Texas has a stem cell statute, and it is narrower than most summaries suggest. Health and Safety Code Chapter 1003, expanded by House Bill 810 in 2017, sets conditions on access to investigational adult cell products rather than permission to sell them. This guide covers what the Texas law says, what it does not, how it compares with the newer Georgia and Tennessee statutes, and which federal rules apply regardless.
TLDR Texas regulates access to investigational adult stem cell products through Health and Safety Code Chapter 1003, expanded by House Bill 810 in 2017. Access is limited to a certified physician, a qualifying institutional review board, and a licensed hospital, ambulatory surgical center, or medical school. Texas has no stem cell advertising statute. Federal law still governs the product. Banking adipose tissue 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, including any condition named in state stem cell legislation. 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, and no state statute changes that. 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.
Patients across Texas hear a simple version: the state passed a law, so the therapy must be legal here. Providers hear one just as simple and just as wrong, that Texas opened a door and the paperwork is a formality. Neither survives a careful reading.
The law is real. Its conditions are strict, its reach is narrow, and it sits underneath a federal framework it never claims to displace. Knowing where the state line stops and the federal line begins is the difference between an informed decision and an expensive assumption.
What the Texas stem cell law actually says
Texas regulates this subject in Health and Safety Code Chapter 1003, titled “Adult Stem Cells.” Section 1003.001 came from Acts 2011, 82nd Legislature, Senate Bill 7. Sections 1003.002 and 1003.003 came from Acts 2015, 84th Legislature, House Bill 177, effective September 1, 2015.
The provisions people usually mean sit in Subchapter B. House Bill 810 of the 85th Legislature, known by its popular name Charlie’s Law, was signed by the Governor on June 12, 2017 and took effect September 1, 2017.
Charlie’s Law is built around one definition. Section 1003.051 describes an “investigational stem cell treatment” as an adult stem cell treatment “under investigation in a clinical trial” and not yet approved by the FDA. The remaining sections set the conditions around it.
The conditions Charlie’s Law attaches
Charlie’s Law is conditional, not permissive. It sets a chain of requirements that must all hold at once, and none of them is optional. Four sections carry those conditions.
| Section | What it requires |
|---|---|
| 1003.053 | The patient must have a severe chronic disease or terminal illness listed in the executive commissioner’s rules, attested by the treating physician, who must determine that all currently approved treatment options are unavailable or unlikely to help. A written physician recommendation is required. |
| 1003.054 | Written informed consent on a form adopted by the executive commissioner. |
| 1003.055 | Administered directly by a certified physician, overseen by a qualifying institutional review board, at a licensed hospital, ambulatory surgical center, or medical school. |
| 1003.059 | The review board must document each patient’s treatment and effects and publish annual non-identifying reports. |
Fail any one of these and the treatment falls outside what the statute permits. A patient weighing a Texas offer can check it against each section in turn.
Section 1003.057 protects the physician on one narrow point. The Texas Medical Board may not act against a license “based solely on the physician’s recommendations” regarding access. That is a shield against state board discipline, and nothing more.
The state-adopted informed consent form requires the patient to acknowledge in writing that the treatment “is not yet approved for general use by the United States Food and Drug Administration (FDA).” Annual review board reporting is governed by 22 Texas Administrative Code 198.6, and the Texas Medical Board hosts the review board report page.
The criminal offense written into Penal Code 48.04
House Bill 810 did more than set conditions. It also created a criminal offense in the Texas Penal Code, which most short summaries leave out.
Penal Code 48.04 reads: “A person commits an offense if the person knowingly offers to buy, offers to sell, acquires, receives, sells, or otherwise transfers any adult stem cells for valuable consideration for use in an investigational stem cell treatment.”
That one sentence changes how the whole chapter should be read. Texas did not build a commercial market and then regulate it. It built a narrow, supervised access route and attached a criminal prohibition to transferring those cells for valuable consideration for use in an investigational treatment.
What the 2019 amendments added
House Bill 3148 of the 86th Legislature amended Chapter 1003 effective September 1, 2019. It added sections 1003.0525 and 1003.0526, which created an investigational stem cell registry at the Texas Department of State Health Services, plus section 1003.060, which provides that the subchapter does not prohibit homologous use of FDA-registered commercial adult stem cells.
Since then, nothing. Texas recorded no stem cell enactments in its 2021, 2023 or 2025 sessions, verified against the Texas Legislative Council summaries of enactments. Anyone reading the Texas rules in 2026 is reading the 2017 statute as amended in 2019.
Does Texas require stem cell advertising disclosures?
No. Texas has no stem cell advertising statute. Chapter 1003 is an access and informed consent law, and it should not be described as an advertising or disclosure law.
This is where Texas differs most from the newer wave of state legislation. States with an enacted stem cell specific statute include several that require a notice in advertising: Georgia, Tennessee, Washington, Vermont, Utah, California and Florida. Texas is not among them.
The absence of a state notice does not mean advertising goes unexamined. Criterion two of 21 CFR 1271.10(a) looks to “labeling, advertising, or other indications of the manufacturer’s objective intent.” Advertising is written into the federal regulation itself.
