The Florida stem cell law, CS/CS/SB 1768, took effect on July 1, 2025. It lets Florida physicians use certain stem cell therapies the FDA has not approved, in orthopedics, wound care and pain management. It also puts a set notice, word for word, in every ad. In June 2026, Florida added a second law with its own notice for podiatric physicians. Here is what both laws mean for your marketing.
TLDR: The Florida stem cell law requires a statutory notice in every stem cell ad, word for word, in type no smaller than the largest type in the ad. Since June 11, 2026, podiatric physicians have their own law and their own notice. Neither law changes federal rules. The FDA sent a warning letter to a Florida clinic after the physician law took effect. Read on for both notices, the limits on scope and products, and the copy rules that keep federal risk in check.
Important Note
This article is for educational purposes only and does not constitute legal, medical, or regulatory advice. Marketing strategies discussed should be reviewed by qualified legal counsel before implementation, particularly regarding FDA, FTC, and state-specific advertising regulations. Regen Portal is a marketing and consulting company, not a law firm.
If you run a regenerative medicine practice in Florida, you have probably heard about SB 1768. It created a state framework for certain stem cell therapies, and it changed what a Florida stem cell ad has to say.
But here is where most practice owners get tripped up. They hear “the state passed a law allowing stem cell therapy” and think it means they can now promote stem cells freely. That is not what this law does. It creates a narrow authorization with strict guardrails, especially around advertising. And federal FDA rules still apply on top of it.
I have been in this industry since 2015, and I have seen what happens when practices over-market after a regulatory change. They get excited, push the boundaries, and end up with an FDA warning letter or worse. This article is about marketing smart within the new rules, not pushing past them.
We updated this guide in November 2026. The notice below now matches the statute word for word, and the podiatric law has its own section. If you copied the notice from an earlier version of this page, replace it.
What the Florida Stem Cell Law Actually Allows
The physician law is section 458.3245 of the Florida Statutes. It lets a Florida physician use stem cell therapy the FDA has not approved. There are two limits. The therapy must be within the physician’s scope of practice, and it must relate to orthopedics, wound care or pain management. Osteopathic physicians have a matching section in their own chapter.
The law also sets rules for where products come from. They must be retrieved, made and stored in an FDA-registered facility. That facility must be accredited by one of four bodies: the National Marrow Donor Program, the World Marrow Donor Association, AABB or the American Association of Tissue Banks. It must follow current good manufacturing practice. The product must hold viable cells after thaw, and the physician gets a viability report for the lot before use.
The law defines stem cell therapy as treatment with afterbirth placental perinatal stem cells, or other cell and tissue products that meet its rules. It shuts out cells or tissue from a fetus or embryo after an abortion. Using them on purpose is a third-degree felony. The law’s definition of cell and tissue products also leaves out secreted or extracted products. Whether a given product meets the definition is a question for counsel, not a sales rep.
Before treatment, the patient signs a consent form. The form explains the treatment and says it is not FDA approved. It also covers expected results, risks, benefits and other options. The law does not apply to physicians who hold an FDA investigational approval for the product. It also skips those who work under contract for certain accredited institutions.
What this means for your practice: This is a narrow law. It covers certain therapies, certain providers and certain product sources. It is not a broad license to market regenerative medicine. The ad rules are where it gets strict.
The Florida Notice Every Physician Ad Must Carry
This is the section that matters most if you market stem cell services in Florida. The statute requires a notice in any ad for the therapy. Treat every promotion as an ad: digital ads, social posts, video, email, print and the web pages that promote the therapy.
Here is the notice, word for word:
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.
The notice must be clearly legible, in a type size no smaller than the largest type in the ad. If your headline is in 24-point font, the notice must be in 24-point font too. This is not a fine-print rule. Florida wants patients to see this notice clearly.
Note what the statute does not require. The physician law does not require an office posting. Some clinics post the notice anyway, which is a choice, not a rule. Utah, Vermont, Washington and California do require postings, so multi-state groups should check each state.
One more detail. The notice says the therapies “have not yet been approved.” That word comes from the statute, so print it exactly as written. Just do not build on it. Nothing else in your copy should suggest that FDA approval is on the way.
What this means for your practice: If you advertise stem cell therapy in Florida, the notice is not optional. It goes in every ad, word for word, at full size. A violation can lead to discipline by the licensing board.
Florida’s Second Notice: Podiatric Physicians
On June 11, 2026, Florida added section 461.011 for podiatric physicians. It lets them use cellular or tissue-based products the FDA has not approved, within their scope of practice. The uses are connective tissue, ligament and tendon repair, wound care and pain management.
