What everyone agrees on
Every reputable research-use-only (RUO) label in the EU, UK, and US includes four clauses: (1) “For laboratory research use only,” (2) “Not for human or animal consumption,” (3) “Not for diagnostic or therapeutic use,” and (4) a species-, route-, or condition-specific restriction where relevant.
These phrases are not interchangeable. “Research use only” without “not for human consumption” has been enough, in several cases, to move a product from RUO-adjacent to over-the-counter-adjacent in regulatory review. We include all four.
Where the EU and UK differ from the US
The EU’s IVDR (In Vitro Diagnostic Regulation) distinguishes RUO materials from medical devices by intended purpose. The UK has inherited a near-identical framework post-Brexit with minor divergences on documentation language. Both require the research-use statement in the instructions for use, not just the vial.
The US approach is different in kind: RUO material is governed under 21 CFR 864 for research reagents and is labeled under FDA guidance on RUO and IUO products. There is no requirement for a separate instructions-for-use document, but there is a stricter restriction on marketing language — specifically, an RUO product cannot be promoted for clinical purposes even in implication.
Our label
Our vial carries a short RUO statement; our outer packaging carries the long statement plus jurisdiction-relevant compliance marks; our COA carries the LC-MS and HPLC chromatograms. None of these are mixed. We do not ship RUO product with language that implies clinical utility, and we do not accept orders from accounts flagged as non-research.