Tennessee’s New Regenerative Medicine Law: What Patients Should Know About HB 2246

Regenerative medicine has attracted significant attention in recent years, but it has also created plenty of confusion.

Patients may hear terms such as stem cells, Wharton’s jelly, exosomes, biologics, cellular therapy, or regenerative injections used interchangeably. They may also encounter very different claims about what these therapies can do, whether they are FDA-approved, and whether they can legally be offered.

Tennessee recently took an important step toward creating a clearer state framework.

In May 2026, Governor Bill Lee signed House Bill 2246, which became Public Chapter 1016. The Tennessee General Assembly lists effective dates of May 19 and July 1, 2026. The law authorizes Tennessee physicians, under specified conditions, to perform certain stem cell and regenerative medicine therapies that have not been approved by the U.S. Food and Drug Administration when the treatment or procedure falls within the physician’s scope of practice.

That is a meaningful change, but it is also one that deserves careful explanation.

HB 2246 does not mean every product marketed as “regenerative medicine” is now approved, proven, or appropriate for every patient. It also does not replace federal regulation by the FDA. Here is what Tennessee patients should know.

What Does Tennessee HB 2246 Actually Do?

The central provision of HB 2246 allows a Tennessee physician to perform certain stem cell or regenerative medicine therapies that have not received FDA approval, provided the therapy is used for a treatment or procedure that falls within that physician’s professional scope of practice.

The legislation passed with overwhelming bipartisan support. The Tennessee House approved the amended bill 92–0, and the Senate approved it 31–0 before it was signed by the governor.

But the law does much more than simply authorize treatment.

It establishes requirements concerning:

• who may provide these therapies;
• where products may be obtained;
• manufacturing and testing documentation;
• informed patient consent;
• advertising disclosures;
• adverse-event reporting; and
• oversight by Tennessee medical licensing boards.

Those safeguards are an important part of understanding the law.

The Law Is Physician-Directed

One of the most significant aspects of HB 2246 is that it places these therapies within a physician-directed medical framework.

The law refers specifically to physicians practicing within their professional scope. This matters because regenerative medicine should not be approached as a standalone product that a patient simply chooses from a menu.

A responsible medical approach begins with evaluation.

Before recommending any procedure, the provider should understand the patient's diagnosis, health history, current symptoms, previous treatment, medications, imaging when appropriate, and overall treatment goals.

The question should not simply be: “Can we perform a regenerative medicine procedure?”

The more important question is: “Is this medically appropriate for this particular patient?”

That distinction is central to how we believe regenerative medicine should be approached.

HB 2246 Establishes Product and Manufacturing Standards

Another important part of the legislation concerns the products themselves.

HB 2246 establishes specific requirements for human cellular and tissue-based products used under the law.

Depending on the type of therapy, manufacturers and facilities may need to provide documentation related to product testing, sterility, cell viability, manufacturing procedures, and facility registration or accreditation.

For products classified as regenerative medicine therapy under the Tennessee statute, requirements include a lot-specific sterility report and certificate of analysis before the product is used on a patient.

The legislation also specifically addresses documentation for different types of products. For example, it references cell viability and surface-marker reporting for cellular products, viscosity reporting for Wharton’s jelly products, and particle counts for exosome-based regenerative products.

Why does this matter to patients?

Because “regenerative medicine” is a broad term. Two products marketed using similar language may differ considerably in sourcing, processing, testing, composition, and documentation.

Patients should feel comfortable asking a provider what is being administered, where it came from, and what documentation exists for that specific product.

Does This Mean These Treatments Are FDA-Approved?

No.

This is probably the single most important distinction for Tennessee patients to understand.

Tennessee authorization and FDA approval are not the same thing.

HB 2246 specifically addresses therapies that may not yet be approved by the FDA. The law creates a Tennessee framework under which qualifying physicians can perform certain therapies subject to the statute's requirements.

It does not convert an unapproved product into an FDA-approved product.

The FDA continues to regulate human cells, tissues, biological products, drugs, and regenerative medicine products under federal law. The agency has specifically addressed products involving stem cells, Wharton’s jelly, umbilical-cord-derived materials, and exosomes.

That is why patients should be cautious when they hear claims such as:

“FDA registered.”

“Made in an FDA-registered facility.”

“FDA compliant.”

“Allowed under Tennessee law.”

None of those statements necessarily means that the therapy itself has been FDA-approved for the condition being treated. They describe different regulatory concepts.

Tennessee Requires Patients to Be Told That

HB 2246 does not allow this distinction to be hidden in fine print. The law requires physicians advertising therapies covered by the statute to provide a specific disclosure informing patients that one or more stem cell or regenerative medicine therapies performed by the physician have not yet been approved by the FDA. It also encourages patients to consult with their primary care provider before undergoing treatment. Importantly, the statute requires that disclosure to be clearly legible and displayed in a type size no smaller than the largest type size used in the advertisement.

That requirement reflects one of the broader themes of the law: patients should understand the regulatory status of a therapy before making a decision.

Written Informed Consent Is Required

The law also requires written patient consent before qualifying stem cell or regenerative medicine therapy is performed. Informed consent should be more than obtaining a signature.

A meaningful medical discussion should help the patient understand:

• what treatment is being proposed;
• why it is being considered;
• the potential benefits;
• known and potential risks;
• realistic expectations;
• the regulatory status of the therapy;
• reasonable alternatives; and
• what may happen if the patient chooses not to proceed.

