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Biorica International Corp. was cited for marketing Plaquex® as a drug without FDA approval by making disease claims on their websites, including statements that the product treats high cholesterol, triglycerides, and liver function issues, thereby violating the Federal Food, Drug, and Cosmetic Act. The company's websites across multiple platforms (plaquex.com, biorica.biz, and Facebook pages) established the product's intended use for cure, mitigation, treatment, or prevention of disease, which classifies it as a drug requiring premarket approval rather than a dietary supplement. The violations centered on unapproved drug marketing and misbranding, as the product lacked the necessary FDA authorization for the therapeutic claims being made to consumers.