Most regenerative medicine clinic owners understand that federal law governs what they can say about stem cell therapies in their marketing. What far fewer understand is that several states have independently enacted their own laws governing stem cell practice and advertising, with mandatory disclaimer language and per-violation penalties that apply on top of the federal framework. This guide covers every state with stem cell legislation in effect as of 2026.
TLDR: Seven US states have enacted specific stem cell practice or marketing laws as of 2026 (Florida, Utah, California, Vermont, Washington, Wyoming, and Nevada), with an eighth (Tennessee) awaiting governor signature. Each imposes distinct advertising and disclosure requirements on clinics offering non-FDA-approved stem cell therapies. Wyoming’s law was signed in March 2026 and takes effect July 1, 2026. State laws do not override federal FDA or FTC authority. The January 2025 FTC action against the Stem Cell Institute of America, resolved with over $5.1 million in penalties, confirms that false marketing claims are actionable regardless of state. This guide breaks down what each state requires and what clinics in no-law states should know.
Important Note
This article is for educational purposes only and does not constitute legal advice. State laws governing stem cell practice and marketing are complex, vary significantly by jurisdiction, and are subject to change. Every clinic must consult qualified legal counsel before relying on any state law for marketing decisions. Regen Portal is a marketing company, not a law firm or compliance consultancy.
The FDA regulates the products. The FTC regulates the claims. That federal compliance layer is the one most clinics focus on, and rightly so.
But several states now impose a second layer of compliance specifically on stem cell therapy marketing. Some require exact disclaimer language in every ad. Some require posted notices in the clinic. Some establish per-violation penalties. Compliance with federal law does not mean compliance with state law. And complying with state law does not limit federal enforcement authority either.
This guide covers every US state that has enacted stem cell legislation as of 2026, what each law requires in advertising, the verbatim mandated disclaimer language where applicable, and what clinics in states without specific legislation should know.
Federal Law Governs Regardless of State
This needs to be established before any state-by-state analysis.
State stem cell laws operate alongside federal law, not in place of it. No state law grants permission to make false or misleading marketing claims. No state law overrides FDA authority over regenerative medicine products that require premarket approval. No state law creates a safe harbor from FTC enforcement.
The January 2025 FTC action against the Stem Cell Institute of America makes this concrete. The co-founders, both chiropractors, were permanently banned from marketing regenerative medicine treatments and ordered to pay $5,155,146 total: $3,310,146 in consumer refunds and $1,845,000 in civil penalties. The case was originally filed in August 2021 jointly by the FTC and the Georgia Attorney General’s Office, with the resolution announced in January 2025. Georgia has no specific stem cell practice law. The FTC enforced regardless.
Clinics in Florida, Utah, Wyoming, Tennessee, and other states with new permissive laws must comply with both their state’s requirements and federal requirements at the same time. State compliance is not a substitute for federal compliance. Consult qualified legal counsel for your specific situation.
The State Tier System
State stem cell laws fall into three practical tiers based on what each statute actually does.
| State | Law | Effective Date | Tier | Advertising Requirement |
|---|---|---|---|---|
| Florida | SB 1768 / HB 1617 | July 1, 2025 | Tier 1 Authorization + Disclosure | Mandatory disclaimer in all ads with size requirements |
| Utah | SB 199 | May 1, 2024 | Tier 1 Authorization + Disclosure | Mandatory disclaimer in all ads; office posting |
| Wyoming | SF 48 (Stem Cell Freedom Act) | July 1, 2026 | Tier 1 Authorization + Disclosure | Informed consent required; advertising provisions in act |
| Tennessee | HB 2246 | July 1, 2026 (pending governor signature) | Tier 1 Authorization + Disclosure | Informed consent; disclosure notice in ads |
| California | SB 512 | January 1, 2018 | Tier 2 Disclosure Only | Mandatory notice in ads, in writing, posted in office |
| Vermont | Act 61 | 2021 | Tier 2 Disclosure Only | FDA non-approval disclosure in ads + consent |
| Washington | RCW Section 18.130.420 | 2018 | Tier 2 Disclosure Only | FDA disclosure + documented consent |
| Nevada | 2023 biologics law | 2023 | Tier 3 General Biologics | Permission for biologics broadly; not stem-cell-marketing-specific |
Tier 1 Authorization + Disclosure states explicitly permit non-FDA-approved stem cell practice for licensed physicians under defined conditions and require specific disclosures in advertising. Tier 2 Disclosure Only states do not establish a permissive practice framework but require FDA non-approval disclosures in advertising and informed consent. Tier 3 General Biologics describes Nevada, whose 2023 law is permission for non-FDA-approved biologics broadly rather than a stem-cell-marketing-specific statute like the others.
