On July 1, 2025, Florida’s new “Stem Cell Therapy” legislation became effective, adding Fla.Stat. § 458.3245 to Florida’s Medical Practices statutes and § 459.0127 to Florida’s Osteopathic Medicine statutes. Florida’s new stem cell laws follow a similar Utah law passed in 2024, but Florida’s higher median age and population size will inevitably create a much larger market and far greater public attention.

The new Florida law allows physicians to administer “stem cell” products derived from human tissue (including birth tissue but excluding aborted fetuses) to patients for orthopedics, pain management, and wound care. The law requires product manufacturers to register with FDA and become certified by one of four listed accrediting organizations, but does not require the “stem cell” products to be FDA approved. In this way, and as I will explain in more detail below, the Florida law and federal law are at loggerheads.

This conflict between state and federal law is more than academic, and should be understood by physicians adding “stem cells” to their practices and patients seeking “stem cells” for their injuries. Fortunately, the recent history of “stem cells” in the United States is rich with data to inform those important decisions.

Twenty Years of Regulatory History, In Brief.

Following an eight-year regulatory process, the United States Food & Drug Administration (“FDA”) finalized its “stem cell” regulations in 2005. Those regulations are found at 21 CFR Part 1271, titled “Human Cells, Tissues, and Cellular and Tissue-Based Products,” (“HCT/Ps”), and  govern most medical products derived from human tissue and intended for the treatment of patients in the United States.

Part 1271 covers an expansive array of HCT/Ps – including birth tissue, skin, bone, bone marrow, and many others – and creates regulatory categories for each based on the tissue source, the type and extent of manufacturing, and the intended use. Speaking generally, FDA takes a “tiered, risk based approach” to regulating HCT/Ps: the more “homologous” the tissue is to its intended use (e.g., skin allografts for wound covering versus fat derived cells for autism), and the less processing is involved (cleaning and sizing versus chemical digestion and culture expansion), the more likely it is that FDA will allow the product onto the market without FDA approval. Critical to this discussion, FDA requires “allogeneic” HCT/Ps (meaning, tissue derived from a donor and administered to a different person) which either have a systemic effect or are “dependent upon the metabolic activity of living cells to achieve [their] primary function” to be approved before they can be marketed and administered to patients in the United States. See, 21 CFR § 1271.10(a)(4)(i).

Over the years, FDA has amplified its position on “stem cell” products derived from donated birth tissue through guidance,  consumer alerts,  web postings, and warning letters, and enforced consistently against many of the products the new Florida law allows, including  exosomes, umbilical cord blood, Wharton’s jelly, and amniotic tissue. FDA’s position is clear: when birth tissue products are marketed as either “cellular” or otherwise “dependent upon the activity of cells” to achieve their intended function, they must be approved prior to commercialization, and companies manufacturing, distributing, or using them without approval violate federal law.

Of course, the violations called out by FDA are not merely technical. In many instances allogeneic “stem cell” products have presented real risks to patients, either because they were genuinely dangerous or contained no beneficial properties. As an example, in 2019 FDA issued a  warning letter to Liveyon Labs, which had manufactured and distributed unapproved umbilical cord products which sickened numerous patients and ultimately resulted in the founder being sentenced to prison. Earlier this year, the Federal Trade Commission (“FTC”) and the attorney general of Georgia obtained a permanent injunction and $5M judgment against the Stem Cell Institute of America and its founders stemming from their false and unsubstantiated “stem cell” advertisements on a national scale. Meanwhile, there has been no shortage of press coverage, with “false hope” being a common refrain.

“Stem cells” or stem cells?

Another key takeaway from the last twenty years is that “stem cells” are not always stem cells, at least as actual stem cells are understood by biologists and implied by patients.

To a cell biologist, a stem cell is a specific type of living cell that can renew itself, develop into different cell types in the body, and multiply in the laboratory when provided with proper nutrients. Ideally, when actual, living stem cells are injected into the body, they can self-renew and “regenerate,” allowing for the repair of cartilage and the regrowth of damaged joints and organs. These characteristics are unique to stem cells, and again, they must be alive to multiply and regenerate.

However, over time, the scientific understanding of the term “stem cell” gave way it becoming marketing jargon. The federal district judge in Stem Cell Institute of America proves this point by defining “stem cell therapy” as involving “the injection of shots with products containing cells or growth factors derived from birth tissue, including amniotic tissue or fluid, placenta, Wharton’s jelly, umbilical cord blood, adipose tissue, and bone marrow.” In other words, even to a federal court judge, a “stem cell” product need not contain actual stem cells. Instead, if the product is derived from human tissue and contains any type of cell or growth factor – living or dead – the product is a “stem cell” product.

Meanwhile, no less than three studies have been published showing that the “stem cell” products widely available on the market do not contain stem cells at all.

First, in 2019, a study in the American Journal of Sports Medicine examined amniotic fluid products from seven companies and found that none contained live stem cells in spite of the presence of dead nucleated cells. This study therefore concluded that the amniotic fluid products should not be considered “stem cell” therapies, and cautioned researchers to “use caution when evaluating commercial claims that products contain stem cells.”

Second, in 2020, a study in the Cartilage journal reviewed nine products derived from amniotic membrane and arrived at the same conclusion. Here, the authors noted that although these products contained a variety of proteins and could have some beneficial effect in orthopedic applications, the actual method of action was unknown, and none contained live or otherwise viable cells which might justify calling them “stem cell” products.

