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BergaMet North America LLC was cited for marketing Cholesterol Command as a drug without FDA approval by making disease claims on their website, social media, and Walmart product listings, including statements that the product is "clinically proven to improve cholesterol levels" and reduces LDL. The company violated the Federal Food, Drug, and Cosmetic Act by establishing through their marketing claims that the product was intended to treat, prevent, or mitigate diseases such as high cholesterol, diabetes, heart disease, and inflammation, thereby requiring it to be approved as a new drug before distribution. Additional violations included unsubstantiated ingredient claims linking magnesium and zinc to disease treatment and a money-back guarantee specifically tied to LDL level improvement.