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Florida’s 2025 Stem Cell Therapy Law: Innovation with Guardrails

On May 11, 2025, Florida lawmakers passed House Bill 1617, a forward-thinking law that expands access to certain unapproved stem cell therapies. While this legislative shift offers hope for patients seeking new treatments, it also establishes rigorous guidelines to ensure ethical practice and patient safety.

Understanding HB 1617: A Legal and Medical Milestone

HB 1617 allows licensed Florida healthcare providers to administer certain stem cell therapies that haven’t yet received U.S. FDA approval, but only under strict conditions. This move reflects Florida’s growing role as a leader in emerging health technologies.

Key Provisions:

Several challenges have emerged for businesses seeking to refinance their commercial loans in this evolving interest rate climate:

  • Informed Consent: Patients must sign detailed disclosures stating the therapy’s unapproved status and potential risks.
  • Ethical Compliance: Use of cells derived from aborted fetuses is explicitly banned, with allowable sources including adult stem cells and umbilical cord blood.
  • Advertising Transparency: All marketing materials must clearly note that the therapies are not FDA-approved.
  • Regulatory Oversight: The Florida Department of Health will enforce standards, including requirements for facilities and stem cell sourcing.

Balancing Innovation and Safety

This law embraces innovation but not at the expense of safety. While it encourages treatment access, it recognizes that unapproved therapies carry medical risks, including adverse reactions.

The FDA has long cautioned against unproven stem cell interventions. As such, patients are urged to:

  • Consult with primary care physicians or specialists.
  • Research providers’ credentials and therapy protocols.
  • Fully understand the risks involved.

What It Means for Patients and Providers

For Patients:

  • Expanded Options: Especially for those with chronic or untreatable conditions.
  • Risk Awareness: Choosing these therapies should involve serious due diligence.

For Providers:

  • Service Expansion: Providers can offer more innovative treatments.
  • Legal Accountability: Missteps in consent, sourcing, or marketing could carry significant legal risk.

How Lumalex Law Helps Emerging Medical Innovators

At Lumalex Law, we specialize in helping clients navigate new frontiers in biotech, health innovation, and regulated emerging markets. With HB 1617 taking effect soon, businesses and healthcare entities must ensure:

  • Regulatory Compliance: Aligning state initiatives with federal standards.
  • Ethical Supply Chains: Sourcing legally and transparently.
  • Consent Protocols: Drafting and managing patient consent that meets both state and federal law.
  • Advertising Review: Ensuring your marketing doesn’t put you at legal risk.

Whether you’re launching a regenerative medicine clinic or developing cutting-edge treatment protocols, Lumalex can help you operate safely, ethically, and competitively.

Learn More

If your business is part of, or looking to enter, the regenerative therapy space, legal clarity is critical. Contact Lumalex Law to discuss how we can help you stay ahead in this evolving landscape.

FAQs

Q1: What is HB 1617’s primary goal?

A: To broaden access to certain stem cell therapies while maintaining ethical standards and transparency.

Q2: Are these therapies safe?

A: Safety varies. Many are still under clinical research. The FDA does not guarantee their efficacy or safety.

Q3: Can providers advertise them?

A: Yes—but only with clear disclosure that the therapy is not FDA-approved.

Q4: What ethical boundaries does the law address?

A: It prohibits the use of stem cells from aborted fetuses and mandates ethical sourcing and manufacturing.

Q5: When does the bill take effect?

A: July 1, 2025.

Q6: Does this law override FDA rules?

A: No. It operates within a state-level framework and providers must still comply with federal regulations.

 

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Legal Advisors for Emerging Industries

LumaLex Law is your legal partner and advisor for securing your growth in any industry, including AI, alternative health, cannabis, healthcare, ketamine clinics, psychedelics, real estate, technology, sports memorabilia, and more.

Do you have questions about emerging industries, navigating your industry’s regulations, or business management? Contact us now, and a member of our team will contact you shortly.

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Horowitz

Ian Horowitz

Of-Counsel
States Licensed: FL

Mr. Horowitz focuses his practice on estate planning, taxation, and business related matters, with advanced proficiency in estate, gift, federal income, and generation-skipping transfer taxation. His extensive knowledge in these areas enables him to craft tailored strategies that optimize tax efficiency and safeguard his clients’ assets. From crafting straightforward wills to designing complex domestic and foreign trusts, his commitment to preserving wealth and ensuring asset protection is unwavering.

