The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Health Policy
BILL: SB 1768
INTRODUCER: Senator Trumbull
SUBJECT: Stem Cell Therapy
DATE: March 31, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Pre-meeting
2. AHS
3. RC
I. Summary:
SB 1768 authorizes physicians (medical doctors and doctors of osteopathic medicine) to perform
stem cell therapies that have not been approved by the U.S. Food and Drug Administration
(FDA) when used for orthopedic conditions, wound care, or pain management. The bill
establishes standards for the manufacturing and storage of stem cells and requires a physician to
obtain a signed informed consent form from a patient before administering any such therapy.
The bill also requires that written notice be provided to a patient prior to the performance of stem
cell therapy, disclosing that the therapy is not approved by the FDA. This disclosure must also be
included in any advertisement for the therapy. The bill directs the Department of Health (DOH)
to adopt rules to implement the bill.
The bill provides an effective date of July 1, 2025.
II. Present Situation:
Overview of Stem Cells and Stem Cell Therapy
Stem cells are undifferentiated cells with the unique ability to develop into specialized cell types
and to divide indefinitely under certain conditions.
1
They are broadly classified as either
embryonic or adult (somatic) stem cells. Embryonic stem cells, derived from early-stage
embryos, are pluripotent and capable of differentiating into nearly all cell types in the human
body. Adult stem cells are more limited in scope and typically generate only cell types consistent
with their tissue of origin.
1
Department of Health, Senate Bill 1617 Legislative Analysis (Mar. 19, 2025) (on file with the Senate Committee on Health
Policy). Note that House Bill 1617 would be substantively identical to Senate Bill 1768 except for the House bill’s exclusion
of legislative intent and the inclusion of the use of afterbirth placental perinatal stem cells in the definition of “stem cell
therapy.”
REVISED: BILL: SB 1768 Page 2
In 2007, researchers developed induced pluripotent stem cells (iPSCs), a type of adult stem cell
reprogrammed to exhibit pluripotency.
2
These iPSCs have opened new frontiers in regenerative
medicine by offering a potential alternative to the use of embryonic stem cells.
Stem cell therapy involves administering stem cells or derivatives to repair, replace, or
regenerate human tissues. While hematopoietic stem cell transplants for blood disorders are
established treatments, many other stem cell therapies remain experimental and are not approved
by the FDA for routine clinical use.
3
Federal Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
The FDA regulates stem cell products that meet the definition of human cells, tissues, or cellular
and tissue-based products (HCT/Ps) through its Center for Biologics Evaluation and Research
(CBER).
4
CBER’s authority derives from the Public Health Service Act (42 U.S.C. § 264) and
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.). Applicable federal
regulations are found primarily in 21 C.F.R., part 1271.
Products that meet all of the criteria under 21 C.F.R. § 1271.10 -- commonly referred to as
“361 HCT/Ps” -- are subject to less stringent oversight. To qualify, the product must be:
• Minimally manipulated;
• Intended solely for homologous use;
• Not combined with another article (except for certain preservatives or water); and
• Either non-systemic and not dependent on the metabolic activity of living cells for its
primary function, or used autologously or in a first- or second-degree blood relative.
Products that do not meet these criteria are classified as “351 HCT/Ps” and are regulated as
biological drugs. These products require premarket approval through the FDA’s Investigational
New Drug (IND) and Biologics License Application (BLA) pathways, under
21 C.F.R., parts 312 and 600–680.
Enforcement and Oversight by FDA
The FDA requires establishments that manufacture or manipulate HCT/Ps to register with CBER
and to comply with current Good Tissue Practices (cGTPs) under 21 C.F.R. part 1271,
subpart D.
5
These practices are designed to prevent the introduction or transmission of
communicable diseases. The FDA conducts inspections, issues warning letters, and may pursue
2
Id.
3
Harvard Stem Cell Institute, Frequently Asked Questions: Stem Cell Therapies, available at:
https://www.hsci.harvard.edu/faq/stem-cell-therapies (last visited Mar. 28, 2025).
