EU vs USA Route for Private-Label Supplements
A side-by-side orientation to the EU food-supplement route and the US dietary-supplement route for a private-label launch. Covers how the product category, claims framework, label panel, pre-market step and documentation differ between the two — kept strictly separate.
What this reference covers
- → EU food supplement vs US dietary supplement — the category difference
- → Claims frameworks — EFSA-authorised wording vs. structure-function claims
- → Label panels — EU NRV declaration vs. US Supplement Facts (%DV)
- → Pre-market step — member-state notification vs. facility registration
- → Documentation emphasis on each route
Who this is for
- → Brand teams launching a private-label supplement into both the EU and US
- → Operators moving an existing range across the Atlantic
- → Founders mapping the documentation and claim differences before the brief
This is an orientation reference, not a substitute for a regulatory consultant. The EU and US frameworks are kept separate and the final mapping is confirmed per project.
Launching into both markets?
Brief your order with both target markets and the team confirms the framework mapping and documentation route for each — EU and US separately.
EU and US route, side by side
| Aspect | EU food supplement | US dietary supplement |
|---|---|---|
| Product category | Food supplement under Directive 2002/46/EC — a foodstuff, not a medicine. | Dietary supplement under DSHEA 1994 and the FD&C Act — a distinct category from drugs. |
| Claims framework | Nutrition and health claims governed by Regulation (EC) 1924/2006; only EFSA-authorised wording (Reg. 432/2012) may be used. Disease claims are prohibited. | Structure-function claims permitted without prior approval if substantiated and not misleading, with the DSHEA disclaimer. Disease claims are prohibited. |
| Label panel | Mandatory particulars per Regulation 1169/2011; amounts declared against EU Nutrient Reference Values (NRV). | Supplement Facts panel per 21 CFR 101.36; amounts declared against US Daily Values (%DV). |
| Pre-market step | Member-state notification of the product on placing on the market (where the country requires it); UK/GB notified separately post-Brexit. | No product pre-approval; facility registration and, for foreign sites, a US agent; new dietary ingredients may need an NDI notification. |
| Documentation emphasis | Specification, EFSA claim mapping, allergen and NRV declaration, notification record. | Specification, 21 CFR Part 111 GMP records, Supplement Facts artwork, structure-function substantiation file. |
The two frameworks are independent and must never be combined on a single label. Framework mapping and claim wording are confirmed per project; final responsibility rests with the brand owner.
How this connects to your order brief
The brief captures your target markets. From there, the team maps the formula to each framework separately — the EU food-supplement route and the US dietary-supplement route — and confirms the documentation each requires. Where a single formula needs a market variant, that is settled per project.
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