In addition to his prowess in estate planning, Mr. Horowitz serves as a trusted advisor to businesses of all sizes from formation to sale assisting with drafting purchase and sale agreements, limited liability operating agreements, or other corporate documents. His counsel on entity formation and tax-efficient structures empowers entrepreneurs and corporations to make informed decisions that drive growth and prosperity.

Mr. Horowitz possesses a wealth of experience in international tax matters. He offers invaluable guidance to foreign clients navigating inbound business and real estate transactions in the United States. He is also recognized for his efficiency in helping individuals become bona fide residents of Puerto Rico under IRC Section 937. This specialized knowledge in tax strategies related to Puerto Rico’s unique tax laws positions him as a sought-after advisor for those seeking to take advantage of the favorable tax incentives offered by Puerto Rico.

Aggeliki Psonis

Associate
States Licensed: NY, NJ. MA

A graduate of Boston University, with a JD from CUNY law school, Aggeliki focuses her practice on real estate transactions, estate planning and administration, business law and general litigation. She has extensive experience representing buyers, sellers, investors and business owners based in New York and internationally.

Aggeliki is admitted in the states of New York, New Jersey and Massachusetts, as well as in the Eastern and Southern Districts of New York. She is also a licensed Real Estate broker. She is a proud member of the Inspiring Women in Law League (IWILL) and the Hellenic Lawyers Association. She speaks fluent Greek and conversational French and Spanish. Aside from lawyering, she enjoys being a radio producer and performing artist.

Dallas Robinson, Of-Counsel

Dallas Robinson

Of-Counsel
States Licensed: FL

 

Dallas Robinson is an AV Preeminent-rated trial attorney who has dedicated his practice to representing injured people throughout Florida. Dallas has litigated and tried many different types of personal injury cases in numerous courthouses and venues in Florida. Dallas believes in prosecuting personal injury cases in a professional and aggressive manner, and has a clear track record of success in obtaining great financial compensation for his clients either through verdicts or settlements. Many lawyers advertise ‘trial experience,’ but have actually never seen the inside of a courtroom. Dallas has spent his entire career in the courtroom and litigating cases. This gives Dallas the real and true experience that it takes to strike fear in the hearts of insurance companies and obtain top financial compensation for his injured clients.

 

Dallas grew up in South Florida and attended Boston University where he played quarterback and defensive back for Boston University’s football team. Dallas graduated in 4 years with bachelor degrees in Classical Civilizations and History. He went straight to law school and attended University of Miami (FL) School of Law. Dallas graduated in 2002 with a Juris Doctorate degree and immediately passed the Florida Bar.

 

Dallas began his legal career representing businesses and insurance companies in workers’ compensation and personal injury cases. This gave him unique insight into exactly how insurance companies work and how they value cases. After achieving a high level of success in litigating these cases, Dallas moved on to representing the injured. Since that time, Dallas has obtained tens of millions of dollars in compensation for his clients through settlements and trial verdicts. Dallas is a member of the Multi-Million Dollar Advocates Forum which is an association of attorneys who have won seven-figure verdicts and settlements on behalf of their clients. This group is one of the most prestigious organizations for trial lawyers in the United States as fewer than 1% of U.S. lawyers have qualified as members.

 

In addition to great results for his clients, Dallas has also gained the respect of his peers for his ethics, ability, and professionalism. Dallas has received the highest level of distinction of an AV ® rated attorney by Martindale-Hubbell, which recognizes Dallas as possessing “Very High-Preeminent” legal ability with “Very High” ethical standards.

Yisroel Szpigiel, Of-Counsel

Yisroel Szpigiel

Of-Counsel States Licensed: NY, NJ  

Yisroel Szpigiel is a corporate and transactional attorney with almost a decade of operating as managing Partner in a New York based general practice. He assists clients through every stage of the business life cycle, from startup and formation all the way to exit, and everything in between. Yisroel has handled numerous multi-million dollar transactions, fundings, and has achieved significant litigation results for his clients. Yisroel is a problem solver, dedicated to figuring out the best options for his clients, and representing them fiercely to ensure they are protected.

Yisroel is licensed in both New York and New Jersey as an attorney. In addition to working with LumaLex Law, Yisroel has his own law firm, Szpigiel Law PC, where he continues to serve as outside general counsel for various businesses in a wide range of industries. He is also an active member of his community, and has received Citations and awards from community leaders.

Yisroel attended Rutgers University as an undergrad, and Hofstra University for law school, where he later returned as an adjunct professor. When he isn’t at the office, Yisroel loves to golf, play pickleball, and travel with his wife and 3 beautiful children.