Finally, in 2021, another study in the American Journal of Sports Medicine reviewed five commercially available products derived from umbilical cords, arrived at the same result, and concluded that whatever therapeutic benefit could be derived was likely due to the presence of proteins or non-viable cells. Again, however, these “stem cell” products contained no actual stem cells.

Unburdened by what has been.

To summarize, “stem cell” products derived from donated birth tissue have proliferated in the United States over the past twenty years in spite of FDA’s unambiguous position that, without approval, they violate federal law. Likewise, although these products are called “stem cell” products, they often contain no actual stem cells, and achieve a therapeutic benefit through proteins or dead cells, or simply by lubricating and cushioning. Thus, in many, many instances, off-the-shelf “stem cell” products are not really stem cell products – in spite of the risks companies take on by commercializing them.

The new Florida “stem cell” law is unburdened by this well-established history and, for the most part, disregards it. For starters, the law does not specifically define “stem cells” or require “stem cell” products to contain actual stem cells. Instead, the law defines “stem cell therapy” as a “treatment involving the use of afterbirth placental perinatal stem cells, or [HCT/Ps]…” Thus, so long as the product is derived from birth tissue or another HCT/P, the product can qualify as a “stem cell” therapy under Florida law.

Similarly, although the new Florida “stem cell” law requires manufacturers to provide doctors with an “analysis report” showing that the products contain “viable or live cells” at the time of manufacturing, the law does not require the “viable or live cells” to be stem cells and does not define “viable or live.” Consequently, the “analysis report” may include cells other than actual stem cells, and characterize them as “viable or live” when, in reality, they are  mostly dead. These are exactly the issues discussed by the studies discussed above.

The law also requires physicians to inform their patients in writing that “stem cell” products have “not yet been approved by FDA.” Physicians must also include this caveat in all of their advertising. However, given the history described above, this “informed consent” requirement might be incomplete, or worse, deceptive, for two reasons:

– The informed consent gives patients an incomplete understanding of the federal regulatory status of these products. In short, a patient might read that a product has not “yet” been approved by FDA and believe that to be the end of the matter. However, the law does not require the patient to be informed that the products actually violate FDA’s regulations, which could be even more relevant to the patient’s choice of treatment. Advising the patient of the former factor but not the latter might create an incomplete sense of security.

– The informed consent falsely assumes that an FDA approval application has been submitted for the product. The Florida laws require the informed consent to advise patients that  products “have not yet” been approved by FDA. By using the word “yet,” the law assumes that FDA approval is forthcoming, but in reality, manufacturers under the new Florida stem cell law are not even required to seek an approval. Only FDA registration is required, which is an exponentially lower barrier to market. In contrast to Florida’s “stem cell” law, Florida’s Right To Try Act, for patients with “terminal” medical conditions, requires products to have an approval application pending with FDA.

In addition to its inherent conflict with federal law, Florida’s new stem cell law is irreconcilable with preexisting Florida law – namely the Florida Drug and Cosmetic Act, which treats violations of federal law as violations of Florida law. So, for instance, if a person selling “stem cell” products in Florida violates federal law because his products lack FDA approval, he also violates Florida law. The new Florida stem cell law provides nothing in the way of reconciliation.

These gaps in the new Florida “stem cell” laws were easily foreseeable by the Florida legislature when the laws were being drafted and passed, and each presents potential risks to patients – either because patients are not receiving what they expected, or because the products are harmful. The Florida Board of Medicine now has the authority to implement the “stem cell” law through rulemaking, and it should consider these defects in the laws when choosing how to proceed.

Parting thoughts.

The best analog for the new Florida “stem cell” laws is cannabis legalization in the United States beginning with California’s Proposition 215 in 1996. Indeed, just as California “legalized” a federally banned substance within its own borders, so too has Florida with
“stem cell” products which FDA treats as adulterated, misbranded, unapproved new drugs.

Many good things have come with state legalization of cannabis, both in terms of commerce and patient access. The Florida law has similarly commendable intentions: greater access to potentially helpful therapies from licensed physicians for patients who might otherwise travel outside of the United States to receive care.

However, the cannabis industry has trudged a steep path since legalization. The United States Supreme Court has long since blessed DEA’s enforcement authority over cannabis companies operating in accordance with state law, and the government has used that authority routinely since then. Here, federal enforcement will remain an evergreen threat, so physicians should proceed with caution when incorporating “stem cells” to their practices.

Hopefully, the new Florida law will push FDA to modernize its HCT/P rules, much like the Justice Department did to its marijuana enforcement priorities beginning in 2013. Legalization in Utah is one thing, but legalization in Florida might be too big for FDA to ignore. As I argued in 2017, “FDA cannot enforce this problem away. FDA now finds itself with a distributed, decentralized drug manufacturing industry, and too few resources to know where all the participants are.” With the horse officially out of the barn, and an HHS commissioner who has promised to end FDA’s “suppression” of stem cells, FDA’s right next move might be to support state stem cell initiatives. I shared my thoughts on how it might do so in 2021, and to its credit, Florida’s new “stem cell” law includes several of the building blocks I called for at the time.

Supreme Court Justice Louis Brandeis once wrote in 1932 that “a single courageous state may, if its citizens choose, serve as a laboratory, and try novel social and economic experiments without risk to the rest of the country.” Florida endeavors to do precisely that with its new stem cell law. But there is no shortage of cases since that time endorsing the federal government’s efforts to crack down on entirely intrastate activity, and that risk is very real for Florida’s stem cell experiment. Whether FDA and Florida go to battle or find a middle ground is to be determined, but for the time being practitioners and patients must be mindful of what has been when deciding on treatments now available under Florida’s “stem cell therapy” law.