--- title: "Stem Cell Law In Tennessee: A Clear 2026 Explainer" description: "Tennessee's 2026 stem cell law explained: what Public Chapter 1016 actually requires, what the amendment removed, and what it did not legalize." url: "https://savemyfat.com/tennessee-stem-cell-law-2026/" --- # Tennessee’s New Stem Cell Law: What Changed and What Didn’t Table of Contents - [Oscar Tellez](https://savemyfat.com/author/oscartellez/) - September 30, 2026 - 10:00 am ![Open enrolled act and a gavel on a walnut desk before the tennessee state flag, the setting for the state's new stem cell law](https://savemyfat.com/wp-content/uploads/2026/08/tennessee-stem-cell-law-2026.webp)Tennessee's new stem cell law: what changed and what didn't 2 Tennessee enacted a stem cell law in 2026, and much of the coverage called it legalization. The enacted text does not do that. Public Chapter 1016 conditions state medical board discipline, mandates an advertising notice, and requires a signed consent form. It approves no product and creates no patient right. **TLDR Tennessee did not legalize any stem cell therapy. The 2026 act conditions state medical board discipline, mandates a verbatim advertising notice, and requires a signed consent form with no specified contents. Federal law is untouched. No adipose-derived product is FDA approved, and banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy or trial.** **Important Disclaimer:** Save My Fat does not provide FDA-approved treatments or cures for any disease. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived stem cell product currently has FDA approval for any disease. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions. --- If the headlines left you thinking Tennessee opened a door to approved cell therapy, that is a fair reading of the coverage. It is not what the statute says. Most articles about House Bill 2246 describe the bill as introduced. It was amended on the House floor before passage, and that amendment changed three substantial things. ## What the Tennessee Stem Cell Law Actually Says It speaks to state professional regulation, not to federal approval. A physician may perform an unapproved therapy within their own scope of practice, and subsection (b) reads: “A physician may perform stem cell therapy or regenerative medicine therapy that is not approved by the United States food and drug administration if the therapy is used for a treatment or procedure that is within the scope of practice of the physician.” The act adds an unnumbered new section to Title 63, Chapter 6, Part 2, cited as a new section of Tenn. Code Ann. tit. 63, ch. 6, pt. 2, enacted by 2026 Tenn. Pub. Ch. 1016. Governor Bill Lee signed it on May 19, 2026. It took effect July 1, 2026, with rulemaking effective earlier, upon becoming law. Read [Public Chapter 1016](https://publications.tnsosfiles.com/acts/114/pub/pc1016.pdf) and the [bill history](https://wapp.capitol.tn.gov/apps/BillInfo/Default.aspx?BillNumber=HB2246&ga=114). Three obligations attach. Subsection (d) requires this notice verbatim in advertising, in type no smaller than the largest in the ad: > “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.” Subsection (e) requires only “a written consent form signed by the patient or, if the patient is not legally competent, the patient’s representative.” Subsection (c) allows material only from a facility that complies with the section. Subsection (h) requires adverse event reports to the manufacturer, the accreditor, and the licensing authority within 30 days. Enforcement is narrow. Under subsection (g), a violating physician “may be subject to disciplinary action by the physician’s licensing authority.” That is the only stated consequence. Subsection (f) carves out FDA investigational drug and device holders, hospitals and affiliated hospital outpatient clinics, and therapy under the state right to try act. The medical and osteopathic boards may write rules, but need not. --- ## The Three Things Amendment #1 Changed Amendment #1 was adopted on April 13, 2026, and it is why so much reporting is wrong. Two of the three changes made the law looser than the bill. Provision Bill as introduced Law as enacted Permitted scope Orthopedics, wound care, or pain management Anything within the physician’s scope of practice Criminal penalty Class E felony None Consent form contents Four mandatory disclosures No specified contents The scope