The product rules look like the physician law: an FDA-registered, accredited facility, viable cells after thaw and a viability report before use. Products from a fetus or embryo after an abortion are excluded. The patient signs a consent form before the procedure.
The podiatric law has its own notice, under the same type size rule:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This podiatric physician performs procedures using cellular or tissue-based products 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 procedure using these products.
Do not swap the two notices. A podiatry ad with the physician notice is wrong, and so is the reverse. If you are a manufacturer or distributor, check that any sample ads you give podiatry accounts carry the podiatric notice.
What this means for your practice: A multi-specialty group in Florida may need both notices, one for each kind of provider. Match the notice to the license of the person who performs the procedure.
Why State Compliance Does Not Protect You From the FDA
This is the part most practice owners miss. Following Florida’s law does not shield you from federal enforcement. The FDA’s position has not changed.
Federal law requires FDA approval before a product is marketed to treat, cure or mitigate disease. Under the Constitution’s Supremacy Clause, federal law generally wins when the two conflict. A state law can let a physician offer a therapy. It cannot make the product FDA approved.
The record shows it. In September 2025, the FDA sent a warning letter to a Florida clinic over its marketing of unapproved stem cell and exosome products. That letter came months after the physician law took effect. The FDA’s consumer alert on regenerative medicine products also remains in place.
| Rule Set | What It Says About Stem Cell Marketing |
|---|---|
| Florida s. 458.3245 and s. 461.011 | Advertising is allowed only with the statutory notice, at full size |
| Federal FDA | Unapproved products cannot be marketed as treating disease |
| FTC | All health advertising must be truthful and substantiated |
| Google Ads | Does not accept ads that promote stem cell therapy |
What this means for your practice: You must satisfy every row. Include the Florida notice and avoid disease-treatment claims. A practice can follow the Florida law to the letter and still receive an FDA warning letter if its copy promises to treat, cure or heal a condition.
We checked both Florida statutes on the Florida Senate site on November 3, 2026. Rules change, and enforcement varies by state. Always ask qualified legal counsel before you make compliance decisions for your practice or business.
What Compliant Stem Cell Marketing Looks Like in Florida
The safest approach is what we call “double compliance.” Meet Florida’s requirements and stay within federal rules at the same time. Here is a practical guide.
| Do Not Use | Better Direction (Counsel Reviews First) |
|---|---|
| “Our stem cell therapy cures knee arthritis” | “Talk with our physicians about whether a regenerative option is right for you,” plus the Florida notice at full size |
| “FDA-approved stem cell treatment” | The Florida notice, word for word, which says the therapy has not yet been approved |
| “Stem cells eliminate your pain” | “Learn what to expect at a consultation with our physicians” |
| No notice in the Facebook ad | The full notice in every ad format, social included |
| Fine-print notice at the bottom | A notice no smaller than the largest type in the ad |
The left column breaks federal law, state law or both. The right column carries the Florida notice and avoids the disease-treatment claims that draw FDA enforcement. Have counsel review the final copy before it runs.
Your paid advertising and content creation should pass this double check every time, on every piece you publish.
How This Looks in Practice
Picture a clinic in Central Florida that launches a stem cell campaign. It puts the state notice in its ads. But its Facebook ad headline reads “Stem Cell Therapy Eliminates Arthritis Pain,” and its landing page promises that “stem cells treat and heal damaged joints.”
The Challenge: The clinic thought the Florida notice covered it. It did not.
The Compliance Problem: The ad copy claims an unapproved product treats a disease. That breaks federal drug law, whatever state law says. It likely breaks Meta’s health ad rules and FTC standards too.
The Risk: An FDA warning letter is possible. So are FTC action, a closed Meta ad account and discipline from the Florida board.
The Fix: The clinic changes the headline to “Learn About Regenerative Options With Our Physicians.” It swaps the landing page claims for plain content about what happens at a consult. The full notice runs at full size. The copy moves from treatment promises to education.
Note: This scenario is illustrative and does not reference any specific Regen Portal client.
How Florida Compares With the Other Notice States
Florida is one of eight states with stem cell notice or consent laws, and it was not the first. Six of the eight require a statutory notice in every ad. The table shows where each state stands.
| State | Law | Notice in Every Ad? |
|---|---|---|
| Florida | s. 458.3245 (physicians); s. 461.011 (podiatric physicians) | Yes, two separate notices |
| Utah | Utah Code 58-1-512 | Yes |
| Tennessee | Public Chapter 1016, effective July 1, 2026 | Yes |
| Vermont | 18 V.S.A. § 4502 | Yes |
| Washington | RCW 18.130.420 | Yes |
| Georgia | O.C.G.A. § 43-34-49, effective July 1, 2026 | Yes |
| California | Business and Professions Code § 684 | No; posted and written notice (house policy: carry it in ads) |
| Wyoming | SF 48 | No notice wording; advertising only if every condition of the act is met |
Three states often land on these lists by mistake. Arizona’s 2026 bill was vetoed, so Arizona has no notice law. Texas has an investigational framework under HB 810 from 2017, not a clinic authorization. Nevada is not a stem cell notice state.
