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Unived Inc was cited for marketing four dietary supplement products (Colox, CalDveg, B12+D3, and D3+K2-7) as unapproved new drugs through their website and Amazon product pages. The FDA determined the products violated the Federal Food, Drug, and Cosmetic Act because marketing claims—such as that Colox "blocks COX-2 and 5-LOX pathways" to reduce pain and inflammation, and that CalDveg's ingredient "increases bone mineral density and reduces fractures"—established the products were intended for use in treating or preventing disease, thereby making them drugs requiring FDA approval. The company failed to comply with drug approval requirements by introducing and delivering these misbranded products into interstate commerce without proper regulatory authorization.