A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain management. The law, which took effect on July 1, 2025, charts new territory in the decades-long debate over whether and when physicians can administer treatments with stem cells, especially if those treatments have not been approved by the FDA.
The New Law
Under the new law, a physician may perform "stem cell therapy" not approved by the FDA "if such therapy is used for treatment or procedures that are within the scope of practice for such physician and the therapies are related to orthopedics, wound care, or pain management."
Florida law defines "stem cell therapy" as "a treatment involving the use of afterbirth placental perinatal stem cells, or human cells, tissues, or cellular or tissue-based products, which complies with the regulatory requirements provided in this section." These regulatory requirements relate to the retrieval, manufacture, storage and use of the stem cells. For example, the law requires that the stem cells be retrieved, manufactured and stored in an FDA-registered facility that is certified or accredited by one of the following entities:
- National Marrow Donor Program
- World Marrow Donor Association
- Association for the Advancement of Blood and Biotherapies
- American Association of Tissue Banks
The law also requires that a physician use stem cell products only if they are obtained from facilities that adhere to the applicable FDA current good manufacturing practices (cGMPs) for the collection, removal, processing, implantation and transfer of stem cells, or products containing stem cells. Physicians administering stem cell therapies must obtain signed consent forms from a patient or the patient's legal guardian that detail potential benefits and risks from the procedure.
Importantly, the Florida law explicitly acknowledges that physicians will market these treatments and requires them to post a disclaimer that the treatment is not FDA-approved. Any marketing material from a physician who provides stem cell therapy must include the following language in any form of advertisement:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.
The Florida law is in direct conflict with federal law and the Federal Food, Drug, and Cosmetic Act (FDCA), which requires products to have the required FDA approval prior to being marketed for treating, curing or mitigating disease. Under FDA regulations and guidance, human cells, tissues, and cellular and tissue-based products (HCT/Ps) may not be marketed to treat diseases or conditions such as pain, wound care or orthopedics unless such products have an approved Biologics License Application (BLA).
It is unclear how or if the FDA will enforce against stem cell treatments in Florida. However, manufacturers and providers of stem cell therapy should be aware of the regulatory risks associated with operating under the new Florida law.
