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ByPro Nutrition LLC was cited for marketing Dodecin as an unapproved new drug and misbranded product based on disease-treatment claims made on the product label and website, including statements that it "address[es] multiple pain and inflammation pathways" and provides "Pain and Inflammation Relief." The FDA determined that claims describing Dodecin's ability to inhibit inflammation, relieve symptoms, and address the causes of chronic pain established the product's intended use as a drug under the Federal Food, Drug, and Cosmetic Act, requiring FDA approval before marketing. The violations were identified following an FDA facility inspection conducted in August 2022 and subsequent review of the company's website in October, November 2022, and March 2023.