What the law does
The 2025 Florida statute allows licensed physicians in the state to offer stem cell therapies that are not FDA-approved, provided a set of conditions are met. The permitted indications are limited to orthopedic conditions, wound care, and pain management. It does not authorize treatments for neurologic disease, autoimmune conditions, cancer, autism, or anti-aging.
Key requirements written into the law include:
- The treating physician must hold a Florida license and the treatment must be within scope of practice
- Cells must be manufactured in a facility that is FDA-registered and meets current good manufacturing practice, or an equivalent accreditation standard, and must be lawfully obtained (no embryonic or fetal sources)
- Patients must receive a written disclosure, before treatment, stating that the therapy has not been approved by the FDA and that the patient should consult their primary physician
- Advertising must carry the same non-approval disclosure
- Providers may not make claims of efficacy not supported by evidence, and the Board of Medicine may discipline violations
What it does not do
- It does not make any product FDA-approved. Federal law over biologics is unchanged, and the FDA can still act against products it considers unapproved drugs, including in Florida. See the 351 vs 361 rule.
- It does not require the treatment to have any evidence of benefit. It requires disclosure of non-approval, not proof that the therapy works.
- It does not cover insurance. Nothing in the law obliges any insurer or Medicare to pay.
- It does not permit the indications most heavily marketed abroad: MS, Parkinson's, stroke, autism, COPD, anti-aging infusions.
How the industry has responded
Predictably, clinics have opened or relocated to Florida, and pricing for expanded-cell orthopedic injections in the state has settled in a range that overlaps with, and sometimes exceeds, Colombian and Mexican pricing. The state law created a legal marketing environment; it did not create new evidence. The knee osteoarthritis data are the same whether the injection happens in Tampa or Medellín; see knee osteoarthritis evidence in 2026.
Florida vs Colombia for an orthopedic patient
| Factor | Florida under the 2025 law | Colombia under INVIMA |
|---|---|---|
| Legal basis | State practice law; federal product law unchanged | National advanced-therapy regulation |
| Permitted indications | Ortho, wound, pain | Depends on the product's authorization or protocol |
| Mandatory disclosure | Yes, in writing | Informed consent required; content varies by clinic |
| Typical expanded-MSC knee, 2026 | USD 6,000 to 12,000 per joint | USD 3,500 to 8,000 per joint |
| Follow-up access | Local | Requires return travel or a cooperating US physician |
What patients should take from this
The Florida law is useful mainly as a benchmark. If a Florida clinic must tell you in writing that the therapy is not FDA-approved, any clinic anywhere that tells you the opposite is misleading you. Use the Florida disclosure standard as your minimum, wherever you go. Then evaluate the evidence for your specific condition using our L1 to L4 evidence framework.
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
Are stem cells legal in Florida now?
Certain non-FDA-approved stem cell treatments for orthopedic, wound and pain indications can be offered by licensed Florida physicians who meet the statute's requirements, including written disclosure of non-approval.
Does the Florida law cover neurological conditions?
No. It is limited to orthopedic, wound care and pain management.
Is treatment in Florida cheaper than in Colombia?
Generally no. Florida expanded-cell pricing overlaps with or exceeds Colombian pricing, though it avoids travel.
Comparing a Florida quote with Colombia?
Send us the Florida clinic's disclosure and quote. We will show you what a documented INVIMA-authorized Colombian clinic would charge for the same protocol.
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