4
U.S. Food & Drug Administration, Center for Biologics Evaluation and Research (CBER), available at:
https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber (last visited Mar. 28, 2025).
5
See also U.S. Department of Health & Human Services, Current Good Tissue Practice (CGTP) and Additional
Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), available at:
https://www.hhs.gov/guidance/document/current-good-tissue-practice-cgtp-and-additional-requirements-manufacturers-
human-cells (last visited Mar. 28, 2025). BILL: SB 1768 Page 3
civil or criminal enforcement actions against facilities or providers offering unapproved or
noncompliant stem cell therapies.
The FDA has issued warnings about the widespread marketing of unapproved regenerative
medicine products, noting that approval is granted only after rigorous evaluation in clinical trials
to ensure safety and efficacy.
6
The FDA has received reports of serious adverse events associated
with unapproved regenerative medicine therapies, including blindness, tumor formation, and
infections.
7
Consumers are advised to exercise caution and are encouraged to report any adverse
effects or file complaints related to these products directly to the FDA.
Oversight by the Florida Boards of Medicine and Osteopathic Medicine
8
The Florida Board of Medicine (BOM), under the DOH, is responsible for licensing, regulating,
and disciplining medical doctors, a.k.a. allopathic physicians, pursuant to ch. 458, F.S. The
Board of Osteopathic Medicine (BOOM), pursuant to ch. 459, F.S., exercises the same authority
for osteopathic physicians. The BOM has the authority to impose disciplinary sanctions,
including license suspension or revocation, for violations of the standard of care, deceptive
advertising, or failure to obtain proper informed consent, under s. 456.072, F.S., and related
provisions of the Medical Practice Act. The BOOM has the authority to impose similar
disciplinary sanctions under s. 459.015, F.S., which governs grounds for disciplinary action
against osteopathic physicians.
In recent years, the BOM has reviewed complaints against providers advertising unproven stem
cell treatments for conditions such as orthopedic pain and neurodegenerative disorders. Some of
these providers have been subject to formal investigations, fines, and, in certain cases, license
restrictions or revocations. In 2013, the BOM revoked the licenses of two physicians in
administrative cases involving stem cells for failing to meet the standard of care. In 2015, the
BOM warned physicians and consumers that they should be aware of the risks involved
accessing stem cell therapies and regenerative medicine that was not approved by the FDA. The
BOM further warned that a physician providing stem cell treatment should do so only with an
investigational new drug application (IND) or a single patient IND for Compassionate or
Emergency Use.
Ethical Considerations and Prohibited Stem Cell Sources
Federal law does not explicitly prohibit the use of fetal-derived stem cells obtained from elective
abortions; however, such use is subject to ethical oversight, particularly in federally funded
research. The National Institutes of Health requires review by an ethics advisory board for
proposed research involving fetal tissue.
9
6
U.S. Food & Drug Administration, Important Patient and Consumer Information About Regenerative Medicine Therapies,
available at: https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-
information-about-regenerative-medicine-therapies (last visited Mar. 28, 2025).
7
Id.
8
Supra note 1.
9
National Institutes of Health, Policies and Procedures for the Use of Human Fetal Tissue (HFT) in Non-Transplantation
Research, available at: https://oir.nih.gov/sourcebook/ethical-conduct/special-research-considerations/policies-procedures-
use-human-fetal-tissue-hft-non-transplantation-research (last visited Mar. 28, 2025). BILL: SB 1768 Page 4
III. Effect of Proposed Changes:
Section 1 of the bill creates s. 456.63, F.S., to authorize allopathic and osteopathic physicians to
perform stem cell therapies that are not approved by the FDA and to impose requirements
relating to the manufacture, use, notice, consent, and oversight of such therapies.
Subsection (1) of this section provides legislative findings and intent, recognizing the potential of
stem cell therapies to advance medical treatment and improve patient outcomes. This portion of
the bill emphasizes the importance of using ethically sourced stem cells and expresses the intent
to prohibit the use of stem cells derived from aborted fetuses. Instead, the bill encourages the use
of adult stem cells, umbilical cord blood, and other ethically obtained human cells, tissues, or
cellular or tissue-based products.
