GLP-1 in food supplement names: what we are observing in AESAN proceedings

A company designs a food supplement. The composition is correct and the product has been duly notified. Yet a formal requirement arrives from AESAN — not about the formula, but about the name.

This is the kind of situation we are observing in active regulatory files concerning GLP-1 food supplements in Spain. The legal framework on medicine by presentation is European. However, its interpretation and administrative application need to be assessed country by country.

Why the name matters more than the formula

GLP-1 receptor agonists and analogues moved to the centre of the clinical debate on obesity and type 2 diabetes. As a result, hundreds of brands began incorporating that term into the names of their food supplements. The commercial logic was understandable: the term connected with a real consumer concern and had become part of the market’s language.

What those brands generally did not calculate is that GLP-1 is now directly associated with medicines carrying authorised therapeutic indications. When a health authority reviews a supplement with that term in its name, the concept of medicine by presentation may apply. Under this concept, a product can fall into that category not only because of what it contains. It can also do so because of how it is presented — if its name suggests pharmacological properties.

Moreover, in the requirement we are currently handling, AESAN refers to Article 8.6 of Royal Legislative Decree 1/2015. Under that provision, where there is doubt as to whether a product falls within the definition of a medicine, pharmaceutical regulations apply.

A common European framework does not mean identical administrative practice

This criterion derives from Directive 2001/83/EC, transposed in all Member States, which establishes the concept of medicine by presentation across the European Union. However, while the regulatory framework is common, administrative practice is not identical in every country.

In Spain, AESAN is the authority that acts on operators not established in the territory. Its competence derives from Royal Legislative Decree 1/2015 and Royal Decree 1487/2009. We are observing AESAN requirements in active regulatory files concerning GLP-1 food supplements and the use of that term in product names. In those cases, the Authority considers that this term may suggest the presence of a pharmacological substance. Such a characterisation could bring the product within the concept of a medicine by presentation.

For companies operating across several European markets, this has a concrete implication. The same product name can generate different regulatory consequences depending on the country. Therefore, that analysis cannot be done once and then extended to all markets.

What AESAN is requiring in the files we are handling

The requirement arrives after AESAN has reviewed the declared composition, label information and overall presentation of the product. In the cases we are seeing, the issue identified relates to the denomination. Specifically, the Authority considers that the use of the term GLP-1 may suggest the presence of a pharmacological substance. That characterisation could bring the product within the concept of a medicine by presentation.

What tends to surprise those who receive it is this: the requirement does not question the composition. Instead, the analysis focuses on the denomination and the overall presentation — not on the ingredients.

The requirement grants fifteen working days to respond or submit observations. If no response is provided within that period, the company will be understood to have desisted from commercialising the product. A resolution will then be issued accordingly.

Who is most affected

The most exposed profile is that of operators not established in Spain who are commercialising GLP-1 food supplements in the Spanish market. These companies file their market notification directly with AESAN, pursuant to Article 9 of Royal Decree 1487/2009. For this reason, understanding the Agency’s administrative practice must be part of the regulatory analysis preceding any commercialisation decision in Spain.

When the same product name is used across several markets, a requirement in one country matters beyond that market alone. It should trigger a review of the regulatory risk in all the others. This is not because the conclusion must be identical everywhere. Rather, administrative practice can vary between authorities, and the regulatory strategy must be assessed independently for each market.

What happens when the requirement arrives

Each file requires its own analysis. This covers the denomination, the overall presentation, the claims used and the composition. It also includes the notification history and the specific criterion expressed by the authority in the requirement. The response may involve defending the denomination with legal arguments, modifying elements of the product’s presentation, or revisiting the regulatory strategy.

In practice, the margin for response narrows significantly once the deadline has started running. If a company waits for the requirement before starting to analyse, the available options are more limited. Consequently, the time needed to restore commercialisation is significantly longer.

Furthermore, a change of name has consequences beyond the notification itself. It can affect packaging already produced, commercial materials, digital channels and the launch strategy in active markets. In addition, that cost is substantially lower when the analysis is done before launch than when it is managed reactively.

The underlying point

As this GLP-1 case shows, completing a notification correctly does not exhaust the regulatory analysis in international expansion.

The denomination, the product presentation, the regulatory interpretation and the administrative practice of each authority can all affect regulatory risk. What appears to be a purely commercial decision may carry significant regulatory exposure. In multi-country projects, the question should not only be whether a product can be notified. It should also be whether the regulatory decision taken before launch can be sustained in each target market — and what consequences it may carry in the medium term.