How Texas compares to Georgia and Tennessee
Texas is older, narrower and harsher than the two statutes enacted in 2026. Georgia and Tennessee both grant a conditional permission to licensed physicians, paired with a mandatory advertising notice and a consent requirement. Texas instead conditions access on listed medical circumstances, review board oversight, and a licensed facility.
| State | Law | Year | What it does |
|---|---|---|---|
| Texas | HB 810, “Charlie’s Law” | 2017 | Right to try style access, severe chronic or terminal illness, IRB oversight |
| Georgia | HB 1275, Act 453 | 2026 | Conditional permission, advertising notice, consent |
| Tennessee | HB 2246, Pub. Ch. 1016 | 2026 | Conditional permission, advertising notice, consent |
Consent separates them further. The Georgia stem cell law lists three disclosures every consent form must cover. Tennessee House Bill 2246 requires a signed consent form and specifies no required contents. Texas requires the form adopted by the state’s executive commissioner.
Enforcement separates them most. Georgia and Tennessee both cap consequences at discipline by the licensing board. Texas has a criminal offense on the books. Set against the wider state law map, these statutes share little beyond the headline.
The federal rules that apply no matter what Texas says
State legislatures regulate professional licensure and discipline. No state statute can approve a product, override FDA jurisdiction, or make an unapproved product legal to market. 21 CFR 1271.20 is a federal rule and it applies in all fifty states.
Under 21 CFR 1271.10(a), a human cell or tissue product is regulated solely under Section 361 only if it is minimally manipulated, intended for homologous use only, not combined with another article beyond narrow exceptions, and either has no systemic effect or is limited to autologous, close relative, or reproductive use. Anything failing those criteria and not otherwise excepted “will be regulated as a drug, device, and/or biological product.” That means an investigational new drug application to study it and a biologics license application to market it.
Adipose matters here specifically. FDA’s July 2020 guidance on minimal manipulation treats adipose as a structural tissue, and its Example 14-1 says isolating stromal vascular fraction is “generally considered more than minimally manipulated.”
Registration does not soften that. Registration and listing are self-submitted, and the FDA patient information page says so directly: “the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed.”
Is any stem cell therapy FDA approved in Texas in 2026?
FDA approval is national, not state by state, so the answer in Texas is the answer everywhere. No adipose-derived product is FDA approved for any disease. FDA’s roster of approved cellular therapy products, last updated August 18, 2026, lists none.
The only FDA-approved mesenchymal stromal cell product, RYONCIL, was approved in December 2024. It is derived from bone marrow, for steroid-refractory acute graft-versus-host disease in pediatric patients 2 months and older only. It is not adipose and it does not validate adipose banking. FDA-licensed cord blood products are blood-forming, approved for disorders of blood production only, and there are currently no FDA-approved exosome products.
FDA’s consumer alert states that no regenerative medicine products are approved for COVID-19, orthopedic conditions, neurological disorders, cardiovascular or pulmonary disease, autism, blindness, or chronic pain. Its consumer information page is blunter: “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.”
Where adipose tissue banking fits in all of this
Adipose tissue banking is a preservation decision, not a route to care. Save My Fat is a connector that links patients and providers with a United States tissue bank, and it does not collect, process, store, or treat tissue.
Nothing in Chapter 1003, and nothing in the Georgia or Tennessee statutes, converts a preserved sample into access to anything. Any future use would depend on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time. Each of those sits outside any legislature’s reach.
Frequently Asked Questions
Does Texas law approve any stem cell product?
No. Chapter 1003 addresses physician conduct, patient consent, review board oversight, and where an investigational stem cell treatment may be administered. It approves no product. A state legislature cannot approve a product or make an unapproved one legal to market, and 21 CFR 1271.20 applies in all fifty states.
Has Texas passed a new stem cell law since 2019?
No. The operative text is House Bill 810 from 2017, as amended by House Bill 3148 effective September 1, 2019. Texas recorded no stem cell enactments in the 2021, 2023 or 2025 sessions.
Does Texas require an advertising notice the way Georgia and Tennessee do?
No. Texas has no stem cell advertising statute. Georgia and Tennessee each require a mandatory notice in advertising, in type no smaller than the largest type size used in the advertisement of the services offered. Texas requires no equivalent.
Does banking adipose tissue create access to a future therapy?
No. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived product is FDA approved for any disease, and adipose-derived cells remain investigational. Anyone weighing the decision should first consult their own licensed healthcare professionals.
Key Takeaways
Texas has a stem cell statute, and it is an access law rather than a market permission. Chapter 1003, expanded by Charlie’s Law in 2017 and amended in 2019, requires a listed severe chronic disease or terminal illness, a physician’s attestation, a state-adopted consent form, review board oversight, and a licensed hospital, ambulatory surgical center, or medical school. It also carries a criminal offense under Penal Code 48.04. Unlike Georgia and Tennessee, Texas requires no advertising notice. Federal law still governs the product, no adipose-derived product is FDA approved for any disease, and banking guarantees no eligibility, access, or benefit.
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.
Anyone weighing adipose tissue banking for potential future use can compare options on the pricing page or bring questions to the contact page.
Save My Fat partners with L2 Bio 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 adipose tissue banking 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.
