The short answer
A food supplement is a foodstuff that supplements the normal diet and is a concentrated source of nutrients or other substances with a nutritional or physiological effect, sold pre-packaged in dose form such as capsules, tablets, sachets of powder or drop dispensing bottles. It is not a medicine, it is not pre-approved by the EU, and it is not a replacement for a varied diet.
What is the legal definition of a food supplement?
The definition sits in Article 2(a) of Directive 2002/46/EC: food supplements are foodstuffs whose purpose is to supplement the normal diet, concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form. Each word does work, and this article unpacks them one at a time.
Three elements carry the weight. First, the product is a foodstuff, not a medicine; Article 1(2) says the Directive does not apply to medicinal products as defined by Directive 2001/83/EC. Second, it is a concentrated source: one dose of oil holding 125 µg of vitamin D3 is concentrated in a way a glass of milk is not. Third, it comes in dose form, meaning forms designed to be taken in measured small unit quantities. Article 1(1) adds that these products are delivered to the consumer only in a pre-packaged form.
What does supplement the normal diet mean?
It means the product adds something on top of what you eat, in a measured dose. It does not replace meals and it does not replace variety. Article 7 of the Directive even forbids labelling that states or implies that a balanced and varied diet cannot provide appropriate quantities of nutrients in general. A supplement tops up; food still does the main job.
What does concentrated source mean in practice?
A concentrated source delivers a relatively large amount of a nutrient or substance in a small quantity of product. One serving of our Vitamin D3 + K2 Drops provides 125 µg (5000 IU) of vitamin D3, with 80 servings per bottle. A normal diet rarely concentrates that much of one vitamin into a single dose of oil. Concentration, plus dose form, is what separates a supplement from a fortified food you eat freely.
What counts as a dose form?
Article 2(a) names the dose forms: capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities. If a product comes in a form that delivers a measured small unit, it fits.
| Dose form | Example from our range | Why it counts |
|---|---|---|
| Drop dispensing bottle | Vitamin D3 + K2 Drops | Liquid in measured drops, named in the definition itself |
| Capsules | Magnesium 7 in 1 capsules | Each capsule is one measured unit |
| Powder | Creatine Monohydrate powder, 100 servings of 5 grams per pack | Powder designed to be taken in measured small unit quantities |
| Fortified food or a drink poured freely | A fortified juice or cereal | Not a dose form; it is a food you consume freely, not in measured units |
Which ingredients can a food supplement contain?
Article 2(b) defines nutrients narrowly: vitamins and minerals. Article 4(1) adds that only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements. Other substances, such as creatine or plant extracts, sit outside that harmonised list but can still be food supplements, because Article 2(a) covers nutrients or other substances with a nutritional or physiological effect.
Our Creatine Monohydrate, Ultra-Micronized Powder illustrates this. Creatine is not a vitamin or mineral, so it is one of the other substances the definition mentions. Its authorised claim is the EU-approved wording: a daily intake of 3 g of creatine increases physical performance in successive bursts of short-term, high-intensity exercise.
What must the label of a food supplement say?
Article 6 of the Directive sets five mandatory particulars plus the sales name, and Article 8(1) requires the amounts of nutrients or substances to be declared in numerical form. Here is the full checklist you can hold against any pack.
| Label item | What the Directive says |
|---|---|
| Sales name | The product must be sold under the name food supplement (Article 6(1)) |
| Characterising nutrients or substances | Names of the categories of nutrients or substances, or an indication of their nature (Article 6(3)(a)) |
| Recommended daily portion | The portion recommended for daily consumption (Article 6(3)(b)) |
| Warning not to exceed the dose | A warning not to exceed the stated recommended daily dose (Article 6(3)(c)) |
| Not a substitute for a varied diet | A statement to that effect (Article 6(3)(d)) |
| Storage warning | Store out of the reach of young children (Article 6(3)(e)) |
| Amounts in numbers | Amounts of nutrients or substances declared in numerical form (Article 8(1)) |
What is a food supplement not allowed to claim?
Article 6(2) is an outright ban: labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties. Article 7 adds that no mention may state or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients. So no supplement may claim to cure, treat or prevent any disease, and no claim may dismiss ordinary food.
What remains are health claims from the EU register of authorised claims under Regulation (EU) No 432/2012. That is why our product pages use exact authorised wording, for example vitamin D contributes to the normal absorption and utilisation of calcium and phosphorus, vitamin K contributes to the maintenance of normal bones, and magnesium contributes to normal muscle function and to normal functioning of the nervous system.
Is a food supplement the same as a medicine?