What this means for your practice: The majority of US states have no specific stem cell legislation. In those states, federal law governs exclusively, without any state-level practice permission framework or guidance.
Florida SB 1768: The Most Active New Market
Florida’s CS/CS/SB 1768, codified at Fla. Stat. Sections 458.3245 and 459.0127, took effect July 1, 2025. It is the most expansive state stem cell practice law to date and the one creating the most marketing activity in 2026.
What the Law Permits: Florida-licensed physicians (MDs and DOs only) may market and administer non-FDA-approved stem cell therapies for orthopedic conditions, wound care, and pain management. Cells must come from FDA-registered facilities accredited by NMDP, WMDA, AABB, or AATB. Stem cells derived from aborted fetuses or embryos are prohibited. Willful violation of the fetal/embryonic prohibition is a third-degree felony under the statute.
Who It Does Not Cover: The law does not extend to nurse practitioners, physician assistants, APRNs, chiropractors, naturopaths, or med spas. It also does not cover exosomes, MSCs (unless they meet the law’s stem cell definition), Wharton’s jelly, amniotic fluid, peptides, or growth factors. Practices marketing these products under SB 1768 are misreading the statute.
Required Advertising Disclaimer (Verbatim):
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration.
You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.
This language must appear in any advertisement from a physician offering covered stem cell therapy. The statute also requires that the notice be clearly legible and in a type size no smaller than the largest type size used in the advertisement. Enforcement runs through the Florida Department of Health, which can impose licensure consequences.
The Marketing Caution: Multiple biologics manufacturers have been marketing aggressively to Florida physicians, claiming their products qualify under SB 1768. Many of those claims are overstated. The law is specifically focused on stem cells produced by cGMP-compliant laboratories, administered by Florida-licensed physicians, for the three covered indications. Products outside that definition are not covered. Any Florida physician relying on SB 1768 for marketing should have qualified legal counsel confirm both the product and the marketing materials comply with both state and federal requirements. For deeper background on this specific law, see Regen Portal’s existing breakdown of Florida’s stem cell law.
California SB 512: The Oldest Law on the Books
California’s SB 512, originally codified at Cal. Bus. & Prof. Code Section 684 in 2017 and since renumbered to Section 2259.7, took effect January 1, 2018. It was the first state stem cell marketing law in the US.
What It Requires: Licensed healthcare practitioners performing non-FDA-approved stem cell therapy must post a required notice in the practice entrance and a patient-visible area, provide the notice in writing before initial therapy, and include the notice in any advertisement.
Required Notice (Verbatim):
THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW.
This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration.
You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.
Penalty: $1,000 per violation after the first violation, with Medical Board annual reporting required. California’s law applies broadly to any non-FDA-approved stem cell intervention, not just specific indications.
Utah SB 199: Broadest Provider Eligibility
Utah’s SB 199, codified at Utah Code Section 58-1-512, took effect May 1, 2024.
What It Permits: Licensed healthcare providers may perform non-FDA-approved placental and perinatal stem cell therapies, provided required notice and consent are given. Utah’s provider eligibility is unusually broad, defined by reference to Utah Code Section 78B-3-403, which encompasses a wide range of licensed practitioners beyond MDs and DOs.
Required Notice (Verbatim):
THIS NOTICE MUST BE PROVIDED TO YOU UNDER UTAH LAW.
This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration.
You are encouraged to consult with your primary care provider before undergoing a stem cell therapy.
Specific Advertising Requirements: In print ads, the notice must appear in font size no smaller than the largest font used in the ad. In broadcast and digital ads, it must be clearly legible or clearly spoken. The office must display the notice on paper at least 8.5 by 11 inches, in no less than 40-point type, prominently posted in the practice entrance.
Penalty: Violation is unprofessional conduct, subject to license discipline.
Wyoming, Tennessee, Vermont, and Washington
Four additional states round out the legislative map.
Wyoming SF 48 (Stem Cell Freedom Act) was signed into law by Governor Gordon in March 2026 (Chapter 64 of the 2026 Session Laws) and takes effect July 1, 2026. The statute is narrower than its name suggests. It authorizes physicians (MDs and DOs, with physician assistants explicitly excluded) to recommend and perform stem cell therapy using only autologous mesenchymal stem cells. The statute also excludes any biological material derived from an abortion. To qualify, the therapy must be conducted under Institutional Review Board oversight or as an investigational drug, biological product, or device, with cells handled in cGMP-compliant facilities. Patients must sign written informed consent acknowledging the FDA non-approval of the therapy. The act also directs the Wyoming Board of Medicine to operate a public registry of physicians qualified to perform stem cell therapy. Specific advertising disclaimer requirements should be confirmed directly with state health authorities or qualified legal counsel before the July 1, 2026 effective date.