Tom Dean | Of-Counsel

Tom Dean

Of-Counsel 
States Licensed: AZ

 

Tom Dean has been an attorney advocate for nationwide cannabis policy reform for over 25 years. As Legal Director for the National Organization for the Reform of Marijuana Laws (NORML) he initiated, managed, and litigated important cannabis related cases of national importance to the cannabis industry/community. In that capacity, he also coordinated the efforts of the NORML Legal Committee (lifetime member) and NORML Amicus Committee (former chair) in key cases throughout the U.S.  In 2015 the organization recognized his successful advocacy by inducting him into the NORML Distinguished Counsel’s Circle. He remains an active member of the NORML Legal Committee.

In 2016, Tom received the President’s Commendation award from the Arizona Attorneys for Criminal Justice (AACJ). In 2020, Tom received a Lifetime Achievement Award from the Errl Cup, a medical marijuana event producer which includes Arizona’s premier cannabis awards festival (30,000 attendees this year).

In 2021, Tom received Mikel Weiser Lifetime Achievement Award from Arizona’s Marijuana Industry Trade Association (MITA). Most recently, in 2023, Tom was honored by NORML with its Al Horn Award, which the organization awards to an attorney each year to in “recognition of a lifetime of ceaseless work to advance the cause of justice” in cannabis law.

Tom was a founding member of the Arizona Cannabis Bar Association (ACBA), an organization that seeks to educate lawyers and the public of the many unique aspects of cannabis law and emerging cannabis related areas of practice. He continues to serve on the board of ACBA. Outside of his practice, Tom enjoys, among other things, presenting at cannabis related seminars and conferences for lawyers and the public.

Josh Sanderlin | Of Counsel

Joshua Sanderlin

Of Counsel
States Licensed: MD, D.C.

Joshua Sanderlin is an experienced cannabis attorney and government affairs expert barred in Maryland and the District of Columbia. He has worked in the cannabis industry since 2013. At that time, he was an attorney and lobbyist at a large, global law firm. His experience working with clients in the earliest legal cannabis market in the U.S. sparked his interest in the field and motivated him to leave big law for the world of cannabis.

Since then, he has served as a lawyer and consultant to clients working in markets across the country, including seven states and the District of Columbia. His experience has given him a wide breadth of knowledge on issues touching the industry and, just as importantly, expanded his network to include experts from all across the industry. Having worked on cannabis issues in a variety of settings, Joshua understands that the industry is best served by specialized services.

Edgar J. Asebey | Of Counsel

Edgar J. Asebey

Of Counsel
States Licensed: FL, D.C.

 

Edgar J. Asebey is a regulatory and transactional attorney with over two decades of experience in federal regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement and cosmetics companies. Since 2015, he has been working on Cannabis-related matters and transactions and since 2018 he has provide regulatory compliance, business transactional, venture finance and international trade services to hemp/CBD companies. Edgar brings a wealth of knowledge and over 20 years of experience to life science, Cannabis and hemp/CBD clients who require novel solutions to complex issues.

Edgar practices before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Customs and Border Protection (CBP), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC), representing client companies on regulatory compliance, product approval/registration and FDA enforcement defense matters. He also assists clients with international and domestic business transactions, IP licensing, venture finance, trademark protection and import/export matters.

Edgar studied molecular biology at the University of Chicago and spent 5 years working in molecular biology research laboratories at the University of Chicago and the University of Illinois.  Early in his career he served as a Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute at the National Institutes of Health (NIH).  He founded and served as president of Andes Pharmaceuticals, Inc., a natural products drug discovery company, from 1994 to 2000 and has served as in-house counsel to two life sciences companies. Most recently he was an equity partner in the Health Care & Life Sciences Practice Group at Jones Day. Edgar is currently a partner at Keller Asebey Life Science Law, PLLC.

While Edgar holds licenses to practice law in Florida and Washington, D.C. he can represent clients on federal regulatory matters in all 50 states.  He is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.

Dan Miller Head-Shot | Of-Counsel

Dan Miller

Of-Counsel
States Licensed: CA

Dan Miller, Esq., with over 15 years of experience in cannabis law and a growing expertise in psychedelics, is a staunch advocate for honoring both traditional and evolving regulated uses of these substances. A Vermont Law School alumnus (Class of 1998), he holds a J.D. and a Master’s in Environmental Law and Policy.

Before his foray into the world of entheogenic medicines, Dan honed his skills as a trial attorney with a focus on both criminal and civil cases. His passion for and in-depth understanding of cannabis and psychedelic substances redirected his career path, leading him to develop a niche practice area that has since become his hallmark.

