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Dynamic Stem Cell Therapy was cited for misbranding and marketing an unapproved umbilical cord-derived stem cell product as a drug without FDA licensure or approval. The company made therapeutic claims on its website that their stem cell product could treat sports injuries, cardiovascular disease, arthritis, and provide anti-aging benefits, thereby establishing it as a drug intended to diagnose, cure, mitigate, treat, or prevent disease in humans. These marketing claims violated Section 301(k) of the Federal Food, Drug, and Cosmetic Act by promoting an unlicensed biological product for uses that required FDA approval before distribution in interstate commerce.