in Another Country”
That does not automatically determine the classification in your intended EU market. Borderline assessments are handled by national competent authorities on a case-by-case basis.
How Makrolife Biotech Can Support Product Classification
Makrolife Biotech supports food, supplement, cosmetic and healthcare companies from early regulatory assessment through testing and market launch.
For borderline products, this can include:
- preliminary regulatory classification
- formula and ingredient review
- dose assessment
- intended-use assessment
- review of scientific mode-of-action evidence
- health-claim and marketing-language review
- label compliance
- analytical testing strategy
- EU market-entry assessment
- identification of regulatory gaps before manufacturing
Makrolife’s current Food & Supplements services explicitly include regulatory classification alongside product testing, quality assurance and market-launch assessment. Its Regulatory & Health Claims team supports compliant positioning and label and claim review.
The objective is simple:
Determine what the product legally is before investing in the regulatory pathway built around it.
Classification Is the First Market-Entry Decision
A strong formulation is not enough.
A clean COA is not enough.
A professionally designed supplement label is not enough.
Before any of those elements matter, the product needs to be placed in the correct regulatory category.
For most conventional supplements, that classification is straightforward.
For borderline products, it can determine whether the business is preparing a food launch or beginning a medicinal-product authorisation project.
That is not a wording detail.
It is a different route to market.
Classify first.
Formulate second.
Test against the correct framework.
Then build the label and claims.
Because the most expensive time to discover that your supplement is legally a medicine is after the product is already ready to launch.
Sources
- European Medicines Agency, Borderline Products, updated March 2026.
- European Parliament and Council, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- European Parliament and Council, Directive 2002/46/EC relating to food supplements.
- European Parliament and Council, Regulation (EU) No 1169/2011 on the provision of food information to consumers.
- Court of Justice of the European Union, Commission v Germany, C-319/05, garlic capsules and medicinal-product classification.
- Court of Justice of the European Union, Hecht-Pharma, C-140/07, medicinal products by function.
- Court of Justice of the European Union, Kwizda Pharma, C-451/24, interpretation of the medicinal-product precedence rule, 2025.
- European Commission, Food Supplements.
- Makrolife Biotech, Food & Supplements.
- Makrolife Biotech, Regulatory & Health Claims.