Dan’s role in the cannabis industry is not just as a lawyer, but as a partner in his clients’ endeavors. He oversees all aspects of business development, from structural planning and licensing to adapting to dynamic legal landscapes. His strategic insights have been key in securing licenses, operational planning, and facilitating interstate business growth.

Dan continues to serve as outside general counsel for various businesses, leveraging his litigation background to offer comprehensive legal advice.

As the legal landscape continues to evolve, Dan Miller remains a steadfast and knowledgeable advocate, committed to bridging the gap between traditional use and modern regulatory frameworks in the world of cannabis and psychedelics.

States Licensed: CA

Christina Jaramillo | Junior Associate

Christina Jaramillo

Junior Associate
States Licensed: FL, CA

Christina Jaramillo is an Associate Attorney at Mr. Cannabis Law and an active member of The Florida Bar. Christina’s primary focus has been in the practice area of business transactions. Christina has legal experience drafting and reviewing various sales and services agreements, completing entity filings and EIN applications, drafting corporate governance documents and business plans, preparing franchise disclosure documents, drafting and reviewing commercial and residential lease agreements, assisting with mergers and acquisitions, preparing demand letters, working on estate plans and probate matters, and trademarks. Prior to joining Mr. Cannabis Law, Christina led the estate planning department at The Law For All, P.A.

Christina is the daughter of two Latinx immigrants, the youngest of five siblings, and the first member of her immediate family to graduate from college. In 2017, after just three short years on campus, Christina received her Bachelor of Science in Political Science, magna cum laude, from Florida State University, where she also minored in Economics. Christina received her Juris Doctor, magna cum laude, from the University of Miami School of Law in 2020.

While attending the University of Miami School of Law, Christina received several honors: Christina was nominated to serve as one of two Articles & Comments Editors for the University of Miami International and Comparative Law Review; Christina was a recipient of the Dean’s Certificate of Achievement Award, which is awarded to the top one or two students in the course, in Legal Communications & Research II; and Christina made the Dean’s List twice.

During her time in law school, Christina served as a Fellow and Blog Editor for the Professional Responsibility and Ethics Program (PREP), an intern for the Human Rights Clinic, and a Civil Procedure Dean’s Fellow. Christina was active on campus and engaged in her community because she understood the value in connecting with those around her and serving the needs of her community, which remains true today.

In her free time, Christina can be found at her local comic book shop or vegan bakery. Christina loves to read, stay up to date on popular television shows and movies, watch soccer, and occasionally jog.

Andy Sick | Partner

Andy Sick

Partner
States Licensed: NY, NJ, MI, CT

Andy Sick has been advising businesses, startups, and entrepreneurs for nearly 15 years. He assists clients through every stage of the business life cycle from incorporation and initial growth phases, to maturity with ongoing general counsel services including regulatory compliance and critical commercial transactions, and dissolution. Licensed to practice in New York, New Jersey, and Connecticut, Andy is the attorney responsible for the firm’s practice in these states.

At Mr. Cannabis Law, Andy represents various cannabis-related businesses on such matters as corporate structuring, licensing, and financing. He navigates clients through the constantly changing sea of cannabis rules and regulations. Andy handles marijuana license applications, business plans, and operating procedures for dispensaries, cultivators, nurseries, manufacturers, distributors, wholesalers, delivery services, and testing facilities. For the firm’s hemp industry clients, Andy helps obtain hemp licenses and maintain compliance with federal and state regulations. In the psychedelic space, Andy has served as a legal advisor to numerous non-profits, companies, and organizations including such groups as Decriminalize Nature and the Native American Church.

Andy began his legal career at boutique law firms serving as outside general counsel to businesses and representing clients in complex commercial litigation. Whether representing a three-person video game startup or a multinational spent nuclear fuel storage company, Andy worked directly with company presidents and other executives to develop and implement corporate legal strategies. Subsequently, he founded several startups, including a legal technology company that adapted artificial intelligence and virtual reality for use in the law. In addition to working with Mr. Cannabis Law, Andy has his own law firm, Sick Legal, which provides business and commercial transactional services to a range of clients.

