What is a food supplement? Is it determined by operators or authorities?

For business leaders, this is a strategic question: Who determines whether a food product is a food supplement? The economic operator or the competent authority? The answer has a direct impact on product launches, labelling and regulatory compliance. As we discussed in our last article, and according to the Interpretative Notes to the AESAN Guide to the Control of Labelling and Composition of Food Supplements of 12 June 2025, the company classifies its product as a food supplement based on its composition, form of presentation and intended use. The competent authority does not authorise this category in advance, but it can review it retrospectively and demand changes if it considers that the classification is not appropriate.

What is a food supplement, in terms of management?

Answering the question of what a food supplement is does not simply involve quoting a legal definition; it also involves detailing the classification in terms of product decisions, labelling and commercial communication. According to the purely legal definition, as set out in Article 2.1 of Spanish Royal Decree 1487/2009 of 26 September:

A food supplement is a food product designed to supplement the diet with nutrients, substances with nutritional or physiological effects, or other permitted ingredients, and is offered in measured doses suitable for consumption.

This does not mean that any mixture containing vitamins or plant extracts is automatically a food supplement. The recipe must be consistent with food use, the presentation must be that of a food product, and the instructions for use cannot shift the product into other categories such as foods for special medical purposes or even medicines by presentation.

The aforementioned guide recalls a relevant European precedent. At the Standing Committee on the Food Chain (general food law section) meeting on 1 February 2012, the European Commission pointed out that, when classifying a product as a food supplement or as a food for special medical purposes, all its characteristics must be assessed: its composition, labelling and overall presentation.

Although, in theory, products with the same formulation but classified differently could coexist on the market, a strict and consistent interpretation of the definitions should not lead to such a scenario, because foods for special dietary uses are, by definition, different from ordinary foods and food supplements. Furthermore, Article 14 of Directive 2009/39/EC on foods for special dietary uses does not apply to food supplements, and the principle of mutual recognition does not apply in areas where harmonised legislation exists.

The decision rests with the operator, and then with the authority.

AESAN is very clear on this point: in any case, it is the economic operator who determines that a food product is a food supplement. That decision must be supported by technical and documentary evidence. Only if the competent authority clearly observes that the product does not meet the definition of a food supplement due to its composition, form of presentation or intended use, may it require the interested party to modify the name and, by extension, all labelling affected by the change.

In business terms, this means that once you have made the decision to go to market with a prepared justification, you are subject to subsequent oversight that may confirm the approach or redirect it.

Importance in the company

The speed of product launch is linked to the final business decision. If classification depended on prior authorisation, the commercial calendar would be more uncertain. Here, the entrepreneur decides and acts, which allows for more control over production, purchasing, and marketing planning, provided that the reasoning is sound.

Another factor to consider is the risk involved in selling the products. Incorrect classification can lead to increased costs for repackaging, changes in messaging, temporary withdrawal or repositioning of products. It is therefore advisable to incorporate an internal regulatory review process to ensure consistency between formulation, presentation and advertising messages.

The multinational strategy should not be overlooked. The guide acknowledges that there are differences in criteria between EU Member States when classifying certain types of food. If the plan envisages European expansion, it is advisable to design a robust product presentation and discourse from the outset that can withstand different interpretations, bearing in mind that mutual recognition does not solve everything when the area is harmonised.

What the authorities look at when reviewing your classification

• Composition. If the recipe, dosage, or combination of substances does not fit with a food intended to supplement the diet, the classification may be questioned.
• Presentation. The legal designation must be ‘food supplement.’ Design elements or claims that suggest therapeutic purposes, non-food uses, or positioning typical of other categories are warning signs.
• Intended use. Instructions for use, messages, and promotional material must describe a food use. When communication approaches the realm of disease treatment or promises unrelated to nutrition, the product may exceed the scope of what is considered a food supplement and fall into another category.

The right decision when planning the product

It is advisable to take these factors into account when planning the marketing of products:

• Classification dossier. Before launch, prepare an internal document explaining why your product fits as a food supplement: describe its composition and nutritional or physiological rationale, include the label and instructions for use, and demonstrate the absence of elements typical of other categories. This dossier will be your basis for audits or inspections.
• Independent review. Even if the internal team performs the analysis, an external review helps to detect weaknesses, such as an ambiguous claim that pushes the product towards medicinal use or a form of use that is not typically food-related.
• Consistency across countries. If you are going to market in several Member States, align your formulation and messages with harmonised criteria and anticipate what local adaptations may be necessary. Consistency in your marketing narrative reduces the risk of redirects.
• Claims governance. Although this issue revolves around classification, it is worth remembering that what you say about the product carries as much weight as what it contains. Keep strict control over nutritional and health claims and avoid messages that blur the line between categories.

What warning signs should we look out for?

• Method of use, format or instructions that are not typically food-related.
• Messages suggesting treatment or relief from medical conditions.
• Formulations that, due to their dosage or combinations, should be evaluated with particular caution.
• Expansion plan in the EU without a prior map of interpretative differences.

If the objective is to understand what a food supplement is from a business perspective, the sequence is clear: the company decides first and then justifies its decision; the authority verifies and can correct if the classification is not valid. A successful product launch requires preparing a solid dossier, a label aligned with the category, and a communication strategy that stays within the food sector. This reduces potential regulatory friction, speeds up the process, and avoids unplanned costs.

Are you planning to launch a food supplement or review a range already on the market? Contact us and we will help you validate its classification, labelling and dossier before producing the next batch. At LegaleGo Regulatory Affairs, we accompany you through the notification process, review of claims and expansion in the EU.