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Mountain Peak Nutritionals was cited for marketing its Mood Support product as a drug without FDA approval by making disease treatment claims on its website and technical data sheet, including claims that the product treats depression and anxiety and has effectiveness comparable to prescription antidepressants like Prozac and Zoloft. The company violated the Federal Food, Drug, and Cosmetic Act by introducing the product into interstate commerce through its website while making explicit claims that it mitigates, treats, and prevents disease, thereby establishing the product's drug status under FDA regulations. The product's marketing materials specifically claimed the formula addresses depression through brain chemistry modification and included comparative efficacy claims against FDA-approved pharmaceutical drugs.