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Essential Elements was cited for marketing CholestAid as a drug without FDA approval by making disease claims on their website and Amazon storefront, including statements that the product "helps reduce LDL levels," "helps you keep cholesterol levels under control," and "help reduce blood pressure." These claims violated the Federal Food, Drug, and Cosmetic Act by establishing the product's intended use for the cure, mitigation, treatment, or prevention of disease, thereby rendering it an unapproved new drug and misbranded product. The FDA identified the violations through a website review conducted in August 2022, during which the agency found that consumers could order CholestAid directly through the company's website and Amazon storefront.