Subsection (2) defines key terms used throughout the section:
• “Health care provider” is defined as a physician licensed under ch. 458, F.S., or an
osteopathic physician licensed under ch. 459, F.S., acting within the scope of their
employment.
• “Human cells, tissues, or cellular or tissue-based products” includes specified articles
consisting of human cells or tissues collected from cord blood donors who are residents of
the United States and intended for implantation, transplantation, infusion, or transfer into a
human recipient. The subsection also lists exclusions from that definition, including
vascularized human organs, whole blood and blood derivatives, secreted or extracted
products (except semen, which is a human cell, tissue, or cellular-based tissue product under
the bill), certain minimally manipulated bone marrow products, ancillary products used in
manufacturing, non-human-derived tissues, in vitro diagnostic products, blood vessels
recovered with organs for transplantation, fetal-derived stem cells, and adipose-derived
mesenchymal stem cells for transplantation.
• “Minimally manipulated” is defined in two parts: for structural tissue, it means processing
that does not alter the original relevant characteristics of the tissue relating to reconstruction,
repair, or replacement; for cells or nonstructural tissues, it means processing that does not
alter the relevant biological characteristics of the cells or tissues.
• “Stem cell therapy” is defined as a treatment involving human cells, tissues, or cellular or
tissue-based products, and explicitly excludes any treatment or research using cells or tissues
derived from a fetus or embryo following an abortion.
Subsection (3) authorizes health care providers licensed under ch. 458 or ch. 459, F.S., to
perform stem cell therapy not approved by the FDA, if the therapy is used for treatment or
procedures within the scope of the provider’s practice and is limited to the fields of orthopedics,
wound care, or pain management.
Subsection (3) also establishes requirements relating to the origin and preparation of the stem
cells used. The stem cells must be manufactured in a clean room certified by the FDA for the use
of high-efficiency particulate air (HEPA) filtration or ultra-low penetration air filtration to
minimize contamination. Additionally, the facility where the stem cells are retrieved,
manufactured, and stored must be registered and regulated by the FDA and licensed or registered
with one of four specified organizations: the National Marrow Donor Program, the World BILL: SB 1768 Page 5
Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or
the American Association of Tissue Banks.
Subsection (4) requires health care providers to comply with applicable current good
manufacturing practices for the collection, removal, processing, implantation, and transfer of
stem cells or stem cell-containing products. These practices must be consistent with the
requirements of the Federal Food, Drug, and Cosmetic Act and relevant regulations under
21 C.F.R., part 1271.
Subsection (5) requires a provider to deliver a specific written notice to the patient before
performing a stem cell therapy. The notice must state that the provider performs one or more
stem cell therapies that have not yet been approved by the FDA and must advise the patient to
consult with their primary care provider before undergoing any such therapy.
Subsection (6) specifies the formatting and delivery requirements for the written notice. The
notice must be printed on paper at least 8.5 inches by 11 inches in size and in no less than 40-
point type. It must be prominently displayed at the entrance to the provider’s office and in an
area visible to patients within the office. In addition, the notice must be included in all
advertisements for the stem cell therapy and must appear in a font size no smaller than the largest
font size used in the advertisement.
Subsection (7) requires that providers obtain a signed consent form from the patient or, if the
patient is not legally competent, from the patient’s representative, before performing the therapy.
The form must include, in language understandable to the patient or representative, a description
of the nature and character of the treatment, a statement about the treatment’s FDA approval
status, the anticipated results, alternative treatment options, and the recognized serious possible
risks, complications, and benefits of the proposed treatment and of any alternatives, including the
possible consequences of not undergoing treatment.
