Florida has taken a bold step forward in regulating regenerative therapies with the passage of Senate Bill 1768, effective July 1, 2025. This law allows licensed physicians (MDs and DOs) to offer certain unapproved stem cell treatments, provided they follow strict safety and sourcing standards.
This guide clarifies what’s legal, restricted, or off-limits under Florida law and federal FDA rules.
✅ What Treatments Are Legal in Florida?
| Treatment Type | Legal Status in Florida | Covered Under SB 1768? | Notes |
|---|---|---|---|
| PRP (Platelet-Rich Plasma) | ✅ Legal | ❌ No | Commonly used for joint, skin, and hair restoration; regulated under standard medical practice. |
| IV NAD+ Therapy | ✅ Legal | ❌ No | Available under physician supervision; not classified as a cell-based therapy. |
| Stem Cell Injections (Orthopedic, Pain, Wound Healing) | ✅ Legal with SB 1768 | ✅ Yes | Must be performed by licensed MDs/DOs using cells from FDA-registered facilities. |
| Aesthetic Cell Therapies (e.g. fat grafts, stem facials) | ⚠️ Case-by-case | ⚠️ Possibly | Legal if autologous and minimally manipulated; not legal if using banned biologics. |
❌ What Treatments Are Restricted or Prohibited?
| Treatment Type | Legal Status | Reason |
|---|---|---|
| Exosome Therapy | ❌ Illegal | FDA considers exosomes unapproved drugs; clinics cannot offer without FDA approval. |
| Allogeneic Umbilical Cord Cell Therapy | ❌ Illegal | Not covered by SB 1768; banned unless part of FDA-approved trials. |
| Embryonic Stem Cell Therapy | ❌ Illegal | Explicitly prohibited under Florida law; use of aborted fetal tissue is banned. |
What Does SB 1768 Allow?
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Who can offer treatments?
Only licensed MDs or DOs in good standing may offer stem cell treatments under this law. -
What conditions are allowed?
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Orthopedic issues (e.g. knee, back, shoulder pain)
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Chronic pain
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Wound healing
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Where must cells come from?
From FDA-registered, compliant tissue facilities. No use of embryonic or fetal tissue is allowed. -
What’s prohibited?
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Advertising unproven treatments as “FDA-approved”
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Offering therapies outside the allowed conditions
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Use of exosomes, amniotic, or umbilical-derived cells without FDA approval
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What About Popular Regenerative Treatments?
| Treatment | Legal in FL? | Safe to Receive? | FDA-Approved? |
|---|---|---|---|
| PRP | ✅ Yes | ✅ Widely used | ⚠️ Not FDA-approved (but not restricted) |
| Exosomes | ❌ No | ❌ Risky | ❌ No |
| IV NAD+ | ✅ Yes | ✅ Safe when physician-supervised | ⚠️ Off-label |
| Bone Marrow Stem Cells | ✅ Yes under SB 1768 | ✅ With MD supervision | ⚠️ Not FDA-approved |
| Aesthetic Fat Grafting | ⚠️ Sometimes | ✅ When autologous | ⚠️ Depends on manipulation method |
⚠️ Important Disclaimer
This guide is for informational purposes only and does not constitute medical or legal advice. Patients should consult with a qualified provider before undergoing any regenerative treatment.
️ Verified Florida Clinics
Visit our Florida Regenerative Medicine Directory to view verified clinics operating legally under SB 1768.