Tennessee is joining a growing list of states taking a firmer regulatory stance on the rapidly evolving landscape of regenerative medicine. With the enactment of Tennessee House Bill 2246, effective July 1, 2026, Tennessee lawmakers have introduced new consumer protection measures aimed at the administration of stem cell treatments.
The new law targets the marketing and provision of non-FDA-approved stem cell therapies, placing explicit disclosure and sourcing requirements directly on physicians.
Here is a breakdown of the core elements of HB 2246 and what they mean for healthcare providers and clinics across the state.
Scope of Practice Restrictions & Sourcing Compliance
HB 2246 establishes that a physician may perform stem cell or regenerative medicine therapies that lack FDA approval, provided two fundamental clinical boundaries are met:
- Scope of Practice: The therapy must be utilized for a treatment or procedure that falls strictly within the physician’s established professional scope of practice. Clinicians cannot branch into unrelated medical specialties simply to offer unapproved regenerative procedures.
- Compliant Material Sourcing: Practitioners are legally restricted from acquiring human cells, tissues, or cellular/tissue-based products from any distributor. Under the new law, a physician must obtain these materials only from a manufacturing or processing facility registered with the FDA or accredited by a recognized third-party accrediting organization.
Mandated Transparency: The Standard Disclosure Rule
The primary operational mechanism of HB 2246 is a mandate for upfront transparency. Healthcare practitioners performing stem cell therapies that have not received formal approval from the U.S. Food and Drug Administration (FDA) must provide a clear, conspicuous disclosure to patients.
This transparency requirement operates on two fronts:
- Mandatory Advertisement Notice: Clinics must prominently feature a written warning within all therapy advertisements. The statutory text requires a specific disclosure stating that the treatments have not yet been approved by the FDA, accompanied by a line encouraging patients to consult their primary care provider.
- Informed Consent Documentation: Practitioners must secure a written consent form signed by the patient (or their legal representative) prior to administering any non-FDA-approved stem cell therapy. This documentation serves as written proof that the patient was fully informed of the regulatory status of the procedure before care was delivered.
Aligning State Regulation with Federal Oversight
HB 2246 does not restrict or penalize the use of stem cell therapies that have successfully completed the federal regulatory pathway. Practitioners utilizing therapies that hold an approved Biologics License Application (BLA) or an active Investigational New Drug (IND) exemption from the FDA are generally exempted from these specific state-level notice requirements. Instead, the legislation specifically addresses the growing market of direct-to-consumer clinics marketing unapproved cellular products.
Compliance Timeline and Enforcement
With the critical implementation date of July 1, 2026 rapidly approaching, Tennessee physicians and providers should immediately audit their patient onboarding paperwork, marketing materials, and supplier registries.
Failure to comply with the mandated disclosures or sourcing cellular products from non-compliant facilities can expose a practitioner to disciplinary action by their respective state licensing boards, as well as potential liability under state consumer protection statutes.
Looking Ahead
Tennessee’s legislative update reflects a broader national trend where state authorities are using disclosure laws and scope restrictions to regulate the gaps in direct federal enforcement of regenerative medicine. For compliant providers and integrated practices, the law provides a framework for patient communication and supply chain security.
Ensuring your informed consents and protocols are tightly drafted and your sources are fully certified is the best way to safeguard your practice while embracing this new era of transparency.