Clinics in Chattanooga, Tennessee

Tennessee cellular therapy is governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in Tennessee for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. Tennessee enacted a state-level investigational regenerative medicine framework in 2017 that does not override federal law.

• Tennessee Regenerative Medicine Act, Tennessee Code Annotated Section 63-6-244 (2017)
  Authorizes Tennessee physicians to provide investigational regenerative therapies under defined conditions while disclaiming any conflict with federal law and requiring informed consent.
• Tennessee Medical Practice Act, TCA Title 63, Chapter 6
  Establishes physician licensure and discipline through the Tennessee Board of Medical Examiners.
• Tennessee Pharmacy Practice Act, TCA Title 63, Chapter 10
  Regulates compounding pharmacies aligned with federal 503A and 503B standards.

The FDA has issued warning letters to Tennessee clinics offering stem cell and exosome therapies. The Tennessee Board of Medical Examiners has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Tennessee Attorney General has used the Tennessee Consumer Protection Act to pursue providers making unsupported clinical claims. The Tennessee Regenerative Medicine Act explicitly does not preempt federal regulation, so Tennessee providers cannot rely on the state framework as a defense to FDA enforcement.