Tennessee HB 2246 passed both chambers of the Tennessee legislature in April 2026 and awaits the governor’s signature as of May 2026. If signed, the law takes effect July 1, 2026. It permits Tennessee-licensed physicians to administer non-FDA-approved stem cell and regenerative cellular therapies for orthopedic, pain management, and wound-care indications. Cells must come from FDA-registered, accredited facilities. Patients must sign informed consent, and advertisements must include a disclosure notice encouraging consultation with a primary care provider. Tennessee clinics should confirm the law’s signed status and final advertising requirements with legal counsel before relying on it for marketing.
Vermont Act 61 (18 V.S.A. Section 4502), effective 2021, requires practitioners administering FDA-unapproved stem cell therapies to issue a standardized patient notice, obtain signed informed consent, and disclose FDA non-approval status in any related advertisement. Vermont’s statutory language is broader than most other states, covering “stem cell or stem cell-related products” rather than the narrower “stem cell therapy” phrase used elsewhere. The specific products covered by that broader phrase are not enumerated in the statute, and any clinic relying on Vermont law should have qualified legal counsel interpret the scope for its specific product offering. The required notice must also include information for filing complaints through the Vermont Attorney General’s Consumer Assistance Program.
Washington RCW Section 18.130.420, enacted 2018. Providers must alert patients that stem cell interventions are not FDA-approved and obtain documented informed consent before treatment. FDA non-approval disclosure is required in advertising.
Nevada: Permission for Biologics, Not Stem-Cell-Specific Marketing
Nevada warrants its own treatment. Its 2023 biologics law permits the use of non-FDA-approved individualized investigational treatments, including gene therapies and certain biologic products, placing the state at the forefront of permissive regulation. The 2023 law is regulatory permission for biologics broadly, not a stem-cell-marketing-specific statute in the same form as California’s SB 512 or Florida’s SB 1768. Specific advertising disclaimer requirements under Nevada law remain less well-defined than in disclosure-required states like California and Utah, and clinics should not assume that Nevada’s permissive practice posture extends to permissive marketing claims.
The Federal Tension: Nevada’s permissive posture exists in direct tension with federal FDA law. State permission to administer or market non-FDA-approved biologics does not limit FDA’s enforcement authority over unapproved regenerative medicine therapies. A clinic operating under Nevada’s biologics framework carries the highest federal regulatory exposure of any state covered in this guide, precisely because the state law most directly conflicts with federal law. Marketing risk in this environment compounds quickly. Consult qualified legal counsel before relying on Nevada law for any marketing decision.
What Clinics in No-Law States Should Know
Most US states have no specific stem cell practice or marketing legislation. Federal law governs exclusively in those states.
The absence of a state law does not reduce the compliance obligation. It increases the exposure in one respect: there is no state-level permission framework to lean on. Any non-FDA-approved procedure is evaluated entirely under federal standards.
For clinics in no-legislation states, the compliant language framework for regenerative medicine marketing is the primary guide. Factual, educational, provider-focused content that does not claim to treat specific diseases with unapproved procedures is the standard. Consult qualified legal counsel for clinic-specific compliance review.
The Three-Layer Compliance Review Every Clinic Needs
State stem cell laws impose advertising obligations on top of federal requirements, not instead of them. The January 2025 FTC enforcement confirms that false marketing claims are actionable regardless of state.
The correct approach for any regenerative medicine marketing team is a three-layer compliance review:
- Federal FDA compliance. What can be said about the product and the procedure. Is the product properly characterized? Is the indication permitted?
- Federal FTC compliance. Are all claims truthful and substantiated? Are testimonials, before-and-after content, and outcome statements compliant with FTC standards for health claims?
- State-specific requirements. Does the state require mandatory disclaimer language? Is the required text appearing in every ad, every digital channel, every printed material, and every clinic location?
Missing any one of the three layers creates exposure. For paid digital advertising specifically, state disclaimer requirements apply to Google and Meta campaigns too, not just websites and print materials.
Frequently Asked Questions
Which States Have Specific Stem Cell Marketing Laws?
As of 2026, seven states have enacted specific stem cell practice or marketing laws: Florida, Utah, California, Vermont, Washington, Wyoming, and Nevada. Wyoming’s law was signed in March 2026 and takes effect July 1, 2026. An eighth state, Tennessee, passed both chambers in April 2026 and awaits the governor’s signature as of May 2026. The remaining states have no specific legislation, leaving federal law as the sole governing framework.