Regenerative medicine is an evolving field. Good medical decision-making requires acknowledging both its potential and its limitations.

The Law Also Requires Adverse-Event Reporting

Tennessee’s new framework does not end when the procedure is completed. HB 2246 requires physicians performing qualifying therapies to report associated adverse events to the physician's licensing authority. For allogeneic stem cell or regenerative medicine therapies, additional reporting to the manufacturer and an accrediting organization is required within 30 days. The statute broadly defines an adverse event to include an untoward medical occurrence associated with therapy, whether or not the event is ultimately determined to have been caused by the therapy. Examples identified in the legislation include infection, allergic reaction, disease transmission, and unanticipated clinical outcomes. The law also encourages physicians to participate in clinical outcomes registries for safety monitoring, quality improvement, and development of evidence-based practice. That emphasis on outcomes is important. As regenerative medicine continues to develop, responsible medicine should involve not only offering new options but also tracking what happens afterward.

What HB 2246 Does Not Mean

Because headlines about new medical laws can easily create confusion, it helps to be equally clear about what Tennessee’s new law does not establish.

It does not mean every regenerative medicine product is FDA-approved.

Many are not.

It does not guarantee that a therapy will work.

Individual results can vary considerably, and no medical treatment should be represented as a guaranteed outcome.

It does not mean regenerative medicine is appropriate for every patient.

Diagnosis, health history, the severity and nature of a condition, previous treatment, and other clinical considerations matter.

It does not eliminate federal regulation.

FDA authority and Tennessee medical practice law are separate regulatory issues.

It does not make every clinic or every product equivalent.

Product sourcing, medical oversight, documentation, patient selection, technique, follow-up care, and clinical judgment all matter.

That is why choosing a provider should involve more than comparing prices or responding to an advertisement.

Questions to Ask Before Receiving Regenerative Medicine Therapy in Tennessee

Patients considering regenerative medicine now have an opportunity to ask better questions. Before undergoing treatment, consider asking:

Who is evaluating me and determining whether I am an appropriate candidate?

A therapy should be based on a medical evaluation rather than simply a patient's willingness to purchase it.

What exactly is the product being used?

“Regenerative medicine” by itself does not tell you what is being administered.

Where does the product come from?

Ask about the manufacturer, source, processing, and applicable facility registration or accreditation.

Is there a certificate of analysis and lot-specific sterility documentation?

These are among the safeguards specifically addressed in Tennessee's new framework for certain regenerative medicine products.

Is this therapy FDA-approved for my condition?

This deserves a direct answer.

What evidence supports its use for my particular condition?

Evidence can vary significantly depending on the product, procedure, and diagnosis.

What are the alternatives?

A good treatment discussion should include established conservative care, medication, rehabilitation, injections, surgical evaluation when appropriate, or simply continued observation depending on the condition.

What happens after treatment?

Ask how outcomes are monitored, what follow-up is provided, and what to do if you experience an unexpected reaction.

Why an Integrated Medical Approach Matters

One of the challenges with regenerative medicine is the temptation to view it as a solution in isolation.

But musculoskeletal problems rarely exist in isolation.

Knee pain, for example, may be related to osteoarthritis, a meniscal injury, ligament damage, biomechanical changes, muscle weakness, referred pain, or several contributing factors at once.

Back pain can arise from discs, joints, nerves, muscles, spinal stenosis, movement patterns, previous injuries, or combinations of these problems.

That means the quality of the diagnosis and treatment plan matters just as much as the procedure being considered.

At True Wellness Integrated Medicine, we believe emerging treatment options should be considered within a broader medical picture. The goal is not to recommend the newest therapy simply because it is available. The goal is to understand the patient, identify the problem as accurately as possible, and determine which combination of care makes sense.

Sometimes that may involve a procedure.

Sometimes another treatment may be more appropriate.

Sometimes the right answer is that a patient is not a good candidate.

That is what physician-guided care should look like.

A New Chapter for Regenerative Medicine in Tennessee

Tennessee HB 2246 is an important development.

It creates a defined state framework for physicians performing certain stem cell and regenerative medicine therapies while establishing requirements around product sourcing, documentation, disclosure, consent, and adverse-event reporting.

It also gives patients another reason to become informed healthcare consumers.

The passage of a new law should not lower the bar for asking questions.

It should raise it.

As regenerative medicine continues to evolve, patients deserve clear information about what is known, what remains uncertain, what is FDA-approved, what Tennessee law permits, and how a treatment fits into their individual healthcare plan.

True Wellness Integrated Medicine will continue following developments in Tennessee regenerative medicine and helping patients understand their options as this area of medicine evolves.

Considering Regenerative Medicine in Chattanooga?

If you are exploring treatment for persistent joint, spine, or musculoskeletal concerns, the first step should be understanding the source of the problem and the options available to you.

Schedule a consultation with the medical team at True Wellness Integrated Medicine in Chattanooga to discuss your condition, previous treatment, and which approaches may be appropriate for your individual needs.

This article is provided for general educational purposes and is not intended as legal advice or a guarantee that any particular treatment is appropriate for an individual patient.

THIS NOTICE MUST BE PROVIDED TO YOU UNDER TENNESSEE LAW. This physician performs one (1) or more stem cell or regenerative medicine 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 or regenerative medicine therapy.