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Clarke Pharmaceutical Manufacturing, Inc. was cited for manufacturing and selling unapproved new drugs and misbranded products, including OsteoBLAST®, Cell Block #19, High Potency Vitamin D3, Neupanex®, and Natural Progesterone Skin Cream, through their website and YouTube channel without FDA approval. The company made disease claims for these products—such as reducing osteoporosis risk, treating osteoarthritis, and mitigating COVID-19—that established them as drugs under federal law, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were intended to cure, mitigate, treat, or prevent disease and/or affect body structure or function, yet were being distributed into interstate commerce without required drug approvals or proper authorization.