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LIV Health LLC (INFINIWELL) and DEAL Media L.L.C. (HARMONIA) were cited for marketing unapproved drugs through their websites, including products such as Thyroid Support, DHH-B, Balance, Clarity, Twilight, and Meditate. The companies made disease claims that established these products as drugs under federal law—specifically claiming Thyroid Support "relieves all symptoms related to an under-active thyroid" and DHH-B has "anxiolytic effects" comparable to benzodiazepines—without obtaining FDA approval as new drugs. By taking orders for these products with therapeutic claims, the companies violated the Federal Food, Drug, and Cosmetic Act by introducing misbranded and unapproved drugs into interstate commerce.