Clinics in Irvine, California

California cellular therapy providers are subject to 21 CFR Part 1271. Minimally manipulated human cells, tissues, and cellular and tissue-based products used for homologous use are regulated under Section 361 without premarket approval. Products that are more than minimally manipulated, used non-homologously, or combined with a drug or device are regulated as biologics under Section 351 and require an IND for clinical use or a BLA for marketing. Adipose-derived stromal vascular fraction, culture-expanded mesenchymal stem cells, and exosomes used for orthopedic, cosmetic, neurologic, and longevity indications are generally Section 351 products.

• California Senate Bill 1004 (2017, Health and Safety Code Section 1644.5)
  Requires providers of non-FDA-approved stem cell therapies to post a notice to patients disclosing that the treatment has not been approved by the FDA.
• California Proposition 71 (2004) and Proposition 14 (2020), California Institute for Regenerative Medicine
  Established and refunded CIRM to fund regenerative medicine research under strict scientific and ethical oversight.
• California Business and Professions Code Section 651
  Prohibits false, misleading, or deceptive medical advertising, regularly cited in disciplinary actions against stem cell marketing.
• California Business and Professions Code Section 2052 (Medical Practice Act)
  Governs physician licensure and prohibits unlicensed practice of medicine, including unauthorized administration of biologic injections.

California has been a focal point of federal enforcement. In United States v California Stem Cell Treatment Center (2022), the Ninth Circuit upheld FDA authority to regulate stromal vascular fraction as a Section 351 drug, resulting in a permanent injunction against the clinic. The FDA has issued multiple warning letters to California providers marketing stem cell and exosome therapies. The Medical Board of California has disciplined physicians for false advertising under BPC 651 and for administering unapproved biologics. The California Department of Public Health enforces tissue bank licensing. Class-action consumer suits against regenerative clinics have produced settlements.