FDA Compliance Statement

Last updated: May 2025

1. Our Commitment to Regulatory Integrity

At BLUEBIOTECH Inc., we are committed to operating in alignment with applicable U.S. regulatory frameworks, including the Food, Drug, and Cosmetic Act (FDCA), FDA guidance for Research Use Only (RUO) materials, and relevant labeling and marketing standards.

We take compliance seriously — not only for internal governance, but to help ensure that our partners, clinics, and research institutions stay informed and aligned with legal expectations.

2. Product Classification & RUO Designation

Many of the compounds, peptides, and reference materials featured on our website are classified as:

RUO – Research Use Only
Not intended for use in humans or animals for therapeutic or diagnostic purposes
Supplied only to qualified professionals or licensed entities

All RUO products are clearly labeled, and no therapeutic claims are made regarding their effects.

See our FDA Disclosure ↗ for full legal information on RUO product use.

3. Labeling and Packaging Policy

All RUO-labeled products include clear disclaimers:

“For Research Use Only. Not for human use.”
No package includes dosage instructions or medical indications
Products are not labeled as dietary supplements, drugs, or medical treatments unless otherwise compliant

We prohibit the resale or relabeling of RUO items in a way that may suggest unapproved therapeutic use.

4. Website & Marketing Compliance

BLUEBIOTECH does not claim that RUO products can diagnose, treat, or cure any disease
Educational content provided on this website is not intended as medical advice
Product descriptions, blogs, and materials are for informational and professional research audiences only

If clinical use or compounded administration is discussed, it is assumed to be under the care of licensed professionals within their regulatory scope.

5. Clinic & Partner Responsibility

We advise all distributors, providers, and compounders to:

Know the difference between research materials and clinical-grade drugs
Use appropriate labeling and disclaimers
Ensure marketing materials and packaging align with FDA rules
Avoid off-label claims or promotional language unless appropriately approved

6. Ongoing Monitoring

We continuously monitor updates from:

U.S. Food & Drug Administration (FDA)
Clinical Laboratory Improvement Amendments (CLIA)
DSHEA and FTC regulations
International standards where applicable (e.g., Hong Kong, EU, Mexico)

Internal procedures are reviewed regularly to stay current and compliant.

7. Contact for Compliance Inquiries

📧 For compliance-related questions, documentation requests, or white-label guidance:
info@bluebiotech.health