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 — reference-intake target reviewed per market 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.
Frequently asked
Is an target-market reviewed label valid in the US?
No. The two routes use different label panels (NRV-based vs. %DV-based), different claim frameworks (EFSA-authorised wording vs. structure-function with a disclaimer) and different pre-market steps. A product serving both markets needs each label and claim set built to its own framework. The frameworks are never mixed.
Who is responsible for compliance on each route?
The brand owner is the food business operator (EU) or the responsible party (US) and carries final responsibility for label content, claims and any notification or registration. Claim wording reviewed per project against the target market; final responsibility remains with the brand owner. DAT Supply reviews documentation per project and coordinates the manufacturing route; it does not publish blanket compliance statements.
Can the same formula be sold in both markets?
Often the formula carries across, but the ingredient forms, permitted levels and claim wording can differ between the EU and US frameworks. Whether a single formula works for both, or needs a variant, is confirmed per project against the two target markets.
Does this page certify anything?
No. This is an orientation reference, not a regulatory determination. It does not assert FDA registration, GMP, organic or any certification. Final framework mapping is confirmed per project and the responsibility rests with the brand owner.
Related guides
- → EU launch guide — EFSA claims, Novel Food, notification routes
- → US launch guide — DSHEA, 21 CFR Part 111, Supplement Facts
- → Shipping routes — EU, UK and US lanes
- → Daily vitamins category — claims reviewed under both frameworks
- → Immunity category — claim wording differs most between EU and US
- → Documentation — what is reviewed per project
- → Browse the catalogue
- → Order samples
Where to next?
Browse the reviewed catalogue, request samples, or start an order when you're ready — the DAT Supply portal routes your brief through the right review step.