Florida lawmakers have unanimously passed CS/CS/SB 1768, a groundbreaking bill that sets firm guidelines for the use of non-FDA-approved stem cell therapies. With strong bipartisan support—passing 37-0 in the Florida Senate and 112-0 in the Florida House—the bill is poised to take effect on July 1, 2025, pending enactment by Florida Governor Ron DeSantis. Here’s what this new legislation means for physicians, patients, and the future of regenerative medicine in Florida.
What Does the Bill Allow?
Under CS/CS/SB 1768, licensed physicians (MDs and DOs) in Florida will be permitted to administer non-FDA-approved stem cell therapies— as long as such is within the scope of his or her practice and for therapies related to:
- orthopedic conditions;
- wound care; or
- pain management.
This bill does not legalize the use of stem cells for any and all conditions, nor does it give carte blanche to providers. It lays out clear boundaries for who can offer these treatments and how.
Strict Standards for Stem Cell Sources
To ensure the highest ethical standards, the bill mandates that any stem cells used must be retrieved, manufactured, and stored in a
- FDA-registered and regulated facility;
- Accredited or certified by one of the following:
- National Marrow Donor Program;
- World Marrow Donor Association;
- Association for the Advancement of Blood and Biotherapies; or
- American Association of Tissue Banks; and
- These facilities must also provide a post-thaw viability analysis before cells are administered—helping ensure quality and efficacy.
Informed Consent Is Non-Negotiable
Before administering a stem cell treatment, physicians must obtain signed informed consent from the patient that clearly communicates the following:
- the therapy is not approved by the FDA;
- the therapy’s intended purpose;
- recognized risks and complications;
- potential benefits and limitations; and
- alternative options, including choosing not to undergo treatment.
Patients must also be encouraged to consult their primary care physician before moving forward.
Transparency in Advertising
To curb misleading marketing, the bill includes strict advertising requirements:
- Any ad promoting non-FDA-approved stem cell therapies must include a clear statutorily required disclosure about the therapy’s unapproved status.
- The notice must be printed in a font size no smaller than the largest font used in the advertisement.
Penalties for Violations
CS/CS/SB 1768 imposes serious consequences on licensees for failure to comply, introducing both criminal and administrative penalties:
- Physicians who willfully use stem cells derived from a human fetus or embryo post-abortion face a third-degree felony.
- Unauthorized sale, manufacture, or distribution of computer products using human cells or tissues, or cellular- or tissue-based products (such as brain organoids for biocomputing or attempting to use live neurons to create hardware–essentially, stem cell-powered AI) constitutes a third-degree felony.
In addition, violations may result in disciplinary action by the Florida Board of Medicine or Florida Board of Osteopathic Medicine.
What’s Next?
If signed into law, the bill will go into effect July 1, 2025. The relevant medical boards will also be tasked with promulgating and implementing rules and providing oversight to implement the bill’s provisions.
Final Thoughts
CS/CS/SB 1768 is a big step toward bringing structure and accountability to a rapidly evolving area of medicine. It strikes a balance between innovation and patient protection, offering access to promising therapies while ensuring responsible medical practices.
As the landscape of regenerative medicine continues to grow, this bill positions Florida as both a progressive and cautious leader in the field.
For physicians considering offering stem cell therapies—or patients exploring these treatments—it’s essential to understand the legal framework, ask the right questions, and prioritize informed consent.