Each state words its notice differently. We keep every state notice in one place, word for word. Our overview of state stem cell laws explains what each state asks of your office.
What this means for your practice: If you operate in more than one state or market across state lines, track which notice each location needs. If you practice in Florida, Utah, Tennessee, Vermont, Washington or Georgia, the ad needs your state’s notice word for word. A marketing partner who knows this map can help you keep every ad current.
To build a marketing plan that keeps up with rule changes, explore Regen Portal’s full services.
For more on the rules that shape regen marketing, subscribe to Oscar’s YouTube channel: https://www.youtube.com/@oatellez.
Frequently Asked Questions
What Does the Florida Stem Cell Law Allow?
It lets Florida physicians use stem cell therapy the FDA has not approved, within their scope of practice, in orthopedics, wound care and pain management. Products must come from an FDA-registered, accredited facility. Cells or tissue from a fetus or embryo after an abortion are excluded, and the patient signs a consent form first.
What Is the Exact Notice Florida Requires in Physician Ads?
Use this text, word for word: 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.
What Notice Do Florida Podiatric Physicians Use?
Since June 11, 2026, s. 461.011 requires this text, word for word: THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This podiatric physician performs procedures using cellular or tissue-based products 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 procedure using these products.
How Big Does the Notice Need to Be in My Ads?
The notice must be clearly legible and no smaller than the largest type in the ad. Both Florida laws use this rule. It is not a fine-print requirement.
Does Florida Require the Notice to Be Posted in My Office?
The physician statute does not require an office posting. It requires the notice in every ad and a signed consent form before treatment. Utah, Vermont, Washington and California do require postings.
Does This Law Mean I Can Make Treatment Claims?
No. The state law allows certain therapies with a required notice. It does not override federal FDA rules, which bar marketing unapproved products as treating, curing or mitigating disease.
Can I Still Get an FDA Warning Letter If I Follow Florida’s Law?
Yes. The FDA sent a warning letter to a Florida clinic in September 2025, after the physician law took effect. Federal law runs on its own track, and federal rules generally win when the two conflict.
Do Other States Have Similar Laws?
Yes. Utah, Tennessee, Vermont, Washington and Georgia also require a statutory notice in every ad. California requires a posted and written notice, and Wyoming limits who may advertise under its act. Each state words its notice differently.
What Happens If I Leave the Notice Out?
A violation of the physician law can lead to discipline by the licensing board. Ask counsel what that could mean for your license and your practice.
Key Takeaways
- The Florida stem cell law is narrow. It covers certain therapies, providers and products, in three fields only.
- Every physician ad needs the statutory notice, word for word, no smaller than the largest type in the ad.
- Since June 11, 2026, podiatric physicians have their own law and their own notice. Do not swap the two.
- Florida compliance does not equal federal compliance. The FDA still enforces against Florida clinics.
- Double compliance is the safest approach: the Florida notice plus no disease-treatment claims.
- The word “yet” in the notice comes from the statute. Print it, but never suggest approval is coming.
- Florida is one of eight states with stem cell notice or consent laws, and each state words its notice differently.
Questions About Compliant Marketing for Stem Cell Services?
Navigating the intersection of state and federal rules is one of the hardest parts of marketing a regenerative medicine practice. Regen Portal was built for this challenge. We have been in the regenerative medicine industry since 2015, and we understand the rules, the risks, and the strategies that keep practices visible while staying compliant.
If you need help building a search engine optimization or advertising strategy that works within these new regulations, let’s talk.
A new state law usually means a pass over pages that were written before it. Our marketing compliance service runs that pass, and your attorney confirms the interpretation.
Email: hello@regenportal.com YouTube: Subscribe for weekly insights
About Regen Portal
Regen Portal is a marketing and consulting company built for the regenerative medicine industry. We handle practice consulting, marketing compliance, search engine optimization, content creation, social media management, paid advertising, website development, branding, and AI and ops consulting for clinics, manufacturers, distributors, and independent providers. For more on me and how we work, visit Regen Portal and contact us.
Oscar Tellez is the founder of Regen Portal, a marketing and consulting company built for the regenerative medicine industry. He has been in this industry since 2015. He started in medical sales and has worked with PRP since 2016. He has reached hundreds of practices and over 200 doctors through sales, teaching and marketing. He holds a B.S. in Exercise Science and Health Promotion from Florida Atlantic University.