Subsection (8) identifies two categories of providers to whom the requirements of the section do
not apply. The first exemption applies to a health care provider who has obtained FDA approval
for an investigational new drug or device for the use of human cells, tissues, or cellular or tissue-
based products. The second exemption applies to a provider who performs stem cell therapy
under an employment or other contract on behalf of an institution that is certified by one of the
following organizations: the Foundation for the Accreditation of Cellular Therapy; the Blood and
Marrow Transplant Clinical Trials Network; the Association for the Advancement of Blood and
Biotherapies; or another entity with expertise in stem cell therapy as determined by the DOH.
Subsection (9) provides that a violation of any provision in the section may subject the provider
to disciplinary action. The appropriate regulatory board, the DOH, or the Agency for Health Care
Administration (AHCA), as applicable, has authority to enforce compliance and impose
sanctions.
Subsection (10) requires the DOH to adopt rules to implement the section.
The bill authorizes health care providers to administer stem cell therapies that have not been
approved by the FDA. This action may expose providers to federal regulatory enforcement. If a BILL: SB 1768 Page 6
provider or supplier administers or distributes stem cell products in violation of FDA
requirements, the FDA may take a range of enforcement actions, including issuing warning
letters, initiating civil or criminal proceedings in coordination with the U.S. Department of
Justice, seeking injunctions to prevent continued noncompliance, and disqualifying parties from
participating in clinical investigations. In addition, the FDA has authority to issue orders for the
retention, recall, destruction, or cessation of manufacturing of human cells, tissues, or cellular-
and tissue-based products (HCT/Ps) when it has reasonable grounds to believe the products were
manufactured in violation of applicable regulations.
Section 2 of the bill provides an effective date of July 1, 2025.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None. BILL: SB 1768 Page 7
C. Government Sector Impact:
The Department of Health through the Board of Medicine and Board of Osteopathic
Medicine, would incur rulemaking and implementation costs, which may include staff
time for developing criteria for exemption determinations, monitoring compliance, and
investigating violations. These costs are likely absorbable within existing resources but
could require additional resources depending on volume and enforcement.
The DOH notes that there would be an undeterminable impact on its Bureau of
Enforcement (BOE), given that the provisions of the bill do not grant the department
authority to inspect facilities to determine compliance with the bill’s notice, informed
consent, or physical plant requirements.
10
It is anticipated that BOE can absorb the
impact with existing resources and budget authority.
11
VI. Technical Deficiencies:
Florida does not specifically regulate clinics that perform treatments using stem cells and that
remains unchanged under this bill. The AHCA should not be tasked with enforcing violations of
the section created by the bill, as referenced at line 186, because the bill does not confer
regulatory authority over stem cell therapies to AHCA. However, AHCA may take enforcement
action against a provider pursuant to other applicable provisions of law.
At line 187, the bill provides rulemaking authority to the DOH. The DOH notes that rulemaking
authority should instead be given to the Boards of Medicine and Osteopathic Medicine because
the bill applies to two specific professions.
12
On lines 43-45, the bill defines the term “health care provider” to mean a physician licensed
under ch. 458, F.S., or an osteopathic physician licensed under ch. 459, F.S., acting within the
course and scope of his or her employment. However, the terms “health care provider” and
“health care practitioner” are used differently throughout the Florida Statutes. For example,
ch. 456, F.S., defines “health care practitioner” broadly to include most individuals licensed by
the DOH to practice a health care profession, while ch. 408, part-II, F.S., defines “provider” to
refer to entities regulated by the AHCA. In contrast, this bill uses “health care provider” to refer
only to licensed physicians. Although the definition in the bill is technically accurate, it may
create confusion when read in the broader statutory context.
The bill creates s. 456.63, F.S., within ch. 456, F.S., which governs general health professions
regulation. However, because the bill’s provisions apply only to physicians licensed under
chs. 458 and 459, F.S., it may be more appropriate to codify the language directly within those
chapters.
VII. Related Issues:
None.
10
Supra note 1.
11
Id.
12
Id. BILL: SB 1768 Page 8
VIII. Statutes Affected:
This bill creates section 456.63 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.