No. Article 1(2) states the Directive shall not apply to medicinal products as defined by Directive 2001/83/EC. A medicine is assessed and authorised before sale; a food supplement is a foodstuff marketed under food law, with disease claims banned. We cover the border between the two categories in detail in our article on the difference between a food supplement and a medicine.
Does the EU approve food supplements before they are sold?
No, the EU does not test or approve food supplements before sale. Article 10 allows Member States to require the manufacturer to notify the competent authority by forwarding a model of the label used for the product. Notification is a copy of the label, not an approval, and the European Commission confirms that EU countries may request this for monitoring purposes.
Because there is no pre-market approval, what a label says carries real weight, and responsibility sits with the company placing the product on the market.
Are there EU maximum doses for vitamins in supplements?
Harmonised maximum amounts are provided for in the Directive: Article 5(1) says maximum amounts per daily portion shall be set, taking into account upper safe levels from scientific risk assessment and intake from other dietary sources, and Article 5(4) says the amounts shall be adopted by the Commission. The Commission page still describes these maximum and minimum amounts as envisaged, not as set. So do not assume one EU ceiling: check the amount per daily portion on the label yourself. We go deeper in our article on whether you can take too much of a vitamin.
What does research say about how people understand supplements?
The evidence here is legal and survey-based rather than clinical, so we stick to what the studies measured. In a large Danish cohort of adults aged 50 to 64 years surveyed between 1993 and 1997, 71 % of participants were dietary supplement users1. Supplement users were already the healthier group: one additional point on a health index was associated with a 19 % higher likelihood of using any dietary supplement1.
Belief in oversight is a separate question. In a US group of Army service members, most users believed supplements were safe (67 %), and 38 % believed government regulations ensure dietary supplement safety2. That is a US population under US rules; EU rules differ, as this article shows, with no pre-market approval. The definition also says nothing about purity testing by the authorities: in one documented case in Tokyo, a supplement capsule contained 85 mg of an undeclared PDE5-inhibiting compound, about 26 % of the 320 mg capsule content3. That is an example of why reliance on the label alone is not enough, not a statement about EU products.
How do our own products fit the definition?
These three products sit squarely inside the definition: each is a concentrated source in dose form, pre-packaged, and labelled with the mandatory particulars. Here is the checklist applied for real.
| Checklist item | D3 + K2 Drops | Magnesium 7 in 1 | Creatine Powder |
|---|---|---|---|
| Dose form | Drop dispensing bottle | Plant-based capsules | Powder, 100 servings of 5 g |
| Nutrient or other substance | Vitamin D3 and vitamin K2 | Magnesium with vitamin C | Creatine monohydrate, an other substance |
| Amounts in numbers | 125 µg (5000 IU) per dose | Declared in numerical form | 5 g per serving, no additives |
| Lab-tested | Yes, in Germany | Yes, in Germany | Yes, in Germany |
The drops, the capsules and the powder are three of the dose forms the definition itself names. Whether supplements are worth taking at all is a separate question we answer in are food supplements worth taking.
Frequently Asked Questions
Is a food supplement a medicine?
No. The Directive explicitly does not apply to medicinal products. Medicines are authorised before sale; supplements are foods, and may not claim to prevent, treat or cure any disease.
Does the EU check supplements before they reach the shelf?
No. There is no EU pre-market approval. Member States may require notification of a label model to the competent authority for monitoring purposes, which is not an approval.
Can a food supplement contain anything?
No. For vitamins and minerals, only those listed in Annex I in the forms of Annex II may be used. Other substances like creatine are allowed as other substances with a nutritional or physiological effect.
Why must a supplement say it is not a substitute for a varied diet?
Because Article 6(3)(d) requires that statement on the label, and Article 7 forbids any suggestion that a varied diet cannot supply adequate nutrients.
Are maximum vitamin doses the same across the EU?
Not as one EU list. The Directive provides for harmonised maximum amounts, but the Commission still describes them as envisaged rather than set.
The Bottom Line
A food supplement is a food: a concentrated source of a nutrient or another substance, in a measured dose form, labelled with its name, its amounts and its warnings, and barred from making any disease claim. It is not a medicine, not pre-approved, not a diet replacement, and not a dose harmonised across the EU. Knowing exactly where the category starts and stops is the first step in judging any product, including ours.
Sources
- Determinants of dietary supplement use: healthy individuals use dietary supplements. The British Journal of Nutrition, 2015
- Dietary Supplement Intake, Adverse Effects, and Reasons for Use by Military Service Members. Advances in Nutrition, 2026
- Structure elucidation of a PDE5 inhibitor detected as an illegal adulteration in a libido-boosting dietary supplement. Food Additives and Contaminants Part A, 2020
- Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements (consolidated text). EUR-Lex, 2002
- Food supplements. European Commission, Food Safety
- Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods. EUR-Lex, 2012
