Words have meaning. In science and medicine the definition of a word is critical when it comes to understanding and communicating the biology of disease and the therapies we deploy as countermeasures.

In response to recent legislation (SB 1768), we’ve observed a notable increase in marketing efforts by biologics manufacturers. Many are positioning themselves as uniquely qualified under the new bill to supply products to healthcare providers, products that would otherwise fall within current federal (FDA) regulatory guidelines. While this bill represents a step in the right direction for expanding access and innovation in biologics, its current language remains significantly more restrictive than some manufacturers are suggesting. Stakeholders are encouraged to interpret the bill with care and to remain guided by the underlying regulatory framework as it evolves.

Let’s take a look at what this bill actually describes. This bill is explicitly focused on STEM CELLS produced by cGMP-compliant laboratories for the use by PHYSICIANS in the state of FLORIDA. Anything outside the use of stem cells by physicians in the state of Florida is NOT addressed in this bill.

This bill DOES NOT cover the use of exosomes, MSCs, peptides, growth factors, extracellular matrix (ECM or Wharton’s Jelly), amniotic fluid or any other biologic other than STEM CELLS. It also does not cover the use of biological cosmetics intended for topical use. It DOES NOT cover the use of ANY biologics by NPs, DCs, med spas or anyone other than a Florida licensed PHYSICIAN. This bill ONLY addresses the use of STEM CELLS, by PHYSICIANS in the state of FLORIDA. Examples of stem cells include hematopoietic stem cells from cord blood or bone marrow (HSCs), induced pluripotent stem cells (iPSCs) and neural stem cells (NSCs).

Most manufacturers of biologics in the USA DO NOT manufacture STEM CELLS for use by PHYSICIANS. Any claim by a manufacturer that, under this bill, they are a compliant source of biologics such as exosomes, MSCs, peptides, growth factors, extracellular matrix, amniotic fluid is false. A stem cell is a very specific cell. Exosomes are NOT cells. ECM is NOT cellular. Purified amniotic fluid is NOT cellular. Growth factors are NOT cellular. A stem cell has a very specific definition in biology and medicine. Again, examples of stem cells include hematopoietic stem cells (HSCs), neural stem cells, dental pulp stem cells and epithelial stem cells. Some in the field are arguing that MSCs are stem cells, but they are NOT. Mesenchymal Signaling/Stromal Cells (MSCs) are often called mesenchymal stem cells in popular text, but in most scientific contexts today, they are not considered true stem cells for the following reasons:

1. Limited Self-Renewal – True stem cells should self-renew indefinitely. MSCs exhibit limited proliferation capacity in vitro and lose potency over few passages.
2. Unproven In Vivo Multipotency – While MSCs can differentiate into bone, fat, and cartilage in vitro, there is no solid evidence they do so in vivo.
3. Heterogeneous Populations – MSC cultures are not pure populations. They consist of mixed cell types, many of which are stromal support cells, not bona fide stem cells.
4. Immunomodulatory Role – The main therapeutic action of MSCs in clinical trials is paracrine signaling and immune modulation, not tissue regeneration via differentiation.
5. ISCT Position Statement (International Society for Cellular Therapy) – The ISCT now prefers the term “Mesenchymal Stromal Cells” instead of “Mesenchymal Stem Cells” because of the lack of evidence for stemness.

MSCs are not true stem cells in the same category as hematopoietic or neural stem cells. They are better described as stromal cells with paracrine, trophic, and immunomodulatory properties, not lineage-committed, self-renewing stem cells.

Also, while not implicitly stated, this bill is intended to address the use of stem cells produced/manufactured IN the state of FLORIDA and used IN the state of Florida, by Florida licensed physicians. What this means is – if stem cells are produced by a cGMP compliant lab that is certified by one of several agencies, they can be sold to Florida based physicians for the purpose of “stem cell therapy” despite not being approved by the FDA. However, a laboratory outside of Florida is still subject to Federal oversight and regulation by the FDA. Only laboratories within FL selling to physicians within FL are compliant with this bill. Once products cross state lines the Federal government (FDA) has jurisdiction, and state mandates are superseded by federal regulations.  To be compliant with this new bill and state law the following has to happen:

1) a manufacturer has to manufacture stem cells and prove their products i) contain stem cells and ii) the stem cells are viable. This does NOT mean exosomes or MSCs or Wharton’s Jelly.  It means stem cells and the manufacturer has to prove every lot is in fact comprised of stem cells and those stem cells are alive.  2) the lab has to be cGMP complaint. 3) the lab has to be certified by an approved authority. 4) the stem cells must be used by a licensed FL-based physician. 5) the physician must have a contract with a lab and receive all above documentation, including stem cell viability counts for each lot.  A certificate of analysis describing stem cell viability is a requirement to be compliant with this bill (it is NOT possible to provide a viability count for exosomes, growth factors, PRP or any other biologic that does not have cells present).  6) the physician must have informed consent from the patient. 7) the physician must make appropriate “stem cell therapy” statements/declarations in their marketing.

Any laboratory outside FL claiming to be compliant with this bill, specifically that of providing “stem cells”, would be incriminating themselves with the FDA by stating they are out of compliance with federal guidelines and supplying drug products across state lines in the absence of a BLA and in violation of Section 351(a) of the PHS Act. Healthcare providers using these products are NOT “protected” by this FL law, but are also incriminating themselves with the FDA by openly marketing the use of prohibited drug products obtained through interstate commerce. ONLY laboratories in the state of FL specifically producing stem cells for Florida licensed physicians are covered by this new FL law.

The terms “stem cell” and “physician” are of critical importance and interstate commerce renders any protective governance implied in this bill mute.

What does this mean? It means that any physician in FL marketing stem cell products unapproved by the FDA cannot obtain them from interstate commerce. Eveything must happen within the state of Florida. It also means that any product used by physicians in Florida under this bill must contain live stem cells. This does not apply to biological cosmetics, MSC, exosomes, PRP, amniotic fluid, growth factors, peptides or anything other than a product containing cells defined by biology as being stem cells. Therefore all marketing should accurately reflect what is being offered. If a Florida-based healthcare provider is offering anything other than a stem cell therapy or obtaining stem cells from out of state this bill does not provide any protection from federal law.