General information, not legal adviceThis page explains the research-use boundary. It does not establish that a particular product or business is lawful.
Intended use matters
FDA can assess intended use from evidence beyond the label, including advertising, website statements and the circumstances of sale. A research disclaimer does not override evidence that a product is marketed as a drug for human use.
Keep research supply separate from human use
- Do not market research material for treatment, personal administration or clinical use.
- Do not provide human dosing instructions or promote personal-use outcomes.
- Review customer-facing copy, partner promotions and support responses as well as labels.
- Confirm that buyers and actual sales practices fit the stated research purpose.
Buyer checks are not a legal guarantee
An attestation can document a stated research purpose. It does not change the material, authorize a prohibited sale or replace a review of the actual business.
Our boundary
Scale supplies businesses and research buyers for laboratory and research use only. Products are not for human or veterinary use, diagnosis, treatment or clinical administration. Available certificates do not establish clinical suitability. Sterility is not tested.