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SoloVital was cited for distributing Umary (marketed as a dietary supplement) as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act sections 505(a) and 301(d), and for misbranding under section 502. FDA laboratory analysis of a product sample identified undeclared active pharmaceutical ingredients—diclofenac (an NSAID with cardiovascular and gastrointestinal risks) and omeprazole (a proton pump inhibitor)—creating serious safety hazards including potential drug interactions and masking of underlying medical conditions. The violations were discovered during an FDA website review in June 2024, which identified the product being offered for sale in interstate commerce without required approval or proper labeling of active ingredients.