FDA WARNING_LETTER - Dynamic Stem Cell Therapy - February 11, 2026

The FDA issued a Warning Letter to Dynamic Stem Cell Therapy on February 11, 2026, following a review of their website, which markets an umbilical cord-derived stem cell product. The agency found significant violations, primarily concerning the misbranding and unapproved status of this biological product. The company markets its product with claims for treating various conditions such as sports injuries (e.g., ligament tears, rotator cuff tears), anti-aging, knee pain, and arthritis. The FDA determined that, based on these claims, the product functions as both an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and an unlicensed biological product under the Public Health Service Act (PHS Act). Crucially, the umbilical cord-derived product fails to meet the regulatory criteria for human cell, tissue, or cellular or tissue-based products (HCT/Ps). Specifically, it is not minimally manipulated, as its processing into an injectable form significantly alters its original physical characteristics. Furthermore, it is not intended for homologous use, as treating cardiovascular disease or arthritis is not a natural function of the umbilical cord in a donor. Consequently, it requires premarket review and approval, which it lacks. The product is also misbranded because it does not bear adequate directions for use, being a prescription drug. The FDA also noted concern over the company"s marketing of exosomes without appropriate approval. Dynamic Stem Cell Therapy must respond within fifteen working days, outlining concrete steps to correct these violations and prevent their recurrence, ensuring full compliance with federal regulations.