EU vs FDA supplement labeling: a side-by-side guide for manufacturers who export

If you manufacture supplements for both the European and US markets, you already know the label is never just translated — it is rebuilt. The two regulatory systems describe the same nutrients in different units, allow different claims, and require different mandatory statements.

Here is a practical side-by-side of where they diverge, and what it means for a manufacturer running both versions of a product.

Two systems, two philosophies

In the EU, food supplements are regulated primarily under Directive 2002/46/EC and the general food information rules of Regulation 1169/2011. In the US, supplements fall under DSHEA and the labeling rules enforced by the FDA.

The practical effect is that a single product needs two distinct labels — not because the formula changes, but because the way the formula is described changes.

Reference values: NRV vs Daily Value

The most visible difference is how nutrient content is expressed relative to a reference intake.

The EU uses Nutrient Reference Values (NRVs) — the percentage of the reference intake a serving provides. The US uses Daily Values (DVs), updated in recent years, with their own reference figures.

The numbers are not interchangeable. The same quantity of vitamin C can show a different percentage on an EU label than on a US one, simply because the reference value behind the percentage is different. A label that copies the EU percentage onto a US panel is wrong.

How content is declared

The EU nutrition declaration for supplements is typically expressed per recommended daily portion, with NRV percentages where one exists. The US uses the Supplement Facts panel, with its own formatting rules, ordering, and required nutrients.

The formats look different, the units sometimes differ, and the rounding rules are not identical. This is one of the most common sources of error when a team adapts a label from one market to the other by hand.

Claims: what you can say

Claims are where the two systems diverge most sharply.

In the EU, health claims must come from the authorised list — you cannot invent a claim, and the exact wording is constrained. Nutrition claims are similarly defined.

In the US, the framework centres on structure/function claims, which carry a mandatory disclaimer stating the product is not intended to diagnose, treat, cure, or prevent any disease. The boundary between an acceptable structure/function claim and a disease claim is its own discipline.

A claim that is fine in one market may be prohibited in the other. This cannot be solved by translation — it requires checking each claim against the right framework.

Mandatory statements and warnings

Both markets require certain fixed statements, but they are not the same statements. Allergen declaration rules differ. Warnings, recommended-use text, and "keep out of reach of children" style notices follow different conventions. The US disclaimer on structure/function claims has no EU equivalent.

What this means for a manufacturer

Running a product in both markets means maintaining two compliant descriptions of the same formula — different reference values, different declaration formats, different permitted claims, different mandatory text. Keeping these in sync by hand, across a catalogue of products, is where mistakes creep in.

The more sustainable approach is to hold the formula once and generate each market's label from the same underlying data, with the right reference values and claim rules applied automatically per market. The formula is the single source of truth; the labels are market-specific outputs.

The takeaway

EU and US labeling are not two translations of one label — they are two different descriptions governed by two different systems. The nutrient is the same; the reference value, the format, the permitted claims, and the mandatory statements are not. Manufacturers who treat the label as a per-market output generated from one formula, rather than a document copied and edited, are the ones who avoid the expensive mistakes.

Lemoniq holds one formula and generates market-specific labels and declarations — EU and US — with the right reference values and claim rules applied automatically. See how it works