What does "research use only" (RUO) mean?
"Research use only" (RUO) is a labeling statement that a product is intended for laboratory research and not for clinical, diagnostic, human or veterinary use.
General information only. This is not legal advice. For your situation, talk to a qualified attorney.
Where does the RUO term come from?
In US regulation the phrase appears in FDA labeling rules for in vitro diagnostic products, which require certain products in the laboratory research phase to carry the statement "For Research Use Only. Not for use in diagnostic procedures." The term is also used more broadly for lab reagents and research materials.
Does an RUO label mean a product is approved or safe?
No. RUO is not an approval, a certification or a statement about safety or quality. It describes intended use only.
Does the label alone decide how a product is regulated?
No. FDA looks at intended use, which can be shown by how a product is labeled, advertised, promoted and distributed, not only by the words on the label. FDA's RUO guidance says marketing or other conduct can show a different intended use despite RUO labeling.
What does "not for human consumption" mean?
It means the product is not intended to be eaten, taken or used in or on a person. Like RUO, it describes intended use; it is not a quality or safety rating.
What does a 21+ requirement mean on a research supplier's site?
It is the seller's own age policy for who may access or buy. It is a business rule, not a statement that a product is suitable for people of any age.
Is RUO the same as "for laboratory use only"?
They are used in a similar way on product labels, but the exact wording that applies depends on the product type and jurisdiction. Check the specific regulation that covers your product.
Sources
- FDA: Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
- 21 CFR 809.10 (eCFR): labeling for in vitro diagnostic products
- 21 CFR 201.128 (eCFR): meaning of "intended uses"