change is the one most people get backwards. The three-category limit is gone and the enacted standard is broader, which widens what a physician may offer without changing any product’s federal status. Coverage naming orthopedics, wound care, or pain management describes the introduced bill. --- ## What the Tennessee Law Does Not Do It approves nothing and it creates no patient right. FDA’s roster of [approved cell therapies](https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products) lists no adipose-derived product, and no state statute can approve one, override FDA jurisdiction, or make an unapproved product legal to market. It does not change federal law, and it never mentions it. The text contains no occurrence of federal, preempt, supersede, or notwithstanding, and no citation to federal statutes or regulations. Under [21 CFR 1271.20](https://www.ecfr.gov/current/title-21/section-1271.20), a product that fails the criteria at 1271.10(a) and is not otherwise excepted is regulated as a drug, device, or biological product. Our guide to [House Bill 2246](https://savemyfat.com/tennessee-stem-cell-law-house-bill-2246/) walks through the enacted provisions. --- ## How Tennessee Compares With Georgia and Nevada Tennessee’s silence stands out next to its neighbors. Georgia’s parallel law, HB 1275 (2026 Ga. Laws Act 453), expressly incorporates federal requirements. The [Georgia enrolled text](https://www.legis.ga.gov/api/legislation/document/20252026/248639) requires products from facilities following current good manufacturing practices under 21 U.S.C. 301 et seq. and 21 C.F.R. Part 1271, and it lists three required consent disclosures. Nevada goes the other way and says so. The [Nevada statute](https://www.leg.state.nv.us/NRS/NRS-629.html) provides at NRS 629.350 that nothing in its nonembryonic cell provisions “shall be construed to indicate the status of any of the activities authorized pursuant to NRS 629.300 to 629.390, inclusive, as regards federal law.” Tennessee does neither. It neither incorporates federal law nor disclaims a federal effect. Silence is not permission. Federal rules apply the same way in Nashville as in Atlanta. We track [state stem cell rules](https://savemyfat.com/state-stem-cell-laws/) as written. --- ## What Tennessee Patients Should Still Verify Start with approval status for your own condition. FDA’s [consumer alert](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes) states that stem cell products are regulated by FDA and that, generally, all stem cell products require FDA approval. A state statute does not change that. Ask whether the offer sits inside a clinical trial. FDA’s [patient information page](https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies) is blunt: “If you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.” Then read the paperwork. Because Tennessee specifies no contents, a signed consent form proves only that you signed something. Look for the required notice in any advertising, ask where the material came from, and follow the notice’s advice about your primary care provider. Adipose tissue banking is a separate question from all of this. It preserves a person’s own tissue and is not a therapy. Any future use would depend on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time. --- ## Frequently Asked Questions ### Did Tennessee legalize stem cell therapy? No. The act conditions state medical board discipline for a physician acting within their scope of practice. It approves no product and creates no patient right. ### Is any stem cell therapy FDA approved in Tennessee now? No. Approval is a federal decision, and FDA’s list of approved cellular and gene therapy products includes no adipose-derived product. State law cannot change that. ### Does the law limit therapy to orthopedics, wound care, or pain management? No. That limit was in the introduced bill and was removed by amendment. The enacted standard is anything within the physician’s scope of practice. ### What must the required consent form say? Nothing in particular. The law requires a signed consent form but specifies no contents, unlike Georgia, which lists three disclosures. --- ## Key Takeaways Tennessee’s 2026 act is a licensure provision, not an approval. It lets a physician perform an unapproved stem cell or regenerative medicine therapy within their scope of practice, requires a verbatim advertising notice, and requires a signed consent form the law never defines. The floor amendment broadened the scope, deleted the Class E felony, and dropped the four consent disclosures, so reporting based on the introduced bill is wrong. Federal requirements are unchanged. Confirm approval status, ask about clinical trials, and talk with your own physician. Save My Fat connects patients and providers with a U.S.