Research Use Only Policy
1. Definition of Research Use Only
Research Use Only (RUO) means that all products offered by Lyos Labs are intended and authorized exclusively for use in in vitro laboratory research, preclinical animal studies, and other non-clinical scientific investigations. RUO products are not approved, cleared, or licensed by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for human diagnostic, therapeutic, or preventive use.
RUO products may not be used for:
- Human consumption or administration
- Clinical diagnosis, treatment, cure, mitigation, or prevention of disease
- Cosmetic applications or administration to humans for aesthetic purposes
- Veterinary therapeutic use or administration to animals for treatment
- Compounding for human or veterinary clinical use (including by licensed practitioners)
- Resale to consumers, patients, or non-institutional parties
2. Eligibility
Lyos Labs supplies orders to qualified researchers and laboratory professionals within the United States. Purchasers must be at least 21 years of age and accept the Research Use Only terms before placing an order.
3. Order Verification
Order verification is limited to:
- Age confirmation: confirmation that the account holder is 21 years of age or older.
- Acceptance of RUO Terms: signed acknowledgment that all products will be used exclusively for research purposes and will not be used for human consumption or clinical applications.
4. Prohibited Uses and Activities
The following uses and activities are strictly prohibited:
- Human Consumption: Ingestion, injection, inhalation, or any other form of human administration.
- Clinical Compounding: Incorporation into preparations intended for human or veterinary clinical use, even by licensed practitioners.
- Resale to Consumers: Distribution, resale, or transfer to individuals, fitness facilities, wellness centers, or any non-research parties.
- Marketing for Human Use: Advertising, promoting, or labeling products with claims of human health benefits, therapeutic effects, or dosing information.
- Off-Label Use: Any use inconsistent with in vitro research or preclinical study protocols approved by institutional oversight bodies (IRB, IACUC).
Violation of these prohibitions may result in immediate account termination, reporting to relevant regulatory authorities, and legal action as applicable.
5. Regulatory Status
All Lyos Labs products are not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for human use. They are not registered as drugs, medical devices, or dietary supplements. They do not carry FDA approval, clearance, or authorization for clinical diagnosis, treatment, cure, mitigation, or prevention of disease.
Certain products (including but not limited to semaglutide, tirzepatide, and retatrutide) are patent-protected pharmaceutical ingredients. Purchase and use are permitted exclusively for bona fide research purposes under research exemption provisions. Commercial development, clinical use, or any application outside of non-clinical research may require licensing agreements with patent holders. Lyos Labs does not grant or convey any patent rights or licenses beyond research use.
6. Safety and Handling
All products are supplied with safety documentation containing hazard information, handling precautions, and emergency procedures. Purchasers are responsible for:
- Compliance with institutional biosafety and chemical safety regulations
- Proper storage, handling, and disposal in accordance with local, state, and federal regulations
- Use of appropriate personal protective equipment (PPE)
- Training of personnel in safe handling and emergency response procedures
- Maintenance of lot-level traceability records as required by applicable regulations
7. Liability Limitation
Lyos Labs provides all products "as is" for research use only. Lyos Labs makes no warranties, express or implied, regarding fitness for any particular purpose, merchantability, or suitability for human use.
The purchaser assumes all responsibility and liability for:
- Proper storage, handling, and use of products
- Compliance with all applicable laws and institutional regulations
- Supervision of personnel and enforcement of RUO restrictions within the purchasing institution
- Any misuse, off-label use, or violations of RUO restrictions by the purchaser or third parties
Lyos Labs is not liable for any direct, indirect, incidental, consequential, or punitive damages arising from use, misuse, or inability to use products, including but not limited to personal injury, property damage, or regulatory penalties.
8. Termination and Enforcement
Lyos Labs reserves the right to terminate accounts, refuse orders, or cancel shipments if:
- Age verification cannot be completed
- Evidence of RUO violation is detected
- Products are suspected to be intended for human consumption or resale
- Purchaser fails to comply with safety, storage, or documentation requirements
Suspected violations may be reported to institutional compliance officers, regulatory authorities, or law enforcement as appropriate.
9. Contact for Compliance Questions
For questions regarding RUO policy, ordering requirements, or compliance documentation, contact Lyos Labs via the Contact Form. Contact Form.
