Tennessee House Bill 2246 is no longer a proposal. It became Public Chapter 1016 and took effect on July 1, 2026. The Tennessee stem cell law approves nothing. It sets notice, consent, sourcing, and reporting duties for physicians who offer stem cell or regenerative medicine therapies in the state.
TLDR: Tennessee House Bill 2246 is now Public Chapter 1016, effective July 1, 2026. It requires an exact advertising notice, written consent signed before therapy, documented product sourcing, and adverse event reporting. Tennessee is the only state that writes numeric viability figures into statute, greater than 90 percent pre-thaw and no less than 80 percent post-thaw. Those figures do not apply to autologous product, which follows its own route. None of this creates FDA approval, and banking adipose tissue does not guarantee eligibility, access, or clinical benefit later.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease. A state practice law does not change federal status, and banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. All content is for educational purposes only and does not constitute medical or legal advice. Patients must consult their own licensed healthcare professionals, and physicians should review the statute with their own counsel.
Physicians watched this bill change shape all spring. An early version would have limited these therapies to orthopedics, wound care, and pain management. House Amendment 1 removed that limit before passage, so the enacted text carries no specialty restriction. What Tennessee kept instead is documentation.
The act sits in T.C.A. Title 63, Chapter 6, Part 2, the medical practice title, and licensing boards enforce it. A physician who cannot produce the file is exposed on licensing grounds. For adipose banking, one detail outranks the rest. Tennessee treats autologous product differently from allogeneic product at nearly every step.
What the Tennessee Stem Cell Law Actually Requires
Public Chapter 1016 defines two categories, stem cell therapy and regenerative medicine therapy, and applies different product standards to each, per the enacted Tennessee text. Rulemaking belongs to the Board of Medical Examiners and the Board of Osteopathic Examination. The act exempts holders of an FDA investigational new drug or device exemption, hospitals and affiliated hospital outpatient clinics, and care under the Phil Timp-Amanda Wilcox Right to Try Act.
These are state stem cell guardrails, not approvals. Tennessee regulates how these therapies are advertised, documented, and sourced. Physicians tracking that pattern can start with the state law map.
The Notice and the Signature
Tennessee mandates exact advertising language, and clinics cannot paraphrase it. The notice reads: “THIS NOTICE MUST BE PROVIDED TO YOU UNDER TENNESSEE LAW. This physician performs one (1) or more stem cell or regenerative medicine therapies that have not yet been approved by the United States food and drug administration. You are encouraged to consult with your primary care provider before undergoing any stem cell or regenerative medicine therapy.”
Consent is shorter than many expected. The statute requires written consent, signed, before the therapy. The enacted text does not itemize what that consent must contain, so physicians build the document against professional standards and their own counsel. Practices comparing informed consent standards will notice that silence.
Product Standards Split Autologous From Allogeneic
This is the section adipose banking families should read twice. Tennessee runs two documentation tracks, and autologous material sits outside the coldest and strictest rules. The table shows how one statute treats two sourcing routes.
| Standard | Allogeneic product | Autologous product |
|---|---|---|
| Facility documentation | Proof of FDA registration given to the physician | CLIA certificate of compliance |
| Freezer temperature | No higher than minus 80 degrees Celsius | Rule does not apply |
| Pre-thaw certificate of analysis | Greater than 90 percent viable | Rule does not apply |
| Post-thaw viability analysis report | No less than 80 percent viable | Rule does not apply |
| Adverse event reporting | Manufacturer and accrediting organization within 30 days, plus licensing authority | Licensing authority |
A physician using a patient’s own banked tissue documents a CLIA certificate of compliance from the laboratory, not an FDA registration number, and the two viability figures do not govern that product.
Regenerative Medicine Products Carry Their Own File
The regenerative medicine category adds manufacturing evidence. The manufacturer must validate its isolation techniques with cell viability and surface marker reports. Wharton’s jelly products need a viscosity report, and exosome products need particle counts. Every lot needs a sterility report and a certificate of analysis before use.
Ethical sourcing of birth tissue becomes a records question here, not a marketing claim. The facility must be FDA registered or accredited by the American Association of Tissue Banks, the American Academy of Stem Cell Medicine, AABB, FACT, or the World Marrow Donor Program. Laboratories built on good tissue practice already generate most of this paperwork.
None of it changes federal status. FDA says cord blood derived blood-forming stem cells are the only approved stem cell products and no exosome product is approved, in its consumer alert.
Adverse Events Now Have a Reporting Clock
Tennessee’s adverse event definition is broad. It reaches infection, allergic reaction, disease transmission, and any unanticipated clinical outcome, related to the product or not. Physicians using allogeneic product report to the manufacturer and any accrediting organization within 30 days. All providers report to their licensing authority.
That clock builds a paper trail, and it runs alongside federal oversight. Clinics marketing unapproved products for non-homologous uses still appear in FDA warning letters, and a clean state file does not resolve a federal problem.
