Update on Peptide and GLP Program Compliance 

Regen Therapy is implementing an update to how peptide and GLP-related programs are structured across our ecosystem.

Based on recent regulatory guidance and enforcement trends, it has become clear that the historical use of “Research Use Only” or “not for human use” labeling does not provide meaningful protection when products are promoted, sold, or used in patient-facing clinical contexts. Regulators have been explicit that intent, marketing, and downstream use are what ultimately determine classification and enforcement risk.

As a result, Regen Therapy is implementing a policy change designed to ensure long-term compliance, operational clarity, and durability under increasing FDA and state-level scrutiny.

What is Changing

Effective January 1, 2026, Regen Therapy and its affiliates, including ZenLabs, will transition away from any model that relies on peptides being positioned as “Research Use Only” when the downstream intent is clinical or patient use.

All peptide use in patient-facing contexts must instead operate under a provider-directed clinical program model with medical director oversight.

This approach removes ambiguity, aligns with current regulatory expectations, and allows clinics and partners to operate with confidence.

What This Means in Practice

Under the approved model:

• Peptides are offered only as part of provider-directed clinical programs, not as standalone consumer products

• Medical directors review and approve structured care pathways rather than retail prescriptions

• Programs include eligibility criteria, contraindications, dosing frameworks, monitoring standards, informed consent, and documentation

• There is no consumer self-selection or patient-facing “menu” of individual peptides

This is a clinically governed program model, not a retail prescribing or e-commerce model.

What is no Longer Supported

Beginning January 1, 2026, the following will not be supported within the Regen Therapy ecosystem:

• Marketing peptides as “Research Use Only” while facilitating or enabling human use

• Any patient-facing purchase flow for peptides without medical director program governance

• Language implying equivalence to FDA-approved drugs or unsupported “generic” claims

• Reliance on disclaimers as a compliance strategy

Important Note on Quantum

Quantum is not classified or positioned as a peptide within Regen Therapy framework and is not subject to peptide-specific RUO enforcement dynamics.

Quantum may continue to be offered as a standalone provider-directed therapy and or as an adjunct within approved clinical programs.

How Regen Therapy Supports This Transition

We provide partners with the infrastructure required to operate successfully under this model, including:

• Licensed medical director oversight

• Standardized program and protocol libraries

• Compliance-forward intake, consent, and monitoring documentation

• Clinic implementation support and staff education

• Governance structures designed for multi-site and multi-provider scaling

Timeline

• Now through December 31, 2025: Transition period for program mapping, documentation updates, and marketing alignment

• January 1, 2026: Full enforcement of this policy across Regen Therapy partnerships

Our goal is to help partners stay ahead of regulatory risk while continuing to deliver high-quality, clinically responsible care.

If you have questions about how this change impacts your current programs or would like support during the transition period, our team is here to help.

Thank you for continuing to build responsibly with us.