-based tissue bank. It is not a tissue bank, a laboratory, a medical practice, or a treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, California, Georgia, and Tennessee 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. Readers considering adipose tissue banking for potential future use can compare options on our [current pricing](https://savemyfat.com/pricing/) page or open a conversation through the [contact page](https://savemyfat.com/contact-us/). --- *Save My Fat works 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. Please consult your own licensed healthcare provider before making any decisions about stem cell therapy 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 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](https://savemyfat.com/state-stem-cell-laws/). Follow Save My Fat on Google Set us as a preferred source and Google will show our latest updates more often in your results. [PrevPreviousStem Cell Advertising Rules: How the FTC and FDA Regulate Marketing Claims](https://savemyfat.com/stem-cell-advertising-rules-ftc-fda/) [NextAATB Accreditation: What the 15th Edition Standards Cover, How to Check a Bank, and What Changes January 31, 2027Next](https://savemyfat.com/aatb-accreditation-tissue-bank-guide/) Regulation ### [Montana’s Experimental Treatment Center Law: What SB 535 (2025) Set Up](https://savemyfat.com/montana-stem-cell-law-sb-535/) [Read More »](https://savemyfat.com/montana-stem-cell-law-sb-535/) Oscar Tellez 10/08/2026 10:00 AM Regulation ### [New York Tissue Bank Licensing: Why Article 43-B Matters for Banked Tissue](https://savemyfat.com/ny-tissue-bank-license-article-43-b/) [Read More »](https://savemyfat.com/ny-tissue-bank-license-article-43-b/) Oscar Tellez 10/07/2026 10:00 AM Cryopreservation ### [DMSO-Free Cryopreservation: What 2026 Research Says About How Banked Cells Are Frozen](https://savemyfat.com/dmso-free-cryopreservation-research/) [Read More »](https://savemyfat.com/dmso-free-cryopreservation-research/) Oscar Tellez 10/06/2026 10:00 AM Regulation ### [The Cell Surgical Network Injunction: What the August 2026 Ruling on Fat-Derived SVF Means for Banked Tissue](https://savemyfat.com/stem-cell-clinic-injunction-2026-ruling/) [Read More »](https://savemyfat.com/stem-cell-clinic-injunction-2026-ruling/) Oscar Tellez 10/05/2026 10:00 AM Adipose ### [GLP-1 Medications and Your Fat: What Research Shows About Adipose Tissue on Semaglutide and Tirzepatide](https://savemyfat.com/glp-1-adipose-tissue-research/) [Read More »](https://savemyfat.com/glp-1-adipose-tissue-research/) Oscar Tellez 10/02/2026 10:00 AM Regulation ### [AATB Accreditation: What the 15th Edition Standards Cover, How to Check a Bank, and What Changes January 31, 2027](https://savemyfat.com/aatb-accreditation-tissue-bank-guide/) [Read More »](https://savemyfat.com/aatb-accreditation-tissue-bank-guide/) Oscar Tellez 10/01/2026 10:00 AM ```json [{"@context":"https:\/\/schema.org","@graph":[{"@type":"BreadcrumbList","@id":"https:\/\/savemyfat.com\/tennessee-stem-cell-law-2026\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":"1","item":{"@id":"https:\/\/savemyfat.com","name":"Home"}},{"@type":"ListItem","position":"2","item":{"@id":"https:\/\/savemyfat.com\/our-blog\/","name":"Our Blog"}},{"@type":"ListItem","position":"3","item":{"@id":"https:\/\/savemyfat.com\/category\/regulation\/","name":"Regulation"}},{"@type":"ListItem","position":"4","item":{"@id":"https:\/\/savemyfat.com\/tennessee-stem-cell-law-2026\/","name":"Tennessee’s New Stem Cell Law: What Changed and What Didn’t"}}]}]},{"@context":"https:\/\/schema.org","@graph":[{"@type":"Person","@id":"https:\/\/savemyfat.com\/oscar-tellez\/#person","name":"Oscar Tellez","jobTitle":"Founder","description":"Oscar Tellez is the Founder of SaveMyFat, a company that connects patients and physicians with a U.S. tissue bank for adipose tissue banking, so a person's own tissue can be preserved for potential future use in FDA-regulated pathways. 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