Florida has allowed stem cell treatments that are not approved by the FDA. The Republican-governed state joins the growing list of states allowing non-FDA-approved stem cell treatments. Here’s everything we know about the legalization and what makes these therapies such a polarizing and controversial topic.
Florida’s law, which came into effect on July 1, restricts the use of stem cell therapy for only orthopedics, wound care, and pain management. “It is the intent of the Legislature to foster medical innovation while upholding ethical standards that respect the sanctity of life,” says the law.
Florida and Utah are now letting patients access stem cell therapies without FDA approval. State laws are taking power from DC and handing it to doctors and patients.
Medical disruption is occurring LIVE.
— Peter H. Diamandis, MD (@PeterDiamandis) June 16, 2025
Florida Allows Stem Cell Therapy with Some Conditions
Meanwhile, Florida hasn’t given a blanket approval for stem cell treatment and has put several conditions. These include
- The patient (or their representatives if the patient is not legally competent) must sign a consent form clearly mentioning that the treatment is non approved by the FDA. It must also mention the risks associated with the therapy and the “anticipated results of the proposed treatment.”
- The physician performing the therapy must be performing a procedure within the scope of their practice.
- The stem cell should be retrieved, manufactured, and stored in an FDA-registered facility and must adhere to the current good manufacturing practices.
- The regulation encourages cell sources like “adult stem cells, umbilical cord blood, and other ethically obtained human cells, tissues, or cellular or tissue-based products.”
- They, however, forbid the use of blood vessels, bone marrow, extracted human products (barring semen), non-human cells, and any organs intended for transplantation.
- The regulations lay a lot of emphasis on non-use of embryonic sources and prohibit cells “derived from a fetus or embryo after an abortion” as well as in vitro diagnostic products.
Physicians violating these conditions may be subject to disciplinary action by the board. However, there are stricter penalties for “treatment or research using human cells or tissues derived from a fetus or an embryo after an abortion,” which would be considered a “felony of third degree.”
Stem Cell Controversy
While stem cell research has been around for a long time, it has been quite controversial from the outset. In the early 2000s, there was considerable debate over stem cell research, particularly regarding human embryonic stem cells (hESCs) derived from embryos through in vitro fertilization (IVF).
The embryo is destroyed in the process, and pro-life activists argue that a human embryo (even if not implanted) is human life and destroying it amounts to murder. However, those who support stem cell research argued that these embryos are leftovers and would have been discarded anyway.
Meanwhile, cell therapies have evolved since the 2000s, when human embryonic stem cells were dominant. In 2006, induced Pluripotent Stem Cells (iPSCs) were discovered, which was a pivotal moment for the industry.
The advent of gene-editing tools like CRISPR in the 2010s also helped revolutionize research. The manufacturing process has also improved significantly, and artificial intelligence is now being increasingly used in research.
Why Does the FDA Not Approve These Treatments?
Currently, the FDA allows for limited stem cell therapies. It allows for therapies using cells derived from umbilical cord blood, but the treatment is limited to rare blood disorders only. Earlier this year, it approved Ryoncil, a mesenchymal stromal cell (MSC) therapy, which was the first of its kind to receive FDA approval.
The FDA hasn’t yet fully approved stem cell therapy for several reasons. The first is, of course, the ethical dilemma. Second, there is still insufficient scientific evidence demonstrating the effectiveness of some of these therapies, a prerequisite to get approval from the FDA.
Finally, analysis done by The Pew Charitable Trusts showed 360 adverse events linked to stem cell therapies between 2004 and 2020. These include injuries as well as deaths. Incidentally, in 2017, an unproven cell treatment blinded three people with macular degeneration in Florida alone.
While the total number of adverse events might seem benign, most experts believe that since the therapy is still not approved, most cases are not reported in the first place.
Can States Sidestep FDA?
According to the FDA, it “has authority to regulate regenerative medicine products, including stem cell products and exosome products.” The agency adds that “generally, all stem cell products require FDA approval.”
Last year, the FDA received a shot in the arm in its strive to regulate stem cell therapy on the national level after a three-judge panel on the Ninth Circuit Court of Appeals ruled that the agency can regulate two stem cell clinics in Southern California. Previously, a lower court had exempted these clinics from FDA regulation.
The case is currently before the US Supreme Court, and last month, the Goldwater Institute submitted a friend-of-the-court brief in a lawsuit challenging the FDA’s authority to restrict treatments involving stem cells. The Supreme Court is yet to hear the case, and in case it decides against doing so – as is the case for most appeals – the Ninth Circuit’s decision granting authority to the FDA to regulate these treatments would remain in place.
However, states have been trying to sidestep the FDA’s authority in regulating stem cell therapy. The FDA did not take any specific action when Nevada and Utah approved cell therapies in 2023 and 2024, respectively.
It is all the more unlikely that the FDA will try to challenge Florida’s regulations now, as the agency is under Health and Human Services Secretary Robert F. Kennedy Jr., who is a proponent of stem cell therapy, even claiming he received one himself in Antigua.
Why Clinics Support Stem Cell Therapy?
Thousands of clinics across the US offer stem cell therapy. They are quite profitable for these clinics, as unapproved therapies can cost tens of thousands of dollars for procedures that typically involve minimal cell processing.
The issue is not only about supply but also demand for these therapies from patients who have incurable or chronic illnesses and see cell therapy as a sign of hope. Along with the various clinics that have mushroomed across several states, some listed companies are also working on cell therapies. For instance, Lineage Cell Therapeutics is working on “off-the-shelf,” cell therapies for serious neurological and ophthalmic conditions. Mesoblast is another company in this space working on allogeneic cellular medicines that can treat complex inflammatory diseases.
Then we have regenerative and cellular medicine company Celularity, which hailed Florida’s law as “groundbreaking.” The stock has gained 60% over the last month amid optimism over the Florida law. Days after the law came into effect, Celularity announced a strategic partnership with Fountain Life to supply stem cell therapy products manufactured and distributed by Celularity.
All said, while stem cell therapies are controversial, many medical professionals see them as a breakthrough for curing previously incurable diseases. Moreover, suppressing further research through regulations is not having much impact, as a many US citizens travel overseas, particularly to Mexico, for these treatments.
