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Osmosis, LLC was cited for marketing three unapproved drug products—Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate—in violation of the Federal Food, Drug, and Cosmetic Act. The products made disease claims on their labels and website, including statements that they "detoxify eczema, psoriasis, and inflamed skin" and "balance digestive causes of rosacea," which caused them to be regulated as drugs rather than cosmetics. Because these products lacked FDA approval as new drugs and were misbranded without appropriate drug labeling, their introduction into interstate commerce violated federal law. The violations were identified during an FDA inspection of the company's Colorado manufacturing facility in January 2023 and confirmed through subsequent review of product labels and the company's website in June 2023.