Regenerative medicine adoption is moving quickly, and state legislatures are beginning to expressly support it. Some states have focused on patient disclosures, research oversight, or access to investigational therapies. Others are beginning to create more specific frameworks for how certain stem cell or regenerative medicine therapies may be offered in clinical practice when those therapies have not been approved by the U.S. Food and Drug Administration (FDA).
Florida’s CS/CS/SB 1768, passed in 2025 and created Florida Statutes §§ 458.3245 and 459.0127, is an important reference point. These laws have established a legal pathway for certain non-FDA approved stem cell therapies in Florida, but only within a limited structure. It applies to licensed medical doctors (MDs) and osteopathic physicians (DOs), and the stem cell therapy must relate to orthopedics, wound care, or pain management. The Florida Law is a “green light” with limits, but only as it relates to state laws. The issues are still what they are at the federal level, grey.
In May 2026, Georgia and Tennessee enacted new stem cell therapy legislation. Georgia HB 1275 was signed into law on May 11, 2026. Tennessee HB 2246 was signed into law on May 19, 2026. Georgia’s law expands on the Florida Law by allowing a physician assistant (PA) or nurse practitioner (NP) to perform qualifying human stem cell therapy following a lawful designation from a physician. Florida needs to follow suit and likely will. Even more bold, the Georgia Law does not expressly limit the therapy to orthopedics, wound care, or pain management. Tennessee expanded into a broader framework allowing stem cell therapy or regenerative medicine therapy within a physician’s scope of practice, presumably (but not expressly) incorporating midlevel application within the scope of their licenses and proper physician supervision that’s typical of mid level involvement.
For regenerative medicine practices, med spas, wellness businesses, orthopedic practices, pain management clinics, product suppliers, and investors, the legal question is not simply whether a state has passed a stem cell law. The more important questions are: (1) what does the law say re who can provide the therapy and for what conditions, (2) what products qualify, (3) what procedures (e.g., informed consent) have to be followed, and (4) how does the new laws square with what else might be happening in each such state.
To be clear, the new state laws aren’t creating anything other than an HOV lane within defined limits. But that doesn’t mean that coloring outside those lines will expose clinicians to discipline. Many such states are applying a variety of regen products (e.g., PRP, exosomes, Wharton’s Jelly, Cell Factors) that didn’t make their way into any state law. Many non specified clinicians (e.g., dentists, chiropractors, podiatrists and mid level) are involved in each such state. And many are administering these products for more conditions than what the new laws green light. Assessing risks will require these business and clinicians to understand the laws, and also the regulatory environment.
Florida’s SB 1768 as a Recent Reference Point
Florida’s SB 1768 is provides a recent and relevant comparison point for providers and businesses evaluating the newly enacted Georgia and Tennessee laws. The comparison shows how one state (Florida) has structured a narrower pathway for certain non-FDA approved stem cell therapies, while Georgia and Tennessee appear to be moving toward broader frameworks in their respective states.
The Florida Law, one of the first states leading the charge, is ironically the most narrow in terms of what can be done and who can do it. Qualifying therapies must be performed by an MD or DO licensed in Florida, and must relate only to orthopedics, wound care, or pain management. The statute also includes operational requirements tied to product sourcing, facility registration and accreditation, post-thaw viability reporting, advertising disclosures, informed consent, and physician discipline.
That structure gives Florida providers a framework to evaluate, but it also leaves out the many clinicians already active in the space as well as many therapies that are common in the regenerative medicine space. Practices focused on longevity, inflammation, recovery, aesthetics, sexual wellness, functional medicine, or broader regenerative health may not fit squarely within the narrow Florida Law. Which is why looking at this law and the others is just a starting point for compliance. Serious businesses in the space also have to know what’s being done at the regulatory level, not just what a law (that anyone can read) says.
Florida gets that and has formed a Stem Cell Therapy Workgroup to study implementation issues, including how accrediting and certifying bodies should be evaluated, how the Florida Department of Health should assess additional entities with expertise in stem cell therapy, and what standards may be needed for consistent oversight. It makes sense that the Workgroup conversation will open the door to expanding the law to meet the current treatment reality in the state.
With that framework in mind, Georgia and Tennessee are useful comparisons because each state appears to respond to a different limitation in the Florida model. Georgia correctly addresses big miss in the Florida Law, that Florida’s current framework does not allow NPs or PAs to perform qualifying stem cell therapy. Tennessee is also asking the right question when it addresses whether the law should extend beyond stem cell therapy into a broader regenerative medicine therapy framework. Florida may have gotten the ball rolling, but both Georgia and Tennessee caught it and are running with it.
