International expansion of food supplements: the mistake of replicating regulatory decisions

The international expansion of food supplements often starts with a sentence that, in regulatory work, is almost a magnet for trouble.

“We already sell it in one EU country, so the rest should be the same”.

Free movement of goods exists and part of the legal framework is shared, so it seems reasonable to think that translating the label, adapting the marketing language and switching distribution on is enough. But as soon as the product lands in the legal reality of each Member State, frictions appear that don’t show up in an Excel sheet.

The key point is this. The existence of harmonised rules does not mean practical enforcement is identical across countries. And in food supplements, that nuance is operational. It translates into different review timelines, specific national requirements and, in the worst case, the product being held or immobilised.

Harmonisation and national practice are not the same thing

It’s worth clarifying a nuance to avoid a common mistake. It’s not that each country “freely interprets” harmonised legislation. In areas such as nutrition and health claims, for example, the European framework is directly applicable.

In this specific case, Regulation (EC) No 1924/2006 applies to nutrition and health claims and is uniform across the EU. Therefore, a claim is compliant or it is not throughout the territory.

What changes between countries is not the material validity of the rule, but how controls are deployed and, in some cases, how they are applied in practice. The focus of inspection may differ, as may the intensity of surveillance or the point in time when a product is reviewed. Administrative priorities can also vary, for example where certain categories or ingredient profiles are targeted.

This distinction matters because it prevents incorrect conclusions. It’s not that a claim is legal in Italy and illegal in Spain. It is that it may not have been reviewed yet, or it may not have been subject to enforcement action, or it may fall under different control plans. That affects the operator’s real exposure, but it does not make regulation arbitrary.

By contrast, there are other areas where national discretion is expressly allowed because they are not fully harmonised. A classic example in food supplements is maximum levels for vitamins and minerals. In the absence of EU-harmonised maximums, while EFSA sets guidance values, Member States may establish their own criteria based on risk assessment. In fact, France and Italy have their own rules. That is why national maximum intakes can be found, as happens in Italy with biotin, even when other markets do not use specific limits.

The same can happen with certain substances or botanicals where national measures have been adopted on precautionary grounds or as part of risk management. In France, for example, temporary precautionary suspensions have been put in place for Garcinia cambogia, even though the ingredient may be seen in circulation in other markets. In these cases we are not talking about “interpretation”, but about regulatory margins and national measures within what the system allows.

With these examples, we can see that for vitamins and minerals there is indeed room for national criteria, but for claims there is not. We all follow the same Regulation.

The risk of copying formulations when you scale into another country

In practice, many companies use the fact that they already sell in another country as their reference point for expansion. It’s also common to assume the manufacturer’s proposal is valid, especially when the manufacturer works with multiple clients and presents the formula as “already established”.

The problem is that formulation is not just a list of permitted ingredients. It is the full fit, in each country, with quantitative limits and any applicable national criteria. It also includes the specific treatment of certain botanicals or extracts, regardless of whether they are accepted elsewhere.

A very everyday example is collagen. Copying a label where “collagen” appears and assuming that is sufficient to sell in other countries often becomes expensive if you don’t verify the source, bovine or marine, and the associated traceability. Also if you don’t check potential allergens or the declaration requirements that may apply depending on origin and processing.

In international expansion, these omissions are not offset by “competitors do it”. Responsibility lies with the operator placing the product on the market, not with whoever supplied the artwork or whoever already had it on shelf.

Replicating labels is not a compliance strategy

In food supplements, many countries operate with communication or notification procedures. A product is notified, placed on the market and the review may take place later. This creates a false sense of security because market presence is mistaken for validation.

If you copy the label of a product that is already circulating, you may be copying a product that has not yet been reviewed, or that is still pending observations. You may also be replicating an approach that worked at a specific time and that would later be out of step.

Here it is worth highlighting a seemingly simple idea. Two identical labels can have different outcomes for a very uncreative reason, for example because they are not reviewed at the same time.

That is why replicating labels that are already on shelf, or about to be, is not a regulatory assessment. It is a bet. And for an expansion strategy, betting is usually the opposite of scaling with safety and control.

Claims and naming, where market presence is most often confused with compliance

This is where conceptual precision matters most. It is not that the legality of a claim changes by country. In claims, the European framework is uniform. The issue lies elsewhere.

A product being notified, appearing in a public database or being visible on a marketplace does not imply material compliance. Market presence does not equal legal validation. Very often it simply means that, up to that point, it has not been reviewed or subject to enforcement action, or that surveillance has focused elsewhere.

This explains why commercial names or approaches such as “hangover cure” or “fat burner” can be seen circulating with apparent normality. Not because sellers have made them bulletproof, but because the market shows what circulates, not what would be defensible if the product were examined in detail tomorrow.

This is where the concept that really matters in international expansion should be elevated. Legal defensibility. It is not enough for something to be on the market. It must be technically and legally defensible if it is reviewed, and it must hold up to the same standard in any EU country, because the legal framework is shared.

When you work with legal defensibility, the debate stops being “let’s see if it slips through” and becomes “if it is checked, I can support it”. That shift in mindset is what makes the difference between internationalising with method or internationalising by inertia.

Free movement facilitates trade, but it does not replace country-by-country regulatory analysis. In international expansion, the difference between replicating and reviewing is the difference between scaling safely or taking unnecessary risks.

If the goal is to grow across multiple markets without turning each launch into an urgent race to see who gets there first, the path is not copying. It is building legal defensibility from the start, with a prior analysis of formulation, labelling and positioning tailored to each country, starting with what is not harmonised and without confusing market visibility with compliance.