Is stem cell therapy legal? A clinic owner's regulatory overview

Why 'is stem cell therapy legal' is not a yes-or-no question

Clinic owners researching this question are usually looking for a single answer, and the honest answer is that legality in the United States runs through three separate layers. The first is FDA's classification of the specific product under the HCT/P framework. The second is whatever state law applies on top of the federal baseline. The third is how the clinic itself describes and markets the service, which can create exposure independent of the product's own regulatory status.

Review product classification, applicable state law, and marketing as separate questions with counsel, rather than treating legality as a single legal-or-illegal switch.

The federal baseline: no stem cell product is FDA-approved for orthopedic or pain use

Mesenchymal stromal cells, often shortened to MSCs, are defined by the International Society for Cell and Gene Therapy's minimal criteria: plastic adherence under standard culture conditions, expression of CD73, CD90, and CD105, and the ability to differentiate into three lineages in vitro. No MSC product currently holds FDA approval for orthopedic use.

A separate consideration applies to commercial umbilical cord allograft products sometimes marketed using stem cell terminology. A 2026 analysis of six commercial Wharton's jelly products found low total cell counts and low viability, with only rare viable MSCs identified, and a 2021 study found no colony-forming MSCs across five cord products examined. Within the products reviewed in those two studies, that evidence does not support 'stem cell' labeling as applied, independent of how any individual product is classified under section 361 or 351. Documentation for the specific lot in question should be requested rather than relying on the term alone.

The state layer adds conditions, not a blanket exemption

Florida's SB 1768, codified at section 459.0127 of the Florida Statutes and effective July 1, 2025, permits licensed MDs and DOs to use certain non-FDA-approved stem cell therapies in orthopedics, wound care, and pain management, subject to informed consent and specific disclosures. Utah and Montana have separate experimental-treatment statutes with their own conditions.

What a state statute like Florida's does not do is change FDA's federal classification of the product being used, or exempt a distributor's or clinic's marketing from FTC and FDA scrutiny. A state law permitting physician use under specific conditions operates alongside the federal framework, not above it.

Enforcement in this space is active, not theoretical

FDA issued warning letters to three distributors of perinatal and exosome products during 2026. The cited letters included disease claims on websites and social media; marketing is evidence of intended use, and a clinic's own promotional language is reviewed independently of the underlying product's classification.

What 'legal' requires in practice, in checklist form

Clinics that want a defensible position, rather than a supplier's assurance, generally need to confirm the following before offering a product clinically:

• The product's regulatory classification is documented, including the basis for a section 361 determination or the status of a BLA or IND if the product falls under section 351.
• If relying on a state statute, the statute's specific conditions, physician licensure requirements, and disclosure and informed consent obligations are met and documented.
• Marketing and consent materials describe the product without naming a disease, condition, or expected outcome.
• Lot-level documentation, including the certificate of analysis and donor eligibility summary, is retained and tied to the patient record.

Where to get an answer that actually holds up

This overview maps the layers involved. It is not legal advice, and it does not replace review by FDA regulatory counsel and, where a state statute is in play, healthcare counsel licensed in that state.

A common source of risk is relying on a supplier's characterization of legality instead of an independent review of the specific product, the specific state, and the specific marketing a clinic plans to use. These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.

Where a product under review is an exosome or extracellular vesicle preparation, note that FDA states there are no FDA-approved exosome products, that they are generally regulated as biologic drugs under section 351, and that purchase and clinical-use decisions belong to the physician together with their own regulatory counsel.