The federal baseline that applies everywhere
FDA approval, or lack of it, does not change at state lines. Every state law below operates on top of federal biologics law, not instead of it. What states can do is regulate the practice of medicine: licensing, disclosure, right-to-try style access, and enforcement priorities. Read the federal framework first if you have not.
States that have expanded access
| State | Law (year) | What it permits | Limits |
|---|---|---|---|
| Texas | HB 810 (2017), expanded since | Investigational stem cell treatments for severe chronic or terminal conditions, under IRB oversight at licensed facilities | Requires IRB; adult stem cells only; disclosure |
| Florida | 2025 statute | Non-FDA-approved stem cell therapy for orthopedic, wound and pain indications by licensed physicians | Written non-approval disclosure; cGMP or accredited manufacturing; no embryonic/fetal cells; see Florida explained |
| Utah | 2024 law | Placental-derived stem cell therapies from licensed providers with disclosure | Disclosure of non-approval required |
| Montana | 2023 right-to-try expansion | Broadened access to experimental treatments including cell therapies | Provider and informed-consent rules |
| New Hampshire | 2025 legislation | Permits certain stem cell treatments with disclosure | Similar structure to Florida |
Other states have bills pending each session. Verify current text before acting on any of this; statutes change and this page is a map, not legal advice.
States with tighter rules
California requires clinics offering non-FDA-approved stem cell treatments to post a specific written notice to patients and in advertising. Several states have used consumer-protection and medical-board enforcement against clinics making unsupported claims. No state prohibits legitimate clinical trials; those are governed by federal rules and IRBs.
What state permission changes for you, and what it does not
- Changes: whether a clinic can operate openly in that state, what disclosure you must receive, whether the state medical board treats the practice as within standards
- Does not change: whether the product has any evidence for your condition, whether your insurer pays, whether the FDA could act against the product, and what happens if something goes wrong (state malpractice law applies as usual)
How this compares with going abroad
The patient in a permissive US state and the patient flying to Colombia face the same core question: what is the evidence for this treatment in this condition, and is the product what the clinic says it is? State law makes the US option more convenient and sometimes better-disclosed; it does not make it better-evidenced. Colombian pricing for comparable expanded-cell orthopedic protocols remains lower, and INVIMA-authorized products come with a national regulatory record you can ask to see. See the Colombia vs US vs Mexico comparison.
Three questions that work in any state or country
- Show me the written non-approval disclosure (US) or the INVIMA authorization or protocol number (Colombia).
- What are the published results for this exact product in my exact condition?
- What does your certificate of analysis say about cell count, viability and sterility for the batch I would receive? See certificate of analysis.
Regulatory status: FDA vs INVIMA
United States (FDA): No stem cell product is FDA-approved for orthopedic, neurologic, or systemic use. Minimally manipulated same-day autologous procedures are marketed under a narrow exemption; culture-expanded cells and most umbilical products are unapproved biologics and the FDA's authority over them was reaffirmed in federal court in 2024. Florida's 2025 law permits certain treatments under state rules but does not create FDA approval.
Colombia (INVIMA): Cell therapies are regulated as advanced-therapy products. Clinics require INVIMA habilitation for the facility and, for laboratory-processed products, product-level authorization or an approved research protocol. Ask to see the INVIMA registration number and verify the treating physician on ReTHUS. "INVIMA registered" for the clinic is not the same as an authorized product.
Frequently asked questions
Which state has the most permissive stem cell law?
Florida's 2025 law and Texas's investigational framework are the broadest, though each is limited in indications and requires disclosure or IRB oversight.
Can I get stem cells for MS in a permissive state?
Florida's law excludes neurologic conditions. Texas requires IRB-overseen investigational treatment. In practice, legitimate MS cell therapy access is through clinical trials.
Does a state law protect me if the treatment fails?
No. It permits the practice; it does not guarantee outcomes or create special remedies. Ordinary malpractice and consumer law apply.
Confused by the patchwork?
Tell us your state and condition. We will explain your realistic options at home and in Colombia, including when the honest answer is a clinical trial.
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