Research-use-only labels
A 'research use only' label does not make an unapproved drug lawful for human use. FDA evaluates the seller's intended use, including website claims, to determine whether the product is a drug intended for human use.
Not legal or medical advice.
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Who this applies to
Products sold online or to consumers with 'research use only' or 'not for human use' labeling
Definitions
- Intended use
- The objective intent of the seller, shown by claims, labeling, and surrounding circumstances.
- New drug
- A drug that is not generally recognized as safe and effective for its labeled uses and that lacks an approved application.
Decision flow
- Does the seller make disease/treatment claims?
- Are dosage forms, routes, or patient populations described?
- If yes, FDA may consider the product an unapproved new drug regardless of a research-only disclaimer.
- A research-only peptide marketed for human disease treatment is not shielded.
Examples
- • FDA's Xcel Research warning letter stated that retatrutide and sermorelin products labeled 'FOR RESEARCH USE ONLY' were still unapproved new drugs because website claims showed intended human use.
Common mistakes / limitations
- ✗ This page addresses U.S. FDA interpretation; state and international rules may differ.
- ✗ It does not apply to legitimate laboratory reagents sold to qualified researchers without human-use claims.
What can change this answer
Rules can change through new legislation, FDA final guidance, declaratory orders, court decisions, or updated bulk-drug-substance lists. Check the latest controlling sources and the update feed for this rule.
Controlling law and sources
- FDA Warning Letter to Xcel Research LLC
U.S. Food and Drug Administration, CDER Office of Compliance · Warning letter · 694608