During law school, Andy worked at the U.S. Justice Department’s Office of Consumer Litigation, the U.S. Attorney’s Office for the Northern District of New York, and for President Joe Biden when he served on the U.S. Senate Judiciary Committee

Andy is responsible for firm operations in New York, New Jersey, Michigan, and Connecticut 

Amanda Barton | Partner

Amanda Barton

Partner
States Licensed: FL

Amanda Barton is an active member of the Florida Bar and is admitted to practice in all U.S. District Courts and U.S. Bankruptcy Courts within the state of Florida.  Amanda has over ten years of legal experience handling complex corporate matters, with a strong focus on corporate governance, corporate finance, and regulatory compliance.  As someone who loves written language, Amanda excels in drafting and negotiating a vast array of legal documents.

Prior to joining Mr. Cannabis Law, Amanda had unique legal opportunities that have made her a well-versed, seasoned transactional business attorney.  Previously, she led the transactional department at The Law for All, P.A., where she assisted business clients with strategic business structuring, mergers and acquisitions, asset protection, business succession planning, and contract drafting, including companies involved in the cannabis and hemp industry.  She served as senior in-house counsel for an alternative financing company, where she built a legal department that leveraged technology, data analysis, and innovative resolution and recovery strategies.  Amanda also served as in-house counsel to a private investment firm, where she handled all in-house transactions with a concentration in Debtor-in-Possession financing for Chapter 11 debtors, secured lending transactions, fund management, and various aspects of municipal bond financing.

Amanda currently volunteers her time to serve as the President of the Broward County chapter of CannabisLAB, a networking and education group for professionals who are in or are looking to get involved in the cannabis marketplace.

Dustin Robinson | Managing Partner

DUSTIN ROBINSON

Managing Partner
States Licensed: FL

Dustin Robinson is the Founding Partner of LumaLex Law. Robinson is licensed in Florida as an Attorney, a Certified Public Accountant, and a Real Estate Agent. He focuses his practice on providing legal, accounting, financial, and business consultation to various small-to-mid-sized businesses. He also handles complex commercial litigation and has been the lead counsel in several high-profile cases, such as the Shohei Ohtani 50-50 basball litigation.

Robinson has worked at one of the largest national accounting firms – Deloitte – as well as one of the largest national law firms – Holland & Knight. After working at Holland & Knight, Robinson applied his legal and accounting background in the business world while running a multi-state manufacturing company.

In addition to being the Founding Partner of LumaLex Law, Robinson is the founder of (1) Iter Investments – a venture capital fund deploying capital into innovative, alternative solutions for mental health; (2) Nucleus – a venture studio launching digital assets in the mental health space; (3) Mr. Cannabis Law – a consulting firm for the cannabis and psychedelic industries; and (4) Mr. Psychedelic Law – a non-profit focused on medical and spiritual research to drive responsible legal reform for psychedelic medicines and other entheogens. He is also on the Board of Directors for Clairvoyant Therapeutics – a biotech company taking psilocybin for alcohol use disorder through clinical trials.

Robinson is deeply involved in the cannabis industry through his consulting firm – Mr. Cannabis Law – and various cannabis-related organizations, including CannabisLAB, ASTM D-37 Global Standards for Cannabis, Leafstyle360, and Broward County Medical Marijuana Advisory Board. Robinson also serves as the Legal Director for NORML of Palm Beach; he is on the Legal Committee for the Florida Hemp Council; and he is on the Operations Sub-committee for Hemp Industries Association. As a member of the Board of Directors of Minorities for Medical Marijuana, Robinson advocates for social equity and inclusion in the cannabis industry. Robinson also represents various psychedelic non-profits including Mind Army and Ketamine Fund.

Robinson created a monthly panel that takes place at Soho Beach House Miami on the second Tuesday of every month. Moderated by Robinson, each panel features experts in the psychedelics space from CEOs, doctors, lawyers and celebrities. Robinson kicked off the first event of the series in July 2021 with NBA Champion Lamar Odom and “psychedelic concierge to the stars” Michael ‘Zappy’ Zapolin. His panels have included various other celebrities including NHL hockey star Daniel Carcillo and Real Housewives star Adriana De Moura.

Robinson has been regularly profiled and featured as an expert in the media, including in Bloomberg News, INSIDER, Dazed, Forbes, VICE, The Florida Bar, The Miami Herald, The Sun Sentinel, The Wall Street Journal, Authority Magazine, Thrive Global, Benzinga, StratCann and more.

He has led panels and presentations on cannabis and psychedelics at global industry events, including the PsyTech Summit, CBC Chatter by Coldwell Banker Commercial, and CanEx Jamaica Business Conference & Expo.

Robinson is a triple gator having earned his Bachelors in Accounting, Masters in Accounting, and Law Degree from University of Florida.