Does the Florida Law Apply to Exosomes or Med Spas?
No. Florida SB 1768 covers stem cell therapies administered by Florida-licensed MDs and DOs for orthopedic, wound care, and pain management indications only. It does not cover exosomes, Wharton’s jelly, amniotic fluid, peptides, growth factors, or providers other than physicians.
Does the Wyoming Law Cover All Stem Cell Therapies?
No. Wyoming’s Stem Cell Freedom Act (SF 48) is limited to autologous mesenchymal stem cells, meaning cells harvested from the patient’s own body (typically bone marrow or fat tissue). The act explicitly excludes any biological material derived from an abortion. Physician assistants are also excluded from performing therapy under the act.
Does a State Stem Cell Law Override Federal FDA or FTC Rules?
No. State law operates on top of federal law, not in place of it. The FDA retains full authority over products requiring premarket approval. The FTC retains full authority over advertising claims. State permission to practice does not create a federal safe harbor.
What Happened in the Stem Cell Institute of America Case?
In January 2025, federal court orders permanently banned the co-founders of the Stem Cell Institute of America, both chiropractors, from marketing regenerative medicine treatments. The action was brought jointly by the FTC and the Georgia Attorney General’s Office, originally filed in August 2021. The resolution totaled $5,155,146: $3,310,146 in consumer refunds and $1,845,000 in civil penalties.
What Is the Required Disclaimer in California?
California’s SB 512, now codified at Bus. & Prof. Code Section 2259.7, requires the verbatim notice reproduced above to appear in every advertisement, be posted in the clinic, and be provided to the patient in writing before the initial therapy. The penalty is $1,000 per violation after the first.
What If My State Has No Stem Cell Law?
Federal FDA and FTC rules apply exclusively. The absence of a state law does not reduce the federal compliance burden, and it removes any state-level practice permission framework. Consult qualified legal counsel for clinic-specific review.
Do State Disclaimer Requirements Apply to Digital Ads?
Yes. State advertising requirements apply across all channels: websites, paid search, paid social, print, broadcast, email, and clinic signage. A disclaimer that appears on the homepage but not in Google Ads is not compliant.
Key Takeaways
- Seven states have enacted specific stem cell practice or marketing laws as of 2026 (Florida, Utah, California, Vermont, Washington, Wyoming, and Nevada), with an eighth (Tennessee) pending governor signature as of May 2026.
- Wyoming’s Stem Cell Freedom Act was signed in March 2026 and is limited to autologous mesenchymal stem cells, with an effective date of July 1, 2026.
- State laws operate alongside federal FDA and FTC requirements, not instead of them. Compliance with one layer does not satisfy the other.
- The January 2025 FTC action against the Stem Cell Institute of America, resolved with $5.1 million in penalties, confirms federal enforcement authority operates independently of state permission.
- Florida SB 1768 is the most expansive state law but narrow in scope: MDs and DOs only, orthopedics, wound care, and pain management only, stem cells only.
- California’s SB 512 is the oldest and carries the most concrete penalty structure at $1,000 per violation after the first, now codified at Bus. & Prof. Code Section 2259.7.
- State-mandated disclaimer language must be reproduced verbatim and must appear across every advertising channel, not selectively.
- Clinics in states without specific legislation are governed entirely by federal law, with no state-level safe harbor.
Need a Compliance-Aware Marketing Partner?
PS: Most regenerative medicine clinics fail compliance reviews not because they are trying to cut corners but because the rules live in three separate places: federal FDA, federal FTC, and state-specific statutes. Missing the state layer is the most common failure point we see.
Regen Portal builds marketing programs with all three layers built into the review process. Reach out at [email protected].
For more on me, subscribe to the Regen Portal YouTube channel: https://www.youtube.com/@oatellez
About Regen Portal
Regen Portal is a marketing company built for the regenerative medicine industry. We provide SEO, content creation, social media management, paid advertising, website development, and branding services for clinics, manufacturers, distributors, and independent providers. Some of the strategies discussed in this content align with services we offer. To learn more, contact us.
About the Author
Oscar Tellez is the founder of Regen Portal, a marketing company built for the regenerative medicine industry. With over 15 years of experience spanning clinical operations, product distribution, and digital marketing, Oscar has helped hundreds of practices, manufacturers, and distributors grow through compliant, high-performance marketing strategies. He holds a B.S. in Exercise Physiology and Health Promotion from Florida Atlantic University.