Georgia’s Law Expands Who May Perform Stem Cell Therapy
The Georgia Law expressly allows an NP or PA to perform human stem cell therapy following a lawful designation from a physician. The Georgia Law requires the therapy to be used for treatment or procedures within the scope of practice of the physician, NP, or PA, and the patient to be properly advised in writing. In this way, the Georgia Law is more aligned with what’s actually happening in regen practices.
Even with this broader language, practices should be careful not to treat the Georgia statute as a simple delegation pathway. The statute refers to a “lawful designation” from a physician, which means practices will need to evaluate how that designation should be documented, what level of physician involvement is required, and whether the therapy falls within the scope of practice of the NP or PA performing the service.
The statute may create room for a more flexible clinical structure, but it also raises important compliance questions. Before offering services under this framework, practices should review provider roles, written protocols, supervision or collaboration requirements, patient selection criteria, informed consent, adverse event response, and medical record documentation. And like the Florida Law, Georgia regen practices need to understand what’s actually happening in the state and how regulators are responding (if at all).
Georgia Is Not Limited to Orthopedics, Wound Care, or Pain Management
Georgia’s law is also different from Florida’s current framework because it does not expressly limit human stem cell therapy to orthopedic conditions, wound care, or pain management. This is where reality meets regulation, which is rare with new regulations. This structure gives Georgia’s law a broader practical reach than the Florida Law. Instead of asking only whether the therapy falls within orthopedics, wound care, or pain management, the Georgia analysis turns on whether the therapy falls within the applicable provider’s scope of practice and whether the statute’s other requirements are met.
This is especially relevant for regenerative medicine businesses, nearly all of which operate well beyond orthopedics, pain management, and wound care. All of that makes the Georgia Law far more compatible with the fast growing longevity sector, where therapies are meshed together for outcomes.
Georgia providers still need to review the product, the intended use, the claims being made, the route of administration, the patient population, the provider’s license, the supplier documentation, and the federal regulatory status of the product. Compared to Florida’s narrower law, Georgia’s law gives certain practices more flexibility.
Tennessee Broadens the Conversation to Regenerative Medicine Therapy
The Tennessee Law is important, but for a different reason. The version of the Tennessee bill as originally introduced looked more similar to Florida’s enacted framework. It focused on stem cell therapy and limited the therapy to orthopedics, wound care, and pain management. However, that is not the version Tennessee enacted. Before passage, the bill was amended to broaden the statutory framework. As enacted, the Tennessee Law authorizes a physician to perform stem cell therapy or regenerative medicine therapy not approved by the FDA, so long as the therapy is used for a treatment or procedure within the physician’s scope of practice. That said, the Tennessee Law does create a gap in failing to specifically include NPs and PAs, as Georgia did.
The regenerative medicine market is not limited to one product category. Practices and suppliers may be dealing with cellular products, tissue-based products, Wharton’s jelly-related products, exosome-based products, or other biologic-adjacent offerings. Tennessee’s enacted framework appears to account for a broader product universe by creating requirements tied to product documentation, certificates of analysis, sterility reports, manufacturer information, advertising notices, informed consent, adverse event reporting, and clinical outcomes registries.
For businesses watching this space, Tennessee may be an early example of a state moving beyond traditional “stem cell therapy” language and into a broader regenerative medicine framework.
What These Laws Mean for Regenerative Medicine Practices
Many regenerative medicine businesses utilize many prescribing and treating professionals to administer many regen therapies for a whole host of matters. And that gap needs to get filled over time at state level regulation. We expect that to happen over time. Even then, regen business have to continue to look at the entire regulatory enforcement landscape and differentiate between “what the law says” from what’s happening in their state.
State Law is Only Part of the Analysis
While most of the regulatory activity is happening at the state level, businesses and clinicians still be mindful of the federal framework. From a federal perspective, the analysis depends on the product itself and how it is being used. Providers and businesses should consider the product’s source, how it is processed, whether it is being used for a homologous purpose, whether it is autologous or allogeneic, the route of administration, and the claims being made. They should also consider whether the product fits within the 361 HCT/P framework, i.e., human cells, tissues, and cellular and tissue-based products. In general, the 361 HCT/P framework refers to certain products regulated under Section 361 of the Public Health Service Act and 21 C.F.R. Part 1271. If a product does not fit within that framework, it may be regulated as a drug or biologic requiring additional FDA authorization. Though state based laws are flowing, the federal framework is still relevant and important.
Final Thoughts
State regulators are driving the bus in terms of creating clearer pathways for regen. More work need sot happen here. And a central unifying body to hold those conversations would help big time. That said, one this is clear: regen is here to stay. And no one seems to want to put that genie back int he bottle.