Tennessee Next to Georgia HB 1275
Georgia moved in the same season. HB 1275 became Act 453, signed May 11, 2026 and effective July 1, 2026, creating O.C.G.A. 43-34-49 in the Georgia legislative record. The two states landed close together, then split on the details that cost clinics money.
| Provision | Tennessee, Public Chapter 1016 | Georgia, Act 453 |
|---|---|---|
| Effective date | July 1, 2026 | July 1, 2026 |
| Advertising notice | Required, exact statutory wording | Required, type no smaller than the largest in the ad |
| Consent contents | Signed before therapy, contents not itemized | Nature and character, not yet FDA approved, anticipated results |
| Viability thresholds | Greater than 90 percent pre-thaw, no less than 80 percent post-thaw, not for autologous | None |
| Facility route | FDA registration for allogeneic, CLIA certificate for autologous | FDA-registered facility in any state or country, or listed accreditation |
Neither state limits practice by specialty. Georgia itemizes consent contents and Tennessee does not, and Georgia sets no post-thaw viability requirement at all. Georgia also lets a physician assistant or nurse practitioner perform the therapy under lawful designation, and accepts facility accreditation by the World Marrow Donor Association, AABB, the American Association of Tissue Banks, or another entity the Department of Public Health approves.
What This Means for Adipose Tissue Banking
Banked autologous adipose tissue sits in the quieter lane of this statute. The freezer ceiling and both viability percentages exclude autologous product, and the sourcing proof is a CLIA certificate of compliance. Families and their physicians should confirm which route their laboratory partner documents, then keep that certificate on file.
No state law makes an adipose-derived product approved, and these materials remain investigational. Ryoncil is the first FDA-approved mesenchymal stromal cell therapy, approved December 18, 2024 for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.
Frequently Asked Questions
What specific guardrails does Tennessee House Bill 2246 establish?
Four, in practical terms. A verbatim advertising notice, written consent signed before therapy, documented product sourcing with facility credentials and lot paperwork, and adverse event reporting. Allogeneic product adds a freezer ceiling of minus 80 degrees Celsius, greater than 90 percent viability pre-thaw, and no less than 80 percent post-thaw.
Does this law apply to adipose-derived cells or only birth tissue products?
It is not a birth tissue only law. The statute builds a separate autologous track with its own sourcing proof and carve-outs, the posture that fits a patient’s own tissue. Its Wharton’s jelly and exosome provisions address donor products. The enacted text does not list tissue types, so read the definitions with counsel.
What medical and ethical standards must Tennessee physicians follow under the law?
Physicians give the statutory notice, obtain signed written consent first, and verify the facility behind the product. Manufacturers validate isolation techniques with viability and surface marker reports, supply Wharton’s jelly viscosity data and exosome particle counts, and provide lot sterility reports. Adverse events go to the licensing authority.
How does this compare to Georgia’s HB 1275?
Both took effect July 1, 2026, both mandate exact advertising language, and neither limits practice by specialty. Georgia itemizes what consent must state and sets no post-thaw viability requirement. Tennessee sets numeric viability thresholds but leaves consent contents unspecified. Georgia also permits physician assistants and nurse practitioners under lawful designation.
Is stem cell therapy now FDA approved in Tennessee under this law?
No. A state practice statute regulates physician conduct and cannot approve a biological product. FDA reviews human cells and tissue products under federal criteria, not state ones, in its tissue product questions and answers. Anything investigational on June 30, 2026 stayed investigational on July 1.
What should patients ask a Tennessee provider before treatment?
Ask whether the product is autologous or allogeneic, and which facility credential backs it. Ask to see the consent document before the appointment. Ask what the provider reports, and to whom, if something goes wrong. Ask whether the therapy is FDA approved for the condition discussed, and expect a no.
Key Takeaways
Tennessee House Bill 2246 is law, and it works through paperwork rather than permission. Public Chapter 1016 took effect July 1, 2026, requires an exact advertising notice, requires written consent signed before therapy without itemizing its contents, and routes adverse events to licensing boards and, for allogeneic product, to manufacturers within 30 days. Tennessee remains the only state to put numeric viability figures in statute, and those figures release autologous product entirely.
For adipose banking, the operative fact is that autologous material is documented through a CLIA certificate of compliance instead of an FDA registration, and sits outside the freezer ceiling and the post-thaw analysis. Georgia reached similar ground with itemized consent and no viability threshold. Neither statute creates FDA approval, and neither guarantees that any patient will be eligible for anything later.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Patients and physicians weighing long-term storage can review current pricing or reach the team through the contact page with documentation questions.
Save My Fat partners with a U.S.-based tissue bank for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review including neurology and neurosurgery input is required before publication. Please consult your neurologist or neurosurgeon before making any decisions about treatment or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent more than a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: state stem cell laws.
